前上市公司董事在過去3年內無菲利普·法克華非執行董事的經驗和專業知識法克華先生在公司戰略、財務和業務發展方面擁有超過35年的經驗,涉及多個行業,包括醫療保健。自2018年以來,FacChina先生一直擔任SurgCenter的首席戰略官,負責公司的戰略關係,包括與廣泛的美國門診外科中心(ASC)市場及其成員的關係。在加入SurgCenter之前,FacChina先生在公共和私人資本市場工作了20年,在那裡他直接管理股權和債務的公共和私人資本交易,領導並購和包括私有化在內的特殊諮詢流程。2008至2017年間,FacChina先生擔任機構投資管理公司Ramsey Asset Management的合夥人、聯合投資組合經理兼首席運營官,1998至2008年間,FacChina先生領導FBR Capital Markets的技術、媒體、通信和醫療保健投資銀行部門。FacChina先生目前是Vion Corporation和MilltechFX的獨立董事顧問,也是Johanna Foods Inc.首席執行官的顧問,並擔任該公司審計委員會的主席。此前,在其他董事和委員會職位中,FacChina先生曾在Web.com(納斯達克代碼:WEB)董事會任職,領導公司治理。其他上市公司現任董事職位過去3年內無上市公司董事職位董事會非執行董事菲利普·克勞斯博士擁有超過30年在食品和藥物管理局的經驗和專業知識,擁有獨特的科學、監管、臨床和公共衛生經驗。他是一名擁有內科和傳染病委員會認證的內科醫生,也是一名研究人員,發表了100多篇論文,主題涵蓋疫苗的臨床評估、病毒發病機制和免疫學以及生物製品開發。他目前是一名獨立顧問,提供與生物製品開發相關的戰略和監管建議。他最近擔任FDA疫苗研究和審查辦公室的副董事,在那裡他領導了對生物製品的評估和許可,並幫助監督了2011-2021年美國授權和許可的所有疫苗的開發和評估。他畢業於耶魯醫學院(MD)、佛羅裡達州立大學(MBA)和伊利諾伊大學(電腦科學學士和碩士)。克勞斯博士在中胚層擔任戰略諮詢顧問,提供監管戰略方面的建議。其他現任上市公司董事職位過去3年內無任何上市公司董事職位BCom非執行董事Michael Sponer於2023年9月26日辭職Sponer先生於2004年至2023年9月在董事會任職的經驗及專業知識。在此期間,他曾擔任多個職位,包括自2004年澳交所上市之日起至2007年擔任主席、審計及風險委員會主席及薪酬委員會成員。在過去的幾年裡,斯普納先生以不同的身分在幾家澳大利亞和國際生物技術公司的董事會任職,包括目錄93
BiVACOR有限公司(2009-2013)、先進外科設計與製造有限公司(2010-2011)、Peplin,Inc.(2004-2009)、夏威夷生物技術公司(2010-2012)、亨特免疫有限公司(2007-2008)和Ventracor Limited(2001-2003)。他自2016年5月以來一直擔任Simavita Ltd的董事長,自2018年2月以來一直擔任MicrofluidX的董事長。在2001年回到澳大利亞之前,他職業生涯的大部分時間都在國際上度過,在那裡他擔任過各種職務,包括英國管理諮詢公司PA Consulting Group的合夥人,以及香港普華永道(Coopers&Lybrand)諮詢服務的主要合夥人和董事。此外,斯普納先生還擁有和經營過幾家提供服務的國際公司,並曾為多家美國和亞洲的上市公司提供諮詢。其他現任上市上市公司董事職位過去3年內曾擔任上市上市公司董事Simavita Ltd(2016-2021年)公司祕書Niva Sivakumar-BCom,LLB聯合公司祕書經驗和專業知識Sivakumar女士於2014年加入Mesoblast法律團隊,是公司知識產權委員會成員。在此之前,她是主要律師事務所德頓律師事務所企業和商業團隊的高級助理,以及K&L蓋茨律師事務所的高級律師。Sivakumar女士擁有墨爾本大學的商業/法律學位。其他現任上市公司董事職位過去3年內無上市公司董事職位BBus(銀行與金融)聯合公司祕書經驗及專業知識Hughes先生於2019年2月開始在Mesoblast工作,並自2020年12月起擔任本公司全球企業傳訊主管。他擁有廣泛的投資銀行家和企業顧問背景,曾為麥格理銀行和澳大利亞聯盟銀行等公司擔任顧問。休斯先生擁有墨爾本莫納什大學的藥學學士學位和商業(銀行與金融)學士學位。現任上市公司董事無上市公司過去3年內無上市公司董事職務無高級管理層關鍵管理人員Silviu Itescu,MBBS(榮譽),FRACP,FACP,FACRA董事會首席執行官(首席執行官)經驗和專業知識伊泰斯庫博士自2004年公司成立以來一直在董事會任職,從2007年起擔任董事首席執行官,並於2011年成為董事首席執行官兼總經理。在2004年創立Mesoblast之前,Itescu博士在幹細胞生物學、自身免疫性疾病、器官移植和心力衰竭等領域建立了國際聲譽的內科科學家。伊特斯庫博士是哥倫比亞大學新目錄表94版的教員
約克大學、澳大利亞墨爾本大學和莫納什大學。2013年,伊特斯庫博士獲得了梵蒂岡教皇文化委員會頒發的首屆關鍵創新者獎,以表彰他在成人幹細胞治療方面的翻譯科學和臨床醫學方面的領導地位。2011年,伊特斯庫博士被評為生物光譜亞洲年度人物。伊特斯庫博士曾為多家國際製藥公司提供諮詢,曾擔任生物技術和醫療保健投資團體的顧問,並曾在幾家上市生命科學公司的董事會任職。上市公司的其他現任董事職位過去3年內沒有任何上市公司的董事職位董事會執行成員、MD首席醫療官(CMO)Eric Rose的經驗和專業知識Rose博士是一位備受尊敬的內科科學家,專注於臨床研究、藥物發現、生物防禦和健康政策。作為世界知名的心臟外科醫生和科學家,羅斯博士從1982年到1992年領導了哥倫比亞長老會心臟移植計劃,並在1984年創造了歷史,他成功地進行了第一例兒科心臟移植手術。從1994年到2007年,他擔任哥倫比亞大學外科主任和紐約哥倫比亞長老會醫學中心的主任醫師。在此期間,他領導了NIH支持的心力衰竭機械迴圈支持隨機評估專案(REMATCH),導致FDA第一次批准了一種用於長期迴圈支持的植入式左心輔助裝置,催生了一個全新的行業。2007年至2011年,羅斯博士在國家生物防禦科學委員會任職,該委員會就生物防禦、流感和新出現的疾病向美國衛生和公共服務部部長提供建議。2007年,他被任命為SIGA Technologies的董事長兼首席執行官,在那裡他監督了美國批准的第一種用於治療天花的抗痘病毒藥物TPOXX的開發。Rose博士在2019年獲得FDA批准該藥物的過程中發揮了關鍵作用,他負責獲得與BARDA的合同,根據合同,美國政府已以超過10美元的億採購了170萬療程的TPOXX,進入國家戰略儲備(SN)。羅斯博士在ABIOMED董事會的任期於2022年12月結束,當時公司以177億美元的億價格賣給了強生。其他現任上市公司董事職務最近3年內無上市公司董事職務西嘉科技股份有限公司董事長(2017年至2021年)董事非執行董事由強生收購。(2007-2012年、2014-2022年)其他高級管理層安德魯·查蓬內爾先生,BCom,CAANZ首席財務官(臨時)Chaponnel先生擁有約25年的財務工作經驗,其中包括在Mesoblast工作13年,最初擔任集團財務總監(6年),然後擔任財務主管(3年),現在擔任臨時首席財務官(過去三年)。作為中原集團財務領導的一部分,他一直是我們借款安排、各種戰略合作夥伴關係、股權配售、納斯達克首次公開募股的實施和維護不可或缺的一部分,並領導澳交所和納斯達克的財務報告。在進入Healthcare之前,Chaponnel先生曾擔任過多個職位,包括特許會計師、物流、零售業的管理職位,以及建築業的CFO職位。他是澳大利亞和紐西蘭特許會計師協會的成員。目錄表95
Peter Howard先生,法學學士,法學士(榮譽)集團總法律顧問兼企業執行董事,專利委員會主席,自2011年7月以來一直擔任我們的集團總法律顧問、企業執行董事和專利委員會主席。作為澳大利亞米德爾頓律師事務所(現為K&L·蓋茨律師事務所)的外部法律顧問和合夥人,Howard先生自Mesoblast成立並於2004年在澳大利亞證券交易所公開上市以來,一直是該公司的完整參與者。更廣泛地說,Howard先生在許多生物製藥公司和主要研究機構擁有豐富的經驗,涉及公開上市、私人融資、戰略、許可、知識產權和並購活動。他曾在幾個職位上做到這一點,包括作為一家大型律師事務所的合夥人、企業家、董事和高管。Justin Horst,BS製造主管Justin Horst在臨床細胞療法制造和行業開發方面擁有18年的經驗。在過去的八年裡,他一直是Mesoblast製造部門的副主管,負責化學、製造和製造過程的控制。在加入Mesoblast之前,Horst先生在Lonza Walkersville Inc.工作了10年,在製造、專案管理和業務開發部門擔任過多個高級職位。在龍沙,他對代工業務的建立起到了重要作用,並管理著多個支持眾多定製供應流程的製造團隊。霍斯特先生在馬利蘭州的陶森大學獲得生物學學士學位。Dagmar Rosa-Bjorkeon,MBA首席運營官,直到2023年11月1日,從那以後一直是兼職顧問。Dagmar Rosa-Bjorkeon在製藥行業擁有超過25年的全球經驗,包括在公司和產品戰略、市場開發和運營執行方面的行政領導。她領導了多次成功的產品發佈,包括治療多發性硬化症的Gilenya®和治療特應性濕疹的Elidel®。在諾華工作的17年中,羅莎-比約克森女士擔任過總裁副總裁兼多發性硬化症業務部負責人;美國業務發展和許可副總裁總裁;以及諾華瑞典公司的區域負責人兼總裁。最近,她在Baxalta擔任生物仿製藥的執行副總裁總裁和總裁,Baxalta現在是武田藥業公司的全資子公司。羅莎-比約克森女士還擔任過美蘭克羅特製藥公司的執行副總裁總裁和首席戰略與發展官。她擁有得克薩斯大學的市場營銷MBA學位、化學碩士學位和化學學士學位。MBA Pharma合夥人Michael Schuster先生於2004年加入Mesoblast,他領導集團的合作討論。在此之前,他是董事投資者關係拓展專案的負責人,也是Mesoblast Limited和Angioblast Systems,Inc.的創始高管團隊成員。2010年至2013年,舒斯特先生擔任全球治療專案執行副總裁總裁,2004年至2010年,擔任董事業務發展部副總裁和運營副總裁總裁。他擁有塔夫茨大學的理科學士學位,紐約醫學院的免疫學和微生物學碩士學位,以及紐約福特漢姆大學的MBA學位。首席執行官博士科學顧問Paul Simmons博士自2011年以來一直擔任我們的研究和新產品開發主管,並在本年度過渡為首席執行官科學顧問。他在幹細胞研究方面有近30年的經驗,特別是在基礎造血和骨髓基質系統的前體細胞方面的研究,並於2006年至2007年擔任國際幹細胞研究學會的總裁。在加入Mesoblast之前,Simmons博士於2008年至2011年在德克薩斯大學健康學院擔任C.Harold和Lorine G.Wallace傑出大學教授,並於2006年至2011年擔任布朗基金會分子醫學研究所幹細胞研究中心的首任教授和董事教授。西蒙斯博士是或曾經擔任過多個科學和醫學期刊的副主編、編輯委員會成員或審稿人,其中包括實驗血液學、細胞療法和幹細胞研究、細胞幹細胞、幹細胞報告、科學和自然。目錄表96
Geraldine Storton女士是一位經驗豐富的製藥業高管,在全球製藥和醫療器械研發、生產和商業化的整個價值鏈上擁有30多年的經驗。她在監管事務和質量方面擁有廣泛的背景,最近擔任細胞治療公司的顧問。在此之前,Storton女士曾在赫士睿及其前身公司擔任法規事務和質量方面的高管職務,專注於主要專案管理。作為赫士睿芝加哥總部專案管理、質量副總裁總裁,她領導了一項全公司範圍的質量補救計劃,以提高全球15家工廠的製造合規性。作為澳新銀行、澳新銀行、亞洲和日本的區域董事商務質量主管,施道頓女士負責亞太地區國家和地區銷售的所有產品的質量監督和管理。她的職責包括合規、批量放行、現場行動、投訴管理、變更控制、盡職調查和新產品發佈。作為董事全球監管業務的負責人,Storton女士負責新產品的開發和註冊,以及在亞太地區開發或製造並在全球分銷的所有赫士睿產品的現有產品組合的市場管理。她於2015年12月加入中胚層。翻譯研究主管、高級副總裁、博士Fiona See博士是一位經驗豐富的科學家,也是生物技術領域翻譯研究和開發的領導者。目前,高級副總裁在紐約中胚層擔任翻譯研究主管,她在間充質系基質細胞治療產品的整個生命週期中提供戰略科學領導,專注於心血管、肌肉骨骼和免疫學疾病。See博士成功地領導團隊開發了非臨床藥理學/毒理學包和產品特性。在此之前,See博士曾擔任中胚層翻譯發展部總裁副總裁和高級董事,負責開發和監督非臨床和翻譯策略。See博士擁有莫納什大學的博士學位和法學/理學(榮譽)學士學位。她在紐約大學朗格尼醫學院、哥倫比亞大學和墨爾本大學進行了NIH資助的研究,並在墨爾本大學進行了NHMRC資助的研究,重點是基於幹細胞的平臺和心臟病治療方法。她在受人尊敬的期刊上發表了許多同行評議的文章,反映了她對翻譯研究和治療創新的貢獻。我們的任何董事和高級管理層之間都沒有家族關係。我們每位董事和高級管理人員的營業地址是澳大利亞墨爾本柯林斯街55號38層Mesoblast Limited,郵編:VIC 3000。中胚層董事會(“董事會”)提交了2023/2024年薪酬報告,該報告是根據相關的2001年公司法(Cth)(“公司法”)和會計準則要求編寫的。薪酬報告列出了截至2024年6月30日的財政年度我公司主要管理人員(“KMP”)的薪酬資訊,該資訊由國際會計準則第24號“關聯方披露”和2001年澳大利亞公司法定義。(開始澳大利亞披露要求的薪酬報告)提名和薪酬委員會主席Bill Burns的介紹性評論全年我們一致專注於推進兒科移植物抗宿主病的生物製品許可證申請(BLA)申請,並與美國食品和藥物管理局(FDA)繼續對話,涉及我們臨床晚期管道中的所有專案。2024年3月26日,FDA通知Mesoblast,經過進一步考慮,來自MSB-GVHD001第三階段研究的現有臨床數據似乎足以支持提交建議的血乳酸,用於雷米斯泰爾-L治療患有類固醇難治性急性移植物抗宿主病(SR-aGVHD)的兒科患者。2024年7月,中胚層細胞為治療兒童SR-aGVHD重新提交了我們的血乳酸-L。年內,中胚層在慢性腰背痛(CLBP)和慢性心力衰竭(CHF)專案中取得進展。FDA通知該小組,它支持在射血分數降低的終末期缺血性心力衰竭患者中加速批准雷克司美羅爾-L的路徑,並使用左心室輔助裝置(LVAD)。總目次97
Rexlemestrocel-L在持續時間不到5年的炎症性退行性腰椎間盤疾病患者中的確證3期試驗已經在美國的多個地點開始登記。自2019年3月起擔任董事長的Joe瑞典人於年內辭去了董事長一職。建恩·貝爾從2024年4月開始擔任董事會主席。Joe將繼續擔任董事董事會成員,直至他在今年晚些時候的股東周年大會上任期結束。集團於2023年12月及2024年3月分別籌集4,000美元萬及2,500美元萬所得款項,鞏固我們的資產負債表,並提供所需資金,使所有現有產品開發及研究計劃得以繼續,以及我們下一個主要技術及臨床發展里程碑得以公佈。通過成功執行2023年8月宣佈的成本控制計劃,減少了年內的現金消耗。總體而言,與2013財年相比,2014財年的淨運營現金使用量減少了23%。成本控制計劃包括在2014財年成功引入和執行的以下薪酬相關舉措:·首席執行官和首席營銷官自願將基本工資削減30%,為期12個月,至2024年8月。為了補償現金薪酬的減少,股東在2023年年度股東大會上以95%的讚成票批准了一項期權授予,增加了他們基於長期股權的風險薪酬,以進一步與股東的利益保持一致;·我們管理團隊的其他成員也自願減少現金薪酬,並獲得長期基於股權的風險薪酬作為補償;·與截至2023年6月30日的財年相關的STI的現金支付已推遲到FDA批准SR-aGVHD;和·非執行董事自願推遲收取董事費用的50%,直到FDA做出決定,並同意以股權形式獲得剩餘50%的費用,並在2023年股東周年大會上獲得批准。在FDA批准做出決定之前,不會支付現金。儘管在2014財年取得了重大進展,但我們治療兒科SR-aGVHD的REMESTEM CELL-L獲得FDA營銷授權的直接目標尚未實現,因此,成本控制計劃將在2015財年繼續實施以下與薪酬相關的計劃:·首席執行官和首席營銷官自願將基本工資削減30%將持續到2025年8月。作為現金薪酬減少的補償,將提出一項期權授予,這將增加他們基於股權的長期風險薪酬,進一步使他們的利益與股東的利益保持一致,但須得到股東的批准。·在2015財年,其他管理團隊成員將繼續可以犧牲現金薪酬來換取期權。·在FDA就兒科SR-aGVHD做出決定之前,董事會已決定不對固定薪酬進行任何增加。·與截至2024年6月30日的財政年度有關的STI的現金支付已被推遲,並取決於FDA的批准(以下詳細說明)。在2014財年之後,STI計劃進行了修改,允許所有員工選擇接受期權授予,以代替現金支付他們在截至FY23和FY24財年的STI權利;以及·非執行董事繼續自願推遲50%的董事費用,直到FDA做出決定,並已同意在股東批准的情況下獲得50%的股權費用。除了退休的董事,在FDA批准做出決定之前,不會支付現金。我們負責任的薪酬管理受到投資者的積極歡迎,在2023年股東周年大會上,94%的投票通過了薪酬報告決議。2014財年薪酬結果Mesoblast的薪酬組合仍然側重於長期業績,使高管業績與長期可持續性和成功保持一致。生物技術領域的里程碑LTI獎項比更廣泛的市場中的獎項具有更高的風險,可能無法達到贈款或一般市場預期的水準。我們對目錄98的決定
維持這一框架符合我們投資者對長期風險薪酬的偏好,即與股東經驗和回報保持一致。在我們的LTI激勵措施中,高管必須同時滿足里程碑和服務要求,然後才能進行歸屬。首席執行官2023年11月授予的88%和基於里程碑的LTI激勵措施總額的66%尚未達到有資格歸屬的里程碑成就要求。一旦滿足基於時間的服務要求,LTI滿足里程碑要求的剩餘部分和這些選項就有資格授予(參見表6a)。在應用里程碑和服務要求後,CEO基於里程碑的期權總額的7%歸屬於2014財年。截至2024年6月30日,這些既有LTI期權100%處於水深火熱之中,內在價值為零。董事會評估我們集團截至2024年6月30日的財政年度的短期激勵(STI)關鍵績效指標(KPI)業績達到100%,大幅超過與我們的融資臨床和監管戰略相關的KPI。儘管如此,考慮到7月份BLA重新提交的緊迫性,董事會已行使酌處權,除非FDA為SR-aGVHD提供營銷授權,否則不向STI付款。在業績方面,Mesoblast將向首席執行官支付最高STI結果加20%。在2014財年之後和支付到期之前,董事會批准了對STI計劃的修改,允許所有員工選擇接受期權授予,以代替現金支付其截至2003財年和2014財年的STI權利。截至本報告之日,參與程度和修改條款尚未確定。總的來說,我們相信,薪酬框架,包括數年來沒有固定的高管薪酬增長,董事會決定推遲支付23財年和24財年STI的現金,直到FDA批准SR-aGVHD,以及2014財年繼續實施成本控制薪酬舉措,確保我們的薪酬戰略適合本集團現階段的增長,並與我們的關鍵里程碑和股東價值密切相關。我邀請您閱讀薪酬報告的其餘部分,並歡迎您的反饋。比爾·伯恩斯提名和薪酬委員會主席關鍵管理人員(KMP)關鍵管理人員(KMP),定義為有權力和責任直接或間接規劃、指導和控制公司活動的個人,包括所有董事。表1-2024財年中層KMP,包括截至本報告日期2024財年擔任KMP非執行董事建恩·貝爾董事會獨立主席(從2024年4月30日起)、提名和薪酬委員會成員、澳大利亞審計和風險委員會全年主席約瑟夫·瑞典獨立主席,董事會成員,審計和風險委員會成員,提名和薪酬委員會美國全年目錄表99
威廉·伯恩斯獨立副主席、董事會主席、提名和薪酬委員會瑞士全年菲利普中國獨立非執行董事成員、審計與風險委員會成員、提名和薪酬委員會美國全年菲利普·克勞斯獨立非執行董事2023年8月28日至2023年8月29日非獨立非執行董事成員提名和薪酬委員會成員至2024年8月28日美國全年。董事獨立非執行主席、審計和風險委員會成員、提名和薪酬委員會新加坡分會於2023年9月26日辭職執行董事西爾維烏·伊泰斯庫首席執行官澳大利亞董事全年首席醫療官埃裡克·羅斯美國全年6.B薪酬KMP薪酬治理董事會負責中原地產的薪酬戰略和方法。提名及薪酬委員會就一般薪酬及獎勵政策及慣例向董事會提供意見,並就執行董事、其他高級行政人員及非執行董事的薪酬福利及其他聘用條款提出具體建議。提名和薪酬委員會完全由獨立成員組成。審計委員會滿意地認為,在本報告所述期間,提名和薪酬委員會的所有成員都是獨立的。提名和薪酬委員會主要負責就以下事項向董事會提出建議:·董事會任命·非執行董事費用·高管薪酬框架·執行董事薪酬,即首席執行官、首席運營官和其他關鍵高管的薪酬目錄100
·短期和長期獎勵·股權計劃提名和薪酬委員會的目標是確保薪酬政策公平和具有競爭力,同時考慮到行業基準,同時與我們公司的目標保持一致。委員會收到執行小組提出的建議,並對其進行嚴格審查。在適當情況下,提名和薪酬委員會將徵求獨立專家顧問的意見或建議,包括基準研究。顧問於年內提供的意見並不構成公司法第90億條所界定的“薪酬建議”,並不受與該意見有關的主要管理人員的任何不當影響。高管薪酬戰略薪酬戰略旨在確保Mesoblast能夠:·吸引和留住創新領域和全球範圍內的經驗豐富的領導者和新興專家·獎勵長期將導致改善患者結果和增加股東財富的業績。我們的隊伍很小。Mesoblast只有73名員工,其中57%在美國,其餘在澳大利亞、新加坡和瑞士。留住這些往往在各自領域處於領先地位的員工,是確保Mesoblast能夠繼續朝著困難、複雜和長期目標努力的當務之急。生物製藥產品開發是一項高度專業化和投機性的工作,涉及很大程度的風險。為了實現和保持長期盈利能力,公司必須成功開發候選產品,獲得監管部門的批准,並製造、營銷和銷售那些獲得監管部門批准的產品。如果發生這種情況,收入取決於候選產品獲得批准的市場規模、實現和保持足夠的市場接受度的能力、定價、第三方付款人的報銷,以及我們的候選產品在這些市場的足夠市場份額。並不是所有的公司都能在這些活動中取得成功,也不是所有的公司都能從產品銷售中獲得足以實現盈利的收入。為了有成功的機會,高管必須a)擁有專業技能,瞭解正在開發的複雜產品和全球實施的各種監管要求b)應用高度的紀律,以確保研究和試驗在嚴格的預算限制下,按照嚴格的標準和時間表安全有效地進行c)尋求更早交付,成本更低,關鍵和明確的里程碑對中胚層技術的進步至關重要d)始終專注於商業化的最終目標。雖然從最初的研究到里程碑產生有利可圖的結果可能需要很多年,但這並不會降低里程碑本身的重要性。如果在治療商業化的道路上沒有臨時的里程碑式的步驟,所需的廣泛的安全性和有效性數據將是不夠的,全球監管機構也不可能批准。時間和成本是這一研究、測試和里程碑式成就過程中的重要組成部分,因為兩者對股東價值都有復合影響。為了解決上述問題,Mesoblast的薪酬框架包括:-有競爭力的固定薪酬--年度獎勵付款取決於按時間和預算進行的密集研究、批准和試驗--基於里程碑的較長期獎勵付款目錄101
-支付部分作為期權交付,這節省了現金,符合股東利益,並使高管專注於戰略、風險管理和執行,以優化股東價值。Mesoblast通常將基於現金的STI設置在低於基於期權的LTI的數量,以保存現金流,使高管專注於價值創造,並使高管與股東保持一致。我們執行團隊目前的平均任期為10年,這表明該框架很好地吸引和保留了適當的行政領導。高管薪酬框架表2-高管薪酬框架中提供了關於中東歐高管薪酬框架的更多細節。表2--行政人員薪酬框架戰略理由通過競爭性薪酬在全球範圍內吸引和留住關鍵人員。遵守地區法定和慣例福利(例如,澳大利亞的養老金;美國的醫療保險)。重點關注關鍵關鍵績效指標(在臨床、財務和合作戰略、製造、商業或組織結構和開發等領域),在成本和時間限制下,將導致患者結果和股東財富的長期改善。多管齊下:-使薪酬結果與股東財富創造保持一致。-通過確定對長期盈利至關重要的關鍵目標的優先順序,提供創造財富的框架。-獎勵成就的速度,這可能會產生長期的復合效應-通過延期留住員工-只有在里程碑導致股價上漲的情況下才提供價值,與股東的體驗一致。-節省現金。-通過Malus實現風險管理。根據職位責任對員工住所的市場相關性進行年度評估的流程。提名和薪酬委員會就高級管理人員的薪酬福利向董事會提出具體建議,以供批准。根據年度公司和個人KPI按年支付績效工資。提名和薪酬委員會確定CEO的KPI。這些指標用於衡量公司績效,這決定了其他員工可以使用的人才庫。從該池中分配給高級管理層的資金是根據首席執行官設定的各個關鍵績效指標來確定的。由此產生的結果由提名和薪酬委員會批准。提名和薪酬委員會評估LTI里程碑成就的歸屬資格。固定薪酬績效薪酬短期激勵長期激勵目錄102
資格所有員工在2024年3月31日或之前錄用的所有員工都有資格被考慮。年內聘用的僱員按比例獲得認可。所有有資格的參與者,他們能夠影響我們長期成果的實現,並在需要時吸引和留住他們。機會的數量根據每個職位的責任、在職者的經驗和資歷以及地區市場相關性而定。設定為固定工資的百分比。量子一般低於LTI,以節省現金。現任CEO最高STI:固定薪酬的50%。當前CMO最高STI:固定薪酬的50%。使用固定工資的百分比作為指導來設置。現任首席執行官的最高LTI:約為固定薪酬的200%。目前CMO的最高LTI:固定薪酬的100%。根據考慮的各種因素,首席執行官和首席營銷官LTI的實際授予價值可能與這一比例每年不同,這些因素包括:-股東稀釋-內部相關性-以現金形式提供的股價波動。現金。在2014財年之後,我們的STI計劃進行了修改,並將為所有員工提供選擇,以獲得期權獎勵,以代替現金支付其截至2013財年和2014財年的STI權利。中原股份有限公司普通股的期權,到期日為7年。購股權行權價將以澳交所截至董事會批准授出前5個交易日的VWAP較高者,以及澳交所普通股於董事會獲批准時的最後收市價為準。業績和服務期N/A為一年三年,提前歸屬的撥備以每年三分之一為限,以(A)鼓勵實現速度,(B)推遲重大金額,以便更好地治理,以及(C)鼓勵高管專注於對股東價值有較長期影響的業績。固定薪酬績效薪酬短期激勵長期激勵目錄103
自由裁量權、欠款和追回不適用董事會有權在任何付款之前,使用其自由裁量權對個別結果進行修訂,包括將結果降至零。此外,從2014財年起,我們通過了一項政策,追回錯誤授予的獎勵薪酬。董事會在決定歸屬結果方面擁有最終決定權。在期權被行使之前,董事會還可以在高管不誠實或欺詐行為導致期權失效的情況下行使自由裁量權(未授予和已授予)。此外,從2014財年起,我們通過了一項政策,追回錯誤授予的獎勵薪酬。終止僱用不適用除非委員會行使其酌情決定權,否則不會向已終止僱用的僱員作出任何補償。除非董事會行使酌情決定權,否則未授予的期權將被沒收。已授予的期權可以保留,但須在我們的員工股票期權規則規定的特定期限內(通常是停止60天)行使。套期保值公司的股票交易政策禁止通過公司的衍生品進行對沖。監督個人結果首先由提名和薪酬委員會審查和批准,然後由董事會審查和批准。固定薪酬基於績效的薪酬短期激勵長期激勵薪酬組合2014財年CEO和CMO的最高目標薪酬組合如圖1所示。圖1-高管KMP薪酬組合。28.6%40.0%14.3%20.0%57.1%40.0%TFR STI LTI 0%10%20%30%40%50%60%70%80%90%100%CEO CMO實際授予價值同比可能與目標薪酬組合有所不同,具體取決於以下因素:·攤薄考慮目錄104
·內部相關性·贈款日期對關於中胚層框架的常見問題的答覆下表列出了對關於中胚層薪酬框架的常見問題的答覆。表3-高管薪酬框架為什麼使用STI和LTI的里程碑績效衡量標準?傳統的財務指標沒有意義,也不能有效地用來準確反映我們公司的業績。創造持久的股東價值的是研發的成功成果、新的合作以及其他計劃和深思熟慮的公司目標的實現。只有在市場重視我們的成就的情況下,成功才會在LTI下帶來可觀的回報。如果是這樣,我們的股價就會上漲。LTI期權變得有價值了。否則,期權就沒有內在價值。里程碑和期權支付的這種結合,共同作用於根據股東回報對業績進行公平支付。這是生物技術公司的標準做法。為什麼一些長期激勵獎的授予時間早於三年?在生物技術領域,將長期激勵建立在實現業績里程碑的基礎上,是將薪酬與業績掛鉤的既定方法。另一個關鍵因素是時間。雖然我們為里程碑留出了三年的時間,但更早的成就更好,因為如果更早實現里程碑,則本集團用於支持計劃和相關管理費用的現金將比在3年結束時實現的現金更少。因此,我們已將計劃配置為允許提前授予以實現早期成就,但僅限於一定程度。我們仍然堅持,即使所有里程碑都提前實現,一些選項仍將保留3年,以確保在預算有限的情況下有選擇,員工專注於那些最有可能在較長時間內實現最大價值的里程碑,並鼓勵員工留任。我們相信這個框架是創新的,非常適合我們的業務性質。我們承認,它看起來和感覺上都不像典型的澳交所上市公司LTI,因此可能不符合許多人應用的標準指南,但我們並不典型。我們願意考慮另一種設計的激勵措施,以解決里程碑成就的價值驅動因素、實現這些成就的時間、在資源有限的情況下對里程碑進行優先排序以及對長期股價的影響,但到目前為止,我們還沒有發現任何同樣有效的激勵措施。中胚層對多樣性的立場是什麼?該集團珍視多樣性,並認識到它可以為本組織實現其目標的能力帶來的好處。多元化可以通過擴大招聘高素質員工的人才庫、鼓勵創新和提高公司的專業精神和聲譽來帶來競爭優勢。因此,專家組致力於促進本組織內部的多樣性,並通過了一項正式政策,概述了專家組的多樣性目標。在性別多樣性方面,截至2024年6月30日,公司52%的員工為女性,30%的公司高級管理人員為女性。2024年4月,任命了一名女性董事會主席。董事會意識到董事會一級的性別不平衡(四名非執行董事中只有一名是女性)。董事會的目標是在出現空缺和情況允許的情況下增加董事會女性成員的數量。目錄表105
2013財年和2014財年STI的付款都已推遲,這取決於FDA對SR-aGVHD的營銷授權是否實現。為什麼STI或LTI的歸屬考慮中沒有考慮ENS(環境和可持續發展)問題?Mesoblast的使命是將由自然產生的細胞材料組成的創新藥物推向市場,以治療嚴重和危及生命的疾病,這從根本上符合ENS原則,儘管存在相關的供應鏈和碳足跡考慮。在這個階段,Mesoblast的實體足跡僅限於辦公和實驗室空間,其員工基數不到100人,因此,儘管管理層積極致力於減少公司的碳足跡,但其實質性改善其ENS影響的能力目前有限。我們將繼續考慮在未來制定與EN相關的薪酬里程碑,特別是如果和當Mesoblast擁有自己的製造設施和批准的產品時。表4提供了股價表現數據和選定的財務結果。表4-公司股價表現和過去五年的部分財務業績貨幣2024 2023 2022 2021 2020股價(澳交所代碼:MSB)-6月30日收於0.99澳元1.14 0.61 1.98 3.25-年內最高1.39 1.28 2.10 5.5 4.45-年內低點0.26 0.68 0.61 1.72 1.02 6月30日市值(百萬)澳元1,130 924 397 1,285 18-增加/(減少)-(百萬)206527(888)-613 1160-增加/(減少)-AS%22%133%(69%)(32)%157%收入(百萬)美元5.9 7.5 10.2 7.5 32.2-增加/(減少)-AS%(21%)(27%)37%(77)%92%所得稅前虧損(百萬)88.1 82.1 91.6 99.6 87.4淨資產(百萬)美元480.4 501.8 497.0 581.4 549.3已支付股息-向股東返還資本-在這一年裡,我們提前提交了針對兒科移植物抗宿主疾病的BLA,並繼續與FDA就我們後期臨床流水線中的所有專案進行了對話。2024年3月26日,FDA通知Mesoblast,經過進一步考慮,來自MSB-GVHD001第三階段研究的現有臨床數據似乎足以支持提交建議的血乳酸,用於雷姆斯泰爾-L治療患有SR-aGVHD的兒童患者。2024年7月,中胚層細胞為治療兒童SR-aGVHD重新提交了我們的血乳酸-L。年內,中胚層在慢性腰背痛(CLBP)和慢性心力衰竭(CHF)專案中取得進展。美國食品藥品監督管理局通知該公司,它支持在射血分數降低的終末期缺血性心力衰竭患者中加速批准雷克司美羅爾-L的審批路徑,並使用左心室輔助裝置(LVAD)。Rexlemestrocel-L在持續時間不到5年的炎症性退行性腰椎間盤疾病患者中的確證3期試驗已經在美國的多個地點開始登記。Mesoblast成功執行了2023年8月宣佈的成本控制計劃,與2013財年相比,2014財年運營現金淨使用量減少了23%。在融資方面,在股東的支持下,公司分別於2023年12月和2024年3月籌集了4,000美元萬和2,500美元萬。這些加薪加強了我們的綜合資產負債表,因為我們正在為潛在的REMESTEMCEL-L的推出和商業化開展活動。目錄表106
總結對以下公司業績的管理:-於2023年12月完成4,000美元的萬配股。-於2024年3月完成2,500美元的萬融資。-年內,我們委任建恩·貝爾為董事會主席。關於我們的候選產品,管理層取得了以下成就:-在我們與FDA在一年中進行互動後,FDA通知Mesoblast,經過額外考慮,其3期研究MSB-GVHD001的現有臨床數據似乎足以支持提交REMSTEM CELL-L的擬議BLA,用於治療SR-aGVHD兒童患者。-在這一年裡,我們提前重新提交了BLA,以供批准雷米斯泰爾-L治療SR-aGVHD兒童,最終導致在2024年7月正式重新提交並被FDA接受。-2024年3月,中胚層宣佈,FDA支持中胚層同種異體間充質前體細胞(MPC)產品rexlemestrocel-L在終末期缺血性HFrEF和左心室AD患者中加速批准路徑。FDA在2024年2月21日與FDA就現有再生醫學高級治療(RMAT)名稱下的rexlemestrocel-L(Revascor®)舉行b型會議後,以正式會議紀要的形式向公司提供了這一反饋。-rexlemestrocel-L在持續時間不到5年的炎症性退行性腰椎間盤疾病患者中的確證3期試驗已經在美國的多個地點開始登記。-達成一項協定,與血液和骨髓移植臨床試驗網路(BMT CTN)一起開發Mesoblast的主要產品候選者Ryoncel®(reemystcel-L)治療成人SR-aGvHD的關鍵試驗,該網路包括負責美國大約80%的異基因骨髓移植的中心。BMT CTN由美國國立衛生研究院(NIH)資助。-在提交了針對患有左心發育不良綜合徵(一種潛在威脅生命的先天性心臟病)的兒童的隨機對照試驗結果後,中胚層因其治療先天性心臟病的異基因細胞療法Revascor®(rexlemestrocel-L)獲得了美國食品和藥物管理局(FDA)的孤兒藥物稱號(ODD)和罕見的兒科疾病稱號(RPDD)。總目次107
截至2024年6月30日的年度薪酬結果STI 2014財年的公司STI目標和結果如表5所示。表5-集團相對於2014財年STI關鍵績效指標目標/績效評估最大值佔總STI評級結果的百分比(佔總STI評級結果的百分比)在我們提前重新提交BLA SR-aGVHD的一年中,我們主要候選產品的臨床和監管戰略(50%)最終被FDA正式重新提交並於2024年7月接受。與血液和骨髓移植臨床試驗網路(BMT CTN)達成協定,開發RERESTEM CEL-L治療成人SR-aGvHD的關鍵試驗,該網路包括負責美國約80%異基因BMT的中心。BMT CTN由美國國立衛生研究院資助。中胚層在我們的CLBP和CHF計劃中取得了積極的結果。FDA的OTAT批准了rexlemestrocel-L用於治療與椎間盤退變相關的CLBP的RMAT,並支持加速批准rexlemestrocel-L用於終末期缺血性HFrEF和LVAD患者。在提交了HLHS(一種潛在威脅生命的先天性心臟病)兒童的隨機對照試驗結果後,中胚層細胞因其同種異基因細胞療法Revascor®(rexlemestrocel-L)治療HLHS獲得了FDA的ODD和RPDD。董事會已經決定這一目標已經實現。50%100%50%執行融資策略(20%)在財務方面,年內取得重大成就。我們在2023年12月完成了4,000美元的萬融資,並在2024年3月完成了2,500美元的萬融資。董事會已經決定這一目標已經實現。20%100%20%執行製造過程開發和成本控制(30%)在過去一年中我們改進了製造過程。另外,通過成功執行2023年8月宣佈的成本控制計劃,我們減少了現金消耗。總體而言,與2013財年相比,2014財年運營現金淨使用量減少了23%,這是2023年年度報告中提出的目標。董事會已經決定這一目標已經實現。30%100%30%目錄108
董事會評估本集團在截至2024年6月30日的財政年度內在這些關鍵績效指標上的表現達到100%的目標,反映出面對FDA 3月份導致Mesoblast重新提交BLA的溝通而改變的優先事項的顯著表現。然而,鑑於BLA重新提交的核心性質和我們目前的現金狀況,董事會行使了消極酌情權,不向2014財年STI付款,除非Mesoblast獲得FDA對SR-aGVHD的營銷授權。考慮到如果FDA沒有獲得營銷授權,董事會將支付零STI的負面自由裁量權,董事會還將如果獲得授權,CEO支付的可能性增加了20%。在2014財年之後,對STI計劃進行了修改,允許所有員工選擇接受期權授予,以代替現金支付其截至2003財年和2014財年的STI權利。截至本報告之日,參與程度和修改條款尚未確定。LTI要授予里程碑期權,必須滿足兩個條件。·必須達到該選項的里程碑·必須在績效期間內完成·必須在設定LTI里程碑時在授予時聘用高管預計不會在接下來的12個月內實現所有或任何里程碑。LTI計劃旨在使首席執行官的目標與創造長期股東價值保持一致。授予首席執行官的LTI是基於達到臨床和商業化里程碑,以及完成許可或合作協定以建立股東價值。表6a、60億和6c匯總了基於2014財年和上一年業績的執行和非執行KMP所獲得的長期目標投資,以及在達到里程碑後將授予這些期權的財政年度。在LTI里程碑仍然是商業機密的情況下,它已經被概括地描述過。許多里程碑還具有相關的交付窗口和/或預算,在確定是否實現時會將其考慮在內。根據結果的質量和/或成本或患者參與的程度,某些臨床結果可以部分滿足。總目次109
表6a-2023年11月CEO基於里程碑的贈款的LTI結果(1)與FDA在CHF開發計劃的某些方面取得一致相關的監管里程碑。242,000財年--242,000--100%--與金融和業務發展相關的里程碑,以完成戰略資本籌集,為發展計劃提供資金,直至關鍵里程碑。726,000 FY24--5,667 161,333-100%--與REMSTEM CEL相關的法規和臨床里程碑--L和雷克斯萊美斯特羅-L平臺。1,452,000待批-2023年11月總計1,452,000待批2,420,000--806,667 161,333-40%1,452,000%2,452,000 11月(2)與REMSTEM CELL-L.1,395,000待批有關的商業和臨床里程碑-1,395,000與REMSTEM-L和Rexlemestrocel-L平臺有關的財務和業務發展里程碑待批930,000待批-930,000 2022年11月批款額2,325,000-2,325,000我們的aGVHD計劃的商業化進展和公司主導計劃的臨床進展,並根據優先順序為每個計劃里程碑進行具體分配。510,000 FY23-510,000(7)-100%-110,000 FY24-110,000-100%-完成重要的許可/協作協定,以建立股東價值和其他保密融資目標。620,000待完成-與工藝開發相關的620,000個製造里程碑。310,000待批-2021年11月總計310,000撥款1,550,000-620,000-40%93,000授予日期里程碑編號在計入基於時間的歸屬條件後,部分已經/將歸屬的期權年度里程碑已實現的FY百分比在24 FY24 FY25 FY26 FY27之前已歸屬的百分比目錄110
2020年11月(4)與公司主導計劃的臨床和商業化進展相關的臨床/商業化里程碑。480,000 FY22 480,000-100%--完成了一項重要的許可/協作協定,以建立股東價值和其他保密融資目標。480,000個待定-480,000個與工藝開發相關的製造里程碑。240,000 FY22 240,000-100%-2020年11月總計1,200,000 720,000-60%480,000 2019年11月(5)授予PDUFA重組日期-L(6)。673,334財年20財年673,334-100%--美國FDA批准雷姆斯泰爾-L(6)。673,333待批-2019年11月總計673,333撥款1,346,667 673,334-50%673,333批准日裡程碑編號在計入基於時間的歸屬條件後,部分已歸屬/將歸屬的部分在24 FY24 FY25 FY26 FY27(1)董事會於2023年10月16日批准,並在股東周年大會上收到股東對授予的批准後於2023年11月28日授予。(2)此項贈款於2022年10月17日獲董事會批准,並於股東周年大會上獲股東批准後於2022年11月23日批出。(3)這筆贈款於2021年9月8日獲董事會批准,並於股東周年大會上獲股東批准後於2021年11月29日批出。(4)此筆贈款於2020年7月16日獲董事會批准,並於股東周年大會上獲股東批准後於2020年11月24日批出。(5)此項授予於2019年7月20日獲董事會批准,並於股東周年大會上獲股東批准後於2019年11月27日授予。授予的538,667份期權不是以里程碑為基礎的,沒有列入上表。538,667份期權被授予,作為減少19財年短期現金獎金以節省現金的替代。(6)治療小兒SR急性移植物抗宿主病。(7)不論里程碑於何時達成,里程碑歸屬日期定為董事會批准的日期。在這種情況下,董事會是在2023年7月批准的。總目次111
表60CMO基於里程碑的贈款的億-LTI結果2023年11月(1)與食品和藥物管理局在慢性心力衰竭發展計劃的某些方面取得一致相關的監管里程碑。148,000 FY24--148,000--100%--與REMSTEM CEL-L和REXLemestrocel-L平臺相關的管理和臨床里程碑。444,000個待完成的-444,000個與REMSTEM CELL-L和Rexlemestrocel-L平臺有關的戰略企業合作夥伴關係里程碑。148,000待完成-2023年11月總計148,000撥款740,000--148,000--20%592,000 2022年11月(2)與REMESTEM CELL的監管進展有關的里程碑--L(3)600,000 FY24-300,000-50%300,000與公司主要產品的臨床進展有關。300,000待定-2022年11月總計300,000撥款900,000-300,000-33%600,000批准日期里程碑編號在計入基於時間的歸屬條件後,部分已歸屬/將歸屬的部分在24 FY24 FY25 FY26 FY27(1)董事會於2023年10月16日批准,並在股東周年大會上收到股東對授予的批准後於2023年11月28日授予。(2)此項贈款於2022年10月17日獲董事會批准,並於股東周年大會上獲股東批准後於2022年11月23日批出。(3)對於患有SR-aGVHD的兒童患者,向FDA提交,包括重新提交其血乳酸並可能獲得FDA的批准。表6c-授予菲爾·克勞斯2023年11月基於里程碑的贈款的LTI結果(1)與REMESTEM CEL的監管進展相關的里程碑-L(3)325,050 FY24--325,050(2)--100%--REMESTCEL-L和REXLEMESTROCEL-L平臺的監管里程碑659,950待批-2023年11月總計659,950撥款985,000--325,050-33%659,950授予里程碑編號在計入基於時間的歸屬條件後,部分已歸屬/將歸屬的部分在24 FY24 FY25 FY26 FY27(1)董事會於2023年10月24日批准,並在股東周年大會上收到股東對授予的批准後於2023年11月28日授予。(2)這一裡程碑於2024年7月實現。目錄表112
根據此等普通收入撥備就以收入賬持有的普通股取得的收益而應課稅的外國股東,將按非澳大利亞居民的澳大利亞稅率評估該等收益,自2024年7月1日起,個人稅率為30.0%(以前為32.5%)。上述“股票銷售稅或其他處置稅--資本利得稅”中關於要求買家在收購TAP時預扣12.5%的稅(從2025年1月1日起增加到15%)的評論同樣適用於外國居民出售澳大利亞房地產資產可能產生收入賬戶收益而不是資本收益的情況。一般而言,澳大利亞居民或非澳大利亞居民無需就發行、協定轉讓、轉讓、交出或以其他方式交易美國存託憑證或本公司普通股繳納澳大利亞印花稅,前提是在進行該等交易時,本公司所有已發行股份均在澳交所報價,且交易不會導致個人或實體收購或開始持有或以其他方式實益有權(按相聯基準)持有或實益享有本公司全部已發行股份的90%或以上。10.G專家聲明不適用。作為一家外國私人發行人,我們不受《交易法》規定的委託書形式和內容的規則的約束,我們的高級管理人員、董事和主要股東也不受《交易法》第16條所載的申報和收回短期周轉利潤條款的約束。目錄表153
10.i附屬公司資料有關我們附屬公司的資料,請參閱“第18項財務報表-附註12。”10.J證券持有人年度報告不適用。專案11.關於市場風險的定量和定性披露關於我們的市場風險敞口以及我們如何管理這一風險的資訊,見“專案18.財務報表--附註10”。第12項除股權證券外的證券說明12.A債務證券不適用。12.B認股權證及權利不適用。12.其他證券不適用。12.美國存托股份美國存托股份美國存託憑證持有人可能須向我們的美國存托股份存託機構--摩根大通銀行(JPMorgan)支付的費用或收費,最高可達下表所述:存入或提取普通股的人或美國存托股份持有人必須支付:服務說明每100個美國存託憑證(或100個美國存託憑證的一部分)$5(或以下)·發行美國存託憑證,包括根據股票、股份或權利分配存款、股票股息、股票拆分、合併或任何其他影響美國存託憑證發行的交易·註銷美國存託憑證每美國存托股份0.05美元(或更少)·向美國存托股份持有人派發現金每美國存托股份每歷年0.005美元·託管銀行不時向發行方支付託管費用所提供的行政服務,託管銀行可向我們付款以償還和/或分享從美國存托股份持有人那裡收取的費用和/或分享所提供服務的費用,或免除所提供服務的費用和開支,通常與建立和維護美國存托股份計劃所產生的成本和開支有關。保管人在履行保管人協定項下的職責時,可以使用作為保管人的附屬機構的經紀人、交易商或其他服務提供者,這些服務提供者可以賺取或分享費用或佣金。總目次154
第二部分第13項違約、拖欠股息和拖欠股息不適用。專案14.對擔保持有人權利的實質性修改和收益的使用不適用。專案15.披露控制和程式的評估我們的管理層在首席執行官和臨時首席財務官的參與下,評估了截至2024年6月30日的披露控制和程式的有效性。根據《交易法》第13a-15(E)條的規定,《披露控制和程式》旨在確保公司在根據《交易法》提交或提交的報告中需要披露的資訊:(I)在美國證券交易委員會的規則和表格規定的時間內記錄、處理、匯總和報告;(Ii)積累並酌情傳達給公司管理層,包括其首席執行官和首席財務官,以便及時做出關於所需披露的決定。根據對我們的披露控制和程式的評估,我們的首席執行官和臨時首席財務官得出結論,我們的披露控制和程式自2024年6月30日起有效。管理層關於財務報告的內部控制報告我們的管理層負責建立和維護對財務報告的充分內部控制,如《交易法》規則13a-15(F)和15d-15(F)所定義的那樣。我們的管理層根據特雷德韋委員會贊助組織委員會發布的《內部控制-綜合框架(2013)》中規定的標準,對截至2024年6月30日的財務報告內部控制的有效性進行了評估。基於這一評估,我們的管理層得出結論,其對財務報告的內部控制自2024年6月30日起有效。財務報告內部控制的變化在本20-F表格所涵蓋的期間,我們對財務報告的內部控制沒有發生任何變化,這些變化對我們的財務報告內部控制產生了重大影響,或有合理的可能性對我們的財務報告內部控制產生重大影響。內部控制的侷限性由於其固有的侷限性,財務報告的內部控制可能無法防止或發現錯誤陳述。此外,對未來期間進行任何有效性評估的預測都有可能因條件的變化而出現控制不足的風險,或者政策或程式的遵守程度可能會惡化。第16項。[保留]專案16A。審計委員會財務專家Mesoblast Ltd.董事會已確定,以下董事各自擁有特定的會計和財務管理專業知識,並且每個董事都是美國證券交易委員會定義的審計委員會財務專家。·Philip FacChina(審計和風險委員會主席,2024年5月1日起);目錄155
·建恩·貝爾(審計和風險委員會主席,2023年9月20日至2024年4月30日)和·邁克爾·斯普納(審計和風險委員會主席至2023年9月20日,從2023年9月26日起辭去董事會職務)董事會還確定,審計和風險委員會成員約瑟夫·瑞安在財務和合規事務方面擁有足夠的經驗和能力,使他們能夠充分履行職責。根據納斯達克全球精選市場的上市標準,審計與風險委員會的所有成員都是“獨立的”。第160項億。道德準則我們的商業行為和道德準則涵蓋利益衝突、保密、公平交易、資產保護、遵守法律法規、告密、證券交易和對利益相關者的承諾。總而言之,《守則》要求所有公司人員在任何時候都要以最大程度的誠信、客觀性和遵守法律和公司政策的文字和精神行事。這份檔案可在我們的互聯網網站上查閱:http://www.mesoblast.com/company/corporate-governance/code-of-conduct-and-values.專案16C。主要會計師費用和服務審計和非審計服務的預先批准普華永道提供的所有服務都需要審計和風險委員會的預先批准。這些服務可包括審計服務、與審計有關的服務、稅務服務和允許的非審計服務,並受特定預算的約束。審計與風險委員會在考慮特定服務或服務類別是否符合美國證券交易委員會關於審計師獨立性的規則時,結合使用了兩種方法--一般預先批准和具體預先批准。在一般預先核准的情況下,擬議的服務可以預先核准,而不考慮具體的個案服務。審計和非審計服務費見“專案18.財務報表--附註18”。就美國證券交易委員會分類而言,在截至2024年6月30日及2023年6月30日的年度內,並無向普華永道支付或應付未經審計與風險委員會預先批准的審計相關費用、稅款或其他費用。專案16D。不適用於審計委員會的上市標準豁免。專案16E。發行人及聯營買家購買股權證券不適用。專案16F。註冊人認證會計師的變更不適用。專案16G。公司治理根據納斯達克證券市場規則第5615(A)(3)條,外國私人發行人,如我公司,被允許遵循某些母國的公司治理實踐,而不是納斯達克證券市場規則的某些規定。例如,在某些公司管治要求方面,例如董事會的組成和適用於股東大會的法定人數要求,我們可能會沿用母國的做法。此外,對於與某些收購或私募相關的證券發行,我們可能會遵循本國的做法,而不是納斯達克股票市場規則的要求,在發行證券之前舉行執行會議並獲得股東批准。此外,在建立或修訂某些股票期權、購買或其他補償計劃之前,我們可能會遵循本國的做法,而不是納斯達克股票市場規則的要求,以獲得股東的批准。選擇遵循本國慣例而不遵循任何納斯達克規則的外國私人發行人必須遵循目錄156
提前向納斯達克提交發行人所在國獨立律師的書面聲明,證明發行人的做法不受本國法律的禁止。我們向納斯達克提交了這樣一份書面聲明。除下文所述外,吾等目前有意在澳洲法律下盡可能遵守納斯達克證券市場規則的企業管治上市標準。然而,我們可能會選擇改變這種做法,以在未來效仿母國的做法。納斯達克證券市場規則要求,上市公司必須明確,任何股本持有人會議的法定人數至少為該公司普通股有表決權股票流通股的33.5%。我們遵循自己國家的做法,而不是遵守這條規則。根據澳大利亞法律,我們的憲法不要求任何股東大會的法定人數至少為Mesoblast已發行有表決權股份的333 1/3%。我們的章程規定,股東大會的法定人數包括兩名親自出席的股東,如股東是法人團體,則由代理人、代理人或代表出席。澳交所上市規則或任何其他澳大利亞法律並不禁止這一規定以及我們與該法定人數舉行會議的做法。此外,我們可能會遵循本國的做法,而不是納斯達克規則5635(D),該規則要求公司在發行證券(公開募股除外)之前,必須獲得股東的批准,證券的發行量等於或超過公司現有投票權的20%或更多。這一納斯達克規則與澳交所上市規則不一致,該規則規定,未經股東批准,公司不得在任何滾動的12個月內發行超過公司已發行資本15%的證券,但須受某些例外情況的限制,例如按比例向所有股東發售證券。第16H項。礦場安全資訊披露不適用。專案16I。披露有關外國司法管轄區的資訊,阻止檢查不適用。專案16J。內幕交易政策我們有一項股票交易政策(“政策”),該政策規定了管理本公司證券的購買、出售和其他處置的政策和程式,並適用於本公司及其子公司的董事、高級管理人員、員工、承包商和顧問(“Mesoblast人員”)。該政策旨在(I)限制持有“內幕消息”的Mesoblast人員交易我們的證券,並(Ii)確保遵守所有適用的證券法律、規則和法規以及上市標準。我們已將保單作為本年度報告20-F表格的證物。第1.6項萬。網路安全該公司的網路安全戰略旨在為我們的全球運營提供一種全面的方法,以確保我們的技術堆棧、治理框架和人員要素之間的網路安全風險。網路安全風險管理是我們更廣泛的風險管理戰略的關鍵組成部分。我們的網路安全計劃建立在行業最佳實踐的基礎上,旨在主動識別、評估和緩解網絡安全風險,包括與使用所有第三方服務提供商相關的威脅。我們的網路安全風險評估框架根據風險的潛在影響和嚴重程度對風險進行分類,公司實施有針對性的風險處理計劃,以確保強大的保護和彈性。臨時首席財務官和監管事務和質量管理負責人是我們執行管理團隊的成員,負責監督網絡安全事件的預防、檢測、緩解和補救。這兩位高管在風險管理和合規方面都有豐富的經驗,並在公司負責網路安全和IT管理超過三年。他們由公司的資訊技術系統管理員和一家外部管理的資訊技術和網路安全服務提供商提供支持。該服務提供商已受聘於該公司十多年,提供戰略資訊技術建議並管理該公司的資訊技術系統和基礎設施。服務提供商在健康和生命科學組織中擁有20多年的安全經驗,管理目錄157
通過一些措施,包括制定和執行網路安全政策和程式、培訓和滲透測試以及系統監測,來應對網路安全風險。我們的執行管理團隊成員定期協作並接收我們管理的IT和網路安全服務提供商的報告,從而能夠對公司的網路風險狀況和計劃進行持續評估和監控。我們的董事會委託其審計和風險委員會監督Mesoblast的網路安全風險管理,包括確保管理層建立了評估和管理網路安全風險的流程。我們的執行管理團隊成員與我們管理的IT和網路安全服務提供商一起,向審計與風險委員會通報了公司的網路安全舉措、重大風險和正在進行的緩解工作的最新情況。在2024財年,我們沒有發現任何已經或可能對我們的業務戰略、運營業績或財務狀況產生重大影響的網路安全威脅。然而,儘管我們採取了積極的措施,但我們不能完全消除網路安全風險,也不能保證沒有未被髮現的事件發生。第三部分專案17.財務報表見“專案18.財務報表”。專案18.財務報表以下財務報表作為本年度報告的一部分以表格20-F的形式提交。澳大利亞資訊披露要求所有新聞稿、財務報告和其他資訊均可在我們的網站上獲得:www.Mesoblast.com。總目次158
獨立註冊會計師事務所財務報表索引(普華永道,澳大利亞墨爾本,審計師事務所ID:1379)160合併損益表1合併全面收益表165合併權益變動表167合併現金流量表168合併財務報表附註169目錄159
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普華永道,荷蘭銀行52 780 433 757 2河濱碼頭,南岸VIC 3006,郵政總局信箱1331,墨爾本VIC 3001電話:61 3 8603 1000,F:61 3 8603 1999,www.pwc.com.au根據專業標準立法批准的計劃責任有限。本人謹此聲明,就本人所知及所信,並無違反2001年公司法有關審計的獨立要求;及(B)並無違反有關審計的任何適用專業操守守則。本聲明針對中原股份有限公司及其在此期間所控制的實體。喬恩·羅伯茨墨爾本合夥人普華永道2024年8月29日161
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Mesoblast Limited合併損益表截至6月30日的年度,(美元,千,收入(25,353)(27,1)(32,815)製造商業化(15,717)(27,733)(30,757)管理和行政(23,626)(25,374)(27,210)重新計量或有對價的公允價值3(9,693)8,771 913權證負債的公允價值重新計量3,779(2,205)5,6其他營業收入和支出3,570 4,250(536)財務成本3(23,009)(20,122)(17,288)虧損前所得稅3(88,147)(82,101)(91,586)所得稅優惠/(開支)4 191 212 239本集團普通股持有人持續經營的每股虧損(87,956)(81,8)(91,347)每股基本虧損19(8.91)(10.53)(13.38)稀釋後每股虧損19(8.91)(10.53)(13.38)上述綜合收益表應與附註一併閱讀。總目次1
(87,956)(81,8)(91,347)可重新分類為損益的其他綜合(虧損)/收益專案7(B)51(573)91項不會通過其他全面收益重新分類為公允價值的損益金融資產7(B)(743)(1)(322)稅後淨額(692)(574)(231)Mesoblast Limited所有者應佔的全面虧損總額(88,8)(82,463)(91,578)以上綜合全面收益表應與附註一併閱讀。目錄表165
Mesoblast Limited權益變動表(美元,千元)已發行的資本股票期權儲備投資重估儲備外幣兌換認股權證儲備留存收益/(累計虧損)截至7月1日的總餘額,2021 1,163,153 92,855(220)(39,791)12,969(7,569)581,397虧損-(91,347)(91,347)(91,347)--(322)91--(231)本期綜合收益/(虧損)總額--(322)91-(91,347)(91,578)以業主身分與業主進行的交易:扣除交易成本後的權益貢獻1,928--1,928-1,928已貸記/(借記)權益的稅款-(239)-(239)轉讓已行使期權228(228)-基於股份支付的公允價值17-5,536-5,536 228 5,069-5,297截至6月30日的餘額,2022 7(A)1,165,309 97,924(542)(39,700)12,969(738,916)497,044截至7月1日的餘額2022 1,165,309 97,924(542)(39,700)12,969(738,916)497,044虧損-(81,8)(81,8)(81,8)其他綜合(虧損)/收入--(1)(573)--(574)本期綜合(虧損)/收入總額--(1)(573)-(81,8)(82,463)以業主身分與業主進行的交易:權益貢獻扣除交易成本淨額83,814--83,814 83,814-83,814已貸記/(借記)到股權的稅款-(212)-(212)基於股份支付的公允價值17-3,655-3,443-3,443截至6月30日的餘額,2023 7(A)1,249,123 101,367(543)(40,273)12,969(820,805)501,838截至7月1日的餘額2023 1,249,123 101,367(543)(40,273)12,969(820,805)501,838虧損-(87,956)(87,956)其他綜合(虧損)/收入--(743)51--(692)本期綜合(虧損)/收入--(743)51-(87,956)(88,8)以業主身分與業主進行的交易:扣除交易成本後的股本貢獻60,486-60,486扣除交易成本淨額1,000-1,000 61,486-61,486已貸記/(借記)權益的稅款-(191)-(191)已行使期權204的轉讓(204)-基於股份支付的公允價值17-5,870-5,870 204 5,475-5,679截至6月30日的餘額,2024 7(A)1,310,813 106,842(1,286)(40,222)12,969(908,761)480,355上述綜合權益變動表應與附註一併閱讀。總目次166
2024年2023年資產流動資產現金及現金等價物5(A)62,960 71,318貿易及其他應收賬款5(B)20,952 6,998預付款5(B)2,551 3,342流動資產總額86,463 81,658非流動資產廠房和設備6(A)1,106 1,357使用權資產6(B)2,732 5,134通過其他全面收入按公允價值計算的金融資產5(C)1,014 1,757其他非流動資產5(D)2,102 2,326無形資產6(C)575,736 577,183總非流動資產582,690 587,757總資產669,153 669,415負債流動負債貿易及其他應付賬款5(E)7,070 20,145撥備6(D)45,038 6,399借款5(F)13,862 5,952租賃負債6(B)2,626,060認股權證負債5(F)4,7 5,426流動負債總額73,243 41,982非流動負債撥備6(D)10,620 16,612借款5(F)100,483 102,811租賃負債6(B)1,952 3,672遞延代價6(F)2,500 2,500非流動負債總額115,555 125,595負債總額188,798 167,577淨資產480,355 501,838已發行股本7(A)1,310,813 1,249,123儲備7(B)78,303 73,520累計虧損(908,761)(820,805)以上綜合資產負債表應連同附註一併閱讀。總目次167
Mesoblast Limited截至6月30日的合併現金流量表,(美元,2024年2023年2022年經營活動現金流量商業化收入收到6,776 7,480 9,980政府贈款和稅收優惠及抵免收到3,819 1,118 24向供應商和僱員付款(包括商品和服務稅)(60,835)(72,683)(75,769)收到利息1,778 796 7收到所得稅/(已支付)4 20(24)經營活動現金淨流出8(B)(48,458)(63,269)(65,782)固定資產投資活動現金流量(271)(2)(157)分租投資收益234 120-許可證支付(60)(50)(75)投資活動淨現金(流出)(97)(194)(232)融資活動現金流量借款收益--51,919償還借款(10,000)-(55,458)借款支付交易成本(1,559)(574)(5,527)支付利息和其他融資成本(5,717)(6,014(6,084)發行股票的收益65,406 88,635 209發行認股權證的收益--8,081支付股票發行成本(4,356)(4,8)(222)支付租賃負債(3,522)(2,656)(2,788)融資活動的現金淨流入/(流出)40,252 74,502(9,870)現金和現金等價物淨增加/(減少)71,318 60,447 136,881 FX(虧損)/收益外國銀行賬戶的折算(55)(168)(550)第8(A)期末的現金和現金等價物8(A)62,960 71,318 60,447上述綜合現金流量表應與附註一併閱讀。總目次168
該集團的主要專有再生醫學技術平臺是基於被稱為間充質系細胞的專門細胞。本公司成立於2004年,是一家澳大利亞公司,自2004年以來一直在澳大利亞證券交易所(“澳大利亞證券交易所”)上市。2015年11月,公司在美國(“美國”)上市。該等財務報表及票據均以美元(“美元”或“美元”)列報,除非另有說明,包括某些金額以澳元(“澳元”或“澳元”)及新加坡元(“新元”或“S元”)列報。1.編制基礎Mesoblast Limited及其附屬公司的一般財務報表是根據國際會計準則委員會發布的國際財務報告準則和澳大利亞會計準則委員會發布的澳大利亞同等標準的國際財務報告準則編制的。Mesoblast Limited是一個以編制財務報表為目的的營利性實體。財務報表包括Mesoblast有限公司及其子公司。該財務報表於2024年8月29日經董事會授權發佈。董事有權修改和重新發布財務報表。(I)持續經營截至2024年6月30日,集團持有的現金儲備總額為6,300萬美元。於截至2024年6月30日止年度,本集團執行重組專案優先次序及營運精簡活動,因此減少了營運活動的現金使用淨額,截至2024年6月30日止年度為4,850萬美元,較上一期間減少23%。隨著本集團準備獲得美國食品及藥物管理局(FDA)的首個產品批准,並配合其商業推出計劃,將需要來自資本市場、戰略合作夥伴關係、產品特定融資或特許權使用費貨幣化的額外資金流入,以滿足本集團至少在未來12個月內與本集團業務戰略一致的預計支出。由於該等事宜,存在與事件或情況有關的重大不確定性,該等事件或情況可能令人對本集團作為持續經營企業的持續經營能力產生重大懷疑(或根據上市公司會計監督委員會(“PCAOB”)準則所設想的重大懷疑),因此本集團可能無法在正常業務過程中變現其資產及履行其負債。合併財務報表不包括這一不確定性結果可能導致的任何調整。(Ii)歷史成本慣例本財務報表乃根據歷史成本慣例編制,並經按其他全面收益按公允價值重估金融資產及透過損益及投資財產按公允價值重估金融資產及負債(包括衍生工具)而修訂。該標準取代了IAS 1《目錄表示法》169
財務報表“影響主要財務報表和附註的列報,包括損益表,公司將被要求列報經營、投資和融資活動的不同類別的收入和費用,並為每個新類別規定小計。該標準還將要求在合併財務報表內的單獨附註中解釋並列入管理層定義的業績衡量標準。該準則適用於2027年1月1日或之後開始的年度報告期,包括中期財務報表,並要求追溯適用。該小組目前正在評估新標準的影響。本集團於2024年6月30日報告期內並無其他尚未採納的新會計準則及詮釋,預期會對本集團造成重大影響。(V)使用估計編制該等綜合財務報表時,本集團須作出影響資產、負債、收入及開支的呈報金額及相關披露的估計及判斷。本集團持續評估其主要會計政策及估計。估計乃根據過往經驗及本集團認為在當時情況下屬合理的各種特定市場及其他相關假設而作出,其結果構成對資產及負債賬面值作出判斷的基礎。(Vi)對“新冠肺炎”後遺症、地緣政治或經濟不穩定因素及氣候事件的影響估計數於每個期間進行評估及更新,以反映最新資料,例如與“新冠肺炎”疫情後遺症、地緣政治及/或經濟不穩定因素有關的經濟考慮因素,或氣候事件可能對本集團的主要會計估計數位產生的影響。本集團預計這些領域不會對本集團的重大會計估計產生重大影響。本報告期間的重大變化(I)重大事件本集團的財務狀況和業績在截至2024年6月30日的年度內受到下列事件的影響:·2023年8月,FDA對本集團的生物製品許可證申請(“BLA”)重新提交了完整的回復函(“CRL”),以治療兒童激素難治性急性移植物抗宿主病(SR-aGVHD),並需要更多數據支持上市批准,包括效力分析或臨床數據。2024年3月,FDA通知專家組,經過進一步考慮,MSB-GVHD001第三階段研究的現有臨床數據似乎足以支持提交建議的REMSTEM-L用於治療SR-aGVHD兒童患者的BLA。如附註15所述,2024年7月,專家組重新提交其BLA,以批准REMESTEM CELL-L治療患有SR-aGVHD的兒科患者,涉及2023年8月CRL中的剩餘專案。2024年7月,FDA接受了該集團的BLA重新提交,並將處方藥使用費法案(PDUFA)的目標日期定為2025年1月7日。與SR-aGVHD相關的假設包含在Osiris間充質幹細胞(“MSC”)產品的減值評估中,包括正在進行的研發、或有對價、上市前庫存和綜合資產負債表上的NovaQuest借款,以及預測運營現金淨使用量。FDA關於該集團重新提交BLA的決定的結果可能會導致這些領域內使用的假設發生變化。·2024年3月,集團完成了按比例加速的不可放棄權利要約,以及於2023年12月啟動的向現有合格股東配售Mesoblast Limited新的全額繳足普通股的機構配售,以每股0.3澳元的發行價籌集了9,700澳元的萬。3,970澳元萬(6,030澳元萬)和2,470澳元萬(3,670澳元萬)的收益分別於2023年12月和2024年3月收到並確認為現金和現金等價物。目錄表170
3.所得稅前虧損收入商業化收入5,902 7,501 9,039里程碑收入--總收入5,902 7,501 10,211臨床試驗和研究開發(3,963)(8,771)(10,483)製造生產和開發(13,252)(25,468)(28,884)員工福利工資和員工福利(20,415)(17,197)(18,997)固定繳費養老金支出(369)(384)(402)股權結算基於股份的支付交易(1)(5,870)(3,655)(5,536)員工福利總額(26,654)(21,236)(24,935)非流動資產折舊及攤銷(410)(953)(1,144)使用權資產折舊(2,771)(1,661)(1,717)知識產權攤銷(1,485)(1,493)(1,519)非流動資產折舊及攤銷總額(4,666)(4,107)(4,380)其他管理費用行政(8,584)(10,104)(10,157)諮詢(2,458)(3,922)(3,751)法律,專利和其他專業費用(2,342)(3,695)(5,571)知識產權費用(不包括上述攤銷金額)(2,777)(2,993)(2,621)其他管理費用總額(16,161)(20,714)(22,100)重新計量或有代價的公允價值重新計量或有代價的重新計量5(G)(Iii)(9,693)8,771 913或有代價的公允價值重新計量(9,693)8,771 913權證負債的公允價值重新計量5(G)779(2,205)5,6重新計量認股權證負債的公允價值總額779(2,205)5,6其他營業收入和支出研究與開發稅收獎勵收入(2)859 3,506--利息收入1,824 831 3外匯(虧損)/收益(76)(163)(536)註銷使用權資產-76--已支付的外國預扣稅(37)--(3)截至6月30日的年度,其他營業收入和支出總額2,570 4,250(536),(美元,千)注2024 2023 2022目錄171
財務(成本)/收益借款安排的重新計量(2,351)(678)(382)利息支出(20,658)(19,444)(16,906)財務總成本(23,009)(20,122)(17,288)所得稅前總虧損(88,147)(82,101)(91,586)截至6月30日的年度(以美元為單位)注2024 2023 2022(1)截至6月30日、2024、2023和2022的基於股票的支付交易基於股份的支付交易已反映在綜合全面收益功能支出類別表中如下:截至6月30日的年度,2024 2023 2022研發2,797,830 1,669,514 3,547,182製造和商業化176,907(1,136)378,096管理和行政2,5,431 1,986,968 1,610,567股權結算的基於股份的支付交易5,870,168 3,655,346 5,555,845(2)研究和開發活動符合澳大利亞政府創新澳大利亞研究和開發稅收激勵計劃的資格,用於與符合法規標準的研究相關的研究和開發活動。管理層對這些活動和支出進行了評估,以確定哪些費用可能符合獎勵計劃的條件。本集團每年評估以前的研發稅務申報額,以及在澳洲申請這項稅務優惠的持續資格。在截至2024年6月30日、2023年6月30日和2022年6月30日的年度,集團分別錄得90美元萬、350美元萬和零研發稅收優惠收入。在截至2023年6月30日的年度確認的350美元萬中,120美元的萬與截至2023年6月30日的年度有關,110美元的萬與截至2022年6月30日的年度有關,120美元的萬與截至2021年6月30日的年度有關。管理層結束了對截至2023年6月30日的年度的合格活動的評估,並確認了截至2023年6月30日、2022年和2021年6月30日的年度的相關收入。於截至2022年及2021年6月30日止年度,由於管理層尚未確認本集團的研發活動是否符合獎勵計劃的資格,故並無確認任何收入。目錄表172
extension, afforded by the governmental authority could be less than we request. In addition, if a patent we wish to extend is owned by another party and licensed to us, we may need to obtain approval and cooperation from our licensor to request the extension. If we are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the period before we might face generic or follow-on competition could be shortened and we may not be able to stop our competitors from launching competing products following our patent expiration, and our revenue could be reduced, possibly materially. Risks Related to Our Business and Industry If we fail to attract and keep senior management and key scientific, commercial, regulatory affairs and other personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates. We are highly dependent on members of our executive management, particularly Dr. Silviu Itescu, our Chief Executive Officer. Dr. Itescu was an early pioneer in the study and clinical development of cell therapeutics and is globally recognized in the field of regenerative medicine. The loss of the services of Dr. Itescu or any other member of the executive management team could impede the achievement of our research, development and commercialization objectives. Recruiting and retaining qualified scientific, clinical, manufacturing, regulatory affairs, sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. Our employees, principal investigators, consultants and collaboration partners may engage in misconduct or other improper activities, including noncompliance with laws and regulatory standards and requirements and insider trading. We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards we have established, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements (including arrangements with healthcare providers, opinion leaders, research institutions, distributors and payors) in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self- dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of activity relating to pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation, or, given we are a listed company in Australia and the United States, breach of insider trading or other securities laws and regulations. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. We may acquire other companies or assets which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results. We have in the past and may in the future seek to acquire businesses, products or technologies that we believe could complement or expand our product offerings, enhance our technical capabilities or otherwise offer growth opportunities. For example, we acquired MSC assets in 2013. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies successfully, or effectively manage the combined business following the acquisition. We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including: • incurrence of acquisition-related costs; Table of Contents 33
• diversion of management’s attention from other business concerns; • unanticipated costs or liabilities associated with the acquisition; • harm to our existing business relationships with collaborators as a result of the acquisition; • harm to our brand and reputation; • the potential loss of key employees; • use of resources that are needed in other parts of our business; and • use of substantial portions of our available cash to consummate the acquisition. In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results arising from the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our business, results of operations and financial condition may be adversely affected. We and our collaborators must comply with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities. We and our collaborators are subject to various federal, state and local environmental laws, rules and regulations, including those relating to the discharge of materials into the air, water and ground, the manufacture, storage, handling, use, transportation and disposal of hazardous and biological materials, and the health and safety of employees with respect to laboratory activities required for the development of products and technologies. In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, it could cause an interruption of our commercialization efforts, research and development efforts, or business operations, and we could be held liable for any resulting damages and any such liability could exceed our assets and resources. We work with outside scientists and their institutions in developing product candidates. These scientists may have other commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to leverage our discovery platform. We work with scientific advisors and collaborators at academic research institutions in connection with our product development. These scientific advisors serve as our link to the specific pools of trial participants we are targeting in that these advisors may: • identify individuals as potential candidates for study; • obtain their consent to participate in our research; • perform medical examinations and gather medical histories; • conduct the initial analysis of suitability of the individuals to participate in our research based on the foregoing; and • collect data and biological samples from trial participants periodically in accordance with our study protocols. These scientists and collaborators are not our employees, rather they serve as either independent contractors or the primary investigators under research collaboration agreements that we have with their sponsoring academic or research institution. Such scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for another entity arises, we may lose their services. It is also possible that some of our valuable proprietary knowledge may become publicly known through these scientific advisors if they breach their confidentiality agreements with us, which would cause competitive harm to our business. If our ability to use cumulative carry forward net operating losses is or becomes subject to certain limitations or if certain tax incentive credits from which we may benefit expire or no longer apply to us, our business, results of operations and financial condition may be adversely affected. We are an Australian company subject to taxation in Australia and other jurisdictions. As of June 30, 2024, our cumulative operating losses have a total potential tax benefit of $214.7 million at local tax rates (excluding other temporary differences). These losses may be available for use once we are in a tax profitable position. These losses were incurred in Table of Contents 34
different jurisdictions and can only be offset against profits earned in the relevant jurisdictions. Tax losses are able to be carried forward at their nominal amount indefinitely in Australia and in Singapore, and for up to 20 years in the U.S. as long as certain conditions are met; however, new tax reform legislation in the United States allows for indefinite carryforward of any net operating loss arising in a tax year ending after December 31, 2018, subject to certain conditions. In order to use these tax losses, it is necessary to satisfy certain tests and, as a result, we cannot assure you that the tax losses will be available to offset profits if and when we earn them. Utilization of our net operating loss and research and development credit carryforwards in the U.S. may be subject to substantial annual limitation due to ownership change limitations that could occur in the future generally provided by Section 382 of the Internal Revenue Code of 1986, as amended. In addition, U.S. tax reform introduced a limitation on the amount of net operating losses arising in taxable years beginning after December 31, 2017, that a corporation may deduct in a single tax year equal to the lesser of the available net operating loss carryover or 80 percent of a taxpayer’s pre-net operating loss deduction taxable income. With respect to carryforward net operating losses in the U.S. that are subject to the 20-year carry-forward limit, our carry forward net operating losses first start to expire in 2032. In addition, we may be eligible for certain research and development tax incentive refundable credits in Australia that may increase our available cash flow. The Australian federal government's Research and Development Tax Incentive grant is available for eligible research and development purposes based on the filing of an annual application. The Australian government may in the future decide to modify the requirements of, reduce the amounts of the research and development tax incentive credits available under, or discontinue its research and development tax incentive program. For instance, the Australian government undertook a review of its Research and Development Tax Incentive program in the May 2020 Federal budget and in October 2020 introduced new legislation for the tax offset applicable to eligible companies for income tax years commencing from July 1, 2021. One of the legislation changes made was to allow a tax offset for companies with an aggregated turnover of A$20.0 million or more. For companies with an aggregated turnover of A$20.0 million or more, the rate of tax offset is the company’s corporate tax rate plus a rate between 8.5% and 16.5% depending on the proportion of research and development expenditures in relation to total expenditures. For companies with an aggregated turnover below A$20.0 million, the rate of the refundable research and development tax offset was set as at 18.5% above the company’s tax rate. If the Research and Development Tax program incentives are revoked or modified, or if we are no longer eligible for such incentives due to other circumstances, our business, results of operations and financial condition may be adversely affected. We assess, on an annual basis, the quantum of previous research and development tax claims and on-going eligibility to claim this tax incentive in Australia. For the years ended June 30, 2024 and 2023, we recognized $0.9 million and $3.5 million in research and development tax incentive income, respectively. During the year ended June 30, 2023, management concluded its assessment of qualifying activities and recognized the relevant income for the years ended June 30, 2023, 2022 and 2021. No income was recognized in the years ended June 30, 2022 and 2021 as management were yet to confirm if our research and development activities were eligible under the incentive scheme and therefore had not applied for a tax offset. There can be no assurances that we will benefit from these incentives in the future if our activities are not eligible under the incentive scheme or that the tax incentive credit programs will not be revoked or modified in any way in the future. Taxing authorities could reallocate our taxable income within our subsidiaries, which could increase our consolidated tax liability. We conduct operations in multiple tax jurisdictions and the tax laws of those jurisdictions generally require that the transfer pricing between affiliated companies in different jurisdictions be the same as those between unrelated companies dealing at arms’ length, and that such prices are supported by contemporaneous documentation. While we believe that we operate in compliance with applicable transfer pricing laws and intend to continue to do so, our transfer pricing procedures are not binding on applicable tax authorities. If tax authorities in any of these countries were to successfully challenge our transfer pricing as not reflecting arms’ length transactions, they could require us to adjust our transfer pricing and thereby reallocate our income to reflect these revised transfer pricing, which could result in a higher tax liability to us, and possibly interest and penalties, and could adversely affect our business, results of operations and financial condition. Table of Contents 35
The pharmaceutical industry is highly regulated and pharmaceutical companies are subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. Healthcare fraud and abuse regulations are complex and can be subject to varying interpretations as to whether or not a statute has been violated. The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute which prohibits, among other things, the knowing and willful payment of remuneration to induce or reward patient referrals, prescribing or recommendation of products, or the generation of business involving any item or service which may be payable by the federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients); • the federal False Claims Act which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment for government funds (e.g., payment from Medicare or Medicaid) or knowingly making, using, or causing to be made or used a false record or statement, material to a false or fraudulent claim for government funds; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HIPAA imposes civil and criminal liability for the wrongful access or disclosure of protected health information; • the federal Physician Payments Sunshine Act, created under Section 6002 of the Patient Protection and Affordable Care Act (“ACA”), as amended, requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, those physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members; • the FDCA, which, among other things, regulates the testing, development, approval, manufacture, promotion and distribution of drugs, devices and biologics. The FDCA prohibits manufacturers from selling or distributing “adulterated” or “misbranded” products. A drug product may be deemed misbranded if, among other things, (i) the product labeling is false or misleading, fails to contain requisite information or does not bear adequate directions for use; (ii) the product is manufactured at an unregistered facility; or (iii) the product lacks the requisite FDA clearance or approval; • the U.S. Foreign Corrupt Practices Act (“FCPA”), which prohibits corrupt payments, gifts or transfers of value to non-U.S. officials; and • non-U.S. and U.S. state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers. Any failure to comply with these laws, or the regulations adopted thereunder, could result in administrative, civil, and/or criminal penalties, and could result in a material adverse effect on our reputation, business, results of operations and financial condition. The federal fraud and abuse laws have been interpreted to apply to arrangements between pharmaceutical manufacturers and a variety of health care professionals and healthcare organizations. Although the federal Anti-Kickback Statute has several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, all elements of the potentially applicable exemption or safe harbor must be met in order for the arrangement to be protected, and prosecutors have interpreted the federal healthcare fraud statutes to attack a wide range of conduct by pharmaceutical companies. In addition, most states have statutes or regulations similar to the federal anti-kickback and federal false claims laws, which apply to items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the payor. Administrative, civil and criminal sanctions may be imposed under these federal and state laws. Further, the ACA, among other things, amended the intent standard under the Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the ACA makes clear that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal False Claims Act. Any Table of Contents 36
violations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition. A failure to adequately protect private health information could result in severe harm to our reputation and subject us to significant liabilities, each of which could have a material adverse effect on our business. Throughout the clinical trial process, we may obtain the private health information of our trial subjects. There are a number of state, federal and international laws protecting the privacy and security of health information and personal data. As part of the American Recovery and Reinvestment Act 2009 (“ARRA”), Congress amended the privacy and security provisions of HIPAA. HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers conducting certain electronic transactions, healthcare clearinghouses, and health insurance plans, collectively referred to as covered entities. The HIPAA amendments also impose compliance obligations and corresponding penalties for non-compliance on certain individuals and entities that provide services to or perform certain functions on behalf of healthcare providers and other covered entities involving the use or disclosure of individually identifiable health information, collectively referred to as business associates. ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement authority to state attorneys general. The amendments also create notification requirements to federal regulators, and in some cases local and national media, for individuals whose health information has been inappropriately accessed or disclosed. Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance with certain encryption or other standards developed by the U.S. Department of Health and Human Services, or HHS. Most states have laws requiring notification of affected individuals and state regulators in the event of a breach of personal information, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significant data security requirements, such as encryption or mandatory contractual terms to ensure ongoing protection of personal information. Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non- compliance. The EU’s General Data Protection Regulation, Canada’s Personal Information Protection and Electronic Documents Act and other data protection, privacy and similar national, state/provincial and local laws and regulations may also restrict the access, use and disclosure of patient health information abroad. We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate problems caused by such breaches, and the failure to so comply may lead to fines or penalties. Our operations are subject to anti-corruption laws, including Australian bribery laws, the United Kingdom Bribery Act, and the FCPA and other anti-corruption laws that apply in countries where we do business. Anti-corruption laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. Although we believe that we have adequate policies and enforcement mechanisms to ensure legal and regulatory compliance with the FCPA, the U.K. Bribery Act 2010 and other similar regulations, we participate in collaborations and relationships with third parties, and it is possible that any of our employees, subcontractors, agents or partners may violate any such legal and regulatory requirements, which may expose us to criminal or civil enforcement actions, including penalties and suspension or disqualification from U.S. federal procurement contracting. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti- corruption laws or other laws including trade related laws. If we are not in compliance with these laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of these laws by respective government bodies could also have an adverse impact on our reputation, our business, results of operations and financial condition. We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur additional legal, accounting and other expenses. In order to maintain our current status as a foreign private issuer, either (1) a majority of our ordinary shares must be either directly or indirectly owned of record by non-residents of the United States or (2) (a) a majority of our executive officers or directors must not be U.S. citizens or residents, (b) more than 50 percent of our assets cannot be located in the Table of Contents 37
U.S. and (c) our business must be administered principally outside the U.S. If we lost this status, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers. We may also be required to make changes in our corporate governance practices in accordance with various SEC rules and Nasdaq listing standards. Further, we would be required to comply with U.S. GAAP, as opposed to IFRS, in the preparation and issuance of our financial statements for historical and current periods. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer may be higher than the cost we would incur as a foreign private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs. If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired. Section 404(a) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) requires that our management assess and report annually on the effectiveness of our internal controls over financial reporting and identify any material weaknesses in our internal controls over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs and significant management oversight. If either we are unable to conclude that we have effective internal controls over financial reporting or our independent auditors are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal controls over financial reporting as required by Section 404(b) of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, the price of the ADSs could decline and we may be subject to litigation or regulatory enforcement actions. In addition, if we are unable to meet the requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to remain listed on Nasdaq Global Select Market (“Nasdaq”). We have incurred and will continue to incur significant increased costs as a result of operating as a company whose ADSs are publicly traded in the United States, and our management will continue to be required to devote substantial time to compliance initiatives. As a company whose ADSs are publicly traded in the United States, we have incurred and will continue to incur significant legal, accounting, insurance and other expenses. The Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform and Consumer Protection Act and related rules implemented by the SEC and Nasdaq, have imposed various requirements on public companies including requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need to continue to devote a substantial amount of time to these compliance initiatives, and we will need to add additional personnel and build our internal compliance infrastructure. Moreover, these rules and regulations have increased and will continue to increase our legal and financial compliance costs and will make some activities more time-consuming and costly. These laws and regulations could also make it more difficult and expensive for us to attract and retain qualified persons to serve on our board of directors, our board committees or as our senior management. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of the ADSs, fines, sanctions and other regulatory action and potentially regulatory investigations and enforcement and/or civil litigation. We have never declared or paid dividends on our ordinary shares, and we do not anticipate paying dividends in the foreseeable future. Therefore, you must rely on price-appreciation of our ordinary shares or ADSs for a return on your investment. We have never declared or paid cash dividends on our ordinary shares. For the foreseeable future, we currently intend to retain all available funds and any future earnings to support our operations and to finance the growth and development of our business. Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to compliance with applicable laws and covenants under the loan facilities with Oaktree and NovaQuest or other current or future credit facilities, which may restrict or limit our ability to pay dividends, and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant. We do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future. As a result, a return on your investment in our ordinary shares or ADSs will likely only occur if our ordinary share or ADS price appreciates. There is no guarantee that our ordinary shares or ADSs will appreciate in value in the future. Table of Contents 38
Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares or ADSs. We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Australian Corporations Act 2001 (the “Corporations Act”). Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting power in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares. This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ opportunity to sell their ordinary shares or ADSs and may further restrict the ability of our shareholders to obtain a premium from such transactions. Significant disruptions of information technology systems, data security breaches or unauthorized disclosure of sensitive data could adversely affect our business by exposing us to liability and affect our business and reputation. The Company is increasingly dependent on critical, complex, and interdependent information technology systems (IT systems), including cloud-based software and external servers, some of which are managed or hosted by third parties, to support business processes as well as internal and external communications. The information and data processed and stored in our IT systems, and those of our research collaborators, CROs, contract manufacturers, suppliers, distributors, or other third parties for which we depend to operate our business, may be vulnerable to cybersecurity breaches from unauthorized activity by our employees, contractors or malware, hacking, business email compromise, phishing or other cyberattacks directed by other parties. Such breaches can result in loss, damage, denial-of-service, unauthorized access or misappropriation and may pose a risk that sensitive data, including our intellectual property, trade secrets or personal information of our employees, patients, customers or other business partners may be exposed to unauthorized persons or to the public. In addition, our increased reliance on personnel working from home may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business. The increase in working remotely could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations or delay necessary interactions with local and federal regulators, manufacturing sites, clinical trial sites, and other third parties. The rapidly moving nature of technology and the increasing sophistication of cybersecurity threats, may mean our measures to prevent, respond to and minimize such risks may be ineffective. If a material incident or interruption were to occur, it could result in a disruption of our development programs and future commercial operations, including due to a loss, corruption or unauthorized disclosure of our proprietary or sensitive information. Additionally, the costs to the company to investigate and mitigate cybersecurity incidents could be significant. Any disruption, security breach, or action by the company, its employees, or contractors that might be inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within Australia and the United States and elsewhere where we conduct business, could result in; enforcement actions by both countries state and federal governments or foreign governments, liability or sanctions under data privacy laws including healthcare laws such as the Privacy Act or HIPAA that protect certain types of sensitive information, regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation which could harm our business and operations. Risks Related to Our Trading Markets The market price and trading volume of our ordinary shares and ADSs may be volatile and may be affected by economic conditions beyond our control. Such volatility may lead to securities litigation. The market price of our ordinary shares and ADSs may be highly volatile and subject to wide fluctuations. In addition, the trading volume of our ordinary shares and ADSs may fluctuate and cause significant price variations to occur. We cannot assure you that the market price of our ordinary shares and ADSs will not fluctuate or significantly decline in the future. Some specific factors that could negatively affect the price of our ordinary shares and ADSs or result in fluctuations in their price and trading volume include: • results of clinical trials of our product candidates; • results of clinical trials of our competitors’ products; Table of Contents 39
• regulatory actions with respect to our products or our competitors’ products; • actual or anticipated fluctuations in our quarterly operating results or those of our competitors; • publication of research reports by securities analysts about us or our competitors in the industry; • our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; • fluctuations of exchange rates between the U.S. dollar and the Australian dollar; • additions to or departures of our key management personnel; • issuances by us of debt or equity securities; • litigation or investigations involving our company, including: shareholder litigation; investigations or audits by regulators into the operations of our company; or proceedings initiated by our competitors or clients; • strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; • the passage of legislation or other regulatory developments affecting us or our industry; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • changes in trading volume of ADSs on the Nasdaq and of our ordinary shares on the ASX; • sales or perceived potential sales of the ADSs or ordinary shares by us, our directors, senior management or our shareholders in the future; • short selling or other market manipulation activities; • announcement or expectation of additional financing efforts; • terrorist acts, acts of war or periods of widespread civil unrest (such as Russia’s invasion of Ukraine); • natural disasters, the impact of climate change and other calamities; • changes in market conditions for biopharmaceutical companies; and • conditions in the U.S. or Australian financial markets or changes in general economic conditions. In the past, following periods of volatility in the market price of a company’s securities, shareholders often instituted securities class action litigation against that company. If we were involved in a class action suit, it could divert the attention of senior management, require significant expenditure for defense costs, and, if adversely determined, could have a material adverse effect on our results of operations and financial condition. A class action proceeding in the Federal Court of Australia was served on the Company in May 2022 by the law firm William Roberts Lawyers on behalf of persons who, between February 22, 2018, and December 17, 2020, acquired an interest in Mesoblast shares, American Depository Receipts, and/or related equity swap arrangements. In June 2022, the firm Phi Finney McDonald commenced a second shareholder class action against the Company in the Federal Court of Australia asserting similar claims arising during the same period. The Australian class actions relate to the Complete Response Letter released by the FDA in relation to our GvHD product candidate; they also relate to certain representations made by the Company in relation to our COVID-19 product candidate and the decline in the market price of our ordinary shares in December 2020. The Australian class actions have been consolidated into one lawsuit. On August 21, 2024, the Company announced that the class action had been resolved subject to Federal Court approval. The settlement (inclusive of interest and costs) will be funded entirely by Mesoblast's insurers and includes no admission of liability. The settlement will have no impact on Mesoblast's cashflow or financial results. The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of these securities. Our ADSs are listed on the Nasdaq and our ordinary shares are listed on the ASX. We cannot predict the effect of this dual listing on the value of our ordinary shares and ADSs. However, the dual listing of our ordinary shares and ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the development of an active trading market for the ADSs in the United States. The price of the ADSs could also be adversely affected by trading in our ordinary shares on the ASX, and vice versa. Table of Contents 40
If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the market price and trading volume of our ordinary shares and/or ADSs could decline. The trading market for our ordinary shares and ADSs could be influenced by the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts may discontinue research on our company, to the extent such coverage currently exists, or in other cases, may never publish research on our company. If too few securities or industry analysts commence coverage of our company, the trading price for our ordinary shares and ADSs would likely be negatively impacted. If one or more of the analysts who cover us downgrade our ordinary shares or ADSs or publish inaccurate or unfavorable research about our business, the market price of our ADSs would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our ordinary shares and/or ADSs could decrease, which might cause our price and trading volume to decline. Risks Related to Ownership of Our ADSs An active trading market for the ADSs may not develop in the United States. Our ADSs are listed in the United States on the Nasdaq under the symbol “MESO.” However, we cannot assure you that an active public market in the United States for the ADSs will develop on that exchange, or if developed, that this market will be sustained. We currently report our financial results under IFRS, which differs in certain significant respect from U.S. GAAP. Currently we report our financial statements under IFRS. There have been and there may in the future be certain significant differences between IFRS and U.S. GAAP, including differences related to revenue recognition, intangible assets, share-based compensation expense, income tax and earnings per share. As a result, our financial information and reported earnings for historical or future periods could be significantly different if they were prepared in accordance with U.S. GAAP. In addition, we do not intend to provide a reconciliation between IFRS and U.S. GAAP unless it is required under applicable law. As a result, you may not be able to meaningfully compare our financial statements under IFRS with those companies that prepare financial statements under U.S. GAAP. As a foreign private issuer, we are permitted and expect to follow certain home country corporate governance practices in lieu of certain Nasdaq requirements applicable to domestic issuers and we are permitted to file less information with the Securities and Exchange Commission than a company that is not a foreign private issuer. This may afford less protection to holders of our ADSs. As a “foreign private issuer”, as defined in Rule 405 under the Securities Exchange Act of 1933, as amended (the “Securities Act”), whose ADSs will be listed on the Nasdaq, we will be permitted to, and plan to, follow certain home country corporate governance practices in lieu of certain Nasdaq requirements. For example, we may follow home country practice with regard to certain corporate governance requirements, such as the composition of the board of directors and quorum requirements applicable to shareholders’ meetings. This difference may result in a board that is more difficult to remove and less shareholder approvals required generally. In addition, we may follow home country practice instead of the Nasdaq Global Select Market requirement to hold executive sessions and to obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions or private placements of securities. The above differences may result in less shareholder oversight and requisite approvals for certain acquisition or financing related decisions. Further, we may follow home country practice instead of the Nasdaq Global Select Market requirement to obtain shareholder approval prior to the establishment or amendment of certain share option, purchase or other compensation plans. This difference may result in less shareholder oversight and requisite approvals for certain company compensation related decisions. A foreign private issuer must disclose in its annual reports filed with the Securities and Exchange Commission, or SEC, and the Nasdaq Global Select Market, the requirements with which it does not comply followed by a description of its applicable home country practice. The Australian home country practices described above may afford less protection to holders of the ADSs than that provided under the Nasdaq Global Select Market rules. Further, as a foreign private issuer, we are exempt from certain rules under the “Exchange Act”, that impose disclosure requirements as well as procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as a company that files as a domestic issuer whose securities are registered under the Exchange Act, nor are we generally required to comply with the SEC’s Regulation FD, which restricts the selective disclosure of material non-public information. Accordingly, the information may not be disseminated in as Table of Contents 41
timely a manner, or there may be less information publicly available concerning us generally than there is for a company that files as a domestic issuer. ADS holders may be subject to additional risks related to holding ADSs rather than ordinary shares. ADS holders do not hold ordinary shares directly and, as such, are subject to, among others, the following additional risks. • As an ADS holder (and not the holder of ordinary shares underlying your ADSs), we will not treat you as one of our shareholders and you will not be able to exercise shareholder rights, except through the American depositary receipt, or ADR, depositary as permitted by the deposit agreement. • Distributions on the ordinary shares represented by your ADSs will be paid to the ADR depositary, and before the ADR depositary makes a distribution to you on behalf of your ADSs, any withholding taxes that must be paid will be deducted. Additionally, if the exchange rate fluctuates during a time when the ADR depositary cannot convert the foreign currency, you may lose some or all of the value of the distribution. • We and the ADR depositary may amend or terminate the deposit agreement without the ADS holders’ consent in a manner that could prejudice ADS holders. ADS holders must act through the ADR depositary to exercise your voting rights and, as a result, you may be unable to exercise your voting rights on a timely basis. As a holder of ADSs (and not the ordinary shares underlying your ADSs), we will not treat you as one of our shareholders, and you will not be able to exercise shareholder rights. The ADR depositary will be the holder of the ordinary shares underlying your ADSs, and ADS holders will be able to exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the deposit agreement relating to the ADSs. There are practical limitations on the ability of ADS holders to exercise their voting rights due to the additional procedural steps involved in communicating with these holders. For example, holders of our ordinary shares will receive notice of shareholders’ meetings by mail or email and will be able to exercise their voting rights by either attending the shareholders meeting in person or voting by proxy. ADS holders, by comparison, will not receive notice directly from us. Instead, in accordance with the deposit agreement, we will provide notice to the ADR depositary of any such shareholders meeting and details concerning the matters to be voted upon. As soon as practicable after receiving notice from us of any such meeting, the ADR depositary will mail to holders of ADSs the notice of the meeting and a statement as to the manner in which voting instructions may be given by ADS holders. To exercise their voting rights, ADS holders must then instruct the ADR depositary as to voting the ordinary shares represented by their ADSs. Due to these procedural steps involving the ADR depositary, the process for exercising voting rights may take longer for ADS holders than for holders of ordinary shares. The ordinary shares represented by ADSs for which the ADR depositary fails to receive timely voting instructions will not be voted. Under Australian law and our Constitution, any resolution to be considered at a meeting of the shareholders shall be decided on a show of hands unless a poll is demanded by the shareholders at or before the declaration of the result of the show of hands. Under voting by a show of hands, multiple “yes” votes by ADS holders will only count as one “yes” vote and will be negated by a single “no” vote, unless a poll is demanded. If we are or become classified as a passive foreign investment company, our U.S. securityholders may suffer adverse tax consequences. Based upon an analysis of our income and assets for the taxable year ended June 30, 2024, we do not believe we were a passive foreign investment company (a "PFIC") for our most recent tax year. In general, if at least 75% of our gross income for any taxable year consists of passive income or at least 50% of the average quarterly value of assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, then we will be classified as a PFIC for U.S. federal income tax purposes. Passive income for this purpose generally includes dividends, interest, certain royalties and rents, and gains from commodities and securities transactions. Passive assets for this purpose generally includes assets held for the production of passive income. Accordingly, passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing, debt instruments or bank deposits that are readily convertible into cash. Since PFIC status depends upon the composition of our income and assets and the market value of our assets from time to time, and since the determination of PFIC status must be made annually at the end of each taxable year, there can be no assurance that we will not be considered a PFIC for any future taxable year. Investors should be aware that our gross income for purposes of the PFIC income test depends on the receipt of active revenue, and there can be no assurances that such active revenue will continue, or that we will receive other gross income that is not considered passive for purposes of the PFIC income test. If we were a PFIC for any taxable year during a U.S. investor’s Table of Contents 42
holding period for the ordinary shares or ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S. investor owned the ordinary shares or ADSs. If we were treated as a PFIC, U.S. investors would be subject to special punitive tax rules with respect to any "excess distribution" received from us and any gain realized from a sale or other disposition (including a pledge) of the ordinary shares or ADSs unless a U.S. investor made a timely "qualified electing fund" or "mark-to-market" election. For a more detailed discussion of the U.S. tax consequences to U.S. investors if we were classified as a PFIC, see Item 10.E - "Taxation — Certain Material U.S. Federal Income Tax Considerations to U.S. Holders — Passive Foreign Investment Company". Changes in foreign currency exchange rates could impact amounts you receive as a result of any dividend or distribution we declare on our ordinary shares. Any significant change in the value of the Australian dollar may impact amounts you receive in U.S. dollars as a result of any dividend or distribution we declare on our ordinary shares as a holder of our ADSs. More specifically, any dividends that we pay on our ordinary shares will be in Australian dollars. The depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses, including any such fees or expenses incurred to convert any such Australian dollars into U.S. dollars. You will receive these distributions in U.S. dollars in proportion to the number of our ordinary shares your ADSs represent. Depreciation of the U.S. dollar against the Australian dollar would have a negative effect on any such distribution payable to you. You may not receive distributions on our ordinary shares represented by the ADSs or any value for such distribution if it is illegal or impractical to make them available to holders of ADSs. While we do not anticipate paying any dividends on our ordinary shares in the foreseeable future, if such a dividend is declared, the depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of our ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to holders of ADSs. We have no obligation to take any other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have a material adverse effect on the value of your ADSs. You may be subject to limitations on transfers of your ADSs. ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deems it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason. U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of our senior management. Several of our officers and directors are non-residents of the United States, and a substantial portion of the assets of such persons are located outside the U.S. As a result, it may be impossible to serve process on such persons in the United States or to enforce judgments obtained in U.S. courts against them based on civil liability provisions of the securities laws of the U.S. Even if you are successful in bringing such an action, there is doubt as to whether Australian courts would enforce certain civil liabilities under U.S. securities laws in original actions or judgments of U.S. courts based upon these civil liability provisions. In addition, awards of punitive damages in actions brought in the U.S. or elsewhere may be unenforceable in Australia or elsewhere outside the U.S. An award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered and is intended to punish the defendant. The enforceability of any judgment in Australia will depend on the particular facts of the case as well as the laws and treaties in effect at the time. The U.S. and Australia do not currently have a treaty or statute providing for recognition and enforcement of the judgments of the other country (other than arbitration awards) in civil and commercial matters. As a result, our public shareholders and holders of the ADSs may have more difficulty in protecting their interests through actions against us, our management, our directors than would shareholders of a corporation incorporated in a jurisdiction in the United States. 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Item 4. Information on the Company 4.A History and Development of Mesoblast Mesoblast Limited Mesoblast Limited was incorporated on June 8, 2004 as a public company in Australia under the Corporations Act 2001 with an indefinite duration. On December 16, 2004 we became listed on the Australian Securities Exchange (the “ASX”). On November 13, 2015, we became listed on the Nasdaq Global Select Market (“Nasdaq”) and from this date we have been dual-listed in Australia and the United States. Our registered office is located at the following address: Mesoblast Ltd Level 38 55 Collins Street Melbourne VIC 3000 Australia Telephone: +61 3 9639 6036 Web: www.mesoblast.com Our agent for service of process in the United States is Mesoblast Inc., 505 Fifth Avenue, Level 3, New York, NY 10017. All information we file with the SEC is available through the SEC's Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC's website at www.sec.gov. For a list of our significant subsidiaries, see Exhibit 8.1 to this Annual Report. Important Corporate Developments Fiscal year 2024 to date of annual report August 2024 Announced that the consolidated shareholder class action, filed in the Federal Court of Australia in 2022, has been resolved subject to Federal Court approval. The settlement (inclusive of interests and costs) will be funded entirely by Mesoblast's insurers and includes no admission of liability. July 2024 Announced the United States Food and Drug Administration ("FDA") has accepted our Biologics License Application ("BLA") resubmission for Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease ("SR-aGVHD"). FDA considered the resubmission to be a complete response and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 7, 2025. The confirmatory Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain ("CLBP") due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. Mesoblast resubmitted its BLA for approval of RYONCIL in the treatment of children with SR- aGVHD. April 2024 Jane Bell AM appointed to the role of non-executive Chair of Mesoblast's Board of Directors. March 2024 Announced that FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SR- aGVHD. Announced that US FDA supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction ("HFrEF") and a left ventricular assist device ("LVAD"). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel- L (Revascor®) under the existing Regenerative Medicine Advanced Therapy ("RMAT") designation. Table of Contents 44
February 2024 Announced that the FDA granted Mesoblast’s allogeneic cell therapy Revascor® (rexlemestrocel- L) an Orphan Drug Designation (“ODD”) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (“HLHS”), a potentially life threatening congenital heart condition. January 2024 Announced that the FDA granted Mesoblast’s cell therapy Revascor® (rexlemestrocel-L) a Rare Pediatric Disease ("RPD") designation following submission of results from the randomized controlled trial in children with HLHS. December 2023 Completed a private placement to institutional and sophisticated investors and 1 for 4 pro-rata accelerated non-renounceable entitlement offer to shareholders in Australia and certain other countries that raised A$60.3 million at an issue price of A$0.30 per ordinary share. November 2023 Announced filing for RPD designation with the FDA for REVASCOR in the treatment of the congenital heart disease HLHS. The filings were based on results from a blinded, randomized, controlled prospective trial of REVASCOR conducted at a single center in the US in 19 children with HLHS and accepted for publication in peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open). Announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs, has entered into an agreement to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with SR-aGvHD. September 2023 Announced the appointment of independent director Ms. Jane Bell as Chair of the Mesoblast Board Audit and Risk Committee. August 2023 The FDA provided a complete response to the BLA resubmission for remestemcel-L for the treatment of pediatric SR-aGVHD and requires more data to support marketing approval, including potency assay or clinical data. Mesoblast intends to conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial strategy, which envisioned a sequenced progression from pediatric to adult SR-aGVHD indications. As part of its review FDA completed the Pre-License Inspection ("PLI") of the manufacturing facility, did not issue any Form 483, and found no objectionable conditions. In addition, FDA acknowledged in the resubmission review that changes implemented appear to improve assay performance relative to the original version of the assay used in the pediatric Phase 3 trial. Environmental, Social and Governance (“ESG”) Statement Introduction: Our Approach to Sustainability We consider the greatest contribution Mesoblast makes to sustainability is its purpose in seeking to provide access to treatment for patients suffering a range of hitherto unmet medical needs including cardiac diseases, immune-mediated and inflammatory conditions, oncology and haematology diseases, and spine orthopaedic disorders, subject to regulatory approval. This has not only a potentially high social and financial value, but in terms of adding value in the way it operates, the Company prizes and develops its people as key assets, while its environmental footprint is light. Together with a strong ethical and governance framework, this puts the Company on a sound footing for delivering on its purpose in the medium to long term. Our commitment to sustainability is instilled through Mesoblast’s five key corporate values which articulate who we are and what we stand for. Mesoblast values reflect our commitment to our customers, our colleagues, and the patients we serve. Integrity is at our core, while accountability to our commitments, collective teamwork, a pursuit of excellence, and Table of Contents 45
outside the-box thinking and innovation surround our every business decision. Mesoblast personnel are expected to practice these values each and every day. Integrity - We act with integrity in all of our dealings, with the best interest of patients, care givers and our people as our guide. What we do we do with conviction. Accountability - We hold ourselves and each other responsible and ensure that our words and actions support Mesoblast’s vision and values Teamwork - We believe in what we can achieve collectively and have an appreciation of our shared and unique ability to collaborate with our people and our partners, while focused on our patients and their families. Excellence - We engage in continual learning so that we, as individuals and as an organization, can reach our highest potential. Innovation - We are focused on the bold pursuit of developing and delivering novel treatments to improve patient outcomes through cutting edge science. Acknowledging that sustainability is an overarching concept that can be applied to all areas of business finance, operations and impact, for the purposes of this Statement, we specifically focus on key environmental, social and governance (“ESG”) matters. When assessing and reporting our ESG initiatives and performance, we take into account: • Mesoblast’s size and stage in its growth cycle: it is a small development-stage biotechnology company with fewer than 100 employees, limited manufacturing and currently no commercialized product. This means that some reporting topics will be less relevant for us and our stakeholders until we grow our product portfolio and operations; and • Appropriate sustainability standards: for example, the Sustainability Accounting Standards Board’s (“SASB”) Biotechnology & Pharmaceuticals Sustainability Accounting Standard, the Global Reporting Initiative’s (“GRI”) Universal Standards, and the Biopharma Investor ESG Communications Guidance 4.0 are relevant. We identified the following material ESG topics based on an assessment of their impact on the business and our understanding of their importance to stakeholders: 1. Corporate Governance 2. Business Ethics, Integrity, and Compliance 3. Risk Management 4. Human Capital Management 5. Product Quality and Patient Safety 6. Supply Chain Management 7. Access to Healthcare 8. Environmental Impacts These are dealt with in turn below. 1. Corporate Governance Mesoblast is committed to implementing and achieving an effective corporate governance framework to ensure that the Company is managed effectively, honestly and ethically. More information on our corporate governance practices is set out in Mesoblast’s Corporate Governance Statement, available at www.mesoblast.com. The Company references and reports against ASX Corporate Governance Council’s (Council) Corporate Governance Principles and Recommendations. Table of Contents 46
Mesoblast’s Board of Directors (the “Board”) provides oversight of the Company’s ESG-related risks and opportunities on a regular basis at Board meetings, and in particular focus through its two committees: • Nomination and Remuneration Committee (“NRC”) • Audit and Risk Committee (“ARC”) The NRC assists the Board in the discharge of its responsibilities, and in particular to ensure that there is an environment where the Board can carry out effective and responsible decision making and oversight, including on ESG matters such as fair remuneration and health & safety. Since June 2022, all independent, Non-Executive Directors of the Board are members of the NRC reflecting the importance the Board places on ESG. In addition to its main financial reporting responsibilities, the ARC is tasked with overseeing the effective operation of Mesoblast’s risk management framework, in which certain ESG matters are considered. Management is responsible for assessing and managing ESG-related risks and opportunities within the board approved control framework, and for reporting progress against goals and targets to the Board. 2. Business Ethics, Integrity, and Compliance We are committed to the highest standards of ethical conduct and transparency in the way we deal with our patients, employees, strategic partners, and other important stakeholders. We comply with all national and local laws and regulations applying to our Company. Zero cases of material non-compliance occurred in FY24. Mesoblast has established a Code of Business Conduct & Ethics (“Code”) to promote honest and ethical conduct, comprehensive disclosures of business dealings, compliance with government laws and regulations, and a positive work environment. All Mesoblast personnel, including Directors, officers, employees, contractors, and consultants, are expected to comply with the principles set out in the Code. The Code covers the following topics: • Our Values • Ethical business practices • Safe workplace and respectful workplace conduct • Fair competition • Conflicts of interest • Social media use • Confidentiality and protection of assets • Quality assurance • Price reporting • Financial reporting • Securities trading • Ethical research • Interactions with the patient community • Ensuring product quality and patient safety • Interactions with healthcare professionals • Ethical marketing and advertising • Compliance with laws and regulations The Code also states that it is against Mesoblast policy for personnel to use illegal drugs or be under the influence of or impaired by alcohol or drugs while on company property or performing company work. No issues of Code non-compliance have been brought forward to the Board in FY24. Table of Contents 47
