[20-F] Opthea Ltd Files Annual Report (Foreign Issuer)
Opthea Limited (CKDXF) filed its Form 20-F describing a company without product revenues that continues development of biologic candidates including sozinibercept and OPT-302. Management disclosed that it has not obtained regulatory approval for any product candidate, has incurred significant losses, and expects to need additional capital to complete clinical development. The company may reformulate candidates to target VEGF-C/D; if reformulation is not viable directors may consider a return of capital and ceasing operations.
The report discloses a resolution of the Development Funding Agreement: DFA investors provided US$20.0 million and were issued equity equal to 9.99% fully diluted (136,661,003 ordinary shares), liens were released and the DFA terminated. As of August 30, 2025 the Group had US$19.3 million of cash and cash equivalents. Management concluded internal control over financial reporting was not effective as of June 30, 2025 due to errors in accounting for the Funding Agreement and investor options.
Opthea Limited (CKDXF) ha presentato il modulo Form 20-F descrivendo una società senza ricavi da prodotti che prosegue lo sviluppo di candidati biologici tra cui sozinibercept e OPT-302. La direzione ha comunicato di non aver ottenuto l'approvazione regolamentare per alcun candidato, ha sostenuto perdite significative e prevede la necessità di ulteriore capitale per completare lo sviluppo clinico. L'azienda potrebbe riformulare i candidati per mirare VEGF-C/D; se tale riformulazione non fosse praticabile, i consiglieri potrebbero considerare un ritorno di capitale e la cessazione delle attività. Il rapporto rende nota una risoluzione del Development Funding Agreement (DFA): gli investitori DFA hanno fornito 20,0 milioni di USD e hanno ricevuto capitale sociale pari al 9,99% in diluizione completa (136.661.003 azioni ordinarie); i gravami sono stati rilasciati e il DFA è stato terminato. Al 30 agosto 2025 il Gruppo disponeva di 19,3 milioni di USD in contanti e equivalenti. La direzione ha concluso che il controllo interno sui rendiconti finanziari non era efficace al 30 giugno 2025 a causa di errori nella contabilizzazione dell'Funding Agreement e delle opzioni per gli investitori.
Opthea Limited (CKDXF) presentó su Form 20-F describiendo una empresa sin ingresos por productos que continúa el desarrollo de candidatos biológicos, entre ellos sozinibercept y OPT-302. La gerencia indicó que no ha obtenido aprobación regulatoria para ningún candidato, ha registrado pérdidas significativas y estima necesitar capital adicional para completar el desarrollo clínico. La empresa podría reformular candidatos para dirigirse a VEGF-C/D; si la reformulación no fuera viable, los miembros de la junta podrían considerar un retorno de capital y cesar operaciones. El informe divulga una resolución del Development Funding Agreement (DFA): los inversores DFA aportaron 20,0 millones de USD y recibieron acciones equivalentes al 9,99% de dilución total (136.661.003 acciones ordinarias); se liberaron gravámenes y el DFA se dio por terminado. Al 30 de agosto de 2025, el grupo tenía 19,3 millones de USD en efectivo y equivalentes. La administración concluyó que el control interno sobre la información financiera no era eficaz al 30 de junio de 2025 debido a errores en la contabilidad del Funding Agreement y de las opciones de los inversores.
Opthea Limited (CKDXF) 은 제품 매출이 없는 회사로 20-F 양식을 제출해 sozinibercept 및 OPT-302 를 포함한 생물학적 후보물질의 개발을 계속하고 있습니다. 경영진은 어떤 후보물질도 규제 승인을 받지 못했고 상당한 손실이 발생했으며 임상 개발을 완료하기 위해 추가 자본이 필요하다고 밝혔습니다. 회사는 VEGF-C/D 를 겨냥하도록 후보물을 재구성할 수 있으며, 재구성이 실현 불가능하면 이사회는 자본 환원 및 운영 중단을 고려할 수 있습니다. 보고서는 Development Funding Agreement(DFA)의 해결을 공시합니다: DFA 투자자들이 2,000만 달러를 제공했고 전체 희석된 지분의 9.99%에 해당하는 주식을 받았으며(136,661,003 주의 일반 주식), 담보권은 해제되었고 DFA가 종료되었습니다. 2025년 8월 30일 현재 그룹은 현금 및 현금성 자산으로 1,930만 달러를 보유하고 있었습니다. 경영진은 2025년 6월 30일 기준 재무 보고에 대한 내부통제가 효과적이지 못하다고 결론지었으며, 이는 Funding Agreement 및 투자자 옵션의 회계 처리에 오류가 있었기 때문입니다.
Opthea Limited (CKDXF) a déposé son Form 20-F décrivant une société sans revenus issus de produits et poursuivant le développement de candidats biologiques, notamment sozinibercept et OPT-302. La direction a indiqué ne pas avoir obtenu l'approbation réglementaire pour aucun candidat, avoir enregistré des pertes importantes et anticiper la nécessité de capitaux supplémentaires pour mener à bien le développement clinique. L'entreprise pourrait reformuler les candidats pour viser VEGF-C/D ; si la reformulation n'était pas viable, les administrateurs pourraient envisager un retour de capital et l'arrêt des activités. Le rapport révèle une résolution du Development Funding Agreement (DFA) : les investisseurs DFA ont fourni 20,0 millions USD et ont reçu des actions équivalant à 9,99% en dilution complète (136 661 003 actions ordinaires); des charges ont été levées et le DFA a été résilié. Au 30 août 2025, le Groupe disposait de 19,3 millions de dollars en espèces et équivalents. La direction a conclu que le contrôle interne sur le reporting financier n'était pas efficace au 30 juin 2025 en raison d'erreurs dans la comptabilisation de l'accord de financement et des options des investisseurs.
Opthea Limited (CKDXF) hat ihr Form 20-F eingereicht und ein Unternehmen beschrieben, das keine Produktumsätze erzielt, aber die Entwicklung biologischer Kandidaten, darunter sozinibercept und OPT-302, fortsetzt. Das Management gab bekannt, dass es für keinen Kandidaten eine behördliche Zulassung erhalten hat, erhebliche Verluste verzeichnete und voraussichtlich zusätzliches Kapital benötigt, um die klinische Entwicklung abzuschließen. Das Unternehmen könnte Kandidaten umformen, um VEGF-C/D anzuvisieren; wenn eine Umformulierung nicht realisierbar ist, könnten die Direktoren in Erwägung ziehen, Kapital zurückzuzahlen und den Betrieb einzustellen. Der Bericht öffnet eine Resolution des Development Funding Agreement (DFA): DFA-Investoren stellten 20,0 Mio. USD bereit und erhielten Aktien in Höhe von 9,99% vollständig verwässert (136.661.003 Stammaktien); Belastungen wurden freigegeben und das DFA wurde beendet. Zum 30. August 2025 verfügte die Gruppe über 19,3 Mio. USD in Bargeld und Barmitteln. Das Management kam zu dem Schluss, dass die interne Kontrolle über den Finanzbericht zum 30. Juni 2025 nicht effektiv war, aufgrund von Fehlern bei der Bilanzierung des Funding Agreement und der Optionen der Investoren.
قدمت Opthea Limited (CKDXF) نموذج Form 20-F يصف شركة بلا إيرادات من المنتجات وتواصل تطوير مرشحات بيولوجية بما في ذلك sozinibercept وOPT-302. ذكرت الإدارة أنها لم تحصل على موافقات تنظيمية لأي مرشح، وأنها تكبدت خسائر كبيرة وتتوقع الحاجة إلى رأس مال إضافي لإكمال التطوير السريري. قد تعيد الشركة صياغة المرشحين لاستهداف VEGF-C/D؛ إذا لم يكن إعادة الصياغة قابلة للتحقق، فقد يفكر المدراء في إعادة رأس المال وإيقاف العمليات. يكشف التقرير عن حل لاتفاق تمويل التطوير: قدّم مستثمرو DFA 20.0 مليون دولار وحصلوا على حقوق ملكية تعادل 9.99% مخفّضة بالكامل (136,661,003 سهم عادي)، وتم رفع الرهون وانهى DFA. حتى 30 أغسطس 2025 كان لدى المجموعة 19.3 مليون دولار من النقد وما يعادله. خلصت الإدارة إلى أن الرقابة الداخلية على التقارير المالية لم تكن فعالة حتى 30 يونيو 2025 بسبب أخطاء في محاسبة اتفاق التمويل وخيارات المستثمرين.
Opthea Limited (CKDXF) 提交了 Form 20-F，描述了一家没有产品收入、但仍在开发生物制剂候选物（包括 sozinibercept 和 OPT-302）的公司。 管理层披露尚未获得任何候选物的监管批准，已发生重大亏损，预计需要额外资金以完成临床开发。公司可能重新制定候选物以针对 VEGF-C/D；如果重新制定不可行，董事将考虑回笼资金并停止运营。报告披露了 Development Funding Agreement（DFA）的一项解决：DFA 投资人提供了 2000 万美元，并获得等同于 9.99% 的全面稀释的股权（136,661,003 股普通股），留置权已解除，DFA 已终止。截至 2025 年 8 月 30 日，该集团拥有 1930 万美元现金及现金等价物。管理层得出结论，因对 Funding Agreement 及投资者期权的会计处理存在错误，至 2025 年 6 月 30 日的财务报告内部控制并不高效。
- DFA resolved with US$20.0 million cash received and issuance of equity equal to 9.99% fully diluted, liens released and DFA terminated
- Cash and cash equivalents of US$19.3 million as of August 30, 2025
- R&D tax incentive program available up to 43.5% of eligible R&D expenditure, with amounts referenced in the financials
- Internal control weakness concluded as of June 30, 2025 due to mis-accounting of the Funding Agreement and investor options
- No product approvals or product revenue; the company has incurred significant losses and expects to continue to do so
- Ongoing financing risk: additional capital is required to complete efficacy and safety stages of clinical trials and to continue operations
- Material operational and regulatory risks disclosed, including patient enrollment difficulties, manufacturing and third-party reliance, and potential delays or failures in clinical trials
Insights
TL;DR: Funding resolution improves near-term liquidity but cash remains limited and development spend plus regulatory risk keep financing risk high.
