附件99.1
新聞稿
Ascendis Pharma報告2024年第三季度財務業績
– YORVIPATH將在美國推出，產品預計於1月中旬上市 中旬 2025; 不包括美國 YORVIPATH在第三季度的營業收入爲8.5百萬歐元
– TransCon CNP NDA submission for achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025
– SKYTROFA Q3 revenue of €47.2 million – 60%+ year-over-year volume growth offset by current and prior period sales deductions
– Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be €200 - €220 million, and full year 2024 operating expenses of approximately €600 million
– Novo Nordisk collaboration for the development of product candidates in metabolic and cardiovascular diseases, including a once-monthly 全球肽-1 receptor agonist, signed last week, seeking to close before the end of 2024
– Conference call today at 4:30 pm Et
COPENHAGEN, Denmark, November2024年14日（環球新聞社） - Ascendis Pharma A/S（納斯達克：ASND）今天宣佈了截至2024年9月30日的第三季度財務業績，並提供了業務更新。
「2024年對Ascendis來說是又一個轉型之年。現在，我們的三個內分泌罕見病項目都已經提供了臨床差異化的關鍵數據，每一個都展示了解決重大未滿足醫療需求的潛力，以及每一個都有望成爲拳頭產品。我們已經準備好並對即將在2025年1月中旬在美國推出YORVIPATH的產品充滿期待，產品可供性預計爲」。 2025年1月中旬 ascendis pharma公司總裁兼首席執行官Jan Mikkelsen表示：「此外，我們與諾和諾德的新合作伙伴關係突顯了我們延續TransCon平台成功的能力，並使Ascendis能夠惠及患者，在這一龐大、高交易量的療法領域獲取巨大價值。」
精選亮點 & 預期的2024年重要事件
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| • | SKYTROFA revenue for the third quarter of 2024 totaled €47.2 million compared to €47.0 million during the same period in 2023. Volume growth was offset by higher sales deductions and a negative adjustment to prior period sales deductions of €2.5 million. |
| • | SKYTROFA revenue for the first nine months of 2024 totaled €138.5 million, a 21% year-over-year increase compared to €114.4 million during the same period of 2023. Volume growth was partially offset by higher sales deductions. In addition, sales deductions attributable to periods prior to January 1, 2024 totaled €9.3 million. |
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| • | Submitted U.S. Food & Drug Administration (FDA) supplemental Biologics License Application for TransCon hGH for the treatment of adults with growth hormone deficiency. |
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| • | Expect to initiate a basket trial evaluating SKYTROFA in other established daily growth hormone indications in the first half of 2025. |
| • | TransCon PTH |
| • | YORVIPATH launching in U.S. with our expanded U.S. field teams engaging with health care providers, our Ascendis Signature Access Program accepting prescriptions and enrolling patients starting in December in preparation for product availability in mid-January 2025 |
| • | Third quarter YORVIPATH revenue outside the U.S. totaled €8.5 million, a sequential quarter-over-quarter revenue increase of more than 60%, reflecting growing physician and patient demand with now over 600 patients on treatment, partially offset by accruals reflecting the end of the free pricing period in the third quarter. Final pricing in Germany is expected to be completed next year. |
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| • | Announced positive topline data from pivotal ApproaCH Trial with children with achondroplasia (ages 2-11 years) treated with once-weekly TransCon CNP. |
