美國
證券交易委員會
華盛頓特區20549
6-K表格
外國私人發行人報告
根據規則13a-16或15d-16
根據1934年證券交易法
2024年10月份
委員會檔案編號：001-39822
Pharming Group
（按其章程規定的確切註冊人名稱）
Darwinweg 24
2333 CR 萊頓
荷蘭
，（主要行政辦公地址）
請勾選指示符，指明申報人是否在20-F或40-F表格的覆蓋下提交或將要提交年度報告。
20-F表格☒ 表格40-F ☐
如果註冊者按規定S-t規則101(b)(1)允許提交紙質6-k表格，請勾選方框: ☐
如果註冊者依據S-t規則101(b)(7)獲准以紙質形式提交6-k表格，請在選框中打勾： ☐
作爲第6k表格的附件99.1，附上了荷蘭pharming group N.V.於2024年10月24日發佈的新聞稿。
1
附件描述
附件編號 | Description | |||||||
99.1 | pharming group報告2024年第三季度財務業績並提供業務更新 | |||||||
簽名
innate pharma
Pharming Group | |||||||||||
通過： | /s/ Sijmen de Vries | ||||||||||
姓名： | Sijmen de Vries | ||||||||||
標題： | 首席執行官 | ||||||||||
日期：2024年10月24日
2
pharming group報告2024年第三季度財務業績並提供業務更新
•2024年第三季度總營業收入 增加 同比2023年第三季度增長12%，達到7480萬美元， 受持續強勁的RUCONEST®和Joenja®營收增長推動
•RUCONEST®第三季度收入增長了 6%，達到6360萬美元，較2023年第三季度增長。
•Joenja®（leniolisib）第三季度狂歡節使用量增加了與2023年第三季度相比，增長72％，達到1,120萬美元
•前九個月總收入增加了 25%，達到20450萬美元，相比2023年前九個月
•目前2號跟蹤24總營業收入指導爲28000萬美元 - 29500萬美元（增長14 - 20%）
•2023年第三季度營業利潤從190萬美元增至410萬美元
•2024年第三季度末，現金和有市場價值的證券總額從2024年第二季度末的16180萬美元增加至17330萬美元
•Sijmen de Vries，我們的執行董事/首席執行官，已通知董事會，他將在2025年5月舉行的股東年度大會上不再接受連任。
•Pharming將於今天下午13:30（CEST，東歐夏季時間，美國東部時間上午7:30）舉行電話會議
荷蘭萊頓，2024年10月24日： pharming group N.V.、「Pharming」或「公司」(歐洲阿姆斯特丹證券交易所：PHARM/納斯達克：PHAR)公佈了截至2024年9月30日三個月的初步未經審計財務報告。
首席執行官Sijmen de Vries評論道：「Pharming在營業收入增長方面再次取得了強勁的季度增長，季度營收增長35％，達到7410萬美元。我們堅定地致力於達到我們的2024年總收入指導值2.8億美元至2.95億美元。與去年第二季度相比，我們在營收基礎上實現了經營虧損的收窄。」
Pharming在第三季度取得了出色的業績，季度營業收入增長12%，達到創紀錄的7480萬美元，全年前九個月創下了20450萬美元的營業收入紀錄。強勁的營收表現，加上與上一季度相比減少的營業費用，使我們在第三季度實現了正的營業利潤。我們堅定地朝着2024年總營業收入指導範圍爲29500萬美元（增長14 - 20%）的目標穩步前行。
第三季度證明了Pharming在競爭激烈的美國HAE市場中繼續增長RUCONEST®的能力，包括新患者註冊在內，底層需求強勁。與2023年同期相比，該產品第三季度營業收入增長了6%。
對於Joenja®，我們繼續不斷增加每季度接受治療的患者數量，並保持這些患者的高依從性率。我們在九月獲得了Joenja®（利妥昔單抗）在英國的批准，展示了我們與監管機構積極合作，以使這種藥物儘可能多地面向患者，並且現在期待未來幾個季度的報銷評估結果以及隨後的商業推出。
2024年10月，我們宣佈啓動了第二階段的 概念板塊、臨床試驗，評估leniolisib在與PI3Kẟ信號相關的原發性免疫缺陷（PIDs）及免疫失調的患者中的療效。對Pharming而言，這是一項重要的步驟，因爲該試驗將包括患有各種PIDs且有顯著未滿足 醫療 需求的患者，整體患病率比APDS高得多，包括ALPS-FAS，CTLA4。
1
單倍體不足症，NFKB1單倍不足和PTEN缺失。這些PID大約每百萬患者中有七名，爲力唑利單增飴酸商業機會帶來了潛在的五倍增長，從而確保Pharming履行其爲無人服藥的罕見病患者提供服務的使命。
我已經通知董事會，我將不會在荷美思公司出任執行董事/首席執行官的重新任命後再次提供席位，我在公司的16年任期即將結束。我們公司今天狀況良好，因此現在正是我爲接班人讓路的正確時刻，領導荷美思公司走向下一個增長階段的策略，基於過去幾年的成就。我爲所有這些成就感到自豪，對多年來患者、員工和投資者對我的信任表示感激。在我的接班人上任之前，我將繼續全力以赴地致力於荷美思公司，並盡我所能確保順利交接。
董事會主席理查德·彼得斯博士評論道:
「我謹代表整個董事會，感謝Sijmen de Vries在過去16年來對Pharming的高度承諾，以及他建立公司的方式，爲今天的公司服務患者併爲公司增長的策略鋪平道路。」
董事會已委託一家領先的全球高管搜索公司來尋找繼任者。進一步的公告將在適當時候發佈。
在接下來的幾個月裏，我們當然會花時間來慶祝Sijmen擔任我司CEO的任期。
第三季度亮點
商業化產品
RUCONEST®用於治療急性HAE發作。
RUCONEST® 在2024年第三季度繼續表現良好，收入爲6,360萬美元，同比增長6％預計 2023 年第三季度。2024年前九個月的收入爲1.726億美元，與2023年同期相比增長了12％。
美國市場貢獻了第三季度97%的營收，而歐盟和世界其他地區貢獻了3%。
在美國市場，我們看到了第三季度市場需求持續增強，包括約100名新患者入學。我們在第三季度取得了其他主要營業收入因子方面的強勁整體表現，包括開方醫生的數量、接受治療患者總數以及寄送給患者的藥瓶數量。增加入學人數有助於推動第三季度獨特患者寄送量大幅增加。
Joenja® (leniolisib) marketed for the treatment of APDS