Mesoblast has an Anti-Bribery and Anti-Corruption Policy and complies with global and regional laws preventing corrupt business practices and bribery, including the U.S. Foreign Corrupt Practices Act and the United Kingdom Bribery Act. We have a Disclosure of Complaints and Concerns Policy which addresses, among other things, breaches under the Company’s Code, Anti-Bribery and Anti-Corruption Policy, or other Company policies. Under the Disclosure of Complaints and Concerns Policy, Mesoblast personnel are entitled to robust employment protections if they report concerns and suspected violations covered under the policy. Personnel can report to Legal, the Audit and Risk Committee, or other officers or senior managers, and may do so anonymously. Further, Mesoblast’s Fair Treatment Policy requires personnel to report workplace harassment and prohibits retaliation of any kind against anyone who does so in good faith. During FY24, Mesoblast was in compliance with the Fair Treatment Policy. The Company is satisfied that it adhered to its policies. In addition, Mesoblast has an ‘Ethics Hotline’ that is managed by a third-party, where our personnel and other stakeholders may make a report anonymously, 24 hours a day, seven days a week. There have been no whistle-blower reports to this hotline in the reporting period. All Mesoblast personnel are required to acknowledge the Code and other key policies and are required to participate in annual compliance training. The Company has a process in place to inform the Board or a committee of the Board of any material breaches of the Code, the Anti-Bribery and Anti-Corruption Policy, and material incidents reported under the Disclosure of Complaints and Concerns Policy. A copy of the Code and other key policies can be found at www.mesoblast.com. 3. Risk Management The Board is responsible for satisfying itself annually, or more frequently as required, that management has developed and implemented an effective system of risk management and internal control. Management is responsible for ensuring there are adequate policies in relation to risk management, compliance, and internal control systems. The ARC monitors Mesoblast’s risk management by overseeing management’s actions in the evaluation, management, monitoring, and reporting of material operational, financial, compliance, strategic, and certain ESG risks. Mesoblast’s risk management group is part of the Operating Committee comprising of executive management. This group is responsible for designing, implementing, monitoring, and reporting on Mesoblast’s management of material business risks and the effectiveness of Mesoblast’s risk management and internal control system. ESG risks have been incorporated into and are considered as part of Mesoblast’s risk management system. The Operating Committee regularly reviews Mesoblast’s risks across its business and operations, and Mesoblast’s material business risks and risk management framework are reviewed at least annually by the ARC. As part of the process of continual improvement, we introduced a standardized tool to assess our portfolio and corporate risk. For cybersecurity management, see Section 16K of this Annual Report. 4. Human Capital Management 4.1 Diversity and Inclusion Mesoblast has a Diversity Policy which encompasses differences in ethnicity, gender, language, age, sexual orientation, religion, socioeconomic status, physical and mental ability, thinking styles, experience, and education. We believe that the wide array of perspectives that results from such diversity promotes innovation and business success. Being diverse makes us more creative, flexible, and productive. Mesoblast’s policy is to engage the most appropriate and relevant partner organizations, consultants, experts, and personnel. This includes recruiting people who are well-qualified for their position and those who as aligned to Mesoblast’s five values and will embrace the Mesoblast culture and work ethic. In order to meet and comply with our Diversity Policy, Mesoblast employs the following principles: • Mesoblast seeks and encourages diversity in current and potential employees; Table of Contents 48
• Mesoblast promotes equal employment opportunities based on capability, performance and potential for growth and progression; • Recruitment, professional development, succession management, promotion, and remuneration decisions are all based on performance and capability aligned to the specific job role, salary ranges, and a pre-set criteria prior to the activities to ensure any biases are reduced; • Mesoblast seeks to build a safe working environment by recognizing and taking action against inappropriate workplace behavior, including bullying, discrimination, harassment, victimization, and vilification; • Mesoblast promotes flexible work practices where possible and reasonable in the circumstances, to meet the differing needs of our employees; and • Mesoblast ensures appropriate policies and procedures exist that encourage diversity and meet legislative requirements. Line management is supported to manage diversity to ensure that employees are treated fairly and objectively. We have clear reporting procedures for any type of discrimination or harassment, combined with follow-up procedures to prevent future incidents. The Board, through the NRC, is responsible for overseeing our Diversity Policy. Mesoblast’s Head of Human Resources, with the support of the Chief Executive Officer and the executive team, is responsible for implementing the Diversity Policy. The Board, through the NRC, is responsible for approving and reviewing measurable objectives for achieving gender diversity in the workplace. Mesoblast has set the following measurable objectives: i) Increase the number of women on the Board as vacancies arise and circumstances permit; ii) Increase the number of women who hold senior executive positions as vacancies arise and circumstances permit; and iii) Ensure the opportunity exists for equal gender participation in all levels of professional development programs. All Mesoblast employees were provided access to the same development programs. A copy of Mesoblast’s Diversity Policy can be found at www.mesoblast.com. Table – Gender diversity statistics* Gender FY24 Senior Executives** FY24 Total Workforce FY23 Senior Executives** FY23 Total Workforce Male 7 35 6 39 Female 3 38 3 44 Other — — — — % Female 30% 52% 33% 53% *Based on number of employees as at June 30. Excludes contractors and consultants. **A senior executive position is one held by an executive who reports directly to the Chief Executive. Every employee, consultant and service provider has the right to work with Mesoblast in an environment that is safe, and free from intimidation, harassment, and abuse. Mesoblast prohibits harassment for any reason, including veteran status, uniform service member status, or any other protected class under federal, state, or local law. Inappropriate behavior, including verbal or physical conduct by any individual that harasses another, disrupts another’s work performance, or creates an intimidating, offensive, abusive, or hostile workplace, is not tolerated. In addition, we will not tolerate comments, jokes, or materials, including emails, which others might consider offensive. All Mesoblast personnel are required to complete mandatory training on an annual basis to recognize and deal with inappropriate behavior in our workplaces, including the New York City Commission on Human Rights – Accredited Program: Confronting Sexual Harassment; Tools & Strategies to Create a Harassment Free Workplace and Mesoblast’s Fair Treatment policy. No cases of harassment reported in FY24, FY23 or in FY22. Table of Contents 49
4.2 Health and Safety Mesoblast provides a workplace that is clean and safe for all associates and one that complies with health and safety laws. As an organization whose activities are predominantly office and laboratory based, Mesoblast chooses to track its safety record using total recordable incident frequency rate (“TRIFR”) i.e., number of recorded injuries for each one million hours worked. No incidents were recorded for FY24. An Environment Health and Safety Management System and supporting policies have been developed and aligned for each jurisdiction in preparation for company wide training. Mesoblast continued to implement hybrid/flexible working arrangements and the employee assistance program was made available across all sites. 4.3 Recruitment, Development and Retention Mesoblast operates at the forefront of a highly specialized industry and we recognize that our talented people are key to developing our cell therapy technology. Our policies and procedures follow equal employment opportunities principles for fair treatment, including diversity and compensation. Our employees are given equal access to job opportunities and promotions based on capability, performance and potential for growth and progression as part of our retention program. Mesoblast’s recruitment process enables our line managers to prepare a job description that outlines accountabilities and selection criteria that emphasize the skills, knowledge and experience. Job criteria and interview guides are prepared for each role advertised to ensure consistency across all the interviews. Jobs are advertised through multiple channels based on the specialization of the job role. All job roles are published on the Mesoblast intranet site providing transparency to all employees within the company and an equal opportunity to apply. Job descriptions are prepared in a way that enables employees to consider lateral moves based on competence rather than expertise in years of service. In FY24, the voluntary turnover rate was approximately 5% with 60% male and 40% females departing the Company. Exit interviews are conducted with all departing employees and trends are monitored so that actions to minimize the turnover can be taken. Mesoblast employed one female and one male for two approved replacement roles. While acting and higher duty opportunities were minimal during this period, job profiles were prepared to enable existing employees to consider lateral moves based on competence rather than years of service, where appropriately credentialed. We provide opportunities for all colleagues to participate in professional training and education so they can enhance their skill sets and career. During FY24, employees were given the opportunity to participate in a development program that is linked to the annual Performance Management System. During the reporting period, Mesoblast continued with an online performance and merit management program and integrated an online professional development program that links the recording of participation in professional development aligned to job role. The online performance management program enables employees to track their performance and receive regular feedback from their manager. The formal annual review process assesses the individual employee’s performance against objectives and quantifiable criteria that are aligned to the Mesoblast business plan, reducing the risk of bias. All employees below the executive level participated in this program during the period. 5. Product Quality and Safety 5.1 Scientific Research and Innovation Over the past decade there has been a surge of interest internationally in the cutting-edge science of cellular medicines and their use in treating a wide range of diseases. Mesoblast is a clinical stage biotechnology company and works in close collaborative associations with leading cell therapy research centers, as well as having our own in-house R&D laboratories and specialists. We ensure rigorous scientific investigations are performed with well characterized cell populations in order to understand mechanisms of action for each potential medical application. We undertake extensive pre-clinical translational studies to guide subsequent clinical trials. Table of Contents 50
5.2 Use of Stem Cells Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses. Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors, and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. This enables manufacturing at industrial scale for commercial purposes. Mesoblast’s cells can be administered to patients without the need for donor-recipient matching or recipient immune suppression. The distinction between embryonic stem cells (“ESCs”) and non-ESCs, such as our mesenchymal lineage cells, can be easily misunderstood by the public and has the potential to create negative public attitudes toward cell therapy. As Mesoblast’s cells are not ESCs, we minimize the risk of being exposed to ethical, legal, or social concerns that have arisen in relation to the collection and use of ESCs. 5.3 Use of Animal in Research Mesoblast is committed to the welfare and humane treatment of animals and only undertakes development studies in animal models where required by applicable regulatory bodies. These studies are undertaken by expert third-party providers who are specialists in the management of animals and their welfare. Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. In the United States where the majority of our clinical development takes place, all of our product candidates are regulated as biological products by the Center for Biologics Evaluation and Research (“CBER”) in the FDA. Biological products are subject to federal regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service (“PHS”) Act, and other federal, state, local and foreign statutes and regulations. Both the FDCA and the PHS Act, as applicable, and their corresponding regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution, import, export, reporting, advertising and other promotional practices involving drugs and biological products. The process required by the FDA before a biological product may be marketed in the U.S. generally involves years of studies and many complex steps. The first of these is completion of nonclinical laboratory studies, meaning in vivo and in vitro experiments in which an investigational product is studied prospectively in a test system under laboratory conditions to determine its safety, must be conducted according to Good Laboratory Practice (“GL”) regulations, as well as, in the case of nonclinical laboratory studies involving animal test systems, in accordance with applicable requirements for the humane use of laboratory animals and other applicable regulations. Some of the manufacturing materials and/or components that we use in, and which are critical to, implementation of our technology involve the use of animal-derived products. Our media is sourced from fetal bovine serum (“FBS”), and is the main consumable used in our manufacturing process. While FBS is commonly used in the production of various marketed biopharmaceuticals, our suppliers of FBS must meet our strict quality standards are thus limited in number and region. 5.4 Product Quality The Company has a Quality Management Department with appropriate controls in place for monitoring and compliance of clinical and non-clinical studies as well as manufacturing operations. Our quality assurance processes align with the widely accepted quality standards from the ICH Guidelines created by The International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) as well as FDA Regulations. All Mesoblast personnel are responsible for the identification and prompt reporting of all actual or potential adverse events or product quality complaints. This may include any reported problem with a finished product, its packaging, inappropriate healthcare professional use, or unintended patient reaction. We have a regulatory obligation to report all adverse events and Table of Contents 51
product complaints, with serious adverse events requiring reporting within 24 hours of receiving notification. The Company provides personnel with regular training in relation to our obligations and responsibilities. 5.5 Clinical Trials and Patient Safety Mesoblast works with healthcare professionals, academic organizations, and contract research organizations (“CRO”) to perform company-sponsored pre-clinical and clinical research. The Company also provides financial support or drug product for independent third-party studies such as Investigator Initiated Trials (IITs) via grant requests. All studies must be scientifically valid and likely to generate data that will be relevant to a defined product development or other clinical and/or business need. These research initiatives are never used as a way to induce a healthcare professional or healthcare organization to use, recommend, or purchase Mesoblast products, or to encourage off-label use of marketed products. Each potential study subject/study subject legal guardian is provided with an Informed Consent Form (“ICF”) by the clinical trial site study team. The ICF contains information that must be provided to each possible study candidate, such as an explanation of the purpose of the research, possible risks/benefits as well as statements describing the confidentiality of information collected, how the information may be used and who may view this information. Each potential study subject/legal guardian is given time to read the ICF and to ask questions about anything they don’t understand. In addition, the ICF provides the Primary Investigator’s (“PI”) and Independent Review Board’s (“IRB”) contact information to the subject to ask questions and/or report any study related concerns. Once all questions are answered, signatures are obtained to record consent. Mesoblast, as the Sponsor, together with the CRO, monitors the sites for any protocol deviations throughout the course of the study. If and when protocol deviations are identified, we will work with the CRO and site(s) to address them as quickly as possible. Study subject safety is front and foremost in our conduct of all our clinical studies. Between our Therapeutic Area Heads, Quality Assurance (“QA”), and Safety and Clinical Operations, we monitor the conduct of our clinical trials extremely thoroughly and work to protect the well-being of the study subjects as well as the integrity of the trial. Company exploration of innovative therapies, including research projects, database reviews, and pre-clinical and clinical trials, are designed to first and foremost protect the rights and safety of study subjects and to maintain the integrity of research data. We do this by complying with all regulatory standards regarding research programs and encouraging all involved persons to report any deviations, including inaccurate reporting of study data, inappropriate use of study funds or pharmaceutical product, falsification of study reports, or failure to obtain Independent Review Board or other required approval prior to conducting a study. This process includes all clinical trial investigators attesting that they’ve read and understood the contents of the clinical trial protocol and agree to conduct the trial in compliance with the protocol, good clinical practice and applicable regulatory requirements. 6. Supply Chain Management Mesoblast has an established vendor assurance program through which suppliers are audited for purposes of being qualified and added to an approved suppliers list. All approved suppliers are audited on a routine basis. Our Supplier Management procedure describes the detailed process for qualifying and managing suppliers which includes quality agreements, supply agreements, due diligence activities, and audits. 6.1 Manufacturing Safe Products Given the current scale of our operations, elements of our business including manufacturing are outsourced to third-party providers. Mesoblast has established a strategic alliance with Lonza, a global leader in biopharmaceutical manufacturing. We monitor Lonza and other third-party providers through our vendor assurance program. In addition, all entities involved in the preparation of therapeutics for clinical studies or commercial sale, including Lonza, are subject to extensive external regulation. Components of a finished therapeutic product approved for commercial sale or used in late- stage clinical studies must be manufactured in accordance with current international Good Manufacturing Practice (“GMP”) and other international regulatory requirements. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Mesoblast, our collaborators, and our suppliers as appropriate must supply all necessary documentation in support of any application for product approval and must adhere to current GLP and current GMP regulations enforced by the FDA and other regulators through their facilities inspection program. Before we can begin commercial manufacture of our Table of Contents 52
products for sale in the United States, we must obtain FDA regulatory approval for the product. In addition, the processes and quality systems associated with the manufacturing of such product must also be approved, which requires a successful FDA inspection of the manufacturing facilities, including Lonza’s manufacturing facilities. In addition, regulators may at any time audit or inspect a manufacturing facility involved with the preparation of our product candidates, raw materials, or the associated quality systems. Although we cannot control the manufacturing process of, and are dependent on, the contract manufacturer for compliance with the regulatory requirements, through our vendor assurance program, we monitor the performance and undertake an annual audit of each contract manufacturer involved in the production of our product candidates. In addition, Lonza is monitored through an established governance structure with multiple feedback loops to ensure compliance to established contracts, specifications, and policies. In addition to having staff onsite and personnel in the plant to oversee ongoing activities, the organizations review numerous manufacturing and quality metrics to ensure consistent product manufacture. 6.2 Bone Marrow The initial stage of manufacturing involves obtaining mesenchymal lineage cell-containing bone marrow from healthy consenting donors. The process of identifying new donor tissue, testing and verifying its validity in order to create new cell banks is tightly regulated and validated with the FDA and other regulators. For example, U.S. federal and state governments and other jurisdictions impose restrictions on the acquisition and use of tissue, including those incorporated in federal Good Tissue Practice regulations. Our manufacturing partner Lonza also has a dedicated U.S. facility for bone marrow acquisition. Lonza maintains all documents and records generated during the lifecycle of donor screening and bone marrow aspiration in a donor-specific file under its site quality system. 6.3 Storage and Distribution Storage and distribution of our product candidates are contracted to CSM on Demand, ICS AmerisourceBergen, CryoSite, and CryoPort Solutions who are experts in innovative storage and/or distribution solutions for pharmaceutical manufacturers. Performance is monitored through established contractual agreements, and the interactions of our joint project teams, as well as through regular supplier audits and qualifications. 7. Access to Healthcare Mesoblast does not currently have a product approved and commercialized. In July 2024, we resubmitted a BLA to the FDA for approval of Ryoncil (remestemcel-L) in the treatment of children with SR-aGVHD. FDA considered the resubmission to be a complete response and set a PDUFA goal date of January 7, 2025. If approved by FDA, this product would constitute the Company’s first commercialized product. We acknowledge and support the social importance of providing access to healthcare across all geographic regions regardless of socio-economic status and recognize this is frequently regarded as one of the top ESG topics for the Biopharma sector. Despite our current size, financial status, and stage of clinical development, we have in place elements that reflect this important social topic. 7.1 Expanded Access Programs Under a compassionate use protocol in the US, Mesoblast has continued to make remestemcel-L available to children as ‘salvage therapy’ where all other treatment avenues have been exhausted and the risk of mortality is high. More than 250 children have had access to remestemcel-L under these circumstances, provided by us at no cost. In 2020, an Expanded Access Protocol (“EAP”) was initiated in the US for compassionate use of remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of MIS-C (multisystem inflammatory syndrome in children). MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous inflammation of multiple critical organs and their vasculature. Mesoblast has provided treatment at no charge to three children under this EAP. 7.2 Product Pricing In the United States, Federal and state government agencies may purchase Mesoblast products and provide reimbursement on those products via the state and federal healthcare programs, such as Medicare and Medicaid, once Mesoblast’s product receives regulatory approval and is able to be commercialized. Various federal laws and/or government contracting requirements give some of these purchasers and reimbursors the right to discounted prices and/or Table of Contents 53
rebates on Company products. Depending on the requirements that apply to the pricing terms the Company is reporting, our prices should reflect any reductions, rebates, up-front payments, coupons, goods in kind, free or reduced-price services, grants, price concessions, or other benefits offered to induce a sale may be considered pricing terms. Mesoblast is committed to accurately taking these items into account. 8. Environment Mesoblast is committed to protecting the world in which we live and work, and we aim to minimize our impact on the wider environment and its component parts. Currently, Mesoblast’s direct physical footprint is limited to office and laboratory space for our employee base of less than 100, so our direct, physical environmental impact is currently limited. Nonetheless, Mesoblast has begun initiatives to improve our impact such as sourcing our electricity from green energy providers and introducing office waste recycling programs. In addition, as noted above, many of our employees and consultants are dispersed and are infrequently in our office spaces. We are also driving initiatives to minimize the inputs and outputs to our manufacturing processes through our investment in research and development that focuses on the scaling of technologies and minimizing waste. We are developing a 3D bioreactor process to expand our cell product which will replace our current 2D process involving plates. This will reduce the amount of plastic and biohazardous waste that will be generated by our manufacturing processes. As mentioned above, we rely on third-party providers for important elements of our business. We and our partners must comply with environmental laws and regulations, including those relating to the discharge of materials into the air, water and ground, the manufacture, storage, handling, use, transportation and disposal of hazardous and biological materials, and the health, wellbeing and safety of employees with respect to laboratory activities required for the development of products and technologies. 4.B Business Overview Mesoblast has developed a range of late-stage product candidates derived from our first and second generation proprietary mesenchymal lineage cell therapy technology platforms. Remestemcel-L is our first-generation mesenchymal lineage stromal cell (“MSC”) product platform and is in late stage development for treatment of systemic inflammatory diseases including: • Steroid refractory acute graft versus host disease (SR-aGVHD); and • Biologic refractory inflammatory bowel disease, including Crohn's disease. Rexlemestrocel-L is our second generation mesenchymal lineage precursor cell product platform and is in late stage development for treatment of: • Chronic heart failure (CHF); and • Chronic low back pain (CLBP) due to degenerative disc disease. Both platforms have life cycle management strategies with promising emerging pipelines. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide upon receiving marketing authorizations. Mesoblast’s immuno-selected, culture expanded cellular medicines are based on mesenchymal precursor cells (“MPCs”) and their progeny, MSCs. These are rare cells (approximately 1:100,000 in bone marrow) found around blood vessels that are central to blood vessel maintenance, repair and regeneration. These cells have a unique immunological profile with immunomodulatory effects that reduce inflammation allowing healing and repair. This mechanism of action enables the targeting of multiple disease pathways across a wide spectrum of complex diseases with significant unmet medical needs. Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. This enables Table of Contents 54
manufacturing at industrial scale for commercial purposes. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression. Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. These safeguards are intended to ensure the integrity and reproducibility of results, and to ensure that outcomes observed are scientifically reliable. Allogeneic, Off-the-Shelf, Commercially Scalable Products Our technology platform enables development of a diverse range of products derived from the mesenchymal cell lineage in adult tissues. MPCs constitute the earliest known cell type in the mesenchymal lineage in-vivo. MPCs can be isolated using monoclonal antibodies and culture-expanded using methods that enable efficient expansion without differentiation. MSCs are defined biologically in culture following density gradient separation from other tissue cell types and following culture by plastic adherence. MSCs presumably represent culture-expanded in-vitro progeny of the undifferentiated MPCs present in-vivo. The functional characteristics of each cell type enable product development for specific indications. Our proprietary mesenchymal lineage cell-based products have distinct biological characteristics enabling their use for allogeneic purposes. Immune Privilege: Mesenchymal lineage cells are immune privileged, in that they do not express specific cell surface co-stimulatory molecules that initiate immune allogeneic responses. Expansion: We have developed proprietary methods that enable the large-scale expansion of our cells while maintaining their ability to produce the key biomolecules associated with tissue health and repair. This allows us to produce a cellular product intended to demonstrate consistent and well-defined characterization and activity. Products Commercialized by Licensees Two allogeneic mesenchymal stromal cell (MSC) products developed and commercialized by Mesoblast licensees have been approved in Japan and Europe, with both licensees the first to receive full regulatory approval for an allogeneic cellular medicine in these major markets. Mesoblast’s licensee in Japan, JCR Pharmaceuticals Co. Ltd. (“JCR”), is marketing its MSC-based product in Japan for the treatment of aGVHD in children and adults. TEMCELL® HS Inj. (“TEMCELL”) was the first allogeneic cellular medicine to receive full regulatory approval in Japan. Mesoblast receives royalty income on sales of TEMCELL® in Japan. In 2017, Mesoblast granted TiGenix S.A.U (“TiGenix”), now a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd. (“Takeda”), exclusive access to certain of its patents to support global commercialization of Alofisel®, the first allogeneic MSC therapy to receive central marketing authorization approval from the European Commission. Mesoblast receives royalty income on Takeda’s worldwide sales of Alofisel® in the local treatment of perianal fistulae. Table of Contents 55
Mesoblast Product Candidates Ryoncil® (remestemcel-L) for the Treatment of Steroid Refractory Acute Graft Versus Host Disease Overview Ryoncil® (remestemcel-L) is an intravenously delivered product candidate for the treatment of steroid-refractory acute graft versus host disease, or SR-aGVHD, following an allogeneic bone marrow transplant (“BMT”). In a bone marrow transplant, donor cells can attack the recipient, causing a-GVHD. The donor T-cell mediated inflammatory response involves secretion of TNF-alpha and IFN-gamma, resulting in activation of pro-inflammatory T- cells and tissue damage in the skin, gut and liver, which can be fatal. Remestemcel-L is suggested to have immunomodulatory properties to counteract the cytokine storm that is implicated in various inflammatory conditions. The mechanism of action is thought to involve down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. This life-threatening disease occurs in approximately 50% of patients who receive an allogeneic BMT. Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing. In patients with the most severe form of SR-aGVHD (Grade C/D or III/IV) mortality can be as high as 90% despite optimal best available therapy. There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD. Current Status and Anticipated Milestones Mesoblast submitted its completed BLA to the FDA for RYONCIL in January 2020. The BLA was subsequently accepted for priority review by the FDA on March 30, 2020, with a Prescription Drug User Fee Act (“PDUFA”) action date set for September 30, 2020. In August 2020, the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted overwhelmingly in favor (nine to one(1)) that the available data support the efficacy of RYONCIL in pediatric patients with SR-aGVHD. FDA issued a CRL on September 30, 2020, noting deficiencies related to clinical and Chemistry, Manufacturing and Controls (“CMC”) data. Mesoblast has worked to address the issues noted in the Complete Response Letter, through multiple interactions with FDA for guidance. Mesoblast provided these new data to FDA to address all CMC outstanding items as required in January 2023. In March, 2023, the FDA accepted the BLA resubmission considering the resubmission to be a complete Table of Contents 56
response and set a PDUFA goal date of August 2, 2023. In August 2023, the FDA provided a CRL to the BLA resubmission for RYONCIL for the treatment of pediatric SR-aGVHD requiring more data to support marketing approval, including potency assay or clinical data. As part of the BLA review, FDA completed the PLI of the manufacturing facility, did not issue any Form 483, and found no objectionable conditions. In February 2024, ahead of a scheduled meeting with FDA, Mesoblast provided new data from a second potency assay for RYONCIL that provided additional product characterization as requested by FDA. In March 2024, FDA informed Mesoblast that following additional consideration the available clinical data from its Phase 3 study MSB- GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SR-aGVHD. In July 2024, Mesoblast resubmitted the BLA for approval. FDA considered the resubmission to be a complete response and provided a Prescription Drug User Fee Act ("PDUFA") goal date of January 7, 2025. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD and only one FDA-approved treatment in the US for other SR-aGVHD patients. Mesoblast intends to conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial strategy, which envisioned a sequenced progression from pediatric to adult SR-aGVHD indications. Adults comprise 80% of the SR-aGVHD market. Mesoblast is collaborating with Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in the United States, a body that is funded by the National Institutes of Health (NIH) and is responsible for approximately 80% of all US allogeneic BMTs, to conduct a pivotal trial in adults with SR-aGVHD. We believe the U.S. adult and pediatric SR-aGVHD market requires a small, targeted commercial footprint. The target call point for SR-aGVHD will primarily be physicians in hematology/oncology who perform hematopoietic stem cell transplants. In the U.S., there are approximately 80 centers that perform pediatric transplants, with 50% of all transplants occurring at approximately 15 centers. Similarly, there are approximately 110 centers that perform adult transplants with half of those transplants occurring at approximately 20 centers. The Company has put in place a lifecycle extension strategy to generate evidence-based clinical outcomes to maximize the value of remestemcel-L in other pediatric and adult rare diseases that do not require large distribution channels. In addition, we plan to expand investigator-initiated clinical trials for chronic GVHD and other indications that are currently underway or planned for the near future. (1) This vote included a change to the original vote by one of the ODAC panel members after electronic voting closed. Remestemcel-L for Inflammatory Bowel Disease (IBD) – Ulcerative Colitis (UC) and Crohn’s Colitis Overview According to recent estimates, more than three million people (1.3%) in the United States alone have inflammatory bowel disease, with more than 33,000 new cases of Crohn’s disease and 38,000 new cases of ulcerative colitis diagnosed every year. Despite recent advances, approximately 30% of patients are primarily unresponsive to anti- TNFα agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically refractory Crohn’s disease eventually require surgical treatment of their disease, which can have a devastating impact on quality of life. Current Status A small investigator-initiated randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury with medically refractory Crohn’s disease and ulcerative colitis was undertaken at Cleveland Clinic. The study is the first in humans using local cell delivery in the gut and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo- controlled trial in patients with biologic-refractory Crohn’s disease where remestemcel-L was administered intravenously. Results from the randomized, controlled study of remestemcel-L by direct endoscopic delivery to areas of inflammation in patients with medically refractory Crohn’s colitis were published in the peer-reviewed journal British Journal of Surgery. Strategically, Mesoblast views UC and Crohn’s colitis as a potentially important label extension for remestemcel- L given the gastrointestinal involvement common to acute graft versus host disease and inflammatory bowel disease. Table of Contents 57
Gastrointestinal damage is the major driver of aGVHD mortality and is linked to systemic inflammation in aGVHD. Biomarkers that predict high mortality in aGVHD, such as blood levels of soluble suppression of tumorigenicity 2 (ST2) have shown to be significantly reduced in patients treated with remestemcel-L. ST2 has also been shown to be associated with active IBD (UC & Crohn’s). Rexlemestrocel-L for Chronic Low Back Pain (CLBP) associated with Degenerative Disc Disease (DDD) Overview Rexlemestrocel-L (MPC-06-ID) for CLBP consists of a unit dose of 6 million MPCs administered by syringe directly into a damaged disc. In CLBP, damage to the disc is the result of a combination of factors related to aging, genetics, and micro-injuries, which compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage to the disc also results in an inflammatory response with ingrowth of nerves which results in chronic pain. This combination of anatomic instability and nerve ingrowth results in CLBP and functional disability. With respect to mechanisms of action in CLBP, extensive pre-clinical studies have established that MLCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. It is estimated that over 7 million people in the U.S. alone suffer from CLBP associated with DDD, of which 3.2 million patients have moderate disease. This market is projected to have annual growth rate similar to that of the US population annual growth rate. After failure of conservative measures (medication, injections, physical therapy etc.), there is a need for non-opioid treatments that are effective over a sustained period of time. When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means, major invasive surgery such as spinal fusion is the most commonly offered option. All non-surgical therapies for progressive, severe and debilitating pain due to degenerating intervertebral discs treat the symptoms of the disease. However, they do not address the underlying cause of the disease. Surgical intervention is not always successful in addressing the patient’s pain and functional deficit. It has been estimated that the incidence of failed back surgery is as high as 50% for standard procedures and may increase for more complex surgeries. Total costs of low back pain are estimated to be between $100.0 billion and $200.0 billion annually with two thirds attributed to patients’ decreased wages and productivity. As a result, we believe that the most significant unmet need and commercial opportunity in the treatment of CLBP is a therapy that has the ability to impact the chronic pain and disability associated with the condition. Current Status and Anticipated Milestones The Phase 3 clinical trial for CLBP completed enrollment in March 2018 with 404 patients enrolled across 48 centers in the United States and Australia randomized 1:1:1 to receive either 6 million MPCs with hyaluronic acid (MPC+HA), 6 million MPCs without hyaluronic acid (MPC) or saline control. Although the trial's composite outcomes of pain reduction together with functional responses to treatment were not met by either MPC group; the MPC+HA treatment group achieved substantial and durable reductions in pain compared to control through 24 months across the entire evaluable study population (n=391) compared with saline controls. Greatest pain reduction was observed in the pre- specified population with CLBP of shorter duration than the study median of 68 months (n=194) and subjects using opioids at baseline (n=168) with the MPC+HA group having substantially greater reduction at all time points (1, 3, 6, 12, 18 and 24 months) compared with saline controls. There was no appreciable difference in the safety of MPC groups compared to saline control over the 24-month period of follow-up in the entire study population. In subjects using opioids at baseline, the MPC+HA demonstrated a reduction in the average opioid dose over 24 months, while saline control subjects had essentially no change. In July 2024, enrollment commenced at multiple sites across the United States in a confirmatory Phase 3 trial of rexlemestrocel-L in patients with CLBP due to inflammatory degenerative disc disease of less than five years duration. The FDA has previously confirmed alignment with Mesoblast on the design of the 300-patient randomized, placebo-controlled trial and the 12-month primary endpoint of pain reduction as an approvable indication. Key secondary measures include improvement in quality of life, function, and reduced opioid usage. Table of Contents 58
In February 2023, FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for rexlemestrocel-L in the treatment of CLBP associated with disc degeneration, in combination with HA as delivery agent for injection into the lumbar disc. RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for the disease or condition. An RMAT designation for rexlemestrocel-L provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a BLA. Revascor® (rexlemestrocel-L) for Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) Overview Mesoblast is developing rexlemestrocel-L to fill the treatment gap for chronic heart failure (CHF). Patients with CHF continue to represent high unmet medical need despite recent advances in new therapeutic agents for chronic heart failure. The American Heart Association (AHA) estimated in 2017 that prevalence is expected to grow 46% by 2030 in the U.S., affecting more than 8 million Americans. CHF causes severe economic, social, and personal costs. In the U.S., it is estimated that CHF results in direct costs of $60.2 billion annually when identified as a primary diagnosis and $115.0 billion as part of a disease milieu. Mesoblast believes that targeting high-risk chronic patients with the highest unmet clinical needs provides the company with the most efficient path to market. Revascor® (rexlemestrocel-L) for HFrEF consists of 150 million mesenchymal precursor cells (MPCs) administered by direct cardiac injection. MPCs release a range of factors when triggered by specific receptor-ligand interactions within damaged tissue. Based on preclinical data, we believe that the factors released from the MPCs induce functional cardiac recovery by simultaneous activation of multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in cardiac fibrosis, and reversal of endothelial dysfunction through activation of intrinsic tissue precursors. CHF is classified in relation to the severity of the symptoms experienced by the patient. The most commonly used classification system for functional severity of heart failure, established by the NYHA, is: • Class I (mild): patients experience none or very mild symptoms with ordinary physical activity • Class II (mild/moderate): patients experience fatigue and shortness of breath during moderate physical activity • Class III (moderate/severe): patients experience shortness of breath during even light physical activity • Class IV or end-stage (severe): patients are exhausted even at rest Risk for recurrent heart failure-related hospitalizations, occurrence of non-fatal myocardial infarction (MI, heart attack) or non-fatal stroke, or death increases progressively with increases in left ventricular volumes, reduction in left ventricular ejection fraction (LVEF), and progression in NYHA functional class. Approximately 50% of all CHF patients have heart failure with reduced ejection fraction (HFrEF) defined as LVEF <40%, and are at considerable risk of repeated hospitalizations and death despite maximal drug therapy. Program in End Stage Heart Failure Patients Requiring Mechanical Support REVASCOR is being evaluated in patients with end-stage HFrEF implanted with a left ventricular assist device (“LVAD”). Every year in the United States over 100,000 patients progress to end-stage HFrEF. In these patients, more than 2,500 life prolonging LVADs are implanted in the U.S. annually, of whom approximately 80% undergo the procedure as destination or permanent therapy. Most patients receiving LVADs as destination therapy have an ischemic HFrEF etiology. Compared to patients with non-ischemic HFrEF, patients with ischemic HFrEF have a 76% lower likelihood of LV functional recovery following LVAD implantation, and increased mortality over the initial 1-2 years. Resistance to functional recovery in ischemic HFrEF patients is thought to be due to excessive inflammation and microvascular insufficiency in the ischemic myocardium. A Phase 2 trial was conducted by a multi-center team of researchers within the United States National Institutes of Health (“NIH”)-funded Cardiothoracic Surgical Trials Network (“CTSN”), led by Icahn School of Medicine at Mount Sinai, New York. The National Institute of Neurological Disorders and Stroke, and the Canadian Institutes for Health Table of Contents 59
Research also supported this trial. Results of this Phase 2 trial were released in November 2018. The trial was a prospective, multi-center, double-blind, placebo controlled, 2:1 randomized (MPC to placebo), single-dose cohort trial to evaluate the safety and efficacy of injecting a dose of 150 million MPCs into the native myocardium of LVAD recipients. Patients with advanced CHF, implanted with an FDA-approved LVAD as bridge-to-transplant or destination therapy, were eligible to participate in the trial. All patients were followed until 12 months post randomization. Across the 159 patients in this Phase 2 trial, the trial did not show a significant difference in the ability for patients to tolerate a wean for a period of 60 minutes. In the, 70 patients with end-stage ischemic HFrEF the key findings were: • Ischemic controls were characterized by persistently elevated levels of the inflammatory cytokine IL-6, by reduced ability to be weaned from LVAD support, and by high mortality. • In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low through 12 months. • 63% of ischemic patients who received a single administration of rexlemestrocel-L successfully underwent temporary weaning from full LVAD support as early as month 2 as compared with 36% of controls (p = 0.008). • The cumulative incidence of successful temporary weans off the LVAD device over 6 months was also increased by 1.55-fold over control in ischemic patients who received rexlemestrocel-L ([95% CI 1.01, 2.36]; p=0.02). • Only 4.9% of ischemic patients treated with a single administration of rexlemestrocel-L died from month 2 through month 12, as compared with 26.9% of ischemic controls, an 82% reduction (p = 0.02). Current Status and Anticipated Milestones In March 2024, FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA in February, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation. The FDA supported an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic HFrEF and a left ventricular assist device (LVAD). In feedback provided to Mesoblast regarding potential pathways to licensure for rexlemestrocel-L, FDA’s comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval. Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation. Rexlemestrocel-L has regenerative medicine advanced therapy (RMAT) designation from the FDA for treatment of chronic heart failure with left ventricular systolic dysfunction in patients with an LVAD. Program for Class II/III CHF patients A multicenter, double-blinded, 1:1 randomized, sham-procedure-controlled Phase 3 study of remestemcel-L was completed across North America with 565 NYHA Class II/III patients at high risk of repeated heart failure hospitalizations or a terminal cardiac event (cardiac death, LVAD placement, heart transplant or insertion of an artificial heart). The enrollment criteria for this trial included a prior decompensated heart failure event (e.g. hospitalization) within the previous nine months and/or very high level of NT-proBNP, a protein used in diagnosis and screening of CHF. These inclusion criteria were designed for enrichment in patients with substantial left ventricular contractile abnormality, advanced CHF due to left ventricular systolic dysfunction and higher risk of recurrent decompensated heart failure hospitalizations and TCEs. This target patient population was shown to respond effectively to treatment with rexlemestrocel-L in our previous Phase 2 trial. Topline results from the 537 patients who met the criteria which allowed for treatment to occur on a 1:1 randomization basis between rexlemestrocel-L and sham control were announced in December 2021. Over a mean 30 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial treatment with rexlemestrocel-L on top of maximal therapies had 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process. Despite significant Table of Contents 60
reduction in the pre-specified endpoint of cardiac death, there was no reduction in study primary end point of recurrent non-fatal decompensated heart failure events, which was the trial’s primary endpoint. The combination of the three pre-specified outcomes of cardiac death, heart attack or stroke into a single composite outcome - called the three-point major adverse cardiovascular event (MACE) is a well-established endpoint used by the FDA to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to controls across the population of 537 patients. In the NYHA class II subgroup of 206 patients, rexlemestrocel-L reduced the three-point MACE by 55% compared to controls. DREAM-HF Phase 3 trial results were published in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC) in February 2023. Complementary Technologies In addition to having the most mature and diverse allogeneic cell therapy product pipeline and technology platform in the field of cellular medicines, we have strategically targeted the acquisition of rights to technologies that are complementary to and synergistic with our mesenchymal lineage cell technology platform. The aim of this activity is to maintain our technology leadership position in the regenerative medicine space, while simultaneously expanding our targeted disease applications and managing the life-cycle of our current lead programs. Our complementary technologies and additional product candidates include other types of mesenchymal lineage cells, cell surface modification technologies, pay-loading technology and protein and gene technologies. Manufacturing and Supply Chain Our manufacturing strategy for our cellular product candidates focuses on the following important factors: (i) ability for product delineation to protect pricing and partner markets by creating distinct products using discrete manufacturing processes, culture conditions, formulations, routes of administration, and/or dose regimens; (ii) establishing proprietary commercial scale-up and supply to meet increasing demand; (iii) implementing efficiencies and yield improvement measures to reduce cost-of-goods; (iv) maintaining regulatory compliance with best practices; and (v) establishing and maintaining multiple manufacturing sites for product supply risk mitigation. The cell therapy manufacturing and distribution process generally involves five major steps. • Procure bone marrow—acquire bone marrow from healthy adults with specific FDA-defined criteria, which is accompanied by significant laboratory testing to establish the usability of the donated tissues. • Create master cell banks—isolate MLCs from the donated bone marrow and perform a preliminary expansion to create master cell banks. Each individual master cell bank comes from a single donor. • Expand to therapeutic quantities—expand master cell banks to produce therapeutic quantities, a process that can yield thousands of doses per master cell bank, with the ultimate number depending on the dose for the respective product candidate being produced. • Formulate, package and cryopreserve. • Distribute—our cellular products are cryopreserved at the manufacturer and shipped to storage sites in the U.S. and other jurisdictions via cryoshippers. Those distribution centers then re-package and send the products on to treatment centers in cryoshippers. Treatment centers will either move the products into their own freezers or receive the cryoshipper in “real time” and the product stays in the cryoshipper until thawed for patient use within a well-defined window. We intend to continue utilizing this approach in the future. To date our product candidates have been manufactured in two-dimensional, or 2D, planar, 10-layer cell factories, using media containing fetal bovine serum, or FBS. Table of Contents 61
The relatively small patient numbers and orphan drug designation for remestemcel-L lead us to believe that 2D manufacturing will be adequate to meet demand for this product candidate if fully approved. We also believe that 2D manufacturing process and facilities are commercially feasible for Phase 3 trial supply and the initial launch of MPC-06-ID for CLBP. However, to build up commercial supply for certain of our product candidates long-term, we are developing novel manufacturing processes using three-dimensional, or 3D, bioreactors with greater capacity to improve efficiency and yields, with resulting lower-cost of goods. We intend to evaluate products produced in 3D bioreactors in pre-clinical and potentially clinical studies, which may serve as FDA required comparability studies to 2D if successful. We are also focusing on the introduction of FBS-free media which has the potential to result in efficiency and yield improvements to the current 2D process. We intend to conduct comparability studies to illustrate that products produced with this media are equivalent to those produced using FBS based media. While we remain confident in our ability to deliver successful outcomes from each of these activities, any unexpected issues or challenges faced in doing so could delay our programs or prevent us from continuing our programs. Our manufacturing activities to date have met stringent criteria set by international regulatory agencies, including the FDA. By using well-characterized cell populations, our manufacturing processes promote reproducibility and batch-to- batch consistency for our allogeneic cell product candidates. We have developed robust quality assurance procedures and lot release assays to support this reproducibility and consistency. Intellectual Property We have a large patent portfolio of issued and pending claims covering compositions of matter, uses for our mesenchymal lineage cell-based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our manufacturing processes. As of July 2024, the patent portfolio comprises approximately 1,085 patents and patent applications across 66 patent families, with protection extending through to at least 2045 in all major markets. One of our major objectives is to continue to protect and expand our extensive estate of patent rights and trade secrets, which we believe enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary technologies, and support our corporate strategy to target large, mature and emerging healthcare markets for our exploratory therapeutic product candidates. More specifically, our patent estate includes issued patent and patent applications in major markets, including, but not limited to, the United States, Europe, Japan and China. The patents that we have obtained, and continue to apply for, cover mesenchymal lineage cell technologies and product candidates derived from these technologies, irrespective of the tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp. These patents cover, among other technology areas, a variety of MLCs (including MPCs and MSCs), and the use of MLC for expansion of hematopoietic stem cells, or HSCs. Among the indication-specific issued or pending patents covering product candidates derived from our mesenchymal lineage cells are those which are directed to our lead product candidates: aGVHD, ARDS, CLBP, CHF and chronic inflammatory conditions such as RA. We also have issued and pending patents covering other pipeline indications, including diabetic kidney disease, inflammatory bowel disease (e.g., Crohn’s disease), neurologic diseases, eye diseases and additional orthopedic diseases. In addition, we have in-licensed patents covering complementary technologies, such as other types of mesenchymal lineage cells, cell surface modification technologies, pay-loading technology and protein and gene technologies, as part of our strategy to expand our targeted disease applications and manage the life-cycle of our current lead programs. Our patent portfolio also includes issued and pending coverage of proprietary manufacturing processes that are being used with our current two-dimensional manufacturing platform as well as the 3D bioreactor manufacturing processes currently under development. These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, aggregates minimization, cryopreservation, release testing and potency assays. In addition, we maintain as a trade secret, among other things, our proprietary FBS-free media used in our 3D bioreactor manufacturing processes. We maintain trade secrets covering a significant body of know-how and proprietary information relating to our core product candidates and technologies. We protect our confidential know-how and trade secrets in a number of ways, including requiring all employees and third parties that have access to our confidential information to sign non-disclosure Table of Contents 62
agreements, limiting access to confidential information on a need-to-know basis, maintaining our confidential information on secure computers, and providing our contract manufacturers with certain key ingredients for our manufacturing process. In addition, in many major jurisdictions there are other means that may be available to us by which we would be able to extend the period during which we have commercial exclusivity for our product candidates, which include, but are not limited to the exclusive right to reference our data, orphan drug exclusivity and patent term extensions. As part of our strategy, we seek patent protection for our product candidates and technologies in major jurisdictions including the United States, Europe, Japan, China, and Australia and file independent and/or counterpart patents and patent applications in other jurisdictions globally that we deem appropriate under the circumstances, including India, Canada, Hong Kong, Israel, Korea and Singapore. As of July 2024, our patent portfolio includes the following patents and patent applications in the following major jurisdictions: 67 granted U.S. patents and 51 pending U.S. patent applications; 64 granted Japanese patents and 35 pending Japanese patent applications; 31 granted Chinese patents and 32 pending Chinese patent applications; 50 granted European patents and 37 pending European patent applications; and 51 granted Australian patents and 32 pending Australian patent applications. Our policy is to patent the technology, inventions and improvements that we consider important to the development of our business, only in those cases in which we believe that the costs of obtaining patent protection is justified by the commercial potential of the technology and associated product candidates, and typically only in those jurisdictions that we believe present significant commercial opportunities to us. In those cases where we choose neither to seek patent protection nor protect the inventions as trade secrets, we may publish the inventions so that it defensively becomes prior art in order for us to secure a freedom to operate position and to prevent third parties from patenting the invention. We also seek to protect as trade secrets our proprietary and confidential know-how and technologies that are either not patentable or where we deem it inadvisable to seek patent protection. To this end, we generally require all third parties with whom we share confidential information and our employees, consultants and advisors to enter into confidentiality agreements prohibiting the disclosure of confidential information. These agreements with our employees and consultants engaged in the development of our technologies require disclosure and assignment to us of the ideas, developments, discoveries and inventions, and associated intellectual property rights, important to our business. Additionally, these confidentiality agreements, among others, require that our employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology. License and Collaboration Agreements All of our revenue relates to upfront, royalty and milestone payments recognized under the license and collaboration agreements below. For further information on the categorical revenue breakdown during the last three fiscal years, see “Item 18. Financial Statements – Note 3”. Grünenthal arrangement In September 2019, Mesoblast entered into a strategic partnership with Grünenthal GmbH (Grünenthal) to develop and commercialize MPC-06-ID, the Company’s Phase 3 allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options. The agreement was amended by the parties in June 2021. Under the partnership, Grünenthal will have exclusive commercialization rights to MPC-06-ID for Europe and Latin America. Mesoblast may receive up to $112.5 million in upfront and milestone payments prior to product launch, inclusive of $17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone payments could exceed $1.0 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast will also receive tiered double-digit royalties on product sales. There cannot be any assurance as to the total amount of future milestone and royalty payments that Mesoblast will receive nor when they will be received. JCR Pharmaceuticals Co., Ltd.—Hematological Malignancies and Hepatocytes Collaboration in Japan In October 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture expanded MSCs. These assets included assumption of a collaboration agreement with JCR (“JCR Agreement”), which will continue in existence until the later of 15 years from the first commercial sale of any product covered by the agreement and expiration of the last Osiris patent covering any such product. JCR is a research and development oriented pharmaceutical Table of Contents 63
company in Japan. Under the JCR Agreement we assumed from Osiris, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the treatment of hematological malignancies by the use of HSCs derived from peripheral blood, cord blood or bone marrow, or the First JCR Field; and non-exclusive for developing assays that use liver cells for non-clinical drug screening and evaluation, or the Second JCR Field. Under the JCR Agreement, JCR obtained rights in Japan to our MSCs, for the treatment of aGVHD. JCR also has a right of first negotiation to obtain rights to commercialize MSC-based products for additional orphan designations in Japan. We retain all rights to those products outside of Japan. JCR received full approval in September 2015 for its MSC-based product for the treatment of children and adults with aGVHD, TEMCELL. TEMCELL is the first culture-expanded allogeneic cell therapy product to be approved in Japan. It was launched in Japan in February 2016. Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. With respect to the First JCR Field, we have received all sales milestone payments, a total of $3.0 million. Ongoing we are entitled to escalating double-digit royalties in the twenties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to an approximately 50% profit share. Intellectual property is licensed both ways under the JCR Agreement, with JCR receiving exclusive and non- exclusive rights as described above from us and granting us non-exclusive, royalty-free rights (excluding in the First JCR Field and Second JCR Field in Japan) under the intellectual property arising out of JCR’s development or commercialization of MSC-based products licensed in Japan. JCR has the right to terminate the JCR Agreement for any reason, and we have a limited right to terminate the JCR Agreement, including a right to terminate in the event of an uncured material breach by JCR. In the event of a termination of the JCR Agreement other than for our breach, JCR must provide us with its owned product registrations and technical data related to MSC-based products licensed in Japan and all licenses of our intellectual property rights will revert to us. We expanded our partnership with JCR in Japan for two new indications: for wound healing in patients with EB in October 2018, and for neonatal hypoxic ischemic encephalopathy ("HIE"), a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019. We will receive royalties on TEMCELL product sales for licensed indications, if and when such indications receive marketing approval in Japan. We have the right to use all safety and efficacy data generated by JCR in Japan to support our development and commercialization plans for our MSC product candidate remestemcel-L in the United States and other major healthcare markets, including for GVHD, EB and HIE. Lonza—Manufacturing Collaboration In September 2011, we entered into a manufacturing services agreement, or MSA, with Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., collectively referred to as Lonza, a global leader in biopharmaceutical manufacturing. Under the MSA, we pay Lonza on a fee for service basis to provide us with manufacturing process development capabilities for our product candidates, including formulation development, establishment and maintenance of master cell banks, records preparation, process validation, manufacturing and other services. We have agreed to order a certain percentage of our clinical requirements and commercial requirements for MPC products from Lonza. Lonza has agreed not to manufacture or supply commercially biosimilar versions of any of our product candidates to any third party, during the term of the MSA, subject to our meeting certain thresholds for sales of our products. We can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for our product candidates. In return if we exercise this option, we will purchase agreed quantities of our product candidates from this facility. We also have a right to buy out this manufacturing facility at a pre-agreed price two years after the facility receives regulatory approval. Table of Contents 64
The MSA will expire on the three-year anniversary of the date of the first commercial sale of product supplied under the MSA, unless it is terminated earlier. We have the option of extending the MSA for an additional 10 years, followed by the option to extend for successive three-year periods subject to Lonza’s reasonable consent. We may terminate the MSA with two years prior written notice, and Lonza may terminate with five years prior written notice. The MSA may also terminate for other reasons, including if the manufacture or development of a product is suspended or abandoned due to the results of clinical trials or guidance from a regulatory authority. In the event we request that Lonza construct the manufacturing facility described above, neither we nor Lonza may terminate before the third anniversary of the date the facility receives regulatory approval to manufacture our product candidates, except in certain limited circumstances. Upon expiration or termination of the MSA, we have the right to require Lonza to transfer certain technologies and lease the Singapore facility or the portion of such facility where our product candidates are manufactured, subject to good faith negotiations. We currently rely, and expect to continue to rely, on Lonza for the manufacture of our product candidates for preclinical and clinical testing, as well as for commercial manufacture of our product candidates if marketing approval is obtained. In October 2019, we entered into an agreement with Lonza for commercial manufacture of remestemcel-L for pediatric SR-aGVHD. This agreement has facilitated inventory build ahead of the planned US market launch of remestemcel-L and commercial supply to meet Mesoblast’s long-term market projections. The agreement provides for Lonza to expand its Singapore cGMP facilities if required to meet long-term growth and capacity needs for the product. Additionally, it anticipates introduction of new technologies and process improvements which are expected to result in significant increases in yields and efficiencies. Singapore Economic Development Board (EDB)—Singapore Operations In 2014, the Economic Development Board of Singapore, or EDB, granted us certain financial incentives tied to revenues generated by our Singapore operations, among other things. The incentive for manufacturing activities is for a 15- year period (broken into five-year increments). We will be eligible for this incentive if we meet certain investment or activity thresholds in Singapore, including employment levels, amounts of business or manufacturing related expenses. For example, in order to obtain full financial benefits from the EDB for our manufacturing-related incentives, we must manufacture at least 50% of the global volume of our first three commercial products in Singapore (subject to certain exceptions), and we would be required to construct and operate a manufacturing facility in Singapore, and hire and maintain a specified number of professionals (including supply chain personnel) in connection with the operation of that facility. The activities under our MSA with Lonza could be used to fulfill all or part of the requirements to obtain the EDB financial incentives. Central Adelaide Local Health Network Incorporated—Mesenchymal Precursor Cell Intellectual Property In October 2004, we, through our wholly-owned subsidiary, Angioblast Systems Inc., now Mesoblast, Inc., acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with our use of the Medvet IP, we are obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments of up to $2.2 million and single-digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) and single-digit royalties on net sales of the specified products for applications outside the specified fields. Additionally, we are obligated to pay CALHNI a double- digit percentage in the teens of any revenue that we receive in exchange for a grant of a sublicense to the Medvet IP in the specified fields. Under the IP Deed, we also granted to Medvet a non-exclusive, royalty-free license to the Medvet IP for non-commercial, internal research and academic research. Pursuant to the IP Deed, we were assigned the rights in three U.S. patents or patent applications (including all substitutions, continuations, continuations-in-part, divisional, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues, reexaminations, extensions, confirmations, revalidations, registrations and patents of addition and foreign equivalents thereof) and all future intellectual property rights, including improvements, that might arise from research conducted at CALHNI related to MPCs and methods of isolating, culturing and expanding MPCs and their use in any therapeutic area. We also acquired all related materials, information and know-how. Table of Contents 65
Osiris Acquisition—Continuing Obligations In October 2013, we and Osiris entered into a purchase agreement, as amended, or the Osiris Purchase Agreement, under which we acquired all of Osiris’ business and assets related to culture expanded MSCs. Pursuant to the Osiris Purchase Agreement, we also agreed to make certain milestone and royalty payments to Osiris pertaining to remestemcel-L for the treatment of aGVHD and Crohn’s disease. Each milestone payment is for a fixed dollar amount and may be paid in cash or our ordinary shares or ADSs, at our option. The maximum amount of future milestone payments we may be required to make to Osiris is $40.0 million. Any ordinary shares or ADSs we issue as consideration for a milestone payment will be subject to a contractual one year holding period, which may be waived in our discretion. In the event that the price of our ordinary shares or ADSs decreases between the issue date and the expiration of any applicable holding period, we will be required to make an additional payment to Osiris equal to the reduction in the share price multiplied by the amount of issued shares under that milestone payment. This additional payment can be made either wholly in cash or 50% in cash and 50% in our ordinary shares, in our discretion. We have also agreed to pay varying earnout amounts as a percentage of annual net sales of acquired products, ranging from low single-digit to 10% of annual sales in excess of $750.0 million. These royalty payments will cease after the earlier of a ten year commercial sales period and the first sale of a relevant competing product. The first royalty payments were made in 2016. Tasly Pharmaceutical Group — Cardiovascular Alliance for China In July 2018, we entered into a Development and Commercialization Agreement with Tasly. The Development and Commercialization Agreement provides Tasly with exclusive rights to develop, manufacture and commercialize REVASCOR in China for the treatment or prevention of CHF and MPC-25-IC for the treatment or prevention of AMI. Tasly will fund all development, manufacturing and commercialization activities in China for REVASCOR and MPC-25-IC. On closing, we received a $20.0 million upfront technology access fee. Further, we will receive $25.0 million upon product regulatory approvals in China. Mesoblast will receive double-digit escalating royalties on net product sales. Mesoblast is eligible to receive six escalating milestone payments upon the product candidates reaching certain sales thresholds in China. Tasly can terminate the Development and Commercialization Agreement with a specified amount of notice, on the later of (a) third anniversary of the agreement coming into effect and (b) receipt of marketing approval in China for each of REVASCOR or MPC-25-IC. Mesoblast has termination rights with respect to certain patent challenges by Tasly and if certain competing activities are undertaken by Tasly. Either party may terminate the agreement on material breach of the agreement if such breach is not cured within the specified cure period or if certain events related to bankruptcy of the other party occur. TiGenix NV – patent license for treatment of fistulae In December 2017, we entered into a Patent License Agreement with TiGenix, now a wholly owned subsidiary of Takeda, which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived MSC product Alofisel®, previously known as Cx601, a product candidate of Takeda, for the local treatment of fistulae. The agreement includes the right for Takeda to grant sub-licenses to affiliates and third parties. As part of the agreement, we received $5.9 million (€5.0 million) before withholding tax as a non-refundable upfront payment, a further payment of $5.9 million (€5.0 million) before withholding tax 12 months after the patent license agreement date, and a further $1.2 million (€1.0 million) product regulatory milestone payment in the year ended June 30, 2022. We are entitled to further payments of up to €9.0 million when Takeda reaches certain product regulatory milestones. Additionally, we receive single digit royalties on net sales of Alofisel®. The agreement will continue in full force in each country (other than the United States) until the date upon which the last issued claim of any licensed patent covering Alofisel® expires in such country (currently expected to be 2029) or, with respect to the United States, until the later of (i) the date upon which the last issued claim of any licensed patent covering Alofisel® in the United States expires (currently expected to be around 2031) or (ii) the expiration of the regulatory exclusivity period in the United States with an agreed maximum term. Either we or Takeda may terminate the agreement for any material breach that is not cured within 90 days after notice thereof. We also have the right to terminate the agreement, with a written notice in the event that Takeda file a petition in bankruptcy or insolvency or Takeda makes an assignment of substantially all of its assets for the benefit of its creditors. Table of Contents 66
Takeda have the right to terminate their obligation to pay royalties for net sales in a specific country if it is of the opinion that there is no issued claim of any licensed patent covering Alofisel® in such country, subject to referral of the matter to the joint oversight/cooperation committee established under the agreement if we disagree. Competition The biotechnology and pharmaceutical industries are highly competitive and are characterized by rapidly advancing technologies and a strong emphasis on proprietary products. Any product candidates that we and our collaborators successfully develop and commercialize will compete with existing products and new products that may become available in the future. A number of our potential competitors, particularly large biopharmaceutical companies, have significantly greater financial resources and general expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Our market has been characterized by significant consolidation by pharmaceutical and biotechnology companies, which is likely to result in even more resources being concentrated among a smaller number of our potential competitors. Government Regulation We are developing cellular therapy product candidates. These products are subject to extensive legislation. Governmental authorities around the world, including the FDA, are charged with the administration and enforcement of numerous laws and regulations that impact all aspects of the development, production, importing, testing, approval, labeling, promotion, advertising, and sale of products such as ours. Such governmental authorities are also charged with administering what is often a lengthy and technical review and approval process before candidate therapies such as ours may be marketed for any use. Authorization or approval for marketing must generally be obtained from the local health authorities in each country in which the product is to be sold. Approval and authorization procedures may differ from country to country, as may the requirements for maintaining approvals. It is typical however for these procedures to require evidence of rigorous testing and documentation regarding the candidate therapy, which may include significant non-clinical and clinical evaluations. Extensive controls and requirements apply to the non-clinical and clinical development of our therapeutic candidates. Those requirements and their enforcement and implementation by local regulatory authorities around the world significantly impact whether a product candidate can be developed into a marketable product, and notably impact the cost, resources and timing for any such development. Changes in regulatory requirements and differences in requirements from country to country may also increase the costs of bringing new technologies such as ours to market and maintaining approvals, if obtained. To obtain marketing approval of a new product, an extensive dossier of evidence establishing the safety, efficacy and quality of the product must be submitted for review by regulatory authorities. Dossier form and substance, while often similar may have notable differences in different countries. Submission of an application to regulators does not guarantee approval to market that product, despite the fact that criteria for approval in many countries may be quite similar. Some regulatory authorities may require additional data and analyses, and may have standards that apply that are more stringent than others for review of the submitted dossier and content. Additionally, the review process, risk tolerance, and openness to new technologies may vary from country to country. Obtaining marketing approval can take several months to several years, depending on the country, the quality of the data, the efficiencies and procedures of the reviewing regulatory authority and their familiarity with the product technology. Some countries, like the US, may have accelerated approval processes for certain categories of products, for example products which represent a breakthrough in the field, or which meet certain thresholds and have obtained certain designations of particular interest. Nevertheless, ultimate availability to patients may be affected, even post approval, by requirements in some countries to negotiate selling prices and reimbursement terms with government regulators or other payors. Maintaining marketing approval may require the conduct of additional post-approval studies in some situations, and the continued capture, monitoring and assessment of safety and other information about the product, as well as adherence to requirements to ensure the purity and integrity of manufactured product. The process for obtaining and maintaining regulatory authorizations and approvals to market our products and the subsequent compliance with appropriate federal, state, local and foreign laws and regulations require the expenditure of substantial time and the commitment of significant financial and other resources, and we may not be able to obtain the required regulatory approvals. Table of Contents 67
Product Development Process All of our product candidates are regulated as biological products by the Center for Biologics Evaluation and Research in the FDA. In the United States, biological products are subject to federal regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service (“PHS”) Act, and other federal, state, local and foreign statutes and regulations. Both the FDCA and the PHS Act, as applicable, and their corresponding regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution, import, export, reporting, advertising and other promotional practices involving drugs and biological products. Before clinical testing of a new drug or biological product may commence, the sponsor of the clinical study must submit an application for investigational new drug (“IND”) application to FDA, which must include, among other information, the proposed clinical study protocol(s). To obtain marketing authorization once clinical testing has concluded, a BLA must be submitted for FDA approval. The process required by the FDA before a biological product may be marketed in the U.S. generally involves the following: • completion of nonclinical laboratory studies, meaning in vivo and in vitro experiments in which an investigational product is studied prospectively in a test system under laboratory conditions to determine its safety, must be conducted according to cGLP (good laboratory practice) regulations, as well as, in the case of nonclinical laboratory studies involving animal test systems, in accordance with applicable requirements for the humane use of laboratory animals and other applicable regulations; • submission to the FDA of an application for an IND, which must become effective before human clinical studies may begin; • performance of adequate and well-controlled human clinical studies according to the FDA’s cGCPs (good clinical practices) and all other applicable regulatory requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed product for its intended use and to ensure the product has an appropriate risk-benefit profile; • development and demonstration of a manufacturing process that can produce product of consistent and adequate quality; • submission to the FDA of a BLA for marketing approval demonstrating the quality, safety, and efficacy of the product which must be supported by substantial evidence from adequate and well-controlled clinical investigations as well as demonstration of mode of action through non-clinical studies, evidence to support appropriate manufacturing capabilities and controls, and evidence of the stability of the product in the form it is intended to be provided; • negotiation with FDA of proposed product labeling (and determination of appropriate risk mitigation strategies and programs, if any required), as well as participation in any required advisory committee proceedings; • satisfactory completion of an FDA inspection of all manufacturing, testing and distribution facilities where the product is produced, tested or stored and distributed, to assess compliance with cGMP (good manufacturing practices) to assure that the facilities, methods and controls for production are adequate to preserve the product’s identity, strength, purity and potency; • potential FDA inspection of nonclinical facilities and likely inspection of select clinical study sites that generated the data in support of the BLA; and • FDA review and approval of the BLA. Human testing of a biological product candidate is preceded by preclinical testing, including nonclinical laboratory studies in which the product candidate is studied prospectively in a test system under laboratory conditions to determine its safety. A test system may include any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. The clinical study sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical study covered by the IND on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical Table of Contents 68