The US$20.0 million cash receipt and termination of the DFA materially reduces near-term covenant and lien uncertainty and produced US$19.3 million in reported cash at August 30, 2025. That provides a finite runway for ongoing R&D but is unlikely to fund late-stage activities or commercialization. The company explicitly has no product revenues and expects continued losses, so additional financing remains necessary. The R&D tax incentive (43.5% refundable offset) and recognition of amounts (A$7.2m and US$10.4m referenced) provide recurring subsidy potential but are not a substitute for capital markets funding. Investors should note the narrow buffer between cash on hand and typical clinical development costs.
TL;DR: Governance gaps are evident: restatements and control weaknesses were identified while significant leadership turnover occurred.
Management concluded internal control over financial reporting was not effective as of June 30, 2025 due to failures in accounting for the Funding Agreement and investor options; these are material control matters that required correction in consolidated financials. The filing also documents CEO and board changes, including a CEO resignation effective September 1, 2025 and an engagement of Dr. Levin to fulfill CEO duties. The equity issuance to DFA investors (9.99%) and use of home-country governance exemptions underscore heightened shareholder governance and disclosure considerations for U.S.-listed holders.
Opthea Limited (CKDXF) ha presentato il modulo Form 20-F descrivendo una società senza ricavi da prodotti che prosegue lo sviluppo di candidati biologici tra cui sozinibercept e OPT-302. La direzione ha comunicato di non aver ottenuto l'approvazione regolamentare per alcun candidato, ha sostenuto perdite significative e prevede la necessità di ulteriore capitale per completare lo sviluppo clinico. L'azienda potrebbe riformulare i candidati per mirare VEGF-C/D; se tale riformulazione non fosse praticabile, i consiglieri potrebbero considerare un ritorno di capitale e la cessazione delle attività. Il rapporto rende nota una risoluzione del Development Funding Agreement (DFA): gli investitori DFA hanno fornito 20,0 milioni di USD e hanno ricevuto capitale sociale pari al 9,99% in diluizione completa (136.661.003 azioni ordinarie); i gravami sono stati rilasciati e il DFA è stato terminato. Al 30 agosto 2025 il Gruppo disponeva di 19,3 milioni di USD in contanti e equivalenti. La direzione ha concluso che il controllo interno sui rendiconti finanziari non era efficace al 30 giugno 2025 a causa di errori nella contabilizzazione dell'Funding Agreement e delle opzioni per gli investitori.
Opthea Limited (CKDXF) presentó su Form 20-F describiendo una empresa sin ingresos por productos que continúa el desarrollo de candidatos biológicos, entre ellos sozinibercept y OPT-302. La gerencia indicó que no ha obtenido aprobación regulatoria para ningún candidato, ha registrado pérdidas significativas y estima necesitar capital adicional para completar el desarrollo clínico. La empresa podría reformular candidatos para dirigirse a VEGF-C/D; si la reformulación no fuera viable, los miembros de la junta podrían considerar un retorno de capital y cesar operaciones. El informe divulga una resolución del Development Funding Agreement (DFA): los inversores DFA aportaron 20,0 millones de USD y recibieron acciones equivalentes al 9,99% de dilución total (136.661.003 acciones ordinarias); se liberaron gravámenes y el DFA se dio por terminado. Al 30 de agosto de 2025, el grupo tenía 19,3 millones de USD en efectivo y equivalentes. La administración concluyó que el control interno sobre la información financiera no era eficaz al 30 de junio de 2025 debido a errores en la contabilidad del Funding Agreement y de las opciones de los inversores.
Opthea Limited (CKDXF) 은 제품 매출이 없는 회사로 20-F 양식을 제출해 sozinibercept 및 OPT-302 를 포함한 생물학적 후보물질의 개발을 계속하고 있습니다. 경영진은 어떤 후보물질도 규제 승인을 받지 못했고 상당한 손실이 발생했으며 임상 개발을 완료하기 위해 추가 자본이 필요하다고 밝혔습니다. 회사는 VEGF-C/D 를 겨냥하도록 후보물을 재구성할 수 있으며, 재구성이 실현 불가능하면 이사회는 자본 환원 및 운영 중단을 고려할 수 있습니다. 보고서는 Development Funding Agreement(DFA)의 해결을 공시합니다: DFA 투자자들이 2,000만 달러를 제공했고 전체 희석된 지분의 9.99%에 해당하는 주식을 받았으며(136,661,003 주의 일반 주식), 담보권은 해제되었고 DFA가 종료되었습니다. 2025년 8월 30일 현재 그룹은 현금 및 현금성 자산으로 1,930만 달러를 보유하고 있었습니다. 경영진은 2025년 6월 30일 기준 재무 보고에 대한 내부통제가 효과적이지 못하다고 결론지었으며, 이는 Funding Agreement 및 투자자 옵션의 회계 처리에 오류가 있었기 때문입니다.
Opthea Limited (CKDXF) a déposé son Form 20-F décrivant une société sans revenus issus de produits et poursuivant le développement de candidats biologiques, notamment sozinibercept et OPT-302. La direction a indiqué ne pas avoir obtenu l'approbation réglementaire pour aucun candidat, avoir enregistré des pertes importantes et anticiper la nécessité de capitaux supplémentaires pour mener à bien le développement clinique. L'entreprise pourrait reformuler les candidats pour viser VEGF-C/D ; si la reformulation n'était pas viable, les administrateurs pourraient envisager un retour de capital et l'arrêt des activités. Le rapport révèle une résolution du Development Funding Agreement (DFA) : les investisseurs DFA ont fourni 20,0 millions USD et ont reçu des actions équivalant à 9,99% en dilution complète (136 661 003 actions ordinaires); des charges ont été levées et le DFA a été résilié. Au 30 août 2025, le Groupe disposait de 19,3 millions de dollars en espèces et équivalents. La direction a conclu que le contrôle interne sur le reporting financier n'était pas efficace au 30 juin 2025 en raison d'erreurs dans la comptabilisation de l'accord de financement et des options des investisseurs.
Opthea Limited (CKDXF) hat ihr Form 20-F eingereicht und ein Unternehmen beschrieben, das keine Produktumsätze erzielt, aber die Entwicklung biologischer Kandidaten, darunter sozinibercept und OPT-302, fortsetzt. Das Management gab bekannt, dass es für keinen Kandidaten eine behördliche Zulassung erhalten hat, erhebliche Verluste verzeichnete und voraussichtlich zusätzliches Kapital benötigt, um die klinische Entwicklung abzuschließen. Das Unternehmen könnte Kandidaten umformen, um VEGF-C/D anzuvisieren; wenn eine Umformulierung nicht realisierbar ist, könnten die Direktoren in Erwägung ziehen, Kapital zurückzuzahlen und den Betrieb einzustellen. Der Bericht öffnet eine Resolution des Development Funding Agreement (DFA): DFA-Investoren stellten 20,0 Mio. USD bereit und erhielten Aktien in Höhe von 9,99% vollständig verwässert (136.661.003 Stammaktien); Belastungen wurden freigegeben und das DFA wurde beendet. Zum 30. August 2025 verfügte die Gruppe über 19,3 Mio. USD in Bargeld und Barmitteln. Das Management kam zu dem Schluss, dass die interne Kontrolle über den Finanzbericht zum 30. Juni 2025 nicht effektiv war, aufgrund von Fehlern bei der Bilanzierung des Funding Agreement und der Optionen der Investoren.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
OR
For the fiscal year ended
OR
OR
Date of event requiring this shell company report ______________
For the transition period from ______________ to ______________
Commission file number:
(Exact name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
AUSTRALIA
(Jurisdiction of incorporation or organization)
+ 61 3 9826 0399
(Address of principal executive offices)
Chairman and Chief Executive Officer
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class |
Trading Symbol |
Name of each exchange on which registered |
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* Not for trading, but only in connection with the registration of the American Depositary Shares. |
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Securities registered or to be registered pursuant to Section 12(g) of the Act.