Joenja® revenues increased to US$11.2 million in the third quarter of 2024, a 72% increase compared to the third quarter of 2023. This increase was mostly driven by higher volume from the 50% increase in patients on paid therapy in the U.S. compared to the third quarter of 2023, and revenues from EU and Rest of World which are from product provided on a named patient basis. Revenue for the first nine months of 2024 was US$31.9 million, compared to US$10.3 million for the same period in 2023.
2
As of September 30, 2024, we have 93 patients on paid therapy in the U.S. and an additional five patients enrolled and pending authorization, representing an increase of both active and pending patients during the third quarter and continued progress enrolling and moving eligible patients to paid therapy.
Joenja® (leniolisib) development updates
Leniolisib for APDS
Pharming made continued progress in the third quarter of 2024 on leniolisib regulatory filings for APDS patients 12 years of age and older in key global markets. Pharming is on track to complete the manufacturing activities requested by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) and submit a response prior to the January 2026 deadline. In addition, Pharming progressed ongoing clinical trials to support regulatory filings for approval in Japan and pediatric label expansion beginning in 2025. Data readout from the clinical trial for children ages 4 to 11 years old is expected in the fourth quarter of 2024.
In total, there are currently 164 patients in a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a named patient program.
United Kingdom
On September 25, 2024, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Joenja® (leniolisib) for the treatment of APDS in adult and pediatric patients 12 years of age and older. Joenja® was the first new medicine approved by the MHRA via the International Recognition Procedure (IRP) using the U.S. FDA as reference regulator. Leniolisib is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.
Leniolisib for additional indications (PI3Kδ platform) - Primary immunodeficiencies (PIDs) beyond APDS
On October 10, 2024, Pharming announced the start of a Phase II, proof of concept, clinical trial evaluating leniolisib in PIDs with immune dysregulation linked to PI3Kẟ signaling in lymphocytes, with similar clinical phenotypes and unmet medical needs to APDS. The first patient is expected to be enrolled in the study in the coming weeks. The clinical trial will include PID patients with ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency and PTEN deficiency, among others. Epidemiology suggests a prevalence of approximately seven patients per million in this targeted PID population, compared to one to two patients per million for APDS.