study can begin. The FDA may also impose clinical holds on a product candidate at any time during clinical studies due to safety concerns or non-compliance. If the FDA imposes a clinical hold, studies may not recommence unless FDA removes the clinical hold and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will not arise that suspend or terminate such studies. Clinical studies involve the administration of the product candidate to subjects under the supervision of qualified independent investigators, generally physicians or other qualified scientists and medical personnel who are not employed by or under the study sponsor’s control. Clinical studies are conducted under protocols detailing, among other things, the objectives of the clinical study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical study will be stopped if certain adverse events, or AEs, should occur. Each new protocol and certain amendments to the protocol must be submitted to the FDA. Clinical studies must be conducted in accordance with the FDA’s cGCP regulations and guidance, and monitored to ensure compliance with applicable regulatory requirements. These include the requirement that written informed consent is obtained from all subjects who participate in the study. Further, each clinical study must be reviewed and approved by an independent Institutional Review Board, or IRB, at or servicing each institution at which the clinical study will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the risks to individuals participating in the clinical studies are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent document that must be signed by each clinical study subject or his or her legal representative and must monitor the clinical study until completed. Throughout the study, certain information about certain serious adverse events must be reported to the IRB, in some cases on an expedited basis, and to FDA (as well as to regulators in other countries in which studies of the product are also being conducted). Human clinical studies are typically conducted in three sequential phases that may in some cases overlap or be combined: • Phase 1. The product candidate is initially introduced into a small number of human subjects. In the case of cellular therapy products, the initial human testing is conducted in patients with the disease or condition targeted by the biological product candidate. Phase 1 studies are intended to determine the metabolism and pharmacologic actions (including adverse reactions), the side effects associated with increasing doses, immunogenicity, and, if possible, to gain early evidence of effectiveness. The information obtained in Phase 1 should be sufficient to permit the design of well-controlled, scientifically valid Phase 2 studies. • Phase 2. Controlled clinical studies are conducted in a larger number of human subjects to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study. Phase 2 studies are intended to assess side effects and risks, and to examine exposure– response relationships, and to further explore pharmacologic actions and immunogenicity associated with the drug. These studies also provide helpful information for the design of phase 3 studies. • Phase 3. Assuming preliminary evidence suggesting effectiveness has been obtained in phase 2 (generally considered to be “proof of concept”), controlled studies are conducted in a larger group of subjects to gather additional information about effectiveness and safety in order to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Post-approval clinical studies, sometimes referred to as Phase 4 clinical studies, may be conducted after initial marketing approval. In some cases, FDA may require a Phase 4 study to be performed as a condition of product approval. Sponsors also can voluntarily conduct Phase 4 studies to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up or in select populations. FDA regulations extend to all phases of clinical development and apply to sponsors and investigators of clinical studies. FDA oversight includes inspection of the sites and investigators involved in conducting the studies. Concurrent with clinical studies, companies usually complete additional animal studies, and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among Table of Contents 69
other things; the sponsor must develop methods for testing the identity, purity and potency of the final biological product. All such testing and controls requires the application of significant human and financial resources. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life. U.S. Review and Approval Processes After the completion of clinical studies of a product candidate, FDA approval of a BLA must be obtained before commercial marketing of the biological product. The BLA must include results of product development, laboratory and animal studies, human studies, information on the manufacture and composition of the product, proposed labeling and other relevant information. In addition, under the Pediatric Research Equity Act (“PREA”), a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all. Under the Prescription Drug User Fee Act (“PDUFA”), as amended, each BLA must be accompanied by a substantial user fee. PDUFA also imposes an annual product fee for biologics and an annual establishment fee on facilities used to manufacture prescription biologics. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, an application fee is not assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication. Within 60 days following submission of the application, the FDA reviews the BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any marketing application that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviews the application to determine, among other things, whether the proposed product is safe and effective, for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, potency and purity. The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS; the FDA will not approve the application without a REMS, if required. Before approving a BLA, the FDA will typically inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical studies were conducted in compliance with IND study and cGCP requirements. To assure cGMP and cGCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control. Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and deny approval. Data obtained from clinical studies are not always conclusive and the FDA may interpret data differently than we interpret the same data. If the agency decides not to approve the marketing application, it will issue a complete response letter describing specific deficiencies in the application identified by the FDA. Additionally, the complete response letter may recommend actions that the applicant might take to place the application in a condition for approval. Such recommended actions could include the conduct of additional Table of Contents 70
studies. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application. If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. In addition, the FDA may require post-approval clinical studies, to further assess a product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized. One of the performance goals agreed to by the FDA under the PDUFA is to complete its review of 90% of standard BLAs within 10 months from filing and 90% of priority BLAs within six months from filing, whereupon a review decision is to be made. The FDA does not always meet its PDUFA goal dates and its review goals are subject to change from time to time. The review process and the PDUFA goal date may be extended by three months if the FDA requests or the application sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date. Post-Approval Requirements Maintaining substantial compliance with applicable federal, state, and local statutes and regulations requires the expenditure of substantial time and the commitment of substantial human and financial resources. Rigorous and extensive FDA regulation of biological products continues after approval, particularly with respect to cGMP. We will rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of any products that we may commercialize. Manufacturers of our products are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation. Other post-approval requirements applicable to drug and biological products include reporting post marketing surveillance to continuously monitor the safety of the approved product. This is done through the collection of spontaneous reports of adverse events and side effects, the assessment of safety signals, if any, and prescription event monitoring, among other methods. FDA maintains a system of postmarketing surveillance because all possible side effects of a new drug may not be evident in preapproval studies, which involve only several hundred to several thousand patients. Through postmarketing surveillance and risk assessment programs, FDA and sponsors seek to identify adverse events that did not appear during the drug approval process. In addition, FDA monitors adverse events such as adverse reactions and poisonings. FDA may use this information for a variety of purposes to identify safety signals not previously identified with the product, to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision with respect to a product. In addition, post-approval regulatory requirements include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements, and complying with electronic record and signature requirements. After a BLA is approved, the product also may be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of drug and biological products. The FDA will also conduct routine scheduled and unannounced inspections of drug production and control facilities and processes, using field investigators and analysts, to assure ongoing safety and effectiveness of approved marketed products. Inspections may be made in conjunction with regulators from other jurisdictions and in certain cases, inspection findings and observations may be made public or may impair our ability to use the inspected facility, or to continue to produce and market a product. We also must comply with the FDA’s advertising and promotion requirements, such as those related to direct- to- consumer advertising, the prohibition on promoting products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label use”), industry-sponsored scientific and educational activities, and promotional activities involving the internet and notably, social media. In addition, discovery of previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of Table of Contents 71
a product or withdrawal of the product from the market as well as possible civil or criminal sanctions. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity. Sanctions authorized under FDA’s legal authorities could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties. Violations of the FDCA may serve as a basis for the refusal of, or exclusion from, government contracts, including federal reimbursement programs, as well as other adverse consequences including lawsuits and actions by state attorneys general. Any agency or judicial enforcement action could have a material adverse effect on us. Drug and biological product manufacturers and other entities involved in the manufacture and distribution of approved drug or biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market. In addition, changes to a manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval. U.S. Patent Term Restoration and Marketing Exclusivity Depending upon the timing, duration and specifics of the FDA approval of the use of our product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one- half the time between the effective date of an IND and the submission date of a new drug application, or NDA, or BLA plus the time between the submission date of an NDA or BLA and the approval of that application. Only one patent applicable to an approved product can be extended and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. A drug or biological product can obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. A new biologic is granted 12 years of exclusivity from the time of first licensure during which a biosimilar may not be launched. Table of Contents 72
Government Regulation Outside of the U.S. European Union Regulation In addition to regulations in the U.S., we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of our products. In particular, we view the EU and Japan as important jurisdictions for our business. For purposes of developing our products, we must obtain the requisite approvals from regulatory authorities in each country prior to the commencement of clinical studies or marketing of the product in those countries. Certain countries outside of the U.S. have a similar process that requires the submission of a clinical study application much like the IND prior to the commencement of human clinical studies. In the EU, for example, a clinical trial application (“CTA”), must be submitted to each country’s national health authority and an independent ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical study development may proceed. The EU has two main procedures for obtaining marketing authorizations in the EU Member States: a centralized procedure or national authorization procedure, under the latter of which one can seek to go through the mutual recognition procedure or the decentralized procedure. All biotechnology products are assessed through the centralized procedure. Under the centralized authorization procedure, sponsors submit a single marketing-authorization application to the EMA. This allows the marketing-authorization holder to market the product and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization. EMA's Committee for Medicinal products for Human Use (“CHMP”) carries out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not. Once granted by the EMA, the centralized marketing authorization is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway. The centralized procedure is mandatory for biotechnology products. Any product candidates we seek to commercialize in the EU are subject to review and approval by the European Medicines Authority (“EMA”). Submissions for marketing authorization to the EMA must be received and validated by that body which appoints a Rapporteur and Co-Rapporteur to review it. The entire review process must be completed within 210 days, with a “clock-stop” at day 120 to allow the submitting company to respond to questions set forth in the Rapporteur and Co-Rapporteur’s assessment report. Once the company responds in full, the clock for review re-starts on day 121. If further clarification is needed, the EMA may request an Oral Explanation on day 180, and the company submitting the application must appear before the CHMP to provide the requested information. On day 210, the CHMP will vote to recommend for or against the approval of the application. The final decision of EMA for marketing authorization following a positive CHMP recommendation is typically made within 60 days, with a draft decision within 15 days of the CHMP recommendation. After Marketing Authorizations have been granted, the company must submit periodic safety reports to the EMA (if approval was granted under the Centralized Procedure) or to the National Health Authorities (if approval was granted under the DCP or the MRP). In addition, pharmacovigilance measures must be implemented and monitored to ensure appropriate adverse event collection, evaluation and expedited reporting, as well as timely updates to any applicable risk management plans. For some medications, post approval studies may be required to complement available data with additional data to evaluate long term effects or to gather additional efficacy data. European marketing authorizations have an initial duration of five years. After this time, the marketing authorization may be renewed by the competent authority on the basis of re-evaluation of the risk/benefit balance. Any marketing authorization which is not followed within three years of its granting by the actual placing on the market of the corresponding medicinal product ceases to be valid. United Kingdom (post BREXIT) Marketing Authorization in the United Kingdom no longer falls under the EMA centralized process, and requires compliance to local laws and regulations, with a separate application required either concurrently or sequentially with the centralized procedure. Table of Contents 73
EU Exclusivity Periods To obtain regulatory approval of an investigational biological product under EU regulatory systems, we must submit a marketing authorization application. The application used to file the BLA in the U.S. is similar to that required in the EU, with the exception of, among other things, country-specific document requirements. The EU also provides opportunities for market exclusivity. For example, in the EU, upon receiving marketing authorization, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application. During the additional two-year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity. Products receiving orphan designation in the EU can receive 10 years of market exclusivity, during which time no similar medicinal product for the same indication may be placed on the market. An orphan product can also obtain an additional two years of market exclusivity in the EU for pediatric studies. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the U.S. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to 10 years of market exclusivity for the approved therapeutic indication. The application for orphan drug designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if: • the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior; • the applicant consents to a second orphan medicinal product application; or • the applicant cannot supply enough orphan medicinal product. In addition to law and regulation specific to drug development, we note that new data protection regulations that have gone into effect in Europe are likely to have a significant impact on our activities, personnel, and may have an impact on our ability to timely complete clinical trials and effectively develop and commercialize our product candidates. The General Data Protection Regulation (the “GDPR”) was approved and adopted by the EU Parliament in April 2016 and went into effect on May 25, 2018. Unlike a Directive, the GDPR does not require any enabling legislation to be passed by any government. The GDPR not only applies to organizations located within the EU but may also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behavior of, EU data subjects or if they process the personal data of subjects residing in the European Union. The implications of this regulation are therefore far reaching and may impose significant burdens on the Company and its processes and systems. Additionally, the UK government has implemented data protection legislation, which also went into effect on May 25, 2018, that substantially implements the GDPR. For other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical studies, product licensing, coverage, pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. Table of Contents 74
Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the availability of coverage and adequate reimbursement from third-party payors. Third-party payors include government programs such as Medicare or Medicaid, managed care plans, private health insurers, and other organizations. These third-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they determine that the product or therapy was not medically appropriate or necessary or if another less expensive potential alternative exists. Third-party payors may attempt to control costs by limiting coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA- approved drug products for a particular indication, and by limiting the amount of reimbursement for particular procedures or drug treatments. In addition, in the United States, participation in government health programs such as Medicare and Medicaid are subject to complex rules and controls relating to price reporting and calculation of prices to ensure that pricing provided to government entities for periodic reporting purposes is aligned and compliant with numerous complex statutory requirements and the lowest possible price is the one used by government programs. The infrastructure and/or external resources necessary to ensure continued compliance with these requirements is extensive and manufacturers are subject to audit both by the Centers for Medicare and Medicaid Services and by State Medicaid authorities. The cost of pharmaceuticals and devices continues to generate substantial governmental and third-party payor interest. We expect that the pharmaceutical industry will experience pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative proposals. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. More recently in the US and for certain high-cost rare disease drugs, payors have negotiated a provision that requires manufactures to refund the cost of the treatment if patients discontinue the drug for clinical reasons. Our product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. Some third-party payors also require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, these requirements or any announcement or adoption of such proposals could have a material adverse effect on our ability to obtain adequate prices for our product candidates and to operate profitably. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings (or mandatory price decreases) on specific products and therapies. There can be no assurance that our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available or that the third-party payors reimbursement policies will not adversely affect our ability to sell our product profitably. Healthcare Reform In the U.S. and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs. In the U.S., the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the Medicare Modernization Act, changed the way Medicare covers and pays for pharmaceutical products. The Medicare Modernization Act expanded Medicare coverage for drug purchases by the elderly by establishing Medicare Part D and introduced a new reimbursement methodology based on average sales prices for physician administered drugs under Medicare Part B. In addition, this legislation provided authority for limiting the number of drugs that will be covered in any therapeutic class under the new Medicare Part D program. Cost reduction initiatives and other provisions of this legislation could decrease the coverage and reimbursement rate that we receive for any of our approved products. While the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Table of Contents 75
Therefore, any reduction in reimbursement that results from the Medicare Modernization Act may result in a similar reduction in payments from private payors. In March 2010, the Affordable Care Act (“ACA”) came into effect, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers and impose additional health policy reforms. We expect that the rebates, discounts, taxes and other costs resulting from the ACA over time will have a negative effect on our expenses and profitability in the future. Furthermore, expanded government investigative authority and increased disclosure obligations may increase the cost of compliance with new regulations and programs. The current presidential administration and Congress are also expected to continue recent attempts to make changes to the current health care laws and regulations. The impact of those changes on us and potential effect on the pharmaceutical industry as a whole is currently unknown. But, any changes to the health care laws or regulations, especially to Medicare drug reimbursement, are likely to have an impact on our results of operations and may have a material adverse effect on our results of operations. We cannot predict what other health care programs and regulations will ultimately be implemented at the federal or state level or the effect of any future legislation or regulation in the United States may have on our business. It is possible that healthcare reform measures that have been and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product, and could seriously harm our future revenue. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, and formulary restrictions among private payors including the largest pharmacy benefit managers have increased over recent months, especially as regards to new and high cost market entrants. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. In addition, different pricing and reimbursement schemes exist in other countries. In the European Community, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may be marketed only once a reimbursement price has been agreed upon. Some of these countries may require, as condition of obtaining reimbursement or pricing approval, the completion of clinical trials that compare the cost- effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross- border imports from low-priced markets exert a commercial pressure on pricing within a country. Other Healthcare Laws and Compliance Requirements In the U.S., the research, manufacturing, distribution, sale and promotion of drug products, including biologics, and medical devices are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, divisions of the U.S. Department of Health and Human Services, including the Office of Inspector General and the Centers for Medicare and Medicaid Services, the U.S. Department of Justice, state Attorneys General, and other state and local government agencies. For example, sales, marketing and scientific/educational grant programs must comply with fraud and abuse laws such as the federal Anti-Kickback Statute, as amended, the federal False Claims Act, as amended, and similar state laws. Pricing and rebate programs must comply with the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the Veterans Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal and state consumer protection and unfair competition laws. The federal Anti-Kickback Statute prohibits any person, including a prescription drug manufacturer (or a party acting on its behalf), from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce or reward either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. The term “remuneration” has been broadly interpreted to Table of Contents 76
include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value. Even the award of grant moneys, or the provision of in kind support, publicity and even authorship, in certain cases, may be deemed to be “remuneration.” Although there are a number of statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution, the exception and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from federal Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the ACA, so that the government need no longer prove, for purposes of establishing intent under the federal Anti-Kickback Statute, that a person or entity had actual knowledge of the statute or specific intent to violate it. In addition, the ACA provides that a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (discussed below). Additionally, many states have adopted laws similar to the federal Anti- Kickback Statute, and some of these state prohibitions apply to the referral of patients for healthcare items or services reimbursed by any third-party payor, including private payors. In at least some cases, these state laws do not contain safe harbors. The federal False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal government and share in any recovery. In recent years, the number of suits brought by private individuals has increased dramatically. In addition, various states have enacted false claims laws analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare program. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The False Claims Act has been used to assert liability on the basis of inadequate care, kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price, improper use of Medicare numbers when detailing the provider of services, improper promotion of off-label uses (i.e., uses not expressly approved by FDA in a drug’s label), and allegations as to misrepresentations with respect to the services rendered. Substantial resources have been allocated by both the Department of Justice and the Federal Bureau of Investigation, among other branches of the US government to identify and investigate possible health care fraud activities. Recent investigations include those relating to allegedly egregious price increases by manufacturers and alleged fraud involving co-pay arrangements supported by sponsors. As new theories of liability arise, there is a corresponding cost of doing business in order to maintain compliance. Our future activities relating to the reporting of discount and rebate information and other information affecting federal, provincial, state and third party reimbursement of our products, and the sale and marketing of our products and our service arrangements or data purchases, among other activities, may be subject to scrutiny under these laws. We are unable to predict whether we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the cost of defending such claims, as well as any sanctions imposed, could adversely affect our financial performance. Also, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), created several new federal crimes including healthcare fraud and false statements relating to healthcare matters. The healthcare fraud provision of HIPAA prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors. The false statements provision prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. In addition, we may be subject to, or our marketing activities may be limited by, data privacy and security regulation by both the federal government and the states in which we conduct our business. For example, HIPAA and its implementing regulations established uniform federal standards for certain “covered entities” (healthcare providers, health plans and healthcare clearinghouses) governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health information. The American Recovery and Reinvestment Act of 2009, commonly referred to as the economic stimulus package, included expansion of HIPAA’s privacy and security standards called the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which became effective on February 17, 2010. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”—independent contractors or agents of covered entities that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, Table of Contents 77
and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. There are also an increasing number of state “sunshine” laws that require manufacturers to make reports to states on pricing and marketing information, as well as regarding payments to healthcare professionals. Several states have enacted legislation requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit certain other sales and marketing practices. State laws are not harmonized and contain different reporting requirements and restrictions which must be noted and adhered to. We currently do not report under these state laws, but will be required to do if we are successful in obtaining marketing authorization for our products. We will need to develop the infrastructure or rely on third party contractors to assist us in our compliance with these laws, and failure to comply may result in financial and other penalties and consequences. In addition, beginning in 2013, a similar “sunshine” federal requirement began requiring manufacturers to track and report to the federal government certain payments and other transfers of value made to certain covered recipients, including physicians and other healthcare professionals, and teaching hospitals. In addition to payments, reporting may encompass requirements to report on ownership or investment interests held by physicians and their immediate family members. The efforts and resources needed to track and report payments go well beyond our affiliates operating in the United States, as reporting is required also for payments made by affiliated entities in many cases to US covered recipients. In other jurisdictions (eg, Australia, Japan and Europe) similar “sunshine-like” laws have also been adopted, which may require disclosure of certain payment and other information to covered recipients. Extensive administration and systems, including to aggregate and categorize spend, are necessary in order to enable compliant and timely reporting under these requirements. The US federal government began disclosing the reported information on a publicly available website in 2014. These laws may affect our development, sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. If we fail to track and report as required by these laws or otherwise fail to comply with these laws, we could be subject to the penalty and sanctions of the pertinent state and federal authorities. Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, exclusion from participation in government healthcare programs, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of premarketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post- approval requirements, including safety surveillance, anti-fraud and abuse laws, implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals. Australian Disclosure Requirements Business Strategies and Prospects for Future Years We are focused on the following core strategic imperatives: • continue to innovate and optimize our disruptive technology platform for cell-based therapeutics; • develop a portfolio of clinically distinct products; • focus on bringing late-stage products to market and portfolio prioritization; • enabling manufacturing scale-up to meet demands of the portfolio; • leverage talent base to continue to establish a culture of shared leadership and accountability; • focus on strategic partnerships; • focus on prudent cash management; and • continue to strengthen our substantial and robust intellectual property estate. Table of Contents 78
Dividends No dividends were paid during the course of the fiscal year ended June 30, 2024. There are no dividends or distributions recommended or declared for payment to members, but not yet paid, during the year. 4.C Organizational Structure See “Item 4. Information on the Company – 4.B Business Overview – Overview”, “Item 18. Financial Statements – Note 12” and Exhibit 8.1 to this Annual Report. 4.D Property, Plants and Equipment We lease approximately 11,150 square feet of office space in Melbourne, Australia, where our headquarters are located. We pay approximately A$1,100,000 per year for this lease, which expires in April 2026. We have sub-leased approximately 5,400 square feet of this space and we receive approximately A$360,000 per year for this sub-lease, which expires in April 2026. We also lease approximately 15,600 square feet in New York City, where significant development and pre-commercial activities are conducted. We pay approximately $1,000,000 per year for this lease, which expires in September 2024. We also lease laboratory and office space in Singapore. We pay approximately S$270,000 per year for this lease, which expires in September 2025. We also lease laboratory space in Texas and pay approximately $320,000 per year for this lease, which expires in December 2026. Our manufacturing operations are primarily located at Lonza’s manufacturing facilities. See “Item 4.B Business Overview – Manufacturing and Supply Chain.” Item 4A. Unresolved Staff Comments Not applicable. Item 5. Operating and Financial Review and Prospects 5.A Operating Results This operating and financial review should be read together with our consolidated financial statements in this Annual Report, which have been prepared in accordance with IFRS as published by the IASB. Financial Overview We have incurred significant losses since our inception. We have incurred net losses during most of our fiscal periods since our inception. As at June 30, 2024, we had an accumulated deficit of $908.8 million. Our net loss for the year ended June 30, 2024 was $88.0 million. We anticipate that we may continue to incur significant losses for the foreseeable future. There can be no assurance that we will ever achieve or maintain profitability. We expect our future capital requirements will continue as we: • continue the research and clinical development of our product candidates; • initiate and advance our product candidates into larger clinical studies; • seek to commercialize remestemcel-L for pediatric steroid refractory acute graft versus host disease ("SR- aGVHD") in the United States in the event that we receive marketing authorization by the United States Food and Drug Administration ("FDA"); • seek to identify, assess, acquire, and/or develop other product candidates and technologies; • seek regulatory and marketing approvals in multiple jurisdictions for our product candidates that successfully complete clinical studies; • establish collaborations with third parties for the development and commercialization of our product candidates, or otherwise build and maintain a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval; • further develop and implement our proprietary manufacturing processes and expand our manufacturing capabilities and resources for commercial production; Table of Contents 79
• seek coverage and reimbursement from third-party payors, including government and private payors for future products; • make interest payments, principal repayments and other charges on our debt financing arrangements; • make milestone or other payments under our agreements pursuant to which we have licensed or acquired rights to intellectual property and technology; • seek to maintain, protect, and expand our intellectual property portfolio; and • seek to attract and retain skilled personnel. Subject to us achieving successful regulatory approval, we expect an increase in our total expenses driven by an increase in our planned research and development, manufacturing commercialization and selling, general and administrative expenses as we move towards commercialization. Therefore, we will need additional capital to fund our operations, which we may raise through equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. We do not know when, or if, we will generate revenues from our product sales significant enough to generate profits. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize one or more of our cell-based product candidates. For further discussion on our ability to continue as a going concern, see Note 1(i) in our accompanying financial statements. Commercialization and Milestone Revenue. Commercialization and milestone revenue relates to upfront, royalty and milestone payments recognized under development and commercialization agreements; milestone payments, the receipt of which is dependent on certain clinical, regulatory or commercial milestones; as well as royalties on product sales of licensed products, if and when such product sales occur; and revenue from the supply of products. Payment is generally due on standard terms of 30 to 60 days. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred consideration in our consolidated balance sheet, depending on the nature of the arrangement. Amounts expected to be recognized as revenue within the 12 months following the consolidated balance sheet date are classified within current liabilities. Amounts not expected to be recognized as revenue within the 12 months following the consolidated balance sheet date are classified within non-current liabilities. Research and Development. Research and development expenditure is recognized as an expense as incurred. Our research and development expenses consist primarily of: • third party costs comprising all external expenditure on our research and development programs such as fees paid to Contract Research Organizations (“CROs”) and on our pre-commercial activities, such as research pertaining to market access and pricing, brand marketing and initiation of trade and distribution contracts. Third party costs also comprise fees paid to consultants who perform research on our behalf and under our direction, rent and utility costs for our research and development facilities, and database analysis fees; • third party costs under license and/or sub-license arrangements for the research and development, license, manufacture and/or commercialization of products and/or product candidates, such as payments for options to acquire rights to products and product candidates as well as contingent obligations under the agreements; • product support costs consisting primarily of salaries and related overhead expenses for personnel in research and development and pre-commercial functions (for example wages, salaries and associated on costs such as superannuation, share-based incentives and payroll taxes, plus travel costs and recruitment fees for new hires); • intellectual property support costs comprising payments to our patent attorneys to progress patent applications and all costs of renewing our granted patents; and • amortization of currently marketed products on a straight-line basis over the life of the asset. Our research and development expenses are not charged to specific products or programs, since the number of clinical and preclinical product candidates or development projects tends to vary from period to period and since internal resources are utilized across multiple products and programs over any given period of time. As a result, our management does not maintain and evaluate research and development costs by product or program. Acquired in-process research and development is capitalized as an asset and is not amortized but is subject to annual impairment review during the Table of Contents 80
development phase. Upon completion of its development, the acquired in-process research and development amortization will commence. Manufacturing Commercialization. Manufacturing commercialization expenditure is recognized as an expense as incurred. Our manufacturing commercialization expenses consist primarily of: • salaries and related overhead expenses including share-based incentives for personnel in manufacturing functions; • fees paid to our contract manufacturing organizations, which perform process development on our behalf and under our direction; • costs related to laboratory supplies used in our manufacturing development efforts; and • provision for the carrying value of pre-launch inventory costs on the balance sheet. Management and Administration. Management and administration expenses consist primarily of salaries and related costs including share-based incentives for directors and employees in corporate and administrative functions, including the executives of those areas. Other significant management and administration expenses include legal and professional services, rent and depreciation of leasehold improvements, insurance and information technology services. Fair Value Remeasurement of Contingent Consideration. Remeasurement of contingent consideration pertains to the acquisition of the MSC assets from Osiris Therapeutics, Inc. (“Osiris”). The fair value remeasurement of contingent consideration is recognized as a net result of changes to the key assumptions of the contingent consideration valuation such as developmental timelines, market growth, probability of success and payment, market penetration, product pricing and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration. Fair Value Movement of Warrants. Remeasurement of warrants pertain to the warrants granted to Oaktree Capital Management, L.P ("Oaktree") in relation to the refinancing and amendment of our senior debt facility. The fair value movement of warrants is recognized when there is a change in the valuation assumptions such as share price, risk-free interest rates and volatility. Other Operating Income and Expenses. Other operating income and expenses primarily comprise foreign exchange gains and losses. Tax incentives comprise payments from the Australian government’s Innovation Australia Research and Development Tax Incentive program for research and development activities conducted in relation to our qualifying research that meets the regulatory criteria. The research and development tax incentive credit is available for our research and development activities in Australia. Eligible companies can receive a refundable tax offset for a percentage of their research and development spending. Foreign exchange gains and losses relate to unrealized foreign exchange gains and losses on our foreign currency amounts in our Australian based entity, whose functional currency is the A$, and foreign currency amounts in our Switzerland and Singapore based entities, whose functional currencies are the US$, plus realized gains and losses on any foreign currency payments to our suppliers due to movements in exchange rates. Interest Revenue. Interest revenue is accrued on a time basis by reference to the principal outstanding and at the effective interest rate applicable. Finance Costs. Finance costs primarily consists of remeasurement of borrowing arrangements, interest expense in relation to finance lease charges, accrued interest expense and interest expense in relation to the amortization of transaction costs and other charges associated with the borrowings as represented in our consolidated balance sheet using the effective interest rate method over the period of initial recognition through maturity. Remeasurement of borrowing arrangements recognized pertain to our loan and security agreements with NovaQuest Capital Management, L.L.C. (“NovaQuest”) and Oaktree. Remeasurement of borrowing arrangements is recognized when there is a modification of the borrowing arrangement with no significant change to the contractual cash flows of the borrowings at the remeasurement date or when there is a revision in the estimated future cash flows which is recorded as an Table of Contents 81
adjustment of the carrying amount of the financial liability. The carrying amount is recalculated by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate. Income Tax Benefit/Expense. Income tax benefit/expense consists of net changes in deferred tax assets and liabilities recognized on the balance sheet during the period. Results of Operations Comparison of Our Results for the Year ended June 30, 2024 with the Year ended June 30, 2023 The following table summarizes our results of operations for the years ended June 30, 2024 and 2023, together with the changes in those items in dollars and as a percentage. Year ended June 30, (in U.S. dollars, in thousands except per share information) 2024 2023 $ Change % Change Consolidated Income Statement Data: Revenue: Commercialization revenue $ 5,902 $ 7,501 (1,599) (21%) Total revenue 5,902 7,501 (1,599) (21%) Research & development (25,353) (27,189) 1,836 (7%) Manufacturing commercialization (15,717) (27,733) 12,016 (43%) Management and administration (23,626) (25,374) 1,748 (7%) Fair value remeasurement of contingent consideration (9,693) 8,771 (18,464) NM Fair value movement of warrants 779 (2,205) 2,984 (135%) Other operating income and expenses 2,570 4,250 (1,680) (40%) Finance costs (23,009) (20,122) (2,887) 14% Loss before income tax (88,147) (82,101) (6,046) 7% Income tax benefit 191 212 (21) (10%) Loss attributable to the owners of Mesoblast Limited $ (87,956) $ (81,889) (6,067) 7% Losses per share from continuing operations attributable to the ordinary equity holders: Cents Cents Cents % Change Basic - losses per share (8.91) (10.53) 1.62 (15%) Diluted - losses per share (8.91) (10.53) 1.62 (15%) * NM = not meaningful. Revenue Revenues were $5.9 million for the year ended June 30, 2024, compared with $7.5 million for the year ended June 30, 2023, a decrease of $1.6 million. The following table shows the movement within revenue for the years ended June 30, 2024 and 2023, together with the changes in those items. Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Revenue: Commercialization revenue 5,902 7,501 (1,599) (21%) Revenue $ 5,902 $ 7,501 (1,599) (21%) Table of Contents 82
Commercialization revenue from royalty income earned on sales of TEMCELL in Japan and Alofisel® decreased by $1.6 million for the year ended June 30, 2024. Royalty income on sales of TEMCELL in Japan by our licensee JCR were $5.5 million in the year ended June 30, 2024 compared to $7.1 million in the year ended June 30, 2023, a decrease of $1.6 million. Of this $1.6 million decrease, $0.4 million was due to foreign exchange rate changes as the Japanese Yen depreciated against the U.S. dollar. Royalty income on sales of Alofisel® by our licensee Takeda were consistent at $0.4 million in the years ended June 30, 2024 and 2023. Research and development Research and development expenses were $25.4 million for the year ended June 30, 2024, compared with $27.2 million for the year ended June 30, 2023, a decrease of $1.8 million. The $1.8 million decrease in research and development expenses is primarily due to the movements in third party costs and product support costs. Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Research and development: Third party costs 3,776 8,398 (4,622) (55%) Product support costs 17,338 14,107 3,231 23% Intellectual property support costs 2,784 3,222 (438) (14%) Amortization of current marketed products 1,455 1,462 (7) 0% Research and development $ 25,353 $ 27,189 (1,836) (7%) Third party costs, which consist of all external expenditure on our research and development programs and pre- commercial activities, decreased by $4.6 million in the year ended June 30, 2024 compared with the year ended June 30, 2023. This $4.6 million decrease was due to a reduction in our third party costs for our Phase 3 clinical trials for the treatment of MPC-150-IM (CHF) and ARDS in COVID-19 patients. The decrease of these costs were primarily due to higher activities in relation to patient monitoring during follow up visits and higher data analysis being performed in the year ended June 30, 2023 compared with the year ended June 30, 2024. In the year ended June 30, 2024, we incurred costs associated with start-up activities for our confirmatory Phase 3 clinical trial for MPC-06-ID (CLBP). In the year ended June 30, 2024, we also incurred costs of $0.6 million associated with our pre-commercial activities as we prepared for the potential launch of remestemcel-L in the United States. Product support costs, which consist primarily of salaries and related overhead expenses for personnel in research and development and pre-commercial functions, have increased by $3.2 million, for the year ended June 30, 2024 compared with the year ended June 30, 2023 due to an increase of $3.2 million in product support costs for research and development functions. The product support costs for pre-commercial functions remained relatively consistent for the year ended June 30, 2024 compared with the year ended June 30, 2023. The $3.2 million increase in product support costs for personnel in research and development functions is primarily due to an increase of $2.7 million in short-term incentives. In the year ended June 30, 2024, we recognized short-term incentives of $1.8 million related to the year ended June 30, 2023 given that subsequent to June 30, 2023 the conditions of achievement of the short-term incentive for year ended June 30, 2023 were modified to make it dependent on Mesoblast achieving FDA marketing authorization. There was also an increase of $1.2 million in share-based payment expenses for the year ended June 30, 2024 compared with the year ended June 30, 2023. These increases were offset by a decrease of $0.2 million in consulting expenses for the year ended June 30, 2024 compared with the year ended June 30, 2023. There was also a decrease of $0.5 million across salaries and associated costs as full time equivalents decreased by 1.7 (4%) from 43.7 for the year ended June 30, 2023 to 42.0 for the year ended June 30, 2024. Also included in research and development expenses are intellectual property support costs, which consist of payments to our patent attorneys to progress patent applications and costs of renewing our granted patents. These costs have decreased by $0.4 million in the year ended June 30, 2024 compared with the year ended June 30, 2023 due to decreased activities across our entire patent portfolio. Table of Contents 83
Manufacturing commercialization Manufacturing commercialization expenses were $15.7 million for the year ended June 30, 2024, compared with $27.7 million for the year ended June 30, 2023, a decrease of $12.0 million. This decrease is due to a decrease in platform technology costs. Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Manufacturing commercialization: Platform technology 13,472 25,964 (12,492) (48%) Manufacturing support costs 2,245 1,769 476 27% Manufacturing commercialization $ 15,717 $ 27,733 (12,016) (43%) Platform technology costs decreased by $12.5 million for the year ended June 30, 2024 compared with year ended June 30, 2023. These costs consist of fees paid to our contract manufacturing organizations, potency assay work that supported the aGVHD Biologics License Application ("BLA") resubmission, process development of our proprietary technology that facilitates the increase in yields necessary for the long-term commercial supply of our product candidates and next generation manufacturing processes to reduce labor, drive down cost of goods and improve manufacturing efficiencies in our MPC and MSC based products. The decrease of these costs was primarily due to lower MSC development activities during the year ended June 30, 2024 compared with the year ended June 30, 2023. Manufacturing support costs, which consist primarily of salaries and related overhead expenses for personnel in manufacturing commercialization functions increased by $0.5 million for the year ended June 30, 2024 compared with the year ended June 30, 2023 primarily due to an increase in short-term incentives for the year ended June 30, 2024 compared with the year ended June 30, 2023. In the year ended June 30, 2024, we recognized short-term incentives of $0.2 million related to the year ended June 30, 2023 given that subsequent to June 30, 2023 the conditions of achievement of the short- term incentive for year ended June 30, 2023 were modified to make it dependent on Mesoblast achieving FDA marketing authorization. Management and administration Management and administration expenses were $23.6 million for the year ended June 30, 2024, compared with $25.3 million for the year ended June 30, 2023, a decrease of $1.7 million. This decrease was primarily due to a decrease in corporate overheads. Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Management and administration: Labor and associated expenses 10,059 9,854 205 2% Corporate overheads 11,129 12,501 (1,372) (11%) Legal and professional fees 2,438 3,019 (581) (19%) Management and administration $ 23,626 $ 25,374 (1,748) (7%) Labor and associated expenses increased by $0.2 million from $9.9 million for the year ended June 30, 2023 to $10.1 million for the year ended June 30, 2024. This $0.2 million increase is primarily due to an increase of $1.0 million in share-based payment expenses and $1.3 million in short-term incentives. In the year ended June 30, 2024, we recognized short-term incentives of $0.9 million related to the year ended June 30, 2023 given that subsequent to June 30, 2023 the conditions of achievement of the short-term incentive for year ended June 30, 2023 were modified to make it dependent on Mesoblast achieving FDA marketing authorization. As a result of managements cost containment strategy, these increases were offset by a decrease of $0.8 million in consulting expenses and $0.3 million in recruitment. There was also a decrease in overall cost of salaries and associated expenses by $0.8 million in the year ended June 30, 2024, compared with the year ended June 30, 2023 due to full time equivalents decreasing by 2.6 (11%) from 24.5 for the year ended June 30, 2023 to 21.9 for the year ended June 30, 2024. Labor and associated expenses also experienced favorable exchange rate fluctuations of $0.2 million in the year ended June 30, 2024 compared with the year ended June 30, 2023, as the A$ Table of Contents 84
weakened against the US$ given the majority of management and administration expenses are incurred in A$ by our headquarter office located in Australia. Corporate overhead expenses decreased by $1.4 million from $12.5 million for the year ended June 30, 2023 to $11.1 million for the year ended June 30, 2024 primarily due to a decrease of insurance premiums. Legal and professional fees decreased by $0.6 million from $3.0 million for the year ended June 30, 2023 to $2.4 million for the year ended June 30, 2024 as legal activities decreased in the period. Fair value remeasurement of contingent consideration Fair value remeasurement of contingent consideration was a $9.7 million loss for the year ended June 30, 2024 compared with a $8.8 million gain for the year ended June 30, 2023. The $9.7 million loss for the year ended June 30, 2024 was due to the remeasurement of contingent consideration pertaining to the acquisition of assets from Osiris. This loss was a net result of changing the key assumptions of the contingent consideration valuation such as probability of success, development timelines and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration. The $8.8 million gain for the year ended June 30, 2023 was due to the remeasurement of contingent consideration pertaining to the acquisition of assets from Osiris. This gain was a net result of changing the key assumptions of the contingent consideration valuation such as probability of payment, development timelines and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration, including the impact from the complete response from the FDA on our BLA for remestemcel-L for the treatment of pediatric SR-aGVHD in August 2023. The assumptions relating to development timelines were updated to reflect expectations as a result of the complete response. With respect to future milestone payments, contingent consideration will be payable in cash or shares at our discretion. With respect to commercialization, product royalties will be payable in cash which will be funded from royalties received from net sales. Fair value movement of warrants Fair value movement of warrants was a $0.8 million gain for the year ended June 30, 2024 compared with a $2.2 million loss for the year ended June 30, 2023. This $0.8 million gain for the year ended June 30, 2024 is a net result of changes to the key valuation inputs of the warrants such as the share price, risk-free interest rates and volatility. Other operating income and expenses In relation to other operating income and expenses, we recognized an income of $2.6 million for the year ended June 30, 2024, compared with an income of $4.3 million for the year ended June 30, 2023, a decrease in income of $1.7 million. The following table shows movements within other operating income and expenses for the year ended June 30, 2024 and 2023, together with the changes in those items: Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Other operating income and expenses: Research and development tax incentive income (859) (3,506) 2,647 (75%) Interest income (1,824) (831) (993) 119% Foreign exchange losses (net) 76 163 (87) (53%) Derecognition of right of use asset — (76) 76 (100%) Foreign withholding tax 37 — 37 NM Other operating (income) and expenses $ (2,570) $ (4,250) 1,680 (40%) * NM = not meaningful. Research and development tax incentive income decreased by $2.6 million from $3.5 million for the year ended June 30, 2023 to $0.9 million for the year ended June 30, 2024. We have recognized incentive income pertaining to the Table of Contents 85
eligible expenditure undertaken in each of these periods. At each period end, management estimates the refundable tax incentive available to us based on available information at the time. We employ independent tax specialist to review, on an annual basis, the quantum of our previous research and development tax claims and our on-going eligibility to claim the research and development tax incentive in Australia. Within the $3.5 million recognized for the year ended June 30, 2023, $1.2 million pertains to the year ended June 30, 2023, $1.1 million pertains to the year ended June 30, 2022 and $1.2 million pertains to the year ended June 30, 2021, whereas in the year ended June 30, 2024 we recognized $0.9 million which pertains to income for the year ended June 30, 2024. Therefore the decrease in income is due to the impact of management concluding its assessment of qualifying activities of prior periods in the year ended June 30, 2023. The $1.0 million increase in interest income for the year ended June 30, 2024 compared with the year ended June 30, 2023 was primarily driven by higher interest rates on A$ and US$ cash deposits in the year ended June 30, 2024, when compared to the year ended June 30, 2023. We are subject to foreign exchange gains and losses on foreign currency cash balances, creditors and debtors. In the year ended June 30, 2024, we recognized a foreign exchange loss of $0.1 million, primarily due to movements in exchange rates on US$ liabilities held in Mesoblast Limited, whose functional currency is the A$, as the A$ depreciated against the US$. In the year ended June 30, 2023, we recognized a foreign exchange loss of $0.2 million. In the year ended June 30, 2023, we recognized an income of $0.1 million for the derecognition of right of use asset. There was no derecognition of right of use asset in the year ended June 30, 2024. Finance costs Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Finance costs: Remeasurement of borrowing arrangements 2,351 678 1,673 NM Interest expense 20,658 19,444 1,214 6% Finance costs $ 23,009 $ 20,122 2,887 14% * NM = not meaningful. In the year ended June 30, 2024, we recognized an overall loss of $2.4 million for remeasurement of borrowing arrangements in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our credit facilities with NovaQuest and Oaktree, an increase in losses of $1.7 million as compared with a $0.7 million loss for the year ended June 30, 2023. Within the $2.4 million loss in the year ended June 30, 2024, in relation to our existing credit facility with NovaQuest, we recognized a $0.1 million loss for remeasurement of borrowing arrangements in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows as a net result of changes to the key assumption in development timelines, a decrease in gains of $1.0 million as compared with a $0.9 million gain recognized for the year ended June 30, 2023. Also within the $2.4 million loss in the year ended June 30, 2024, in relation to our existing credit facility with Oaktree, we recognized a $2.3 million loss for remeasurement of borrowing arrangements in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows, an increase in losses of $0.7 million as compared with a $1.6 million loss for the year ended June 30, 2023. Within the $1.6 million loss recognized in the year ended June 30, 2023, $1.0 million related to the remeasurement due to additional warrants being issued to Oaktree as a result of the first amendment to the loan agreement and $0.6 million related to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows. Interest expense increased by $1.2 million from $19.4 million for the year ended June 30, 2023 to $20.6 million for the year ended June 30, 2024. Table of Contents 86
In the year ended June 30, 2024, in relation to our loan and security agreement with Oaktree, we recognized $9.4 million of interest expense, compared with $9.2 million for the year ended June 30, 2023. Within the $9.4 million recognized in the year ended June 30, 2024, $5.6 million was recognized with regards to interest expense payable on the loan balance within the year of which $5.2 million was paid and $0.4 million was added to the outstanding loan balance and shall accrue further interest. A further $3.8 million of interest expense was recognized with regard to the amortization of transaction costs incurred on the outstanding loan principal for the year ended June 30, 2024 using the effective interest rate method over the period of initial recognition through maturity. In the year ended June 30, 2024, in relation to our loan and security agreement with NovaQuest, we recognized $10.6 million of interest expense, an increase of $1.5 million as compared with $9.1 million for the year ended June 30, 2023. Interest expense relating to the NovaQuest loan is accrued on the loan principal balance and all interest payments are deferred until the earlier of loan maturity or from after the first commercial sale of our allogeneic product candidate remestemcel-L for the treatment of pediatric patients with SR-aGVHD in the United States and other geographies excluding Asia. In line with IFRS 16 Leases, we also recognized interest expenses of $0.4 million and $0.5 million in relation to lease charges for the year ended June 30, 2024 and 2023, respectively. In the year ended June 30, 2024 and 2023, we recognized $0.2 million and $0.6 million of interest charges in relation to manufacturing payments, respectively. Loss after income tax Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Loss before income tax (88,147) (82,101) (6,046) 7% Income tax benefit 191 212 (21) (10%) Loss after income tax $ (87,956) $ (81,889) (6,067) 7% Loss before income tax was $88.1 million for the year ended June 30, 2024 compared with $82.1 million for the year ended June 30, 2023, an increase in the loss by $6.0 million. This increase is the net effect of the changes in revenues and expenses that have been discussed above. A non-cash income tax benefit of $0.2 million was recognized in the year ended June 30, 2024, in relation to the net change in deferred tax assets and liabilities recognized on the consolidated balance sheet during the period. A non-cash income tax benefit of $0.2 million was recognized in the year ended June 30, 2023 in relation to the net change in deferred tax assets and liabilities recognized on the consolidated balance sheet during the period. Comparison of Our Results for the Year ended June 30, 2023 with the Year ended June 30, 2022 For results of operations for the years ended June 30, 2023 and 2022, together with the changes in those items in dollars and as a percentage and the related discussions on these results, refer to Results of Operations within “Item 5.A Operating Results” in our Annual Report on Form 20-F for the year ended June 30, 2023, filed with the SEC on August 31, 2023. Certain Differences Between IFRS and U.S. GAAP IFRS differs from U.S. GAAP in certain respects. Management has not assessed the materiality of differences between IFRS and U.S. GAAP. Our significant accounting policies are described in “Item 18 Financial Statements – Note 23”. Quantitative and Qualitative Disclosure about Market Risk We are exposed to interest rate risk, share price risk, price risk and foreign currency exchange risk. We make use of sensitivity analyses which are inherently limited in estimating actual losses in fair value that can occur from changes in market conditions. For further assessment on our market risks, see “Item 18. Financial Statements – Note 10(a).” Table of Contents 87
Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, other than the purchase commitments and contingent liabilities as mentioned below. Contractual Obligations and Commitments Contractual commitments: Purchase commitments means an agreement to purchase goods or services that is enforceable and legally binding that specifies all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. Purchase obligations are not recognized as liabilities at June 30, 2024. For a description of our contractual commitment, refer to "Item 18. Financial Statements - Note 14(b)." Lease commitment – as lessee: We lease various offices under non-cancellable leases expiring within 1 to 3 years. The leases have varying terms, escalation clauses and renewal rights. On renewal, the terms of the leases are renegotiated. We subleased a portion of our office in Melbourne Australia under a non-cancellable lease expiring within 2 years. We also lease a manufacturing suite under a manufacturing services agreement with Lonza for the supply of commercial product for the potential approval and launch of remestemcel-L for the treatment of pediatric SR-aGVHD in the US market expiring within 2 years from June 30, 2024, which is cancellable in limited circumstances. Contingent liabilities We acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with our use of the Medvet IP, on completion of certain milestones we will be obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments of up to $2.2 million, and single-digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) single-digit royalties on net sales of the specified products for applications outside the specified fields. We have entered into a number of agreements with other third parties pertaining to intellectual property. Contingent liabilities may arise in the future if certain events or developments occur in relation to these agreements and as of June 30, 2024 we have assessed that the probability of outflows is remote. Capital commitments We did not have any commitments for future capital expenditure outstanding as of June 30, 2024. Australian Disclosure Requirements Significant Changes in the State of Affairs There have been no significant changes within the state of our affairs during the year ended June 30, 2024 except as noted in the “Important Corporate Developments” section included in Item 4.A. Likely Developments and Expected Results of Operations In March 2024, the FDA informed us that following additional consideration, the available clinical data from our Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for the treatment of pediatric patients with SR-aGVHD. The BLA was resubmitted to FDA in July 2024 and was accepted within two weeks. FDA considered the resubmission to be a complete response and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 7, 2025. Other significant milestones are expected in the upcoming financial year in relation to our other lead product candidates, as detailed elsewhere in this report. Table of Contents 88
Environmental Regulations Our operations are not subject to any significant environmental regulations under either Commonwealth of Australia or State/Territory legislation. We consider that adequate systems are in place to manage our obligations and are not aware of any breach of environmental requirements pertaining to us. 5.B Liquidity and Capital Resources Sources of Liquidity As of June 30, 2024, we held total cash reserves of $63.0 million. During the year ended June 30, 2024, we executed on reprioritization of projects and operational streamlining activities and as a result has reduced net cash usage for operating activities, which was $48.5 million for the year ended June 30, 2024, a reduction of 23% compared to the prior period. As we prepare for a potential first product approval by the FDA, and in line with our commercial launch plans, additional inflows from capital markets, strategic partnerships, product specific financing or royalty monetization will be required to meet our projected expenditure consistent with our business strategy over at least the next 12 months. As a result of these matters, there is material uncertainty related to events or conditions that may cast significant doubt (or raise substantial doubt as contemplated by Public Company Accounting Oversight Board (“PCAOB”) standards) on our ability to continue as a going concern and, therefore, that we may be unable to realize our assets and discharge our liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our primary sources of liquidity have historically been equity raisings, upfront and milestone payments from strategic license agreements, and borrowings under our loan agreements. We also expect net sales to become a source of liquidity. While in the long-term we expect to be able to complete transactions, draw upon these facilities and achieve approval of our product candidates to provide liquidity as needed, there can be no assurance as to whether we will be successful or, if successful, what the terms or proceeds may be. Cash flows Year ended June 30, (in U.S. dollars, in thousands) 2024 2023 $ Change % Change Cash Flow Data: Net cash (outflows) in operating activities (48,458) (63,269) 14,811 (23%) Net cash (outflows) in investing activities (97) (194) 97 (50%) Net cash inflows by financing activities 40,252 74,502 (34,250) (46%) Net (decrease)/increase in cash and cash equivalents (8,303) 11,039 (19,342) (175%) Comparison of cash flows for the Year ended June 30, 2024 with the Year ended June 30, 2023 Net cash outflows in operating activities Net cash outflows for operating activities were $48.5 million for the year ended June 30, 2024, compared with $63.3 million for the year ended June 30, 2023, a decrease of $14.8 million. The decrease of $14.8 million is due to a decrease in cash outflows of $11.8 million and an increase in cash inflows of $3.0 million in the year ended June 30, 2024, compared with the year ended June 30, 2023. The $3.0 million increase of inflows comprised: inflows from royalty income earned on sales of TEMCELL in Japan and Alofisel® decreased by $0.7 million during the year ended June 30, 2024, compared with the year ended June 30, 2023; received $3.8 million of receipts for research and development tax incentive during the year ended June 30, 2024, compared to $1.1 million for the year ended June 30, 2023; and inflows from interest receipts increased by $1.0 million in the year ended June 30, 2024, compared with the year ended June 30, 2023. Outflows for payments to suppliers and employees decreased by $11.8 million from $72.7 million for the year ended June 30, 2023 to $60.8 million for the year ended June 30, 2024. The decrease in payments was primarily due to the cost Table of Contents 89
containment strategy introduced in August 2024, which reduced payroll payments and director fees, insurance, manufacturing and clinical trials given clinical trial activities were reduced in the period. Net cash outflows in investing activities Net cash outflows for investing activities decreased by $0.1 million in the year ended June 30, 2024, compared with the year ended June 30, 2023. Net cash inflows in financing activities Net cash inflows for financing activities decreased by $34.2 million for the year ended June 30, 2024, compared with the year ended June 30, 2023. The decrease of $34.2 million is due to a decrease in cash inflows of $23.2 million and an increase in cash outflows of $11.0 million in the year ended June 30, 2024 compared with the year ended June 30, 2023. The $23.2 million decrease in inflows comprised: $45.1 million of proceeds received in August 2022 and $43.5 million of proceeds received in April 2023 on completion of private placements during the year ended June 30, 2023, compared with $65.4 million of proceeds received from an institutional placement and entitlement offer during the year ended June 30, 2024; The $11.0 million increase in outflows comprised: payments of $3.5 million and $2.6 million for lease liabilities during the years ended June 30, 2024 and 2023, respectively; payments of $5.7 million and $6.0 million for interest and other costs of finance during the years ended June 30, 2024 and 2023, respectively; payments of $4.3 million and $4.9 million for capital raising costs in the years ended June 30, 2024 and 2023, respectively; payments of $1.5 million and $0.5 million for borrowings costs in the years ended June 30, 2024 and 2023, respectively; principal repayment of $10.0 million to reduce debt under our five-year facility with Oaktree during the year ended June 30, 2024, compared to $Nil for the year ended June 30, 2023. Operating Capital Requirements We do not know when, or if, we will generate revenues from our product sales significant enough to generate profits. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize more of our cell-based product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our cell-based product candidates, and begin to commercialize any approved products either directly ourselves or through a collaborator or partner. We are subject to all of the risks inherent in the development of new cell-based products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. Subject to us achieving successful regulatory approval we expect an increase in our total expenses driven by an increase in our planned research and development, manufacturing commercialization and selling, general and administrative expenses as we move towards commercialization. Therefore, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our ordinary shares. If we incur further indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. Borrowings For a description of our borrowing arrangements, refer to "Item 18. Financial Statements - Note 5(f)." Table of Contents 90
5.C Research and Development, Patents and Licenses For a description of the amount spent during each of the last three fiscal years on company-sponsored research and development activities, as well as the components of research and development expenses, see “Item 5.A Operating Results – Results of Operations.” For a description of our research and development process, see “Item 4.B Business Overview.” 5.D Trend Information As a biotechnology company which primarily is still in the development stage, we are subject to costs of our clinical trials and other work necessary to support applications for regulatory approval of our product candidates. Health regulators have increased their focus on product safety. In addition, regulators have also increased their attention on whether or not a new product offers evidence of substantial treatment effect. These developments have led to requests for more clinical trial data, for the inclusion of a higher number of patients in clinical trials, and for more detailed analyses of the trials. In light of these developments, we expect these aspects of our research and development expenses may need to increase as we continue to fund our programs to the market. Notwithstanding this upward trend, our research and development expenses may still fluctuate from period to period due to varied rates of patient enrollment and the timing of our clinical trials as our existing trials are completed and new trials commence. We cannot predict with any degree of accuracy the outcome of our research or commercialization efforts. 5.E Critical Accounting Estimates Not applicable. See “Item 18. Financial Statements.” Item 6. Directors, Senior Management and Employees 6.A Directors and Senior Management Personnel Details of Directors and Senior Management Board of Directors Jane Bell – B.Ec, LLB, LLM (London) Non-Executive Member of the Board of Directors Commenced as Board Chair April 30, 2024 Experience and expertise Ms. Bell AM has 30 years experience as a banking and finance lawyer with leading law firms, financial services and corporate treasury operations in the United States, Canada, Australia and the United Kingdom. She is an experienced Chair and non-executive Director in highly regulated sectors including delivery of healthcare, life sciences, medical research, and funds management. Ms. Bell currently serves as Deputy Chair of Monash Health, Australia’s largest and most diverse public health service delivering more than 3.46 million episodes of care, and Chair of its Audit Committee. She is also a director of publicly-listed biotechnology company Amplia Therapeutics and Chair of its Audit Committee and of Jessie McPherson Private Hospital. She is a former Chair of Royal Melbourne Hospital and former Chair of Biomedical Research Victoria as well as of Advisory Groups for the Royal Australian and New Zealand College of Obstetricians and Melbourne Genomics Health Alliance, a former director of Hudson Institute of Medical Research and Chair of its Intellectual Property and Commercialization Committee and director of U Ethical, Australia’s first ethical funds manager. Ms Bell holds a Master of Laws from King’s College (London), Bachelor of Laws University of Melbourne, and Bachelor of Economics Monash University. In 2023 Ms Bell was appointed a Member of the Order of Australia (AM) for her significant service to governance in the medical research, healthcare and not-for-profit sectors. Other current directorships of listed public companies Non-Executive Director, Amplia Therapeutics Limited (since 2021) Former directorships of listed public companies within the last 3 years None Table of Contents 91
Joseph Swedish, MHA Non-Executive Member of the Board of Directors Board Chair until April 30, 2024 Experience and expertise Joseph R. Swedish is the former Chairman, President and CEO of Anthem, Inc, (currently Elevance Health) a Fortune 22 company and the nation’s leading health benefits provider. This became the foundation for Elevance Health today serving nearly 47.3 million members – or one in seven Americans – through its affiliated health plans, and over 117 million individuals across 33 states through its broad portfolio of health insurance and service subsidiaries. He served as the Chairman, President and CEO from 2013 to 2018. Subsequently he served as a Strategic Advisor from 2018 to 2020. During his tenure Anthem’s membership grew by four million, or 11 percent, the average share price nearly quadrupled, and operating revenue increased 39 percent to over $89 billion. Core strategic imperatives included improving medical costs, working with physicians and health care organizations to improve quality and access, and improving the consumer experience. As a business executive, conservationist, and philanthropist, Joe serves on the board of directors for CDW, Centrexion Therapeutics, Accelus and Navitus Health Solutions. Most recently, he served on the board of directors for IBM, as chairman of America’s Health Insurance Plans (AHIP), and chairman of the Catholic Health Association. He currently serves as a board member for The Nature Conservancy (Colorado). He has also held board and advisory positions with American Hospital Association, Coventry Health Care, Inc., RehabCare Group, Inc., Cross Country, National Quality Forum, the National Center for Healthcare Leadership, and Loyola University Chicago. He is also a member and past chairman of Duke University’s Fuqua School of Business Board of Visitors. Prior to joining Anthem, Joe served as CEO for several major integrated health care delivery systems, including president and CEO of Trinity Health, an 18-state integrated health care delivery system. He also held CEO and senior leadership positions with the Hospital Corporation of America, Colorado’s Centura Health, and integrated health systems in Florida, Virginia, and the Carolinas. In 2018, he continued to apply his expertise leveraging his extensive health care experience as co-founder of Concord Health Partners, a private equity firm investing in data analytics, provider enablement services and consumer engagement enterprises. He is now Partner Emeritus having recently departed active status. More broadly, he has built a reputation as a trend-setter by leveraging value-creating assets through high-performing governance, creative strategies, consumer marketing, clinical innovations, and mergers/acquisitions – all efforts focused on organization renewal and growth. For 12 years in a row, Modern Healthcare named him one of the 100 Most Influential People in Healthcare, ranking in the top 20 of the health sector’s most senior-level executives, high-level government administrators, elected officials, academics, and thought- leaders for five consecutive years. He received his bachelor’s degree from the University of North Carolina at Charlotte and his master’s degree in health administration from Duke University. Other current directorships of listed public companies Non-Executive Director, IBM Corporation (since 2017) Non-Executive Director, CDW Corporation (since 2015) Former directorships of listed public companies within the last 3 years None William Burns, BA Non-Executive Member of the Board of Directors Experience and expertise Mr. Burns has served on the Board of Directors since 2014 and was appointed Vice Chairman in 2016. He spent his entire management career at the Beecham Group and F. Hoffmann-La Roche Ltd. Mr Burns was Chief Executive Officer of Roche Pharmaceuticals from 2001 to 2009, when he joined the Board of Directors of F. Hoffmann-La Roche Ltd. until he retired in 2014. He is the Chair of Molecular Partners, and has been a Non-Executive Director of Shire PLC, Chugai Pharmaceutical Co., Genentech, Crucell, and Chairman of Biotie Therapies Corp. from 2014 until its sale to Acorda Therapeutics Inc. in 2016. Mr Burns is also a member of the Oncology Advisory Board of the Universities of Cologne/ Bonn in Germany. In 2014, he was appointed a trustee of the Institute of Cancer Research(ICR), London, and in 2016 a Governor of The Wellcome Trust in London, UK. Mr Burns completed his terms of office at both ICR and Wellcome Trust and has retired from both positions. Other current directorships of listed public companies Chair of Molecular Partners (since 2018) Table of Contents 92
Former directorships of listed public companies within the last 3 years None Philip Facchina Non-Executive Member of the Board of Directors Experience and expertise Mr. Facchina brings more than 35 years of experience in corporate strategy, finance, and business development across several industries, including healthcare. Since 2018, Mr. Facchina has been Chief Strategy Officer at SurgCenter, overseeing the company’s strategic relationships, including its relationships with the broad US ambulatory surgical center (ASC) market and its constituents. Prior to SurgCenter, Mr. Facchina spent two decades in the public and private capital markets, where he directly managed public and private capital transactions of equity and debt, led M&A and special advisory processes including take-privates. From 2008 to 2017, Mr. Facchina served as a Partner, Co-Portfolio Manager and the Chief Operating Officer of Ramsey Asset Management, an institutional investment management firm, and from 1998 to 2008 Mr. Facchina led the technology, media, and communications and healthcare investment banking groups of FBR Capital Markets. Mr. Facchina currently serves as an independent director for ViON Corporation and MilltechFX, and is Advisor to the CEO of Johanna Foods Inc, where he chairs the Audit Committee. Previously, among other directorships and committee posts, Mr. Facchina served on the Board of Web.com (Nasdaq: WEB), where he led Corporate Governance. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years None Philip Krause, MD Non-Executive Member of the Board of Directors Experience and expertise With over 30 years of experience at the Food and Drug Administration, Dr. Krause has a unique combination of scientific, regulatory, clinical, and public health experience. He is a physician with board certification in internal medicine and infectious diseases and a researcher with over 100 publications on topics spanning clinical evaluation of vaccines, viral pathogenesis and immunology, and biological product development. He is currently an independent consultant, providing strategic and regulatory advice related to biological product development. He recently served as deputy director of FDA’s Office of Vaccines Research and Review, where he led assessments of biological products for evaluation and licensure and helped to oversee the development and evaluation of all vaccines authorized and licensed in the US from 2011-2021. He graduated from Yale Medical School (MD), Florida State University (MBA) and the University of Illinois (BS and MS in Computer Science). Dr Krause has a strategic advisory consulting role with Mesoblast, providing advice on regulatory strategies. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years None Michael Spooner, BCom Non-Executive Member of the Board of Directors - resigned effective September 26, 2023 Experience and expertise Mr. Spooner served on the Board of Directors from 2004 to September 2023. During this period he has filled various roles including as Chairman from the date of the ASX public listing in 2004 until 2007, Chair of the Audit and Risk Committee as well as a member of the Remuneration Committee . Over the past several years Mr. Spooner has served on the board of directors in various capacities at several Australian and international biotechnology companies, including Table of Contents 93