| • | Plan to submit New Drug Application (NDA) to the FDA for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and a Marketing Authorisation Application (MAA) for the treatment of children with achondroplasia to the European Medicines Agency during the third quarter of 2025. |
| • | 預計於2025年第二季度公佈COACH項目的頂線第26週數據，這是關於懸停生長素和TransCon CNP試驗在骨發育障礙兒童（年齡 2-11 歲）方面的試驗。 |
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| • | 在ESMO 2024上發佈了第一批鉑類耐藥卵巢癌（PROC）隊列的1/2期IL-Believe試驗結果。初步數據顯示在重度PROC患者中出現臨床效果，並且TransCon 項目的結果 表明 通過TKI預處理後的ALK陽性患者篩選進行擴大隊列試驗以評估NVL-655的療效和安全性。 結 IL-2 ß/g in combination with chemotherapy was generally well-tolerated. |
| • | Recently, we closed enrollment to dose expansion cohorts involving TransCon TLR7/8 Agonist in the transcendIt-101 and IL Believe trials to prioritize our efforts on TransCon IL-2 ß/g. |
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| • | 戰略合作 |
| • | Ascendis Pharma A/S於11月授予Novo Nordisk A/S獨家、多產品、全球許可，使用TransCon技術平台開發、製造和商業化Novo Nordisk專有產品，涉及代謝疾病和心血管疾病的獨家許可。合作中的主要項目是一種一月一次的受體激動劑產品候選藥物，最初將瞄準肥胖症和2型糖尿病。對於主要項目，Ascendis將有資格獲得高達2.85億美元的預付款、開發和監管里程碑支付，以及基於銷售的里程碑支付和逐漸增加的分層支付。 逐產品 獨家許可證涉及心血管疾病。合作中的主要項目是一種一月一次的受體激動劑產品候選藥物，最初將瞄準肥胖症和2型糖尿病。 全球肽-1 對於主要項目，Ascendis有資格獲得高達2850萬美元的總付款，其中包括預付款、開發和監管里程碑支付，以及基於銷售的里程碑支付和逐漸遞增的分層支付 |
| • | 對於主要項目，Ascendis將有資格獲得高達2850萬美元的總付款，其中包括預付款、開發和監管里程碑支付，以及基於銷售額的里程碑支付和遞增的分層支付 中等單數 全球淨銷售額上的數字版稅。 |
| • | 擬諾和諾德將負責升和生物公司的早期開發成本，以及臨床開發、監管、商業製造和商業化活動。 |
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| • | 截至2024年9月30日，ascendis pharma擁有現金、現金等價物和可交易證券，合計626歐元，與2023年12月31日的399歐元相比。 |
| • | 2024年全年SKYTROFA營業收入，不包括與之前年度相關的銷售扣除項，預計爲200-220百萬歐元。 |
| • | 預計2024年總營業費用（銷售、一般及行政以及研發費用）約爲600百萬歐元。 |
2024年第三季度財務業績
2024年第三季度總收入爲57.8百萬歐元，而2023年同期爲48.0百萬歐元。總收入同比增長的主要原因是2024年第一季度YORVIPATH商業推出後貢獻的8.5百萬歐元收入。 非產品2024年第三季度非產品收入爲2.1百萬歐元，而2023年同期爲1.1百萬歐元。
| 總營業收入 (以千歐元爲單位) |
截至三個月的數據 9月30日, |
截至九個月 9月30日, |
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| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 外部客戶營業收入 |
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| 商品的商業銷售 |
55,710 | 46,968 | 153,598 | 114,414 | ||||||||||||
| 許可證 |
851 | 571 | 26,490 | 1,774 | ||||||||||||
| 其他 |
1,272 | 495 | 9,637 | 12,828 | ||||||||||||
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57,833 | 48,034 | 189,725 | 129,016 | ||||||||||||
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2024年第三季度的研發(R&D)費用爲73.5百萬歐元，相比之下，2023年同期爲111.4百萬歐元。這一下降主要是由於TransCon hgh、TransCon PTH和TransCon CNP以及Eyconis的外部開發成本較低所致分拆。
2024年第三季度銷售、管理和行政支出爲69.8百萬歐元，而2023年同期爲63.6百萬歐元。主要增加是因爲員工成本增加，包括商業擴張的影響。
2024年第三季度總營業費用爲143.4百萬歐元，而2023年同期爲175.1百萬歐元。
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2024年第三季度淨財務收入爲2.9百萬歐元，而2023年同期淨財務支出爲20.4百萬歐元。這種變化主要是由貨幣波動的影響造成的。
截至2024年第三季度，Ascendis Pharma報告的淨虧損爲99.2百萬歐元，每股1.72歐元（基本和攤薄），而2023年同期的淨虧損爲162.2百萬歐元，每股2.88歐元（基本和攤薄）。
截至2024年9月30日，Ascendis Pharma的現金、現金等價物和市場證券總計爲625.5百萬歐元，而2023年12月31日爲399.4百萬歐元。截至2024年9月30日，Ascendis Pharma擁有60642144普通股，其中包括公司持有的881730普通股代表的ADS。
電話會議和網絡研討會信息：
Ascendis Pharma將於今天下午4:30（東部時間）舉行電話會議和網絡直播，討論其2024年第三季度財務業績。
希望參與的人可以訪問現場網絡廣播 這裏，或者提前註冊參加電話會議 這裏。現場網絡廣播的鏈接也將在Ascendis Pharma網站的投資者與新聞欄目上提供https://investors.ascendispharma.com。活動結束後，Ascendis Pharma網站的這一欄目將提供網絡廣播的重播，持續30天。