The Phase II clinical trial is a single arm, open-label, dose range-finding study to be conducted in approximately 12 patients. The objectives for the trial will be to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy of leniolisib in the targeted PID population. The trial has been designed to inform a subsequent Phase III program.
Pharming has also prioritized development of leniolisib for an additional PID indication. Pharming will provide further updates and details on our plans, including the proposed clinical development plan, later this year.
3
Organizational update
Sijmen de Vries, our Executive Director/Chief Executive Officer, has informed the Board of Directors that he will not be available for reappointment at the Company’s next Annual General Meeting of Shareholders (AGM) in May 2025. The mandate of Sijmen de Vries is scheduled to expire at the closing of the AGM to be held in May 2025. Further announcements on the search of a successor will be made when appropriate.
Financial Summary
| Consolidated Statement of Income | 3Q 2024 | 3Q 2023 | 9M 2024 | 9M 2023 | ||||||||||
| Amounts in US$m except per share data | ||||||||||||||
| Total Revenues | 74.8 | 66.7 | 204.5 | 164.1 | ||||||||||
| Cost of sales | (6.8) | (8.3) | (23.2) | (18.1) | ||||||||||
| Gross profit | 68.0 | 58.4 | 181.3 | 146.0 | ||||||||||
| Other income | 0.8 | 0.3 | 2.1 | 22.8 | ||||||||||
| Research and development | (20.7) | (20.8) | (60.8) | (57.3) | ||||||||||
| General and administrative | (15.3) | (10.9) | (46.0) | (31.9) | ||||||||||
| Marketing and sales | (28.7) | (25.1) | (91.9) | (86.1) | ||||||||||
| Other Operating Costs | (64.7) | (56.8) | (198.7) | (175.3) | ||||||||||
| Operating profit (loss) | 4.1 | 1.9 | (15.3) | (6.5) | ||||||||||
Finance income (expense) and share of net profits in associates | (2.6) | 1.4 | 0.1 | (3.5) | ||||||||||
| Profit (loss) before tax | 1.5 | 3.3 | (15.2) | (10.0) | ||||||||||
| Income tax credit (expense) | (2.5) | 0.2 | 0.5 | 2.6 | ||||||||||
| Profit (loss) for the period | (1.0) | 3.5 | (14.7) | (7.4) | ||||||||||
| Share Information | ||||||||||||||
| Basic earnings per share (US$) | (0.002) | 0.005 | (0.022) | (0.011) | ||||||||||
| Diluted earnings per share (US$) | (0.002) | 0.005 | (0.022) | (0.011) | ||||||||||
Segment information - Revenues | 3Q 2024 | 3Q 2023 | 9M 2024 | 9M 2023 | ||||||||||
Amounts in US$m | ||||||||||||||
| Revenue - RUCONEST® (US) | 62.0 | 58.4 | 168.4 | 149.3 | ||||||||||
| Revenue - RUCONEST® (EU and RoW) | 1.6 | 1.8 | 4.2 | 4.5 | ||||||||||
| Total Revenues - RUCONEST® | 63.6 | 60.2 | 172.6 | 153.8 | ||||||||||
| Revenue - Joenja® (US) | 10.0 | 6.5 | 28.7 | 10.3 | ||||||||||
| Revenue - Joenja® (EU and RoW) | 1.2 | — | 3.2 | — | ||||||||||
| Total Revenues - Joenja® | 11.2 | 6.5 | 31.9 | 10.3 | ||||||||||
| Total Revenues - US | 72.0 | 64.9 | 197.1 | 159.6 | ||||||||||
| Total Revenues - EU and RoW | 2.8 | 1.8 | 7.4 | 4.5 | ||||||||||
| Total Revenues | 74.8 | 66.7 | 204.5 | 164.1 | ||||||||||
4
| Consolidated Balance Sheet | September 30, 2024 | December 31, 2023 | ||||||
| Amounts in US$m | ||||||||
| Cash and cash equivalents, restricted cash and marketable securities | 173.3 | 215.0 | ||||||
| Current assets | 282.2 | 316.3 | ||||||
| Total assets | 425.5 | 462.9 | ||||||
| Current liabilities | 79.8 | 78.0 | ||||||
| Equity | 225.8 | 218.8 | ||||||
Financial highlights
Third quarter 2024
For the third quarter of 2024, total revenues increased by US$8.2 million, or 12%, to US$74.8 million, compared to US$66.7 million in the third quarter of 2023. RUCONEST® revenues amounted to US$63.6 million, a 6% increase compared to the third quarter of 2023. The volume increase in the U.S., and a U.S. price increase in line with CPI, were the primary factors behind this increase in RUCONEST® revenues. Joenja® revenues amounted to US$11.2 million in the third quarter of 2024, a 73% increase compared to the third quarter of 2023. This increase was primarily driven by an increase in volume.