BiVacor Pty Ltd (2009-2013), Advanced Surgical Design & Manufacture Limited (2010-2011), Peplin, Inc. (2004-2009), Hawaii Biotech, Inc. (2010-2012), Hunter Immunology Limited (2007-2008), and Ventracor Limited (2001-2003). He has been the Chairman of Simavita Ltd since May 2016 and Chairman of MicrofluidX since February 2018. Prior to returning to Australia in 2001, he spent much of his career internationally where he served in various roles including as a partner to PA Consulting Group, a UK-based management consultancy, and a Principal Partner and Director of Consulting Services with PricewaterhouseCoopers (Coopers & Lybrand) in Hong Kong. In addition Mr Spooner has owned and operated several international companies providing services and has consulted to a number of American and Asian public companies. Other current directorships of listed public companies Former directorships of listed public companies within the last 3 years Chairman, Simavita Ltd (2016 - 2021) Company Secretary Niva Sivakumar – BCom, LLB Joint Company Secretary Experience and expertise Ms. Sivakumar joined Mesoblast’s legal team in 2014 and is a member of the Company’s Intellectual Property Committee. Previously, she was a senior associate in the corporate and commercial teams at major law firm, Dentons, and a senior lawyer at K&L Gates. Ms. Sivakumar has a Commerce/Law degree from the University of Melbourne. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years None Paul Hughes – BPharm, BBus (Banking & Finance) Joint Company Secretary Experience and expertise Mr. Hughes began working with Mesoblast in February 2019 and has served as the Company’s Global Head of Corporate Communications since December 2020. He has an extensive background as an investment banker and corporate advisor for firms including Macquarie Bank and Commonwealth Bank of Australia. Mr. Hughes has a Bachelor of Pharmacy and Bachelor of Business (Banking & Finance) from Monash University, Melbourne. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years None Senior Management – Key Management Personnel Silviu Itescu, MBBS (Hons), FRACP, FACP, FACRA Chief Executive Officer (CEO) Executive Member of the Board of Directors Experience and expertise Dr. Itescu has served on the Board of Directors since the Company's founding in 2004, was Executive Director from 2007, and became Chief Executive Officer and Managing Director in 2011. Prior to founding Mesoblast in 2004, Dr. Itescu established an international reputation as a physician scientist in the fields of stem cell biology, autoimmune diseases, organ transplantation, and heart failure. Dr Itescu has been a faculty member of Columbia University in New Table of Contents 94
York, and the University of Melbourne and Monash University in Australia. In 2013, Dr Itescu received the inaugural Key Innovator Award from the Vatican’s Pontifical Council for Culture for his leadership in translational science and clinical medicine in relation to adult stem cell therapy. In 2011, Dr. Itescu was named BioSpectrum Asia Person of the Year. Dr. Itescu has consulted for various international pharmaceutical companies, has been an adviser to biotechnology and health care investor groups, and has served on the board of directors of several publicly listed life sciences companies. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years None Eric Rose, MD Chief Medical Officer (CMO) Executive Member of the Board of Directors Experience and expertise Dr. Rose is a highly respected physician scientist with focus on clinical investigation, drug discovery, biodefense, and health policy. As a world-renowned heart surgeon and scientist, Dr. Rose led the Columbia Presbyterian heart transplantation program from 1982 through 1992 and made history in 1984 when he performed the first successful pediatric heart transplant. From 1994 through 2007, he served as Chairman of Columbia University’s Department of Surgery and Surgeon-in-Chief of Columbia Presbyterian Medical Center in New York. During this time his leadership of the NIH supported program Randomized Evaluation of Mechanical Circulatory Support in Heart Failure (REMATCH) resulted in the first FDA approval of an implantable left ventricular assist device for long term circulatory support, spawning an entire new industry. From 2007-2011, Dr. Rose served on the National Biodefense Scientific Board which advises the United States Health and Human Services Secretary on biodefense, influenza, and emerging diseases. In 2007 he was appointed Chairman and CEO of SIGA Technologies where he oversaw development of the first antipoxviral drug approved in the United States, TPOXX for the treatment of smallpox. Dr. Rose played a key role in obtaining FDA approval of the drug in 2019, and he was responsible for securing contracts with BARDA under which the US Government has procured 1.7 million courses of TPOXX for more than US$1billion into the Strategic National Stockpile (SNS). Dr. Rose’s tenure on the ABIOMED board ended in December 2022 with the sale of the company to Johnson & Johnson for $17.7 billion. Other current directorships of listed public companies None Former directorships of listed public companies within the last 3 years Chairman, SIGA Technologies, Inc. (2017 - 2021) Non-executive Director, ABIOMED, Inc. which was acquired by Johnson & Johnson. (2007 - 2012, 2014 - 2022) Other Senior Management Andrew Chaponnel, BCom, CAANZ Chief Financial Officer (interim) Mr. Chaponnel has around 25 years of experience in finance roles including 13 years with Mesoblast, initially as the Group Financial Controller (6 years), then as Head of Finance (3 years) and now as interim Chief Financial Officer for the past three years. As part of Mesoblast Group finance leadership he has been integral to the implementation and maintenance of our borrowing arrangements, various strategic partnerships, equity placements, the NASDAQ IPO and leads both ASX and NASDAQ financial reporting. Previously Mr. Chaponnel has held several roles including management roles in chartered accountancy, logistics, retail and a CFO role within construction before moving into Healthcare. He is a member of the Chartered Accountants of Australia & New Zealand. Table of Contents 95
Peter Howard, BSc, LLB (Hons) Group General Counsel and Corporate Executive, Chair of the Patent Committee Mr. Howard has served as our Group General Counsel and Corporate Executive, and Chair of the Patent Committee, since July 2011. As external counsel and partner at Australian law firm, Middletons (now, K&L Gates), Mr. Howard has been integrally involved with Mesoblast since its inception and public listing on the ASX in 2004. More generally, Mr. Howard has extensive experience with many biopharmaceutical firms and major research institutions, covering public listings, private financings, strategic, licensing, intellectual property and mergers and acquisition activities. He has done so in several roles, including as a partner at a major law firm, entrepreneur, director and senior executive. Justin Horst, BS Head of Manufacturing Justin Horst has 18 years of experience in clinical cell therapy manufacturing and industry development. During the past eight years, he has been Mesoblast’s Deputy Head of Manufacturing, with accountability for chemistry, manufacturing and control of the manufacturing processes. Before joining Mesoblast, Mr. Horst was at Lonza Walkersville Inc. for 10 years, holding numerous senior level positions within the manufacturing, project management, and business development groups. At Lonza, he was instrumental in the establishment of the contract manufacturing business, and managed multiple manufacturing teams supporting numerous custom supply processes. Mr. Horst obtained his B.S. in Biology from Towson University in Maryland. Dagmar Rosa-Bjorkeson, MS, MBA Chief Operating Officer until November 1, 2023 from which time has been a part-time consultant. Dagmar Rosa-Bjorkeson has more than 25 years of global experience in the pharmaceutical industry, including executive leadership in corporate and product strategy, market development and operational execution. She has led multiple successful product launches, including Gilenya® for multiple sclerosis and Elidel® for atopic eczema. During her 17 years at Novartis, Ms. Rosa-Bjorkeson was Vice President and Head of its Multiple Sclerosis Business Unit; Vice President, Business Development and Licensing in the United States; and Country Head and President for Novartis Sweden. More recently, she served as Executive Vice President and President, Biosimilars, at Baxalta, now a wholly owned subsidiary of Takeda Pharmaceutical Company. Ms. Rosa-Bjorkeson was also Executive Vice President and Chief Strategy and Development Officer at Mallinckrodt Pharmaceuticals. She holds an MBA in Marketing, an MS in Chemistry and a BS, Chemistry from the University of Texas. Michael Schuster, MBA Pharma Partnering Mr. Schuster, who joined Mesoblast in 2004, leads the Group's partnering discussions. Previously he was the head of the Group's investor relations outreach program and was part of the founding executive team at both Mesoblast Limited and Angioblast Systems, Inc. Mr. Schuster was Executive Vice President of Global Therapeutic Programs from 2010 to 2013 and was the Director of Business Development and Vice President of Operations from 2004 to 2010. He holds an undergraduate degree in science from Tufts University, a Master’s degree in Immunology & Microbiology from New York Medical College, and an MBA from Fordham University in New York. Paul Simmons, PhD Scientific Advisor to the Chief Executive Officer Dr. Simmons served as our Head of Research and New Product Development since 2011 and transitioned to Scientific Advisor to the Chief Executive Officer in the current year. He has nearly 30 years of experience in stem cell research, especially research in basic hematopoiesis and in precursor cells for the stromal system of the bone marrow, and served as President of the International Society of Stem Cell Research, or ISSCR, from 2006 to 2007. Prior to joining Mesoblast, Dr. Simmons held the C. Harold and Lorine G. Wallace Distinguished University Chair at the University of Texas Health from 2008 to 2011 and served as the inaugural Professor and Director of the Centre for Stem Cell Research at the Brown Foundation Institute of Molecular Medicine from 2006 to 2011. Dr. Simmons is, or has served as, an associate editor, a member of the editorial board, or a reviewer on multiple scientific and medical journals including Experimental Hematology, Cytotherapy and Stem Cell Research, Cell Stem Cell, Stem Reports, Science and Nature. Table of Contents 96
Geraldine Storton, BSc, MMS, MBA Head of Regulatory Affairs and Quality Management Ms. Storton is a seasoned pharmaceutical executive with more than 30 years’ experience across the full value chain of Pharmaceutical and Medical Device Research and Development, production and commercialization worldwide. She has an extensive background in regulatory affairs and quality, most recently as a consultant to cell therapy companies. Prior to this, Ms. Storton held executive roles at Hospira, and its predecessor companies in both regulatory affairs and quality, with a focus on major program management. As Vice President, Program Management, Quality, at Hospira headquarters in Chicago, she led a company-wide quality remediation program to improve compliance in manufacturing across 15 facilities worldwide. As Regional Director, Commercial Quality ANZ, Asia and Japan, Ms. Storton was responsible for quality oversight and management of all products sold in Asia Pacific countries. Her responsibilities included regulatory compliance, batch release, field actions, complaints management, change control, due diligence and new product launch. As director of global regulatory operations, Ms. Storton managed development and registration of new products and on-market management of the existing product portfolio for all Hospira’s products developed or manufactured within Asia Pacific for global distribution. She joined Mesoblast in December 2015. Fiona See, PhD SVP and Head, Translational Research Dr. Fiona See is an experienced scientist and leader in translational research and development within the biotechnology sector. Currently serving as the Senior Vice President and Head of Translational Research at Mesoblast in New York, she provides strategic scientific leadership across the lifecycle of mesenchymal lineage stromal cell (MLC) therapy products, focusing on cardiovascular, musculoskeletal, and immunological diseases. Dr. See has successfully led teams in developing nonclinical pharmacology/toxicology packages and product characterization. Previously, Dr. See served as Vice President and Senior Director of Translational Development at Mesoblast, developing and overseeing nonclinical and translational strategies. Dr. See holds a PhD and a Bachelor of Laws/Bachelor of Science (Honors) from Monash University. She has conducted NIH-funded research at NYU Langone School of Medicine, Columbia University, and NHMRC-funded research at The University of Melbourne, focusing on stem cell-based platforms and therapies for heart disease. She has published numerous peer-reviewed articles in respected journals, reflecting her contributions to translational research and therapeutic innovation. There are no family relationships among any of our directors and senior management. The business address of each of our directors and senior management is Mesoblast Limited, Level 38, 55 Collins Street, Melbourne, VIC 3000, Australia. The Mesoblast board of directors (the "Board”) presents the 2023/2024 Remuneration Report, which has been prepared in accordance with the relevant Corporations Act 2001 (Cth) (“Corporations Act”) and accounting standards requirements. The remuneration report sets out remuneration information for our company’s key management personnel (“KMP”) as defined in the International Accounting Standards 24 ‘Related Party Disclosures’ and the Australian Corporations Act 2001 for the financial year ended June 30, 2024. (Start of the Remuneration Report for Australian Disclosure Requirements) Introductory Comments from Bill Burns, Nomination and Remuneration Committee Chairman Throughout the year there was a concerted focus on advancing the Biologics License Application (BLA) submission for paediatric Graft versus Host Disease and continued dialogue with the United Sates Food and Drug Administration (FDA) involving all programs in our late-stage clinical pipeline. On March 26, 2024, the FDA informed Mesoblast that following additional consideration the available clinical data from the Phase 3 study MSB-GVHD001 appeared sufficient to support submission of the proposed BLA for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). In July 2024, Mesoblast resubmitted our BLA for remestemcel-L for the treatment of pediatric SR-aGVHD. During the year, Mesoblast progressed our Chronic Low Back (CLBP) and Chronic Heart Failure (CHF) programs. The FDA informed the Group that it supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). Table of Contents 97
The confirmatory Phase 3 trial of rexlemestrocel-L in patients with CLBP due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. Joe Swedish, who served as chair since March 2019, stepped down from the Board chair role during the year. Jane Bell took over as Chair of Board from April 2024. Joe remains with us as a Board director until completion of his term at the Annual General Meeting later this year. The Group raised proceeds of US$40 million and US$25 million in December 2023 and March 2024 respectively, strengthening our balance sheet and providing the funds necessary to enable all existing product development and research programs to continue and our next major technical and clinical development milestones to readout. Cash burn was reduced during the year through the successful executing of the cost containment plan announced in August 2023. Overall, net operating cash usage was reduced by 23% for FY24 as compared to FY23. The cost containment plan included the following remuneration related initiatives which were successfully introduced and executed during FY24: • The CEO and CMO volunteered base salary reductions of 30% for a 12-month period to August 2024. In compensation for the reduction in cash pay, an option grant was approved by shareholders with an approval vote of 95% at the 2023 AGM, increasing their long-term equity-based at risk pay for further alignment of their interests with shareholders; • Other members of our management team also volunteered to reduce cash pay and receive long-term equity based at-risk pay in compensation; • Cash payment of the STI relating to the fiscal year ended June 30, 2023 has been deferred until an FDA approval for SR-aGVHD; and • Non-executive directors voluntarily deferred 50% of their director fees until an FDA decision and agreed to receive the remaining 50% of their fees in equity, approved by shareholders at the 2023 AGM. No cash payment will be made until a decision is made on FDA approval. Despite the significant strides made during FY24, our immediate goal of obtaining FDA marketing authorization for remestemcel-L for the treatment of pediatric SR-aGVHD has not yet been achieved and therefore the cost containment plan will continue in FY25 for the following remuneration related initiatives continuing: • The CEO and CMO voluntary base salary reductions of 30% will continue through until August 2025. In compensation for the reduction in cash pay, an option grant will be proposed which will increase their long-term equity-based at-risk pay, further aligning their interests to those of shareholders, subject to shareholder approval. • Other management team members will continue to be able to sacrifice cash pay for options in FY25. • The Board has decided against awarding any increases to fixed remuneration prior to the FDA decision on pediatric SR-aGVHD. • Cash payment of the STI relating to the financial year ended June 30, 2024 has been deferred and is dependent on an FDA approval (further detail on this below). Subsequent to FY24, there has been a modification to the STI plan providing all employees with the choice to elect into receiving an option grant in lieu of cash payment of their STI entitlements for the years ended FY23 and FY24; and • Non-executive directors are continuing to voluntarily defer 50% of their director fees until an FDA decision and have agreed to receive 50% of their fees in equity, subject to shareholder approval. Aside from retiring directors, no cash payments will be made until a decision is made on FDA approval. Our responsible management of remuneration was positively received by investors with a vote approval of 94% for the remuneration report resolution at the 2023 AGM. FY24 Remunerations Outcomes Mesoblast's remuneration mix remains weighted towards long term performance, aligning executive outcomes to long term sustainability and success. Milestone LTI awards in the biotechnology sector have a higher risk profile than those in the broader market and may not materialize to levels anticipated at grant or in the general market. Our decision to Table of Contents 98
maintain this framework is consistent with the preference of our investors for long term at risk pay that is aligned to shareholder experience and returns. Within our LTI incentives, executives must meet both milestone and service requirements before vesting can occur. 88% of the CEO's Nov 2023 grant and 66% of his total outstanding milestone-based LTI incentives have not yet met milestone achievement requirements to be eligible for vesting. The remaining portion of the LTI's met milestone requirements and these options become eligible to vest once time-based service requirements are met (see table 6a). After application of both milestone and service requirements, 7% of the CEO’s total milestone-based options vested in FY24. At June 30, 2024, 100% of these vested LTI options were underwater and had zero intrinsic value. The Board assessed our Group’s short-term incentive (STI) key performance indicator (KPI) performance for the financial year ended June 30, 2024, as achieving 100% of maximum after significantly exceeding KPIs related to our financing clinical and regulatory strategy. Nevertheless, given the criticality of the BLA resubmission in July, Board discretion has been exercised not to pay the STI unless and until the FDA provides marketing authorization for SR- aGVHD. On achievement, Mesoblast will pay the CEO the maximum STI outcome plus 20%. Subsequent to FY24 and prior to payment being due, the Board approved a modification to the STI plan providing all employees with the choice to elect into receiving an option grant in lieu of cash payment of their STI entitlements for the years ended FY23 and FY24. The level of participation and the terms of the modification are yet to be determined at the date of this report. On balance, we believe the remuneration framework, including several years’ absence of fixed remuneration increases for executives, the Board’s decision to defer cash payment of the FY23 and FY24 STI until FDA approval for SR-aGVHD has been achieved, and the continuation of cost containment remuneration initiatives in FY24 ensure our remuneration strategy is appropriate for this stage of our Group’s growth and is strongly aligned to our key milestones and shareholder value. I invite you to read the remainder of the remuneration report and welcome your feedback. Bill Burns Nomination and Remuneration Committee Chairman Key Management Personnel (KMP) Key management personnel (KMP), defined as individuals who have authority and responsibility for planning, directing and controlling the activities of the company, directly or indirectly, and including all directors, are listed in Table 1. Table 1 – Mesoblast KMP during FY2024, including to the Date of this Report Name Position Country Portion of FY2024 year served as KMP Non-executive directors Jane Bell Independent Chair of Board (from April 30, 2024) Member, Nomination and Remuneration Committee Member, Audit and Risk Committee Australia Full Year Joseph Swedish Independent Chair (until April 30, 2024), Board of Directors Member, Audit and Risk Committee Member, Nomination and Remuneration Committee US Full Year Table of Contents 99
William Burns Independent Vice Chair, Board of Directors Chair, Nomination and Remuneration Committee Switzerland Full Year Philip Facchina Independent Non-executive Director Member, Audit and Risk Committee Member, Nomination and Remuneration Committee US Full Year Philip Krause Independent Non-Executive Director to August 28, 2023 Non-independent Non-executive Director from August 29, 2023 Member, Nomination and Remuneration Committee until August 28, 2024 US Full Year. Michael Spooner Independent Non-executive Director Chair, Audit and Risk Committee Member, Nomination and Remuneration Committee Singapore Resigned effective September 26, 2023 Executive directors Silviu Itescu Chief Executive Officer Executive Director Australia Full Year Eric Rose Chief Medical Officer Executive Director US Full Year 6.B Compensation KMP Remuneration Governance The Board is responsible for Mesoblast’s remuneration strategy and approach. The Nomination and Remuneration Committee advises the Board on remuneration and incentive policies and practices generally, and makes specific recommendations on remuneration packages and other terms of employment for executive Directors, other senior executives and non-executive Directors. The Nomination and Remuneration Committee is wholly comprised of independent members. The board is satisfied that all members of the Nomination and Remuneration Committee during the reporting period are independent. The Nomination and Remuneration Committee is primarily responsible for making recommendations to the Board on: • Board appointments • Non-executive director fees • Executive remuneration framework • Remuneration for executive directors, namely the CEO, CMO and other key executives Table of Contents 100
• Short-term and long-term incentive awards • Share ownership plans The Nomination and Remuneration Committee’s objective is to ensure remuneration policies are fair and competitive having regard for industry benchmarks whilst being aligned with the objectives of our company. The Committee receives proposals from the executive team, which it critically reviews. When appropriate the Nomination and Remuneration Committee will seek advice or recommendations from independent expert consultants, including benchmarking studies. Advice provided by consultants during the year did not constitute a ‘remuneration recommendation’ as defined in section 9B of the Corporations Act and was received free from any undue influence by Key Management Personnel to whom the advice related. Executive Remuneration Strategy The remuneration strategy is designed to ensure Mesoblast can: • Attract and retain experienced leaders and emerging experts in an innovative field and on a global basis • Reward performance that will lead in the long term to improved patient outcomes and increased shareholder wealth. Our team is small. Mesoblast has only 73 employees, 57% of whom are in the US, with the remainder in Australia, Singapore and Switzerland. Retaining these employees, who often are at the top of their respective fields, is imperative in ensuring Mesoblast can continue to work towards what are difficult, complex and long-term goals. Biopharmaceutical product development is a highly specialized and speculative undertaking and it involves a substantial degree of risk. To achieve and maintain long term profitability, companies must successfully develop product candidates, obtain regulatory approval, and manufacture, market and sell those products for which regulatory approval is obtained. If this occurs, revenues depend on the size of markets in which product candidates receive approval, the ability to achieve and maintain sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for our product candidates in those markets. Not all companies succeed in these activities, and not all companies generate revenue from product sales that is significant enough to achieve profitability. To have a chance of success, it is imperative that executives a) possess the specialized skills to understand the complex products being developed and the various regulatory requirements imposed across the globe b) apply high degrees of discipline to ensure research and trials are undertaken safely and effectively, to a rigorous standard and schedule, within tight budget constraints c) seek to deliver earlier, with lower costs, key, well-defined milestones critical to progressing Mesoblast technology d) stay focused on the end goal of commercialization. While it may be many years from initial research until milestones lead to profitable outcomes, this does not reduce the importance of the milestones themselves. Without the interim milestone steps on the way to therapy commercialization, the extensive safety and efficacy data required would not be sufficient and approval by global regulatory authorities would not be achievable. Time and costs are an important component in this process of research, testing and milestone achievement, as both have compounding effects on shareholder value. To address the above, Mesoblast’s remuneration framework comprises: - competitive fixed remuneration - annual incentive payments contingent on intensive research, approvals and trials being undertaken on time and budget - longer term milestone-based incentive payments Table of Contents 101
- payment delivered, in part, as options, which conserves cash, aligns with shareholder interests, and focuses executives on strategy, risk management, and execution that optimizes shareholder value. Mesoblast generally sets cash-based STIs at a lower quantum than option-based LTIs to conserve cash flow, focus executives on value creation, and align executives with shareholders. The current average tenure of our executive team of 10 years suggests that the framework works well to attract and retain appropriate executive leadership. Executive Remuneration Framework Further details on the Mesoblast Executive Remuneration Framework is provided in Table 2 – Executive Remuneration Framework. Table 2 – Executive Remuneration Framework Strategic Rationale Attract and retain key personnel on a global basis via competitive remuneration. Comply with regional statutory and customary benefits (e.g., superannuation in Australia; medical insurance in the US.) Focuses attention on key KPIs (in areas such as clinical, financial and partnering strategy, manufacturing, commercial, or organizational structure and development) under cost and time constraints that will lead to long-term improvement in patient outcomes and shareholder wealth. Serves multi-pronged purpose: - Aligns remuneration outcomes with shareholder wealth creation. - Provides a framework for wealth creation by prioritizing key objectives that are critical for long-term profitability. - Rewards speed of achievement, that can have long term compounding effects - Retains employees via deferral - Provides value only if milestones lead to increases in share price, aligning with the shareholder experience. - Conserves cash. - Enables risk management via malus. Process Assessed annually on market relativities in employee's domicile based on position accountabilities. The Nomination and Remuneration Committee makes specific recommendations to the board on remuneration packages for senior executives for approval. Paid annually for performance against annual corporate and individual KPIs. The Nomination and Remuneration Committee sets the CEO’s KPIs. These are used to measure company performance, which determines the pool available for other employees. Allocations from that pool for senior management are determined with reference to individual KPIs set by the CEO. Resulting outcomes are approved by the Nomination and Remuneration Committee. The Nomination and Remuneration Committee assesses LTI milestone achievement for vesting eligibility. Fixed Pay Performance-based Remuneration Short-term Incentives Long-term Incentives Table of Contents 102
Eligibility All employees All employees hired on or before March 31, 2024 are eligible for consideration. Employees hired during the year are recognized on a pro- rata basis. All eligible participants who are in positions to influence achievement of our long- term outcomes and, where required, for attraction and retention. Quantum of opportunity Set according to each position’s accountabilities, the incumbent’s experience and qualifications, and regional market relativities. Set as a percentage of fixed pay. Quantum generally lower than LTI to conserve cash. Current CEO maximum STI: 50% of Fixed Remuneration. Current CMO maximum STI: 50% of Fixed Remuneration. Set using a percentage of fixed pay as a guideline. Current CEO maximum LTI: approximately 200% of fixed remuneration. Current CMO maximum LTI: 100% of fixed remuneration. The actual grant value for the CEO and CMO LTI may vary year on year from this proportion based on various factors being taken account including: - shareholder dilution - internal relativities - share price volatility Delivered as Cash. Cash. Subsequent to FY24, our STI plan was modified and will provide all employees with the choice to receive an option grant in lieu of cash payment of their STI entitlements for the years ended FY23 and FY24. Options over ordinary shares in Mesoblast Limited with a 7-year expiry date. Option exercise price will be based on the higher of the VWAP of the 5 ASX trading days up to board approval of the grant, and the last closing price of an ordinary share on the ASX at board approval. Performance and service period N/A 1 year Three years, with provision for earlier vesting limited to one third per year to (a) encourage speed of achievement, (b) defer material amounts for better governance and (c) encourage executive focus on achievements that have a longer term impact on shareholder value. Fixed Pay Performance-based Remuneration Short-term Incentives Long-term Incentives Table of Contents 103
Discretion, malus and clawback N/A The board has the authority to use its discretion to amend individual outcomes “in year”, including down to zero, prior to any payment. Additionally, effective FY24 we adopted a policy for the recovery of erroneously awarded incentive compensation. The board has ultimate discretion in determining vesting outcomes. Until options are exercised, the board may also apply discretion in situations where executives have behaved dishonestly or fraudulently to lapse options (unvested and vested). Additionally, effective FY24 we adopted a policy for the recovery of erroneously awarded incentive compensation. Cessation of employment N/A No award will be made to employees who have ceased employment unless the Board exercises it's discretion. Unvested options are forfeited unless Board exercises discretion. Vested options can be retained subject to being exercised within a certain period specified in our Employee Share Option Rules (usually 60 days of cessation). Hedging The Company’s share trading policy prohibits hedging via the Company’s derivatives. Oversight Individual outcomes are reviewed and approved first by the Nomination & Remuneration Committee and then the Board. Fixed Pay Performance-based Remuneration Short-term Incentives Long-term Incentives Remuneration Mix FY24 target remuneration mix at maximum for the CEO and the CMO is described in Figure 1. Figure 1 – Executive KMP Remuneration Mix. 28.6% 40.0% 14.3% 20.0% 57.1% 40.0% TFR STI LTI 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% CEO CMO The actual grant value year-on-year may vary from the target remuneration mix depending on factors such as: • Dilution considerations Table of Contents 104
• Internal relativities • Date of grant Responses to frequent questions on the Mesoblast framework The following table presents responses to common queries on the Mesoblast remuneration framework. Table 3 – Executive Remuneration Framework Why do you use milestone performance measures for the STI and LTI? Traditional financial metrics are not meaningful, nor can they be effectively used to accurately reflect the performance of our company. What creates lasting shareholder value are successful outcomes from research and development, entry into new collaborations and achievement of other planned and well considered corporate objectives. Success will only result in significant reward under the LTI if the market values our achievements. If it does, our share price increases. The LTI options become valuable. If not, the options have no intrinsic value. This combination of milestones and payment in options work in tandem for fair payment for performance aligned with shareholder returns. This is a standard biotechnology company practice. Why does some of the long term incentive award vest earlier than a three year period? Within biotechnology, basing long term incentives on achievement of performance milestones is an established method for aligning pay with performance. The other factor that is critical is time. While we allow three years for milestones, earlier achievement is better, because if milestones are achieved earlier then less cash will have been used by the Group to support the program and associated overheads than if achieved at the end of 3 years. Therefore, we have configured the plan to allow for early vesting for early achievement, but only to a point. We still insist that even if all milestones are achieved early, some options remain unvested for 3 years, to ensure that, if given a choice with a limited budget, employees focus on those milestones most likely to deliver the most value over the longer term, as well as encouraging employee retention. We believe that this framework is innovative, and a great fit for the nature of our business. We acknowledge it does not look and feel like a typical ASX-listed company LTI, and therefore may not meet the standard guidelines applied by many, but we are not typical. We are open to considering alternatively designed incentives that address the value drivers of milestone achievement, time to achieve them, prioritization of milestones given limited resourcing, and impact on longer term share price, but so far we have not found any quite as effective. What is Mesoblast’s position on diversity? The Group values diversity and recognizes the benefits it can bring to the organization’s ability to achieve its goals. Diversity can lead to a competitive advantage through broadening the talent pool for recruitment of high quality employees, by encouraging innovation and improving a corporation’s professionalism and reputation. Accordingly, the Group is committed to promoting diversity within the organization and has adopted a formal policy outlining the Group’s diversity objectives. With respect to gender diversity, as at June 30, 2024, 52% of the Company’s employee base were female and 30% of the Company’s senior executives were female. In April 2024, a female Board Chair was appointed. The Board is conscious of the gender imbalance at board level (with only one of the four non-executive directors being female). The Board has an objective to increase the number of female board members as vacancies arise and circumstances permit. Table of Contents 105
What is Mesoblast's position on STI deferral? STI deferral is applied as and when considered appropriate. Payment of both the FY23 and FY24 STI has been deferred and is dependent on FDA marketing authorization for SR-aGVHD being achieved. Why is there no consideration of ENS (Environment and Sustainability) issues in the STI or LTI vesting considerations? Mesoblast’s mission to bring to market innovative medicines comprised of naturally-occurring cellular materials to treat serious and life-threatening illnesses is fundamentally consistent with ENS principles, although there are relevant supply chain and carbon footprint considerations. At this stage, Mesoblast’s physical footprint is limited to office and laboratory space for its employee base of less than 100, so while management is actively engaged in reducing the Company’s carbon footprint, its ability to materially improve its ENS impact is currently limited. We will continue to consider having ENS- related remuneration milestones in the future, in particular if and when Mesoblast has its own manufacturing facilities and approved products. Mesoblast performance during FY2024 Table 4 provides share price performance data and selected financial results. Table 4 – Company share price performance and selected financial results over the last five years Currency 2024 2023 2022 2021 2020 Share price (ASX:MSB) – closing at June 30 A$ 0.99 1.14 0.61 1.98 3.25 – high for the year A$ 1.39 1.28 2.10 5.5 4.45 – low for the year A$ 0.26 0.68 0.61 1.72 1.02 Market capitalization at June 30 (millions) A$ 1,130 924 397 1,285 1898 – increase/(decrease) – (millions) A$ 206 527 (888) -613 1160 – increase/(decrease) – as % 22% 133% (69%) (32)% 157% Revenue (millions) US$ 5.9 7.5 10.2 7.5 32.2 – increase/(decrease) – as % (21%) (27%) 37% (77)% 92% Loss before income tax (millions) US$ 88.1 82.1 91.6 99.6 87.4 Net Assets (millions) US$ 480.4 501.8 497.0 581.4 549.3 Dividends paid — — — — — Return of Capital to Shareholders — — — — — During the year we advanced BLA submission for pediatric Graft versus Host Disease and had continued dialogue with the FDA involving all programs in our late-stage clinical pipeline. On March 26, 2024, the FDA informed Mesoblast that following additional consideration the available clinical data from the Phase 3 study MSB-GVHD001 appeared sufficient to support submission of the proposed BLA for remestemcel-L for the treatment of pediatric patients with SR- aGVHD. In July 2024, Mesoblast resubmitted our BLA for remestemcel-L for the treatment of pediatric SR-aGVHD. During the year, Mesoblast progressed our Chronic Low Back (CLBP) and Chronic Heart Failure (CHF) programs. The FDA informed the Company that it supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). The confirmatory Phase 3 trial of rexlemestrocel-L in patients with CLBP due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. Mesoblast successfully executed on its cost containment plan announced in August 2023, reducing net operating cash usage by 23% in FY24 as compared to FY23. In relation to funding, with support from its shareholders the Company raised US$40 million and US$25 million in December 2023 and March 2024, respectively. These raises strengthen our consolidated balance sheet as we undertake activities for the potential launch and commercialization of remestemcel-L. Table of Contents 106
In summary management executed on the following corporate achievements: - Completed US$40 million rights issue in December 2023. - Completed US$25 million capital raise in March 2024. - During the year we appointed Jane Bell as Board Chair. In relation to our product candidates, management executed on the following achievements: - After our interactions with the FDA during the year, the FDA informed Mesoblast that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SR-aGVHD. - During the year we advanced our resubmission of the BLA for approval of remestemcel-L in the treatment of children with SR-aGVHD which ultimately resulted in the formal resubmission and acceptance by the FDA of the filing in July 2024. - In March 2024 Mesoblast announced that the FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic HFrEF and an LVAD. FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation. - The confirmatory Phase 3 trial of rexlemestrocel-L in patients with CLBP due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. - Entered into an agreement to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with SR-aGvHD with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs. The BMT CTN is funded by the United States National Institutes of Health (NIH). - Following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition, Mesoblast was granted orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration (FDA) for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease HLHS. Table of Contents 107
Remuneration outcomes for the year ended June 30, 2024 STI The Corporate STI objectives and outcomes for FY24 are described in Table 5. Table 5 - Group Performance against FY24 STI KPIs Objectives/Performance Assessment Maximum as % of total STI Rating Outcome as % of total STI Execute on clinical and regulatory strategy of our key product candidates (50%) During the year we advanced our resubmission of the BLA SR-aGVHD which ultimately resulted in the formal resubmission and acceptance by the FDA of the filing in July 2024. Entered into an agreement to develop a pivotal trial of remestemcel-L in the treatment of adults SR-aGvHD with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs,. The BMT CTN is funded by the NIH. Mesoblast progressed our CLBP and CHF programs with positive results. The FDA’s OTAT granted RMAT designation for rexlemestrocel-L in the treatment of CLBP associated with disc degeneration and supported an accelerated approval for rexlemestrocel-L in patients with end-stage ischemic HFrEF and an LVAD. Following submission of results from the randomized controlled trial in children with HLHS, a potentially life threatening congenital heart condition, Mesoblast was granted ODD and RPDD with the FDA for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease HLHS. The Board has decided this objective has been met. 50% 100% 50% Execute on Financing Strategy (20%) In relation to Finance, there have been substantial achievements during the year. We completed a capital raise of $40 million in December 2023 and $25 million in March 2024. The Board has decided this objective has been met. 20% 100% 20% Execute on Manufacturing Process Development & Cost Containment (30%) During the year we enhanced our manufacturing processes. Separately, we reduced our cash burn through the successful execution of the cost containment plan announced in August 2023. Overall, net operating cash usage was reduced by 23% for FY24 as compared to FY23, a target flagged in the 2023 annual report. The Board has decided this objective has been met. 30% 100% 30% Table of Contents 108
The Board assessed our Group’s performance on these KPIs for the financial year ended June 30, 2024 as achieving 100% of targets, reflecting significant out performance in the face of changing priorities in reaction to the FDA's communications in March that lead to Mesoblast's BLA resubmission. Nevertheless, given the central nature of the BLA resubmission and our current cash position, the Board has exercised negative discretion not to pay the FY24 STI unless and until Mesoblast receives FDA marketing authorization for SR-aGVHD. Considering the negative discretion to pay a zero STI if FDA marketing authorization is not achieved, the Board has also increased the potential of the CEO’s payment by 20% if authorization is achieved. Subsequent to FY24, there has been a modification to the STI plan providing all employees with the choice to elect into receiving an option grant in lieu of cash payment of their STI entitlements for the years ended FY23 and FY24. The level of participation and the terms of the modification are yet to be determined at the date of this report. LTI Two conditions must be met for milestone options to vest. • The milestone for that option must be met • Achievement must be within the performance period • The executive must be employed at the time of vesting When LTI milestones are set it is not expected that all or any milestones will be achieved within the next 12 months. The LTI plan is designed to align the CEO objectives with creating long term shareholder value. The vesting of the CEO’s LTI is based on meeting clinical and commercialization milestones, as well as completion of licensing or collaboration agreements to build shareholder value. The LTI vesting for our executive and non-executive KMPs, based on FY24 and prior year performance, along with the financial year in which those options will vest once milestones have been met, are summarized in Tables 6a, 6b and 6c. Where an LTI milestone remains commercial in confidence it has been described in general terms. Many milestones also have an associated delivery window and/or budget which are taken into account when determining if it was achieved. Some clinical outcomes can be partially met depending on the quality and/or cost of results or extent of patient participation. Table of Contents 109
Table 6a – LTI Outcomes of CEO's milestone-based grants Nov 2023(1) Regulatory milestone related to gain alignment with FDA on certain aspects of the development program for CHF. 242,000 FY24 — — 242,000 — — 100% — Financial & Business Development related milestone to completion of a strategic capital raise to fund development programs through to key milestones. 726,000 FY24 — — 564,667 161,333 — 100% — Regulatory and clinical milestones in relation to the remestemcel-L and rexlemestrocel-L platforms. 1,452,000 Pending — — — — — — 1,452,000 Total for Nov 2023 Grant 2,420,000 — — 806,667 161,333 — 40% 1,452,000 Nov 2022(2) Commercial and clinical milestones in relation to the potential launch of remestemcel- L. 1,395,000 Pending — — — — — — 1,395,000 Financial and business development milestones in relation to remestemcel-L and rexlemestrocel-L platforms 930,000 Pending — — — — — — 930,000 Total for Nov 2022 Grant 2,325,000 — — — — — — 2,325,000 Nov 2021(3) Regulatory/ Commercialization progress with respect to our aGVHD program and clinical progress across the Company’s lead programs with specific allocation for each program milestone based on priority. 510,000 FY23 — 510,000(7) — — — 100% — 110,000 FY24 — 110,000 — — — 100% — Completion of a significant licensing/ collaboration agreement to build shareholder value and other confidential financing objectives. 620,000 Pending — — — — — — 620,000 Manufacturing milestones related to process development. 310,000 Pending — — — — — — 310,000 Total for Nov 2021 Grant 1,550,000 — 620,000 — — — 40% 930,000 Date Granted Milestone No. of Options Year Milestone Achieved FY in which the tranche has/will vest after factoring in time- based vesting conditions % Vested Pending Pre FY24 FY24 FY25 FY26 FY27 Table of Contents 110
Nov 2020(4) Clinical/ Commercialization milestones related to clinical and commercialization progress across the Company’s lead programs. 480,000 FY22 480,000 — — — — 100% — Completion of a significant licensing/ collaboration agreement to build shareholder value and other confidential financing objectives. 480,000 Pending — — — — — — 480,000 Manufacturing milestones related to process development. 240,000 FY22 240,000 — — — — 100% — Total for Nov 2020 Grant 1,200,000 720,000 — — — — 60% 480,000 Nov 2019(5) Granting of a PDUFA date for remestemcel- L(6). 673,334 FY20 673,334 — — — — 100% — US FDA approval of remestemcel-L(6). 673,333 Pending — — — — — — 673,333 Total for Nov 2019 Grant 1,346,667 673,334 — — — — 50% 673,333 Date Granted Milestone No. of Options Year Milestone Achieved FY in which the tranche has/will vest after factoring in time- based vesting conditions % Vested Pending Pre FY24 FY24 FY25 FY26 FY27 (1) This grant was approved by the Board on October 16, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) This grant was approved by the Board on October 17, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (3) This grant was approved by the Board on September 8, 2021 and granted on November 29, 2021 after shareholder approval for the grant was received at the AGM. (4) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the grant was received at the AGM. (5) This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the grant was received at the AGM. 538,667 of the options granted were not milestone based and have not been included in the above table. The 538,667 options were granted as a substitute for a reduction made to the FY19 short-term cash bonus to conserve cash. (6) For the treatment of pediatric SR acute GVHD. (7) Regardless of when the milestone was achieved, the milestone vesting date is determined as the date of Board approval. In this case Board approval was in July 2023. Table of Contents 111
Table 6b – LTI Outcomes of CMO's milestone-based grants Nov 2023(1) Regulatory milestone related to gain alignment with FDA on certain aspects of the development program for CHF. 148,000 FY24 — — 148,000 — — 100% — Regulatory and clinical milestones in relation to the remestemcel-L and rexlemestrocel-L platforms. 444,000 Pending — — — — — — 444,000 Strategic corporate partnership milestones in relation to the remestemcel-L and rexlemestrocel-L platforms. 148,000 Pending — — — — — — 148,000 Total for Nov 2023 Grant 740,000 — — 148,000 — — 20% 592,000 Nov 2022(2) Milestones related to the regulatory progress of remestemcel-L(3) 600,000 FY24 — 300,000 — — — 50% 300,000 Milestone related to the clinical progress of the Company’s lead products. 300,000 Pending — — — — — — 300,000 Total for Nov 2022 Grant 900,000 — 300,000 — — — 33% 600,000 Date Granted Milestone No. of Options Year Milestone Achieved FY in which the tranche has/will vest after factoring in time- based vesting conditions % Vested Pending Pre FY24 FY24 FY25 FY26 FY27 (1) This grant was approved by the Board on October 16, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) This grant was approved by the Board on October 17, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (3) For pediatric patients with SR-aGVHD with the FDA, including the resubmission of its BLA and its potential approval by the FDA. Table 6c – LTI Outcomes of milestone-based grants to Phil Krause Nov 2023(1) Milestones related to the regulatory progress of remestemcel-L(3) 325,050 FY24 — — 325,050(2) — — 100% — Regulatory milestones in relation to the remestemcel-L and rexlemestrocel-L platforms 659,950 Pending — — — — — — 659,950 Total for Nov 2023 Grant 985,000 — — 325,050 — — 33% 659,950 Date Granted Milestone No. of Options Year Milestone Achieved FY in which the tranche has/will vest after factoring in time- based vesting conditions % Vested Pending Pre FY24 FY24 FY25 FY26 FY27 (1) This grant was approved by the Board on October 24, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) The milestone was achieved in July 2024. Table of Contents 112
(3) For pediatric patients with SR-aGVHD with the FDA, including the resubmission of its BLA and its potential approval by the FDA. Table 7 represents remuneration paid to each executive KMP during the year as required by Section 300A of the Corporations Act 2001. Table 7 – Statutory remuneration paid to executive KMP Short-term benefits Base salary Short- term cash bonus(1) Annual Leave/ Holiday Pay(2) Non- monetary benefits Health and Other Benefits(3) Post- employm ent benefits Super- annuatio n Long- term benefits Long service leave(2) Share- based payments Options Other Termi- nation benefits Total Statutory Remuneration % of performance- based remuneration Name Year Currency $ $ $ $ $ $ $ $ $ $ % Silviu Itescu 2024 A$ 757,500 1,007,187 77,904 — — 27,399 16,926 1,137,219 — 3,024,136 71% Silviu Itescu 2023 A$ 1,010,000 — 77,694 — — 25,292 16,880 536,138 — 1,666,004 32% Eric Rose 2024 A$ 701,841 848,348 (5,984) — 28,561 — — 714,708 — 2,287,474 68% Eric Rose 2023 A$ 916,542 — 5,878 — 34,194 — — 578,236 — 1,534,850 38% Total Executive Directors 2024 A$ 1,459,341 1,855,535 71,920 — 28,561 27,399 16,926 1,851,927 — 5,311,610 70% Total Executive Directors 2023 A$ 1,926,542 — 83,572 — 34,194 25,292 16,880 1,114,374 — 3,200,854 35% Total Executive Directors 2024 US$(4) 959,079 1,219,458 47,266 — 18,770 18,006 11,124 1,217,086 — 3,490,790 70% Total Executive Directors 2023 US$(4) 1,292,710 — 56,077 — 22,944 16,971 11,326 747,745 — 2,147,773 35% (1) Includes $457,812 related to the FY23 period but not yet paid and $549,375 related to the FY24 period but not yet paid. Subsequent to FY23, the conditions of achievement of the FY23 STI was modified to make it dependent on Mesoblast achieved FDA marketing authorization. Payment of the FY23 and FY24 bonus is dependent on Mesoblast achieving FDA marketing authorization. Furthermore, subsequent to FY24, there has been a modification to the STI plan providing all employees with the choice to elect into receiving an option grant in lieu of cash payment of their STI entitlements for the years ended FY23 and FY24. The level of participation and the terms of the modification are yet to be determined at the date of this report. (2) Annual leave and Long service leave reflect the movement in provision balances at June 30, 2024 compared with June 30, 2023. (3) Includes health, dental, vision, life, long and short-term disability insurances. (4) The A$ results have been determined by calculating the average rate of the exchange rates on the last trading day of each month during the period. A US$:A$ exchange rate of 1:0.6572 has been used for the year ended June 30, 2024 and 1:0.6710 for the year ended June 30, 2023. Fixed remuneration The CEO's fixed remuneration has not changed since 2015. Eric Rose was appointed as our CMO in FY22, his monthly fixed remuneration has not changed since his appointment. Both our CEO and CMO volunteered base salary reductions of 30% for a 12-month period to 30 June 2024. In compensation for the reduction in cash pay, an option grant was approved by shareholders with an approval vote of 95% at the 2023 AGM, increasing the CEO and CMO's long-term equity-based at risk pay for further alignment of their interests with shareholders. Non-Executive Director (“NED”) Remuneration As at June 30, 2024 the Board comprised of four NEDs; one based in Australia, two in the United States, and one in Switzerland. These directors are global experts in the biopharmaceutical industry and capital markets, each with relevant experience in biotechnology and/or healthcare industries. The NED fees (in Table 8) reflect responsibilities and work involved with directing a company of Mesoblast’s technological and geographical complexity, our financial position, regulatory and compliance context, and market practice in each director’s domicile. The fee levels and structures reflect what is necessary to recruit and retain directors with global Table of Contents 113
experience in this industry. There have been no changes to NED fees from last year. No NED fees were paid during the year – 50% are deferred until an FDA approval decision and 50% were paid as options (more detail below). Table 8 – Annual NED fees (exclusive of superannuation where applicable for Australian directors) As at June 30, 2024 Position Currency Board of Directors Audit and Risk Committee Nomination and Remuneration Committee Chair(1) A$ 250,000 20,000 20,000 Vice Chair A$ 175,000 — — Member A$ 128,250 10,000 10,000 (1) Joe Swedish NED fees for his position as Chair of the Board were US$250,000 per annum. The NEDs' fixed fees for their services are not to exceed a maximum fee pool of A$1,500,000, as approved by shareholders at the 2018 Annual General Meeting. NEDs do not receive performance-related remuneration and are not provided with retirement benefits other than statutory superannuation. An exception is a performance based LTI grant to our non-independent NED, Philip Krause, in relation to his role as a strategic regulatory advisor. NEDs are reimbursed for costs directly related to conducting Mesoblast business. The key terms of NED service are documented in a letter of appointment to the Board. Mesoblast grants options to NEDs, usually at the start of their tenure. Additionally in FY24 options were granted to replace NED cash fees which were reduced by 50%. Options in lieu of cash are typical in the biotechnology industry. These options vest one third each after one, two and three years. For our NEDs, options are only forfeited if the director engages in conduct that is adverse to the company or breach the terms of their engagement. The grants enable Mesoblast to secure NEDs with global pharmaceutical experience cash-effectively. Governance is not compromised because no performance or service conditions apply. The majority of shareholders voted in favor of our NED LTI grants at the November 2023, 2022 and 2021 AGMs. Philip Krause has been a non-executive director of Mesoblast since March 2022. Philip Krause was appointed to a formal strategic advisory role on June 4, 2023 where he was remunerated at an hourly rate and the agreement was able to be terminated on 15 written days notice. The consulting agreement was in addition to Philip Krause's existing role as non- executive director. Philip Krause was determined not to be independent on August 28, 2023 and his director fees ceased from August 1, 2023. On October 1, 2023, Philip Krause's consulting agreement was amended, where he is now remunerated via a monthly retainer of US$20,000 for strategic advisory services and his role as non-executive director. In addition to the monthly retainer, Philip Krause will receive 540,000 time-based options issued in three equal tranches vesting at 12, 24 and 26 months from grant date, which are subject to shareholder approval, and 985,000 milestone-based options which will vest subject to achieving the performance milestones and time-based vesting conditions. All options will have a 7 year term. The agreement is ongoing, with either party able to terminate on 90 written days notice. The total aggregate fees paid to Philip Krause through the original consulting agreement for the year ended June 30, 2023 and 2024 was US$110,383 and US$220,900 respectively. As the fees relating to the amended consulting agreement are in relation to both his advisory and director roles, they are disclosed in Table 9. Further details on the number of options and exercise price can be found in section “Terms and conditions of share-based payment arrangements”. Table of Contents 114
Remuneration Details - NEDs Details of the remuneration of our NEDs for the years ended June 30, 2024 and June 30, 2023 are in Table 9. Table 9 – Director Fees Year Currency Base Salary(2) Super- annuation Share-based payments Options Total Statutory Remuneration Jane Bell 2024 A$ 91,851 1,359 137,214 230,424 Jane Bell 2023 A$ 128,798 13,524 66,804 209,126 William Burns 2024 A$ 105,625 — 95,349 200,974 William Burns 2023 A$ 195,247 — 3,989 199,236 Philip Facchina 2024 A$ 81,135 — 87,475 168,611 Philip Facchina 2023 A$ 148,497 — 55,120 203,617 Philip Krause(3) 2024 A$ 285,410 — 229,861 515,271 Philip Krause(3) 2023 A$ 138,497 — 69,199 207,696 Eric Rose(4) 2023 A$ — — 3,989 3,989 Michael Spooner 2024 A$ 38,153 — — 38,153 Michael Spooner 2023 A$ 158,250 — — 158,250 Joseph Swedish 2024 A$ 186,266 — 192,507 378,773 Joseph Swedish 2023 A$ 372,276 — — 372,276 Shawn Tomasello 2023 A$ 23,042 — — 23,042 Total Non-Executive Directors 2024 A$ 788,441 1,359 742,406 1,532,205 Total Non-Executive Directors 2023 A$ 1,164,607 13,524 199,101 1,377,232 Total Non-Executive Directors (1) 2024 US$ 518,163 893 487,909 1,006,965 Total Non-Executive Directors (1) 2023 US$ 781,451 9,075 133,597 924,123 (1) The A$ results have been determined by calculating the average rate of the exchange rates on the last trading day of each month during the period. A US$:A$ exchange rate of 1:0.6572 has been used for the year ended June 30, 2024 and 1:0.6710 for the year ended June 30, 2023. (2) Other than fees for the month of July 2024 and all fees owed to Michael Spooner on his retirement, no payments of monthly fees have been made in 2024 given the decision to defer NED fee payments until a decision is made by the FDA on the BLA resubmission. (3) Philip Krause has been a non-executive director of Mesoblast since March 2022. FY2023 relates to Director Fees earned in his role as an independent non-executive director. Within FY2024, A$11,521 relates to Director Fees earned in his role as an independent non-executive director and A$273,889 relates to his amended consulting agreement through which he was paid a monthly retainer of US$20,000 as compensation for strategic advisory services and his role as non executive director from October 1, 2023 to June 30, 2024. (4) Eric Rose has been a non-executive director of Mesoblast since 2013. On February 1, 2022, he was appointed as an executive director of Mesoblast and payments of director fees ceased at that time. Share-based payments reported as part of Eric’s director fees above relate to options granted during his appointment as a non-executive director. Table of Contents 115
Terms and conditions of option grants and equity holdings Details of options over ordinary shares provided as remuneration to each director and member of key management personnel for the years ended June 30, 2024 and June 30, 2023 are provided in the tables below. Table 10 – The value of options granted, exercised and lapsed. Number of options granted Remuneration consisting of options (1) Values of options granted (2) A$ Value of options exercised (3) A$ Value of options lapsed (4) A$ For the year ended June 30, 2024 Silviu Itescu(5) 3,693,070 38% 767,005 — — Eric Rose(5) 1,960,765 31% 451,305 — — Jane Bell(6) 326,729 60% 85,178 — — William Burns(6) 409,651 47% 106,796 — — Philip Facchina(6) 290,432 52% 75,716 — — Philip Krause(7)(8) 985,000 45% 256,790 — — Michael Spooner — — — — — Joseph Swedish(6) 827,077 51% 215,619 — — For the year ended June 30, 2023 Silviu Itescu(9) 2,325,000 32% 1,422,203 — — Eric Rose(9) 2,150,000 38% 1,315,155 — — Jane Bell(10) 200,000 32% 128,780 — — William Burns — 2% — — — Philip Facchina — — — — — Philip Krause(11) 200,000 33% 120,120 — — Michael Spooner — — — — — Joseph Swedish — — — — — Shawn Tomasello — — — — — (1) The percentage of the value of remuneration consisting of options, based on the value of options expensed during the year presented in accordance with IFRS 2 Share-based Payment. For details on the assumptions made for each grant, see information in note 17 Share-based payments within Item 18 Financial Statements of this report. (2) The fair value at grant date of options that were granted during the year presented as part of remuneration, determined using Black-Scholes valuation model and in accordance with IFRS 2 Share-based Payment. The grant date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement. (3) The intrinsic value at exercise date of options that were exercised during the year presented, having been granted as part of remuneration previously. (4) The intrinsic value at lapse date of options that lapsed during the year. (5) These grants were approved by the Board on October 12, 2023 and October 16, 2023, respectively, and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (6) This grant was approved by the Board on October 12, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (7) This grant was approved by the Board on October 24, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (8) The board approved a grant of 540,000 options for Philip Krause on March 11, 2024, this grant is subject to shareholder approval at the upcoming AGM. (9) This grant was approved by the Board on October 17, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. Table of Contents 116
(10) This grant was approved by the Board on August 24, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (11) This grant was approved by the Board on May 23, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. There have been no modifications to any terms and conditions of share-based payment transactions during the years ended June 30, 2024 and 2023. Reconciliation of Options held by KMP The table below shows a reconciliation of options over ordinary shares of Mesoblast Limited held by each KMP from the beginning to the end of FY24. Table 11 – Reconciliation of options held by each KMP during FY24. Balance at July 1, 2023 Granted as compensat ion during FY24 Vested during FY24 Exercised during FY24 Forfeited / Lapsed during FY24 Balance at June 30, 2024 Name Grant Date Vested Unvested Number Number % Number % Number % Vested and exercisable Unvested Silviu Itescu 28-Nov-23(1) — — 2,420,000 — — — — — — — 2,420,000 Silviu Itescu 28-Nov-23(2) — — 1,273,070 424,357 33 — — — — 424,357 848,713 Silviu Itescu 23-Nov-22(3) — 2,325,000 — — — — — — — — 2,325,000 Silviu Itescu 29-Nov-21(4) — 1,550,000 — 620,000 40 — — — — 620,000 930,000 Silviu Itescu 24-Nov-20(5) 720,000 480,000 — — — — — — — 720,000 480,000 Silviu Itescu 27-Nov-19(6) 1,212,001 673,333 — — — — — — — 1,212,001 673,333 Eric Rose 28-Nov-23(1) — — 740,000 — — — — — — — 740,000 Eric Rose 28-Nov-23(2) — — 1,220,765 406,922 33 — — — — 406,922 813,843 Eric Rose 23-Nov-22(3) — 1,250,000 — 416,667 33 — — — — 416,667 833,333 Eric Rose 23-Nov-22(3) — 900,000 — — — — — — — — 900,000 Eric Rose 30-Nov-18 120,000 — — — — — — — — 120,000 — Eric Rose 27-Nov-19 100,000 — — — — — — — — 100,000 — Jane Bell 28-Nov-23(2) — — 326,729 108,910 33 — — — — 108,910 217,819 Jane Bell 23-Nov-22(7) — 200,000 — 66,667 33 — — — — 66,667 133,333 William Burns 28-Nov-23(2) — — 409,651 136,551 33 — — — — 136,551 273,100 William Burns 30-Nov-18 120,000 — — — — — — — — 120,000 — William Burns 27-Nov-19 100,000 — — — — — — — — 100,000 — Philip Facchina 28-Nov-23(2) — — 290,432 96,811 33 — — — — 96,811 193,621 Philip Facchina 29-Nov-21(8) 133,334 66,666 — 66,666 33 — — — — 200,000 — Philip Krause(11) 28-Nov-23(9) — — 985,000 — — — — — — — 985,000 Philip Krause 23-Nov-22(10) 66,667 133,333 — 66,667 33 — — — — 133,334 66,666 Michael Spooner(12) 30-Nov-18 100,000 — — — — — — — — 100,000 — Joseph Swedish 28-Nov-23(2) — — 827,077 275,693 33 — — — — 275,693 551,384 Joseph Swedish 27-Nov-19 300,000 — — — — — — — — 300,000 — Joseph Swedish 30-Nov-18 200,000 — — — — — — — — 200,000 — (1) This grant was approved by the Board on October 16, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) This grant was approved by the Board on October 12, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (3) This grant was approved by the Board on October 17, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (4) This grant was approved by the Board on September 8, 2021 and granted on November 29, 2021 after shareholder approval for the grant was received at the AGM. Table of Contents 117
(5) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the grant was received at the AGM. (6) This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the grant was received at the AGM. (7) This grant was approved by the Board on August 24, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (8) This grant was approved by the Board on April 15, 2021 and granted on November 29, 2021 after shareholder approval for the grant was received at the AGM. (9) This grant was approved by the Board on October 24, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (10) This grant was approved by the Board on May 23, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (11) The board approved a grant of 540,000 options for Philip Krause on March 11, 2024, this grant is subject to shareholder approval at the upcoming AGM. (12) On September 26, 2023, Mr. Spooner resigned as director of the Company. Terms and conditions of share-based payment arrangements The terms and conditions of each grant of options affecting remuneration in the current or a future reporting period are as follows: Table 12 – Terms and conditions of share-based payment arrangements 28-Nov-23(1) Philip Krause Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 24-Oct-2024 one third - 24-Oct-2025 one third - 24-Oct-2026 23-Oct-30 0.37 0.26 28-Nov-23(2) Silviu Itescu Eric Rose Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 16-Oct-2024 one third - 16-Oct-2025 one third - 16-Oct-2026 15-Oct-30 0.35 0.18 28-Nov-23(3) Silviu Itescu Eric Rose Jane Bell William Burns Philip Facchina Joseph Swedish one third - 12-Apr-2024 one third - 12-July-2024 one third - 12-Oct-2024 11-Oct-30 0.36 0.26 23-Nov-22(4) Philip Krause one third - 23-May-2023 one third - 23-May-2024 one third - 23-May-2025 22-May-29 1.01 0.60 23-Nov-22(5) Jane Bell one third - 24-Aug-2023 one third - 24-Aug-2024 one third - 24-Aug-2025 23-Aug-29 0.85 0.64 23-Nov-22(6) Eric Rose one third - 17-Oct-2023 one third - 17-Oct-2024 one third - 17-Oct-2025 16-Oct-29 1.03 0.61 23-Nov-22(6) Silviu Itescu Eric Rose Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 17-Oct-2023 one third - 17-Oct-2024 one third - 17-Oct-2025 16-Oct-29 1.03 0.61 Grant date Recipients of Grants Vesting date Expiry date Exercise price A$ Value per option at grant date A$ Table of Contents 118
29-Nov-21(7) Silviu Itescu Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 8-Sep-2022 one third - 8-Sep-2023 one third - 8-Sep-2024 7-Sep-28 1.77 0.42 29-Nov-21(8) Philip Facchina one third - 15 Apr 2022 one third - 15 Apr 2023 one third - 15 Apr 2024 14-Apr-28 2.28 1.11 24-Nov-20(9) Silviu Itescu Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 16-Jul-2021 one third - 16-Jul-2022 one third - 16-Jul-2023 15-Jul-27 3.41 0.92 27-Nov-19(10) Silviu Itescu Vesting in accordance with the following schedule, but only after achievement of performance milestones: one third - 19-Jul-2020 one third - 19-Jul-2021 one third - 19-Jul-2022 19-Jul-26 1.47 1.03 27-Nov-19(10) Silviu Itescu one third - 19-Jul-2020 one third - 19-Jul-2021 one third - 19-Jul-2022 19-Jul-26 1.47 1.03 27-Nov-19 William Burns Eric Rose one third - 17 Nov 2020 one third - 17 Nov 2021 one third - 17 Nov 2022 17-Nov-26 1.83 0.94 27-Nov-19 Joseph Swedish one third - 4 Apr 2020 one third - 4 Apr 2021 one third - 4 Apr 2022 3-Apr-26 1.48 0.78 30-Nov-18 William Burns Eric Rose Michael Spooner one third - 30 Nov 2019 one third - 30 Nov 2020 one third - 30 Nov 2021 29-Nov-25 1.33 0.54 30-Nov-18 Joseph Swedish one third - 18 Jun 2019 one third - 18 Jun 2020 one third - 18 Jun 2021 17-Jun-25 1.52 0.85 Grant date Recipients of Grants Vesting date Expiry date Exercise price A$ Value per option at grant date A$ (1) This grant was approved by the Board on October 24, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) This grant was approved by the Board on October 16, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (3) This grant was approved by the Board on October 12, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (4) This grant was approved by the Board on May 23, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (5) This grant was approved by the Board on August 24, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (6) This grant was approved by the Board on October 17, 2022 and granted on November 23, 2022 after shareholder approval for the grant was received at the AGM. (7) This grant was approved by the Board on September 8, 2021 and granted on November 29, 2021 after shareholder approval for the grant was received at the AGM. (8) This grant was approved by the Board on April 15, 2021 and granted on November 29, 2021 after shareholder approval for the grant was received at the AGM. (9) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the grant was received at the AGM. Table of Contents 119
(10) This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the grant was received at the AGM. Table 13 - Shares provided to KMPs on the exercise of remuneration options No. of options exercised during the period No. of ordinary shares in Mesoblast Limited issued Exercise Date Value per share at exercise date A$ Exercise price per option A$ For the year ended June 30, 2024 Nil — — — — — For the year ended June 30, 2023 Nil — — — — — KMP Shareholdings The table below shows a reconciliation of ordinary shares held by each KMP from the beginning to the end of the 2024 financial year. Table 14 – KMP Shareholdings Name Balance at the start of the year Received during the year upon exercise of options Acquisitions/ (Disposals) during the year Balance at the end of the year Silviu Itescu 68,958,928 — 10,000,000 78,958,928 Eric Rose — — 411,620 411,620 Jane Bell 247,618 — 295,823 543,441 William Burns 85,000 — 21,250 106,250 Philip Facchina 273,225 — (150,005)(2) 123,220 Philip Krause 100,000 — 187,500 287,500 Michael Spooner(1) 1,091,335 — — 1,091,335 Joseph Swedish — — 459,420 459,420 (1) This total includes shareholdings of related parties, of this balance, Mr. Spooner has a relevant interest, as defined under the Corporations Act, of 1,069,000 ordinary shares. On September 26, 2023, Mr. Spooner resigned as director of the Company. (2) Philip Facchina disposed 150,000 ordinary shares during FY24. An adjustment down of 5 ordinary shares was made on January 10, 2024 following the ratio change to Mesoblast's ADR program from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). Employment Agreements The employment of our CEO and CMO are formalized in agreements, the key terms of which are as follows: Table 15 – KMP Employment Agreements Name Term Agreement Type Notice period Termination benefit Silviu Itescu (CEO) Initial term of 3 years commencing April 1, 2014, and continuing subject to a 12 months’ notice period. Employment 12 months 12 months base salary Eric Rose (CMO) An ongoing employment agreement until notice is given by either party. Employment 3 months 3 months base salary Table of Contents 120
On termination of employment our CEO, who is based in Australia, is entitled to receive his statutory entitlements of accrued annual and long service leave, together with any superannuation benefits. On termination of employment our CMO, who is based in the United States, is entitled to participate in the Company’s healthcare plan during the severance period. There is no entitlement to a termination payment in the event of resignation (except, in the case of the CMO, if the Company has materially reduced his role or benefits or materially moved office location) or removal for misconduct. KMP Loans or other related transactions There were no loans or other related transactions with KMP during the financial year other than that described above. (End of Remuneration Report) Table of Contents 121
Employee Profile As of June 30, 2024, we had 73 (2023:83) employees globally: Employees by Education 5 36 18 12 2 Diploma/Certificates Bachelor Masters PhD MD Employees by Region 419 22 1 USA Singapore Australia Switzerland Employees by Gender 38 35 Female Male 57% of our employees and a majority of our executives are based in the United States where Mesoblast operational activities are concentrated. Australia is the corporate headquarters where 30% of the employees work. This includes the CEO and a portion of the executive team. The remaining 12% of employees are located in Singapore and 1% in Switzerland where research and development activities are primarily conducted. Table of Contents 122
Australian Disclosure Requirements Options Granted as Remuneration The following table presents options that have been granted over unissued shares during or since the end of the year ended June 30, 2024, to our Directors and our next 5 most highly remunerated officers. Table 16 – Options Granted as Remuneration Name Issue Date Exercise Price A$ Number of shares, under option Directors Silviu Itescu 28-Nov-23(1) 0.35 2,420,000 Silviu Itescu 28-Nov-23(2) 0.36 1,273,070 Eric Rose 28-Nov-23(1) 0.35 740,000 Eric Rose 28-Nov-23(2) 0.36 1,220,765 Non-Directors Geraldine Storton 16-Oct-23 0.35 480,000 Kenneth Borow 16-Oct-23 0.35 1,398,393 Michael Schuster 16-Oct-23 0.35 590,000 Peter Howard 16-Oct-23 0.35 660,000 Roger Brown 16-Oct-23 0.35 490,000 (1) This grant was approved by the Board on October 16, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. (2) This grant was approved by the Board on October 12, 2023 and granted on November 28, 2023 after shareholder approval for the grant was received at the AGM. KMP Interests The relevant interest of each KMP, as defined by section 608 of the Corporations Act, in the share capital of Mesoblast, as notified by the directors to the ASX in accordance with section 205G(1) of the Corporations Act, at the date of this report is as follows: Table 17 – KMP Interests Director Mesoblast Limited ordinary shares Options over Mesoblast Limited ordinary shares Silviu Itescu 78,958,928 10,653,404 Eric Rose 411,620 4,330,765 Jane Bell 543,441 526,729 William Burns 106,250 629,651 Philip Facchina(1) 123,220 490,432 Philip Krause(2) 287,500 1,185,000 Michael Spooner(3) 1,069,000 100,000 Joseph Swedish 459,420 1,327,077 (1) Mr Facchina also has a relevant interest in 68,306 warrants over ordinary shares. (2) The board approved a grant of 540,000 options for Philip Krause on March 11, 2024, this grant is subject to shareholder approval at the upcoming AGM. (3) On September 26, 2023, Mr. Spooner resigned as director of the Company. Table of Contents 123
Meeting of Directors The number of meetings our board of directors (including committee meetings of directors) held during the year ended June 30, 2024 and the number of meetings attended by each director were: Table 18 – Meeting of Directors Board of Directors Audit and Risk Committee Nomination and Remuneration Committee Director A* B* A B A B Silviu Itescu 19 19 — — — — Eric Rose 19 19 — — — — Jane Bell 19 19 2 2 4 4 William Burns 19 19 — — 4 4 Philip Facchina 19 17 2 2 4 4 Philip Krause 19 19 — — 2 2 Michael Spooner 8 8 2 1 2 1 Joseph Swedish 19 18 2 1 4 4 A = Number of meetings held during the time the director held office or was a member of the committee. B = Number of meetings attended by board/committee members * = This includes both meetings scheduled in the board calendar as well as teleconference meetings organized on an ad-hoc basis. For the most part, each director attended every scheduled meeting in the board calendar. Shares under option Unissued ordinary shares of Mesoblast Limited under option at the date of this Directors’ report are as follows: 16-Sep-17 1.52 15-Sep-24 50,000 13-Oct-17 1.92 12-Oct-24 815,000 13-Oct-17 1.74 12-Oct-24 902,425 24-Nov-17 1.39 23-Nov-24 750,000 24-Nov-17 1.26 23-Nov-24 750,000 18-Jun-18 1.50 17-Jun-25 200,000 11-Jul-18 1.54 10-Jul-25 200,000 18-Jul-18 1.85 17-Jul-25 2,998,332 18-Jul-18 1.85 17-Jul-25 350,000 30-Nov-18 1.31 29-Nov-25 590,000 19-Jan-19 1.43 18-Jan-26 3,333 19-Jan-19 1.43 18-Jan-26 150,000 4-Apr-19 1.46 3-Apr-26 300,000 20-Jul-19 1.60 19-Jul-26 2,708,669 20-Jul-19 1.45 19-Jul-26 2,833,332 20-Jul-19 1.45 19-Jul-26 1,346,667 20-Jul-19 1.45 19-Jul-26 538,667 20-Jul-19 1.45 19-Jul-26 700,000 25-Nov-19 1.96 24-Nov-26 20,000 29-May-19 1.46 28-May-26 350,000 18-Nov-19 1.81 17-Nov-26 200,000 25-Nov-19 1.78 24-Nov-26 100,000 Grant date Exercise price of options A$ Expiry date of options Number of shares under option Table of Contents 124
25-Nov-19 1.96 24-Nov-26 150,000 24-Jan-20 3.36 23-Jan-27 10,000 18-May-20 4.00 17-May-27 1,200,000 18-May-20 3.63 17-May-27 1,200,000 16-Jul-20 3.73 15-Jul-27 3,040,000 16-Jul-20 3.39 15-Jul-27 1,735,000 16-Jul-20 3.39 15-Jul-27 350,000 16-Jul-20 3.39 15-Jul-27 300,000 16-Jul-20 3.39 15-Jul-27 1,200,000 11-Sep-20 4.76 10-Sep-27 200,000 20-Nov-20 3.58 19-Nov-27 200,000 20-Nov-20 3.58 19-Nov-27 100,000 17-Feb-21 2.65 16-Feb-28 250,000 15-Apr-21 2.26 14-Apr-28 200,000 8-Sep-21 1.93 7-Sep-28 2,929,666 8-Sep-21 1.75 7-Sep-28 3,850,000 8-Sep-21 1.75 7-Sep-28 1,550,000 23-Dec-21 1.40 22-Dec-28 200,000 17-Oct-22 1.01 16-Oct-29 1,250,000 23-May-22 0.99 22-May-29 200,000 24-Aug-22 0.83 23-Aug-29 200,000 17-Oct-22 1.11 16-Oct-29 5,054,500 17-Oct-22 1.01 16-Oct-29 4,350,000 17-Oct-22 1.11 16-Oct-29 225,000 17-Oct-22 1.01 16-Oct-29 3,225,000 17-Oct-22 1.01 16-Oct-29 1,200,000 8-Aug-22 0.91 7-Aug-29 100,000 11-Dec-20 4.58 10-Dec-27 100,000 21-Nov-22 1.10 20-Nov-29 100,000 30-Mar-23 1.01 29-Mar-30 45,000 30-Mar-23 0.92 29-Mar-30 600,000 12-Oct-23 0.36 11-Oct-30 2,493,835 12-Oct-23 0.36 11-Oct-30 1,853,889 16-Oct-23 0.39 15-Oct-30 5,434,500 16-Oct-23 0.35 15-Oct-30 1,995,000 16-Oct-23 0.35 15-Oct-30 3,160,000 16-Oct-23 0.35 15-Oct-30 2,730,000 16-Oct-23 0.35 15-Oct-30 873,393 24-Oct-23 0.37 23-Oct-30 985,000 16-Oct-23 0.35 15-Oct-30 300,000 30-May-24 1.23 29-May-31 220,000 30-May-24 1.23 29-May-31 200,000 30-May-24 1.35 29-May-31 210,000 Grand Total 72,626,208 Grant date Exercise price of options A$ Expiry date of options Number of shares under option No option holder has any right under the options plan to participate in any other of our share issues. Table of Contents 125
Shares issued on exercise of options during the year There were no exercise of options during or since the end of the financial year. Indemnification of Officers During the financial year, we paid premiums in respect of a contract insuring our directors and company secretaries, and all of our executive officers. The liabilities insured are to the extent permitted by the Corporations Act 2001. Further disclosure required under section 300(9) of the Corporations Act 2001 is prohibited under the terms of the insurance contract. Proceedings on Our Behalf The Corporations Act 2001 allows specified persons to bring, or intervene in, proceedings on our behalf. No proceedings have been brought or intervened in on our behalf with leave of the Court under section 237 of the Corporations Act 2001. Non-Audit Services We may decide to employ the auditor on assignments additional to their statutory audit duties where the auditor’s expertise and experience are relevant and considered to be important. The board of directors considers the position and in accordance with advice received from the audit committee, only permits the provision of the non-audit services compatible with the general standard of independence for auditors imposed by the Corporations Act 2001. During both the current and prior financial years, no fees were paid or payable for non-audit services provided by the auditor of the parent entity, its related practices and non-related audit firms. Auditor’s Independence Declaration A copy of the auditor’s independence declaration under Section 307C of the Corporations Act in relation to the audit for the year ended June 30, 2024 is included in Exhibit 99.2 of this annual report on Form 20-F. Rounding of Amounts Our company is of a kind referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191, issued by the Australian Securities and Investments Commission, relating to the ‘rounding off’ of amounts in the directors’ report. Unless mentioned otherwise, amounts within this report have been rounded off in accordance with that Legislative Instrument to the nearest thousand dollars, or in certain cases, to the nearest dollar. The components of our directors’ report are incorporated in various places within this annual report on the Form 20-F. A table charting these components is included within ‘Exhibit 99.1 Appendix 4E’. Directors’ Resolution This report is made in accordance with a resolution of the directors. /s/ Jane Bell /s/ Silviu Itescu Jane Bell Silviu Itescu Chair of Board Chief Executive Officer Dated: August 29, 2024 Table of Contents 126