None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ☐ |
Accelerated filer ☐ |
Emerging growth company |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b) ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
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U.S. GAAP |
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Other |
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If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes
TABLE OF CONTENTS
PRESENTATION OF FINANCIAL AND OTHER INFORMATION |
4 |
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ENFORCEMENT OF CIVIL LIABILITIES |
6 |
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FORWARD-LOOKING STATEMENTS |
7 |
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PART I |
9 |
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Item 1. |
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Identity of Directors, Senior Management and Advisers |
9 |
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Item 2. |
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Offer Statistics and Expected Timetable |
9 |
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Item 3. |
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Key Information |
9 |
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3A. |
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Reserved |
9 |
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3B. |
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Capitalization and Indebtedness |
9 |
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3C. |
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Reasons for the offer and use of proceeds |
9 |
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3D. |
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Risk Factors |
9 |
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Item 4. |
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Information on the Company |
62 |
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4A. |
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History and Development of Opthea |
62 |
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4B. |
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Business Overview |
62 |
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4C. |
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Organizational Structure |
82 |
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4D. |
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Property, Plants and Equipment |
82 |
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Item 4A. |
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Unresolved Staff Comments |
82 |
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Item 5. |
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Operating and Financial Review and Prospects |
83 |
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5A. |
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Operating Results |
84 |
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5B. |
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Liquidity and Capital Resources |
90 |
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5C. |
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Research and Development, Patents and Licenses |
94 |
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5D. |
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Trend Information |
94 |
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5E. |
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Critical Accounting Estimates |
94 |
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Item 6. |
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Directors, Senior Management and Employees |
99 |
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6A. |
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Directors and Senior Management |
99 |
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6B. |
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Compensation |
103 |
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6C. |
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Board Practices |
108 |
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6D. |
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Employees |
111 |
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6E. |
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Share Ownership |
111 |
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6F. |
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Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation |
112 |
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Item 7. |
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Major Shareholders and Related Party Transactions |
112 |
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7A. |
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Major Shareholders |
112 |
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7B. |
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Related Party Transactions |
114 |
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7C. |
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Interests of Experts and Counsel |
117 |
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Item 8. |
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Financial Information |
117 |
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8A. |
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Consolidated Statements and Other Financial Information |
117 |
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8B. |
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Significant Changes |
117 |
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Item 9. |
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The Offer and Listing |
117 |
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9A. |
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Offer and Listing Details |
117 |
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9B. |
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Plan of Distribution |
117 |
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9C. |
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Markets |
117 |
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9D. |
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Selling Shareholders |
117 |
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9E. |
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Dilution |
117 |
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9F. |
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Expenses of the Issue |
117 |
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Item 10. |
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Additional Information |
118 |
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10A. |
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Share Capital |
118 |
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10B. |
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Constitution |
118 |
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10C. |
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Material Contracts |
118 |
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10D. |
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Exchange Controls |
118 |
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10E. |
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Taxation |
118 |
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10F. |
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Dividends and Paying Agents |
126 |
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10G. |
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Statement by Experts |
126 |
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10H. |
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Documents on Display |
126 |
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10I. |
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Subsidiary Information |
127 |
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10J. |
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Annual Report to Security Holders |
127 |
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Item 11. |
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Quantitative and Qualitative Disclosures about Market Risk |
127 |
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TABLE OF CONTENTS
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Item 12. |
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Description of Securities Other than Equity Securities |
127 |
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12A. |
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Debt Securities |
127 |
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12B. |
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Warrants and Rights |
127 |
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12C. |
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Other Securities |
127 |
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12D. |
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American Depositary Shares |
127 |
PART II |
130 |
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Item 13. |
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Defaults, Dividend Arrearages and Delinquencies |
130 |
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Item 14. |
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Material Modifications to the Rights of Security Holders and Use of Proceeds |
130 |
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Item 15. |
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Controls and Procedures |
130 |
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Item 16 |
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Reserved |
131 |
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16A. |
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Audit Committee Financial Expert |
131 |
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16B. |
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Code of Ethics |
131 |
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16C. |
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Principal Accountant Fees and Services |
131 |
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16D. |
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Exemptions from the Listing Standards for Audit Committees |
132 |
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16E. |
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Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
132 |
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16F. |
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Change in Registrant’s Certifying Accountant |
132 |
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16G. |
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Corporate Governance |
132 |
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16H. |
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Mine Safety Disclosure |
133 |
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16I. |
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Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
133 |
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16J. |
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Insider Trading Policies |
133 |
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16K |
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Cybersecurity |
133 |
PART III |
135 |
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Item 17. |
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Financial Statements |
135 |
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Item 18. |
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Financial Statements |
135 |
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Item 19. |
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Exhibits |
135 |
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presentation of financial and other information
Our reporting and functional currency is the U.S. dollar, and our financial statements included elsewhere in this Annual Report on Form 20-F, or annual report, are presented in U.S. dollars. The consolidated financial statements and related notes included elsewhere in this annual report have been prepared under the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, which differs in certain significant respects from U.S. Generally Accepted Accounting Principles, or GAAP.
Except where the context requires otherwise and for purposes of this annual report only:
Except with respect to U.S. dollar amounts presented as contractual terms, amounts denominated in U.S. dollars when received or paid and unless otherwise indicated, certain Australian dollar amounts contained in this annual report have been translated into U.S. dollars at the rate published by the Reserve Bank of Australia as of June 30, 2025. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars or Australian dollars at that or any other exchange rate as of that or any other rate. We have made rounding adjustments to some of the figures included in this annual report. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them.
This annual report includes trademarks, tradenames and service marks, certain of which belong to us and others that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this annual report appear without the ® and ™ symbols, but the absence of those references is not intended to indicate, in any way, that we will not assert our rights or that the applicable owner will not assert its rights to these trademarks and tradenames to the fullest extent under applicable law. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
In July 2023, Opthea announced “sozinibercept” as the non-proprietary drug name for OPT-302. The American Medical Association’s United States Adopted Names (USAN) Council, in consultation with the World Health Organization’s International Non-proprietary Names (INN) Expert Committee, approved and adopted the non-proprietary drug name. Opthea will use the name sozinibercept in upcoming publications, public statements, and in corporate materials moving forward.
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This annual report contains estimates and information concerning our industry and our business, including estimated market size and projected growth rates of the markets for our product candidates. Unless otherwise expressly stated, we obtained this industry, business, market, medical and other information from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources.
This information involves a number of assumptions and limitations. Although we are responsible for all of the disclosure contained in this annual report and we believe the third-party market position, market opportunity and market size data included in this annual report are reliable, we have not independently verified the accuracy or completeness of this third-party data. In addition, projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and in “Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
Australian Disclosure Requirements
Our ordinary shares are primarily quoted on the Australian Securities Exchange (“ASX”) in addition to our listing of our ADSs on the Nasdaq Global Select Market, or Nasdaq. As part of our ASX listing, we are required to comply with various disclosure requirements as set out under the Australian Corporations Act 2001 and the ASX Listing Rules. Information furnished under the sub-heading “Australian Disclosure Requirements” is intended to comply with ASX listing and Corporations Act 2001 disclosure requirements and is not intended to fulfill information required by this annual report.
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ENFORCEMENT OF CIVIL LIABILITIES
We are a public limited company incorporated under the laws of Australia. Certain of our directors are non-residents of the United States and substantially all of their assets are located outside the United States. As a result, it may not be possible or practicable for you to:
You may also have difficulties enforcing in courts outside the United States judgments that are obtained in U.S. courts against any of our non-U.S. resident directors or us, including actions under the civil liability provisions of the U.S. securities laws.
With that noted, there are no treaties between Australia and the United States that would affect the recognition or enforcement of foreign judgments in Australia. We also note that investors may be able to bring an original action in an Australian court against us to enforce liabilities based in part upon U.S. federal securities laws. The disclosure in this section is not based on the opinion of counsel.
We have appointed Corporation Service Company, located at 1180 Avenue of the Americas, Suite 210 New York, NY 10036 as our agent to receive service of process with respect to any action brought against us under the federal securities laws of the United States.
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FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this annual report, including statements regarding our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties, other factors and assumptions, including the risks described in “Risk Factors” and elsewhere in this annual report, regarding, among other things:
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These risks are not exhaustive. Other sections of this annual report may include additional factors that could harm our business and financial performance. New risk factors may emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this annual report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We undertake no obligation to update any forward-looking statements made in this annual report to reflect events or circumstances after the date of this annual report or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this annual report. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits to this annual report with the understanding that our actual future results, levels of activity, performance and achievements may be different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
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PART I
Item 1. Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2. Offer Statistics and Expected Timetable
Not applicable.
Item 3. Key Information
3A. Reserved
3B. Capitalization and Indebtedness
Not applicable.
3C. Reasons for the offer and use of proceeds
Not applicable.
3D. Risk Factors
Investing in our securities involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as other information included in this annual report, including our consolidated financial statements and related notes included elsewhere in this annual report, before making an investment decision. If any of the following risks actually occur, it could harm our business, prospects, results of operations and financial condition. In such event, the trading price of the ADSs could decline and you might lose all or part of your investment. You should not interpret our disclosure of any of the following risks to imply that such risks have not already materialized.
As described further in Item 4B. Business Overview, in March 2025, after the primary endpoints were not met in our COAST and ShORe Phase 3 trials, Opthea and the investors (the “DFA Investors”) under our Development Funding Agreement (the “DFA”) agreed to discontinue the development of sozinibercept in wet AMD, and agreed that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea to the DFA Investors. Following the discontinuation of the clinical trials we streamlined our operations, reduced our workforce and Board of Directors and exited all contracts related to our clinical trials. We also entered into negotiations with the DFA Investors to settle the DFA. On August 19, 2025, we reached a binding agreement with the DFA Investors to terminate the DFA, pursuant to which the DFA Investors received a cash payment of US$20 million and 136,661,003 ordinary shares, equal to 9.99% of our then outstanding issued share capital on a fully diluted basis. Upon receipt of the cash payment and ordinary shares, the DFA Investors agreed to release all liens on the collateral and terminate the DFA (these transactions are referred to as the “DFA Settlement”).
Following the DFA Settlement, the Board is conducting a full strategic review of our business. The first phase of the strategic review will be focused on reformulating our portfolio of drug candidates targeting VEGF-C and/or VEGF-D, of which OPT-302 is one of these drug candidates, which was previously delivered to the eye via injection to treat wet AMD, to various other forms of delivery that may be appropriate for delivering our portfolio of drug candidates to other organs. To implement phase one, we have already taken steps to apply for a patent in order to protect the use of OPT-302 in various delivery methods. Following completion of phase one and subject to the successful reformulation of one of our drug candidates targeting VEGF-C and/or VEGF-D, we will look to conduct clinical trials to assess the efficacy of any future drug candidate in treating VEGF-C and/or VEGF-D mediated disorders in other organs. Similar to previous clinical trials conducted for sozinibercept in wet AMD, we expect that any future clinical trials will be outsourced to third party providers.