Gross profit increased by US$9.7 million or 17% to US$68.0 million (3Q 2023: US$58.4 million), mainly due to the increase in revenues.
The operating profit amounted to US$4.1 million compared to an operating profit of US$1.9 million in the third quarter of 2023. This increase was primarily due to the increase in gross profit mentioned above, offset by the increase in operating expenses from US$56.8 million in the third quarter of 2023 to US$64.7 million. The increase in operating expenses compared to the same quarter in 2023 was caused by a combination of continuing investments in Joenja® in the U.S., launch preparation for leniolisib outside of the U.S., increasing R&D investments to expand the leniolisib franchise and increased payroll expenses due to business growth. Third quarter 2024 operating expenses decreased 8% from US$70.1 million in the second quarter of 2024.
The net finance result amounted to a loss of US$2.2 million compared to a gain of US$1.9 million in the third quarter of 2023. This was primarily driven by unfavorable EUR/USD exchange rate developments, resulting in a foreign currency loss of US$1.5 million compared to a gain of US$1.7 million in the third quarter of 2023. Additionally, interest expense increased by US$1.0 million in the third quarter of 2024 compared to the previous year, following the convertible bond issuance in the second quarter of 2024.
The Company had a net loss of US$1.0 million, compared to a net profit of US$3.5 million in the third quarter of 2023. This change was mainly due to higher finance expense resulting from unfavorable EUR/USD exchange rate developments and higher income tax expenses, despite higher operating profit. While the exchange rate fluctuations resulted in a foreign currency loss in the income statement, currency translation differences in other comprehensive income led to a positive result of US$2.9 million, compared to a negative result of US$5.2 million in the third quarter of 2023. This outcome was driven by the Company’s predominantly euro-denominated assets, including the vast majority of the cash and marketable securities position.
Cash and cash equivalents, including restricted cash and marketable securities, increased from US$161.8 million at the end of second quarter of 2024 to US$173.3 million at the end of the third quarter of 2024.
5
This increase was primarily driven by positive cash flows from operations of US$9.7 million (3Q 2023: US$3.5 million), which includes a deduction of US$9.1 million in paid taxes (3Q 2023: US$0.0 million).
Nine months 2024
Total revenues increased 25% during the first nine months of 2024 to US$204.5 million, versus US$164.1 million during the first nine months of 2023. Total RUCONEST® revenues were 12% higher at US$172.6 million, compared to revenues of US$153.8 million for the first nine months of 2023. Joenja® revenues amounted to US$31.9 million in the first nine months of 2024, a 210% increase compared to the first nine months of 2023 (first sales commenced at the start of the second quarter of 2023). This increase was primarily driven by an increase in volume.
Gross profit increased by US$35.3 million or 24% to US$181.3 million (9M 2023: US$146.0 million), mainly due to the increase in revenues.
Other income decreased to US$2.0 million compared to US$22.8 million in the first nine months of 2023. Other income in the first nine months of 2023 was supported by the sale of the Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis for a pre-agreed, one-time payment of US$21.1 million.
The operating loss amounted to US$15.3 million compared to an operating loss of US$6.5 million in the first nine months of 2023. This change was mainly due to the decrease in other income and the expected increase in operating expenses from US$175.3 million in the first nine months of 2023 to US$198.7 million, offset by the above mentioned increase in gross profit in the first nine months of 2024. The first nine months of 2023 operating expenses included milestone payments for Joenja® of US$10.5 million in the second quarter. The increase in operating expenses in the first nine months of 2024 was caused by a combination of continuing investments in Joenja® in the U.S., launch preparation for leniolisib outside of the U.S., increasing R&D investments to expand the leniolisib franchise and increased payroll expenses due to business growth. Excluding the one time proceeds from the PRV sale and the milestone payment expenses for Joenja® in the first nine months of 2023, the operating loss decreased from US$17.1 million to US$15.3 million in the first nine months of the current year.