6.C Board Practices Our board of directors currently consists of seven members: five non-executive directors and two executive directors, being Dr, Silviu Itescu, our Chief Executive Officer and Dr. Eric Rose, our Chief Medical Officer. Our directors are generally elected to serve three-year terms in a manner similar to a “staggered” board of directors under Delaware law. No director, except the Managing Director (currently designated as our Chief Executive Officer, Silviu Itescu), may hold office for a period in excess of three years, or beyond the third annual general meeting following the director’s last election, whichever is the longer, without submitting himself or herself for re-election. As a result of the staggered terms, not all of our directors will be elected in any given year. Name First election at AGM Last election at AGM End of current term William Burns 2014 2023 2026 Eric Rose 2013 2022 2025 Michael Spooner(1) 2004 2021 N/A Joseph Swedish 2018 2021 2024 Philip Facchina 2021 2023 2026 Philip Krause 2022 2022 2025 Jane Bell 2022 2022 2025 (1) Mr. Spooner resigned from the board on September 26, 2023. We believe that each of our directors has relevant industry experience. The membership of our board of directors is directed by the following requirements: • our Constitution specifies that there must be a minimum of 3 directors and a maximum of 10, and our board of directors may determine the number of directors within those limits; • we may appoint or remove any director by resolution passed in the general meeting of shareholders; • our directors may appoint any person to be a director, and that person only holds office until the next general meeting at which time the director may stand for election by shareholders at that meeting; • it is the intention of our board of directors that its membership consists of a majority of independent directors who satisfy the criteria for independence recommended by the ASX’s Corporate Governance Principles and Recommendations and the Rulebook of the Nasdaq Stock Market; • the chairperson of our board of directors should be an independent director who satisfies the criteria for independence recommended by the ASX’s Corporate Governance Principles and Recommendations; • Australia's Corporations Act requires that at least two of our directors must be resident Australians; and • our board of directors should, collectively, have the appropriate level of personal qualities, skills, experience, and time commitment to properly fulfill its responsibilities or have ready access to such skills where they are not available. Our board of directors is responsible for, and has the authority to determine, all matters relating to our corporate governance, including the policies, practices, management and operation. The principal roles and responsibilities of our board of directors are to: • facilitate board of directors and management accountability to our company and its shareholders; • ensure timely reporting to shareholders; • provide strategic guidance to us, including contributing to the development of, and approving, the corporate strategy; • oversee management and ensure there are effective management processes in place; • monitor: ◦ organizational performance and the achievement of our strategic goals and objectives; Table of Contents 127
◦ financial performance including approval of the annual and half-year financial reports and liaison with our auditors; ◦ progress of major capital expenditures and other significant corporate projects including any acquisitions or divestments; ◦ compliance with our code of conduct; ◦ progress in relation to our diversity objectives and compliance with its diversity policy; • review and approve business plans, the annual budget and financial plans including available resources and major capital expenditure initiatives; • approve major corporate initiatives; • enhance and protect the reputation of the organization; • oversee the operation of our system for compliance and risk management reporting to shareholders; and • ensure appropriate resources are available to senior management. Our non-executive directors do not have any service contracts with Mesoblast that provide for benefits upon termination of those services. Committees To assist our board of directors with the effective discharge of its duties, it has established a Nomination and Remuneration Committee and an Audit and Risk Committee. Each committee operates under a specific charter approved by our board of directors. Nomination and Remuneration Committee. The members of our Nomination and Remuneration Committee for the full year ended June 30, 2024 to the date of this report unless otherwise noted are Messrs. Burns (Chair), Swedish, Spooner (resignation effective September 26, 2023), Facchina, Krause (resignation from the committee effective August 28, 2023) and Ms. Bell. The remuneration committee is a committee of our board of directors, and is primarily responsible for making recommendations to our board of directors on: • board appointments; • non-executive director fees; • the executive remuneration framework; • remuneration of executive directors, including the CEO and other key executives; • short-term and long-term incentive awards; and • share ownership plans. The committee’s objective is to ensure remuneration policies are fair and competitive and in line with similar industry benchmarks while aligned with our objectives. The remuneration committee seeks independent advice from remuneration consultants as and when it deems necessary. See “Management—Remuneration.” Audit and Risk Committee. The members of our Audit and Risk Committee for the full year ended June 30, 2024 to the date of this report unless otherwise noted are Messrs. Spooner (Chair until his resignation from this committee effective September 20, 2023), Facchina (Chair from April 30, 2024), Swedish and Ms. Bell (Chair between September 20, 2023 to April 30, 2024), all of whom are independent, non-executive directors. This committee oversees, reviews, acts on and reports on various auditing and accounting matters to our board of directors, including the selection of our independent accountants, the scope of our annual audits, fees to be paid to the independent accountants, the performance of our independent accountants and our accounting practices. In addition, the committee oversees, reviews, acts on and reports on various risk management matters to our board of directors. The effective management of risk is central to our ongoing success. We have adopted a risk management policy to ensure that: • appropriate systems are in place to identify, to the extent that is reasonably practical, all material risks that we face in conducting our business; Table of Contents 128
• the financial impact of those risks is understood and appropriate controls are in place to limit exposures to them; • appropriate responsibilities are delegated to control the risks; and • any material changes to our risk profile are disclosed in accordance with our continuous disclosure reporting requirements in Australia. It is our objective to appropriately balance, protect and enhance the interests of all of our shareholders. Proper behavior by our directors, officers, employees and those organizations that we contract to carry out work is essential in achieving this objective. We have established a code of conduct, which sets out the standards of behavior that apply to every aspect of our dealings and relationships, both within and outside Mesoblast. The following standards of behavior apply: • patient well-being; • comply with all laws that govern us and our operations; • act honestly and with integrity and fairness in all dealings with others and each other; • avoid or manage conflicts of interest; • use our assets properly and efficiently for the benefit of all of our shareholders; and • seek to be an exemplary corporate citizen. Board Diversity The following matrix sets forth Board diversity information required by the Nasdaq’s rules for Mesoblast as a foreign private issuer. Board Diversity Matrix as at June 30, 2024 Country of Principal Executive Offices Australia Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law No Total Number of Directors 7 Female Male Non-Binary Did Not Disclose Gender Part I: Gender Identity Directors 1 4 — 2 Part II: Demographic Background Underrepresented Individual in Home Country Jurisdiction — LGBTQ+ — Did not Disclose Demographic Background 2 Table of Contents 129
Board Diversity Matrix as at June 30, 2023 Country of Principal Executive Offices Australia Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law No Total Number of Directors 8 Female Male Non-Binary Did Not Disclose Gender Part I: Gender Identity Directors 1 3 — 4 Part II: Demographic Background Underrepresented Individual in Home Country Jurisdiction 1 LGBTQ+ — Did not Disclose Demographic Background 7 6.D Employees As of June 30, 2024, we had 73 employees, 42 of whom are based in the United States, 21 of whom are based in Australia, including our CEO and certain executive team members, 9 of whom are based in Singapore, and 1 of whom is based in Switzerland. We had 83 and 77 employees as of June 30, 2023 and 2022, respectively. The table below sets forth the breakdown of the total year-end number of our employees by main category of activity and geographic area for the past three years: As of June 30, 2024 Research & Development Commercial Manufacturing Corporate Total USA 30 — 4 7 41 Australia 7 — 1 14 22 Singapore 1 — 7 1 9 Switzerland 1 — — — 1 Total 39 — 12 22 73 As of June 30, 2023 Research & Development Commercial Manufacturing Corporate Total USA 35 — 5 9 49 Australia 8 — 1 15 24 Singapore 4 — 4 1 9 Switzerland 1 — — — 1 Total 48 — 10 25 83 As of June 30, 2022 Research & Development Commercial Manufacturing Corporate Total USA 32 — 4 8 44 Australia 8 — 1 15 24 Singapore 1 — 6 1 8 Switzerland 1 — — — 1 Total 42 — 11 24 77 We have no collective bargaining agreement with our employees. We have not experienced any work stoppages to date and consider our relations with our employees to be good. Table of Contents 130
See “Item 6.A Directors and Senior Management – Employee Profile”. 6.E Share Ownership The table below sets forth information regarding the beneficial ownership of our ordinary shares based on 1,141,784,114 ordinary shares outstanding at August 29, 2024 by each of our directors and key management personnel. We have determined beneficial ownership in accordance with the rules of the SEC. A person has a beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including options that are exercisable within 60 days of August 29, 2024. Ordinary shares subject to options currently exercisable or exercisable within 60 days of August 29, 2024 are deemed to be outstanding for computing the percentage ownership of the person holding these options and the percentage ownership of any group of which the holder is a member, however are not deemed outstanding for computing the percentage of any other person. Unless otherwise indicated, to our knowledge each shareholder possesses sole voting and investment power over the ordinary shares listed. None of our shareholders has different voting rights from other shareholders. Unless otherwise indicated, the principal address of each of the shareholders below is c/o Mesoblast Limited, Level 38, 55 Collins Street, Melbourne 3000, Australia. Ordinary Shares beneficially owned Name Number % Directors and key management personnel: Silviu Itescu(1) 83,590,666 7.3% Eric Rose(2) 3,433,719 * Jane Bell(3) 1,003,504 * William Burns(4) 735,901 * Philip Facchina(5) 681,958 * Philip Krause(6) 745,884 * Michael Spooner(7) 1,169,000 * Joseph Swedish(8) 1,786,497 * All directors and key management personnel as a group (8 persons) 93,147,129 8.1% _______________ * Less than 1% of the outstanding ordinary shares. (1) Includes (a) 67,756,838 ordinary shares owned by Dr. Itescu, (b) 8,821,137 ordinary shares owned by Josaka Investments Pty Ltd, the trustee of Dr. Itescu’s self-managed superannuation fund, (c) 2,380,953 ordinary shares owned by Tamit Nominees Pty Ltd, an Australian corporation owned by Dr. Itescu and (d) 4,631,738 ordinary shares subject to options of which; 1,212,001 exercisable at a price of A$1.45 per share until July 19, 2026, 720,000 exercisable at a price of A$3.39 per share until July 15, 2027, 620,000 exercisable at a price of A$1.75 per share until September 7, 2028, 1,273,070 exercisable at a price of A$0.36 per share until October 11, 2030 and 806,667 exercisable at a price of A$0.35 per share until October 15, 2030. (2) Includes (a) 411,620 ordinary shares owned by Dr. Rose (held as American Depository Shares) and (b) 3,022,099 ordinary shares subject to options of which; 120,000 exercisable at a price of A$1.31 per share until November 29, 2025, 100,000 exercisable at a price of A$1.81 per share until November 17, 2026, 1,433,334 exercisable at a price of A$1.01 per share until October 16, 2029, 1,220,765 exercisable at a price of A$0.36 per share until October 11, 2030 and 148,000 exercisable at a price of A$0.35 per share until October 15, 2030. (3) Includes (a) 543,441 ordinary shares owned by Ms. Bell and Mr. Geoffrey Arthur Bell as trustees for Ms. Bell's family trust, (b) 460,063 ordinary shares subject to options of which: 133,334 exercisable at a price of A$0.83 per share until August 23, 2029 and 326,729 exercisable at a price of A$0.36 per share until October 11, 2030. (4) Includes (a) 106,250 ordinary shares owned by Mr. Burns (through a custodian) and (b) 629,651 ordinary shares subject to options of which; 120,000 exercisable at a price of A$1.31 per share until November 29, 2025, 100,000 Table of Contents 131
exercisable at a price of A$1.81 per share until November 17, 2026 and 409,651 exercisable at a price of A$0.36 per share until October 11, 2030. (5) Includes (a) 123,220 ordinary shares owned by HNP, LLC (held as American Depository Shares), (b) 68,306 warrants over ordinary shares owned by HNP, LLC and (c) 490,432 ordinary shares subject to options of which: 200,000 exercisable at a price of A$2.26 per share until April 14, 2028 and 290,432 exercisable at a price of A$0.36 per share until October 11, 2030. (6) Includes (a) 287,500 ordinary shares owned by Mr. Krause (held as American Depository Shares) and (b) 458,384 ordinary shares subject to options of which: 133,334 exercisable at a price of A$0.99 per share until May 22, 2029 and 325,050 exercisable at a price of A$0.37 per share until October 23, 2030. (7) Includes (a) 356,533 ordinary shares owned by Mr. Spooner, (b) 712,467 ordinary shares owned by Mr. Spooner's family trusts and (c) 100,000 ordinary shares subject to options exercisable at a price of A$1.31 per share until November 29, 2025. On September 26, 2023, Mr. Spooner resigned as director of the Company. (8) Includes (a) 459,420 ordinary shares owned by Mr. Swedish (held as American Depository Shares) and (b) 1,327,077 ordinary shares subject to options of which; 200,000 are exercisable at a price of A$1.50 per share until June 17, 2025, 300,000 are exercisable at a price of A$1.46 per share until April 3, 2026 and 827,077 exercisable at a price of A$0.36 per share until October 11, 2030. 6.F Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation Not applicable. Item 7. Major Shareholders and Related Party Transactions 7.A Major Shareholders The following table and accompanying footnotes present certain information regarding the beneficial ownership of our ordinary shares based on 1,141,784,114 ordinary shares outstanding at August 29, 2024 by each person known by us to be the beneficial owner of more than 5% of our ordinary shares. Based upon information known to us, as of August 16, 2024 we had approximately 38 registered shareholders (ordinary shares) with addresses in the United States. These shareholders held an aggregate of 327,584,347 of our ordinary shares, or approximately 37.43% of our outstanding ordinary shares. None of our shareholders has different voting rights from other shareholders. Ordinary Shares beneficially owned Name Number % 5% or Greater Shareholders: Silviu Itescu(1) 83,590,666 7.3% G to the Fourth Investments, LLC(2) 186,678,344 16.3% (1) Includes (a) 67,756,838 ordinary shares owned by Dr. Itescu, (b) 8,821,137 ordinary shares owned by Josaka Investments Pty Ltd, the trustee of Dr. Itescu’s self-managed superannuation fund and (c) 2,380,953 ordinary shares owned by Tamit Nominees Pty Ltd, an Australian corporation owned by Dr. Itescu, (d) 1,212,001 ordinary shares subject to options exercisable at a price of A$1.45 per share until July 19, 2026, (e) 720,000 ordinary shares subject to options exercisable at a price of A$3.39 per share until July 15, 2027, and (f) 620,000 ordinary shares subject to options exercisable at a price of A$1.75 per share until September 7, 2028, (g) 806,667 ordinary shares subject to options exercisable at a price of A$0.35 per share until October 15, 2030; and (h) 1,273,070 ordinary shares subject to options exercisable at a price of A$0.36 per share until October 11, 2030. (2) Includes (a) 61,347,527 ordinary shares owned by G to the Fourth Investments, LLC and Gregory George, (b) 5,538,970 ordinary shares owned by James George (held as American Depository Shares), (c) 6,000,000 ordinary shares owned by Grant George (held as American Depository Shares) (d) 106,961,245 ordinary shares owned by Gregory George and (e) 6,830,602 ordinary shares subject to warrants. Table of Contents 132
To our knowledge, there have not been any significant changes in the ownership of our ordinary shares by major shareholders over the past three years, except as follows (which is based on notices filed with the ASX and SEC). • M&G Investment Group reported that as of August 12, 2022 in total it held 93,150,226 ordinary shares (including 1,320,000 ADSs, each representing 5 ordinary shares), or 12.64% of the total voting power as of that date. It reported that as of May 1, 2023 it held 86,251,092 ordinary shares (including 532,981 ADSs, each representing 5 ordinary shares), or 10.60% of the total voting power as of that date. It reported that as of July 27, 2023 in total it held 76,996,783 ordinary shares, or 9.46% of the total voting power as of that date. It reported that as of August 4, 2023 in total it held 58,312,858 ordinary shares, or 7.16% of the total voting power as of that date. It reported that as of August 8, 2023 in total it held 48,079,421 ordinary shares, or 5.91% of the total voting power as of that date. It reported that as of August 9, 2023 that it had ceased to be a substantial shareholder. • G to the Fourth Investments, LLC reported that as of May 1, 2023 it held 53,920,195 ordinary shares, or 6.62% of the total voting power as of that date. It reported that as of August 24, 2023 in total it held 66,366,800 ordinary shares, or 8.15% of the total voting power as of that date. It reported that as of March 18, 2024, it held 116,316,795 ordinary shares, or 10.23% of the total voting power as of that date. It reported that as of March 28, 2024 it held 136,435,560 ordinary shares, or 11.99% of the total voting power as of that date. It reported that as of April 5, 2024 it held 150,183,635 ordinary shares, or 13.20% of the total voting power as of that date. It reported that as of April 30, 2024 it held 166,849,364 ordinary shares, or 14.67% of the total voting power as of that date. It reported that as of July 9, 2024 it held 179,847,742 ordinary shares, or 15.81% of the total voting power as of that date. • Dr.Itescu reported that as of December 12, 2023 he held 78,958,928 ordinary shares, or 7.8% of the total voting power as of that date. 7.B Related Party Transactions The Company has not entered into any related party transactions during the years ended June 30, 2024 or 2023 other than compensation and other services provided by Directors and other members of key management personnel, see “Item 6.B Compensation”. 7.C Interests of Experts and Counsel Not applicable. Item 8. Financial Information 8.A Consolidated Statements and Other Financial Information See “Item 18. Financial Statements.” Legal Proceedings A class action proceeding in the Federal Court of Australia was served on the Company in May 2022 by the law firm William Roberts Lawyers on behalf of persons who, between February 22, 2018, and December 17, 2020, acquired an interest in Mesoblast shares, American Depository Receipts, and/or related equity swap arrangements. In June 2022, the firm Phi Finney McDonald commenced a second shareholder class action against the Company in the Federal Court of Australia asserting similar claims arising during the same period. The Australian class actions relate to the Complete Response Letter released by the FDA in September 2020 in relation to the Company's GvHD product candidate; they also relate to certain representations made by the Company in relation to our COVID-19 product candidate and the decline in the market price of the Company's ordinary shares in December 2020. The Australian class actions have been consolidated into one lawsuit. On August 21, 2024, the Company announced that the class action had been resolved subject to Federal Court approval. The settlement (inclusive of interest and costs) will be funded entirely by Mesoblast's insurers and includes no admission of liability. Table of Contents 133
Dividend policy Since our inception, we have not declared or paid any dividends on our shares. We intend to retain any earnings for use in our business and do not currently intend to pay cash dividends on our ordinary shares. Dividends, if any, on our outstanding ordinary shares will be declared by and subject to the discretion of our board of directors, and subject to Australian law. Any dividend we declare will be paid to the holders of ADSs, subject to the terms of the deposit agreement, to the same extent as holders of our ordinary shares, to the extent permitted by applicable law and regulations, less the fees and expenses payable under the deposit agreement. Any dividend we declare will be distributed by the depositary bank to the holders of our ADSs, subject to the terms of the deposit agreement. See “Item 12.D. Description of American Depositary Shares.” 8.B Significant Changes In July 2024, we resubmitted our Biologic License Application ("BLA") with United States Food & Drug Administration ("FDA") for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease ("SR-aGVHD") and the FDA accepted our resubmission and set a Prescription Drug User Fee Act goal date of January 7, 2025. In August 2024, we modified the short term incentive plan providing employees with the choice to elect into receiving an option grant in lieu of cash payment of their short term incentive entitlements for the years ended June 30, 2024 and 2023, which have been deferred to BLA approval. The level of participation and the terms of the modification are yet to be determined at the date of this report. In August 2024, we announced that the consolidated shareholder class action, filed in the Federal Court of Australia in 2022, has been resolved subject to Federal Court approval. The settlement (inclusive of interest and costs) will be funded entirely by Mesoblast's insurers and includes no admission of liability. There were no other events that have arisen subsequent to June 30, 2024 and prior to the signing of this report that would likely have a material impact on the financial results presented. Item 9. The Offer and Listing 9.A Offer and Listing Details Our ordinary shares have been listed in Australia on the Australian Securities Exchange (ASX) since December 2004. Our ordinary shares have been trading under the symbol “MSB”. American Depositary Shares (“ADSs”), each representing ten ordinary shares, are available in the US through an American Depositary Receipts (“ADR”) program. On January 10, 2024, the ratio under Mesoblast's ADR program was changed from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). This program was established under the deposit agreement which we entered into with JP Morgan Chase Bank N.A. as depositary and our ADR holders. Our ADRs have been listed on the Nasdaq Global Select Market since November 2015 and are traded under the symbol “MESO”. 9.B Plan of Distribution Not applicable. 9.C Markets See “Item 9.A Offer and Listing Details.” Table of Contents 134
9.D Selling Shareholders Not applicable. 9.E Dilution Not applicable. 9.F Expenses of the Issue Not applicable. Item 10. Additional Information 10.A Share Capital Not applicable. 10.B Memorandum and Articles of Association Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or purposes of Mesoblast. Our Constitution is subject to the terms of the ASX Listing Rules and the Australian Corporations Act. It may be modified or repealed and replaced by special resolution passed at a meeting of shareholders, which a resolution is passed by at least 75% of the votes cast by shareholders (including proxies and representatives of shareholders) entitled to vote on the resolution. Under Australian law, a company has the legal capacity and powers of an individual both within and outside Australia. The material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a definitive statement of the rights and liabilities of our shareholders, and is qualified in its entirety by reference to the complete text of our Constitution, a copy of which is on file with the SEC. Directors Interested Directors Except as permitted by the Corporations Act and the ASX Listing Rules, a director must not vote in respect of a matter that is being considered at a directors' meeting in which the director has a material personal interest according to our Constitution. Such director must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being considered, unless the non-interested directors resolve otherwise. Pursuant to our Constitution, the fact that a director holds office as a director, and has fiduciary obligations arising out of that office will not require the director to account to us for any profit realized by or under any contract or arrangement entered into by or on behalf of Mesoblast and in which the director may have an interest. Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of certain interests and prohibits directors of companies listed on the ASX from voting on matters in which they have a material personal interest and from being present at the meeting while the matter is being considered. In addition, unless a relevant exception applies, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision of financial benefits (including the issue by us of ordinary shares and other securities) to our directors, including entities controlled by them and certain members of their families. Borrowing Powers Exercisable by Directors Pursuant to our Constitution, our business is managed by our board of directors. Our board of directors has the power to raise or borrow money, and charge any of our property or business or all or any of our uncalled capital, and may issue debentures or give any other security for any of our debts, liabilities or obligations or of any other person, and may guarantee or become liable for the payment of money or the performance of any obligation by or of any other person. Table of Contents 135
Election, Removal and Retirement of Directors We may appoint or remove any director by resolution passed in a general meeting of shareholders. Additionally, our directors are elected to serve maximum three-year terms in a manner similar to a “staggered” board of directors under Delaware law. No director except the Managing Director (currently designated as our chief executive officer, Silviu Itescu) may hold office for a period in excess of three years, or beyond the third annual general meeting following the director’s last election, whichever is the longer, without submitting himself or herself for re-election. If no such director would be required to submit for re-election but the ASX Listing Rules require an election of directors to be held, the director to retire will be as agreed by the directors among themselves or, failing agreement, determined by lot. A director who is appointed during the year by the other directors only holds office until the next general meeting at which time the director may stand for election by shareholders at that meeting. In addition, provisions of the Corporations Act apply where at least 25% of the votes cast on a resolution to adopt our remuneration report (which resolution must be proposed each year at our annual general meeting) are against the adoption of the report at two successive annual general meetings. Where these provisions apply, a resolution must be put to a vote at the second annual general meeting to the effect that a further meeting, or a spill meeting, take place within 90 days. At the spill meeting, the directors in office when the remuneration report was considered at the second annual general meeting (other than the Managing Director) cease to hold office and resolutions to appoint directors (which may involve re- appointing the former directors) are put to a vote. Voting restrictions apply in relation to the resolutions to adopt our remuneration report and to propose a spill meeting. These restrictions apply to our key management personnel and their closely related parties. See “Rights and Restrictions on Classes of Shares—Voting Rights” below. Pursuant to our Constitution, a person is eligible to be elected as a director at a general meeting only if: • the person is in office as a director immediately before the meeting, in respect of an election of directors at a general meeting that is a spill meeting as defined in section 250V(1) of the Corporations Act; • the person has been nominated by the directors before the meeting; • where the person is a shareholder, the person has, at least 35 business days but no more than 90 business days before the meeting, given to us a notice signed by the person stating the person's desire to be a candidate for election at the meeting; or • where the person is not a shareholder, a shareholder intending to nominate the person for election at that meeting has, at least 35 business days but no more than 90 business days before the meeting, given to us a notice signed by the shareholder stating the shareholder's intention to nominate the person for election, and a notice signed by the person stating the person's consent to the nomination. Share Qualifications There are currently no requirements for directors to own our ordinary shares in order to qualify as directors. Rights and Restrictions on Classes of Shares Subject to the Corporations Act and the ASX Listing Rules, the rights attaching to our ordinary shares are detailed in our Constitution. Our Constitution provides that any of our ordinary shares may be issued with preferential, deferred or special rights, privileges or conditions, with any restrictions in regard to dividends, voting, return of share capital or otherwise as our board of directors may determine from time to time. Subject to the Corporations Act, the ASX Listing Rules and any rights and restrictions attached to a class of shares, we may issue further ordinary shares on such terms and conditions as our board of directors resolve. Currently, our outstanding ordinary share capital consists of only one class of ordinary shares. Dividend Rights Our board of directors may from time to time determine to pay dividends to shareholders; however, no dividend is payable except in accordance with the thresholds set out in the Corporations Act. Table of Contents 136
Voting Rights Under our Constitution, the general conduct and procedures of each general meeting of shareholders will be determined by the chairperson, including any procedures for casting or recording votes at the meeting whether on a show of hands or on a poll. A poll may be demanded by the chairman of the meeting; by at least five shareholders present and having the right to vote on at the meeting; or any shareholder or shareholders representing at least 5% of the votes that may be cast on the resolution on a poll. On a show of hands, each shareholder entitled to vote at the meeting has one vote regardless of the number of ordinary shares held by such shareholder. If voting takes place on a poll, rather than a show of hands, each shareholder entitled to vote has one vote for each ordinary share held and a fractional vote for each ordinary share that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid (not credited) of the total amounts paid and payable, whether or not called (excluding amounts credited), to such date on that ordinary share. Under Australian law, an ordinary resolution is passed on a show of hands if it is approved by a simple majority (more than 50%) of the votes cast by shareholders present (in person or by proxy) and entitled to vote. If a poll is demanded or required, an ordinary resolution is passed if it is approved by holders representing a simple majority of the total voting rights of shareholders present (in person or by proxy) who (being entitled to vote) vote on the resolution. Special resolutions require the affirmative vote of not less than 75% of the votes cast by shareholders present (in person or by proxy) and entitled to vote at the meeting. Votes on resolutions set out in a notice of meeting must be voted on by poll. Pursuant to our Constitution, each shareholder entitled to attend and vote at a meeting may attend and vote: • in person physically or by electronic means; • by proxy, attorney or by representative; or • other than in relation to any clause which specifies a quorum, a member who has duly lodged a valid vote delivered to us by post, fax or other electronic means approved by the directors in accordance with the Constitution. Under Australian law, shareholders of a public listed company are generally not permitted to approve corporate matters by written consent. Our Constitution does not specifically provide for cumulative voting. Note that ADS holders may not directly vote at a meeting of the shareholders but may instruct the depositary to vote the number of deposited ordinary shares their ADSs represent. Under voting by a show of hands, multiple “yes” votes by ADS holders will only count as one “yes” vote and will be negated by a single “no” vote, unless a poll is demanded. There are a number of circumstances where the Corporations Act or the ASX Listing Rules prohibit or restrict certain shareholders or certain classes of shareholders from voting. For example, key management personnel whose remuneration details are included elsewhere in this prospectus are prohibited from voting on the resolution that must be proposed at each annual general meeting to adopt our remuneration report, as well as any resolution to propose a spill meeting. An exception applies to exercising a directed proxy which indicates how the proxy is to vote on the proposed resolution on behalf of someone other than the key management personnel or their closely related parties; or that person is chair of the meeting and votes an undirected proxy where the shareholder expressly authorizes the chair to exercise that power. Key management personnel and their closely related parties are also prohibited from voting undirected proxies on remuneration related resolutions. A similar exception to that described above applies if the proxy is the chair of the meeting. Right to Share in Our Profits Subject to the Corporations Act and pursuant to our Constitution, our shareholders are entitled to participate in our profits by payment of dividends. The directors may by resolution declare a dividend or determine a dividend is payable, and may fix the amount, the time for and method of payment. Rights to Share in the Surplus in the Event of Winding Up Our Constitution provides for the right of shareholders to participate in a surplus in the event of our winding up. Table of Contents 137
Redemption Provisions Under our Constitution and subject to the Corporations Act, the directors have power to issue and allot shares with any preferential, deferred or special rights, privileges or conditions; with any restrictions in regard to the dividend, voting, return of capital or otherwise; and preference shares which are liable to be redeemed or converted. Sinking Fund Provisions Our Constitution allows our directors to set aside any amount available for distribution as a dividend such amounts by way of reserves as they think appropriate before declaring or determining to pay a dividend, and may apply the reserves for any purpose for which an amount available for distribution as a dividend may be properly applied. Pending application or appropriation of the reserves, the directors may invest or use the reserves in our business or in other investments as they think fit. Liability for Further Capital Calls According to our Constitution, our board of directors may make any calls from time to time upon shareholders in respect of all monies unpaid on partly paid shares respectively held by them, subject to the terms upon which any of the partly paid shares have been issued. Each shareholder is liable to pay the amount of each call in the manner, at the time and at the place specified by our board of directors. Calls may be made payable by instalment. Provisions Discriminating Against Holders of a Substantial Number of Shares There are no provisions under our Constitution discriminating against any existing or prospective holders of a substantial number of our ordinary shares. Variation or Cancellation of Share Rights The rights attached to shares in a class of shares may only be varied or cancelled by a special resolution of shareholders, together with either: • a special resolution passed at a separate meeting of members holding shares in the class; or • the written consent of members with at least 75% of the votes in the class. General Meetings of Shareholders General meetings of shareholders may be called by our board of directors or, under the Corporations Act, by a single director. Except as permitted under the Corporations Act, shareholders may not convene a meeting. Under the Corporations Act, shareholders with at least 5% of the votes that may be cast at a general meeting may call and arrange to hold a general meeting. The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that may be cast at a general meeting. Notice of the proposed meeting of our shareholders is required at least 28 days prior to such meeting under the Corporations Act. No business shall be transacted at any general meeting unless a quorum is present at the time when the meeting proceeds to business. Under our Constitution, the presence, in person or by proxy, attorney or representative, of two shareholders constitutes a quorum, or if we have less than two shareholders, then those shareholders constitute a quorum. If a quorum is not present within 30 minutes after the time appointed for the meeting, the meeting must be either dissolved if it was requested or called by shareholders or adjourned in any other case. A meeting adjourned for lack of a quorum is adjourned to the same day in the following week at the same time and place, unless otherwise decided by our directors. The reconvened meeting is dissolved if a quorum is not present within 30 minutes after the time appointed for the meeting. Change of Control Takeovers of listed Australian public companies, such as Mesoblast, are regulated by the Corporations Act, which prohibits the acquisition of a “relevant interest” in issued voting shares in a listed company if the acquisition will lead to that person’s or someone else’s voting power in Mesoblast increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below 90% (“Takeovers Prohibition”), subject to a range of exceptions. Table of Contents 138
Generally, a person will have a relevant interest in securities if the person: • is the holder of the securities or the holder of an ADS over the shares; • has power to exercise, or control the exercise of, a right to vote attached to the securities; or • has the power to dispose of, or control the exercise of a power to dispose of, the securities (including any indirect or direct power or control) If, at a particular time:- • a person has a relevant interest in issued securities; and • the person has: ◦ entered or enters into an agreement with another person with respect to the securities; ◦ given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in relation to the securities; or ◦ granted or grants an option to, or has been or is granted an option by, another person with respect to the securities; and • the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised, then, the other person is taken to already have a relevant interest in the securities. There are a number of exceptions to the above Takeovers Prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the more significant exceptions include: • when the acquisition results from the acceptance of an offer under a formal takeover bid; • when the acquisition is conducted on market by or on behalf of the bidder during the bid period for a full takeover bid that is unconditional or only conditional on certain 'prescribed' matters set out in the Corporations Act; • when the acquisition has been previously approved by resolution passed at general meeting by shareholders of Mesoblast; • an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had voting power in Mesoblast of at least 19% and, as a result of the acquisition, none of the relevant persons would have voting power in Mesoblast more than three percentage points higher than they had six months before the acquisition; • when the acquisition results from the issue of securities under a pro rata rights issue; • when the acquisition results from the issue of securities under a dividend reinvestment plan or bonus share plan; • when the acquisition results from the issue of securities under certain underwriting arrangements; • when the acquisition results from the issue of securities through a will or through operation of law; • an acquisition that arises through the acquisition of a relevant interest in another company listed on the ASX or other Australian financial market or a foreign stock exchange approved in writing by ASIC; • an acquisition arising from an auction of forfeited shares; or • an acquisition arising through a compromise, arrangement, liquidation or buy-back. A formal takeover bid may either be a bid for all securities in the bid class or a fixed proportion of such securities, with each holder of bid class securities receiving a bid for that proportion of their holding. Under our Constitution, a proportionate takeover bid must first be approved by resolution of our shareholders in a general meeting before it may proceed. Breaches of the takeovers provisions of the Corporations Act are criminal offenses. In addition, ASIC and, on application by ASIC or an interested party, such as a shareholder, the Australian Takeovers Panel have a wide range of Table of Contents 139
powers relating to breaches of takeover provisions, including the ability to make orders cancelling contracts, freezing transfers of, and rights (including voting rights) attached to, securities, and forcing a party to dispose of securities including by vesting the securities in ASIC for sale. There are certain defenses to breaches of the takeover provisions provided in the Corporations Act. Ownership Threshold There are no provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. The Corporations Act, however, requires a substantial shareholder to notify us and the ASX once a 5% interest in our ordinary shares is obtained. Further, once a shareholder has (alone or together with associates) a 5% or greater interest in us, such shareholder must notify us and the ASX of any increase or decrease of 1% or more in its interest in our ordinary shares. In addition, the Constitution requires a shareholder to provide information to the Company in relation to its entry into any arrangement restricting the transfer or other disposal of shares, which are of the nature of arrangements that Mesoblast is required to disclose under the ASX Listing Rules. Following our initial public offering in the United States, our shareholders are also subject to disclosure requirements under U.S. securities laws. Issues of Shares and Change in Capital Subject to our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time grant options over unissued shares and issue shares on any terms, with any preferential, deferred or special rights, privileges or conditions; with any restrictions in regard to dividend, voting, return of capital or otherwise, and for the consideration and other terms that the directors determine. Our power to issue shares includes the power to issue bonus shares (for which no consideration is payable to Mesoblast), preference shares and partly paid shares. Subject to the requirements of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, including relevant shareholder approvals, we may reduce our share capital (provided that the reduction is fair and reasonable to our shareholders as a whole, does not materially prejudice our ability to pay creditors and obtains the necessary shareholder approval) or buy back our ordinary shares including under an equal access buy-back or on a selective basis. Under the Constitution, the directors may do anything required to give effect to any resolution altering or approving the reduction of our share capital. Access to and Inspection of Documents Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our share registers on the payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our share registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial records and other documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books. 10.C Material Contracts Manufacturing Service Agreements with Lonza Bioscience Singapore Pte. Ltd. In September 2011, we entered into a manufacturing services agreement, or MSA, with Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., collectively referred to as Lonza, a global leader in biopharmaceutical manufacturing. Under the MSA, we pay Lonza on a fee for service basis to provide us with manufacturing process development capabilities for our product candidates, including formulation development, establishment and maintenance of master cell banks, records preparation, process validation, manufacturing and other services. We have agreed to order a certain percentage of our clinical requirements and commercial requirements for MPC products from Lonza. Lonza has agreed not to manufacture or supply commercially biosimilar versions of any of our product candidates to any third party, during the term of the MSA, subject to our meeting certain thresholds for sales of our products. We can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for our product candidates. In return if we exercise this option, we will purchase agreed quantities of our product candidates from this facility. We also have a right to buy out this manufacturing facility at a pre-agreed price two years after the facility receives regulatory approval. Table of Contents 140
The MSA will expire on the three-year anniversary of the date of the first commercial sale of product supplied under the MSA, unless it is sooner terminated. We have the option of extending the MSA for an additional 10 years, followed by the option to extend for successive three-year periods subject to Lonza’s reasonable consent. We may terminate the MSA with two years prior written notice, and Lonza may terminate with five years prior written notice. The MSA may also terminate for other reasons, including if the manufacture or development of a product is suspended or abandoned due to the results of clinical trials or guidance from a regulatory authority. In the event we request that Lonza construct the manufacturing facility described above, neither we nor Lonza may terminate before the third anniversary of the date the facility receives regulatory approval to manufacture our product candidates, except in certain limited circumstances. Upon expiration or termination of the MSA, we have the right to require Lonza to transfer certain technologies and lease the Singapore facility or the portion of such facility where our product candidates are manufactured, subject to good faith negotiations. We currently rely, and expect to continue to rely, on Lonza for the manufacture of our MPC product candidates for preclinical and clinical testing, as well as for commercial manufacture of our MPC product candidates if marketing approval is obtained. In October 2019, we entered into an agreement with Lonza for commercial manufacture of remestemcel-L for pediatric SR-aGVHD. This agreement has facilitated inventory build ahead of the planned US market launch of remestemcel-L and commercial supply to meet Mesoblast’s long-term market projections. The agreement provides for Lonza to expand its Singapore cGMP facilities if required to meet long-term growth and capacity needs for the product. Additionally, it anticipates introduction of new technologies and process improvements which are expected to result in significant increases in yields and efficiencies. Under the agreement, we agree to order a certain percentage of our commercial requirements for remestemcel-L from Lonza. The agreement is subject to standard provisions for termination and its effects, including termination by either party for uncured, material breach of the other, by us in the event of FDA related rejection or delay of approval of remestemcel-L and after a specified minimum period following the initiation date by either party, on advance notice to the other, which in the case Lonza is the terminating party is intended to provide us sufficient time to transfer the manufacture of the product to an alternative manufacturer. License Agreement with Grünenthal GmbH In September 2019, we entered into a strategic partnership with Grünenthal GmbH (Grünenthal) to develop and commercialize MPC-06-ID, the Company’s Phase 3 allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options. The agreement was amended by the parties in June 2021. Under the partnership, Grünenthal will have exclusive commercialization rights to MPC-06-ID for Europe and Latin America. We may receive up to $112.5 million in upfront and milestone payments prior to product launch, inclusive of $17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone payments could exceed $1.0 billion depending on the final outcome of Phase 3 studies and patient adoption. We will also receive tiered double-digit royalties on product sales. There cannot be any assurance as to the total amount of future milestone and royalty payments that Mesoblast will receive nor when they will be received. Grünenthal is able to terminate the agreement with a specified period of notice without cause, or on shorter notice in the case of certain clinical, regulatory and commercial events. We have termination rights with respect to certain patent challenges by Grünenthal. Either party may terminate the agreement on material breach of the agreement if such breach is not cured within the specified cure period or if certain events related to bankruptcy of the other party occurs. For more information, see “Item 18. Financial Statements - Note 23 – Revenue recognition.” Agreements with JCR Pharmaceuticals Co., Ltd. In October 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture expanded MSCs. These assets included assumption of a collaboration agreement with JCR (“JCR Agreement”), which will continue in existence until the later of 15 years from the first commercial sale of any product covered by the agreement and expiration of the last Osiris patent covering any such product. JCR is a research and development oriented pharmaceutical company in Japan. Under the JCR Agreement we assumed from Osiris, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the treatment of hematological malignancies by the use of HSCs derived from peripheral blood, cord blood or bone marrow, or the First JCR Field; and non-exclusive for developing Table of Contents 141
assays that use liver cells for non-clinical drug screening and evaluation, or the Second JCR Field. Under the JCR Agreement, JCR obtained rights in Japan to our MSCs, for the treatment of aGVHD. JCR also has a right of first negotiation to obtain rights to commercialize MSC-based products for additional orphan designations in Japan. We retain all rights to those products outside of Japan. JCR received full approval in September 2015 for its MSC-based product for the treatment of children and adults with aGVHD, TEMCELL. TEMCELL is the first culture-expanded allogeneic cell therapy product to be approved in Japan. It was launched in Japan in February 2016. Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. With respect to the First JCR Field, we have received all sales milestone payments, a total of $3.0 million. Ongoing we are entitled to escalating double-digit royalties in the twenties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to an approximately 50% profit share. Intellectual property is licensed both ways under the JCR Agreement, with JCR receiving exclusive and non- exclusive rights as described above from us and granting us non-exclusive, royalty-free rights (excluding in the First JCR Field and Second JCR Field in Japan) under the intellectual property arising out of JCR’s development or commercialization of MSC-based products licensed in Japan. JCR has the right to terminate the JCR Agreement for any reason, and we have a limited right to terminate the JCR Agreement, including a right to terminate in the event of an uncured material breach by JCR. In the event of a termination of the JCR Agreement other than for our breach, JCR must provide us with its owned product registrations and technical data related to MSC-based products licensed in Japan and all licenses of our intellectual property rights will revert to us. We expanded our partnership with JCR in Japan for two new indications: for wound healing in patients with EB in October 2018, and for neonatal hypoxic ischemic encephalopathy ("HIE"), a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019. We will receive royalties on TEMCELL product sales for licensed indications, if and when such indications receive marketing approval in Japan. We have the right to use all safety and efficacy data generated by JCR in Japan to support our development and commercialization plans for our MSC product candidate remestemcel-L in the United States and other major healthcare markets, including for GVHD, EB and HIE. Loan Agreement with Oaktree In November 2021, we entered into a five-year senior debt facility provided by funds associated with Oaktree. The balance of funds drawn down is $50.0 million as of June 30, 2024. The facility has a three-year interest only period, at a fixed rate of 9.75% per annum, after which the principal amortizes 5% per quarter beginning December 2024 and a final payment is due no later than November 2026. The facility also allowed us to make quarterly payments of interest at a rate of 8.0% per annum for the first two years, and the unpaid interest portion (1.75% per annum) has been added to the outstanding loan balance and shall accrue further interest at a fixed rate of 9.75% per annum. The loan agreement contains certain covenants, see “Item 18. Financial Statements - Note 5(f).” In November 2021, Oaktree was granted warrants to purchase 1,769,669 American Depositary Shares (“ADSs”) at $7.26 per ADS, a 15% premium to the 30-day VWAP. The warrants were legally issued in January 2022 and may be exercised within 7 years of issuance. In December 2022, we amended the terms of the loan agreement with Oaktree and in connection with the loan amendment, Oaktree was granted warrants to purchase 455,000 ADSs at $3.70 per ADS, a 15% premium to the 30-day VWAP. The warrants were legally issued in March 2023 and may be exercised within 7 years of issuance. In January 2024, the ratio under Mesoblast's American Depository Receipt ("ADR") program was changed from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). As a result of this ratio change and as a result of initiating the pro-rata accelerated non-renounceable rights issue in December Table of Contents 142
2023, the number and exercise price for the warrants granted to Oaktree was adjusted in accordance with the terms of these warrants. The warrants issued to Oaktree in November 2021 changed from 1,769,669 ADSs at $7.26 per ADS to 884,838 ADSs at $14.36 per ADS. The warrants issued to Oaktree in December 2022 changed from 455,000 ADSs at $3.70 per ADS to 227,502 ADSs at $7.24 per ADS. Loan Agreement with NovaQuest In June 2018, we entered into an eight-year non-dilutive secured loan with NovaQuest for $40.0 million. We drew the first tranche of $30.0 million on closing. The loan term includes an interest only period of approximately four years through until July 8, 2022, then a four-year amortization period through until maturity on July 8, 2026. All interest and principal payments will be deferred until after the first commercial sale of our allogeneic product candidate remestemcel-L for the treatment in pediatric patients with SR-aGVHD, in the United States and other geographies excluding Asia (“pediatric aGVHD”). Principal is repayable in equal quarterly instalments over the amortization period of the loan and is subject to the payment cap described below. Interest on the loan will accrue at a fixed rate of 15% per annum. If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable at maturity. We can elect to prepay all outstanding amounts owing at any time prior to maturity, subject to a prepayment charge, and may decide to do so if net sales of pediatric aGVHD are significantly higher than current forecasts. Following approval and first commercial sales, repayments commence based on a percentage of net sales and are limited by a payment cap which is equal to the principal due for the next 12 months, plus accumulated unpaid principal and accrued unpaid interest. During the four-year period commencing July 8, 2022, principal amortizes in equal quarterly instalments payable only after approval and first commercial sales. If in any quarterly period, 25% of net sales of pediatric SR-aGVHD exceed the annual payment cap, we will pay the payment cap and an additional portion of excess sales which will be used towards the prepayment amount in the event there is an early prepayment of the loan. If in any quarterly period 25% of net sales of pediatric SR-aGVHD is less than the annual payment cap, then the payment is limited to 25% of net sales of pediatric SR-aGVHD. Any unpaid interest will be added to the principal amounts owing and will accrue further interest. At maturity date, any unpaid loan balances are repaid. The loan agreement contains certain covenants, see “Item 5.B Liquidity and Capital Resource – Borrowings.” Osiris Acquisition—Continuing Obligations In October 2013, we and Osiris entered into a purchase agreement, as amended, or the Osiris Purchase Agreement, under which we acquired all of Osiris’ business and assets related to culture expanded MSCs. Pursuant to the Osiris Purchase Agreement, we also agreed to make certain milestone and royalty payments to Osiris pertaining to remestemcel-L for the treatment of aGVHD and Crohn’s disease. Each milestone payment is for a fixed dollar amount and may be paid in cash or our ordinary shares or ADSs, at our option. The maximum amount of future milestone payments we may be required to make to Osiris is $40.0 million. Any ordinary shares or ADSs we issue as consideration for a milestone payment will be subject to a contractual one year holding period, which may be waived in our discretion. In the event that the price of our ordinary shares or ADSs decreases between the issue date and the expiration of any applicable holding period, we will be required to make an additional payment to Osiris equal to the reduction in the share price multiplied by the amount of issued shares under that milestone payment. This additional payment can be made either wholly in cash or 50% in cash and 50% in our ordinary shares, in our discretion. We have also agreed to pay varying earnout amounts as a percentage of annual net sales of acquired products, ranging from low single-digit to 10% of annual sales in excess of $750.0 million. These royalty payments will cease after the earlier of a ten year commercial sales period and the first sale of a relevant competing product. The first royalty payments were made in 2016. Agreements with Tasly Pharmaceutical Group In July 2018, we entered into a Development and Commercialization Agreement with Tasly. The Development and Commercialization Agreement provides Tasly with exclusive rights to develop, manufacture and commercialize in China MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction. Tasly will fund all development, manufacturing and commercialization activities in China for MPC-150-IM and MPC-25-IC. On closing, we received a $20.0 million upfront technology access fee. Further, we will receive $25.0 million on product regulatory approvals in China. Mesoblast will receive double-digit escalating royalties on net product sales. Mesoblast is eligible to receive six escalating milestone payments upon the product candidates reaching certain sales thresholds in China. Table of Contents 143
The Development and Commercialization Agreement provides that Tasly can terminate this agreement with a specified amount of notice, on the later of (a) third anniversary of the agreement coming into effect and (b) receipt of marketing approval in China for each of MPC-150-IM or MPC-25-IC. Mesoblast has termination rights with respect to certain patent challenges by Tasly and if certain competing activities are undertaken by Tasly. Either party may terminate the agreement on material breach of the agreement if such breach is not cured within the specified cure period or if certain events related to bankruptcy of the other party occurs. TiGenix NV – patent license for treatment of fistulae In December 2017, we entered into a Patent License Agreement with TiGenix NV, now a wholly owned subsidiary of Takeda, which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived mesenchymal stromal cell product Alofisel®, previously known as Cx601, a product candidate of Takeda, for the local treatment of fistulae. The agreement includes the right for Takeda to grant sub-licenses to affiliates and third parties. As part of the agreement, we received $5.9 million (€5.0 million) before withholding tax as a non-refundable upfront payment, a further payment of $5.9 million (€5.0 million) before withholding tax 12 months after the patent license agreement date, and a further $1.2 million (€1.0 million) product regulatory milestone payment in the year ended June 30, 2022. We are entitled to further payments up to €9.0 million when Takeda reaches certain product regulatory milestones. Additionally, we receive single digit royalties on net sales of Alofisel®. The agreement will continue in full force in each country (other than the United States) until the date upon which the last issued claim of any licensed patent covering Alofisel® expires in such country (currently expected to be 2029) or, with respect to the United States, until the later of (i) the date upon which the last issued claim of any licensed patent covering Alofisel® in the United States expires (currently expected to be around 2031) or (ii) the expiration of the regulatory exclusivity period in the United States with an agreed maximum term. Either we or Takeda may terminate the agreement for any material breach that is not cured within 90 days after notice. We also have the right to terminate the agreement with a written notice in the event that Takeda file a petition in bankruptcy or insolvency or Takeda makes an assignment of substantially all of its assets for the benefit of its creditors. Takeda has the right to terminate its obligation to pay royalties for net sales in a specific country if it is of the opinion that there is no issued claim of any licensed patent covering Alofisel® in such country, subject to referral of the matter to the joint oversight/cooperation committee established under the agreement if we disagree. 10.D Exchange Controls The Australian dollar is freely convertible into U.S. dollars. In addition, there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Transaction Reports and Analysis Centre (“AUSTRAC”), which monitors such transaction, and amounts on account of potential Australian tax liabilities may be required to be withheld unless a relevant taxation treaty can be shown to apply. Regulation of acquisition by foreign entities Under Australian law, in certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of the shares in an Australian company without approval from the Australian Treasurer (or their delegate). These limitations are set forth in the Foreign Acquisitions and Takeovers Act 1975 (Cth) (FATA) and its associated legislative instruments. These limitations are in addition to the more general overarching Takeovers Prohibition of an acquisition of more than a 20% interest in a public company (in the absence of an applicable exception) under the takeovers provisions of the Corporations Act 2001 (Cth) (Corporations Act) by any person whether foreign or otherwise. Under the FATA, as currently in effect, any foreign person, together with associates (including parties acting in concert) is prohibited from acquiring 20% or more of the shares in any company having consolidated total assets of or that is valued at A$330.0 million or more (or A$1,427.0 million or more for investors from certain Foreign Trade Agreement countries including the U.S.). A smaller interest threshold of 10% applies to foreign government investors, and no asset threshold applies to this class of investors. Different rules apply to national security sectors (including critical infrastructure, critical goods, services or technology for a military use, and businesses that have access to security classified information and/or information that could compromise Australia's national security) sensitive industries (such as media, Table of Contents 144
telecommunications, and encryption and security technologies), companies owning land or that are agribusinesses. “Associates” is a broadly defined term under the FATA and includes in relation to any person: • any relative of the person; • any person with whom the person is acting or proposes to act in concert in relation to an action to which the FATA applies; • any person with whom the person carries on a business in partnership; • any entity of which the person is a ‘senior officer’ (such as a director or executive); • if the person is an entity, any holding entity or any senior officer of the entity; • any entity whose senior officers are accustomed or obliged to act in accordance with the directions, instructions or wishes of the person or if the person is an entity, its senior officers or vice versa; • any corporation in which the person holds a ‘substantial interest’ (generally, 20% or more) or any person holding a substantial interest in the person if a corporation; • a trustee of a trust in which the person holds a substantial interest or if the person is the trustee of a trust, a person who holds a substantial interest in the trust; • if the person is a foreign government, a separate government entity or a foreign government investor in relation to a foreign country, any other person that is a foreign government, a separate government entity or foreign government investor, in relation to that country. The Australian Treasurer also has power in certain circumstances to make an order specifying that two or more persons are associates. Each foreign person seeking to acquire holdings in excess of the above caps (including their associates, as the case may be) would need to complete an application form setting out the proposal and relevant particulars of the acquisition/ shareholding and pay the relevant application fees. The Australian Treasurer then has 30 days to consider the application and make a decision. However, the Australian Treasurer may extend the period if more time is required to complete the assessment, including by up to a further 90 days by publishing an interim order. The Australian Foreign Investment Review Board (FIRB), an Australian advisory board to the Australian Treasurer, has provided a guideline titled Australia’s Foreign Investment Policy which provides an outline of the policy. As for the risk associated with seeking approval, the policy provides, among other things, that the Treasurer will prohibit a proposed transaction if it is contrary to Australia's national interest (or national security). If the necessary approvals are not obtained, the Australian Treasurer is empowered to make a number of adverse orders, including an order requiring the acquirer to dispose of the shares it has acquired within a specified period of time. Civil and criminal penalties also apply for breaches of the FATA including imprisonment for up to 10 years and fines of up to 150,000 penalty units. As a public company with its primary listing on the Australian Securities Exchange (ASX), Mesoblast will be considered a foreign person under the FATA where: • a single foreign person (including an individual not ordinarily resident in Australia, a foreign corporation, or a foreign government) holds a substantial interest; or • multiple foreign persons hold together, in aggregate, 40% or more of the total issued shares after discounting any person holding an interest (alone or with its associates) that is not a 'substantial holding' within the meaning of the Corporations Act. In such event, we would be required to obtain the approval of the Australian Treasurer for our company, together with our associates, to acquire (i) more than 20% of an Australian company or business having total assets of, or that is valued at, A$330.0 million or more; or (ii) any interest in Australian land; or (iii) any ‘direct interest’ in any agribusiness or national security business. Different thresholds will apply to the extent that we are considered to be a foreign government investor due to our ownership. The percentage of foreign ownership in our company may also be included in determining the foreign ownership of any Australian company or business in which we may choose to invest. Since we have no current plans for any such Table of Contents 145
acquisition and do not own any property, any such approvals required to be obtained by us as a foreign person under the FATA will not affect our current or future ownership or lease of property in Australia. Our Constitution does not contain any additional limitations on the right to hold or vote our securities by reason of being a non-resident. Australian law requires the transfer of shares in our company to be made in writing or electronically through the Clearing House Electronic Sub-register System. 10.E Taxation The following summary of the material Australian and U.S. federal income tax consequences of an investment in our ADSs or ordinary shares is based upon laws and relevant interpretations thereof in effect as of the date of this Form 20- F, all of which are subject to change, possibly with retroactive effect. This summary does not deal with all possible tax consequences relating to an investment in our ADSs or ordinary shares, such as the tax consequences under U.S. state, local and other tax laws other than Australian and U.S. federal income tax laws. Certain Material U.S. Federal Income Tax Considerations to U.S. Holders The following summary describes certain material U.S. federal income tax consequences to U.S. holders (as defined below) of the ownership and disposition of our ordinary shares and ADSs as of the date hereof. Except where noted, this summary deals only with our ordinary shares or ADSs acquired and held as capital assets within the meaning of Section 1221 of the Internal Revenue Code of 1986, as amended (the “Code”). This section does not discuss the tax consequences to any particular holder, nor any tax considerations that may apply to holders subject to special tax rules, such as: • banks, insurance companies, regulated investment companies and real estate investment trusts; • financial institutions; • individual retirement and other tax-deferred accounts; • certain former U.S. citizens or long-term residents; • brokers or dealers in securities or currencies; • traders that elect to use a mark-to-market method of accounting; • partnerships and other entities treated as partnership or pass through entities for U.S. federal income tax purposes, and partners or investors in such entities; • tax-exempt organizations (organizations that would be exempt from tax under U.S. law, including public charities and private foundations); • persons that may have been subject to the alternative minimum tax; • persons that hold or dispose of ordinary shares or ADSs as a position in a straddle or as part of a hedging, constructive sale, conversion or other integrated transaction; • persons that have a functional currency other than the U.S. dollar; • persons that own (directly, indirectly or constructively) 10% or more of the vote or value of our equity; • persons subject to special tax accounting rules as a result of any item of gross income with respect to ordinary shares or ADSs being taken into account in an applicable financial statement; • persons who acquire ordinary shares or ADSs pursuant to the exercise of any employee share option or otherwise as compensation; or • persons that are not U.S. holders (as defined below). In this section, a “U.S. holder” means a beneficial owner of ordinary shares or ADSs, other than a partnership or other entity treated as a partnership for U.S. federal income tax purposes, that is, for U.S. federal income tax purposes: • an individual who is a citizen or resident of the United States (for U.S. federal income tax purposes); Table of Contents 146
• a corporation (or other entity classified for purposes of and pursuant to U.S. federal income tax laws as a corporation) created or organized in or under the laws of the United States or any state thereof or the District of Columbia; • an estate the income of which is includable in gross income for U.S. federal income tax purposes regardless of its source; or • a trust (i) the administration of which is subject to the primary supervision of a court in the United States and for which one or more U.S. persons have the authority to control all substantial decisions or (ii) that has an election in effect under applicable U.S. income tax regulations to be treated as a U.S. person. The discussion below is based upon the provisions of the Code, and the U.S. Treasury regulations, rulings and judicial decisions thereunder as of the date hereof, and such authorities may be replaced, revoked or modified, possibly with retroactive effect, so as to result in U.S. federal income tax consequences different from those discussed below. In addition, this summary is based, in part, upon the terms of the deposit agreement and assumes that the deposit agreement, and all other related agreements, will be performed in accordance with their terms. If a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes acquires, owns or disposes of ordinary shares or ADSs, the U.S. federal income tax treatment of a partner generally will depend on the status of the partner and the activities of the partnership. Partners of partnerships that acquire, own or dispose of ordinary shares or ADSs should consult their tax advisors. You are urged to consult your own tax advisor with respect to the U.S. federal, as well as state, local and non-U.S., tax consequences to you of acquiring, owning and disposing of ordinary shares or ADSs in light of your particular circumstances, including the possible effects of changes in U.S. federal income and other tax laws and the effects of any tax treaties. ADSs Assuming the deposit agreement and all other related agreements will be performed in accordance with their terms, a U.S. holder of ADSs will be treated as the beneficial owner for U.S. federal income tax purposes of the underlying shares represented by the ADSs. The U.S. Treasury has expressed concerns that parties to whom American depositary shares are released before shares are delivered to the depositary, or intermediaries in the chain of ownership between holders of American depositary shares and the issuer of the security underlying the American depositary shares, may be taking actions that are inconsistent with claiming foreign tax credits by holders of American depositary shares. These actions would also be inconsistent with claiming the reduced rate of tax, described below, applicable to dividends received by certain non-corporate holders. Accordingly, the creditability of any foreign taxes and the availability of the reduced tax rate for dividends received by certain non-corporate U.S. holders, each described below, could be affected by actions taken by such parties or intermediaries. Distributions Subject to the passive foreign investment company, or PFIC, rules discussed below, U.S. holders generally will include as gross dividend income the U.S. dollar value of the gross amount of any distributions of cash or property, other than certain pro rata distributions of ordinary shares, with respect to ordinary shares or ADSs to the extent the distributions are made from our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. Subject to the PFIC rules, a U.S. holder may be permitted to credit the taxes withheld, subject to a limitation, or deduct the taxes withheld. A U.S. holder will include the dividend income on the day actually or constructively received: (i) by the holder, in the case of ordinary shares, or (ii) by the depositary, in the case of ADSs. To the extent, if any, that the amount of any distribution by us exceeds our current and accumulated earnings and profits, as so determined, the excess with respect to any share (ordinary share or ADS) will be treated first as a tax-free return of the U.S. holder’s tax basis in such ordinary share or ADS and thereafter as capital gain on such share. Notwithstanding the foregoing, we do not intend to determine our earnings and profits on the basis of U.S. federal income tax principles. Consequently, any distributions generally will be reported as dividend income for U.S. information reporting purposes. See “—Backup Withholding Tax and Information Reporting Requirements” below. Dividends paid by us will not be eligible for the dividends-received deduction generally allowed to U.S. corporate shareholders. The U.S. dollar amount of dividends received by an individual, trust or estate with respect to the ordinary shares or ADSs will be subject to taxation at preferential rates if the dividends are “qualified dividends.” Dividends paid on Table of Contents 147
ordinary shares or ADSs will be treated as qualified dividends if (i)(a) we are eligible for the benefits of a comprehensive income tax treaty with the United States that the Secretary of the Treasury of the United States determines is satisfactory for this purpose and includes an exchange of information program or (b) the dividends are with respect to ordinary shares (or ADSs in respect of such shares) which are readily tradable on a U.S. securities market; (ii) certain holding period requirements are met; and (iii) we are not classified as a PFIC for the taxable year in which the dividend is paid or for the preceding taxable year. The Agreement between the Government of the United States of America and the Government of Australia for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, or the Treaty, has been approved for the purposes of the qualified dividend rules, and we expect to qualify for benefits under the Treaty. In addition, our ADSs are listed on the Nasdaq Global Select Market, and as such U.S. Treasury Department guidance indicates that our ADSs will be readily tradable on an established U.S. securities market. Thus, we believe that as long as we are not a PFIC, dividends we pay generally should be eligible for the preferential tax rates on qualified dividends. However, the determination of whether a dividend qualifies for the preferential tax rates must be made at the time the dividend is paid. U.S. holders should consult their own tax advisors regarding the availability of the preferential tax rates on dividends. Includible distributions paid in Australian dollars, including any Australian withholding taxes, will be included in the gross income of a U.S. holder in a U.S. dollar amount calculated by reference to the spot exchange rate in effect on the date of actual or constructive receipt, regardless of whether the Australian dollars are converted into U.S. dollars at that time. If Australian dollars are converted into U.S. dollars on the date of actual or constructive receipt, the tax basis of the U.S. holder in those Australian dollars will be equal to their U.S. dollar value on that date and, as a result, a U.S. holder generally should not be required to recognize any foreign currency exchange gain or loss. If Australian dollars so received are not converted into U.S. dollars on the date of receipt, the U.S. holder will have a basis in the Australian dollars equal to their U.S. dollar value on the date of receipt. Any foreign currency exchange gain or loss on a subsequent conversion or other disposition of the Australian dollars generally will be treated as ordinary income or loss to such U.S. holder and generally will be income or loss from sources within the United States for foreign tax credit limitation purposes. Dividends received by a U.S. holder with respect to ordinary shares (or ADSs in respect of such shares) will be treated as foreign source income, which may be relevant in calculating the holder’s foreign tax credit limitation. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to ADSs or ordinary shares will generally constitute “passive category income” but could, in the case of certain U.S. holders, constitute “general category income.” Subject to certain complex limitations, including the PFIC rules discussed below, a U.S. holder generally will be entitled, at such holder’s option, to claim either a credit against such holder’s U.S. federal income tax liability or a deduction in computing such holder’s U.S. federal taxable income in respect of any Australian taxes withheld. If a U.S. holder elects to claim a deduction, rather than a foreign tax credit, for Australian taxes withheld for a particular taxable year, the election will apply to all foreign taxes paid or accrued by or on behalf of the U.S. holder in the particular taxable year. The availability of the foreign tax credit and the application of the limitations on its availability are fact specific and are subject to complex rules. You are urged to consult your own tax advisor as to the consequences of Australian withholding taxes and the availability of a foreign tax credit or deduction. See “—Australian Tax Considerations Australian —Income Tax—Taxation of Dividends” below. Sale, Exchange or Other Disposition of Ordinary Shares or ADSs Subject to the PFIC rules discussed below, a U.S. holder generally will, for U.S. federal income tax purposes, recognize capital gain or loss, if any, on a sale, exchange or other disposition of ordinary shares or ADSs equal to the difference between the amount realized on the disposition and the U.S. holder’s tax basis (in U.S. dollars) in the ordinary shares or ADSs. This recognized gain or loss will generally be long-term capital gain or loss if the U.S. holder has held the ordinary shares or ADSs for more than one year. Generally, for U.S. holders who are individuals (as well as certain trusts and estates), long-term capital gains are subject to U.S. federal income tax at preferential rates. For foreign tax credit limitation purposes, gain or loss recognized upon a disposition generally will be treated as from sources within the United States. The deductibility of capital losses is subject to limitations for U.S. federal income tax purposes. You should consult your own tax advisor regarding the tax consequences if a foreign tax is imposed on a disposition of ADSs or ordinary shares, including availability of a foreign tax credit or deduction in respect of any Table of Contents 148
Australian tax imposed on a sale or other disposition of ordinary shares or ADSs. See “—Australian Tax Considerations— Australian Income Tax—Tax on Sales or Other Dispositions of Shares—Capital Gains Tax.” Passive Foreign Investment Company As a non-U.S. corporation, we will be a PFIC for any taxable year if either: (i) 75% or more of our gross income for the taxable year is passive income (such as certain dividends, interest, rents or royalties and certain gains from the sale of shares and securities or commodities transactions, including amounts derived by reason of the temporary investment of funds raised in offerings of our ordinary shares or ADSs); or (ii) the average quarterly value of our gross assets during the taxable year that produce passive income or are held for the production of passive income is at least 50% of the value of our total assets. For purposes of the PFIC asset test, passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing debt instruments or bank deposits that are readily convertible into cash. If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC income and asset tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income. We do not believe that we were a PFIC for the taxable year ending June 30, 2024. However, if there is a change in the type or composition of our gross income, or our actual business results do not match our projections, it is possible that we may become a PFIC in future taxable years. Investors should be aware that our gross income for purposes of the PFIC income test depends on the receipt of Australian research and development tax incentive credits and other revenue, and there can be no assurances that such tax incentive credit programs will not be revoked or modified, that we will continue to conduct our operations in the manner necessary to be eligible for such incentives or that we will receive other gross income that is not considered passive for purposes of the PFIC income test. The value of our assets for purposes of the PFIC asset test will generally be determined by reference to our market capitalization, which may fluctuate. The composition of our income and assets will also be affected by how, and how quickly, we spend the cash raised in offerings of our ordinary shares or ADSs. Under circumstances where our gross income from activities that produce passive income significantly increases relative to our gross income from activities that produce non-passive income or where we decide not to deploy significant amounts of cash for active purposes, our risk of becoming classified as a PFIC may substantially increase. Since a separate factual determination as to whether we are or have become a PFIC must be made each year (after the close of such year), we cannot assure you that we will not be or become a PFIC in the current year or any future taxable year. There can be no assurance that we will not be a PFIC for any taxable year, as PFIC status is determined each year and depends on the composition of our income and assets and the value of our assets in such year. If we are a PFIC for any taxable year, upon request, we intend to provide U.S. holders with the information necessary to make and maintain a “Qualified Electing Fund” election, as described below. Default PFIC Rules If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, unless you make the mark-to-market election or the Qualified Electing Fund election described below, you will generally be (and remain) subject to additional taxes and interest charges, regardless of whether we remain a PFIC in any subsequent taxable year, (i) on certain “excess distributions” we may make; and (ii) on any gain realized on the disposition or deemed disposition of your ordinary shares or ADSs. Distributions in respect of your ordinary shares (or ADSs in respect of such shares) during the taxable year will generally constitute “excess” distributions if, in the aggregate, they exceed 125% of the average amount of distributions in respect of your ordinary shares (or ADSs) over the three preceding taxable years or, if shorter, the portion of your holding period before such taxable year. To compute the tax on “excess” distributions or any gain: (i) the “excess” distribution or the gain will be allocated ratably to each day in your holding period for the ADSs or the ordinary shares; (ii) the amount allocated to the current taxable year and any taxable year before we became a PFIC will be taxed as ordinary income in the current year; (iii) the amount allocated to other taxable years will be taxable at the highest applicable marginal rate in effect for that year; and (iv) an interest charge at the rate for underpayment of taxes will be imposed with respect to any portion of the “excess” distribution or gain described under (iii) above that is allocated to such other taxable years. In addition, if we are a PFIC or, with respect to a particular U.S. holder, we are treated as a PFIC for the taxable year in which the distribution was paid or the prior taxable year, no distribution that you receive from us will qualify for taxation at the preferential rate for non- corporate holders discussed in “—Distributions” above. You should consult with your own tax advisor regarding the application of the default PFIC rules based on your particular circumstances. Table of Contents 149