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Risk Factors Summary
Our business is subject to a number of risks and uncertainties, including those risks discussed at-length below in this summary. These risks include, among others, the following:
Risks Related to our Financial Position and the Need for Capital
Risks Related to Development and Commercialization of Our Product Candidate
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Risks Related to Legal and Regulatory Compliance Matters
Risks Related to Our Reliance on Third Parties
Risks Related to Employee Matters and Managing Our Growth
Risks Related to Intellectual Property
Risks Related to Ownership of the ADSs
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Risks Related to Our Financial Position and Need for Capital
We are a clinical-stage biopharmaceutical company with no products approved for commercial sale. We have incurred net losses since our inception, we expect to incur significant losses and increasing operating losses for the foreseeable future, and we may never be profitable.
We are a clinical-stage biopharmaceutical company with no products approved for commercial sale and no current product candidates. To date, our operations have been limited to organizing and staffing our company, business planning, raising capital, developing our prior lead product candidate, sozinibercept, and licensing certain related technology, conducting research and development activities, including preclinical studies and clinical trials, and providing general and administrative support for these operations. In March 2025, after the primary endpoints were not met in our COAST and ShORe Phase 3 trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD, and agreed that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea to the DFA Investors. In August 2025, a Settlement Agreement was signed with our DFA Investors for a one off payment of US$20 million and issuance of 9.99% share capital to finalize the DFA. Our Board of Directors is conducting a full strategic review of our business and is focused on reformulating our portfolio of drug candidates to treat diseases known to be mediated by VEGF-C and/or VEGF-D Investment in biopharmaceutical product development is highly speculative because it entails substantial up front capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect and/or an acceptable safety profile, gain regulatory approval and become commercially viable. We have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operation
We are not profitable and have incurred net losses since our inception. Our total comprehensive losses were US$220.2 million and US$162.8 million for the years ended June 30, 2024 and 2025, respectively. As of June 30, 2025, we had an accumulated loss of US$742.5 million. We expect to continue to spend, significant resources to fund our strategic review, including research and development of, and seeking regulatory approvals for, other future product candidates. Following the DFA Settlement, as of August 20, 2025 we have $20 million in cash on hand. We have no other committed external source of funds. We expect that our current cash balance will be sufficient to fund our operations into the fourth calendar quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect, requiring us to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. The estimate is also dependent on whether the reformulation process is successful and the nature and size of clinical trials to be conducted in the future. The various ways we could raise additional capital carry potential risks. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. See Note 2, Going Concern of our consolidated financial statements for more information.
Due to uncertainties regarding our future operations following the strategic review and the potential for future clinical trials of our drug candidates in other disorders, we may need to raise additional capital, the timing and amount of which is unknown at this time. If any potential product candidate is approved for commercial sale, our commercialization expenses will increase significantly as we seek a commercialization partner or establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure. As a result, our accumulated losses will also increase significantly. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may negatively affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and may continue to have a negative impact on our shareholders' equity and working capital. The net losses we incur may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Even if we eventually generate product revenue, we may never be profitable and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
We currently have no source of product revenue and may never become profitable.
We do not currently have a product candidate. Following the DFA Settlement, our Board of Directors is conducting a full strategic review of our business and is focused on reformulating our portfolio of drug candidates to treat diseases known to be mediated by VEGF-C and/or VEGF-D. The first phase of the strategic review will be focused on reformulating our portfolio of drug candidates targeting VEGF-C and/or VEGF-D, of which OPT-302 is one of these drug candidates, which was previously delivered to the eye via injection to treat wet AMD, to various other forms of delivery that may be appropriate for delivering our portfolio of drug candidates to other
12
organs. To implement phase one, we have already taken steps to apply for a patent in order to protect the use of OPT-302 in various delivery methods. Following completion of phase one and subject to the successful reformulation of one of our drug candidates targeting VEGF-C and/or VEGF-D, we will look to conduct clinical trials to assess the efficacy of any future drug candidate in treating VEGF-C and/or VEGF-D mediated disorders in other organs. We will not be able to generate product revenue unless and until any future product candidate, alone or with future partners, successfully completes clinical trials, receives regulatory approval and is successfully commercialized. Although we may seek to obtain revenue from collaboration or licensing agreements with third parties, we currently have no such agreements that could provide us with material, ongoing future revenue and we may never enter into any such agreements. Our ability to generate future product revenue from any future product candidates also depends on a number of additional factors, including our or our future partners’ ability to:
In addition, because of the numerous risks and uncertainties associated with biologic product development, including that any future product candidate may not advance through development, achieve the endpoints of applicable clinical trials or receive approval for use in combination with one or more approved therapies, we are unable to predict the timing or amount of increased expenses, or if or when we will achieve or maintain profitability. In addition, our expenses could increase beyond expectations if we decide, or are required by the U.S. Food and Drug Administration, or the FDA, or comparable non-U.S. regulatory authorities, including the European Medicines Agency, or the EMA, to perform studies or trials in addition to those that we currently anticipate. Even if we complete the development and regulatory processes described above, we anticipate incurring significant costs associated with launching and commercializing these products.
Even if we generate revenue from the sale of any of our future product candidates that may be approved, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or do not sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
We will require substantial additional capital to finance our operations, which may not be available to us on acceptable terms, or at all. As a result, we may not be able to develop new product candidates.
As a clinical-stage biopharmaceutical company, our operations have consumed significant amounts of cash since our inception. We expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we reformulate our existing therapeutic products and related intellectual property, and explore other indications relating to anti-VEGF treatment. Even if we are able to obtain regulatory
13
approval for any future product candidates that we may develop, we will require substantial additional capital to commercialize such product candidates.
Our future funding requirements, both short-and long-term, will depend on many factors, including:
We will require additional capital to develop, obtain regulatory approval for and commercialize any future product candidates. We expect to finance future cash needs through public or private issuances of equity or collaborations. We also intend to continue to apply for tax incentives under the Research and Development Tax Incentive scheme provided by the Australian government dependent on the outcome of the strategic review. See “—Risks Related to Development and Commercialization of Our Product Candidates—We have received tax credits under the Research and Development Tax Incentive scheme in Australia that may become repayable if we did not or do not comply with the rules of the scheme, or we may become ineligible for tax credits in our current or future tax years, which could harm our business, financial condition and results of operations.” Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If we are not able to raise additional capital, we may not be able to complete the clinical trials or complete them as originally planned, manufacture materials in preparation for filing and if approved commercialization continue operations or otherwise capitalize on our business opportunities, and our business and financial condition will be negatively impacted.
Raising additional capital may cause dilution to holders of our ordinary shares and ADSs, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Holders of our ordinary shares and ADSs could suffer dilution or be negatively affected by fixed payment obligations we may incur if we raise additional funds through the issuance of additional equity securities or debt. Issuances of our ordinary shares will have a dilutive effect on our existing stockholders. Further, these securities may have rights senior to those of our ordinary shares and could contain covenants or protective rights 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 negatively impact our ability to conduct our business. If we need to secure additional
14
financing, such additional fundraising efforts may divert our management and research efforts from our day-to-day activities, which may negatively affect our ability to develop and commercialize any future product candidates.
To the extent we obtain additional funding through product collaborations, these arrangements would generally require us to relinquish rights to some of our technologies, product candidates or products, and we may not be able to enter into such agreements, on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our development programs or product candidates.
Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.
Global credit and financial markets have experienced extreme disruptions at various points over the last few decades, characterized by diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, rising inflation and interest rates, bank failures, supply chain disruptions, increases in unemployment rates and uncertainty about economic stability. If another such disruption in credit and financial markets and deterioration of confidence in economic conditions occurs, our business may be harmed. If the equity and credit markets were to deteriorate significantly in the future, it may make any necessary debt or equity financing more difficult to complete, more costly and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could harm our growth strategy, financial performance and share price and could require us to delay or abandon development or commercialization plans. In addition, there is a risk that one or more of our service providers, manufacturers or other partners would not survive or be able to meet their commitments to us under such circumstances, which could directly affect our ability to attain our operating goals on schedule and on budget.
Risks Related to Development and Commercialization of Any Future Product Candidates
Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes. Our clinical trials may fail to adequately demonstrate the safety and efficacy of any future product candidates.
Any future product candidates will be subject to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA and comparable non-U.S. regulatory authorities before obtaining marketing approval from these regulatory authorities. The drug development and approval process is lengthy and expensive, and approval is never certain. Investigational new drugs, may not prove to be safe and effective in clinical trials. We may be unable in the future to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical trials in a timely fashion, if at all. In particular, we have incurred and experienced, and may continue to incur and experience in the future, significantly increased costs and delays in connection with the activities conducted by third-party Clinical Research Organizations ("CROs"), CDMOs and other third parties to progress our clinical trials. In addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced
We have in the past experienced, and if we continue to experience delays in clinical testing, our commercial prospects will be harmed, our costs may increase and our business may be harmed.
Conducting clinical trials for any product candidates in the United States requires filing an investigational new drug application, or IND, and reaching agreement with the FDA on clinical protocols, finding appropriate clinical sites and clinical investigators, securing approvals for such trials from the institutional review board at each such site, manufacturing clinical quantities of product candidates and supplying drug product to clinical sites. If any such future IND is not cleared by the FDA, our clinical development timeline may be negatively impacted and any future clinical programs may be delayed or terminated.
We cannot guarantee that we will be able to successfully accomplish required regulatory activities or all of the other activities necessary to initiate and complete clinical trials. As a result, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approvals or successfully commercialize our products. We do not know whether any other clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. In particular, we have incurred and experienced, and may continue to incur and experience in the future, significantly increased costs and delays in connection with the activities
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conducted by third-party CROs, CDMOs and other third parties. Our product development costs will increase if we experience delays in clinical testing. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize any future product candidates or allow our competitors to bring products to market before we do, which would impair our ability to successfully commercialize any future product candidates and may harm our business, results of operations and prospects. Events that have in the past and may in the future result in a delay or unsuccessful completion of clinical development include:
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Our or our future collaborators’ inability to timely complete clinical trials could result in additional costs to us as well as impair our ability to, continue development, commercialize any future product candidates and generate product revenue or receive royalties on product sales. In addition, if we make changes to a product candidate, we may need to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of our modified product candidate to earlier versions, which could delay our clinical development plan or marketing approval for our current product candidate and any future product candidates.