The net finance result amounted to a gain of US$1.4 million compared to a loss of US$2.6 million in the first nine months of 2023. This was primarily driven by a fair value gain of US$5.2 million upon the reclassification of the convertible bond-related derivative to equity. This fair value gain was a result of the decrease in value of the option component classified as a derivative from issuance until the physical settlement date of the newly issued convertible bond. In addition, interest income from investments in marketable securities, which commenced in the second quarter of 2023, increased by US$1.7 million. These positive results were partially offset by US$1.1 million higher interest expense on the 2024 issued convertible bond and unfavorable EUR/USD exchange rate developments, which led to a foreign currency loss of US$1.3 million compared to a loss of US$0.1 million in the first nine months of 2023.
The Company had a net loss of US$14.7 million, compared to a net loss of US$7.4 million in the first nine months of 2023. In addition to the support in other income from the PRV and the milestone payments for Joenja® in the first nine months of 2023, the change was mainly due to an increase in gross profit, higher interest income and the fair value gain upon the reclassification of the convertible bond-related derivative to equity, offset by an increase in operating expenses, unfavorable EUR/USD exchange rate developments and higher interest expenses on the 2024 issued convertible bond.
Cash and cash equivalents, including restricted cash and marketable securities, decreased from US$215.0 million at the end of 2023 to US$173.3 million at the end of September 2024. This decrease
6
was primarily driven by the repurchase of the outstanding convertible bonds amounting to US$134.9 million and paid taxes of US$13.9 million, offset by net proceeds of US$104.5 million for newly issued convertible bonds.
On 5 October 2023, Orchard Therapeutics Plc. (Orchard) announced it had entered into a definitive agreement with Japanese company Kyowa Kirin Co. LTD for the acquisition of Orchard. During the first nine months of 2024, Pharming received US$2.0 million in cash for its shares held in Orchard. Pharming has terminated the research collaboration & licensing agreement with Orchard Therapeutics and discontinued the OTL-105 program.
Outlook/Summary
For the remainder of 2024 and the full year, the Company anticipates:
•Total revenues between US$280 million and US$295 million (14% to 20% growth).
•Continued progress finding additional APDS patients in the U.S., supported by family testing and VUS validation efforts, and subsequently converting patients to paid Joenja® (leniolisib) therapy.
•Increasing leniolisib ex-U.S. revenues - through our Named Patient Program and other funded early access programs in key global markets.
•Completion of leniolisib clinical trials to support regulatory filings for approval in Japan and pediatric label expansion in key global markets.
•Progress towards regulatory approvals for leniolisib in the EEA, Canada and Australia.
•Advancing the Phase II clinical trial for leniolisib in PIDs with immune dysregulation linked to PI3Kδ signaling to significantly expand the long-term commercial potential of leniolisib.
•Continued focus on potential acquisitions and in-licensing of clinical stage opportunities in rare diseases. Financing, if required, would come via a combination of our strong balance sheet and access to capital markets.
No further specific financial guidance for 2024 is provided.
Additional information
Presentation
The conference call presentation is available on the Pharming.com website from 07:30 CEST today.
Conference Call
The conference call will begin at 13:30 CEST/07:30 EDT on Thursday, October 24. A transcript will be made available on the Pharming.com website in the days following the call.
Please note, the Company will only take questions from dial-in attendees.
Webcast Link:
https://edge.media-server.com/mmc/p/yotjk8ib
Conference call dial-in details:
https://register.vevent.com/register/BId118ac68d9124f67b1a83e3769559100
Additional information on how to register for the conference call/webcast can be found on the Pharming.com website.
7
For further public information, contact:
Pharming Group N.V., Leiden, the Netherlands
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com
FTI Consulting, London, UK
Victoria Foster Mitchell/Alex Shaw
T: +44 203 727 1000
LifeSpring Life Sciences Communication, Amsterdam, the Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: pharming@lifespring.nl
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.
For more information, visit www.pharming.com and find us on LinkedIn.