If we are a PFIC for any taxable year during which a U.S. holder holds our ADSs or ordinary shares and any of our non-U.S. subsidiaries is also a PFIC (i.e., a lower-tier PFIC), such U.S. holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC and would be subject to the rules described above on certain distributions by the lower-tier PFIC and our disposition of shares of the lower-tier PFIC, even though such U.S. holder may not receive the proceeds of those distributions or dispositions. You should consult with your own tax advisor regarding the application to you of the PFIC rules to any of our subsidiaries if we are a PFIC. Mark-to-Market Election If we are a PFIC for any taxable year during which you own our ADSs or ordinary shares, you will be able to avoid the rules applicable to “excess” distributions or gains described above if the ordinary shares or ADSs are “marketable” and you make a timely “mark-to-market” election with respect to your ordinary shares or ADSs. The ordinary shares or ADSs will be “marketable” stock as long as they remain regularly traded on a national securities exchange, such as the Nasdaq Global Select Market, or a foreign securities exchange regulated by a governmental authority of the country in which the market is located and which meets certain requirements, including that the rules of the exchange effectively promote active trading of listed stocks. If such stock is traded on such a qualified exchange or other market, such stock generally will be “regularly traded” for any calendar year during which such stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter, but no assurances can be given in this regard. Our ordinary shares are traded on the ASX, which may qualify as an eligible foreign securities exchange for this purpose. If you are eligible to make a “mark-to-market” election with respect to our ordinary shares or ADSs and you make this election in a timely fashion, you will generally recognize as ordinary income or ordinary loss the difference between the fair market value of your ordinary shares or ADSs on the last day of any taxable year and your adjusted tax basis in the ordinary shares or ADSs. Any ordinary income resulting from this election will generally be taxed at ordinary income rates. Any ordinary losses will be deductible only to the extent of the net amount of previously included income as a result of the mark-to-market election, if any. Your adjusted tax basis in the ordinary shares or ADSs will be adjusted to reflect any such income or loss. Any gain recognized on the sale or other disposition of your ordinary shares or ADSs in a year when we are a PFIC will be treated as ordinary income, and any loss will be treated as an ordinary loss (but only to the extent of the net amount previously included as ordinary income as a result of the mark-to-market election). Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. holder may continue to be subject to the PFIC rules with respect to such holder’s indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes, including shares in any of our subsidiaries that are treated as PFICs. You should consult with your own tax advisor regarding the applicability and potential advantages and disadvantages to you of making a “mark-to-market” election with respect to your ordinary shares or ADSs if we are or become a PFIC, including the tax issues raised by lower-tier PFICs that we may own and the procedures for making such an election. QEF Election Alternative rules to those set forth under “Default PFIC Rules” above apply if an election is made to treat us as a “Qualified Electing Fund,” or QEF, under Section 1295 of the Code. A QEF election is available only if a U.S. holder receives an annual information statement from us setting forth such holder’s pro rata share of our ordinary earnings and net capital gains, as calculated for U.S. federal income tax purposes. Upon request from a U.S. holder, we will endeavor to provide to the U.S. holder within 90 days after the request an annual information statement, in order to enable the U.S. holder to make and maintain a QEF election for us or for any of our subsidiaries that is or becomes a PFIC. However, there is no assurance that we will have timely knowledge of our or our subsidiaries’ status as a PFIC in the future or of the required information to be provided. You should consult your own tax advisor regarding the availability and tax consequences of a QEF election with respect to the ordinary shares or ADSs or with respect to any lower-tier PFIC that we may own under your particular circumstances. Reporting If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, as a U.S. holder, you will generally be required to file IRS Form 8621 on an annual basis and other reporting requirements may apply. The PFIC Table of Contents 150
rules are complex and you should consult with your own tax advisor regarding whether we or any of our subsidiaries are a PFIC, the tax consequences of any elections that may be available to you, and how the PFIC rules may affect the U.S. federal income tax consequences of the receipt, ownership, and disposition of our ordinary shares or ADSs. Tax on Net Investment Income Certain non-corporate U.S. holders will be subject to a 3.8% tax on the lesser of (i) the U.S. holder’s “net investment income” for the relevant taxable year; and (ii) the excess of the U.S. holder’s modified adjusted gross income for the taxable year over a certain threshold. A U.S. holder’s net investment income will generally include dividends received on the ordinary shares or ADSs and net gains from the disposition of ordinary shares or ADSs, unless such dividend income or net gains are derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). A U.S. holder that is an individual, estate or trust should consult the holder’s tax advisor regarding the applicability of the tax on net investment income to the holder’s dividend income and gains in respect of the holder’s investment in the ordinary shares or ADSs. Backup Withholding Tax and Information Reporting Requirements U.S. backup withholding tax and information reporting requirements generally apply to payments to non- corporate holders of ordinary shares or ADSs. Information reporting will apply to payments of dividends on, and to proceeds from the disposition of, ordinary shares or ADSs by a paying agent within the United States to a U.S. holder, other than U.S. holders that are exempt from information reporting and properly certify their exemption. A paying agent within the United States will be required to withhold at the applicable statutory rate, currently 24%, in respect of any payments of dividends on, and the proceeds from the disposition of, ordinary shares or ADSs within the United States to a U.S. holder (other than U.S. holders that are exempt from backup withholding and properly certify their exemption) if the holder fails to furnish its correct taxpayer identification number or otherwise fails to comply with applicable backup withholding requirements. U.S. holders who are required to establish their exempt status generally must provide a properly completed IRS Form W-9. Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. holder’s U.S. federal income tax liability. A U.S. holder generally may obtain a refund of any amounts withheld under the backup withholding rules in excess of such holder’s U.S. federal income tax liability by filing the appropriate claim for refund with the IRS in a timely manner and furnishing any required information. Certain U.S. holders may be required to report (on IRS Form 8938) information with respect to such holder’s interest in “specified foreign financial assets” (as defined in Section 6038D of the Code), including stock of a non-U.S. corporation that is not held in an account maintained by a U.S. “financial institution.” Persons who are required to report specified foreign financial assets and fail to do so may be subject to substantial penalties. U.S. holders are urged to consult their own tax advisors regarding foreign financial asset reporting obligations and their possible application to the holding of ordinary shares or ADSs. The discussion above is a general summary only. It is not intended to constitute a complete analysis of all tax considerations applicable to an investment in our ADSs or ordinary shares. You should consult with your own tax advisor concerning the tax consequences to you of an investment in our ADSs or ordinary shares in light of your particular circumstances. Australian Tax Considerations In this section, we discuss the material Australian income tax, stamp duty and goods and services (“GST”) tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs. It is based upon existing Australian tax law as of the date of this annual report, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian tax law which may be important to particular investors in light of their individual investment circumstances, such as shares held by investors subject to special tax rules (for example, financial institutions, insurance companies, tax exempt organizations or employee share scheme participants). In addition, this summary does not discuss any non-Australian tax considerations. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the acquisition, ownership and disposition of the shares. This summary is based upon the premise that the holder is not an Australian tax resident and is not carrying on business in Australia through a permanent establishment (referred to as a “Foreign Shareholder” in this summary). Table of Contents 151
Australian Income Tax Nature of ADSs for Australian Taxation Purposes Ordinary shares represented by ADSs held by a U.S. holder will be treated for Australian income tax purposes as held under a “bare trust” for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for Australian income tax (including capital gains tax (“CGT”)) purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to the ADS holder, as the person beneficially entitled to those dividends. Taxation of Dividends Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent of tax paid on company profits. Fully franked dividends paid to Foreign Shareholders are not subject to dividend withholding tax. Dividends paid to Foreign Shareholders are generally subject to dividend withholding tax, to the extent that the dividends are not foreign (i.e. non-Australian) sourced, are not declared to be “conduit foreign income” (“CFI”), and are unfranked. Dividend withholding tax will be imposed at 30%, unless a Foreign Shareholder is a resident of a country with which Australia has a double taxation agreement ("DTA") and qualifies for the benefits of the DTA. Under the provisions of the current DTA between Australia and the United States (“Australia-U.S. DTA”), the rate of tax Australian tax to be withheld on unfranked dividends paid by Mesoblast Limited (the “Company”) (which are not declared to CFI) to which a resident of the United States is beneficially entitled, is generally limited to 15% if the U.S. resident holds less than 10% of the voting power in the Company. If a Foreign Shareholder that is a company and is a resident of the United States holds 10% or more of the voting power in the Company and is beneficially entitled to dividends from the Company, the rate of Australian dividend withholding tax is limited to 5%. In limited circumstances, the rate of withholding can be reduced to zero. Tax on Sales or Other Dispositions of Shares – CGT A Foreign Shareholder will not be subject to Australian CGT on any gain made on the sale or other disposal of ordinary shares in the Company, unless broadly it, together with associates, holds 10% or more of the issued capital in the Company, at the time of disposal or for 12 months of the last 2 years prior to disposal. A Foreign Shareholder who, together with associates, owns a 10% or more interest would be subject to Australian CGT on the sale of that interest if more than 50% of the Company’s assets by market value (held directly or indirectly and determined by reference to market value), consists of interests in Australian real property, which includes land and leases of land, as well as mining, quarrying or prospecting rights (this is referred to as “taxable Australian property” (“TAP”)). The Australian Government has announced changes to the TAP rules which are expected to take effect from 1 July 2025 and expand the definition, but legislation has not yet been introduced in this regard. Relief from Australian CGT is unlikely to be provided by the Australian-U.S. DTA. Australian CGT applies to net capital gains of Foreign Shareholders at the Australian tax rates for non-Australian residents, which start at a marginal rate of 30% for individuals effective from 1 July 2024 (previously this was 32.5%). Net capital gains are calculated after reduction for capital losses (including carry forward net capital losses provided that the relevant loss utilization tests have been satisfied), noting that capital losses may only be offset against capital gains. The 50% CGT discount is not available to non-Australian residents on gains that accrued after May 8, 2012. Companies, whether Australian resident or not, are not entitled to the CGT discount. Broadly, where there is a disposal of TAP, the purchaser will be required to withhold and remit to the Australian Taxation Office (“ATO”) 12.5% of the proceeds from the sale. A transaction is excluded from the withholding requirements in certain circumstances, including where the value of the TAP is less than A$750,000, the transaction is an on-market transaction conducted on an approved stock exchange, a securities lending arrangement, or the transaction is conducted using a broker operated crossing system. The Foreign Shareholder may be entitled to receive a tax credit for the tax withheld by the purchaser which they may claim in their Australian income tax return. The Government has announced amendments with effect from 1 January 2025 which will increase the withholding rate from 12.5% to 15.0% and remove the current A$750,000 threshold. The amendments will require non-Australian residents disposing of shares and other interests exceeding A$20 million in value to notify the ATO prior to the transaction being executed. Table of Contents 152
Tax on Sales or Other Dispositions of Shares – Shareholders Holding Shares on Revenue Account Some Foreign Shareholders may hold ordinary shares on “revenue” account rather than on capital account – for example, share traders. These shareholders may have the gains made on the sale or other disposal of the ordinary shares included in their assessable income under the ordinary income or trading stock provisions of the income tax law, if the gains are sourced in Australia. Foreign Shareholders assessable under these ordinary income provisions in respect of gains made on ordinary shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 30.0% for individuals effective from 1 July 2024 (previously 32.5%). Relief from Australian income tax may be available to such Foreign Shareholders under the Australia-U.S. DTA. The comments above in “Tax on Sales or Other Dispositions of Shares—Capital Gains Tax” regarding a purchaser being required to withhold 12.5% tax on the acquisition of TAP (increasing to 15% from 1 January 2025) equally applies where the disposal of the Australian real property asset by a foreign resident is likely to generate gains on revenue account, rather than a capital gain. Australian Death Duty Australia does not have estate or death duties. As a general rule, no CGT liability is realized upon the inheritance of a deceased person’s ordinary shares. The disposal of inherited ordinary shares by beneficiaries may, however, give rise to a CGT liability if the gain falls within the scope of Australia’s jurisdiction to tax (as discussed above). Stamp Duty Generally, no Australian stamp duty is payable by Australian residents or non-Australian residents on the issue, agreement to transfer, transfer, surrender of, or other dealing in, the ADSs or the ordinary shares in the Company, provided that at the time of such dealing, all of the issued shares in the Company are quoted on the ASX and the dealing does not result in a person or entity acquiring or commencing to hold or otherwise being beneficially entitled to (on an associate inclusive basis) 90% or more of the total issued shares in the Company. GST The supply of ADSs and/or ordinary shares in the Company will not be subject to Australian GST. Similarly, any distributions or dividends will not be subject to Australian GST. 10.F Dividends and Paying Agents Not applicable. 10.G Statement by Experts Not applicable. 10.H Documents on Display Any statement in this Form 20-F about any of our contracts or other documents is not necessarily complete. If the contract or document is filed as an exhibit to the Form 20-F the contract or document is deemed to modify the description contained in this Form 20-F. You must review the exhibits themselves for a complete description of the contract or document. In addition, the SEC maintains a website at http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the SEC. These SEC filings are also available to the public from commercial document retrieval services. We are required to file or furnish reports and other information with the SEC under the Securities Exchange Act of 1934 and regulations under that act. As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the form and content of proxy statements and our officers, directors and principal shareholders are exempt from the reporting and short swing profit recovery provisions contained in Section 16 of the Exchange Act. Table of Contents 153
10.I Subsidiary Information For information about our subsidiaries, see “Item 18. Financial Statements – Note 12.” 10.J Annual Report to Security Holders Not applicable. Item 11. Quantitative and Qualitative Disclosures about Market Risk For information about our exposure to market risk and how we manage this risk, see “Item 18. Financial Statements – Note 10.” Item 12. Description of Securities Other than Equity Securities 12.A Debt Securities Not applicable. 12.B Warrants and Rights Not applicable. 12.C Other Securities Not applicable. 12.D American Depositary Shares Fees Payable by ADR Holders Holders of our ADRs may have to pay our ADS depositary, JPMorgan Chase Bank N.A. (JPMorgan), fees or charges up to the amounts described in the following table: Persons depositing or withdrawing ordinary shares or ADS holders must pay: Description of service $5.00 (or less) per 100 ADSs (or portion of 100 ADSs) • Issuance of ADSs, including issuances pursuant to a deposits of shares, share or rights distributions, stock dividend, stock split, merger or any other transactions affecting the issuance of ADSs • Cancellation of ADSs for the purpose of withdrawal of deposited securities $0.05 (or less) per ADS • Cash distribution to ADS holders $0.005 per ADS per calendar year • Administrative services performed by the depositary Fees Payable by the Depositary to the Issuer From time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions. Table of Contents 154
PART II Item 13. Defaults, Dividend Arrearages and Delinquencies Not applicable. Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds Not applicable. Item 15. Controls and Procedures Evaluation of Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and our interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2024. “Disclosure controls and procedures,” as defined in Rules 13a-15(e) under the Exchange Act, are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (ii) accumulated and communicated to the company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and interim Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2024. Management’s Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal control over financial reporting as of June 30, 2024 based on the criteria set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that assessment, our management has concluded that its internal control over financial reporting was effective as of June 30, 2024. Changes in Internal Control over Financial Reporting There were no changes to our internal control over financial reporting that occurred during the period covered by this Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Limitations on Internal Control Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Item 16. [Reserved] Item 16A. Audit Committee Financial Expert The Board of Directors of Mesoblast Ltd has determined that the following directors each possess specific accounting and financial management expertise and that each is an Audit Committee Financial Expert as defined by the SEC. • Philip Facchina (Audit and Risk Committee Chair, from May 1, 2024); Table of Contents 155
• Jane Bell (Audit and Risk Committee Chair, from September 20, 2023 to April 30, 2024) and; • Michael Spooner (Audit and Risk Committee Chair until September 20, 2023, resigned from the Board effective September 26, 2023) The Board of Directors has also determined that Joseph Swedish, member of the Audit and Risk Committee, has sufficient experience and ability in finance and compliance matters to enable them to adequately discharge their responsibilities. All members of the Audit and Risk Committee are “independent” according to the listing standards of the Nasdaq Global Select Market. Item 16B. Code of Ethics Our Code of Business Conduct and Ethics covers conflicts of interest, confidentiality, fair dealing, protection of assets, compliance with laws and regulations, whistle blowing, security trading and commitments to stakeholders. In summary, the Code requires that at all times all Company personnel act with the utmost integrity, objectivity and in compliance with the letter and the spirit of the law and Company policies. This document is accessible on our internet website at: http://www.mesoblast.com/company/corporate-governance/code-of-conduct-and-values. Item 16C. Principal Accountant Fees and Services Pre-Approval of Audit and Non-Audit Services The Audit and Risk Committee’s pre-approval is required for all services provided by PwC. These services may include audit services, audit-related services, tax services and permissible non-audit services, and are subject to a specific budget. The Audit and Risk Committee uses a combination of two approaches – general pre-approval and specific pre- approval – in considering whether particular services or categories of services are consistent with the SEC’s rules on auditor independence. Under general pre-approval proposed services may be pre-approved without consideration of specific case-by-case services. Audit and Non-Audit Services Fees See “Item 18. Financial Statements – Note 18”. For the purpose of SEC classification, there were no audit-related, tax or other fees that were paid or payable to PwC that were not pre-approved by the Audit and Risk Committee during the years ended June 30, 2024 and 2023. Item 16D. Exemptions from the Listing Standards for Audit Committees Not applicable. Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers Not applicable. Item 16F. Change in Registrant’s Certifying Accountant Not applicable. Item 16G. Corporate Governance Under Nasdaq Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home country corporate governance practices instead of certain provisions of the Nasdaq Stock Market Rules. For example, we may follow home country practice with regard to certain corporate governance requirements, such as the composition of the board of directors and quorum requirements applicable to shareholders’ meetings. In addition, we may follow home country practice instead of the Nasdaq Stock Market Rules requirement to hold executive sessions and to obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions or private placements of securities. Further, we may follow home country practice instead of the Nasdaq Stock Market Rules requirement to obtain shareholder approval prior to the establishment or amendment of certain share option, purchase or other compensation plans. A foreign private issuer that elects to follow a home country practice instead of any Nasdaq rule must Table of Contents 156
submit to Nasdaq, in advance, a written statement from an independent counsel in such issuer’s home country certifying that the issuer’s practices are not prohibited by the home country’s laws. We submitted such a written statement to Nasdaq. Other than as set forth below, we currently intend to comply with the corporate governance listing standards in the Nasdaq Stock Market Rules to the extent possible under Australian law. However, we may choose to change such practices to follow home country practice in the future. The Nasdaq Stock Market Rules require that a listed company specify that the quorum for any meeting of the holders of share capital be at least 33 1/3% of the outstanding shares of the company’s common voting stock. We follow our home country practice, rather than complying with this rule. Consistent with Australian law, our constitution does not require a quorum of at least 33 1/3% of the issued voting shares of Mesoblast for any general meeting of its shareholders. Our constitution provides that a quorum for a general meeting of our shareholders constitutes two shareholders present in person, by proxy, by attorney, or, where the shareholders is a body corporate, by representative. This provision and our practice of holding meetings with this quorum are not prohibited by the ASX Listing Rules or any other Australian law. In addition, we may follow home country practice instead of Nasdaq Rule 5635(d), which requires a company to obtain shareholder approval for an issuance of securities (other than a public offering) that equals of 20% or more of the outstanding voting power in the company before such issuance. This Nasdaq rule is inconsistent with an ASX Listing Rule that provides a company cannot issue a number of securities over any rolling 12-month period exceeding 15% of the outstanding capital of the company without approval of shareholders but subject to certain exceptions such as pro-rata offers of securities to all shareholders. Item 16H. Mine Safety Disclosure Not applicable. Item 16I. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections Not applicable. Item 16J. Insider Trading Policies We have a Share Trading Policy (“Policy”) which sets out the policy and procedures governing the purchase, sale and other dispositions of the Company’s securities and applies to directors, officers, employees, contractors and consultants of the Company and its subsidiaries ("Mesoblast Personnel"). The Policy aims to (i) restrict Mesoblast Personnel in possession of "inside information" from trading in our securities and (ii) ensure compliance with all applicable securities laws, rules and regulations, and listing standards. We have filed the Policy as an exhibit to this Annual Report on Form 20-F. Item 16K. Cybersecurity The Company’s cybersecurity strategy is designed to provide a comprehensive approach to securing cybersecurity risks across our technology stack, governance framework, and human elements for our operations globally. Cybersecurity risk management is a critical component of our broader risk management strategy. Our cybersecurity program is built on industry best practices and is designed to proactively identify, assess, and mitigate cybersecurity risks, including threats associated with the use of all third-party service providers. Our cybersecurity risk assessment framework categorizes risks based on their potential impact and severity, and the Company implements targeted risk treatment plans to ensure robust protection and resilience. The interim Chief Financial Officer and Head of Regulatory Affairs & Quality Management are the members of our executive management team who oversee the prevention, detection, mitigation, and remediation of cybersecurity incidents. Both these executives have extensive experience in risk management and compliance generally, and have been overseeing cybersecurity and IT management at the Company for over three years. They are supported by the Company’s IT systems administrator and an external managed IT and cybersecurity service provider. The service provider has been engaged by the Company for over ten years, to provide strategic IT advice and manage the Company's IT systems and infrastructure. The service provider, who has over 20 years of experience in securing IT in health and life sciences organizations, manages Table of Contents 157
cybersecurity risks through a number of measures including the development and implementation of cybersecurity policies and procedures, training and penetration testing and systems monitoring. Our executive management team members regularly collaborate and receive reports from our managed IT and cybersecurity service provider, enabling ongoing assessment and monitoring of the Company’s cyber risk profile and initiatives. Our Board of Directors entrusts its Audit & Risk Committee with overseeing Mesoblast’s cybersecurity risk management, including ensuring that management has established processes to evaluate and manage cybersecurity risks. Our executive management team members together with our managed IT and cybersecurity service provider update the Audit and Risk Committee on the Company’s cybersecurity initiatives, significant risks and mitigation work being undertaken. In the fiscal year 2024, we did not identify any cybersecurity threats that have materially impacted or are likely to materially impact our business strategy, operational results, or financial condition. However, despite our proactive measures, we cannot entirely eliminate cybersecurity risks or guarantee that no undetected incidents have occurred. PART III Item 17. Financial Statements See “Item 18. Financial Statements”. Item 18. Financial Statements The following financial statements are filed as part of this Annual Report on Form 20-F. Australian Disclosure Requirements All press releases, financial reports and other information are available on our website: www.mesoblast.com. Table of Contents 158
Index to Financial Statements Report Of Independent Registered Public Accounting Firm (PricewaterhouseCoopers, Melbourne, Australia, Auditor Firm ID: 1379) 160 Consolidated Income Statement 164 Consolidated Statement of Comprehensive Income 165 Consolidated Statement of Changes in Equity 166 Consolidated Balance Sheet 167 Consolidated Statement of Cash Flows 168 Notes to Consolidated Financial Statements 169 Table of Contents 159
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PricewaterhouseCoopers, ABN 52 780 433 757 2 Riverside Quay, SOUTHBANK VIC 3006, GPO Box 1331, MELBOURNE VIC 3001 T: 61 3 8603 1000, F: 61 3 8603 1999, www.pwc.com.au Liability limited by a scheme approved under Professional Standards Legislation. Auditor’s Independence Declaration As lead auditor for the audit of Mesoblast Limited for the year ended 30 June 2024, I declare that to the best of my knowledge and belief, there have been: (a) no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and (b) no contraventions of any applicable code of professional conduct in relation to the audit. This declaration is in respect of Mesoblast Limited and the entities it controlled during the period. Jon Roberts Melbourne Partner PricewaterhouseCoopers 29 August 2024 161
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Mesoblast Limited Consolidated Income Statement Year Ended June 30, (in U.S. dollars, in thousands, except per share amount) Note 2024 2023 2022 Revenue 3 5,902 7,501 10,211 Research & development (25,353) (27,189) (32,815) Manufacturing commercialization (15,717) (27,733) (30,757) Management and administration (23,626) (25,374) (27,210) Fair value remeasurement of contingent consideration 3 (9,693) 8,771 913 Fair value remeasurement of warrant liability 3 779 (2,205) 5,896 Other operating income and expenses 3 2,570 4,250 (536) Finance costs 3 (23,009) (20,122) (17,288) Loss before income tax 3 (88,147) (82,101) (91,586) Income tax benefit/(expense) 4 191 212 239 Loss attributable to the owners of Mesoblast Limited (87,956) (81,889) (91,347) Losses per share from continuing operations attributable to the ordinary equity holders of the Group: Cents Cents Cents Basic - losses per share 19 (8.91) (10.53) (13.38) Diluted - losses per share 19 (8.91) (10.53) (13.38) The above consolidated income statement should be read in conjunction with the accompanying Notes. Table of Contents 164
Mesoblast Limited Consolidated Statement of Comprehensive Income Year Ended June 30, (in U.S. dollars, in thousands) Note 2024 2023 2022 Loss for the period (87,956) (81,889) (91,347) Other comprehensive (loss)/income Items that may be reclassified to profit and loss Exchange differences on translation of foreign operations 7(b) 51 (573) 91 Items that will not be reclassified to profit and loss Financial assets at fair value through other comprehensive income 7(b) (743) (1) (322) Other comprehensive (loss)/income for the period, net of tax (692) (574) (231) Total comprehensive losses attributable to the owners of Mesoblast Limited (88,648) (82,463) (91,578) The above consolidated statement of comprehensive income should be read in conjunction with the accompanying Notes. Table of Contents 165
Mesoblast Limited Consolidated Statement of Changes in Equity (in U.S. dollars, in thousands) Note Issued Capital Share Option Reserve Investment Revaluation Reserve Foreign Currency Translation Reserve Warrant Reserve Retained Earnings/ (accumulated losses) Total Balance as of July 1, 2021 1,163,153 92,855 (220) (39,791) 12,969 (647,569) 581,397 Loss for the period — — — — — (91,347) (91,347) Other comprehensive income/(loss) — — (322) 91 — — (231) Total comprehensive income/(loss) for the period — — (322) 91 — (91,347) (91,578) Transactions with owners in their capacity as owners: Contributions of equity net of transaction costs 1,928 — — — — — 1,928 1,928 — — — — — 1,928 Tax credited / (debited) to equity — (239) — — — — (239) Transfer of exercised options 228 (228) — — — — — Fair value of share-based payments 17 — 5,536 — — — — 5,536 228 5,069 — — — — 5,297 Balance as of June 30, 2022 7(a) 1,165,309 97,924 (542) (39,700) 12,969 (738,916) 497,044 Balance as of July 1, 2022 1,165,309 97,924 (542) (39,700) 12,969 (738,916) 497,044 Loss for the period — — — — — (81,889) (81,889) Other comprehensive (loss)/income — — (1) (573) — — (574) Total comprehensive (loss)/income for the period — — (1) (573) — (81,889) (82,463) Transactions with owners in their capacity as owners: Contributions of equity net of transaction costs 83,814 — — — — — 83,814 83,814 — — — — — 83,814 Tax credited / (debited) to equity — (212) — — — — (212) Fair value of share-based payments 17 — 3,655 — — — — 3,655 — 3,443 — — — — 3,443 Balance as of June 30, 2023 7(a) 1,249,123 101,367 (543) (40,273) 12,969 (820,805) 501,838 Balance as of July 1, 2023 1,249,123 101,367 (543) (40,273) 12,969 (820,805) 501,838 Loss for the period — — — — — (87,956) (87,956) Other comprehensive (loss)/income — — (743) 51 — — (692) Total comprehensive (loss)/income for the period — — (743) 51 — (87,956) (88,648) Transactions with owners in their capacity as owners: Contributions of equity net of transaction costs 60,486 — — — — — 60,486 Contributions of equity for unissued ordinary shares, net of transaction costs 1,000 — — — — — 1,000 61,486 — — — — — 61,486 Tax credited / (debited) to equity — (191) — — — — (191) Transfer of exercised options 204 (204) — — — — — Fair value of share-based payments 17 — 5,870 — — — — 5,870 204 5,475 — — — — 5,679 Balance as of June 30, 2024 7(a) 1,310,813 106,842 (1,286) (40,222) 12,969 (908,761) 480,355 The above consolidated statement of changes in equity should be read in conjunction with the accompanying Notes. Table of Contents 166
Mesoblast Limited Consolidated Balance Sheet As of June 30, (in U.S. dollars, in thousands) Note 2024 2023 Assets Current Assets Cash & cash equivalents 5(a) 62,960 71,318 Trade & other receivables 5(b) 20,952 6,998 Prepayments 5(b) 2,551 3,342 Total Current Assets 86,463 81,658 Non-Current Assets Property, plant and equipment 6(a) 1,106 1,357 Right-of-use assets 6(b) 2,732 5,134 Financial assets at fair value through other comprehensive income 5(c) 1,014 1,757 Other non-current assets 5(d) 2,102 2,326 Intangible assets 6(c) 575,736 577,183 Total Non-Current Assets 582,690 587,757 Total Assets 669,153 669,415 Liabilities Current Liabilities Trade and other payables 5(e) 7,070 20,145 Provisions 6(d) 45,038 6,399 Borrowings 5(f) 13,862 5,952 Lease liabilities 6(b) 2,626 4,060 Warrant liability 5(f) 4,647 5,426 Total Current Liabilities 73,243 41,982 Non-Current Liabilities Provisions 6(d) 10,620 16,612 Borrowings 5(f) 100,483 102,811 Lease liabilities 6(b) 1,952 3,672 Deferred consideration 6(f) 2,500 2,500 Total Non-Current Liabilities 115,555 125,595 Total Liabilities 188,798 167,577 Net Assets 480,355 501,838 Equity Issued Capital 7(a) 1,310,813 1,249,123 Reserves 7(b) 78,303 73,520 Accumulated losses (908,761) (820,805) Total Equity 480,355 501,838 The above consolidated balance sheet should be read in conjunction with the accompanying Notes. Table of Contents 167
Mesoblast Limited Consolidated Statement of Cash Flows Year Ended June 30, (in U.S. dollars, in thousands) Note 2024 2023 2022 Cash flows from operating activities Commercialization revenue received 6,776 7,480 9,980 Government grants and tax incentives and credits received 3,819 1,118 24 Payments to suppliers and employees (inclusive of goods and services tax) (60,835) (72,683) (75,769) Interest received 1,778 796 7 Income taxes received /(paid) 4 20 (24) Net cash (outflows) in operating activities 8(b) (48,458) (63,269) (65,782) Cash flows from investing activities Investment in fixed assets (271) (264) (157) Receipts from investment in sublease 234 120 — Payments for licenses (60) (50) (75) Net cash (outflows) in investing activities (97) (194) (232) Cash flows from financing activities Proceeds from borrowings — — 51,919 Repayment of borrowings (10,000) — (55,458) Payment of transaction costs from borrowings (1,559) (574) (5,527) Interest and other costs of finance paid (5,717) (6,014) (6,084) Proceeds from issue of shares 65,406 88,635 209 Proceeds from issue of warrants — — 8,081 Payments for share issue costs (4,356) (4,889) (222) Payments for lease liabilities (3,522) (2,656) (2,788) Net cash inflows/(outflows) by financing activities 40,252 74,502 (9,870) Net increase/(decrease) in cash and cash equivalents (8,303) 11,039 (75,884) Cash and cash equivalents at beginning of period 71,318 60,447 136,881 FX (loss)/gain on the translation of foreign bank accounts (55) (168) (550) Cash and cash equivalents at end of period 8(a) 62,960 71,318 60,447 The above consolidated statement of cash flows should be read in conjunction with the accompanying Notes. Table of Contents 168
Mesoblast Limited Notes to Consolidated Financial Statements Mesoblast Limited (“the Company”) and its subsidiaries (“the Group”) are primarily engaged in the development of regenerative medicine products. The Group’s primary proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage cells. The Company was formed in 2004 as an Australian company and has been listed on the Australian Securities Exchange (the “ASX”) since 2004. In November 2015, the Company listed in the United States of America (“U.S.”) on the Nasdaq Global Select Market (“Nasdaq”) and from this date has been dual- listed in Australia and the U.S. These financial statements and notes are presented in U.S. dollars (“$” or “USD” or “US$”), unless otherwise noted, including certain amounts that are presented in Australian dollars (“AUD” or “A$”) and Singapore dollars (“SGD” or “S$”). 1. Basis of preparation The general purpose financial statements of Mesoblast Limited and its subsidiaries have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board and Australian equivalent International Financial Reporting Standards, as issued by the Australian Accounting Standards Board. Mesoblast Limited is a for-profit entity for the purpose of preparing the financial statements. The financial statements cover Mesoblast Limited and its subsidiaries. The financial statements were authorized for issue by the board of directors on August 29, 2024. The directors have the power to amend and reissue the financial statements. (i) Going concern As of June 30, 2024, the Group held total cash reserves of $63.0 million. During the year ended June 30, 2024, the Group executed on reprioritization of projects and operational streamlining activities and as a result has reduced net cash usage for operating activities, which was $48.5 million for the year ended June 30, 2024, a reduction of 23% compared to the prior period. As the Group prepares for a potential first product approval by the United States Food and Drug Administration ("FDA"), and in line with its commercial launch plans, additional inflows from capital markets, strategic partnerships, product specific financing or royalty monetization will be required to meet the Group's projected expenditure consistent with the Group's business strategy over at least the next 12 months. As a result of these matters, there is material uncertainty related to events or conditions that may cast significant doubt (or raise substantial doubt as contemplated by Public Company Accounting Oversight Board (“PCAOB”) standards) on the Group’s ability to continue as a going concern and, therefore, that the Group may be unable to realize its assets and discharge its liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. (ii) Historical cost convention These financial statements have been prepared under the historical cost convention, as modified by the revaluation of financial assets at fair value through other comprehensive income and financial assets and liabilities (including derivative instruments) at fair value through profit or loss and investment property. (iii) New and amended standards adopted by the Group There were no new or amended standards adopted by the Group in the year ended June 30, 2024 that materially impacted the Group. These financial statements follow the same accounting policies as compared to the June 30, 2023 consolidated financial statements and related notes as filed with the Australian Securities Exchange and the Securities and Exchange Commission. (iv) New accounting standards and interpretations not yet adopted by the Group In April 2024, IFRS 18, “Presentation and Disclosure in Financial Statements” was issued to achieve comparability of the financial performance of similar entities. The standard, which replaces IAS 1 “Presentation of Table of Contents 169
Financial Statements”, impacts the presentation of primary financial statements and notes, including the statement of earnings where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management- defined performance measures to be explained and included in a separate note within the consolidated financial statements. The standard is effective for annual reporting periods beginning on or after January 1, 2027, including interim financial statements, and requires retrospective application. The Group is currently assessing the impact of the new standard. There were no other new accounting standards and interpretations not yet adopted by the Group for the June 30, 2024 reporting period that are expected to materially impact the Group. (v) Use of estimates The preparation of these consolidated financial statements requires the Group to make estimates and judgments that affect the reported amounts of assets, liabilities, income and expenses and related disclosures. On an ongoing basis, the Group evaluates its significant accounting policies and estimates. Estimates are based on historical experience and on various market-specific and other relevant assumptions that the Group believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. (vi) Impact of after effects of COVID-19, geopolitical or economic instability and climate events Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the after effects of the COVID-19 pandemic, geopolitical and/or economic instability or the impact of climate events could have on the Group’s significant accounting estimates. The Group does not expect these areas to have a material impact on the Group's significant accounting estimates. 2. Significant changes in the current reporting period (i) Significant events The financial position and performance of the Group was affected by the following events during the year ended June 30, 2024: • In August 2023, the FDA provided a complete response letter ("CRL") to the Group's Biologics License Application ("BLA") resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease ("SR-aGVHD") and required more data to support marketing approval, including potency assay or clinical data. In March 2024, the FDA informed the Group that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for the treatment of pediatric patients with SR-aGVHD. In July 2024, as discussed in Note 15, the Group resubmitted its BLA for approval of remestemcel-L for the treatment of pediatric patients with SR-aGVHD, addressing remaining items in the August 2023 CRL. In July 2024, the FDA accepted the Group's BLA resubmission and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 7, 2025. Assumptions associated with SR-aGVHD are included within the impairment assessment of Osiris mesenchymal stem cell ("MSC") products within in-process research and development, contingent consideration, pre-launch inventory and the NovaQuest borrowings on the consolidated balance sheet and forecast net operating cash usage. The outcome from the FDA decision on the Group's BLA resubmission could lead to a change in the assumptions used within these areas. • In March 2024, the Group completed a pro-rata accelerated non-renounceable entitlement offer together with an institutional placement of new fully paid ordinary shares in Mesoblast Limited to existing eligible shareholders that was launched in December 2023, raising A$97.0 million at an issue price of A$0.30 per share. Proceeds of $39.7 million (A$60.3 million) and $24.7 million (A$36.7 million) were received and recognized in cash and cash equivalents in December 2023 and March 2024, respectively. Table of Contents 170
3. Loss before income tax Revenue Commercialization revenue 5,902 7,501 9,039 Milestone revenue — — 1,172 Total Revenue 5,902 7,501 10,211 Clinical trial and research & development (3,963) (8,771) (10,483) Manufacturing production & development (13,252) (25,468) (28,884) Employee benefits Salaries and employee benefits (20,415) (17,197) (18,997) Defined contribution superannuation expenses (369) (384) (402) Equity settled share-based payment transactions(1) (5,870) (3,655) (5,536) Total Employee benefits (26,654) (21,236) (24,935) Depreciation and amortization of non-current assets Plant and equipment depreciation (410) (953) (1,144) Right of use asset depreciation (2,771) (1,661) (1,717) Intellectual property amortization (1,485) (1,493) (1,519) Total Depreciation and amortization of non-current assets (4,666) (4,107) (4,380) Other Management & administration expenses Overheads & administration (8,584) (10,104) (10,157) Consultancy (2,458) (3,922) (3,751) Legal, patent and other professional fees (2,342) (3,695) (5,571) Intellectual property expenses (excluding the amount amortized above) (2,777) (2,993) (2,621) Total Other Management & administration expenses (16,161) (20,714) (22,100) Fair value remeasurement of contingent consideration Remeasurement of contingent consideration 5(g)(iii) (9,693) 8,771 913 Total Fair value remeasurement of contingent consideration (9,693) 8,771 913 Fair value remeasurement of warrant liability Remeasurement of warrant liability 5(g)(vi) 779 (2,205) 5,896 Total Fair value remeasurement of warrant liability 779 (2,205) 5,896 Other operating income and expenses Research and development tax incentive income(2) 859 3,506 — Interest income 1,824 831 3 Foreign exchange (losses)/gains (76) (163) (536) Derecognition of right-of-use asset — 76 — Foreign withholding tax paid (37) — (3) Total Other operating income and expenses 2,570 4,250 (536) Year Ended June 30, (in U.S. dollars, in thousands) Note 2024 2023 2022 Table of Contents 171
Finance (costs)/gains Remeasurement of borrowing arrangements (2,351) (678) (382) Interest expense (20,658) (19,444) (16,906) Total Finance costs (23,009) (20,122) (17,288) Total loss before income tax (88,147) (82,101) (91,586) Year Ended June 30, (in U.S. dollars, in thousands) Note 2024 2023 2022 (1) Share-based payment transactions For the years ended June 30, 2024, 2023 and 2022, share-based payment transactions have been reflected in the Consolidated Statement of Comprehensive Income functional expense categories as follows: Year Ended June 30, (in U.S. dollars) 2024 2023 2022 Research and development 2,797,830 1,669,514 3,547,182 Manufacturing and commercialization 176,907 (1,136) 378,096 Management and administration 2,895,431 1,986,968 1,610,567 Equity settled share-based payment transactions 5,870,168 3,655,346 5,535,845 (2) Research and development tax incentive The Group's research and development activities are eligible under the Australian government's Innovation Australia Research and Development Tax Incentive program for research and development activities conducted in relation to qualifying research that meets the regulatory criteria. Management has assessed these activities and expenditures to determine which costs are likely to be eligible under the incentive scheme. The Group assesses, on an annual basis, the quantum of previous research and development tax claims and on-going eligibility to claim this tax incentive in Australia. The Group recorded $0.9 million, $3.5 million and $nil in research and development tax incentive income for the years ended June 30, 2024, 2023 and 2022, respectively. Within the $3.5 million recognized in the year ended June 30, 2023, $1.2 million pertained to the year ended June 30, 2023, $1.1 million pertained to the year ended June 30, 2022 and $1.2 million pertained to the year ended June 30, 2021. Management concluded it's assessment of qualifying activities during the year ended June 30, 2023 and recognized the relevant income for the years ended June 30, 2023, 2022 and 2021. No income was recognized in the years ended June 30, 2022 and 2021 as management were yet to confirm if the Group's research and development activities were eligible under the incentive scheme. Table of Contents 172
4. Income tax benefit/(expense) Year Ended June 30, (in U.S. dollars, in thousands) 2024 2023 2022 (a) Reconciliation of income tax to prima facie tax payable Loss from continuing operations before income tax (88,147) (82,101) (91,586) Tax benefit at the Australian tax rate of 30% (2023: 30%, 2022: 30%) (26,444) (24,630) (27,476) Tax effect of amounts which are not deductible/(exempt) in calculating taxable income: Share-based payments expense 1,752 1,089 1,588 Research and development tax concessions 324 (730) (869) Foreign exchange translation (losses)/gains (103) 501 159 Contingent consideration 2,908 (2,631) (274) Other sundry items (231) 695 (2,036) Subtotal (21,794) (25,706) (28,908) Adjustments for current tax of prior periods 198 274 (923) Differences in overseas tax rates 6,051 8,537 8,407 Tax benefit not recognized 15,354 16,683 21,185 Change in tax rate on Deferred tax assets(1) — — (8,326) Change in tax rate on Deferred tax liability(1) — — 8,326 Income tax benefit attributable to loss before income tax (191) (212) (239) (1) On June 30, 2022, there was a change in the expected tax rate applicable on future taxable profits in Singapore. The Group was expecting to benefit from concessionary tax rates (tax holiday) in Singapore under the tax incentives granted to the Group by the Singapore Economic Development Board, however at June 30, 2022 the Group had not met the conditions under the agreement to access the concessionary tax rates and therefore have recognized a change in the expected tax rate in Singapore to reflect the statutory tax rate of 17%. The Group is in current discussions with the Singapore Economic Development Board to amend the conditions of the incentive agreement and access these concessionary tax rates in the future. Year Ended June 30, (in U.S. dollars, in thousands) 2024 2023 2022 (b) Income tax (benefit)/expense Current tax Current tax — — — Total current tax (benefit)/expense — — — Deferred tax (Increase)/decrease in deferred tax assets 56 38 (8,317) (Decrease)/increase in deferred tax liabilities (247) (250) 8,078 Total deferred tax (benefit)/expense (191) (212) (239) Income tax (benefit)/expense (191) (212) (239) Deferred tax assets have been brought to account only to the extent that it is foreseeable that they are recoverable against future tax liabilities. Deferred tax assets are recognized for unused tax losses to the extent that it is probable that future taxable profit will be available against which the unused tax losses can be utilized. Deferred tax assets are offset against taxable temporary differences (deferred tax liabilities) when the deferred tax balances relate to the same tax jurisdiction in accordance with our accounting policy. Table of Contents 173
Deferred taxes are measured at the rate in which they are expected to settle within the respective jurisdictions, which can change based on factors such as new legislation or timing of utilization and reversal of associated assets and liabilities. Year Ended June 30, (in U.S. dollars, in thousands) 2024 2023 2022 (c) Amounts that would be recognized directly in equity if brought to account Aggregate current and deferred tax arising in the reporting period and not recognized in net loss or other comprehensive income but which would have been directly applied to equity had it been brought to account: Current tax recorded in equity (if brought to account) (1,329) (1,716) (142) Deferred tax recorded in equity (if brought to account) 1,029 839 715 (300) (877) 573 Year Ended June 30, (in U.S. dollars, in thousands) 2024 2023 2022 (d) Amounts recognized directly in equity Aggregate current and deferred tax arising in the reporting period and not recognized in net loss or other comprehensive income but debited/credited to equity Current tax recorded in equity — — — Deferred tax recorded in equity 191 212 239 191 212 239 Year Ended June 30, (in U.S. dollars, in thousands) 2024 2023 2022 (e) Deferred tax assets not brought to account Unused tax losses Potential tax benefit at local tax rates 140,129 125,728 111,283 Other temporary differences Potential tax benefit at local tax rates 14,204 12,318 11,046 Other tax credits Potential tax benefit at local tax rates 3,220 3,220 3,220 157,553 141,266 125,549 The Group has not brought to account $620.6 million (2023: $553.0 million, 2022: $477.8 million) of gross tax losses, which includes the benefit arising from tax losses in overseas countries. As of June 30, 2024 $620.6 million of tax losses not brought to account have an indefinite life. Gross tax losses of $44.5 million recognized as deferred tax asset expire within a range of 9 to 14 years. The benefits of unused tax losses will only be brought to account when it is probable that they will be realized. This benefit of tax losses will only be obtained if: • the Group derives future assessable income of a nature and an amount sufficient to enable the benefit from the deductions for the losses to be realized; • the Group continues to comply with the conditions for deductibility imposed by tax legislation; and • no changes in tax legislation adversely affect the Group in realizing the benefit from the deductions for the losses. Table of Contents 174
5. Financial assets and liabilities This note provides information about the Group's financial instruments, including: • an overview of all financial instruments held by the Group; • specific information about each type of financial instrument; • accounting policies; and • information used to determine the fair value of the instruments, including judgments and estimation uncertainty involved. The Group holds the following financial instruments: Financial assets (in U.S. dollars, in thousands) Notes Assets at FVOCI(1) Assets at FVTPL(2) Assets at amortized cost Total As of June 30, 2024 Cash & cash equivalents 5(a) — — 62,960 62,960 Trade & other receivables 5(b) — — 20,952 20,952 Financial assets at fair value through other comprehensive income 5(c) 1,014 — — 1,014 Other non-current assets 5(d) — — 2,102 2,102 1,014 — 86,014 87,028 As of June 30, 2023 Cash & cash equivalents 5(a) — — 71,318 71,318 Trade & other receivables 5(b) — — 6,998 6,998 Financial assets at fair value through other comprehensive income 5(c) 1,757 — — 1,757 Other non-current assets 5(d) — — 2,326 2,326 1,757 — 80,642 82,399 (1) Fair value through other comprehensive income (2) Fair value through profit or loss Financial liabilities (in U.S. dollars, in thousands) Notes Liabilities at FVOCI(1) Liabilities at FVTPL(2) Liabilities at amortized cost Total As of June 30, 2024 Trade and other payables 5(e) — — 7,070 7,070 Borrowings 5(f) — — 114,345 114,345 Contingent consideration 5(g)(iii) — 26,892 — 26,892 Warrant liability 5(g)(vi) — 4,647 — 4,647 — 31,539 121,415 152,954 As of June 30, 2023 Trade and other payables 5(e) — — 20,145 20,145 Borrowings 5(f) — — 108,763 108,763 Contingent consideration 5(g)(iii) — 17,199 — 17,199 Warrant liability 5(g)(vi) — 5,426 — 5,426 — 22,625 128,908 151,533 (1) Fair value through other comprehensive income (2) Fair value through profit or loss Table of Contents 175
The Group’s exposure to various risks associated with the financial instruments is discussed in Note 10. The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of financial assets mentioned above. a. Cash and cash equivalents As of June 30, (in U.S. dollars, in thousands) 2024 2023 Cash at bank 62,563 70,920 Deposits at call(1) 397 398 62,960 71,318 (1) As of June 30, 2024 and June 30, 2023, interest-bearing deposits at call include amounts of $0.4 million and $0.4 million, respectively, held as security and restricted for use. (i) Classification as cash equivalents Term deposits are presented as cash equivalents if they have a maturity of three months or less from the date of acquisition. b. Trade and other receivables and prepayments (i) Trade and other receivables As of June 30, (in U.S. dollars, in thousands) Note 2024 2023 Trade receivables 1,403 2,276 Tax incentives recoverable 854 2,363 Foreign withholding tax recoverable 471 471 U.S. Tax credits — 1,473 Net investment in sublease 224 195 Interest receivables 23 18 Other recoverable taxes (Goods and services tax and value-added tax) 423 202 Insurance Asset 22 17,554 — Trade and other receivables 20,952 6,998 (ii) Prepayments As of June 30, (in U.S. dollars, in thousands) 2024 2023 Clinical trial research and development expenditure 391 950 Prepaid insurance and subscriptions 1,775 2,025 Other 385 367 Prepayments 2,551 3,342 (iii) Classification as trade and other receivables Trade receivables and other receivables represent the principal amounts due at balance date less, where applicable, any provision for expected credit losses. The Group uses the simplified approach to measuring expected credit losses, which uses a lifetime expected credit loss allowance. Debts which are known to be uncollectible are written off in the consolidated income statement. All trade receivables and other receivables, with the exception of the net investment in sublease, are recognized at the value of the amounts receivable, as they are due for settlement within 60 days and therefore Table of Contents 176
do not require remeasurement. The net investment in sublease is recognized at the present value of minimum lease payments receivable over the remaining life of the lease. (iv) Fair values of trade and other receivables Due to the short-term nature of the current receivables, their carrying amount is assumed to be the same as their fair value. (v) Impairment and risk exposure Information about the impairment of trade and other receivables, their credit quality and the Group’s exposure to credit risk, foreign currency risk and interest rate risk can be found in Note 10(a) and (b). c. Financial assets at fair value through other comprehensive income Financial assets at fair value through other comprehensive income include the following classes of financial assets: As of June 30, (in U.S. dollars, in thousands) 2024 2023 Unlisted securities: Equity securities 1,014 1,757 1,014 1,757 (i) Classification of financial assets at fair value through other comprehensive income Financial assets at fair value through other comprehensive income comprises equity securities which are not held for trading, and which the Group has irrevocably elected at initial recognition to recognize in this category. These are strategic investments and the Group considers this classification to be more relevant. The financial assets are presented as non-current assets unless they mature, or management intends to dispose of them within 12 months of the end of the reporting period. (ii) Impairment indicators for financial assets at fair value through other comprehensive income Impairment losses (and reversal of impairment losses) on equity investments measured at FVOCI are not reported separately from other changes in fair value. See Note 23(m)(iv) for further details about the Group’s impairment policies for financial assets. (iii) Amounts recognized in other comprehensive income For the years ended June 30, 2024, 2023 and 2022, the Group recognized in statement of comprehensive income a loss of $0.7 million, a $Nil gain/loss and a loss of $0.3 million respectively, for change in fair value of the financial assets through other comprehensive income. (iv) Fair value, impairment and risk exposure Information about the methods and assumptions used in determining fair value is provided in Note 5(g). None of the financial assets through other comprehensive income are either past due or impaired. All financial assets at fair value through other comprehensive income are denominated in US$. Table of Contents 177
d. Other non-current assets As of June 30, (in U.S. dollars, in thousands) 2024 2023 Bank guarantee 481 481 Net investment in sublease 190 414 Letter of credit 1,179 1,179 Security deposit 252 252 2,102 2,326 (i) Classification of financial assets as other non-current assets Bank guarantee These funds are held in an account named Mesoblast Limited at National Australia Bank according to the terms of a Bank Guarantee which is security for the sublease agreement for our occupancy of Level 38, 55 Collins Street, Melbourne, Victoria, Australia. The Bank Guarantee is security for the full and faithful performance and observance by the subtenant of the terms, covenants and conditions of the sublease. The Bank Guarantee continues in force until it is released by the lessor. Letter of credit These funds held in an account named Mesoblast, Inc. at the Bank of America according to the terms of an irrevocable standby letter of credit which is security for the sublease agreement for our occupancy of 505 Fifth Avenue, New York, New York, United States of America. The letter of credit is security for the full and faithful performance and observance by the subtenant of the terms, covenants and conditions of the sublease. The letter of credit is deemed to automatically extend without amendment for a period of one year at each anniversary. (ii) Impairment and risk exposure Information about the impairment of other non-current assets and their credit quality and the Group’s exposure to credit risk can be found in Note 10(b). e. Trade and other payables As of June 30, (in U.S. dollars, in thousands) 2024 2023 Trade payables and other payables 7,070 20,145 Trade and other payables 7,070 20,145 The carrying amounts of trade and other payables are assumed to be the same as their fair values, due to their short-term nature. Table of Contents 178
f. Borrowings As of June 30, (in U.S. dollars, in thousands) 2024 2023 Borrowings Secured liabilities: Borrowing arrangements 81,919 81,919 Less: transaction costs (9,833) (8,740) Amortization of carrying amount, net of payments made 42,259 35,584 114,345 108,763 As of June 30, (in U.S. dollars, in thousands) 2024 2023 Borrowings Current Borrowings - NovaQuest 1,869 336 Borrowings - Oaktree 11,993 5,616 13,862 5,952 Non-current Borrowings - NovaQuest 64,562 55,739 Borrowings - Oaktree 35,921 47,072 100,483 102,811 114,345 108,763 (i) Borrowing arrangements Funds associated with Oaktree Capital Management, L.P. (“Oaktree”) In November 2021, the Group entered into a five-year senior debt facility provided by funds associated with Oaktree. The balance of funds drawn down is $50.0 million as of June 30, 2024. The facility has a three-year interest only period, at a fixed rate of 9.75% per annum, after which the principal amortizes 5% per quarter beginning December 2024 and a final payment is due no later than November 2026. The facility also allows the Group to make quarterly payments of interest at a rate of 8.0% per annum for the first two years, and the unpaid interest portion (1.75% per annum) has been added to the outstanding loan balance and currently accrues further interest at a fixed rate of 9.75% per annum. On November 19, 2021, Oaktree were granted warrants to purchase 1,769,669 American Depositary Shares (“ADSs”) at US$7.26 per ADS, a 15% premium to the 30-day VWAP. The Group determined that an obligation to issue the warrants arose from the time the debt facility was signed; consequently, a liability for the warrants was recognized in November 2021. The warrants were legally issued on January 11, 2022 and may be exercised within 7 years of issuance. On the issuance date of the Oaktree facility and the warrants, the warrants were initially measured at fair value and the Oaktree borrowing liability measured as the difference between the initial draw down of funds from the Oaktree facility and the fair value of the warrants. In December 2022, the Group amended the terms of the loan agreement with Oaktree and in connection with the loan amendment, Oaktree was granted warrants to purchase 455,000 ADSs at $3.70 per ADS, a 15% premium to the 30-day VWAP. The Group determined that an obligation to issue the warrants arose from the time the first amendment to the loan agreement was signed; consequently, a liability for the warrants was recognized in December 2022. The warrants were legally issued on March 8, 2023 and may be exercised within 7 years of issuance. Refer to Note 5(g)(vi) for more details on warrants issued. On January 10, 2024, the ratio under Mesoblast's American Depository Receipt ("ADR") program was changed from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). As a result of this ratio change and as a result of initiating the pro-rata accelerated non-renounceable rights issue in December 2023, the number and exercise price for the warrants was adjusted in accordance with the terms of these warrants. The warrants issued in November 2021 changed from 1,769,669 ADSs at $7.26 per ADS to 884,838 ADSs at $14.36 per ADS. The warrants issued in December 2022 changed from 455,000 ADSs at $3.70 per ADS to 227,502 ADSs at $7.24 per ADS. Table of Contents 179
In the years ended June 30, 2024, 2023 and 2022, respectively, the Group recognized losses of $2.3 million, $1.6 million and a minimal gain in the Consolidated Income Statement as remeasurement of borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our facility. Within the $1.6 million loss recognized in the year ended June 30, 2023, $1.0 million related to the remeasurement due to additional warrants being issued to Oaktree as a result of the first amendment to the loan agreement and $0.6 million related to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our credit facility. The Group has pledged substantially all of its assets as collateral under the loan facility with Oaktree. NovaQuest Capital Management, L.L.C. On June 29, 2018, the Group entered into an eight-year, $40.0 million loan and security agreement with NovaQuest before drawing the first tranche of $30.0 million of the principal in July 2018. The loan term includes an interest only period of approximately four years through until July 8, 2022. All interest and principal payments (i.e. the amortization period) are deferred until the earlier of loan maturity or from after the first commercial sale of remestemcel-L for the treatment in pediatric patients with SR-aGVHD in the United States and other geographies excluding Asia ("remestemcel-L for pediatric SR-aGVHD"). Principal is repayable in equal quarterly instalments over the amortization period of the loan and is subject to the payment cap described below. The loan has a fixed interest rate of 15% per annum. If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable at maturity. The Group can elect to prepay all outstanding amounts owing at any time prior to maturity, subject to a prepayment charge. Following approval and first commercial sales, repayments commence based on a percentage of net sales and are limited by a payment cap which is equal to the principal due for the next 12 months, plus accumulated unpaid principal and accrued unpaid interest. During the four-year period commencing July 8, 2022, principal amortizes in equal quarterly instalments payable only after approval and first commercial sales. If in any quarterly period, 25% of net sales of remestemcel-L for pediatric SR-aGVHD exceed the annual payment cap, the Group will pay the payment cap and an additional portion of excess sales which will be used towards the prepayment amount in the event there is an early prepayment of the loan. If in any quarterly period 25% of net sales of remestemcel-L for pediatric SR-aGVHD is less than the annual payment cap, then the payment is limited to 25% of net sales of remestemcel-L for pediatric SR-aGVHD. Any unpaid interest will be added to the principal amounts owing and shall accrue further interest. At maturity date, any unpaid loan balances are repaid. Because of this relationship of net sales and repayments, changes in our estimated net sales may trigger an adjustment of the carrying amount of the financial liability to reflect the revised estimated cash flows. The carrying amount is recalculated by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate. The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs in the period the revision is made. In the years ended June 30, 2024, 2023 and 2022, respectively, the Group recognized a loss of $0.1 million and gains of $0.9 million and $0.5 million in the Consolidated Income Statement as remeasurement of borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of the Group's financial liability to reflect the revised estimated future cash flows as a net result of changes to the key assumptions in development timelines. The Group recognizes a liability as current based on repayments linked to estimates of sales of remestemcel-L. However, if sales of remestemcel-L are higher than estimated, actual repayments will exceed this amount, subject to the annual payment cap described above. The carrying amount of the loan and security agreement with NovaQuest is subordinated to the Group’s fixed rate loan with the senior creditor, Oaktree. The Group have pledged a portion of our assets relating to the SR-aGVHD product candidate as collateral under the loan facility with NovaQuest. (ii) Compliance with loan covenants Our loan facilities with Oaktree and NovaQuest contain a number of covenants that impose operating restrictions on us, which may restrict our ability to respond to changes in our business or take specified actions. The Group has an operating objective to at all times maintain unrestricted cash reserves in excess of six months liquidity. The objective aligns Table of Contents 180
with our loan and security agreement with Oaktree where the Group is currently obliged to maintain a minimum unrestricted cash balance of $25.0 million. The Group has complied with the financial and other restrictive covenants of its borrowing facilities during the year ended June 30, 2024 and during the year ended June 30, 2023. (iii) Net debt reconciliation As of June 30, (in U.S. dollars, in thousands) 2024 2023 Cash and cash equivalents 62,960 71,318 Borrowings (114,345) (108,763) Lease liabilities (4,578) (7,732) Warrant liability (4,647) (5,426) Net Debt(1) (60,610) (50,603) Cash and cash equivalents 62,960 71,318 Gross debt - fixed interest rates (118,923) (116,495) Gross debt - variable interest rates — — Warrant liability (4,647) (5,426) Net Debt(1) (60,610) (50,603) (1) Net debt amount includes leases and borrowing arrangements Liabilities from financing activities Other assets (in U.S. dollars, in thousands) Borrowings Leases Warrant liability Sub-total Cash and cash equivalents Total Net Debt as at June 30, 2023 (108,763) (7,732) (5,426) (121,921) 71,318 (50,603) Cash Flows(1) 16,921 3,877 — 20,798 (8,303) 12,495 Remeasurement adjustments (2,351) — 779 (1,572) — (1,572) Other Changes(2) (20,152) (724) — (20,876) — (20,876) Foreign exchange adjustments — 1 1 (55) (54) Net Debt as at June 30, 2024 (114,345) (4,578) (4,647) (123,570) 62,960 (60,610) (1) Cash flows for borrowings and leases include the payments of borrowings, lease liabilities, interest and debt transaction costs which are presented as financing cash flows in the statement of cash flows. (2) Other changes include modification of leases and accrued interest expenses for borrowings and leases. (i) Fair values of borrowing arrangements The carrying amount of the borrowings at amortized cost in accordance with our accounting policy is a reasonable approximation of fair value. Table of Contents 181
g. Recognized fair value measurements (i) Fair value hierarchy The following table presents the Group's financial assets and financial liabilities measured and recognized at fair value as of June 30, 2024 and June 30, 2023 on a recurring basis, categorized by level according to the significance of the inputs used in making the measurements: As of June 30, 2024 (in U.S. dollars, in thousands) Notes Level 1 Level 2 Level 3 Total Financial Assets Financial assets at fair value through other comprehensive income: Equity securities - biotech sector 5(c) — — 1,014 1,014 Total Financial Assets — — 1,014 1,014 Financial Liabilities Financial liabilities at fair value through profit or loss: Contingent consideration 5(g)(iii) — — 26,892 26,892 Warrant liabilities 5(g)(vi) — — 4,647 4,647 Total Financial Liabilities — — 31,539 31,539 There were no transfers between any of the levels for recurring fair value measurements during the period. As of June 30, 2023 (in U.S. dollars, in thousands) Notes Level 1 Level 2 Level 3 Total Financial Assets Financial assets at fair value through other comprehensive income: Equity securities - biotech sector 5(c) — — 1,757 1,757 Total Financial Assets — — 1,757 1,757 Financial Liabilities Financial liabilities at fair value through profit or loss: Contingent consideration 5(g)(iii) — — 17,199 17,199 Warrant liabilities 5(g)(vi) — — 5,426 5,426 Total Financial Liabilities — — 22,625 22,625 The Group’s policy is to recognize transfers into and transfers out of fair value hierarchy levels as at the end of the reporting period. Level 1: The fair value of financial instruments traded in active markets (such as publicly traded derivatives, and trading and financial assets at fair value through other comprehensive income securities) is based on quoted market prices at the end of the reporting period. The quoted market price used for financial assets held by the Group is the current bid price. These instruments are included in level 1. Level 2: The fair value of financial instruments that are not traded in an active market (for example, foreign exchange contracts) is determined using valuation techniques which maximize the use of observable market data and rely as little as possible on entity-specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2. Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for provisions (contingent consideration), equity securities (unlisted) and warrant liabilities. Table of Contents 182
(ii) Valuation techniques used. The Group did not hold any level 1 or 2 financial instruments as at June 30, 2024 or June 30, 2023. The Group’s level 3 assets consists of an investment in unlisted equity securities in the biotechnology sector. Level 3 assets were 100% of total assets measured at fair value as at June 30, 2024 and June 30, 2023. The Group’s level 3 liabilities consist of a contingent consideration provision related to the acquisition of Osiris’ MSC business and warrant liabilities related to the warrants granted to Oaktree as part of the debt facility. Level 3 liabilities were 100% of total liabilities measured at fair value as at June 30, 2024 and June 30, 2023. The Group used discounted cash flow analysis to determine the fair value measurements of Osiris’ MSC business and used the Black-Scholes valuation method to determine the fair value of warrant liabilities. Refer to Note 5(g)(vi) for the fair value measurement and movements in warrant liability for the period ended June 30, 2024 and June 30, 2023. (iii) Fair value measurements using significant unobservable inputs (level 3) The following table presents the changes in the contingent consideration balances within the level 3 instruments for the years ended June 30, 2024 and June 30, 2023: (in U.S. dollars, in thousands) Contingent consideration provision Opening balance - July 1, 2022 23,284 Reclassification during the period 2,686 Charged/(credited) to consolidated income statement: Remeasurement(1) (8,771) Closing balance - June 30, 2023 17,199 Opening balance - July 1, 2023 17,199 Charged/(credited) to consolidated income statement: Remeasurement(2) 9,693 Closing balance - June 30, 2024 26,892 (1) In the year ended June 30, 2023, a gain of $8.8 million was recognized on the remeasurement of contingent consideration pertaining to the acquisition of assets from Osiris. This remeasurement was a net result of changing the key assumptions of the contingent consideration valuation such as probability of payment, development timelines and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration, including the impact from the CRL from the FDA on the Group's BLA for remestemcel-L for the treatment of pediatric SR-aGVHD in August 2023. The assumptions relating to development timelines were updated to reflect expectations as a result of the CRL. (2) In the year ended June 30, 2024, a loss of $9.7 million was recognized on the remeasurement of contingent consideration pertaining to the acquisition of assets from Osiris. This remeasurement was a net result of changing key assumptions of the contingent consideration valuation, such as probability of success, development timelines and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration. The outcome from the FDA decision on the Group's BLA resubmission in July 2024, as discussed in Note 15, could lead to a change in the assumptions used within the valuation of the contingent consideration. Table of Contents 183
(iv) Valuation inputs and relationship to fair value The following table summarizes the quantitative information about the significant unobservable inputs used in level 3 fair value measurements: Range of inputs (weighted average) (in U.S. dollars, in thousands, except percent data) Description Fair value as of June 30, 2024) Fair value as of June 30, 2023) Valuation technique Unobservable inputs(1) Year Ended June 30, 2024 Year Ended June 30, 2023 Relationship of unobservable inputs to fair value Contingent consideration provision 26,892 17,199 Discounted cash flows Risk adjusted discount rate 11%-13% (12.5%) 11%-13% (12.5%) Year ended June 30, 2024: A change in the discount rate by 0.5% would have no impact to the fair value. Year ended June 30, 2023: A change in the discount rate by 0.5% would increase/decrease the fair value by 0.01%. Expected unit sales price Various Various Year ended June 30, 2024: A change in the price assumptions by 10% would increase/decrease the fair value by 0.1%. Year ended June 30, 2023: A change in the price assumptions by 10% would increase/decrease the fair value by 0.1%. Expected sales volumes Various Various Year ended June 30, 2024: A change in the volume assumptions by 10% would increase/decrease the fair value by 0.1%. Year ended June 30, 2023: A change in the volume assumptions by 10% would increase/decrease the fair value by 0.1%. Probability of success and payment Various Various Year ended June 30, 2024: A change in the probability of success and payment assumptions by 10% and 20% would increase/decrease the fair value by 10% and 20.1%, respectively. Year ended June 30, 2023: A change in the probability of success and payment assumptions by 10% and 20% would increase/decrease the fair value by 8% and 16%, respectively. (1) There were no significant inter-relationships between unobservable inputs that materially affect fair values. (v) Valuation processes In connection with the Osiris acquisition, on October 11, 2013 (the “acquisition date”), an independent valuation of the contingent consideration was carried out by an independent valuer. For the years ended June 30, 2024 and June 30, 2023, the Group has adopted a process to value contingent consideration internally. This valuation has been completed by the Group’s internal valuation team and reviewed by the interim Chief Financial Officer (the "CFO"). The valuation team is responsible for the valuation model. The valuation team also manages a process to continually refine the key assumptions within the model. This is done with input from the relevant business units. The key assumptions in the model have been clearly defined and the responsibility for refining those assumptions has been assigned to the most relevant business units. For each indication we determine the probability Table of Contents 184
of success based on the current development status within each jurisdiction and payment provisions within the agreement. Cash flows relevant to each jurisdiction are discounted appropriately based on the discount rate assumed. The remeasurement charged to the consolidated income statement in the year ended June 30, 2024 was a net result of changing the key assumptions of the contingent consideration valuation such as probability of success, development timelines and the increase in valuation as the time period shortens between the valuation date and the potential settlement dates of contingent consideration. The outcome from the FDA decision on the Group's BLA resubmission in July 2024, with a PDUFA goal date of January 7, 2025, as discussed in Note 15, could lead to a change in the assumptions associated with SR-aGVHD and a remeasurement of contingent consideration, up or down, could occur. As of June 30, The fair value of contingent consideration (in U.S. dollars, in thousands) 2024 2023 Fair value of cash or stock payable, dependent on achievement of future late-stage clinical or regulatory targets 26,236 16,606 Fair value of royalty payments from commercialization of the intellectual property acquired 656 593 26,892 17,199 The main level 3 inputs used by the Group are evaluated as follows: Risk adjusted discount rate: The discount rate used in the valuation has been determined based on required rates of returns of listed companies in the biotechnology industry (having regards to their stage of development, their size and number of projects) and the indicative rates of return required by suppliers of venture capital for investments with similar technical and commercial risks. This assumption is reviewed as part of the valuation process outlined above. Expected unit sales prices: Expected market sale price giving consideration to comparable products available in the market place and a value based pricing assessment. This assumption is reviewed as part of the valuation process outlined above. Expected sales volumes: Expected sales volumes of the most comparable products currently available in the market place. This assumption is reviewed as part of the valuation process outlined above. Probability of success and payment: Expected cash flows used to measure contingent consideration are risk adjusted for the probability of successful development of products and payment provisions with the agreement. These assumptions are reviewed as part of the valuation process outlined above. (vi) Warrant liability (in U.S. dollars, in thousands) As of June 30, Warrant liability 2024 2023 Opening balance 5,426 2,185 Warrants fair value at grant date - December 22, 2022 — 1,036 Remeasurement of warrant liability (779) 2,205 Closing Balance 4,647 5,426 On November 19, 2021, in connection with the initial draw down of the Oaktree debt, Oaktree was granted the right to warrants to purchase 1,769,669 ADSs at US$7.26 per ADS, a 15% premium to the 30-day VWAP. Given that Oaktree received an unconditional right to the warrants on November 19, 2021, this date has been determined as the measurement date. The warrant instruments were issued on January 11, 2022, following the required administrative process, and these warrants may be exercised within 7 years of issuance of the warrant instruments. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. On December 21, 2022, the Group amended the terms of the loan agreement with Oaktree and in connection with the loan amendment, Oaktree was granted warrants to purchase 455,000 ADSs at $3.70 per ADS, a 15% premium to the 30-day VWAP. The Group determined that an obligation to issue the warrants arose from the time the first amendment to Table of Contents 185