We have in the past encountered difficulties in enrolling patients in our clinical trials and if we encounter such difficulties in the future, our clinical development activities could be delayed or otherwise negatively affected.
The timely completion of clinical trials largely depends on patient enrollment. We have encountered delays in the past and may in the future encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Many factors may continue to affect patient enrollment for any of our future clinical trials, including:
In addition, other companies are conducting clinical trials for the same indications and seek to enroll patients in their trials that may otherwise be eligible for our clinical studies or trials, which could lead to slow recruitment and delays in our clinical programs. Further, since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are available for our clinical trials in these sites.
Any future product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or limit the commercial profile of an approved label.
Undesirable side effects caused by any future product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable non-U.S. regulatory authorities. Additional clinical trials may be required to evaluate the safety profile of any future product candidates.
Future results of our trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics, including, for example, immunogenicity. In such an event, we could suspend or terminate our trials, or the FDA or comparable non-U.S. regulatory authorities could order us to cease clinical trials or deny approval of any future product candidates for any or all targeted indications. Drug-related side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product
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liability claims. Any of these occurrences could materially and negatively affect our business, financial condition, results of operations and prospects.
It may be difficult to discern whether certain events or symptoms observed during our clinical trials or by patients using our approved products are related to any future product candidates or approved products. As a result, we and our development programs may be negatively affected even if such events or symptoms are ultimately determined to be unlikely related to any future product candidates or approved products.
We cannot assure you that additional or more severe adverse side effects related to any future product candidates will not be observed in our clinical trials or in the commercial setting. If observed, such adverse side effects could delay or preclude regulatory approval of any future product candidates, limit commercial use or result in the withdrawal of previously granted marketing approvals. If we or others identify undesirable or unacceptable side effects caused by any future product candidates or products:
Any of these results could decrease or prevent any sales of our approved product or substantially increase the costs and expenses of commercializing and marketing our product.
If we identify a future product candidate, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of any other product candidate we develop.
Any product candidate we may develop and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, and sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable non-U.S. regulatory authorities. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction. We have not received approval to market any product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we may seek to develop in the future will ever obtain regulatory approval. We have no prior experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely in part on third-party CROs or regulatory consultants to assist us in this process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the biologic product candidate’s safety, purity, efficacy and potency. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be
18
only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.
The process of obtaining marketing approvals, both in the United States and in other jurisdictions, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit, or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.
If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates, may be harmed, and our ability to generate revenues will be materially impaired.
The results of completed clinical trials may not be predictive of future results. Data from our clinical trials to date may not be indicative of results obtained when these trials are completed or in later-stage trials.
There is a high failure rate for drugs and biologic products proceeding through clinical trials. Failure can occur at any time during the clinical trial process. The results of completed clinical trials of any future product candidate may not be predictive of the results of later-stage clinical trials, and the results of trials in certain patients may not be predictive of those obtained in another. In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in earlier stage clinical trials. In addition, data obtained from clinical activities is subject to varying interpretations, which may delay, limit or prevent regulatory approval. For example, the results of our Phase 2b clinical trial of sozinibercept combination therapy was not predictive of the results of our Phase 3 clinical program and the primary endpoints were not met in both our COAST and ShORe Phase 3 clinical trials and we discontinued the development of sozinibercept in March 2025.
Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Once we identify a future product candidate we expect that from time to time, we may publicly disclose preliminary or top-line data from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line results that we report for any future product candidate may differ from future results of the same trials or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as more patient data become available.
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In addition, adverse changes between interim data and final data could significantly harm our business and prospects. Additional disclosure of interim data by us or by our competitors in the future could also result in volatility in the price of the ADSs and our ordinary shares. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If the top-line data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize any future product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.
We may face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than us.
The biopharmaceutical industry is intensely competitive and subject to rapid innovation and significant technological advancements. We believe the key competitive factors that will affect the development and commercial success of any future product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price, the level of generic competition and reimbursement. Our competitors include multinational pharmaceutical companies, specialized biotechnology companies, universities and other research institutions. A number of biotechnology and pharmaceutical companies are pursuing the development or marketing of pharmaceuticals that target the same diseases that we are targeting. Smaller or earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
There are a number of large pharmaceutical and biotechnology companies that are currently pursuing the development of products for the treatment of anti-VEGF indications or have commercially approved products for the treatment of anti-VEGF indications, including Roche, Regeneron and Novartis. In addition to competition from other companies directly targeting VEGF-C,D and R3, any products we may develop may also face competition from other types of therapies or patient and physician preferences. In addition, many companies are developing new therapeutics, and we cannot predict what the standard of care will be as any future product candidates progress through development to potential commercialization.
If our competitors market products that are more effective, safer or cheaper than our products, are more durable, have reduced injection burden compared to our products, or reach the market sooner than our products, we may not achieve commercial success. In addition, the biopharmaceutical industry is characterized by rapid technological change. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies, products or product candidates obsolete, less competitive or not economical.
Many of our competitors have substantially greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly longer operating histories and greater experience than we have in undertaking nonclinical studies and human clinical trials of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Clinical trials for the treatment of anti-VEGF indications may be relatively costly and time-consuming. The requirements for approval by the FDA and comparable non-U.S. regulatory authorities may change over time and this may require changes to ongoing or future clinical trial designs that could impact timelines and cost. Further, many of our competitors have established distribution channels for the commercialization of their products, whereas we have no such channel or capabilities. In addition, many competitors have greater name recognition and more extensive collaborative relationships
As a result, our competitors may obtain regulatory approval of their products more rapidly than we do or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize any future product candidates. Our competitors may also develop and succeed in obtaining approval for drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than we are in manufacturing and marketing their products. If we are unable to compete effectively against these companies, then we may not be able to commercialize any
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future product candidates or achieve a competitive position in the market. This would negatively affect our ability to generate revenue. Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and enrolling patients for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our inability to compete effectively in any of these aspects of our business could harm our business, financial condition, results of operations and prospects.
A Fast-Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
If a drug or biologic is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the sponsor may apply for FDA Fast-Track designation for a particular indication. We may seek Fast-Track designation for certain of our future product candidates, but there is no assurance that the FDA will grant this status to any of our future product candidates. If granted, Fast-Track designation makes a product eligible for more frequent interactions with the FDA to discuss the development plan and clinical trial design, as well as rolling review of the application, which means that the company can submit completed sections of its marketing application for review prior to completion of the entire submission. Marketing applications of products candidates with Fast-Track designation may qualify for Priority Review under the policies and procedures offered by the FDA, but the Fast-Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant Fast-Track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive Fast-Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a fast-track designation does not provide any assurance of ultimate FDA approval. In addition, the FDA may withdraw Fast-Track designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, the FDA may withdraw any Fast-Track designation at any time.
Any future product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors and others in the medical community. If we are unsuccessful in achieving a differentiated profile with any future product candidate, based on efficacy, safety and tolerability, dosing and administration, market acceptance will be limited. As a result, doctors may continue to use such existing treatments as first-line therapies
The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including:
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Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost-effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that our products are safe, therapeutically effective and cost-effective as compared with competing treatments.
Demonstrating the safety and efficacy of our product candidates and obtaining regulatory approvals will not guarantee future revenue. Our commercial success also depends on coverage and adequate reimbursement of our product candidates by third-party payors, including government payors, which may be difficult or time-consuming to obtain, may be limited in scope and may not be obtained in all jurisdictions in which we may seek to market our products.
If the market opportunities for any product that we or our strategic collaborators develop are smaller than we believe they are, our revenue may be negatively affected and our business may suffer.
We intend to focus our product candidate development on therapies for the treatment of anti-VEGF-C,D and R3 therapies. Our projections of addressable patient populations that have the potential to benefit from treatment with our product candidate are based on estimates. These estimates have been derived from a variety of sources, including the scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates may not ultimately be amenable to treatment with our product candidates. Our market opportunity may also be limited by future competitor treatments that enter the market. If any of our estimates are inaccurate, the market opportunities for any of our product candidates could be significantly diminished and have an adverse impact on our business.
If we fail to develop and commercialize additional product candidates, we may be unable to grow our business.
Following the termination of our development of sozinibercept, we plan to reformulate our portfolio of drug candidates targeting VEGF-C and /or D to treat VEGF-C and/or D mediated disorders in other organs. The success of this strategy depends primarily upon our ability to identify and validate new therapeutic candidates, and to identify, develop and commercialize new drugs and biologics. Our research efforts may initially show promise in discovering potential new drugs and biologics, yet fail to yield product candidates for clinical development for a number of reasons, including:
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If any of these events occur, we may be forced to abandon our development efforts for one or more programs, which could harm our business, operating results and prospects and could potentially cause us to cease operations. Future research programs to identify new product candidates may require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.
Product candidates may require additional, time-consuming development efforts prior to commercial sale, including preclinical studies, clinical trials and approval by the FDA and/or comparable non-U.S. regulatory authorities. All product candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot assure you that any such products that are approved will be manufactured or produced economically, be successfully commercialized, be widely accepted in the marketplace or be more effective than other commercially available alternatives.
Our business was and may in the future be negatively affected by the effects of health epidemics, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
Health epidemics in regions where we have concentrations of clinical trial sites or other business operations could negatively affect our business, including by causing significant disruption in the operations of third-party manufacturers and CROs upon whom we rely. Moreover, we rely on third-party CROs, CDMOs and other third parties to assist us with clinical development activities. We experienced significantly increased costs and delays in connection with the activities conducted by third-party CROs CDMOs and other third parties to prepare for and progress our Phase 3 clinical trials, due in part to the COVID-19 pandemic and its related effects. The outbreak of health epidemics in the future could cause significant disruptions to our clinical development timelines, which would harm our business, financial condition, results of operations and growth prospects.