Auditor’s involvement
The Condensed Consolidated Interim Financial Statements have not been audited by the Company’s statutory auditor.
Forward-looking Statements
This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2023 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their
8
entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.
Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.
9
Pharming Group N.V.
Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)
For the period ended September 30, 2024
•Condensed consolidated interim statement of income
•Condensed consolidated interim statement of comprehensive income
•Condensed consolidated interim balance sheet
•Condensed consolidated interim statement of changes in equity
•Condensed consolidated interim statement of cash flows
10
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF INCOME | ||||||||||||||
| For the period ended September 30 | ||||||||||||||
| Amounts in US$ ‘000 | 3Q 2024 | 3Q 2023 | 9M 2024 | 9M 2023 | ||||||||||
| Revenues | 74,849 | 66,661 | 204,528 | 164,099 | ||||||||||
| Costs of sales | (6,819) | (8,295) | (23,186) | (18,094) | ||||||||||
| Gross profit | 68,030 | 58,366 | 181,342 | 146,005 | ||||||||||
| Other income | 777 | 304 | 2,034 | 22,811 | ||||||||||
| Research and development | (20,721) | (20,753) | (60,839) | (57,287) | ||||||||||
| General and administrative | (15,292) | (10,886) | (45,999) | (31,849) | ||||||||||
| Marketing and sales | (28,686) | (25,123) | (91,863) | (86,136) | ||||||||||
| Other Operating Costs | (64,699) | (56,762) | (198,701) | (175,272) | ||||||||||
| Operating profit (loss) | 4,108 | 1,908 | (15,325) | (6,456) | ||||||||||
| Fair value gain (loss) on revaluation | 21 | — | 5,159 | — | ||||||||||
| Other finance income | 825 | 1,251 | 3,760 | 2,050 | ||||||||||
| Other finance expenses | (2,998) | 633 | (7,488) | (4,621) | ||||||||||
| Finance result, net | (2,152) | 1,884 | 1,431 | (2,571) | ||||||||||
| Share of net profits (loss) in associates using the equity method | (442) | (485) | (1,276) | (954) | ||||||||||
| Profit (loss) before tax | 1,514 | 3,307 | (15,170) | (9,981) | ||||||||||
| Income tax credit (expense) | (2,548) | 157 | 470 | 2,556 | ||||||||||
| Profit (loss) for the period | (1,034) | 3,464 | (14,700) | (7,425) | ||||||||||
| Basic earnings per share (US$) | (0.002) | 0.005 | (0.022) | (0.011) | ||||||||||
| Diluted earnings per share (US$) | (0.002) | 0.005 | (0.022) | (0.011) | ||||||||||
11
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE INCOME | ||||||||||||||
| For the period ended September 30 | ||||||||||||||
| Amounts in US$ ‘000 | 3Q 2024 | 3Q 2023 | 9M 2024 | 9M 2023 | ||||||||||
| Profit (loss) for the period | (1,034) | 3,464 | (14,700) | (7,425) | ||||||||||
| Currency translation differences | 2,883 | (5,158) | (1,352) | (2,079) | ||||||||||
| Items that may be subsequently reclassified to profit or loss | 2,883 | (5,158) | (1,352) | (2,079) | ||||||||||
| Fair value remeasurement investments | 1 | 281 | 79 | 419 | ||||||||||
| Items that shall not be subsequently reclassified to profit or loss | 1 | 281 | 79 | 419 | ||||||||||
| Other comprehensive income (loss), net of tax | 2,884 | (4,877) | (1,273) | (1,660) | ||||||||||
| Total comprehensive income (loss) for the period | 1,850 | (1,413) | (15,973) | (9,085) | ||||||||||
12
| CONDENSED CONSOLIDATED INTERIM BALANCE SHEET | ||||||||
| Amounts in US$ ‘000 | September 30, 2024 | December 31, 2023 | ||||||
| Non-current assets | ||||||||
| Intangible assets | 67,096 | 71,267 | ||||||
| Property, plant and equipment | 8,692 | 9,689 | ||||||
| Right-of-use assets | 21,975 | 23,777 | ||||||