the loan agreement was signed; consequently, a liability for the warrants was recognized in December 2022. The warrants were legally issued on March 8, 2023 and may be exercised within 7 years of issuance. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. On January 10, 2024, the ratio under Mesoblast's American Depository Receipt ("ADR") program was changed from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). As a result of this ratio change and as a result of completing the pro-rata accelerated non-renounceable rights issue in December 2023, the number and exercise price for the warrants was adjusted in accordance with the terms of these warrants. The warrants issued in November 2021 changed from 1,769,669 ADSs at US$7.26 per ADS to 884,838 ADSs at US$14.36 per ADS. The warrants issued in December 2022 changed from 455,000 ADSs at US$3.70 per ADS to 227,502 ADSs at US$7.24 per ADS. The exercise price of the warrants will be received in US$, which is different to Mesoblast Limited’s functional currency of A$ which gives rise to variability in the cash flow. As a result, the warrants are classified as a financial liability in accordance with IAS32 Financial Instruments: Presentation. The financial liability is recorded in warrant liability at fair value at grant date and subsequently remeasured at each reporting period with changes being recorded in the Consolidated Income Statement as remeasurement of warrant liability. The warrant liabilities are considered level 3 liabilities as the determination of fair value includes various assumptions about the share prices and historical volatility as inputs. As of June 30, 2024 and 2023, the fair value of warrant liability was $4.6 million and $5.4 million, respectively. During the year ended June 30, 2024, a remeasurement gain of $0.8 million was recognized on the remeasurement of warrant liability. During the year ended June 30, 2023, a remeasurement loss of $2.2 million was recognized on the remeasurement of warrant liability. (vii) Fair value of warrants The warrants granted are not traded in an active market and therefore the fair value has been estimated by using the Black-Scholes valuation method based on the following assumptions. Key terms of the warrants are included below. The following assumptions were based on observable market conditions that existed as of June 30, 2024 and 2023. (in U.S. dollars, except percent data and as otherwise noted) Assumption As of June 30, 2024 As of June 30, 2023 Rationale Share Price $6.81 $3.91 Closing share price on valuation date from external market source Exercise Price(1) $7.24 to $14.36 $3.70 to $7.26 As per subscription agreement Expected Term 5 to 6 years 6 to 7 years As per subscription agreement Dividend Yield 0% 0% Based on Company’s nil dividend history Expected Volatility 91.91% 81.26% Based on historical volatility data for the Company Risk Free Interest Rate 4.38% 4.01% Based on the closing U.S. treasury issued 7 year bonds on valuation date Fair value per warrant $3.9352 to $5.1211 $2.3103 to $2.9401 Determined using Black-Scholes valuation model with the inputs above Fair value $4,647,075 $5,426,212 Fair value of 1,112,340(1)warrants of $4,647,075 as of June 30, 2024 and fair value of 2,224,669(1) warrants of $5,426,212 as of June 30, 2023 (1) As a result of the ratio change under Mesoblast's ADR program on January 10, 2024 and as a result of completing the pro-rata accelerated non-renounceable rights issue in December 2023, the warrants issued in November 2021 changed from 1,769,669 ADSs at US$7.26 per ADS to 884,838 ADSs at US$14.36 per ADS. The warrants issued in December 2022 changed from 455,000 ADSs at US$3.70 per ADS to 227,502 ADSs at US$7.24 per ADS. Table of Contents 186
6. Non-financial assets and liabilities a. Property, plant and equipment (in U.S. dollars, in thousands) Plant and Equipment Office Furniture and Equipment Computer Hardware and Software Total Year Ended June 30, 2023 Opening net book amount 1,208 692 145 2,045 Additions 171 43 60 274 Exchange differences (104) 113 (18) (9) Depreciation charge (818) (45) (90) (953) Closing net book value 457 803 97 1,357 As of June 30, 2023 Cost 6,910 2,074 3,353 12,337 Accumulated depreciation (6,453) (1,271) (3,256) (10,980) Net book value 457 803 97 1,357 Year Ended June 30, 2024 Opening net book amount 457 803 97 1,357 Additions 38 — 120 158 Disposals — (2) (7) (9) Exchange differences (6) (8) 16 2 Depreciation charge (281) (41) (80) (402) Closing net book value 208 752 146 1,106 As of June 30, 2024 Cost 6,067 2,044 644 8,755 Accumulated depreciation (5,859) (1,292) (498) (7,649) Net book value 208 752 146 1,106 (i) Depreciation methods and useful lives Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts, net of their residual values, over the estimated useful lives. The estimated useful lives are: • Plant and equipment 3 – 15 years • Office furniture and equipment 5 – 20 years • Computer hardware and software 3 – 5 years See Note 23(o) for other accounting policies relevant to property, plant and equipment. Table of Contents 187
b. Leases (i) Amounts recognized on the consolidated balance sheet Right-of-use assets (in U.S. dollars, in thousands) Buildings Manufacturing Total Year Ended June 30, 2023 Opening net book amount 5,096 2,824 7,920 Additions/(derecognition) (649) — (649) Remeasurement 526 (302) 224 Exchange differences (15) — (15) Depreciation charge (1,661) (685) (2,346) Closing net book value 3,297 1,837 5,134 As of June 30, 2023 Cost 9,957 6,178 16,135 Accumulated depreciation (6,660) (4,341) (11,001) Net book value 3,297 1,837 5,134 Year Ended June 30, 2024 Opening net book amount 3,297 1,837 5,134 Additions — — — Remeasurement — 369 369 Exchange differences — — — Depreciation charge (1,570) (1,201) (2,771) Closing net book value 1,727 1,005 2,732 As of June 30, 2024 Cost 9,128 6,245 15,373 Accumulated depreciation (7,401) (5,240) (12,641) Net book value 1,727 1,005 2,732 Lease liabilities As of June 30, 2024 2023 Current 2,626 4,060 Non-current 1,952 3,672 Lease liabilities included in the balance sheet 4,578 7,732 The lease liability is measured at the present value of the fixed and variable lease payments net of cash lease incentives that are not paid at the balance date. Lease payments are apportioned between the finance charges and reduction of the lease liability using the incremental borrowing rate to achieve a constant rate of interest on the remaining balance of the liability. Lease payments for buildings exclude service fees for cleaning and other costs. The interest expense (included in finance costs) for leases was $0.4 million, $0.5 million and $0.6 million for the years ended June 30, 2024, 2023 and 2022, respectively. In the years ended June 30, 2024 and 2023, total payments associated with lease liabilities were $3.9 million and $3.2 million, respectively. Payments associated with short-term leases with a lease term of 12 months or less, contracts that contain lease and non-lease components that are cancellable within 12 months and leases of low-value assets are recognized on a straight-line Table of Contents 188
basis as an expense in profit or loss. The expense relating to short-term leases was $0.3 million for the year ended June 30, 2024 and $1.1 million for the year ended June 30, 2023. (ii) Depreciation methods and useful lives of right-of use assets Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts over the estimated useful lives. Depreciation for leases relating to buildings for the years ended June 30, 2024, 2023 and 2022 was $1.6 million, $1.7 million and $1.7 million, respectively. Depreciation for the lease relating to manufacturing was $1.2 million, $0.7 million, and $1.4 million for the years ended June 30, 2024, 2023 and 2022, respectively, of which the $1.2 million of depreciation in the year ended June 30, 2024 was recognized in the consolidated income statement. Prior to the year ended June 30, 2024, depreciation on the manufacturing lease was capitalized within pre-launch inventory. (iii) Extension and termination options Extension options and termination options may be included in the right-of-use asset leases across the Group. These are used to maximize operational flexibility in terms of managing the assets used in the Group’s operations. In determining the lease term, management considers all facts and circumstances that create an economic incentive to exercise an extension option, or not exercise a termination option. Extension options and periods after termination options are only included in the lease term if the lease is reasonably certain to be extended or not terminated. A right-of-use asset and lease liability has been recognized in relation to the manufacturing service agreement entered into with Lonza in October 2019 for the supply of commercial product for the potential approval and launch of remestemcel-L for the treatment of SR-aGVHD in the US market. Management has determined that this agreement has a non-cancellable lease term expiring within 2 years from June 30, 2024, which is cancellable in limited circumstances. As of June 30, 2024, the anticipated future contractual cash flows relating to the lease component of the Lonza agreement are $1.9 million on an undiscounted basis, as included within lease liabilities in Note 10(c). The anticipated future contractual cash flows exclude cashflows beyond the non-cancellable lease term as it is not reasonably certain the Group will extend the agreement. At the Group's discretion, the minimum financial commitment relating to the lease component under this manufacturing services agreement can be reduced by $1.0 million under certain conditions. See Note 23(v) for other accounting policies relevant to lease accounting. Table of Contents 189
c. Intangible assets (in U.S. dollars, in thousands) Goodwill Acquired licenses to patents In-process research and development acquired Current marketed products Total Year Ended June 30, 2023 Opening net book amount 134,453 1,632 427,779 14,788 578,652 Additions/reversals — 23 — — 23 Exchange differences — 1 — — 1 Amortization charge — (38) — (1,455) (1,493) Closing net book amount 134,453 1,618 427,779 13,333 577,183 As of June 30, 2023 Cost 134,453 2,993 489,698 23,999 651,143 Accumulated amortization — (1,375) — (10,666) (12,041) Accumulated impairment — — (61,919) — (61,919) Net book amount 134,453 1,618 427,779 13,333 577,183 Year Ended June 30, 2024 Opening net book amount 134,453 1,618 427,779 13,333 577,183 Additions — 37 — — 37 Exchange differences — 1 — — 1 Amortization charge — (30) — (1,455) (1,485) Closing net book amount 134,453 1,626 427,779 11,878 575,736 As of June 30, 2024 Cost 134,453 3,032 489,698 24,000 651,183 Accumulated amortization — (1,406) — (12,122) (13,528) Accumulated impairment — — (61,919) — (61,919) Net book amount 134,453 1,626 427,779 11,878 575,736 (i) Carrying value of in-process research and development acquired by product As of June 30, (in U.S. dollars, in thousands) 2024 2023 Cardiovascular products(1) 254,351 254,351 Intravenous products for metabolic diseases and inflammatory/immunologic conditions(2) 70,730 70,730 MSC products(3) 102,698 102,698 427,779 427,779 (1) Includes MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction (2) Includes MPC-300-IV for the treatment of biologic-refractory rheumatoid arthritis and diabetic nephropathy (3) Includes remestemcel-L for the treatment of SR-aGVHD and remestemcel-L for the treatment of Crohn’s disease For all products included within the above balances, the underlying currency of each item recorded is US$. Table of Contents 190
(ii) Amortization methods and useful lives The Group amortizes intangible assets with a finite useful life using the straight-line method over the following periods: • Acquired licenses to patents 7 – 16 years • Current marketed products 15 – 20 years See Note 23(p) for the other accounting policies relevant to intangible assets and Note 23(j) for the Group’s policy regarding impairments. (iii) Significant estimate: Impairment of goodwill and assets with an indefinite useful life The Group tests annually, or more frequently if events or changes in circumstances indicate that they might be impaired, whether goodwill and its assets with indefinite useful lives have suffered any impairment in accordance with its accounting policy stated in Note 23(j). The recoverable amounts of these assets and cash-generating units have been determined based on fair value less costs to dispose calculations, which require the use of market-participant assumptions that are based on development strategies using external data sources as well as past experience. The full annual impairment assessment was performed at March 31, 2024 and no impairment of the in-process research and development and goodwill was identified. In August 2023, the FDA issued a CRL to the Group's BLA for remestemcel-L for the treatment of pediatric SR- aGVHD and the Group has considered this to be an impairment indicator that could cause the carrying amount of its intangible assets to exceed its recoverable amounts. As a result, the Group completed an impairment assessment on its MSC products intangible asset and goodwill, which considered the impact of the FDA's CRL. An external valuation was also obtained for the MSC products for the impairment assessment performed as a result of the receipt of the CRL. No impairment of the in-process research and development and goodwill was identified. In July 2024, as discussed in Note 15, the Group resubmitted its BLA for approval of remestemcel-L for the treatment of pediatric SR-aGVHD, and the FDA accepted the Group's BLA resubmission and set a PDUFA goal date of January 7, 2025. The outcome from the FDA decision on the Group's BLA resubmission could lead to a change in the assumptions used within the impairment assessment associated with SR-aGVHD that could cause the carrying amount of our intangible asset to exceed its recoverable amount. (iv) Impairment tests for goodwill and intangible assets with an indefinite useful life The Group has recognized goodwill as a result of two separate acquisitions. Goodwill of $118.4 million was recognized on acquisition of Angioblast Systems Inc. in 2010, $13.9 million was recognized on the acquisition of the MSC assets from Osiris (“MSC business combination”) in 2013 and $2.1 million was recognized on finalization of the MSC business combination of Osiris in 2015. In all cases the goodwill recognized represented excess in the purchase price over the net identifiable assets and in-process research and development acquired in the transaction. On acquisition, goodwill was not able to be allocated to the cash generating unit (“CGU”) level or to a group of CGU given the synergies of the underlying research and development. For the purpose of impairment testing, goodwill is monitored by management at the operating segment level. The Group is managed as one operating segment, being the development of cell technology platform for commercialization. IFRS requires that acquired in-process research and development be measured at fair value upon acquisition and carried as an indefinite life intangible asset subject to annual impairment reviews. The Group have recognized in-process research and development as a result of two separate acquisitions. In-process research and development of $387.0 million was recognized on the acquisition of Angioblast Systems Inc. in 2010 and $126.7 million was recognized on the acquisition of assets from Osiris in 2013 and $24.0 million was reclassified to current marketed products upon the TEMCELL asset becoming available for use in Japan. In 2016, the Group fully impaired $61.9 million of in-process research and development relating to our product candidates, MPC-MICRO-IO for the treatment of age-related macular degeneration and MPC-CBE for the expansion of hematopoietic stem cells within cord blood, as the Group suspended further patient enrollment of the Phase IIa MPC-MICRO-IO clinical trial and the Phase III MPC-CBE clinical trial as the Group prioritized the funding of its lead product candidates. Table of Contents 191
The Group still believe these product candidates remain viable upon further funding, or partnership, and accordingly these products should not be regarded as abandoned, where typically, abandoned programs would be closed down and the related research and development efforts are considered impaired and the asset is fully expensed. The remaining carrying amount of in-process research and development as at June 30, 2024 and June 30, 2023 was $427.8 million. In-process research and development acquired is considered to be an indefinite life intangible asset on the basis that it is incomplete and cannot be used in its current form (see Note 23(p)(iii)). The intangible asset’s life will remain indefinite until such time it is completed and commercialized or impaired. The carrying value of in-process research and development is a separate asset which has been subject to impairment testing at the cash generating unit level, which has been determined to be at the product level. The recoverable amount of both goodwill and in-process research and development was assessed as of March 31, 2024 based on the fair value less costs to dispose. No impairment was identified as a result of this impairment assessment. Management assess for indicators of impairment as at June 30, 2024, including considering events up to the date of the approval of the financial statements. In July 2024, as discussed in Note 15, the Group resubmitted its BLA for approval of remestemcel-L for the treatment of pediatric SR-aGVHD, and the FDA accepted the Group's BLA resubmission and set a PDUFA goal date of January 7, 2025. The outcome from the FDA decision on the Group's BLA resubmission could lead to a change in the assumptions used within the impairment assessment associated with SR- aGVHD that could cause the carrying amount of our intangible asset to exceed its recoverable amount. (v) Key assumptions used for fair value less costs to dispose calculations In determining the fair value less costs to dispose the Group has given consideration to the following internal and external indicators: • discounted expected future cash flows of programs valued by the Group’s internal valuation team and reviewed by the interim CFO. The valuation team also manages a process to continually refine the key assumptions within the model. This is done with input from the relevant business units. The key assumptions in the model have been clearly defined and the responsibility for refining those assumptions has been assigned to the most relevant business units. When determining key assumptions, the business units refer to both external sources and past experience as appropriate. The valuation is considered to be level 3 in the fair value hierarchy due to unobservable inputs used in the valuation; • the scientific results and progress of the trials since acquisition; • the market capitalization of the Group on the ASX (ASX:MSB); and • the valuation of the Group’s assets from an independent valuation. An independent valuation was obtained for all assets at March 31, 2023 and for the MSC products for the impairment assessment performed as a result of the receipt of the complete response in August 2023. Costs of disposal were assumed to be immaterial. Discounted cash-flows used a real post-tax discount rate range of 13.8% to 15.5%, and include estimated real cash inflows and outflows for each program through to expected patent expiry which ranges from 8 to 24 years. In relation to cash outflows consideration has been given to cost of goods sold, selling costs and clinical trial schedules including estimates of numbers of patients and per patient costs. Associated expenses such as regulatory fees and patent maintenance have been included as well as any further preclinical development if applicable. In relation to cash inflows consideration has been given to product pricing, market population and penetration, sales rebates and discounts, launch timings and probability of success in the relevant applicable markets. There are no standard growth rates applied, other than our estimates of market penetration which increase initially, plateau and then decline. Table of Contents 192
The assessment of the recoverable amount of each product has been made in accordance with the discounted cash- flow assumptions outlined above. The assessments showed that the recoverable amount of each product exceeds the carrying amount and therefore there is no impairment. The assessment of goodwill showed the recoverable amount of the Group's operating segment, including goodwill and remaining in-process research and development, exceeds carrying amounts, and therefore there is no impairment. (vi) Impact of possible changes in key assumptions The Group has considered and assessed reasonably possible changes in the key assumptions and has not identified any instances that could cause the carrying amount of our intangible assets to exceed its recoverable amount. Whilst there is no impairment, the key sensitivities in the valuation are dependent on the continued successful development of our technology platforms. In July 2024, as discussed in Note 15, the Group resubmitted its BLA for approval of remestemcel-L for the treatment of pediatric SR-aGVHD, and the FDA accepted the Group's BLA resubmission and set a PDUFA goal date of January 7, 2025. The outcome from the FDA decision on the Group's BLA resubmission could lead to a change in the assumptions used within the impairment assessment associated with SR- aGVHD that could cause the carrying amount of our intangible asset to exceed its recoverable amount. If the Group is unable to successfully develop our technology platforms, an impairment of the carrying amount of our intangible assets may result. d. Provisions As of June 30, 2024 As of June 30, 2023 (in U.S. dollars, in thousands) Notes Current Non- current Total Current Non- current Total Contingent consideration 16,298 10,594 26,892 636 16,563 17,199 Employee benefits 7,436 26 7,462 2,013 49 2,062 Provision for license agreements 3,750 — 3,750 3,750 — 3,750 Provision for litigation settlements 22 17,554 — 17,554 — — — 45,038 10,620 55,658 6,399 16,612 23,011 (i) Information about individual provisions and significant estimates Contingent consideration The contingent consideration provision relates to the Group’s liability for certain milestones and royalty achievements pertaining to the acquired MSC assets from Osiris. Further disclosures can be found in Note 5(g)(iii). Employee benefits The provision for employee benefits relates to the Group’s liability for annual leave, short term incentives, long service leave and deferred director fees. Employee benefits include accrued annual leave. As of June 30, 2024 and 2023, the entire amount of the annual leave accrual was $1.2 million and $1.1 million respectively, and is presented as current, since the Group does not have an unconditional right to defer settlement for any of these obligations. Employee benefits include a provision for the Group's liability for short term incentives. As of June 30, 2024 and 2023, the provision for short term incentive incentives was $5.4 million and $0.4 million, respectively, and the provision as of June 30, 2024 of $5.4 million includes $2.4 million and $3.0 million relating to the entitlements for the years ended June 30, 2024 and 2023, respectively, given that subsequent to June 30, 2023 the conditions of achievement of the short- term incentive for year ended June 30, 2023 were modified to make it dependent on Mesoblast achieving FDA marketing authorization. In August 2024, as discussed in Note 15, the Group modified the short term incentive plan providing employees with the choice to elect into receiving an option grant in lieu of cash payment of their short term incentive Table of Contents 193
entitlements for the years ended June 30, 2024 and 2023, which have been deferred to BLA approval. The level of participation and the terms of the modification are yet to be determined at the date of this report. (ii) Movements The contingent consideration provision relates to the Group’s liability for certain milestones and royalty achievements. Refer to Note 5(g)(iii) for movements in contingent consideration for the years ended June 30, 2024 and 2023. e. Deferred tax balances (i) Deferred tax balances As of June 30, (in U.S. dollars, in thousands) 2024 2023 Deferred tax assets The balance comprises temporary differences attributable to: Tax losses 74,602 76,020 Other temporary differences 13,143 11,972 Total deferred tax assets 87,745 87,992 Deferred tax liabilities The balance comprises temporary differences attributable to: Intangible assets 87,745 87,992 Total deferred tax liabilities 87,745 87,992 Net deferred tax liabilities — — (ii) Movements (in U.S. dollars, in thousands) Tax losses(1) (DTA) Other temporary differences(1) (DTA) Intangible assets (DTL) Total (DTL) As of June 30, 2022 80,411 7,831 (88,242) — Credited/(charged) to: - profit or loss (4,179) 4,141 250 212 - directly to equity (212) — — (212) As of June 30, 2023 76,020 11,972 (87,992) — Credited/(charged) to: - profit or loss (1,227) 1,171 247 191 - directly to equity (191) — — (191) As of June 30, 2024 74,602 13,143 (87,745) — (1) Deferred tax assets are netted against deferred tax liabilities. f. Deferred consideration As of June 30, (in U.S. dollars, in thousands) 2024 2023 Opening balance(1) 2,500 2,500 Amount recognized as revenue during the period — — Balance as of the end of the period 2,500 2,500 Table of Contents 194
(1) The $2.5 million milestone payment received in December 2019 from Grünenthal was considered constrained and resulted in deferred consideration as of June 30, 2024. 7. Equity a. Contributed equity (i) Share capital As of June 30, 2024 2023 2022 2024 2023 2022 Shares No. (U.S. dollars, in thousands) Contributed equity (i) Share capital Ordinary shares 1,141,784,114 814,204,825 650,454,551 1,310,813 1,249,123 1,165,309 Less: Treasury Shares (542,903) (542,903) (542,903) — — — Total Contributed Equity 1,141,241,211 813,661,922 649,911,648 1,310,813 1,249,123 1,165,309 (ii) Movements in ordinary share capital As of June 30, As of June 30, 2024 2023 2022 2024 2023 2022 Shares No. (U.S. dollars, in thousands) Opening balance 814,204,825 650,454,551 648,696,070 1,249,123 1,165,309 1,163,153 Issues of ordinary shares during the period Exercise of share options(1) — — — 7 — 209 Transfer to employee share trust(1) 1,072,363 — — — — — Share based compensation for services rendered — — 1,758,481 — — 1,698 Entitlement offer to existing eligible shareholders and institutional placement(2) 326,506,926 — — 64,399 — — Placement of shares under a share placement agreement(3) — 163,750,274 — — 89,141 — Transaction costs arising on share issue — — — (3,920) (5,327) 21 327,579,289 163,750,274 1,758,481 60,486 83,814 1,928 Unissued ordinary shares during the period Placement of shares under a share placement agreement(2) — — — 1,000 — — — — — 1,000 — — Total contributions of equity during the period 327,579,289 163,750,274 1,758,481 61,486 83,814 1,928 Share options reserve transferred to equity on exercise of options — — — 204 — 228 Ending balance 1,141,784,114 814,204,825 650,454,551 1,310,813 1,249,123 1,165,309 (1) Options are issued to employees, directors and consultants in accordance with the Mesoblast Employee Share Option Plan. Unpaid shares are issued to the share trust to enable future option exercises to be settled. On exercise of options, the proceeds of the exercise are recorded in ordinary share capital in Mesoblast Limited and the exercise is settled by transfer of the shares from the share trust to the employee. Table of Contents 195
(2) In December 2023 and March 2024, respectively, 201,137,412 and 125,369,514 shares were issued in a 1 for 4 pro- rata accelerated non-renounceable entitlement offer of new fully paid ordinary shares in Mesoblast Limited to existing shareholders in Australia and certain other countries together with an institutional placement of new fully paid ordinary shares in Mesoblast Limited, at A$0.30 per share. As part of the placement in March 2024, Dr. Eric Rose, the Company's Chief Medical Offer and a director of Mesoblast, subscribed for 5,039,814 shares in Mesoblast Limited at A$0.30 per share, subject to shareholder approval, and therefore the shares remain in unissued capital until the shares are issued. (3) In August 2022, 86,666,667 shares were issued in an equity purchase of Mesoblast Limited at A$0.75 per share to existing and new institutional investors, representing a 5.00% discount to the thirty trading-day volume weighted average price. In April 2023, 77,083,607 shares were issued in an equity purchase of Mesoblast Limited at A$0.85 per share primarily to existing major shareholders, representing a 15.00% discount to the five trading-day volume weighted average price. (iii) Movements of shares in share trust As of June 30 As of June 30 2024 2023 2022 2024 2023 2022 Shares No. (U.S. dollars, in thousands) Opening balance 542,903 542,903 771,983 — — — Movement of shares in share trust Transfer to employee share trust(1) 1,072,363 — — — — — Exercise of share options(1) (1,072,363) — (229,080) — — — Ending balance 542,903 542,903 542,903 — — — (1) Options are issued to employees, directors and consultants in accordance with the Mesoblast Employee Share Option Plan. Unpaid shares are issued to the share trust to enable future option exercises to be settled. On exercise of options, the proceeds of the exercise are recorded in ordinary share capital in Mesoblast Limited and the exercise is settled by transfer of the shares from the share trust to the employee. (iv) Ordinary shares Ordinary shares participate in dividends and the proceeds on winding up of the Group in equal proportion to the number of shares held. At shareholders meetings each ordinary share is entitled to one vote when a poll is called, otherwise each shareholder has one vote on a show of hands. Ordinary shares have no par value and the Company does not have a limited amount of authorized capital. (v) Employee share options Information relating to the Group’s employee share option plan, including details of shares issued under the scheme, is set out in Note 17. b. Reserves (i) Reserves As at June 30, (in U.S. dollars, in thousands) 2024 2023 Share-based payments reserve 106,842 101,367 Investment revaluation reserve (1,286) (543) Foreign currency translation reserve (40,222) (40,273) Warrants reserve 12,969 12,969 78,303 73,520 Table of Contents 196
(ii) Reconciliation of reserves (in U.S. dollars, in thousands) As at June 30, Share-based payments reserve 2024 2023 Opening balance 101,367 97,924 Tax credited / (debited) to equity (191) (212) Transfer to ordinary shares on exercise of options (204) — Share-based payment expense for the year 5,870 3,655 Closing Balance 106,842 101,367 Investment revaluation reserve Opening balance (543) (542) Changes in the fair value of financial assets through other comprehensive income (743) (1) Closing Balance (1,286) (543) Foreign currency translation reserve Opening balance (40,273) (39,700) Currency gain/(loss) on translation of foreign operations net assets 51 (573) Closing Balance (40,222) (40,273) Warrant reserve Opening balance 12,969 12,969 Movements during the period — — Closing Balance 12,969 12,969 (iii) Nature and purpose of reserves Share-based payment reserve The share-based payments reserve is used to recognize: • the fair value(1) of options issued but not exercised; and • the fair value(1) of deferred shares granted but not yet vested. (1) The fair value recognized is determined at the acceptance date, which is the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement or when they are approved by shareholders when this is required. Foreign currency translation reserve Exchange differences arising on translation of a foreign controlled entity are recognized in other comprehensive income and accumulated in a separate reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is disposed of. Warrants reserve In March 2021, the Group completed a A$138.0 million (US$110.0 million) private placement of 60,109,290 new fully-paid ordinary shares at a price of A$2.30. As part of this placement, the Group also issued one warrant for every four ordinary shares issued in the placement, which resulted in a further 15,027,327 warrants issued. Each warrant has an exercise price of A$2.88 per share and a 7 year term. The Group has a right to compel exercise of the warrants at any time, subject to the price of the Group’s ordinary shares trading at least A$4.32 for 45 consecutive days on the ASX. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. As a Table of Contents 197
result of completing the pro-rata accelerated non-renounceable rights issue in December 2023, the exercise price for the warrants was adjusted from A$2.88 per share to A$2.86 per share with effect from January 5, 2024. The terms of the warrants include certain anti-dilution clauses, which adjust the exercise price or conversion ratio in the event of a rights issue or bonus issue. Management analyzed these clauses and determined the fixed-for-fixed requirement was still satisfied because the relative rights of shareholders and warrant holders were maintained. Therefore the warrants were classified as equity. The warrants were initially measured in equity at fair value, which was determined using a Monte Carlo simulation (refer to Note 7(b)(iv)), with the residual consideration being attributed to the ordinary shares issued in the same transaction. The warrants are not remeasured for subsequent changes in fair value. (iv) Fair value of warrants The warrants granted are not traded in an active market and therefore the fair value has been estimated by using the Monte Carlo pricing model based on the following assumptions. Key terms of the warrants are included above. The following assumptions were based on observable market conditions that existed at the issue date. (in U.S. dollars, except percent data and as otherwise noted) Assumption At Issue date - March 18, 2021 Rationale Share Price A$2.41 Closing share price on valuation date from external market source Exercise Price(1) A$2.88 As per subscription agreement Expected Term 7 years As per subscription agreement Dividend Yield 0% Based on Company’s nil dividend history Expected Volatility 66.88% Based on historical volatility data for the Company A$-US$ FX Spot Rate 0.7827 Closing FX rate on valuation date from the Reserve Bank of Australia historical foreign exchange rate tables Risk Free Interest Rate 1.24% Based on the mid-point of the Australian Government issued 5 year and 10 year bonds Fair value per warrant $0.863 (A$1.103) Determined using Monte Carlo pricing models with the inputs above Fair value $12,968,583 Fair value of 15,027,327 warrants as at issue date (1) As a result of completing the pro-rata accelerated non-renounceable rights issue in December 2023, the exercise price for the warrants was adjusted from A$2.88 per share to A$2.86 per share with effect from January 5, 2024. Table of Contents 198
8. Cash flow information (in U.S. dollars, in thousands) As of June 30, (a) Reconciliation of cash and cash equivalents 2024 2023 2022 Cash at bank 62,563 70,920 60,034 Deposits at call 397 398 413 62,960 71,318 60,447 (in U.S. dollars, in thousands) As of June 30, (b) Reconciliation of net cash flows used in operations with loss after income tax 2024 2023 2022 Loss for the period (87,956) (81,889) (91,347) Add/(deduct) net loss for non-cash items as follows: Depreciation and amortization 4,666 4,107 4,380 Foreign exchange losses/(gains) 78 62 536 Finance costs 22,792 20,122 17,288 Remeasurement of contingent consideration 9,693 (8,771) (913) Remeasurement of warrant liabilities (779) 2,205 (5,896) Equity settled share-based payment 5,870 3,655 5,536 Deferred tax benefit (191) (212) (235) Gain on derecognition of right-of-use assets — (76) — Change in operating assets and liabilities: Decrease/(increase) in trade and other receivables (15,466) (118) 140 Decrease/(increase) in prepayments 807 1,650 1,555 Increase/(decrease) in trade and other payables (12,378) (398) 4,777 Decrease/(increase) in tax incentive recoverable 1,490 (2,388) — Increase/(decrease) in provisions 22,916 (1,218) (1,603) Net cash outflows used in operations (48,458) (63,269) (65,782) 9. Significant estimates, judgments and errors The preparation of financial statements requires the use of accounting estimates which, by definition, will seldom equal the actual results. Management also needs to exercise judgment in applying the Group’s accounting policies. This note provides an overview of the areas that involved a higher degree of judgment or complexity, and of items which are more likely to be materially adjusted due to estimates and assumptions turning out to be wrong. Detailed information about each of these estimates and judgments is included in Notes 1 to 8 together with information about the basis of calculation for each affected line item in the financial statements. In addition, this note also explains where there have been actual adjustments this year as a result of an error and of changes to previous estimates. Significant estimates and judgments The areas involving significant estimates or judgments are: • recognition of revenue (Note 3 and Note 23(e)); • fair value of contingent liabilities and contingent purchase consideration in a business combination (Note 5(g) and 13); • recoverable amount of goodwill and other intangible assets including in-process research and development (Note 6(c)); • useful life of intangible assets (Note 6(c)); • recognition of deferred tax assets and deferred tax liabilities (Note 4); • fair value of share-based payments (Note 17); Table of Contents 199
• remeasurement of borrowings due to change in estimated cash flows (Note 5(f)); • recognition of pre-launch inventory costs (Note 23(f)); and • fair value of warrant liability (Note 5(g)). The preparation of these consolidated financial statements requires the Group to make estimates and judgments that affect the reported amounts of assets, liabilities, income and expenses and related disclosures. On an ongoing basis, the Group evaluates its significant accounting policies and estimates. Estimates are based on historical experience and on various market-specific and other relevant assumptions that the Group believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. 10. Financial risk management This note explains the Group’s exposure to financial risks and how these risks could affect the Group’s future financial performance. Current year profit and loss information has been included where relevant to add further context. Risk Exposure arising from Measurement Management Market risk – currency risk Future commercial transactions Recognized financial assets and liabilities not denominated in the functional currency of each entity within the Group Cash flow forecasting Sensitivity analysis The future cash flows of each currency are forecast and the quantum of cash reserves held for each currency are managed in line with future forecasted requirements. Cross currency swaps are undertaken as required. Market risk – interest rate risk Term deposits at fixed rates Cash deposits at variable rates Sensitivity analysis Vary length of term deposits, utilize interest bearing accounts and periodically review interest rates available to ensure we earn interest at market rates. Market risk – price risk Long-term borrowings Sensitivity analysis Forecasts of net sales of the product underlying the NovaQuest borrowing arrangement are updated on a quarterly basis to evaluate the impact on the carrying amount of the financial liability. Market risk - share price risk Warrant liability Sensitivity analysis The future exercise of warrants will not impact the Group's future cash flows significantly given the warrants will be paid in shares upon exercise. Therefore there are no significant cashflow risks associated with these warrants. The Group monitors the profit or loss impact that share price movements have on the valuation of the warrant liability each period. Credit risk Cash and cash equivalents, trade and other receivables and other non-current assets Aging analysis Credit ratings Transact primarily with the best risk rated banks available in each region giving consideration to the products required, the quantum of cash reserves held and future forecasted requirements Liquidity risk Cash and cash equivalents, borrowings, trade payables, lease liabilities and contingent consideration Rolling cash flow forecasts Future cash flows requirements are forecasted and capital raising strategies are planned to ensure sufficient cash balances are maintained to meet the Group’s future commitments. a. Market risk (i) Currency risk The Group has foreign currency amounts owing relating to clinical, regulatory and overhead activities and foreign currency deposits held primarily in the Group’s Australian based entity, whose functional currency is the A$. The Group Table of Contents 200
also has foreign currency amounts owing in the Group’s Swiss and Singapore based entities, whose functional currencies are the US$. The Group also has foreign currency amounts owing in various other non-US$ currencies in A$ and US$ functional currency entities in the Group relating to clinical, regulatory and overhead activities. These foreign currency balances give rise to a currency risk, which is the risk of the exchange rate moving, in either direction, and the impact it may have on the Group’s financial performance. Currency risk is minimized by ensuring the proportion of cash reserves held in each currency matches the expected rate of spend of each currency. As of June 30, 2024, the Group held 76% of its cash in US$, 23% in A$ and 1% in other currencies. As of June 30, 2023 the Group held 67% of its cash in US$, and 33% in A$. The balances held at the end of the year that give rise to currency risk exposure are presented in US$ in the following table, together with a sensitivity analysis which assesses the impact that a change of +/-20% in the exchange rate as of June 30, 2024 and June 30, 2023 would have had on the Group’s reported net profits/(losses) and/or equity balance. The bank balances held at the end of the year that are presented in the following table give rise to currency risk exposure as they are not in the functional currency of the entity in which it is held. +20% -20% (in U.S. dollars, in thousands, unless otherwise noted) As of June 30, 2024 Foreign currency balance held Profit/(Loss) US$ Profit/(Loss) US$ Bank accounts – USD US$819 $ 164 $ (164) Bank accounts – CHF CHF96 $ 21 $ (21) Bank accounts – SGD S$62 $ 9 $ (9) Bank accounts – EUR EUR151 $ 32 $ (32) Trade and other receivables - USD US$400 $ 80 $ (80) Trade and other receivables - SGD S$396 $ 58 $ (58) Trade and other receivables - CHF CHF4 $ 1 $ (1) Trade and other receivables - EUR EUR175 $ 37 $ (37) Trade payables and accruals - USD (US$1,024) $ (204) $ 204 Trade payables and accruals - AUD (A$130) $ (17) $ 17 Trade payables and accruals - SGD (S$217) $ (32) $ 32 Trade payables and accruals - GBP (GBP60) $ (15) $ 15 Trade payables and accruals - EUR (EUR36) $ (8) $ 8 Trade payables and accruals - CHF (CHF19) $ (4) $ 4 Provisions – USD (US$1,750) $ (350) $ 350 $ (228) $ 228 Table of Contents 201
+20% -20% (in U.S. dollars, in thousands, unless otherwise noted) As of June 30, 2023 Foreign currency balance held Profit/(Loss) US$ Profit/(Loss) US$ Bank accounts – USD US$60 $ 12 $ (12) Bank accounts – CHF CHF79 $ 18 $ (18) Bank accounts – SGD S$80 $ 12 $ (12) Bank accounts – EUR EUR4 $ 1 $ (1) Trade and other receivables - USD US$400 $ 80 $ (80) Trade and other receivables - SGD S$106 $ 16 $ (16) Trade and other receivables - CHF CHF3 $ 1 $ (1) Trade and other receivables - EUR EUR292 $ 63 $ (63) Trade payables and accruals - USD (US$1,361) $ (272) $ 272 Trade payables and accruals - AUD (A$1,064) $ (141) $ 141 Trade payables and accruals - SGD (S$422) $ (62) $ 62 Trade payables and accruals - GBP (GBP45) $ (11) $ 11 Trade payables and accruals - EUR (EUR26) $ (6) $ 6 Trade payables and accruals - CHF (CHF40) $ (9) $ 9 Provisions – USD (US$1,750) $ (350) $ 350 $ (648) $ 648 (ii) Cash flow and interest rate risk The Group is exposed to interest rate movements which impacts interest income earned on its deposits and at call accounts. The interest rate risk is managed by spreading the maturity date of our deposits across various periods. The Group ensures that sufficient funds are available, in at call accounts, to meet the working capital requirements of the Group. The deposits held which derive interest revenue are described in the table below, together with the maximum and minimum interest rates being earned as of June 30, 2024 and June 30, 2023. The effect on profit is shown if interest rates change by 10%, in either direction, is as follows: As of Jun 30, 2024 As of June 30, 2023 (in U.S. dollars, in thousands, except percent data) Low High US$ Low High US$ Funds invested – US$ 1.84 % 1.84 % 25,123 1.79 % 1.79 % 40,569 Rate increase by 10% 2.02 % 2.02 % 46 1.97 % 1.97 % 73 Rate decrease by 10% 1.66 % 1.66 % (46) 1.61 % 1.61 % (73) As of Jun 30, 2024 As of June 30, 2023 (1) (in Australian dollars, in thousands, except percent data) Low High A$ Low High A$ Funds invested – A$ 3.85 % 4.86 % 22,169 3.60 % 4.59 % 35,707 Rate increase by 10% 4.24 % 5.35 % 95 3.96 % 5.05 % 143 Rate decrease by 10% 3.47 % 4.37 % (95) 3.24 % 4.13 % (143) (1) A$ deposits held as of June 30, 2023 have been updated to reflect the increasing impact of higher interest rates. (iii) Price risk Price risk is the risk that future cash flows derived from financial instruments will be altered as a result of a market price movement, which is defined as movements other than foreign currency rates and interest rates. The Group is Table of Contents 202
exposed to price risk which arises from long-term borrowings under its facility with NovaQuest, where the timing and amounts of principal and interest payments is dependent on net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric patients in the United States and other territories excluding Asia. As net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric patients in these territories increase/decrease, the timing and amount of principal and interest payments relating to the financing arrangement will also fluctuate, resulting in an adjustment to the carrying amount of financial liability. The adjustment is recognized in the Consolidated Income Statement as remeasurement of borrowing arrangements within finance costs in the period the revision is made. The exposure of the Group’s borrowing to price rate changes are as follows: As of Jun 30, 2024 As of June 30, 2023 (in U.S. dollars, in thousands, except percent data) Total % of total borrowings Total % of total borrowings Financial liabilities Current borrowings Borrowings – NovaQuest 1,869 2 % 336 0 % Non-current borrowings Borrowings – NovaQuest 64,562 56 % 55,739 51 % 66,431 58 % 56,075 51 % As at June 30, 2024, all other factors held constant, a +/-20% change in the forecast net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric patients in the United States and other territories excluding Asia would not have a significant impact on non-current borrowings and profit. The Group is also exposed to price risk on contingent consideration provision balances, as expected unit revenues are a significant unobservable input used in the level 3 fair value measurements. As at June 30, 2024, all other factors held constant, the increase/decrease in price assumptions adopted in the fair value measurements of the contingent consideration provision are discussed in Note 5(g)(iv). The Group does not consider it has any exposure to price risk other than those already described above. (iv) Share price risk The Group's exposure to share price risk arises from warrant liabilities held by the Group and classified in the statement of financial position at fair value through profit or loss. The future exercise of these warrants will not impact the Group's future cash flows significantly given the warrants will be paid in shares upon exercise, therefore there are no significant cashflow risks associated with these warrants. The Group monitors the impact on profit or loss that share price movements have on the valuation of the warrant liability each period. The table below summarizes the impact of the increase/decrease of Mesoblast's share price on the Group's profit or loss during the period, based on the assumption that the share price had increased/decreased by 10% and 10% with all other variables held constant as of June 30, 2024 and June 30, 2023 respectively. (in U.S. dollars, in thousands) As of June 30, 2024 As of June 30, 2023 Financial liabilities Warrant liability 4,647 5,426 Impact on profit or (loss) Share price increase by 10% (2023: 10%) (598) (698) Share price decrease by 10% (2023: 10%) 587 686 Table of Contents 203
b. Credit risk Credit risk is the risk that one party to a financial instrument will fail to discharge its obligation and cause financial loss to the other party. The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of financial assets. The Group’s receivables are tabled below. As of June 30, (in U.S. dollars, in thousands) 2024 2023 Cash and cash equivalents Deposits at call (Note 5(a)) - minimum A rated 397 398 Cash at bank (Note 5(a)) - minimum A rated 62,563 70,920 Trade and other receivables Receivable from other parties (non-rated) 1,403 2,276 Receivable from the Australian Government (Income Tax) 854 2,363 Receivable from the United States Government (U.S. tax credits) — 1,473 Receivable from the Australian Government (Foreign Withholding Tax) 400 400 Receivable from the Australian Government (Goods and Services Tax) 126 121 Receivable from the Singapore Government (Goods and Services Tax) 292 78 Receivable from the United States Government (Foreign Withholding Tax) 71 71 Receivable from minimum A rated bank deposits (interest) 23 18 Receivable from the Swiss Government (Value-Added Tax) 5 3 Receivable from the United States Government (Income Tax) — — Other non-current assets Minimum A rated bank deposits (held as security) 1,912 1,912 c. Liquidity risk Liquidity risk is the risk that the Group will not be able to pay its debts as and when they fall due. Liquidity risk has been assessed in Note 1(i). All financial liabilities, excluding contingent consideration, borrowings and lease liabilities held by the Group as of June 30, 2024 and June 30, 2023 mature within 6 months. Trade payables and contingent consideration held by the Group as of June 30, 2024 and June 30, 2023 are non-interest bearing. The total contractual cash flows associated with trade payables equate to the carrying amount disclosed within the financial statements. As of June 30, 2024, the maturity profile of the anticipated future contractual cash flows, on an undiscounted basis and removing probability adjustments as applicable for contingent consideration, and which, therefore differs from the carrying value, is as follows: (in U.S. dollars, in thousands) Within 1 year Between 1-2 years Between 2-5 years Over 5 years Total contractual cash flows Carrying amount Borrowings(1)(2) (15,763) (140,716) — — (156,479) (114,345) Trade payables (7,071) — — — (7,071) (7,070) Lease liabilities (2,819) (1,797) (206) — (4,822) (4,578) Contingent consideration(3) (5,500) (1,604) — — (7,104) (656) (31,153) (144,117) (206) — (175,476) (126,649) (1) Contractual cash flows include payments of principal, interest and other charges. Interest is calculated based on debt held at June 30, 2024 without taking into account drawdowns of further tranches. (2) In relation to the contractual maturities of the NovaQuest borrowings, there is variability in the maturity profile of the anticipated future contractual cash flows given the timing and amount of payments are calculated based on our estimated net sales of remestemcel-L for the treatment of pediatric SR-aGVHD in the United States and other territories excluding Asia. Table of Contents 204
(3) In relation to the contractual maturities of the royalty payments related to contingent consideration, there is variability in the maturity profile of the anticipated future contractual cash flows given the timing and amount of payments are calculated based on our estimated net sales of remestemcel-L for the treatment of children and adults with aGVHD. Product royalties will be payable in cash which will be funded from royalties received from net sales. With respect to future milestone payments, contingent consideration will be payable in cash or shares at our discretion. The carrying amount reflects the discounted and probability adjusted contractual balance related to royalty payments. 11. Capital management The Group’s objective when managing capital is to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders. See Note 5(a) for the cash reserves of the Group as at the end of the financial reporting period. 12. Interests in other entities The Group’s subsidiaries as of June 30, 2024 and 2023 are set out below. Unless otherwise stated, they have share capital consisting solely of ordinary shares that are held directly by the Group, and the proportion of ownership interests held equals the voting rights held by the Group. The country of incorporation or registration is also their principal place of business, aside from BeiCell Ltd, which was incorporated in the Cayman Islands however operates in Hong Kong. Country of incorporation Class of shares Equity holding As of June 30, 2024 2023 % % Mesoblast, Inc. USA Ordinary 100 100 Mesoblast International Sàrl (includes Mesoblast International Sàrl Singapore Branch) Switzerland Ordinary 100 100 Mesoblast Australia Pty Ltd Australia Ordinary 100 100 Mesoblast UK Ltd United Kingdom Ordinary 100 100 BeiCell Ltd Cayman Islands Ordinary 100 100 13. Contingent assets and liabilities a. Contingent assets The Group did not have any contingent assets outstanding as of June 30, 2024 and June 30, 2023. b. Contingent liabilities (i) Central Adelaide Local Health Network Incorporated (“CALHNI”) (formerly Medvet) The Group acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with its use of the Medvet IP, on completion of certain milestones the Group will be obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments of up to $2.2 million and single-digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) single-digit royalties on net sales of the specified products for applications outside the specified fields. (ii) Other contingent liabilities The Group has entered into a number of other agreements with other third parties pertaining to intellectual property. Contingent liabilities may arise in the future if certain events or developments occur in relation to these Table of Contents 205
agreements. As of June 30, 2024, the Group has assessed these contingent liabilities to be remote and specific disclosure is not required. 14. Commitments a. Capital commitments The Group did not have any commitments for future capital expenditure outstanding as of June 30, 2024 and June 30, 2023. b. Purchase commitments In December 2019, the Group commenced production under its manufacturing service agreement with Lonza for the supply of commercial product for the potential approval and launch of remestemcel-L for the treatment of pediatric SR- aGVHD in the US market. This agreement contains lease and non-lease components. As of June 30, 2024, the agreement contains a minimum remaining financial commitment of the non-lease component of $9.1 million, payable until December 2025, which is cancellable in limited circumstances. The Group has accounted for the lease component within the agreement as a lease liability separately from the non-lease components. As of June 30, 2024, the lease component is $1.9 million on an undiscounted basis, as disclosed within the total contractual cash flows as lease liabilities in Note 10(c). At the Group's discretion, the minimum financial commitment under this manufacturing services agreement can be reduced by $4.9 million under certain conditions, with $1.0 million of this reduction relating to the lease component and $3.9 million relating to the non-lease component of the agreement. The group have agreements with third parties related to contract manufacturing and other goods and services. As of June 30, 2024, the Group had $3.4 million of non-cancellable purchase commitments related to raw materials, manufacturing agreements and other goods and services. This amount represents our minimum contractual obligations, including termination fees. Certain agreements provide for termination rights subject to termination fees. Under such agreement, the Group are contractually obligated to make certain payments, mainly, to reimburse them for their unrecoverable outlays incurred prior to cancellation. The Group did not have any other purchase commitments as of June 30, 2024. 15. Events occurring after the reporting period In July 2024, the Group resubmitted it's BLA with the FDA for approval of remestemcel-L in the treatment of children with SR-aGVHD and the FDA accepted the Group's BLA resubmission and set a PDUFA goal date of January 7, 2025. Assumptions associated with SR-aGVHD are included within the impairment assessment of Osiris MSC products within in-process research and development, contingent consideration, pre-launch inventory and the NovaQuest borrowings on the consolidated balance sheet and forecast net operating cash usage. In August 2024, the Group modified the short term incentive plan providing employees with the choice to elect into receiving an option grant in lieu of cash payment of their short term incentive entitlements for the years ended June 30, 2024 and 2023, which have been deferred to BLA approval. The level of participation and the terms of the modification are yet to be determined at the date of this report. In August 2024, the Group announced that the consolidated class action, filed in the Federal Court in Australia in 2022, has been resolved subject to Federal Court approval and includes no admission of liability. In relation to the settlement of the class action, which was assessed as an adjusting subsequent event, the Group recognized a provision for litigation settlement as of June 30, 2024 in the consolidated balance sheet (inclusive of interest and costs), refer to Note 6(d). Given the settlement will be funded entirely by Mesoblast's insurers, the Group has also recognized an insurance asset within trade and other receivables in the consolidated balance sheet as of June 30, 2024, refer to Note 5(b). There were no other events that have occurred after June 30, 2024 and prior to the signing of this financial report that would likely have a material impact on the financial results presented. Table of Contents 206
16. Related party transactions a. Parent entity The parent entity within the Group is Mesoblast Limited. b. Subsidiaries Details of interests in subsidiaries are disclosed in Note 12 to the financial statements. c. Key management personnel compensation The aggregate compensation made to Directors and other members of key management personnel ("KMP") of the Group is set out below: Year Ended June 30, (in U.S. dollars) 2024 2023 Short-term employee benefits 2,762,736 2,153,181 Long-term employee benefits 11,124 11,326 Post-employment benefits 18,900 23,935 Share based payments 1,704,995 881,342 4,497,755 3,069,784 The aggregate other service payments made to Directors and other members of key management personnel of the Group is set out below: Philip Krause has been a non-executive director of Mesoblast since March 2022. Philip Krause was appointed to a formal strategic advisory role on June 4, 2023 where he was remunerated at an hourly rate and the agreement was able to be terminated on 15 written days notice. The consulting agreement was in addition to Philip Krause's existing role as non- executive director. Philip Krause was determined not to be independent on August 28, 2023 and his director fees ceased from August 1, 2023. On October 1, 2023, Philip Krause's consulting agreement was amended, where he is now remunerated via a monthly retainer of $20,000 for strategic advisory services and his role as non-executive director and these fees are included in the table above. The agreement is ongoing, with either party able to terminate on 90 written days notice. The total aggregate fees paid to Philip Krause through the original consulting agreement for the year ended June 30, 2024 and 2023 was $220,900 and $110,383, respectively. There were no loans or other related transactions with KMP during the financial year. d. Transactions with other related parties Accounts receivable from revenues, accounts payable to expenses and loans from subsidiaries as at the end of the fiscal year have been eliminated on consolidation of the Group. e. Terms and conditions All other transactions were made on normal commercial terms and conditions and at market rates, except that there are no fixed terms for the repayment of loans between the parties. Outstanding balances are unsecured and are repayable in cash. 17. Share-based payments The Company has adopted an Employee Share Option Plan (“ESOP”) to foster an ownership culture within the Company and to motivate senior management and consultants to achieve performance targets. Selected directors, employees and consultants may be eligible to participate in ESOP at the absolute discretion of the board of directors, and in the case of directors, upon approval by shareholders. Table of Contents 207
Grant policy In accordance with the Company’s policy, options are typically issued in three equal tranches. The length of time from grant date to expiry date is typically 7 years. Options issued to employees generally vest based on performance or time conditions, or both. In the year ended June 30, 2024, senior executives were issued options that vest based on performance and time conditions. These options are required to satisfy certain pre-specified performance conditions and time-based vesting conditions prior to vesting. Time- based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. For time-based vesting options, the first tranche typically vests 12 months after grant date, the second tranche 24 months after grant date, and the third tranche 36 months after grant date. The exercise price is determined by reference to the Company policy. Generally the exercise price is the higher of the volume weighted average share price of the five ASX trading days up to Board approval of the grant, and the last closing price of an ordinary share on the ASX at Board approval. In the case of options that have time-based vesting conditions only, the board of directors adds a 10% premium to the market price. Options with performance based vesting conditions are issued with no premium. The board of directors’ policy is not to issue options at a discount to the market price. The aggregate number of options which may be issued pursuant to the ESOP must not exceed 10,000,000 with respect to US incentive stock options, and with respect to Australian residents, the limit imposed under the Australian Securities and Investments Commission Class Order 14/1000. a. Reconciliation of outstanding share based payments 35a 08-Jul-20 08-Jul-23 A$2.86 1,500,000 — (1,500,000) — — 36 06-Dec-16 05-Dec-23 A$1.31 533,000 — (533,000) — — 36a 06-Dec-16 05-Dec-23 A$1.19 1,950,730 — (1,950,730) — — 38 16-Sep-17 15-Sep-24 A$1.52 50,000 — — 50,000 50,000 39 13-Oct-17 12-Oct-24 A$1.92 975,000 — (160,000) 815,000 815,000 39a 13-Oct-17 12-Oct-24 A$1.74 902,425 — — 902,425 902,425 40 24-Nov-17 23-Nov-24 A$1.39 750,000 — — 750,000 750,000 40a 24-Nov-17 23-Nov-24 A$1.26 750,000 — — 750,000 — 41 18-Jun-18 17-Jun-25 A$1.50 200,000 — — 200,000 200,000 42 11-Jul-18 10-Jul-25 A$1.54 200,000 — — 200,000 200,000 43 18-Jul-18 17-Jul-25 A$1.85 3,133,332 — (135,000) 2,998,332 2,998,332 43b 18-Jul-18 17-Jul-25 A$1.85 350,000 — — 350,000 350,000 45 30-Nov-18 29-Nov-25 A$1.31 590,000 — — 590,000 590,000 46 19-Jan-19 18-Jan-26 A$1.43 3,333 — — 3,333 3,333 47 19-Jan-19 18-Jan-26 A$1.43 150,000 — — 150,000 150,000 48 04-Apr-19 03-Apr-26 A$1.46 300,000 — — 300,000 300,000 49 20-Jul-19 19-Jul-26 A$1.60 3,018,669 — (310,000) 2,708,669 2,708,669 49a 20-Jul-19 19-Jul-26 A$1.45 2,833,332 — — 2,833,332 1,883,332 49b 20-Jul-19 19-Jul-26 A$1.45 1,346,667 — — 1,346,667 673,334 49c 20-Jul-19 19-Jul-26 A$1.45 538,667 — — 538,667 538,667 50 20-Jul-19 19-Jul-26 A$1.45 700,000 — — 700,000 175,000 54 25-Nov-19 24-Nov-26 A$1.96 20,000 — — 20,000 20,000 55 29-May-19 28-May-26 A$1.46 350,000 — — 350,000 300,000 56 18-Nov-19 17-Nov-26 A$1.81 200,000 — — 200,000 200,000 57 25-Nov-19 24-Nov-26 A$1.78 100,000 — — 100,000 100,000 58 25-Nov-19 24-Nov-26 A$1.96 150,000 — — 150,000 150,000 59 24-Jan-20 23-Jan-27 A$3.36 10,000 — — 10,000 10,000 63 18-May-20 17-May-27 A$4.00 1,200,000 — — 1,200,000 1,200,000 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) Table of Contents 208
63a 18-May-20 17-May-27 A$3.63 1,200,000 — — 1,200,000 500,000 64 16-Jul-20 15-Jul-27 A$3.73 3,253,333 — (213,333) 3,040,000 3,040,000 64a 16-Jul-20 15-Jul-27 A$3.39 1,735,000 — — 1,735,000 478,334 64c 16-Jul-20 15-Jul-27 A$3.39 350,000 — — 350,000 116,666 64d 16-Jul-20 15-Jul-27 A$3.39 300,000 — — 300,000 200,000 64e 16-Jul-20 15-Jul-27 A$3.39 1,200,000 — — 1,200,000 720,000 66 11-Sep-20 10-Sep-27 A$4.76 200,000 — — 200,000 100,000 68 20-Nov-20 19-Nov-27 A$3.58 200,000 — — 200,000 200,000 69 20-Nov-20 19-Nov-27 A$3.58 100,000 — — 100,000 100,000 71 17-Feb-21 16-Feb-28 A$2.65 250,000 — — 250,000 250,000 72 15-Apr-21 14-Apr-28 A$2.26 200,000 — — 200,000 200,000 74 08-Sep-21 07-Sep-28 A$1.93 3,186,333 — (143,335) 2,929,666 1,942,003 74 08-Sep-21 07-Sep-28 A$1.93 (113,332) * 74a 08-Sep-21 07-Sep-28 A$1.75 3,850,000 — — 3,850,000 1,653,334 74b 08-Sep-21 07-Sep-28 A$1.75 1,550,000 — — 1,550,000 620,000 75 23-Dec-21 22-Dec-28 A$1.40 200,000 — — 200,000 200,000 76 17-Oct-22 16-Oct-29 A$1.01 1,250,000 — — 1,250,000 416,667 77 23-May-22 22-May-29 A$0.99 200,000 — — 200,000 133,334 78 24-Aug-22 23-Aug-29 A$0.83 200,000 — — 200,000 66,667 79 17-Oct-22 16-Oct-29 A$1.11 5,754,500 — (30,000) 5,054,500 1,668,167 79 17-Oct-22 16-Oct-29 A$1.11 (670,000) * 79a 17-Oct-22 16-Oct-29 A$1.01 4,350,000 — — 4,350,000 635,000 79b 17-Oct-22 16-Oct-29 A$1.11 225,000 — — 225,000 75,000 79c 17-Oct-22 16-Oct-29 A$1.01 3,225,000 — — 3,225,000 — 79d 17-Oct-22 16-Oct-29 A$1.01 1,200,000 — — 1,200,000 390,000 80 08-Aug-22 07-Aug-29 A$0.91 100,000 — — 100,000 100,000 81 11-Dec-20 10-Dec-27 A$4.58 100,000 — — 100,000 100,000 82 21-Nov-22 20-Nov-29 A$1.10 100,000 — — 100,000 33,334 83 30-Mar-23 29-Mar-30 A$1.01 150,000 — (105,000) * 45,000 15,000 84 30-Mar-23 29-Mar-30 A$0.92 — 600,000 — — 600,000 100,000 85 12-Oct-23 11-Oct-30 A$0.36 — 2,493,835 — — 2,493,835 831,279 86 12-Oct-23 11-Oct-30 A$0.36 — 1,853,889 — — 1,853,889 617,965 87 16-Oct-23 15-Oct-30 A$0.39 — 5,459,500 — (25,000) * 5,434,500 — 87a 16-Oct-23 15-Oct-30 A$0.35 — 1,995,000 — — 1,995,000 — 87b 16-Oct-23 15-Oct-30 A$0.35 — 3,160,000 — — 3,160,000 — 87c 16-Oct-23 15-Oct-30 A$0.35 — 2,730,000 — — 2,730,000 — 88 16-Oct-23 15-Oct-30 A$0.35 — 873,393 — — 873,393 291,131 89 24-Oct-23 23-Oct-30 A$0.37 — 985,000 — — 985,000 — 90 28-Feb-24 28-May-24 A$0.01 — 1,072,363 (1,072,363) — — — 92 16-Oct-23 15-Oct-30 A$0.35 — 300,000 — — 300,000 — 93 30-May-24 29-May-31 A$1.23 — 220,000 — — 220,000 — 94 30-May-24 29-May-31 A$1.23 — 200,000 — — 200,000 — June 30, 2024 57,434,321 21,942,980 (1,072,363) (5,888,730) 72,416,208 31,061,973 Weighted average share purchase price A$1.85 A$0.38 A$0.01 A$1.79 A$1.43 A$1.98 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) (1) The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per IFRS 2, refer to Note 17(c). Table of Contents 209
34 27-Apr-16 06-Mar-23 A$2.80 1,678,979 — — (1,678,979) — — 34b 31-Oct-16 06-Mar-23 A$2.80 200,000 — — (200,000) — — 35a 08-Jul-20 08-Jul-23 A$2.86 1,500,000 — — — 1,500,000 1,500,000 36 06-Dec-16 05-Dec-23 A$1.31 533,000 — — — 533,000 533,000 36a 06-Dec-16 05-Dec-23 A$1.19 1,950,730 — — — 1,950,730 1,809,064 38 16-Sep-17 15-Sep-24 A$1.54 50,000 — — — 50,000 50,000 38a 16-Sep-17 15-Sep-24 A$1.40 150,000 — — (150,000) — — 39 13-Oct-17 12-Oct-24 A$1.94 975,000 — — — 975,000 975,000 39a 13-Oct-17 12-Oct-24 A$1.76 902,425 — — — 902,425 902,425 40 24-Nov-17 23-Nov-24 A$1.41 750,000 — — — 750,000 750,000 40a 24-Nov-17 23-Nov-24 A$1.28 750,000 — — — 750,000 — 41 18-Jun-18 17-Jun-25 A$1.52 200,000 — — — 200,000 200,000 42 11-Jul-18 10-Jul-25 A$1.56 200,000 — — — 200,000 200,000 43 18-Jul-18 17-Jul-25 A$1.87 3,793,332 — — (660,000) 3,133,332 3,133,332 43b 18-Jul-18 17-Jul-25 A$1.87 350,000 — — — 350,000 350,000 45 30-Nov-18 29-Nov-25 A$1.33 590,000 — — — 590,000 590,000 46 19-Jan-19 18-Jan-26 A$1.45 3,333 — — — 3,333 3,333 47 19-Jan-19 18-Jan-26 A$1.45 150,000 — — — 150,000 150,000 48 04-Apr-19 03-Apr-26 A$1.48 300,000 — — — 300,000 300,000 49 20-Jul-19 19-Jul-26 A$1.62 3,098,670 — — (66,667) 3,018,669 3,018,669 49 20-Jul-19 19-Jul-26 A$1.62 — — (13,334) * 49a 20-Jul-19 19-Jul-26 A$1.47 3,499,998 — — (466,666) 2,833,332 1,883,332 49a 20-Jul-19 19-Jul-26 A$1.47 — — (200,000) * 49b 20-Jul-19 19-Jul-26 A$1.47 1,346,667 — — — 1,346,667 673,334 49c 20-Jul-19 19-Jul-26 A$1.47 538,667 — — — 538,667 538,667 50 20-Jul-19 19-Jul-26 A$1.47 700,000 — — — 700,000 175,000 50a 20-Jul-19 19-Jul-26 A$1.47 400,000 — — (400,000) * — — 52 29-Aug-19 28-Aug-26 A$1.62 400,000 — — (400,000) — — 53 29-Aug-19 28-Aug-26 A$1.47 800,000 — — (800,000) — — 54 25-Nov-19 24-Nov-26 A$1.98 153,334 — — (133,334) 20,000 20,000 55 29-May-19 28-May-26 A$1.48 350,000 — — — 350,000 300,000 56 18-Nov-19 17-Nov-26 A$1.83 200,000 — — — 200,000 200,000 57 25-Nov-19 24-Nov-26 A$1.80 100,000 — — — 100,000 100,000 58 25-Nov-19 24-Nov-26 A$1.98 450,000 — — (200,000) 150,000 150,000 58 25-Nov-19 24-Nov-26 A$1.98 — — (100,000) * 59 24-Jan-20 23-Jan-27 A$3.38 10,000 — — — 10,000 10,000 63 18-May-20 17-May-27 A$4.02 1,200,000 — — — 1,200,000 1,200,000 63a 18-May-20 17-May-27 A$3.65 2,400,000 — — (800,000) 1,200,000 200,000 63a 18-May-20 17-May-27 A$3.65 — — (400,000) * 64 16-Jul-20 15-Jul-27 A$3.75 3,498,333 — — (176,668) 3,253,333 2,160,009 64 16-Jul-20 15-Jul-27 A$3.75 — — (68,332) * 64a 16-Jul-20 15-Jul-27 A$3.41 2,700,000 — — (965,000) * 1,735,000 478,334 64c 16-Jul-20 15-Jul-27 A$3.41 350,000 — — — 350,000 116,666 64d 16-Jul-20 15-Jul-27 A$3.41 300,000 — — — 300,000 100,000 64e 16-Jul-20 15-Jul-27 A$3.41 1,200,000 — — — 1,200,000 720,000 65 26-Aug-20 25-Aug-27 A$5.76 5,000 — — (3,334) — — 65 26-Aug-20 25-Aug-27 A$5.76 — — (1,666) * 66 11-Sep-20 10-Sep-27 A$4.78 200,000 — — — 200,000 100,000 68 20-Nov-20 19-Nov-27 A$3.60 200,000 — — — 200,000 133,333 69 20-Nov-20 19-Nov-27 A$3.60 100,000 — — — 100,000 100,000 71 17-Feb-21 16-Feb-28 A$2.67 250,000 — — — 250,000 166,667 72 15-Apr-21 14-Apr-28 A$2.28 200,000 — — — 200,000 133,334 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) Table of Contents 210
74 08-Sep-21 07-Sep-28 A$1.77 3,423,000 — — (50,001) 3,186,333 1,051,007 74 08-Sep-21 07-Sep-28 A$1.77 — — (186,666) * 74a 08-Sep-21 07-Sep-28 A$1.77 4,150,000 — — (300,000) * 3,850,000 923,334 74b 08-Sep-21 07-Sep-28 A$1.77 1,550,000 — — — 1,550,000 — 74c 08-Sep-21 07-Sep-28 A$1.77 650,000 — — (650,000) * — — 75 23-Dec-21 22-Dec-28 A$1.42 200,000 — — — 200,000 100,000 76 17-Oct-22 16-Oct-29 A$1.03 — 1,250,000 — — 1,250,000 — 77 23-May-22 22-May-29 A$1.01 — 200,000 — — 200,000 66,667 78 24-Aug-22 23-Aug-29 A$0.85 — 200,000 — — 200,000 — 79 17-Oct-22 16-Oct-29 A$1.13 — 5,844,500 — (90,000) * 5,754,500 — 79a 17-Oct-22 16-Oct-29 A$1.03 — 4,350,000 — — 4,350,000 — 79b 17-Oct-22 16-Oct-29 A$1.13 — 225,000 — — 225,000 — 79c 17-Oct-22 16-Oct-29 A$1.03 — 3,225,000 — — 3,225,000 — 79d 17-Oct-22 16-Oct-29 A$1.03 — 1,200,000 — — 1,200,000 — 80 08-Aug-22 07-Aug-29 A$0.93 — 100,000 — — 100,000 100,000 81 11-Dec-20 10-Dec-27 A$4.60 — 100,000 — — 100,000 100,000 82 21-Nov-22 20-Nov-29 A$1.12 — 100,000 — — 100,000 — 83 30-Mar-23 29-Mar-30 A$1.03 — 180,000 — (30,000) * 150,000 — June 30, 2023 49,650,468 16,974,500 — (9,190,647) 57,434,321 26,464,507 Weighted average share purchase price A$2.21 A$1.08 A$— A$2.39 A$1.85 A$2.12 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) (1) The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per IFRS 2, refer to Note 17(c). 32 10-Jul-15 30-Jun-22 US$4.20 1,753,334 — — (1,753,334) — — 33 26-Aug-15 16-Aug-22 A$4.05 75,000 — — (75,000) — — 34 27-Apr-16 6-Mar-23 A$2.80 1,858,979 — — (180,000) 1,678,979 1,678,979 34b 31-Oct-16 6-Mar-23 A$2.80 200,000 — — — 200,000 200,000 35a 8-Jul-20 8-Jul-23 A$2.86 1,500,000 — — — 1,500,000 1,500,000 36 6-Dec-16 5-Dec-23 A$1.31 623,000 — (50,000) (40,000) 533,000 533,000 36a 6-Dec-16 5-Dec-23 A$1.19 1,950,730 — — — 1,950,730 1,809,064 38 16-Sep-17 15-Sep-24 A$1.54 50,000 — — — 50,000 50,000 38a 16-Sep-17 15-Sep-24 A$1.40 150,000 — — — 150,000 150,000 39 13-Oct-17 12-Oct-24 A$1.94 1,090,000 — — (115,000) 975,000 975,000 39a 13-Oct-17 12-Oct-24 A$1.76 902,425 — — — 902,425 902,425 40 24-Nov-17 23-Nov-24 A$1.41 750,000 — — — 750,000 750,000 40a 24-Nov-17 23-Nov-24 A$1.28 750,000 — — — 750,000 — 41 18-Jun-18 17-Jun-25 A$1.52 200,000 — — — 200,000 200,000 42 11-Jul-18 10-Jul-25 A$1.56 200,000 — — — 200,000 200,000 43 18-Jul-18 17-Jul-25 A$1.87 4,201,666 — (20,000) (388,334) 3,793,332 3,793,332 43b 18-Jul-18 17-Jul-25 A$1.87 350,000 — — — 350,000 350,000 44 15-Jul-18 14-Jul-25 A$1.72 150,000 — — (150,000) — — 45 30-Nov-18 29-Nov-25 A$1.33 590,000 — — — 590,000 590,000 46 19-Jan-19 18-Jan-26 A$1.45 3,333 — — — 3,333 3,333 47 19-Jan-19 18-Jan-26 A$1.45 150,000 — — — 150,000 150,000 48 4-Apr-19 3-Apr-26 A$1.48 300,000 — — — 300,000 300,000 49 20-Jul-19 19-Jul-26 A$1.62 3,638,671 — (113,334) (277,999) 3,098,670 1,940,654 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) Table of Contents 211
49 20-Jul-19 19-Jul-26 A$1.62 — (148,668) * 49a 20-Jul-19 19-Jul-26 A$1.47 3,999,998 — — (333,334) 3,499,998 1,316,665 49a 20-Jul-19 19-Jul-26 A$1.47 — (166,666) * 49b 20-Jul-19 19-Jul-26 A$1.47 1,346,667 — — — 1,346,667 673,334 49c 20-Jul-19 19-Jul-26 A$1.47 538,667 — — — 538,667 359,112 50 20-Jul-19 19-Jul-26 A$1.47 700,000 — — — 700,000 — 50a 20-Jul-19 19-Jul-26 A$1.47 400,000 — — — 400,000 — 51 29-Aug-19 28-Aug-26 A$1.47 150,000 — — (150,000) * — — 52 29-Aug-19 28-Aug-26 A$1.62 400,000 — — — 400,000 266,666 53 29-Aug-19 28-Aug-26 A$1.47 800,000 — — — 800,000 533,334 54 25-Nov-19 24-Nov-26 A$1.98 295,000 — — (25,000) 153,334 146,668 54 25-Nov-19 24-Nov-26 A$1.98 — (116,666) * 55 29-May-19 28-May-26 A$1.48 350,000 — — — 350,000 300,000 56 18-Nov-19 17-Nov-26 A$1.83 200,000 — — — 200,000 133,332 57 25-Nov-19 24-Nov-26 A$1.80 100,000 — — — 100,000 100,000 58 25-Nov-19 24-Nov-26 A$1.98 450,000 — — — 450,000 300,000 59 24-Jan-20 23-Jan-27 A$3.38 10,000 — — — 10,000 10,000 61 17-Apr-20 16-Apr-27 A$2.51 50,000 — — (16,666) — — 61 17-Apr-20 16-Apr-27 A$2.51 — (33,334) * 63 18-May-20 17-May-27 A$4.02 1,200,000 — — — 1,200,000 800,000 63a 18-May-20 17-May-27 A$3.65 2,400,000 — — — 2,400,000 400,000 64 16-Jul-20 15-Jul-27 A$3.75 4,280,000 — — (225,003) 3,498,333 1,201,676 64 16-Jul-20 15-Jul-27 A$3.75 (556,664) * 64a 16-Jul-20 15-Jul-27 A$3.41 3,050,000 — — (350,000) * 2,700,000 133,334 64b 16-Jul-20 15-Jul-27 A$3.41 325,000 — — (325,000) * — — 64c 16-Jul-20 15-Jul-27 A$3.41 350,000 — — — 350,000 — 64d 16-Jul-20 15-Jul-27 A$3.41 300,000 — — — 300,000 — 64e 16-Jul-20 15-Jul-27 A$3.41 1,200,000 — — — 1,200,000 — 65 26-Aug-20 25-Aug-27 A$5.76 5,000 — — — 5,000 1,667 66 11-Sep-20 10-Sep-27 A$4.78 200,000 — — — 200,000 100,000 67 8-Oct-20 7-Oct-27 A$3.84 200,000 — — (66,667) — — 67 8-Oct-20 7-Oct-27 A$3.84 — (133,333) * 68 20-Nov-20 19-Nov-27 A$3.60 200,000 — — — 200,000 66,666 69 20-Nov-20 19-Nov-27 A$3.60 100,000 — — — 100,000 100,000 71 17-Feb-21 16-Feb-28 A$2.67 250,000 — — — 250,000 — 72 15-Apr-21 14-Apr-28 A$2.28 — 200,000 — — 200,000 66,667 73 30-Jun-21 30-Aug-21 A$— 45,746 — (45,746) — — — 74 08-Sep-21 07-Sep-28 A$1.77 — 3,973,000 — (550,000) * 3,423,000 — 74a 08-Sep-21 07-Sep-28 A$1.77 — 4,150,000 — — 4,150,000 — 74b 08-Sep-21 07-Sep-28 A$1.77 — 1,550,000 — — 1,550,000 — 74c 08-Sep-21 07-Sep-28 A$1.77 — 650,000 — — 650,000 — 75 23-Dec-21 22-Dec-28 A$1.42 — 200,000 — — 200,000 — June 30, 2022 45,333,216 10,723,000 (229,080) (6,176,668) 49,650,468 23,084,908 Weighted average share purchase price A$2.42 A$1.77 A$1.25 A$2.99 A$2.21 A$2.06 Series Grant Date(1) Expiry Date Exercise Price Opening Balance Granted No. (during the year) Exercised No. (during the year) Lapsed/ Forfeited* No. (during the year) Closing Balance Vested and exercisable No (end of year) (1) The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per IFRS 2, refer to Note 17(c). The weighted average share price at the date of exercise of options exercised during the years ended June 30, 2024, 2023 and 2022 were A$0.93, N/A and A$1.82 respectively. The weighted average remaining contractual life of share options outstanding as of June 30, 2024, 2023 and 2022 were 4.24 years, 4.13 years and 4.16 years, respectively. Table of Contents 212
b. Existing share-based payment arrangements General terms and conditions attached to share based payments Share options pursuant to the employee share option plan are generally granted in three equal tranches. The length of time from grant date to expiry date is typically seven years. Vesting occurs based on achievement of performance conditions and/or progressively over the life of the option with the first tranche vesting one year from grant date, the second tranche two years from grant date, and the third tranche three years from grant date. On cessation of employment the Company’s board of directors determines if a leaver is a bad leaver or not. If a participant is deemed a bad leaver, all rights, entitlements and interests in any unexercised options held by the participant will be forfeited and will lapse immediately. If a leaver is not a bad leaver they may retain vested options, however, they must be exercised within 60 days of cessation of employment (or within a longer period if so determined by the Company’s board of directors), after which time they will lapse. Unvested options will normally be forfeited and lapse. This policy applies to all issues shown in the above table with the exception of the following: 35a Additional incentive rights granted pursuant to the Amendment Deed of the Equity Facility Agreement with Kentgrove Capital, dated July 30, 2019, had fully vested on the agreement date and will expire thirty six months after the date of the issue of the incentive right. 36a Options were granted in two or three equal tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. 49a, 49b, 50, 50a, 53, 64b, 64c, 64d, 64e, 71, 74a, 74b, 74c, 79c, 84, 87a, 89, 94 Options were granted in two or three equal tranches and are required to satisfy certain pre-specified performance conditions and time-based vesting conditions prior to vesting. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 38a, 40a, 57 & 66 Options were granted in one tranche and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. 39a Options were granted in one or two equal tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. 51 & 75 Options were granted in two equal tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. 55 Options were granted in five tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. 63a Options were granted in three or eight tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 64a Options were granted in one, two, three or five tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 69, 73, 80, 81 & 90 Options were granted in one tranche and vested on the date on which board approval was obtained Table of Contents 213
79a, 79d Options were granted in two, three, four or five tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company's board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 85, 86, 88, 93 Options were granted in three equal tranches and are required to satisfy time-based vesting conditions. Time-based conditions restrict vesting to a maximum of one third at 6 months, two thirds at 9 months and full grant at 12 months. 87c Options were granted in three tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 87b Options were granted in four or five tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. 92 Options were granted in four tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions have been met. Modifications to share-based payment arrangements During the year ended June 30, 2024, as a result of a 1 for 4 pro-rata accelerated non-renounceable entitlement offer to existing eligible shareholders in December 2023, the exercise price of all outstanding options at the time was reduced by A$0.02 per option subject to the ESOP plan under clause 8.3. There were no further modifications made to share-based payment arrangements during the years ended June 30, 2024, June 30, 2023, and June 30, 2022. c. Fair values of share based payments The weighted average fair value of share options granted during the years ended June 30, 2024, 2023 and 2022 were A$0.39, A$0.66 and A$0.56, respectively. The fair value of all shared-based payments made has been calculated using the Black-Scholes model. This model requires the following inputs: Share price at acceptance date The share price used in valuation is the share price at the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement or at shareholder approval date where this approval is required. This price is generally the volume weighted average share price for the five trading days leading up to the date. Exercise price The exercise price is a known value that is contained in the agreements. Share price volatility The model requires the Company’s share price volatility to be measured. In estimating the expected volatility of the underlying shares our objective is to approximate the expectations that would be reflected in a current market or negotiated exchange price for the option. Historical volatility data is considered in determining expected future volatility. Table of Contents 214
Life of the option The life is generally the time period from grant date through to expiry. Certain assumptions have been made regarding “early exercise” i.e. options exercised ahead of the expiry date. These assumptions have been based on historical trends for option exercises within the Company and take into consideration exercise trends that are also evident as a result of local taxation laws. Dividend yield The Company has yet to pay a dividend so it has been assumed the dividend yield on the shares underlying the options will be 0%. Risk free interest rate This has been sourced from the Reserve Bank of Australia historical interest rate tables for government bonds. Model inputs The model inputs for the valuations of options approved and granted during the year ended June 30, 2024 are as follows: Series Valuation date(1) Exercise price per share A$ Share price at valuation date A$ Expected share price volatility Life(2) Dividend yield Risk-free interest rate 84 31-Jul-23 0.92 1.18 64.95% 6.1 yrs 0% 3.84% 85 28-Nov-23 0.36 0.39 69.82% 6.3 yrs 0% 4.21% 86 28-Nov-23 0.36 0.39 69.82% 6.3 yrs 0% 4.21% 87 09-Jan-24 0.39 0.29 70.10% 6.2 yrs 0% 3.79% 87a 03-Jun-24 0.35 1.17 72.84% 5.8 yrs 0% 4.07% 87b 12-Jan-24 0.35 0.29 70.07% 6.1 yrs 0% 3.74% 87c(3) 30-Jun-24 0.35 0.99 72.72% 5.7 yrs 0% 4.08% 88 15-Nov-23 0.35 0.37 69.82% 6.3 yrs 0% 4.23% 89 28-Nov-23 0.37 0.39 69.82% 6.3 yrs 0% 4.21% 90 28-Feb-24 0.01 0.30 69.97% 0.2 yrs 0% 3.80% 92 11-Apr-24 0.35 0.89 72.66% 5.9 yrs 0% 3.90% 93 03-Jun-24 1.23 1.17 72.84% 6.4 yrs 0% 4.07% 94(3) 30-Jun-24 1.23 0.99 72.72% 6.3 yrs 0% 4.08% (1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement. (2) Expected life after factoring likely early exercise. (3) Fair value estimated at June 30, 2024 as the valuation date under AASB2 has not been met as of June 30, 2024. The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2024 was A$0.99. Table of Contents 215
The model inputs for the valuations of options approved and granted during the year ended June 30, 2023 are as follows: Series Valuation date(1) Exercise price per share A$ Share price at valuation date A$ Expected share price volatility Life(2) Dividend yield Risk-free interest rate 76 23-Nov-22 1.03 0.99 65.37% 6.3 yrs 0% 3.38% 77 23-Nov-22 1.01 0.99 65.37% 5.9 yrs 0% 3.38% 78 23-Nov-22 0.85 0.99 65.37% 6.1 yrs 0% 3.38% 79 09-Dec-22 1.13 1.04 65.43% 6.2 yrs 0% 3.11% 79a 21-Jun-23 1.03 1.18 65.04% 5.8 yrs 0% 3.88% 79b 16-Mar-23 1.13 0.97 65.29% 6.0 yrs 0% 2.99% 79c 23-Nov-22 1.03 0.99 65.37% 6.3 yrs 0% 3.38% 79d 07-Jul-23 1.01 1.15 64.98% 5.7 yrs 0% 4.19% 80 18-Nov-22 0.93 0.95 65.35% 6.1 yrs 0% 3.35% 81 18-Nov-22 4.60 0.95 65.35% 4.6 yrs 0% 3.35% 82 30-Dec-22 1.12 0.89 65.31% 6.3 yrs 0% 3.70% 83 06-Apr-23 1.03 0.97 65.17% 6.4 yrs 0% 2.90% (1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement. (2) Expected life after factoring likely early exercise. The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2023 was A$1.14. The model inputs for the valuations of options approved and granted during the year ended June 30, 2022 are as follows: Series Valuation date(1) Exercise price per share A$ Share price at valuation date A$ Expected share price volatility Life(2) Dividend yield Risk-free interest rate 72 05-May-21 2.28 1.94 66.62% 6.3 yrs 0% 0.69% 74 10-Nov-21 1.95 1.69 65.85% 6.2 yrs 0% 1.31% 74a 07-Nov-22 1.77 0.93 65.41% 5.3 yrs 0% 3.55% 74b 07-Nov-22 1.77 0.93 65.41% 5.3 yrs 0% 3.55% 74c 15-Feb-22 1.77 1.16 65.89% 5.9 yrs 0% 1.91% 75 17-Mar-22 1.42 1.21 65.98% 6.1 yrs 0% 2.18% (1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the arrangement. (2) Expected life after factoring likely early exercise. The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2022 was A$0.61. Table of Contents 216
18. Remuneration of auditors During the year the following fees were paid or payable for services provided by the auditor of the parent entity, its related practices and non-related audit firms: Year Ended June 30, (in U.S. dollars) 2024 2023 2022 a. PricewaterhouseCoopers Australia Audit and other assurance services Audit and review of financial reports 623,605 669,603 745,021 Other audit services(1) 33,180 180,339 67,238 Total remuneration of PricewaterhouseCoopers Australia 656,785 849,942 812,259 b. Network firms of PricewaterhouseCoopers Australia Audit and other assurance services Audit and review of financial reports 65,722 144,864 133,309 Total remuneration of Network firms of PricewaterhouseCoopers Australia 65,722 144,864 133,309 Total auditors' remuneration(2) 722,507 994,806 945,568 (1) Other audit services relates to services performed in connection with the filing of registration statements on the Form F-3. (2) All services provided are considered audit fees for the purpose of SEC classification. Table of Contents 217
19. Losses per share Years Ended June 30, 2024 2023 2022 (Losses) per share (in cents) (a) Basic (losses) per share From continuing operations attributable to the ordinary equity holders of the company (8.91) (10.53) (13.38) Total basic (losses) per share attributable to the ordinary equity holders of the company (8.91) (10.53) (13.38) (b) Diluted (losses) per share From continuing operations attributable to the ordinary equity holders of the company (8.91) (10.53) (13.38) Total basic (losses) per share attributable to the ordinary equity holders of the company (8.91) (10.53) (13.38) (c) Reconciliation of (losses) used in calculating (losses) per share (in U.S. dollars, in thousands) Basic (losses) per share (Losses) attributable to the ordinary equity holders of the company used in calculating basic (losses) per share: From continuing operations (87,956) (81,889) (91,347) Diluted (losses) per share (Losses) from continuing operations attributable to the ordinary equity holders of the company: Used in calculating basic (losses) per share (87,956) (81,889) (91,347) (Losses) attributable to the ordinary equity holders of the company used in calculating diluted losses per share (87,956) (81,889) (91,347) 2024 Number 2023 Number 2022 Number Weighted average number of ordinary shares used as the denominator in calculating basic losses per share 986,702,919 777,719,091 682,861,425 Weighted average number of ordinary shares and potential ordinary shares used in calculating diluted losses per share 986,702,919 777,719,091 682,861,425 Options granted to employees and warrants (see Note 17) are considered to be potential ordinary shares. These securities have been excluded from the determination of basic losses per shares in the years ended June 30, 2024, 2023 and 2022. Shares that may be paid as contingent consideration have also been excluded from basic losses per share. They have also been excluded from the calculation of diluted losses per share because they are anti-dilutive for the years ended June 30, 2024, 2023 and 2022. The calculations for the years ended June 30, 2023 and 2022 have been adjusted to reflect the bonus element in the entitlement offer to existing eligible shareholders which occurred during December 2023. Table of Contents 218