Risks Related to Legal and Regulatory Compliance Matters
Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, otherwise prevent new products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA or other comparable foreign regulatory authorities to review and approve new products or take action with respect to other regulatory matters can be affected by a variety of factors, including government budget and funding levels, leadership changes, the ability to hire and retain key personnel and accept payment of user fees, the availability of personnel and other resources, changes in statutes, regulations and policies that affect the FDA’s or comparable foreign regulatory authorities’ ability to perform routine functions, and other business disruptions. Average review times at the FDA and comparable foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
Over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. In addition, there have recently been terminations of large numbers of federal employees at various federal agencies, including the FDA. Changes and cuts in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion, or at all. A prolonged government shutdown occurs and/or employee terminations or resignations could significantly impact the ability of the FDA or other federal agencies to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns and/or employee terminations or resignations at the
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SEC could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
There is substantial uncertainty as to whether and how the current administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges as we navigate development and approval of our product candidates. Some of these efforts have manifested to date in the form of personnel cuts and measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory approvals in the future. There is uncertainty as to whether we will be materially and negatively impacted by governmental orders, regulations, policies or guidance, or disruptions to the normal operations of government agencies.
Even if we commercialize any future product candidate, we may face challenges to achieving profitability such as our products becoming subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
In the United States and in other countries, patients who are prescribed treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. The availability of coverage and adequacy of reimbursement for our products by third-party payors, including government health care programs (e.g., Medicare, Medicaid, TRICARE), managed care providers, private health insurers, health maintenance organizations and other organizations are essential for most patients to be able to afford medical services and pharmaceutical products such as any our product candidates. Third-party payors decide which medications they will pay for and establish reimbursement levels. The availability of coverage and extent of reimbursement by governmental and other third-party payors are essential for most patients to be able to afford treatments .
In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS. CMS decides whether and to what extent our products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Other countries have equivalent authorities who play a similar role. Factors payors consider in determining reimbursement are based on whether the product is:
Our ability to commercialize any products successfully will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors, including government health care programs and private health insurers. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.
In the United States, no uniform policy for coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for our products can differ significantly from payor to payor. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the reimbursement rate that the payor will pay for the product. One payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for the
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product. Third-party payors may also limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication.
Government authorities and other third-party payors in the United States and abroad have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications and for newly approved products, and as a result, they may not cover or provide adequate reimbursement for any future product candidates. Increasingly, certain third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that coverage and reimbursement will be available for any product that we or our future collaborators commercialize and, if reimbursement is available, what the level of reimbursement will be. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we or our future collaborators obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we and our future collaborators may not be able to successfully commercialize any product candidate for which marketing approval is obtained. A decision by a third-party payor not to cover or not to separately reimburse for our medical products or therapies using our products could reduce physician utilization of our products once approved. Assuming there is coverage for our product candidates, or therapies using our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States will be available for any future product candidates and any reimbursement that may become available may not be adequate or may be decreased or eliminated in the future.
There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable non-U.S. regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may only be temporary. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable reimbursement rates from both government-funded and private payors for any approved products that we develop could harm our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
The regulations that govern marketing approvals, pricing and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product-licensing approval is granted. In some non-U.S. markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay or limit our commercial launch of the product, possibly for lengthy time periods, which could negatively impact the revenue we generate from the sale of the product in that particular country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.
To become and remain profitable, we or any potential future collaborator must develop and eventually commercialize any future product candidates with significant market potential at an adequate profit margin after cost of goods sold and other expenses. Commercialization of any future product candidates may entail a substantial cost of goods sold and there can be no assurance that we will be able to achieve a suitable gross margin with respect to sales of any future product candidates.
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Changes in U.S. healthcare law and implementing regulations, as well as changes in healthcare policy, and equivalent changes in the laws and policies in other countries may impact our business in ways that we cannot currently predict and may harm our business and results of operations.
There have been, and likely will continue to be, several executive, legislative and regulatory changes and proposed and enacted changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. Among policy-makers and payors in the United States there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access, and the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively referred to as the Affordable Care Act, substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act, among other things contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws.
On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 or the IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in the Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible that the Affordable Care Act will be subject to additional challenges in the future. It is unclear how any such challenges and future healthcare reform measures will impact the Affordable Care Act.
Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011 and subsequent laws, which began in 2013 and will remain in effect until 2032, unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three (3) to five (5) years. New laws may result in additional reductions in Medicare and other healthcare funding, which may materially negatively affect customer demand and affordability for our products and, accordingly, the results of our financial operations.
Also, there has been heightened governmental scrutiny recently over the manner in which pharmaceutical companies set prices for their marketed products, which have resulted in several U.S. presidential executive orders, Congressional inquiries and proposed and enacted federal legislation, as well as state efforts, designed to, among other things, bring more transparency to product-pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug-pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA directs the HHS Secretary to establish a Drug Price Negotiation Program (the “Program”) to lower prices for certain high-expenditure, single-source prescription drugs and biologics covered under Medicare Part B and Part D that have been approved by the FDA for at least seven (7) years for prescription drugs and at least eleven (11) years for biologics. Under the Program, the HHS Secretary will publish a list of “selected drugs,” and will then negotiate maximum fair prices (“MFP”) with their manufacturers. The Program will be implemented in stages. Beginning in 2026, ten (10) Medicare Part D “selected drugs” will be subject to price negotiations. By 2029, and in subsequent years thereafter, the number will increase to twenty (20) drugs and biologics covered under Medicare Part B and Part D. Agreements between HHS and manufacturers will remain in place until a drug or biologic is no longer considered a “selected drug” for negotiation purposes. Manufacturers who do not comply with the negotiated prices set under the Program will be subject to an excise tax based on a percentage of total sales of a “selected drug” up to 95% and potential civil monetary penalties. Further, effective October 2023, the IRA requires manufacturers that increase prices of certain Medicare Part B and Part D drugs or biologics at a rate greater than inflation to pay rebates to CMS or be subject to civil monetary penalties. HHS has and will continue to issue and update guidance as these programs are implemented.
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On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. It is unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry.
At the state level, individual states in the United States are increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product-pricing, including price or patient-reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk-purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions on coverage or access could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates that we successfully commercialize or put pressure on our product-pricing.
We expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and lower reimbursement and put additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of cost-containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs once marketing approval is obtained. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
As a company with substantial operations outside of the United States, our business is subject to economic, political, regulatory and other risks associated with international operations.
As a company with substantial operations in Australia with headquarters in Melbourne, and an international clinical trial program, our business is subject to risks associated with conducting business outside the United States. Many of our suppliers and clinical-trial relationships are located outside the United States. Accordingly, our future results could be harmed by a variety of factors, including:
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If we fail to comply with non-U.S. regulatory requirements governing clinical trials and marketing approval for drugs, we could be prevented from selling our product candidates in non-U.S. markets, which may negatively affect our operating results and financial condition.
The requirements governing the conduct of clinical trials, product-licensing, pricing and reimbursement for marketing our product candidates outside the United States vary greatly from country to country and may require additional testing. We expect that our future clinical development of our product candidates will involve a number of clinical trials in non-U.S. jurisdictions. We have no direct experience as a company in obtaining non-U.S. regulatory approvals. The time required to obtain approvals outside the United States may differ from that required to obtain FDA approval. We may not obtain non-U.S. regulatory approvals on a timely basis, if at all. Approval by the FDA does not guarantee approval by comparable non-U.S. regulatory authorities, and approval by one non-U.S. regulatory authority does not ensure approval by regulatory authorities in other countries or by the FDA. Failure to comply with these regulatory requirements or obtain required approvals could impair our ability to develop non-U.S. markets for our product candidates and may harm our results of operations and financial condition.
Price controls may be imposed in non-U.S. markets, which may negatively affect our future profitability.
In some countries, particularly EU member states, Japan, Australia and Canada, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost-containment measures. Political, economic, and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference-pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, revenues, or profitability could be harmed.
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We have received tax incentives under the Research and Development Tax Incentive scheme in Australia that may become repayable if we did not or do not comply with the rules of the scheme, or we may become ineligible for tax incentives in our current or future tax years, which could harm our business, financial condition and results of operations.
We have received cash incentives in the past under the Research and Development Tax Incentive scheme, or the R&D Scheme, to offset the costs of our clinical trials and other qualifying expenses incurred both in Australia and other jurisdictions. Certain research and development costs that we incur in the future may be ineligible for cash incentives under the R&D Scheme. For example, costs incurred outside Australia in connection with our future clinical trials are generally not eligible for cash incentives under the R&D Scheme. In addition, the federal government of Australia and the Australian Taxation Office, or ATO, could change the rules of the regulatory regime or amend past tax returns and, as a result, amounts paid to us may become repayable to the ATO including the amount of tax incentives in respect to our fiscal year ended June 30, 2025, included as current receivables in our consolidated financial statements. We have received an aggregate of US$33.7 million (A$48.7 million) in cash tax incentives during the five fiscal years ended June 30, 2025, under the R&D Scheme. As of June 30, 2025, our current tax receivable under the R&D Scheme was US$7.2 million. This receivable amount as of June 30, 2025, is based on Australian legislation as enacted as of June 30, 2025. Any proposed changes to the legislation, such as rate changes to eligibility requirements, may have a retrospective impact on our current tax receivable under the R&D Scheme - currently, no such legislative changes have occurred. Any rule changes made to reduce the amount we are able to claim under the R&D Scheme currently or in the future and any retrospective changes made to the R&D Scheme that reduce the incentives that we have claimed in past tax years could harm our business, financial condition and results of operations.
Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations.
New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, legislation informally titled the One Big Beautiful Bill Act and the Inflation Reduction Act enacted many significant changes to the U.S. tax laws. Future guidance from the Internal Revenue Service and other tax authorities with respect to new and existing legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation. In addition, it is uncertain if and to what extent various states will conform to such legislation or any newly enacted federal tax legislation. Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings and the deductibility of expenses or future reform legislation could have a material impact on the value of our deferred tax assets, could result in one-time charges and could increase our future U.S. tax expense.
The withdrawal of the United Kingdom, or the U.K., from the European Union, or the EU, commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the U.K. or the EU and may require us to incur additional expenses to develop and commercialize our product candidates in the U.K. or the EU or receive clinical supply of our product candidates from manufacturing partners in the U.K.
Following the result of a referendum in 2016, the U.K. left the EU on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements agreed between the U.K. and the EU, the U.K. was subject to a transition period until December 31, 2020 (the "Transition Period"), during which EU rules continued to apply. A trade and cooperation agreement (the "Trade and Cooperation Agreement") that outlines the future trading relationship between the United Kingdom and the European Union was agreed in December 2020.
Since a significant proportion of the regulatory framework in the U.K. applicable to our business and our product candidate is derived from EU directives and regulations, Brexit has had, and may continue to have, a material impact upon the regulatory regime with respect to the development, approval and commercialization of our product candidate in the U.K. or the EU. For example, Great Britain is no longer covered by the centralized procedures for obtaining EU-wide marketing authorization from the EMA, and a separate marketing authorization will be required to market our product candidate in Great Britain. It is currently unclear whether the Medicines & Healthcare products Regulatory Agency in the U.K. is sufficiently prepared to handle the increased volume of marketing authorization applications that it is likely to receive. Any delay in obtaining, or an inability to obtain, any marketing approvals, would delay or prevent us from commercializing our product candidate in the U.K. or the EU and restrict our ability to generate revenue and achieve and sustain profitability.
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While the Trade and Cooperation Agreement provides for the tariff-free trade of medicinal products between the U.K. and the E.U. there may be additional non-tariff costs to such trade which did not exist prior to the end of the Transition Period. Further, should the U.K. diverge from the EU from a regulatory perspective in relation to medicinal products, tariffs could be put into place in the future. We could therefore, both now and in the future, face significant additional expenses (when compared to the position prior to the end of the Transition Period) to operate our business, which could significantly and materially harm or delay our ability to generate revenues or achieve profitability of our business. Any further changes in international trade, tariff and import/export regulations as a result of Brexit or otherwise may impose unexpected duty costs or other non-tariff barriers on us. These developments, or the perception that any of them could occur, may significantly reduce global trade and, in particular, trade between the impacted nations and the U.K. It is also possible that Brexit may negatively affect our ability to attract and retain employees, particularly those from the EU.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercialize any resulting products. Product liability claims may be brought against us by subjects enrolled in our clinical trials, patients, or others using our products. If we cannot successfully defend ourselves against claims that our product candidates or products that we may develop caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
Our clinical trial liability insurance coverage may not adequately cover all liabilities that we may incur. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or delay the commercialization of any products or product candidates that we develop. We intend to expand our insurance coverage for products to include the sale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. Large judgments have been awarded in class-action lawsuits based on drugs that had unanticipated side effects. If we are sued for any injury caused by our products, product candidates or processes, our liability could exceed our product liability insurance coverage and our total assets. Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or harm our ability to obtain physician endorsement of our products or expand our business.
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Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers are subject to broadly applicable healthcare laws and regulations, which could expose us to civil penalties, criminal sanctions, contractual damages, reputational harm and diminished profits and future earnings.
Healthcare providers and third-party payors will play a primary role in the recommendation and prescription of any product candidate for which we obtain regulatory approval. Our current and future arrangements may expose us to broadly applicable fraud and abuse and other healthcare laws that may constrain the business or financial arrangements and relationships through which we would market, sell and distribute our products. In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business or financial arrangements.
Such laws include, but are not limited to, the following:
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Pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as providing free trips, free or discounted goods, improper consulting fees and grants and other monetary benefits to prescribers reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates, engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If any actions are instituted against us for violation of these laws or regulations, and we are not successful in defending ourselves, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative sanctions, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could harm our ability to operate our business and our results of operations.
We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations (or that of the third parties with whom we work) could lead to regulatory investigations or actions; litigation (including class actions); mass arbitration demands; fines and penalties; a disruption of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, "process") personal data and other sensitive information including proprietary and confidential business data. trade secrets. intellectual property, data we collect about trial participants in connection with clinical trials. and other sensitive third-party data. Our data processing activities subject us to numerous data privacy and security obligations. such as various laws,
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regulations guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.
In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws. personal data privacy laws, consumer protection laws (e.g. Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. In the past few years, numerous U.S. states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services. Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of 2018 (“CCPA”) applies to personal data of consumers, business representatives, and employees, and requires businesses to provide specific disclosures in privacy notices and honor requests of California residents to exercise certain privacy rights. The CCPA provides for civil penalties of up to $7,500 per violation and allows private litigants affected by certain data breaches to recover significant statutory damages. Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. The CCPA and other comprehensive U.S. state privacy laws exempt some data processed in the context of clinical trials, but these developments may further complicate compliance efforts and increase legal risk and compliance costs for us and the third parties with whom we work.
Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security. For example, the European Union's General Data Protection Regulation (“EU GDPR”), the United Kingdom’s GDPR (“UK GDPR”)(collectively, “GDPR”), Brazil's General Data Protection Law (Lei Geral de Protecão de Dados Pessoais, or “LGPD”) (Law No. 13,709/2018), and China's Personal Information Protection Law (“PIPL”) impose strict requirements for processing personal data. For example, under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions, fines of up to 20 million Euros / 17.5 million pounds sterling, or 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. China’s PIPL imposes a set of specific obligations on covered businesses in connection with their processing and transfer of personal data and imposes fines of up to RMB 50 million or 5% of the prior year’s total annual revenue of the violator. In Canada, the Personal Information Protection and Electronic Documents Act (“PIPEDA”) and various related provincial laws, as well as Canada's Anti-Spam Legislation (“CASL”), may apply to our operations. We may be subject to new and emerging data privacy and security regimes, including Australia's Privacy Act China's Personal Information Protection Law, Japan's Act on the Protection of Personal Information, and Singapore's Personal Data Protection Act.
In the ordinary course of business. we may transfer personal data from Europe and other jurisdictions to the United States or other countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the European Economic Area (“EEA”) and the United Kingdom (“UK”) have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it believes are inadequate. Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the EEA, the UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners. vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to
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increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the GDPR's cross-border data transfer limitations.
Our employees and personnel may use generative artificial intelligence (“AI”) technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.
In addition to data privacy and security laws, we are or may become contractually subject to industry standards adopted by industry groups. We are also bound by contractual obligations related to data privacy and security. and our efforts to comply with such obligations may not be successful. For example, certain data privacy laws. such as the GDPR and the CCPA, require covered businesses to impose specific contractual restrictions on their service providers. We publish privacy policies, marketing materials and other statements, such as compliance with certain certifications or self-regulatory principles, regarding data privacy and security. If these policies. materials or statements are found to be deficient, lacking in transparency. deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.
Obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties with whom we work. In addition, these obligations may require us to change our business model.
We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations. If we or the third parties with whom we work fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) or mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials.
Any of these events could have a material adverse effect on our reputation, business, or financial condition including but not limited to: loss of customers; interruptions or stoppages in our business operations (including clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity, or substantial changes to our business model or operations.
If we are not able to obtain required regulatory approvals, we will not be able to commercialize any future product candidate, and our ability to generate product revenue will be impaired.
Any future product candidate that we may develop, as well as the activities associated with their development and commercialization, including their design, research, testing, manufacture, safety, efficacy, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale and distribution are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by similar regulatory authorities outside the United States. Failure to obtain marketing approval for, and thus commercialize any product candidate, could negatively impact our ability to generate any revenue from product sales
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We have not received approval from regulatory authorities to market any product candidate in any jurisdiction, and it is possible that our lead product candidate will never obtain the appropriate regulatory approvals necessary for us to commence product sales. Neither we nor any collaborator is permitted to market our product candidate in the United States or any other jurisdiction until we receive regulatory approval of a BLA from the FDA or similar application from regulatory authorities outside of the United States.
The time required to obtain approval of a BLA by the FDA or similar application from regulatory authorities outside of the United States is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authority. Prior to submitting a BLA to the FDA or any comparable application to any other non-U.S. regulatory authorities for approval of any product candidate, we will need to complete pivotal Phase 3 clinical trials and demonstrate favorable results with respect to safety, tolerability and efficacy. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.
Securing marketing approvals requires the submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the safety and efficacy of our product candidate for the specified indications. We expect to rely on third-party CROs, consultants and our collaborators to assist us in filing and supporting the applications necessary to gain marketing approvals. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, regulatory authorities. Errors in the submission of applications for marketing approval or issues, including those related to gathering the appropriate data and the inspection process, may ultimately delay or affect our ability to obtain regulatory approval, commercialize our product candidate and generate product revenue.
Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.
If we succeed in developing any products, we intend to market them in non-U.S. jurisdictions in addition to the United States. In order to market and sell our products in other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. We may not obtain non-U.S. regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions. Approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. If we fail to obtain approval of any of our product candidates by regulatory authorities in another country, we will be unable to commercialize our product in that country, and the commercial prospects of that product candidate and our business prospects could decline. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, we must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that country. Obtaining non-U.S. regulatory approvals and compliance with non-U.S. regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries and regulatory approval in one country does not ensure approval in any other country, while a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory approval process in others. Also, regulatory approval for any of our product candidates may be withdrawn if we fail to comply with regulatory requirements, if problems occur after the product candidate reaches the market or for other reasons. If we fail to comply with the regulatory requirements in international markets and fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed and our business will be negatively affected.