| Long-term prepayments | 93 | 92 | ||||||
| Deferred tax assets | 36,752 | 29,761 | ||||||
| Investment accounted for using the equity method | 1,016 | 2,285 | ||||||
| Investments in equity instruments designated as at FVTOCI | — | 2,020 | ||||||
| Investment in debt instruments designated as at FVTPL | 6,150 | 6,093 | ||||||
| Restricted cash | 1,548 | 1,528 | ||||||
| Total non-current assets | 143,322 | 146,512 | ||||||
| Current assets | ||||||||
| Inventories | 62,227 | 56,760 | ||||||
| Trade and other receivables | 48,199 | 46,158 | ||||||
| Marketable securities | 111,104 | 151,683 | ||||||
| Cash and cash equivalents | 60,662 | 61,741 | ||||||
| Total current assets | 282,192 | 316,342 | ||||||
| Total assets | 425,514 | 462,854 | ||||||
| Equity | ||||||||
| Share capital | 7,750 | 7,669 | ||||||
| Share premium | 487,079 | 478,431 | ||||||
| Other reserves | 9,334 | (2,057) | ||||||
| Accumulated deficit | (278,371) | (265,262) | ||||||
| Shareholders’ equity | 225,792 | 218,781 | ||||||
| Non-current liabilities | ||||||||
| Convertible bonds | 92,099 | 136,598 | ||||||
| Lease liabilities | 27,784 | 29,507 | ||||||
| Total non-current liabilities | 119,883 | 166,105 | ||||||
| Current liabilities | ||||||||
| Convertible bonds | 3,319 | 1,824 | ||||||
| Trade and other payables | 72,638 | 72,528 | ||||||
| Lease liabilities | 3,882 | 3,616 | ||||||
| Total current liabilities | 79,839 | 77,968 | ||||||
| Total equity and liabilities | 425,514 | 462,854 | ||||||
13
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY | |||||||||||||||||
| For the period ended September 30 | |||||||||||||||||
| Attributable to owners of the parent | |||||||||||||||||
| Amounts in US$ ‘000 | Share capital | Share premium | Other reserves | Accumulated deficit | Total equity | ||||||||||||
| Balance at January 1, 2023 | 7,509 | 462,297 | (8,737) | (256,431) | 204,638 | ||||||||||||
| Profit (loss) for the period | — | — | — | (7,425) | (7,425) | ||||||||||||
| Reserves | — | — | — | — | — | ||||||||||||
| Other comprehensive income (loss) for the period | — | — | (1,660) | — | (1,660) | ||||||||||||
| Total comprehensive income (loss) for the period | — | — | (1,660) | (7,425) | (9,085) | ||||||||||||
| Other reserves | — | — | (518) | 518 | — | ||||||||||||
| Income tax benefit from excess tax deductions related to share-based payments | — | — | — | 574 | 574 | ||||||||||||
| Share-based compensation | — | — | — | 5,935 | 5,935 | ||||||||||||
| Options exercised / LTIP shares issued | 141 | 13,686 | — | (5,947) | 7,880 | ||||||||||||
| Value of conversion rights of convertible bonds | — | — | — | — | — | ||||||||||||
| Total transactions with owners, recognized directly in equity | 141 | 13,686 | (518) | 1,080 | 14,389 | ||||||||||||
| Balance at September 30, 2023 | 7,650 | 475,983 | (10,915) | (262,776) | 209,942 | ||||||||||||
| Balance at January 1, 2024 | 7,669 | 478,431 | (2,057) | (265,262) | 218,781 | ||||||||||||
| Profit (loss) for the period | — | — | — | (14,700) | (14,700) | ||||||||||||
| Reserves | — | — | 1,560 | (1,560) | — | ||||||||||||
| Other comprehensive income (loss) for the period | — | — | (1,273) | — | (1,273) | ||||||||||||
| Total comprehensive income (loss) for the period | — | — | 287 | (16,260) | (15,973) | ||||||||||||
| Other reserves | — | — | (31) | 31 | — | ||||||||||||
| Income tax benefit from excess tax deductions related to share-based payments | — | — | — | (241) | (241) | ||||||||||||
| Share-based compensation | — | — | — | 8,605 | 8,605 | ||||||||||||
| Options exercised / LTIP shares issued | 81 | 8,648 | — | (5,244) | 3,485 | ||||||||||||