20. Parent entity financial information a. Summary financial information The parent entity financial information disclosure is an Australian Disclosure Requirement as required by Corporations Regulations 2001. The individual financial statements for the parent entity show the following aggregate amounts: As of June 30, (in U.S. dollars, in thousands) 2024 2023 Balance Sheet Current Assets 37,166 28,850 Total Assets 958,323 890,120 Current Liabilities 30,709 11,941 Total Liabilities 33,358 15,282 Shareholders' Equity Issued Capital 1,310,813 1,249,123 Reserves Foreign Currency Translation Reserve (261,745) (261,377) Share Options Reserve 91,940 86,274 Warrant Reserve 12,969 12,969 (Accumulated losses)/retained earnings (229,012) (212,165) 924,965 874,824 Loss for the period (16,847) (18,848) Total comprehensive loss for the period (16,847) (18,848) b. Contingent liabilities of the parent entity (i) Central Adelaide Local Health Network Incorporated (“CALHNI”) (formerly Medvet) Mesoblast Limited acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with its use of the Medvet IP, on completion of certain milestones Mesoblast Limited will be obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments of up to $2.2 million and single- digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) single-digit royalties on net sales of the specified products for applications outside the specified fields. 21. Segment information Operating segments are identified on the basis of whether the allocation of resources and/or the assessment of performance of a particular component of the Company’s activities are regularly reviewed by the Company’s chief operating decision maker as a separate operating segment. By these criteria, the activities of the Company are considered to be one segment being the development of cell technology platform for commercialization, and the segmental analysis is the same as the analysis for the Company as a whole. The chief operating decision maker (Chief Executive Officer) reviews the consolidated income statement, consolidated balance sheet, and statement of cash flows regularly to make decisions about the Company’s resources and to assess overall performance. Table of Contents 219
22. Legal proceedings A class action proceeding in the Federal Court of Australia was served on the Company in May 2022 by the law firm William Roberts Lawyers on behalf of persons who, between February 22, 2018, and December 17, 2020, acquired an interest in Mesoblast shares, American Depository Receipts, and/or related equity swap arrangements. In June 2022, the firm Phi Finney McDonald commenced a second shareholder class action against the Company in the Federal Court of Australia asserting similar claims arising during the same period. The Australian class actions relate to the Complete Response Letter released by the FDA in September 2020 in relation to the Company's GvHD product candidate; they also relate to certain representations made by the Company in relation to our COVID-19 product candidate and the decline in the market price of the Company's ordinary shares in December 2020. The Australian class actions have been consolidated into one lawsuit. On August 21, 2024, the Company announced that the class action had been resolved subject to Federal Court approval and includes no admission of liability. In relation to the settlement of the class action, which was assessed as an adjusting subsequent event, the Group recognized a provision for litigation settlement as of June 30, 2024 in the consolidated balance sheet (inclusive of interest and costs), refer to Note 6(d). Given the settlement will be funded entirely by Mesoblast's insurers, the Group has also recognized an insurance asset within trade and other receivables in the consolidated balance sheet as of June 30, 2024, refer to Note 5(b)(i). 23. Summary of material accounting policies This note provides the principal accounting policies adopted in the preparation of these consolidated financial statements as set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. The financial statements are for the consolidated entity consisting of Mesoblast Limited and its subsidiaries. a. Change in accounting policies There were no new accounting policies adopted by the Group that materially impacted the Group in the year ended June 30, 2024. b. Principles of consolidation i. Subsidiaries The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Mesoblast Limited (“Company” or “Parent Entity”) as of June 30, 2024 and the results of all subsidiaries for the year then ended. Mesoblast Limited and its subsidiaries together are referred to in this financial report as the Group or the consolidated entity. Subsidiaries are all entities (including structured entities) over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that control ceases. The acquisition method of accounting is used to account for business combinations by the Group. Intercompany transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. ii. Employee share trust The Group has formed a trust to administer the Group’s employee share scheme. This trust is consolidated, as the substance of the relationship is that the trust is controlled by the Group. c. Segment reporting The Group operates in one segment as set out in Note 21. Table of Contents 220
d. Foreign currency translation (i) Functional and presentation currency Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (the “functional currency”). The functional currency of Mesoblast Limited is A$. The consolidated financial statements are presented in US$, which is the Group’s presentation currency. (ii) Translations and balances Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the transaction at period end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in net loss, except when they are deferred in equity as qualifying cash flow hedges and qualifying net investment hedges or attributable to part of the net investment in a foreign operation. Non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair value through profit or loss are recognized in net loss as part of the fair value gain or loss and translation differences on non-monetary assets such as equities classified as financial assets at fair value are recognized in other comprehensive income. (iii) Group companies The results and financial position of all the Group entities (none of which has the currency of a hyperinflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows: • assets and liabilities for the consolidated balance sheets presented are translated at the closing rate at the date of that consolidated balance sheets; • income and expenses for the statements of comprehensive income are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and • all resulting exchange differences are recognized in other comprehensive income. (iv) Other On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings and other financial instruments designated as hedges of such investments, are recognized in other comprehensive income. When a foreign operation is sold or any borrowings forming part of the net investment are repaid, the associated exchange differences are reclassified to net loss, as part of the gain or loss on sale. Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities of the foreign entities and translated at the closing rate. e. Revenue recognition Revenue from contracts with customers is measured and recognized in accordance with the five step model prescribed by IFRS 15 Revenue from Contracts with Customers. First, contracts with customers within the scope of IFRS 15 are identified. Distinct promises within the contract are identified as performance obligations. The transaction price of the contract is measured based on the amount of consideration the Group expect to be entitled from the customer in exchange for goods or services. Factors such as requirements around variable consideration, significant financing components, noncash consideration, or amounts payable to customers also determine the transaction price. The transaction is then allocated to separate performance obligations in the contract based on relative standalone selling prices. Revenue is recognized when, or as, performance obligations are satisfied, which is when control of the promised good or service is transferred to the customer. Table of Contents 221
Revenues from contracts with customers comprise commercialization and milestone revenue. (i) Commercialization and milestone revenue Commercialization and milestone revenue generally includes non-refundable upfront license and collaboration fees; milestone payments, the receipt of which is dependent upon the achievement of certain clinical, regulatory or commercial milestones; as well as royalties on product sales of licensed products, if and when such product sales occur; and revenue from the supply of products. Payment is generally due on standard terms of 30 to 60 days. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue or deferred consideration in our consolidated balance sheets, depending on the nature of arrangement. Amounts expected to be recognized as revenue within the 12 months following the consolidated balance sheet date are classified within current liabilities. Amounts not expected to be recognized as revenue within the 12 months following the consolidated balance sheet date are classified within non-current liabilities. Milestone revenue The Group applies the five-step method under the standard to measure and recognize milestone revenue. The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is therefore considered variable consideration. The Group estimate the transaction price of the contingent milestone using the most likely amount method. The Group include in the transaction price some or all of the amount of the contingent milestone only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the contingent milestone is subsequently resolved. Milestone payments that are not within the control of the Company, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are received. Any changes in the transaction price are allocated to all performance obligations in the contract unless the variable consideration relates only to one or more, but not all, of the performance obligations. When consideration for milestones is a sale-based or usage-based royalty that arises from licenses of IP (such as cumulative net sales targets), revenue is recognized at the later of when (or as) the subsequent sale or usage occurs, or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Licenses of intellectual property When licenses of IP are distinct from other goods or services promised in the contract, the Group recognize the transaction price allocated to the license as revenue upon transfer of control of the license to the customer. The Group evaluate all other promised goods or services in the license agreement to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. The transaction price allocated to the license performance obligation is recognized based on the nature of the license arrangement. The transaction price is recognized over time if the nature of the license is a “right to access” license. This is when the Group undertake activities that significantly affect the IP to which the customer has rights, the rights granted by the license directly expose the customer to any positive or negative effects of our activities, and those activities do not result in the transfer of a good or service to the customer as those activities occur. When licenses do not meet the criteria to be a right to access license, the license is a “right to use” license, and the transaction price is recognized at the point in time when the customer obtains control over the license. Sales-based or usage-based royalties Licenses of IP can include royalties that are based on the customer’s usage of the IP or sale of products that contain the IP. The Group apply the specific exception to the general requirements of variable consideration and the constraint on variable consideration for sales-based or usage-based royalties promised in a license of IP. The exception requires such revenue to be recognized at the later of when (or as) the subsequent sale or usage occurs and the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Table of Contents 222
Grünenthal arrangement In September 2019, the Group entered into a strategic partnership with Grünenthal for the development and commercialization in Europe and Latin America of the Group’s allogeneic mesenchymal precursor cell (“MPC”) product, MPC-06-ID, receiving exclusive rights to the Phase 3 allogeneic product candidate for the treatment of low back pain due to degenerative disc disease. The Group received a non-refundable upfront payment of $15.0 million in October 2019, on signing of the contract with Grünenthal. The Group received a milestone payment in December 2019 of $2.5 million in relation to meeting a milestone event as part of the strategic partnership with Grünenthal. In June 2022, the Group amended the strategic partnership with Grünenthal and is eligible to receive payments up to US$112.5 million prior to product launch, inclusive of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies and patient adoption. The Group will also receive tiered double-digit royalties on product sales as per the original agreement. The $2.5 million milestone payment received in December 2019 from Grünenthal was considered deferred consideration as of June 30, 2024, as the performance obligation has not been met. There was no milestone revenue recognized in relation to this strategic partnership with Grünenthal in the years ended June 30, 2024, 2023 and 2022. Tasly arrangement In July 2018, the Group entered into a strategic alliance with Tasly Pharmaceutical Group (“Tasly”) for the development, manufacture and commercialization in China of the Group’s allogeneic MPC products, MPC-150-IM and MPC-25-IC. Tasly received all exclusive rights for MPC-150-IM and MPC-25-IC in China and Tasly will fund all development, manufacturing and commercialization activities in China. The Group received a $20.0 million upfront technology access fee from Tasly upon closing of this strategic alliance in October 2018. The Group recognized $10.0 million from this $20.0 million up-front technology access fee at closing in October 2018 and the remaining $10.0 million was recognized in revenue in February 2020. The Group is also entitled to receive $25.0 million on product regulatory approvals in China, double-digit escalating royalties on net product sales and up to six escalating milestone payments when the product candidates reach certain sales thresholds in China. For the years ended June 30, 2024, 2023 and 2022, no revenue was recognized in relation to this strategic alliance with Tasly. TiGenix arrangement In December 2017, the Group entered into a patent license agreement with TiGenix NV (“TiGenix”), now a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”), which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived MSC product, Alofisel® a registered trademark of TiGenix, previously known as Cx601, for the local treatment of fistulae. The agreement includes the right for Takeda to grant sub-licenses to affiliates and third parties. As part of the agreement, the Group received $5.9 million (€5.0 million) before withholding tax as a non-refundable up-front payment, a further payment of $5.9 million (€5.0 million) before withholding tax 12 months after the patent license agreement date, and a further $1.2 million (€1.0 million) product regulatory milestone payment in the year ended June 30, 2022. The Group is entitled to further payments up to €9.0 million when Takeda reaches certain product regulatory milestones. Additionally, the Group receive single digit royalties on net sales of Alofisel®. In the years ended June 30, 2024, 2023 and 2022, the Group earned $0.4 million, $0.4 million and $0.3 million, respectively, of royalty income on sales of Alofisel® by our licensee Takeda. No milestone revenue was recognized in the years ended June 30, 2024 and 2023 in relation to the Group's patent license agreement with Takeda entered into in December 2017. In the year ended June 30, 2022, $1.2 million milestone revenue was recognized with regards to the €1.0 million regulatory milestone payment receivable from Takeda given Takeda received approval to manufacture and market Alofisel® (darvadstrocel) in Japan for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s Disease. Table of Contents 223
JCR arrangement In October 2013, the Group acquired all of the culture-expanded, MSC-based assets from Osiris. These assets included assumption of a collaboration agreement with JCR, a research and development oriented pharmaceutical company in Japan. Revenue recognized under this agreement is limited to the amount of cash received or for which the Group is entitled, as JCR has the right to terminate the agreement at any time. Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. Under the JCR Agreement, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the treatment of hematological malignancies by the use of hematopoietic stem cells derived from peripheral blood, cord blood or bone marrow, or the First JCR Field; and non-exclusive for developing assays that use liver cells for non-clinical drug screening and evaluation, or the Second JCR Field. With respect to the First JCR Field, the Group are entitled to payments when JCR reaches certain commercial milestones and to escalating double-digit royalties in the twenties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, the Group are entitled to an approximately 50% profit share. The Group expanded our partnership with JCR in Japan for two new indications: for wound healing in patients with Epidermolysis Bullosa (“EB”) in October 2018, and for neonatal hypoxic ischemic encephalopathy (“HIE”), a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019. The Group will receive royalties on TEMCELL product sales for licensed indications, if and when JCR begins selling TEMCELL for such indications in Japan. The Group applies the sales-based and usage-based royalty exception for licenses of intellectual property and therefore recognizes royalty revenue at the later of when the subsequent sale or usage occurs and the associated performance obligation has been satisfied. In the years ended June 30, 2024, 2023 and 2022, the Group recognized $5.5 million, $7.1 million, and $8.7 million in commercialization revenue, respectively, relating to royalty income earned on sales of TEMCELL in Japan by our licensee JCR. These amounts were recorded in revenue as there are no further performance obligations required in regards to these items. (ii) Interest income Interest income is accrued on a time basis by reference to the principal outstanding and at the effective interest rate applicable, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to that asset’s net carrying amount. (iii) Research and development tax incentive Tax incentives comprise payments from the Australian government’s Innovation Australia Research and Development Tax Incentive program for research and development activities conducted in relation to our qualifying research that meets the regulatory criteria. The research and development tax incentive credit is available for the Group's research and development activities in Australia. Eligible companies can receive a refundable tax offset for a percentage of their research and development spending. The research and development tax incentive credit is available for the Group’s research and development activities in Australia as well as research and development activities outside of Australia to the extent such non-Australian based activities relate to intellectual property owned by our Australian resident entities do not exceed half the expenses for the relevant activities and are approved by the Australian government. Eligible companies can receive a refundable tax offset for a percentage of their research and development spending. In October 2020, the Australian Government introduced new legislation for the tax offset applicable to eligible companies for income tax years commencing from July 1, 2021. Per the new legislation, the tax offset for companies with an aggregated turnover of A$20.0 million or more is the Company’s corporate tax rate plus a rate between 8.5% and 16.5% depending on the proportion of research and development expenditures in relation to total expenditures. For companies with an aggregated turnover below A$20.0 million, the refundable research and development tax offset is 18.5% above the Company's tax rate. The Group recorded $0.9 million and $3.5 million and $nil in research and development tax incentive income for the years ended June 30, 2024, 2023 and 2022, respectively. Within the $3.5 million recognized in the year ended June 30, 2023, $1.2 million pertained to the year ended June 30, 2023, $1.1 million pertained to the year ended June 30, 2022 and $1.2 million pertained to the year ended June 30, 2021. Management concluded it's assessment of qualifying activities during the year ended June 30, 2023 and recognized the relevant income for the years ended June 30, 2023, 2022 and 2021. Table of Contents 224
No income was recognized in the years ended June 30, 2022 and 2021 as management were yet to confirm if the Group's research and development activities were eligible under the incentive scheme. f. Inventories Inventories are included in the financial statements at the lower of cost (including raw materials, direct labour, other direct costs and related production overheads) and net realizable value. Pre-launch inventory is held as an asset when there is a high probability of regulatory approval for the product in accordance with IAS 2 Inventories. Before that point, a provision is made against the carrying value to its recoverable amount in accordance with IAS 2 Inventories; the provision is then reversed at the point when a high probability of regulatory approval is determined. The Group considers a number of factors in determining the probability of the product candidate realizing future economic benefit, including the product candidate’s current status in the regulatory approval process, results from the related pivotal clinical trial, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, the market need, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, commercialization and market trends. When a provision is made against the carrying value of pre-launch inventory the costs are recognized within Manufacturing Commercialization expenses. When the high probability threshold is met, the provision will be reversed through Manufacturing Commercialization expenses. All inventory costs are currently fully provided for and are recognized within Manufacturing Commercialization expenses. Where it is determined that the pre-launch inventory will be used within a clinical trial, that amount is removed from the cost of pre-launch inventory. There is no impact on the consolidated income statement as the carrying value has been previously fully provided for. As of June 30, 2024 and June 30, 2023, there was $19.2 million and $22.4 million of pre-launch inventory recognized on the consolidated balance sheet that was fully provided for, respectively. The future commercial use of the remaining pre-launch inventory recognized on the consolidated balance sheet will be dependent on future discussions with the FDA and remains fully provided for. For the year ended June 30, 2024, $3.2 million of pre-launch inventory was used for chemistry and manufacturing controls ("CMC") and research and development activities. For the years ended June 30, 2023 and 2022, $3.5 million and $7.0 million of pre-launch inventory costs have been recognized within Manufacturing Commercialization expenses in relation to the provision against the carrying value of pre-launch inventory, respectively. g. Research and development undertaken internally The Group currently does not have any capitalized development costs. Research expenditure is recognized as an expense as incurred. Costs incurred on development projects, which consist of preclinical and clinical trials, manufacturing development, and general research, are recognized as intangible assets when it is probable that the project will, after considering its commercial and technical feasibility, be completed and generate future economic benefits and its costs can be measured reliably. The expenditure capitalized comprises all directly attributable costs, including costs of materials, services, direct labor and an appropriate proportion of overheads. Other development costs that do not meet these criteria are expensed as incurred. Development costs previously recognized as expenses, are not recognized as an asset in a subsequent period and will remain expensed. Capitalized development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight-line basis over its useful life. h. Income tax The income tax expense or benefit for the period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses. The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Group’s subsidiaries and associates operate and generate taxable income. Table of Contents 225
Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities. Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, the deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination or lease transaction that at the time of the transaction affects neither accounting, nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized or the deferred income tax liability is settled. Deferred tax assets are recognized for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilize those temporary differences and losses. Deferred tax assets are only recognized to the extent that there are sufficient deferred tax liabilities unwinding. Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount and tax bases of investments in controlled entities where the parent entity is able to control the timing of the reversal of the temporary differences and it is probable that the differences will not reverse in the foreseeable future. Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities and when the deferred tax balances relate to the same taxation authority. Current tax assets and tax liabilities are offset where the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously. Current and deferred tax is recognized in net loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively. Pillar Two legislation has been enacted or substantially enacted in certain jurisdictions in which the Group operates. However, this legislation does not apply to the Group as its consolidated revenue is less than the threshold of €750 million. i. Business combinations The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments or other assets are acquired. The consideration transferred for the acquisition of a subsidiary comprises the fair values of the assets transferred, the liabilities incurred and the equity interests issued by the Group. The consideration transferred also includes the fair value of any asset or liability resulting from a contingent consideration arrangement and the fair value of any pre-existing equity interest in the subsidiary. Acquisition-related costs are expensed as incurred. Identifiable assets acquired and liabilities and contingent liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date. On an acquisition-by-acquisition basis, the Group recognizes any noncontrolling interest in the acquiree either at fair value or at the non-controlling interest’s proportionate share of the acquiree’s net identifiable assets. The excess of the consideration transferred and the amount of any non-controlling interest in the acquiree over the fair value of the net identifiable assets acquired is recorded as goodwill. If those amounts are less than the fair value of the net identifiable assets of the subsidiary acquired and the measurement of all amounts has been reviewed, the difference is recognized directly in net loss as a bargain purchase. Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate used is the entity’s incremental borrowing rate, being the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and conditions. Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are subsequently remeasured to fair value with changes in fair value recognized in profit or loss. Table of Contents 226
j. Impairment of assets Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested annually for impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to dispose and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from other assets or groups of assets (cash-generating units). Non-financial assets (other than goodwill) that have suffered impairment are reviewed for possible reversal of the impairment at the end of each reporting period. Management maintains internal valuations of each asset annually (or more frequently should indicators of impairment be identified) and valuations from independent experts are requested periodically, within every three year period. The internal valuations are continually reviewed by management and consideration is given as to whether there are indicators of impairment which would warrant impairment testing. An external valuation of our assets was carried out by an independent expert as at March 31, 2023 with the recoverable amount of each asset exceeding its carrying amount. In August 2023,the FDA issued a CRL to the Group's BLA for remestemcel-L for the treatment of pediatric SR- aGVHD and the Group considered this to be an impairment indicator that could cause the carrying amount of its intangible assets to exceed its recoverable amounts. As a result, the Group completed an impairment assessment on its MSC products and intangible asset and goodwill, which considered the impact of the FDA's CRL. An external valuation was also obtained for the MSC products for the impairment assessment performed as a result of the receipt of the CRL. No impairment of the in-process research and development and goodwill was identified. In July 2024, as discussed in Note 15, the Group resubmitted its BLA for approval of remestemcel-L for the treatment of pediatric SR-aGVHD, and the FDA accepted the Group's BLA resubmission and set a PDUFA goal date of January 7, 2025. The outcome from the FDA decision on the Group's BLA resubmission could lead to a change in the assumptions used within the impairment assessment associated with SR-aGVHD that could cause the carrying amount of our intangible asset to exceed its recoverable amount. k. Cash and cash equivalents For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term and highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value. l. Trade and other receivables Trade receivables and other receivables represent the principal amounts due at balance date less, where applicable, any provision for expected credit losses. The Group uses the simplified approach to measuring expected credit losses, which uses a lifetime expected credit loss allowance. Debts which are known to be uncollectible are written off in the consolidated income statement. All trade receivables and other receivables are recognized at the value of the amounts receivable, as they are due for settlement within 60 days and therefore do not require remeasurement. m. Investments and other financial assets (i) Classification The Group classifies its financial assets in the following measurement categories: • those to be measured subsequently at fair value (either through OCI or through profit or loss); and • those to be measured at amortized cost The classification depends on the Group’s business model for managing the financial assets and the contractual terms of the cash flow. For assets measured at fair value, gains and losses will either be recorded in profit or loss or OCI. Table of Contents 227
For investments in equity instruments that are not held for trading, this will depend on whether the group has made an irrevocable election at the time of initial recognition to account for the equity investment at fair value through other comprehensive income (FVOCI). See Note 5 for details about each type of financial asset. (ii) Recognition and derecognition Regular way purchases and sales of financial assets are recognized on trade-date, the date on which the Group commits to purchase or sell the asset. Financial assets are derecognized when the rights to receive cash flows from the financial assets have expired or have been transferred and the Group has transferred substantially all the risks and rewards of ownership. (iii) Measurement At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets carried at FVPL are expensed in profit or loss. Financial assets with embedded derivatives are considered in their entirety when determining whether their cash flows are solely payment of principal and interest. Details on how the fair value of financial instruments is determined are disclosed in Note 5(g). Equity instruments The group subsequently measures all equity investments at fair value. Where the Group has elected to present fair value gains and losses on equity investments in OCI, there is no subsequent reclassification of fair value gains and losses to profit or loss following the derecognition of the investment. Dividends from such investments continue to be recognized in profit or loss as other income when the group’s right to receive payments is established. Changes in the fair value of financial assets at FVPL are recognized in other gains/(losses) in the statement of profit or loss as applicable. Impairment losses (and reversal of impairment losses) on equity investments measured at FVOCI are not reported separately from other changes in fair value. (iv) Impairment For trade receivables, the group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables, see Note 5(b) for further details. n. Derivatives Derivatives are initially recognized at fair value on the date a derivative contract is entered into and are subsequently remeasured to their fair value at the end of each reporting period. As at June 30, 2024 and 2023, the Group did not have any derivative instruments that qualified for hedge accounting. Derivatives that do not qualify for hedge accounting Certain derivative instruments do not qualify for hedge accounting. Changes in the fair value of any derivative instrument that does not qualify for hedge accounting are recognized immediately in profit or loss and are included in other income or other expenses. o. Property, plant and equipment Plant and equipment are stated at historical cost less accumulated depreciation and impairment. Cost includes expenditure that is directly attributable to the acquisition of the item. Subsequent cost are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associates with the item will flow to the Group and the cost of the item can be measured reliably. All other repairs and maintenance are charged to profit and loss during the reporting period in which they are incurred. Table of Contents 228
Property, plant and equipment, other than freehold land, are depreciated over their estimated useful lives using the straight line method (see Note 6(a)). The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount. Gains and losses on disposal of plant and equipment are taken into account in determining the profit for the year. p. Intangible assets (i) Goodwill Goodwill is measured as described in Note 23(i). Goodwill on acquisition of subsidiaries is included in intangible assets (Note 6(c)). Goodwill is not amortized but it is tested for impairment annually or more frequently if events or changes in circumstances indicate that it might be impaired, and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold. Goodwill is tested for impairment in accordance with IAS 36 Impairment of Assets which requires testing be performed at any time during an annual period, provided the test is performed at the same time every year. The Group tests for impairment annually in the third quarter of each year. Additionally, assets must be tested for impairment if there is an indication that an asset may be impaired. The recoverable amounts of our assets and cash-generating units have been determined based on fair value less costs to sell calculations, which require the use of certain assumptions. Goodwill is allocated to cash generating units for the purpose of impairment testing. The allocation is made to those cash generating units or groups of cash generating units that are expected to benefit from the business combination in which the goodwill arose, identified according to operating segments (Note 21). (ii) Acquired licenses to patents Acquired licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses. Each asset is amortized through to the estimated patent expiry date which is reviewed and adjusted as patent extensions are granted. Payments made to third parties to acquire licenses to patents, including initial upfront and subsequent milestone payments are capitalized. For subsequent payments under existing license agreements payments are capitalized if they meet the definition of an intangible asset. Management reviews the substance of the payment to determine its classification. Generally, payments made for a verifiable outcome, such as completion of a clinical trial, regulatory approvals and sales target milestones would be accumulated into the cost of the intangible. The Group periodically evaluates whether current facts or circumstances indicate that the carrying value of its acquired intangibles may not be recoverable. If such circumstances are determined to exist, an estimate of the undiscounted future cash flow of these assets, or appropriate assets grouping is compared to the carrying value to determine whether an impairment exists. If the asset is determined to be impaired, the loss is measured based on the differences between the carrying value of the intangible asset and its fair value, which is determined based on the net present value of estimated future cash flows. Royalty payments under license and sublicense agreements are expensed. (iii) In-process research and development acquired In-process research and development that has been acquired as part of a business acquisition is considered to be an indefinite life intangible asset on the basis that it is incomplete and cannot be used in its current form. Indefinite life intangible assets are not amortized but rather are tested for impairment annually in the third quarter of each year, or whenever events or circumstances present an indication of impairment. Table of Contents 229
In-process research and development will continue to be tested for impairment until the related research and development efforts are either completed or abandoned. Upon completion of the related research and development efforts, management determines the remaining useful life of the intangible assets and amortizes them accordingly. In order for management to determine the remaining useful life of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the product life cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and various other relevant factors. At the time of completion, when the asset becomes available for use, all costs recognized in in-process research and development that related to the completed asset are transferred to the intangible asset category, current marketed products, at the asset’s historical cost. In the case of abandonment, the related research and development efforts are considered impaired and the asset is fully expensed. (iv) Current marketed products Current marketed products contain products that are currently being marketed. The assets are recognized on our consolidated balance sheet as a result of business acquisitions or reclassifications from In-process research and development upon completion. Upon completion, when assets become available for use, assets are reclassified from in- process research and development to current marketed products at the historical value that they were recognized at within the in-process research and development category. Upon reclassification to the current market products category management determines the remaining useful life of the intangible assets and amortizes them from the date they become available for use. In order for management to determine the remaining useful life of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the product life cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and any other relevant factors. Management have chosen to amortize all intangible assets with a finite useful life on a straight-line basis over the useful life of the asset. Current marketed products are tested for impairment in accordance with IAS 36 Impairment of Assets which requires testing whenever there is an indication that an asset may be impaired. q. Trade and other payables Payables represent the principal amounts outstanding at balance date plus, where applicable, any accrued interest. Liabilities for payables and other amounts are carried at cost which approximates fair value of the consideration to be paid in the future for goods and services received, whether or not billed. The amounts are unsecured and are usually paid within 30 to 60 days of recognition. r. Borrowings Borrowings are initially recognized at fair value, net of transaction costs incurred. Borrowings are subsequently measured at amortized cost. Any difference between the proceeds (net of transaction costs) and the redemption amount is recognized in profit or loss over the period of the borrowings using the effective interest method. Borrowings are removed from the consolidated balance sheet when the obligation specified in the contract is discharged, cancelled or expired. The difference between the carrying amount of a financial liability that has been extinguished or transferred to another party and the consideration paid, including any non-cash assets transferred of liabilities assumed, is recognized in profit or loss as other income or finance costs. Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the reporting period Funds associated with Oaktree Capital Management, L.P. (“Oaktree”) In November 2021, the Group entered into a five-year senior debt facility provided by funds associated with Oaktree. The balance of funds drawn down is currently $50.0 million as of June 30, 2024. The facility has a three-year interest only period, at a fixed rate of 9.75% per annum, after which the principal amortizes 5% per quarter beginning December 2024 and a final payment is due no later than November 2026. The facility also allows the Group to make quarterly payments of interest at a rate of 8.0% per annum for the first two years, and the unpaid interest portion (1.75% Table of Contents 230
per annum) has been added to the outstanding loan balance and currently accrues further interest at a fixed rate of 9.75% per annum. On November 19, 2021, Oaktree were granted warrants to purchase 1,769,669 American Depositary Shares (“ADSs”) at US$7.26 per ADS, a 15% premium to the 30-day VWAP. The Group determined that an obligation to issue the warrants arose from the time the debt facility was signed; consequently, a liability for the warrants was recognized in November 2021. The warrants were legally issued on January 11, 2022 and may be exercised within 7 years of issuance. On the issuance date of the Oaktree facility and the warrants, the warrants were initially measured at fair value and the Oaktree borrowing liability measured as the difference between the initial draw down of funds from the Oaktree facility and the fair value of the warrants. In December 2022, the Group amended the terms of the loan agreement with Oaktree and in connection with the loan amendment, Oaktree was granted warrants to purchase 455,000 ADSs at $3.70 per ADS, a 15% premium to the 30-day VWAP. The Group determined that an obligation to issue the warrants arose from the time the first amendment to the loan agreement was signed; consequently, a liability for the warrants was recognized in December 2022. The warrants were legally issued on March 8, 2023 and may be exercised within 7 years of issuance. Refer to Note 5(g)(vi) for more details on warrants issued. On January 10, 2024, the ratio under Mesoblast's American Depository Receipt ("ADR") program was changed from 5 ordinary shares representing 1 ADS (5:1 ratio) to a new ratio of 10 ordinary shares representing 1 ADS (10:1 ratio). As a result of this ratio change and as a result of initiating the pro-rata accelerated non-renounceable rights issue in December 2023, the number and exercise price for the warrants was adjusted in accordance with the terms of these warrants. The warrants issued in November 2021 changed from 1,769,669 ADSs at $7.26 per ADS to 884,838 ADSs at $14.36 per ADS. The warrants issued in December 2022 changed from 455,000 ADSs at $3.70 per ADS to 227,502 ADSs at $7.24 per ADS. In the years ended June 30, 2024, 2023 and 2022, respectively, the Group recognized losses of $2.3 million, $1.6 million and a minimal gain in the Consolidated Income Statement as remeasurement of borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our facility. Within the $1.6 million loss recognized in the year ended June 30, 2023, $1.0 million related to the remeasurement due to additional warrants being issued to Oaktree as a result of the first amendment to the loan agreement and $0.6 million related to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our credit facility. The Group has pledged substantially all of its assets as collateral under the loan facility with Oaktree. NovaQuest Capital Management, L.L.C. On June 29, 2018, the Group entered into an eight-year, $40.0 million loan and security agreement with NovaQuest before drawing the first tranche of $30.0 million of the principal in July 2018. The loan term includes an interest only period of approximately four years through until July 8, 2022. All interest and principal payments (i.e. the amortization period) are deferred until the earlier of loan maturity or from after the first commercial sale of remestemcel-L for the treatment in pediatric patients with SR-aGVHD in the United States and other geographies excluding Asia ("remestemcel-L for pediatric SR-aGVHD"). Principal is repayable in equal quarterly instalments over the amortization period of the loan and is subject to the payment cap described below. The loan has a fixed interest rate of 15% per annum. If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable at maturity. The Group can elect to prepay all outstanding amounts owing at any time prior to maturity, subject to a prepayment charge. Following approval and first commercial sales, repayments commence based on a percentage of net sales and are limited by a payment cap which is equal to the principal due for the next 12 months, plus accumulated unpaid principal and accrued unpaid interest. During the four-year period commencing July 8, 2022, principal amortizes in equal quarterly instalments payable only after approval and first commercial sales. If in any quarterly period, 25% of net sales of remestemcel-L for pediatric SR-aGVHD exceed the annual payment cap, the Group will pay the payment cap and an additional portion of excess sales which will be used towards the prepayment amount in the event there is an early prepayment of the loan. If in any quarterly period 25% of net sales of remestemcel-L for pediatric SR-aGVHD is less than the annual payment cap, then the payment is limited to 25% of net sales of remestemcel-L for pediatric SR-aGVHD. Any unpaid interest will be added to the principal amounts owing and shall accrue further interest. At maturity date, any unpaid loan balances are repaid. Table of Contents 231
Because of this relationship of net sales and repayments, changes in our estimated net sales may trigger an adjustment of the carrying amount of the financial liability to reflect the revised estimated cash flows. The carrying amount is recalculated by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate. The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs in the period the revision is made. In the years ended June 30, 2024, 2023 and 2022, respectively, the Group recognized a loss of $0.1 million and gains of $0.9 million and $0.5 million in the Consolidated Income Statement as remeasurement of borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of the Group's financial liability to reflect the revised estimated future cash flows as a net result of changes to the key assumptions in development timelines. The Group recognizes a liability as current based on repayments linked to estimates of sales of remestemcel-L. However, if sales of remestemcel-L are higher than estimated, actual repayments will exceed this amount, subject to the annual payment cap described above. The carrying amount of the loan and security agreement with NovaQuest is subordinated to the Group’s fixed rate loan with the senior creditor, Oaktree. The Group have pledged a portion of our assets relating to the SR-aGVHD product candidate as collateral under the loan facility with NovaQuest. s. Provisions Provisions are recognized when the Group has a present legal obligation as a result of a past event, it is probable that the Group will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present obligation at the end of the reporting period. The discount rate used to determine the present value is a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the liability. The increase in the provision due to the passage of time is recognized as interest expense. Provisions are recorded on acquisition of a subsidiary, to the extent they relate to a subsidiary’s contingent liabilities, if it relates to a past event, regardless of whether it is probable the amount will be paid. t. Employee benefits A liability is recognized for benefits accruing to employees in respect of wages and salaries, bonuses, annual leave and long service leave. Liabilities recognized in respect of employee benefits which are expected to be settled within 12 months after the end of the period in which the employees render the related services are measured at their nominal values using the remuneration rates expected to apply at the time of settlement. Liabilities recognized in respect of employee benefits which are not expected to be settled within 12 months after the end of the period in which the employees render the related services are measured as the present value of the estimated future cash outflows to be made by the Group in respect of services provided by employees up to reporting date. The obligations are presented as current liabilities in the consolidated balance sheet if the entity does not have an unconditional right to defer settlement for at least twelve months after the reporting period, regardless of when the actual settlement is expected to occur. Termination benefits are payable when employment is terminated by the Group before the normal retirement date, or when an employee accepts voluntary redundancy in exchange for these benefits. The Group recognizes termination benefits at the earlier of the following dates: when the Group can no longer withdraw the offer of those benefits and when the entity recognizes costs for a restructuring that is within the scope of IAS 37 and involves the payment of termination benefits. Table of Contents 232
u. Share-based payments Share-based payments are provided to eligible employees, directors and consultants via the Employee Share Option Plan (“ESOP”). Equity-settled share-based payments with employees and others providing similar services are measured at the fair value of the equity instrument at acceptance date. Fair value is measured using the Black-Scholes model. The expected life used in the model has been adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions, and behavioral considerations. It does not make any allowance for the impact of any service and non-market performance vesting conditions. Further details on how the fair value of equity-settled share-based transactions has been determined can be found in Note 17. The fair value determined at the acceptance date of the equity-settled share-based payments is expensed on a straight-line basis over the vesting period, based on management’s estimate of shares that will eventually vest, with a corresponding increase in equity. At the end of each period, the entity revises its estimates of the number of shared-based payments that are expected to vest based on the non-market vesting conditions. It recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to equity. v. Leases Leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use by the Group. Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments: • fixed payments (including in-substance fixed payments), less any lease incentives receivable; • variable lease payment that are based on an index or a rate; • amounts expected to be payable by the lessee under residual value guarantees; • the exercise price of a purchase option if the lessee is reasonably certain to exercise that option; and • payments of penalties for terminating the lease, if the lease term reflects the lessee exercising that option. Variable lease payments that are not based on an index or a rate are not included in the initial measurement of the lease liability and are expensed in the Consolidated Income Statement when incurred. There were no variable lease payments that were expensed in the Consolidated Income Statement for the years ended June 30, 2024, 2023 and 2022. The Group remeasures the lease liability and makes a corresponding adjustment to the related right-of-use asset whenever there is a change to the lease terms or expected payments under the lease, or a modification that is not accounted for as a separate lease. For certain contracts that contain lease and non-lease components, the Group accounts for each lease component within the contract as a lease separately from non-lease components of the contract. The Group identifies a separate lease component if there is an explicit or implicit identified asset in the contract and if the Group controls use of the identified asset. The lease payments are discounted using the interest rate implicit in the lease, if that rate can be determined, or the Group’s incremental borrowing rate. Right-of-use assets are measured at cost comprising the following: • the amount of the initial measurement of lease liability; • any lease payments made at or before the commencement date, less any lease incentives received; • any initial direct costs; and • restoration costs. Payments associated with short-term leases with a lease term of 12 months or less, contracts that contain lease and non-lease components that are cancellable within 12 months and leases of low-value assets are recognized on a straight-line Table of Contents 233
basis as an expense in profit or loss. Low-value assets comprise IT-equipment, small items of office furniture or low-value storage costs. w. Warrants Warrants reserve is measured as described in Note 7(b). For details on warrant liability, see Note 5(g)(vi). x. Contributed equity Ordinary shares are classified as equity. Transaction costs arising on the issue of equity instruments are recognized separately in equity. Transaction costs are the costs that are incurred directly in connection with the issue of those equity instruments and which would not have been incurred had those instruments not been issued. y. Loss per share (i) Basic losses per share Basic losses per share is calculated by dividing: • the loss attributable to equity holders of the Group, excluding any costs of servicing equity other than ordinary shares; • by the weighted average number of ordinary shares outstanding during the fiscal year, adjusted for bonus elements in ordinary shares issued during the year. (ii) Diluted losses per share Diluted losses per share adjusts the figures used in the determination of basic earnings per share to take into account • the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares; and • the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares. z. Goods and services tax (“GST”) Revenues, expenses and assets are recognized net of the amount of GST except where the GST incurred on a purchase of goods and services is not recoverable from the taxation authority, in which case the GST is recognized as part of the cost of acquisition of the asset or as part of the expense. Receivables and payables are stated with the amount of GST included. The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables in the Consolidated Balance Sheet. Cash flows are included in the statement of cash flow on a gross basis. The GST component of cash flows arising from investing and financing activities, which is recoverable from, or payable to, the taxation authority, are classified as operating cash flows. aa. Rounding of amounts Our company is of a kind referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191, issued by the Australian Securities and Investments Commission, relating to the ‘rounding off’ of amounts in the financial report. Unless mentioned otherwise, amounts within this report have been rounded off in accordance with that Legislative Instrument to the nearest thousand dollars, or in certain cases, to the nearest dollar. Table of Contents 234
Additional Australian Financial Reporting Requirements Consolidated entity disclosure statement As at June 30, 2024 Name of entity Type of entity Trustee, partner or participant in JV % of share capital Place of incorporation Australian resident or foreign resident Foreign jurisdiction(s) of foreign residents Mesoblast Limited Body corporate — — Australia Australian N/A Mesoblast, Inc. Body corporate — 100 United States of America Foreign United States of America Mesoblast International Sàrl (includes Mesoblast International Sàrl Singapore Branch) Body corporate — 100 Switzerland Foreign Switzerland Mesoblast Australia Pty Ltd Body corporate Trustee(1) 100 Australia Australian N/A Mesoblast UK Limited Body corporate — 100 United Kingdom Foreign United Kingdom BeiCell Ltd Body corporate — 100 Cayman Islands Australian N/A Mesoblast Employee Share Trust(2) Trust — — N/A Australian N/A Mesoblast Employee Share Trust(3) Trust — — N/A Australia N/A (1) Mesoblast Australia Pty Ltd is a trustee of Mesoblast Employee Share Trust established in 2011. (2) Established in 2011 (3) Established in 2020 Basis of preparation This consolidated entity disclosure statement ("CEDS") has been prepared in accordance with the Corporations Act 2001 and includes information for each entity that was part of the consolidated entity as at the end of the financial year in accordance with AASB 10 Consolidated Financial Statements. Determination of tax residency Section 295 (3A)(vi) of the Corporation Act 2001 defines tax residency as having the meaning in the Income Tax Assessment Act 1997. The determination of tax residency involves judgement as there are different interpretations that could be adopted, and which could give rise to a different conclusion on residency. In determining tax residency, the consolidated entity has applied the following interpretations: • Australian tax residency The consolidated entity has applied current legislation and judicial precedent, including having regard to the Tax Commissioner's public guidance in Tax Ruling TR 2018/5. • Foreign tax residency Where necessary, the consolidated entity has used independent tax advisers in foreign jurisdictions to assist in its determination of tax residency to ensure applicable foreign tax legislation has been complied with (see section 295(3A)(vii) of the Corporations Act 2001). Trusts Australian tax law generally does not contain corresponding residency tests for trusts and these entities are typically taxed on a flow-through basis. Additional disclosures on the tax status of trusts have been provided where relevant. Table of Contents 235
Directors’ Declaration In the directors’ opinion: (a) the financial statements and Notes set out on pages 164 to 234 are in accordance with the Corporations Act 2001, including: (i) Complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements, and (ii) Giving a true and fair view of the consolidated entity’s financial position as at June 30, 2024 and of its performance for the fiscal year ended on that date, and (b) There are reasonable grounds to believe that the Group will be able to pay its debts as and when they become due and payable, and (c) the consolidated entity disclosure statement on page 235 is true and correct. Note 1 ‘Basis of preparation’ confirms that the financial statements also comply with International Financial Reporting Standards as issued by the International Accounting Standards Board. The directors have been given the declarations by the chief executive officer and chief financial officer required by section 295A of the Corporations Act 2001. This declaration is made in accordance with a resolution of the directors. /s/ Jane Bell /s/ Silviu Itescu Jane Bell Silviu Itescu Chair of Board Chief Executive Officer Melbourne, August 29, 2024 Table of Contents 236
PricewaterhouseCoopers, ABN 52 780 433 757 2 Riverside Quay, SOUTHBANK VIC 3006, GPO Box 1331, MELBOURNE VIC 3001 T: 61 3 8603 1000, F: 61 3 8603 1999 Liability limited by a scheme approved under Professional Standards Legislation. Independent auditor’s report To the members of Mesoblast Limited Report on the audit of the financial report Our opinion In our opinion: The accompanying financial report of Mesoblast Limited (the Company) and its controlled entities (together the Group) is in accordance with the Corporations Act 2001, including: (a) giving a true and fair view of the Group's financial position as at 30 June 2024 and of its financial performance for the year then ended (b) complying with Australian Accounting Standards and the Corporations Regulations 2001. What we have audited The financial report comprises: the consolidated balance sheet as at 30 June 2024 the consolidated income statement for the year then ended. the consolidated statement of comprehensive income for the year then ended. the consolidated statement of changes in equity for the year then ended. the consolidated statement of cash flows for the year then ended. the notes to the consolidated financial statements, including material accounting policy information and other explanatory information. the consolidated entity disclosure statement as at 30 June 2024 the directors’ declaration. Basis for opinion We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those standards are further described in the Auditor’s responsibilities for the audit of the financial report section of our report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Independence We are independent of the Group in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional & Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code) that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code. 237
Material uncertainty related to going concern We draw attention to Note 1(i) in the financial report, which indicates that the Group had net cash outflows from operating activities of $48.5 million and the ability of the Group to continue as a going concern is dependent upon the Group obtaining additional funding from one or more sources to meet the Group's projected expenditure consistent with its business strategy. These conditions, along with other matters set forth in Note 1(i), indicate that material uncertainty exists that may cast significant doubt on the Group's ability to continue as a going concern. Our opinion is not modified in respect to this matter. Our audit approach An audit is designed to provide reasonable assurance about whether the financial report is free from material misstatement. Misstatements may arise due to fraud or error. They are considered material if individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial report. We tailored the scope of our audit to ensure that we performed enough work to be able to give an opinion on the financial report as a whole, taking into account the geographic and management structure of the Group, its accounting processes and controls and the industry in which it operates. The Group is a biopharmaceutical entity headquartered in Melbourne, Australia. lt is in the process of developing and commercialising innovative cell-based medicines for inflammatory diseases. The Group has operations in Australia, the United States and Singapore. Audit Scope Our audit focused on where the Group made subjective judgements; for example, significant accounting estimates involving assumptions and inherently uncertain future events. Audit procedures were performed over Australian, United States and Singaporean operations to enable us to give an opinion over the financial report as a whole. Key audit matters Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the financial report for the current period. The key audit matters were addressed in the context of our audit of the financial report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. Further, any commentary on the outcomes of a particular audit procedure is made in that context. We communicated the key audit matters to the Audit and Risk Committee. In addition to the matter described in the Material uncertainty related to going concern section, we have determined the matters described below to be the key audit matters to be communicated in our report. 238
Key audit matter How our audit addressed the key audit matter Impairment assessment of in-process research and development intangible assets and goodwill As described in Note 6(c) to the consolidated financial statements, the Group’s consolidated in-process research and development (“IPRD”) intangible assets balance and consolidated goodwill balance were $427.8 million and $134.5 million as at 30 June 2024, respectively. The Group tests the IPRD intangible assets and goodwill balances for impairment on an annual basis or more frequently if events or changes in circumstances indicate that they might be impaired. The recoverability of the carrying values of IPRD intangible assets and goodwill are estimated by the Group using future cash flow projections and assumptions related to the outcome of research and development activities. These significant judgements and assumptions made by the Group are specific to the nature of the Group’s activities including estimates of market populations, product pricings, launch timings, probabilities of success and discount rates. The principal considerations for our determination that performing procedures relating to the impairment assessment of IPRD intangible assets and goodwill is a key audit matter are there were significant judgements made by the Group in estimating the recoverable amount of the Group’s IPRD intangible assets and goodwill. This in turn led to a high degree of auditor judgement, subjectivity and effort in performing procedures to evaluate the Group’s cash flow projections and significant assumptions, including estimates of market populations, product pricings, launch timings, probabilities of success and discount rates applied. In addition, the audit effort involved the use of professionals with specialised skill and knowledge to assist in performing these procedures and evaluating the audit evidence obtained. Our audit procedures included, amongst others, testing the Group’s process used to develop the fair value estimate, which included: evaluating the appropriateness of the valuation methodology and discounted cash flow models used to estimate the recoverable amount of the Group’s IPRD intangible assets and goodwill; testing the completeness, accuracy and relevance of the underlying data used in the models; and evaluating the appropriateness of significant assumptions used by the Group, including estimates of market populations, product pricings, launch timings, probabilities of success and discount rates applied. Evaluating the significant assumptions relating to the estimates of the recoverable amount of IPRD intangible assets and goodwill involved evaluating whether the significant assumptions used by the Group were appropriate considering consistency with: external market and industry data; the outcome of clinical trials; formal communications from regulatory authorities; announcements made by the Group; and other comparable estimates of the Group’s valuation released by securities analysts. Professionals with specialised skill and knowledge were used to assist in the evaluation of the Group’s discount rates assumptions. 239
Key audit matter How our audit addressed the key audit matter Fair value measurement of contingent consideration As described in Note 5(g) to the consolidated financial statements, the Group had a balance of $26.9 million as at 30 June 2024 for contingent consideration, which the Group determined using an internal valuation with a discounted cash flow model requiring the use of inputs classified as level 3 in the fair value hierarchy. Significant assumptions used by the Group to value contingent consideration included probabilities of success and probability of payment. The principal considerations for our determination that performing procedures relating to the fair value measurement of contingent consideration is a key audit matter are there were significant judgements made by the Group in estimating the fair value of contingent consideration. This in turn led to a high degree of auditor judgement, subjectivity and effort in performing procedures to evaluate the Group’s cash flow projections and significant assumptions, including probabilities of success and probability of payment. Our audit procedures included, amongst others, testing the Group’s process used to develop the fair value estimate, which included: evaluating the appropriateness of the valuation methodology and discounted cash flow model used to estimate the value of contingent consideration; testing the completeness, accuracy and relevance of the underlying data used in the model; and evaluating the appropriateness of significant assumptions used by the Group, including probabilities of success and probability of payment. Evaluating the significant assumptions relating to the estimates of the fair value measurement of contingent consideration involved evaluating whether the significant assumptions used by the Group were appropriate considering consistency with: external market and industry data; the outcome of clinical trials; formal communications from regulatory authorities; announcements made by the Group; and the impairment assessment of IPRD intangible assets. Other information The directors are responsible for the other information. The other information comprises the information included in the annual report for the year ended 30 June 2024, but does not include the financial report and our auditor’s report thereon included in Item 18 of the Form 20-F. Prior to the date of this auditor's report, the other information we obtained included all other sections of the Form 20-F. We expect the remaining other information to be made available to us after the date of this auditor's report. Our opinion on the financial report does not cover the other information and we do not and will not express an opinion or any form of assurance conclusion thereon through our opinion on the financial report. We have issued a separate opinion on the remuneration report. 240
In connection with our audit of the financial report, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial report or our knowledge obtained in the audit, or otherwise appears to be materially misstated. If, based on the work we have performed on the other information that we obtained prior to the date of this auditor’s report, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard. When we read the other information not yet received, if we conclude that there is a material misstatement therein, we are required to communicate the matter to the directors and use our professional judgement to determine the appropriate action to take. Responsibilities of the directors for the financial report The directors of the Company are responsible for the preparation of the financial report in accordance with Australian Accounting Standards and the Corporations Act 2001, including giving a true and fair view, and for such internal control as the directors determine is necessary to enable the preparation of the financial report that is free from material misstatement, whether due to fraud or error. In preparing the financial report, the directors are responsible for assessing the ability of the Group to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the Group or to cease operations, or have no realistic alternative but to do so. Auditor’s responsibilities for the audit of the financial report Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial report. A further description of our responsibilities for the audit of the financial report is located at the Auditing and Assurance Standards Board website at: https://www.auasb.gov.au/admin/file/content102/c3/ar1_2020.pdf. This description forms part of our auditor's report. Report on the remuneration report Our opinion on the remuneration report We have audited the remuneration report included in in Item 6 (Directors, Senior Management and Employees) of the Form 20-F for the year ended 30 June 2024 identified by the title ‘Start of the Remuneration Report for Australian Disclosure Requirements’ to ‘End of Remuneration Report’. In our opinion, the remuneration report of Mesoblast Limited for the year ended 30 June 2024 complies with section 300A of the Corporations Act 2001. 241
Responsibilities The directors of the Company are responsible for the preparation and presentation of the remuneration report in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the remuneration report, based on our audit conducted in accordance with Australian Auditing Standards. PricewaterhouseCoopers Jon Roberts Melbourne Partner 29 August 2024 242
Item 19. Exhibits Item 1.1 Constitution of Mesoblast Limited adopted on November 28, 2023 1.2 Certificate of Registration of Mesoblast Limited (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 2.1 Description of Securities (incorporated by reference to Exhibit 2.1 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.1 Form of Amended and Restated Deposit Agreement between Mesoblast Limited and JPMorgan Chase Bank, N.A., as depositary, and Holders of the American Depositary Receipts (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.2 Form of Amendment No. 1 to the Amended and Restated Deposit Agreement among Mesoblast Limited, JP Morgan Chase Bank, N. A., as depositary, and all Holders of the American Depositary Receipts. 4.3 Form of American Depositary Receipt evidencing American Depositary Shares (included in Exhibit 4.1). 4.4† Manufacturing Services Agreement by and between Mesoblast Limited and Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., dated September 20, 2011 (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.5 Purchase Agreement by and between Mesoblast International Sàrl and Osiris Therapeutics, Inc., dated October 10, 2013 (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.6 Amendment #1 to Purchase Agreement by and between Mesoblast International Sàrl and Osiris Therapeutics, Inc., dated December 17, 2014 (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.7† License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co., Ltd., dated August 26, 2003 (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.8† Amendment 1 to License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co., Ltd., dated June 27, 2005 (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.9# Employment Agreement, dated August 8, 2014, by and between Mesoblast Limited and Silviu Itescu (incorporated by reference to Exhibit 10.19 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.10 Amendment to employment agreement, dated September 15, 2023, by and between Mesoblast Limited and Silviu Itescu. 4.11# Form of employment agreement between Mesoblast Limited and executive officers (incorporated by reference to Exhibit 4.9 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.12 Form of 2012 Deed of Indemnity, Insurance and Access (incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.13 Form of 2014 Deed of Indemnity, Insurance and Access (incorporated by reference to Exhibit 10.24 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015). 4.14† Patent License and Settlement Agreement with TiGenix S.A.U., dated December 14, 2017 (incorporated by reference to Exhibit 4.21 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018). 4.15† Loan and Security Agreement by and between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast International (UK) Limited, Mesoblast International Sàrl and NQP SPV II, L.P., dated June 29, 2018 (incorporated by reference to Exhibit 4.23 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018). 4.16† Development and Commercialization Agreement by and between Mesoblast Inc., Mesoblast International Sàrl and Tasly Pharmaceutical Group Co., Ltd. dated July 17, 2018 (incorporated by reference to Exhibit 4.24 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018). 4.17✓ Supplementary Agreement for Additional License by and between Mesoblast International Sarl and JCR Pharmaceuticals Co., Ltd., dated October 12, 2018 (incorporated by reference to Exhibit 4.25 to the Company’s Annual Report on Form 20-F filed with the SEC on September 9, 2019). Table of Contents 243
4.18✓ Second Supplementary Agreement for Additional License by and between Mesoblast International Sarl and JCR Pharmaceuticals Co., Ltd., dated June 5, 2019 (incorporated by reference to Exhibit 4.27 to the Company’s Annual Report on Form 20-F filed with the SEC on September 9, 2019). 4.19 Employee Share Option Plan (incorporated by reference to Exhibit 99.1 to the Company’s Post-Effective Amendment to the Registration Statement on Form S-8 (File No. 333- 267663) filed with the SEC on December 20, 2022). 4.20✓ Development and Commercialization Agreement by and between Mesoblast Limited and Mesoblast International Sàrl and Grünenthal GmbH, dated September 9, 2019 (incorporated by reference to Exhibit 4.22 to the Company’s Annual Report on Form 20-F filed with the SEC on September 3, 2020). 4.21✓ Manufacturing Services Agreement by and between Lonza Biosciences Singapore Pte. Ltd. and Mesoblast International Sàrl, dated October 9, 2019 (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F filed with the SEC on September 3, 2020). 4.22✓ Amendment to Development and Commercialization Agreement by and between Mesoblast Limited and Mesoblast International Sàrl and Grünenthal GmbH dated June 30, 2021 (incorporated by reference to Exhibit 4.27 to the Company’s Annual Report on Form 20-F filed with the SEC on August 31, 2021). 4.23 Form of Warrant to purchase Ordinary Shares (incorporated by reference to Exhibit 4.31 to the Company’s Annual Report on Form 20-F filed with the SEC on August 31, 2021). 4.24✓ Loan Agreement and Guaranty between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast International Sàrl and Oaktree Fund Administration, LLC, dated November 19, 2021 (incorporated by reference to Exhibit 4.32 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2022). 4.25 Form of Warrant, dated January 11, 2022, to purchase American Depositary Shares (incorporated by reference to Exhibit 4.23 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.26✓ First Amendment to Loan Agreement and Guaranty between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast International Sàrl and Oaktree Fund Administration, LLC, dated December 22, 2022 (incorporated by reference to Exhibit 4.24 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.27 Form of Warrant, dated March 7, 2023, to purchase American Depositary Shares (incorporated by reference to Exhibit 4.25 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.28✓ Third Amendment to Loan Agreement and Guaranty between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast International Sàrl and Oaktree Fund Administration, LLC, dated May 19, 2023 (incorporated by reference to Exhibit 4.26 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 4.29✓ Fifth Amendment to Loan Agreement and Guaranty between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast International Sàrl and Oaktree Fund Administration, LLC, dated February 29, 2024. 8.1 List of Significant Subsidiaries of Mesoblast Limited. (incorporated by reference to Exhibit 8.1 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 12.1 Certification of the Chief Executive Officer pursuant to rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. 12.2 Certification of the Chief Financial Officer pursuant to rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. 13.1 Certification of the Chief Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 13.2 Certification of the Chief Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 15.1 Consent of independent registered public accounting firm. 15.2 Share Trading Policy of Mesoblast Limited (incorporated by reference to Exhibit 15.2 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2023). 97.1 Recovery of Erroneously Awarded Incentive Compensation Policy 99.1 Appendix 4E preliminary final report for the twelve months to June 30, 2024. 99.2* Auditor’s independence declaration, dated August 29, 2024. 101.INS Inline XBRL Instance Document Table of Contents 244
101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) # Indicates management contract or compensatory plan. * Filed herewith. † Confidential treatment has been requested for portions of this exhibit. These portions have been omitted and have been filed separately with the Securities and Exchange Commission. ✓ Certain confidential portions of this exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions are not material and are the type that the registrant treats as private or confidential. Table of Contents 245
SIGNATURES The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf. Mesoblast Limited By: /s/ Jane Bell Name: Jane Bell Title: Chair of Board By: /s/ Silviu Itescu Name: Silviu Itescu Title: Chief Executive Officer Dated: August 29, 2024 Table of Contents 246
SHAREHOLDER INFORMATION A. Substantial Shareholders Holders of substantial holdings of ordinary shares in the Company and the numbers of shares in which they and their associates have a relevant interest as of 27 September 2024 (as disclosed in notices announced on the Australian Securities Exchange): Shareholder Number of ordinary shares held Gregory George and G to the Fourth Investments, LLC 179,847,742 Professor Silviu Itescu 78,958,928 B. Distribution of Equity Securities and Voting Rights Distribution of holders of equity securities as of 27 September 2024: Range Ordinary shares(1) Options(2) Warrants(3) ADS Warrants(4) ADS Warrants 2(5) Number of holders % of Ordinary shares held by holders Number of holders % of Options held by holders Number of holders % of Warrants held by holders Number of holders % of ADS Warrants held by holders Number of holders % of ADS Warrants 2 held by holders 1 – 1,000 12,662 0.55% 0 0% 0 0% 0 0% 0 0% 1,001 – 5,000 10,943 2.51% 0 0% 0 0% 0 0% 0 0% 5,001 – 10,000 3,671 2.50% 0 0% 3 0.13% 0 0% 2 6.37% 10,001 – 100,000 4,866 12.76% 20 2% 10 2.08% 7 45.04% 7 93.63% 100,001 and over 724 81.68% 70 98% 16 97.79% 3 54.96% 0 0% Total number of holders of equity securities 32,866 – 90 – 29 – 10 – 9 – (1) There are 6,227 holders of less than a marketable parcel of 445 ordinary shares ($1.125 per share) as of 27 September 2024. (2) There are 69,436,208 Options on issue as of 27 September 2024. (3) 15,027,327 Warrants are on issue as of 27 September 2024, including 6,830,602 Warrants issued to G to the Fourth Investments, LLC. (4) 884,838 ADS Warrants are on issue as of 27 September 2024, including 248,801 ADS Warrants issued to Oaktree LSL Fund Holdings EURRC S.A.R.L. (5) 227,502 ADS Warrants 2 are on issue as of 27 September 2024, including 63,970 ADS Warrants 2 issued to Oaktree LSL Fund Holdings EURRC S.A.R.L. The voting rights attaching to each class of equity securities are: i. Ordinary shares On a show of hands, every member present at a meeting, in person or by proxy, shall have one vote and upon a poll each share shall have one vote. ii. Other classes of equity securities There are no voting rights attaching to Options, Warrants, ADS Warrants or ADS Warrants 2. MESOBLAST LIMITED 2024 ANNUAL REPORT 247
C. Twenty Largest Holders of Quoted Securities The names of the 20 largest shareholders in the Company’s one class of quoted equity security as of 27 September 2024 are listed below. Rank Name No. of shares held % of total shares 1 J P Morgan Nominees Australia Pty Limited 372,563,409 32.63 2 HSBC Custody Nominees (Australia) Limited 127,511,937 11.17 3 Citicorp Nominees Pty Limited 73,041,006 6.40 4 Professor Silviu Itescu 67,751,838 5.93 5 UBS Nominees Pty Ltd 14,630,688 1.28 6 Tiga Trading Pty Ltd 10,000,000 0.88 6 Thorney Holdings Pty Ltd 10,000,000 0.88 7 BNP Paribas Noms Pty Ltd 9,515,494 0.83 8 Josaka Investments Pty Ltd 8,821,137 0.77 9 Independent Asset Management Pty Limited 6,715,891 0.59 10 Merrill Lynch (Australia) Nominees Pty Limited 5,684,853 0.50 11 HSBC Custody Nominees (Australia) Limited 5,301,000 0.46 12 BNP Paribas Nominees Pty Ltd 5,011,552 0.44 13 BNP Paribas Nominees Pty Ltd 4,086,170 0.36 14 Mr Gregory John Matthews & Mrs Janine Marie Matthews 3,141,063 0.28 15 National Nominees Limited 2,856,026 0.25 16 Finclear Services Pty Ltd 2,729,106 0.24 17 Citicorp Nominees Pty Limited 2,502,195 0.22 18 Tamit Nominees Pty Ltd 2,380,953 0.21 19 Mann Securities Pty Ltd 2,352,942 0.21 20 Lavya Pty Ltd 2,000,166 0.18 738,597,426 64.69 D. Securities under escrow There are no current securities under escrow. E. On-Market Buy-Back There is no current on-market buy-back of the Company’s ordinary shares. F. Stock Exchanges The Company’s ordinary shares are listed on the Australian Securities Exchange and are traded under the symbol ‘MSB’. The Company’s American Depositary Shares, each representing ten ordinary shares, are listed on the NASDAQ Global Select Market and are traded under the symbol ‘MESO’. 248 MESOBLAST LIMITED 2024 ANNUAL REPORT
CORPORATE DIRECTORY Directors Jane Bell (Chair) Silviu Itescu William Burns Joseph Swedish Eric Rose Philip Facchina Philip Krause Company Secretaries Niva Sivakumar Paul Hughes Registered Office Level 38, 55 Collins Street Melbourne VIC 3000 Australia Telephone +61 3 9639 6036 Facsimile +61 3 9639 6030 Country of Incorporation Australia Listing Australian Securities Exchange (ASX Code: MSB) NASDAQ Global Select Market (NASDAQ Code: MESO) Website www.mesoblast.com Share Registry Link Market Services Limited Level 10, Tower 4 727 Collins Street Melbourne Victoria 3008 Australia Telephone +61 1300 554 474 Facsimile +61 2 9287 0303 www.linkmarketservices.com.au Auditors PricewaterhouseCoopers 2 Riverside Quay Southbank Victoria 3006 Australia Telephone +61 3 8603 1000 Facsimile +61 3 8603 1999 MESOBLAST LIMITED 2024 ANNUAL REPORT 249
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