hgh集團正在應用其創新的TransCon技術平台，打造一個領先的、完全一體化的生物製藥公司，專注於在患者生活中產生有意義的影響。Ascendis秉承患者、科學和激情的核心價值觀，利用其TransCon技術來創造新的、潛在的治療方法。 最佳類別 Ascendis總部位於丹麥哥本哈根，在歐洲和美國設有額外的設施。請訪問 ascendispharma.com了解更多。
前瞻性聲明
本新聞稿包含涉及重大風險和不確定性的前瞻性聲明。除歷史事實聲明外，本新聞稿中包括的Ascendis未來運營、計劃和管理目標的所有聲明均屬於前瞻性聲明。此類聲明的示例包括但不限於 (i) YORVIPATH在美國的推出時間；(ii) TransCon CNP的新藥申請和MAA提交時間；(iii) 關於2024年SKYTROFA營收和營業費用預測；(iv) 諾和諾德合作的完成時間；(v) Ascendis三個內分泌罕見病項目解決重大未滿足醫療需求和實現巨頭地位的能力；(vi) Ascendis延續TransCon平台成功並在代謝和心血管疾病領域實現重要價值的能力；(vii) Turner綜合徵2期New InsiGHTS試驗的最終結果公佈時間；(viii) 評估SKYTROFA在其他每日生長激素適應症中的籃子試驗啓動時間；(ix) Ascendis Signature Access Program開始接受處方和招募患者的時間；(x) YORVIPATH在德國定價最終結果的時間；(xi) COACH項目，兒童髂小背短孩童TransCon hGH和TransCon CNP聯合試驗26周最終數據公佈時間；(xii) Ascendis
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revenues from the Novo Nordisk collaboration; (xiii) Novo Nordisk’s responsibilities under the collaboration; (xiv) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xv) Ascendis’ use of its TransCon technologies to create new and potentially 最佳類別 therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or 在市場上 products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, ascendis pharma, Ascendis Pharma標誌, 公司標誌, TransCon, SKYTROFA® ® 是Ascendis Pharma集團擁有的商標。 ©
2024年11月Ascendis Pharma a/s。
| 投資者聯繫方式： | 媒體聯繫： | |||
| 斯科特·史密斯 | Melinda Baker | |||
| Ascendis Pharma | Ascendis Pharma | |||
| ir@ascendispharma.com | +1 (650) 709-8875 | |||
| media@ascendispharma.com |
Patti Bank
ICR Healthcare
+1 (415) 513-1284
patti.bank@icrhealthcare.com
第 5 頁，共 7 頁
財務表格如下
ascendis pharma a/s
綜合利潤表或損益及綜合利潤/(損益)
| 截至三個月 9月30日, |
截至九個月 9月30日, |
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| 2024 | 2023 | 2024 | 2023 | |||||||||||||
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| 收入 |
57,833 | 48,034 | 189,725 | 129,016 | ||||||||||||
| 銷售成本 |
11,201 | 7,388 | 30,235 | 24,938 | ||||||||||||
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| 毛利潤 |
46,632 | 40,646 | 159,490 | 104,078 | ||||||||||||
| 研發費用 |
73,544 | 111,439 | 227,708 | 322,573 | ||||||||||||
| 銷售、一般和管理費用 |
69,831 | 63,614 | 210,928 | 200,435 | ||||||||||||
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| 營業利潤/(虧損) |
(96,743 | ) | (134,407 | ) | (279,146 | ) | (418,930 | ) | ||||||||
| 合營企業利潤（虧損）份額 |
(4,367 | ) | (6,794 | ) | (15,485 | ) | (15,471 | ) | ||||||||
| 財務收入 |
28,279 | 4,142 | 29,262 | 76,985 | ||||||||||||
| 財務費用 |
25,347 | 24,519 | 70,488 | 35,640 | ||||||||||||
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| 稅前利潤（虧損） |
(98,178 | ) | (161,578 | ) | (335,857 | ) | (393,056 | ) | ||||||||
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(1,020 | ) | (645 | ) | (3,758 | ) | (1,513 | ) | ||||||||
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(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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| 歸屬於公司業主 |
(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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€ | (1.72 | ) | € | (2.88 | ) | € | (5.93 | ) | € | (7.02 | ) | ||||
| 基本和稀釋計算所用的股數 |
57,535,349 | 56,272,698 | 57,255,764 | 56,194,956 | ||||||||||||
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(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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| 外幣翻譯差異 |