| Value of conversion rights of convertible bonds | — | — | 11,135 | — | 11,135 | ||||||||||||
| Total transactions with owners, recognized directly in equity | 81 | 8,648 | 11,104 | 3,151 | 22,984 | ||||||||||||
| Balance at September 30, 2024 | 7,750 | 487,079 | 9,334 | (278,371) | 225,792 | ||||||||||||
14
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH FLOWS | ||||||||||||||
| For the period ended September 30 | ||||||||||||||
| Amounts in $’000 | 3Q 2024 | 3Q 2023 | 9M 2024 | 9M 2023 | ||||||||||
| Profit (loss) before tax | 1,514 | 3,307 | (15,170) | (9,981) | ||||||||||
| Adjustments to reconcile net profit (loss) to net cash used in operating activities: | ||||||||||||||
| Depreciation, amortization, impairment of non-current assets | 2,743 | 2,902 | 8,371 | 8,370 | ||||||||||
| Equity settled share based payments | 2,918 | 1,965 | 8,605 | 5,935 | ||||||||||
| Fair value loss (gain) on revaluation | (21) | — | (5,159) | — | ||||||||||
| Gain on disposal from PRV sale | — | — | — | (21,080) | ||||||||||
| Other finance income | (182) | (1,251) | (3,117) | (2,050) | ||||||||||
| Other finance expenses | 2,315 | (633) | 6,765 | 4,621 | ||||||||||
| Share of net result in associates using the equity method | 442 | 485 | 1,276 | 954 | ||||||||||
| Other | — | 1,055 | — | (1,130) | ||||||||||
| Operating cash flows before changes in working capital | 9,729 | 7,830 | 1,571 | (14,361) | ||||||||||
| Changes in working capital: | ||||||||||||||
| Inventories | (2,133) | (396) | (5,248) | (11,113) | ||||||||||
| Trade and other receivables | 2,919 | (7,363) | (2,044) | (12,902) | ||||||||||
| Payables and other current liabilities | 6,560 | 3,242 | 4,305 | 8,075 | ||||||||||
| Restricted cash | — | (47) | — | 363 | ||||||||||
| Total changes in working capital | 7,346 | (4,563) | (2,987) | (15,577) | ||||||||||
| Interest received | 1,784 | 260 | 4,154 | 1,059 | ||||||||||
| Income taxes received (paid) | (9,117) | — | (13,864) | — | ||||||||||
| Net cash flows generated from (used in) operating activities | 9,742 | 3,527 | (11,126) | (28,879) | ||||||||||
| Capital expenditure for property, plant and equipment | (366) | (147) | (660) | (1,133) | ||||||||||
| Proceeds on PRV sale | — | — | — | 21,080 | ||||||||||
| Investment intangible assets | — | 23 | — | 23 | ||||||||||
| Disposal of investment designated as at FVOCI | 8 | — | 1,972 | — | ||||||||||
| Purchases of marketable securities | (109,796) | (144,554) | (222,249) | (231,901) | ||||||||||
| Proceeds from sale of marketable securities | 114,504 | 86,451 | 262,345 | 86,451 | ||||||||||
| Net cash flows generated from (used in) investing activities | 4,350 | (58,227) | 41,408 | (125,480) | ||||||||||
| Payment of lease liabilities | (918) | (1,007) | (2,485) | (3,022) | ||||||||||
| Interests on lease liabilities | (258) | (270) | (784) | (825) | ||||||||||
| Net proceeds of issued convertible bonds | (263) | — | 104,539 | — | ||||||||||
| Repurchase of convertible bonds | (9) | — | (134,931) | — | ||||||||||
| Interests on convertible bonds | (8) | (2,029) | (2,032) | (4,052) | ||||||||||
| Settlement of share based compensation awards | 23 | 8,546 | 3,485 | 7,880 | ||||||||||
| Net cash flows generated from (used in) financing activities | (1,433) | 5,240 | (32,208) | (19) | ||||||||||
| Increase (decrease) of cash | 12,659 | (49,460) | (1,926) | (154,378) | ||||||||||
| Exchange rate effects | 861 | (913) | 847 | 1,689 | ||||||||||
| Cash and cash equivalents at the beginning of the period | 47,142 | 105,026 | 61,741 | 207,342 | ||||||||||
| Total cash and cash equivalents at September 30 | 60,662 | 54,653 | 60,662 | 54,653 | ||||||||||
15