154 | 571 | 232 | (1,232 | ) | |||||||||||
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| 本期其他綜合收益/（綜合損失），淨額 |
154 | 571 | 232 | (1,232 | ) | |||||||||||
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| 注3——重要的會計判斷和估計 |
(99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | ||||||||
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| 歸屬於公司業主 |
(99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | ||||||||
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第6頁
ascendis pharma a/s
合併財務狀況表
| (以歐元'000) | 9月30日, 2024 |
12月31日 2023 |
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| 資產 |
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| 非當前 資產 |
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| 無形資產 |
4,106 | 4,419 | ||||||
| 物業、廠房和設備 |
97,522 | 110,634 | ||||||
| 對聯營企業的投資 |
16,213 | 5,686 | ||||||
| 其他應收款 |
2,202 | 2,127 | ||||||
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| 120,043 | 122,866 | |||||||
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| 流動資產 |
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| 存貨 |
265,433 | 208,931 | ||||||
| 應收賬款 |
33,098 | 35,874 | ||||||
| 所得稅應收款 |
1,995 | 802 | ||||||
| 其他應收款 |
15,259 | 19,097 | ||||||
| 預付款項 |
32,440 | 38,578 | ||||||
| 可交易證券 |
— | 7,275 | ||||||
| 現金及現金等價物 |
625,515 | 392,164 | ||||||
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| 973,740 | 702,721 | |||||||
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| 總資產 |
1,093,783 | 825,587 | ||||||
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| 股東權益和負債 |
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| 股權 |
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| 股本 |
8,143 | 7,749 | ||||||
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(105,463 | ) | (153,446 | ) | ||||
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| 總股本 |
(97,320 | ) | (145,697 | ) | ||||
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| 非當前 負債 |
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| 借款 |
338,930 | 222,996 | ||||||
| 合同責任 |
5,000 | 5,949 | ||||||
| 遞延所得稅負債 |
8,716 | 5,830 | ||||||
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| 352,646 | 234,775 | |||||||
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| 流動負債 |
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| 931,527 |
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| 借款 |
422,064 | 407,095 | ||||||
| 衍生負債 |
168,346 | 143,296 | ||||||
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| 590,410 | 550,391 | |||||||
| 其他流動負債 |
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| 借款 |
27,668 | 14,174 | ||||||
| 合同責任 |
1,586 | 1,184 | ||||||
| 應付賬款和應計費用 |
75,268 | 94,566 | ||||||
| 其他負債 |
42,241 | 41,176 | ||||||
| 應交所得稅 |
1,016 | 2,299 | ||||||
| 備用金 |
100,268 | 32,719 | ||||||
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| 248,047 | 186,118 | |||||||
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| 838,457 | 736,509 | |||||||
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| 總負債 |
1,191,103 | 971,284 | ||||||
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| 所有板塊權益和負債總計 |
1,093,783 | 825,587 | ||||||
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第7頁