Even if any future product candidate receives regulatory approval, it may still face future development and regulatory difficulties.
Even if we obtained regulatory approval for a product candidate, it would be subject to ongoing requirements by the FDA and comparable non-U.S. regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. The FDA and comparable non-U.S. regulatory authorities will continue to closely monitor the safety profile of any product even after
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approval. If the FDA, or comparable non-U.S. regulatory authorities, become aware of new safety information after approval of any of our product candidates, it may require labeling changes or establishment of a risk evaluation and mitigation strategy or similar strategy, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.
In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, regulations and standards. If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:
The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.
Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress and the public. Violations, including promotion of our products for unapproved (or off-label) uses, are subject to enforcement letters, inquiries and investigations and significant civil and criminal sanctions by the government. In the United States, engaging in the impermissible promotion of our products for off-label uses can also subject us to false claims litigation under federal and state statutes, which can lead to significant civil and criminal penalties. Additionally, comparable non-U.S. regulatory authorities will heavily scrutinize advertising and promotion of any product candidate that obtains approval outside of the United States.
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The FDA’s policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would negatively affect our business, prospects and ability to achieve or sustain profitability.
Risks Related to Our Reliance on Third Parties
We have relied on, and expect to continue to rely on, third-party manufacturers to produce any future product candidates. Any failure by a third-party manufacturer to produce acceptable product candidates for us pursuant to our specifications and regulatory standards may delay or impair our ability to initiate or complete our clinical trials, obtain and maintain regulatory approvals or commercialize approved products
The manufacturing of biologic drugs is complex and the process of identifying the qualifying suppliers takes a significant investment of time and money. We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. As a result, we expect to rely for the foreseeable future, on third-party manufacturers to supply us with any future product candidates.
Reliance on third-party suppliers and manufacturers entails risks to which we would not be subject if we manufacture product candidates or products ourselves. For example, if we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities in a timely manner or at all, which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us in a timely manner, if at all, and there could be a substantial delay before new facilities could be qualified and registered with or licensed by the FDA and other comparable non-U.S. regulatory authorities.
Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
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The FDA and other comparable non-U.S. regulatory authorities require manufacturers to register manufacturing facilities. The FDA and other comparable non-U.S. regulatory authorities also inspect these facilities to confirm compliance with cGMP. Contract manufacturers may face manufacturing or quality control problems causing drug-substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. We may have little to no control regarding the occurrence of third-party manufacturer incidents. Failure by our third-party manufacturers and suppliers to pass such inspections and otherwise satisfactorily complete the FDA approval regimen with respect to our product candidate may result in regulatory actions such as the issuance of FDA Form 483 notices of observations, warning letters or injunctions or the loss of operating licenses. In addition, our third-party manufacturers and suppliers are subject to numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of waste products, and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal fines and penalties for such third parties. Any failure to comply with cGMP requirements or other FDA or comparable non-U.S. regulatory requirements could negatively impact our clinical research activities and our ability to develop sozinibercept or any future product candidates and market our products following approval.
If any future product candidates are approved by the FDA or other comparable non-U.S. regulatory authorities for commercial sale, we may need to manufacture such product candidate in larger quantities. We intend to use third-party manufacturers for commercial quantities of any future product candidate to the extent we advance any future product candidates. Our manufacturers may not be able to successfully increase the manufacturing capacity for any of our product candidates in a timely or efficient manner, or at all. If we are unable to successfully increase the manufacturing capacity for a product candidate, the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage in the supply of the product candidate.
In addition, the operations of our third-party manufacturers may be subject to earthquakes, power shortages, telecommunications failures, failures or breaches of information technology systems, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, and other natural or man-made disasters or business interruptions. Damage or extended periods of interruption to our facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause us to cease or delay development of some or all of our product candidates. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.
Our current and anticipated future dependence upon others for the manufacture of our product candidates may negatively affect our future profit margins and our ability to develop our product candidates and commercialize any products that receive regulatory approval on a timely basis.
In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to the original manufacturer, we may have difficulty transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines and the manufacturer may be required to obtain applicable licenses or approvals. The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to develop product candidates in a timely manner or within budget.
The manufacture of biologic products is complex and we are subject to many manufacturing risks, any of which could substantially increase our costs and limit supply of our products.
The manufacture of biologic products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up and validating initial production and ensuring the avoidance of contamination. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error and shortages of qualified personnel, as well as compliance with strictly enforced federal, state and non-U.S. regulations. We cannot assure you that any stability or other issues relating to the manufacture of any future product candidate will not occur in the future.
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The process of manufacturing any future product candidate is complex, highly regulated and subject to several risks, including:
We have limited process-development capabilities and have access only to external manufacturing capabilities. We do not have and we do not currently plan to acquire or develop the facilities or capabilities to manufacture bulk drug substance or filled drug product for use in clinical trials or commercialization. Any delay or interruption in the supply of clinical trial materials, could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates proceed through nonclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause any future product candidate to perform differently and affect the results of clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of any future product candidate or jeopardize our ability to commence sales and generate revenue.
We rely on third parties to conduct our clinical trials and some aspects of our research and development activities, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
We expect to continue to rely on, third parties, such as CROs, clinical data management organizations, medical institutions, consultants and clinical investigators, to conduct our clinical trials for any future product candidate and certain aspects of our research and development activities. Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it would delay our product development activities and such alternative arrangements may not be available on terms acceptable to us.
Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and clinical trial protocols. Moreover, the FDA requires us to comply with standards, commonly referred to as current Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We are also required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database within certain time frames. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
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Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements, standard operating procedures or clinical trial protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for any future product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development, marketing approval and/or commercialization of any future product candidates, producing additional losses and depriving us of potential revenue.
Disputes under key agreements or conflicts of interest with our scientific advisors or clinical investigators could delay or prevent development or commercialization of our product candidates.
Any agreements we have or may enter into with third parties, such as collaboration, license, formulation supplier, manufacturing, clinical research organization or clinical trial agreements, may give rise to disputes regarding the rights and obligations of the parties. Disagreements could develop over contract interpretation, rights to ownership or use of intellectual property, the scope and direction of research and development, the approach for regulatory approvals or commercialization strategy. We intend to conduct research programs in a range of therapeutic areas, but our pursuit of these opportunities could result in conflicts with the other parties to these agreements that may be developing or selling pharmaceuticals or conducting other activities in these same therapeutic areas. Any disputes or commercial conflicts could lead to the termination of our agreements, delay progress of our product development programs, compromise our ability to renew agreements or obtain future agreements, lead to the loss of intellectual property rights, result in increased financial obligations for us or result in costly litigation.
We work with outside scientific advisors and collaborators at academic and other institutions that assist us in our research and development efforts. Our scientific advisors are not our employees and may have other commitments that limit their availability to us. If a conflict of interest between their work for us and their work for another entity arises, we may lose their services.
We may seek to establish commercial collaborations for our product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
Our drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. We may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of our product candidates.
We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or comparable non-U.S. regulatory authorities, the potential market for the product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate.
Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.
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We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
Risks Related to Employee Matters and Managing Our Growth
We must attract and retain highly skilled employees in order to succeed. If we are not able to retain our current senior management team and our scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, our business will suffer.
We may not be able to attract or retain qualified personnel and consultants due to the intense competition for such individuals in the biotechnology and pharmaceutical industries. Although we streamlined our operations and reduced our workforce following the discontinuation of our clinical trials in March 2025, we may increase our workforce in the future. In particular, we have hired and may in the future hire employees, including senior employees, in the United States if we identify a future product candidate following completion of the Board’s strategic review. The hiring environment in the United States for such candidates is extremely competitive. Many of the other pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. If we are not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development and commercial objectives, our ability to raise additional capital and our ability to implement our business strategy.
Our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on the development, regulatory, commercialization and business development expertise of the members of our executive team, as well as other key employees and consultants. If we lose one or more of our executive officers or other key employees or consultants, our ability to implement our business strategy successfully could be seriously harmed. Any of our executive officers or other key employees or consultants may terminate their employment at any time with three months’ notice, subject to certain exceptions, and replacing such individuals may be difficult and time-consuming because of the limited number of individuals in our industry with the necessary breadth of skills and experience. Competition to hire and retain employees and consultants from this limited pool is intense, and we may be unable to hire, train, retain or motivate such individuals. Additionally, we do not currently maintain “key person” life insurance on the lives of our executives or any of our employees. This lack of insurance means that we may not receive adequate compensation for the loss of the services of these individuals. If we are unable to continue to attract and retain high-quality personnel, the rate and success with which we can discover and develop product candidates and our business will be limited.
Our employees, contractors, vendors, principal investigators, consultants and future partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
We are exposed to the risk of fraud or other misconduct by our employees, contractors, vendors, principal investigators, consultants or future partners. Misconduct by these parties could include failures to comply with FDA or comparable non-U.S. authority regulations, to provide accurate information to the FDA or comparable non-U.S. regulators, to comply with U.S. federal and state and non-U.S. healthcare fraud and abuse laws and regulations, to report financial information or data timely, completely or accurately, or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Third-party 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. Although we have adopted a Code of Conduct, it is not always possible to identify and deter misconduct, and the precautions we take to detect and
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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 comply with these laws or regulations. If any such actions are instituted against us resulting from this misconduct 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. If we or our future partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or our future partners violate government price reporting laws, we or our future partners may be subject to administrative civil and/or criminal penalties, among other sanctions.
Most states also have statutes or regulations similar to these federal laws, which may apply to items such as pharmaceutical products and services reimbursed by private insurers. We and/or our future partners may be subject to administrative, civil and criminal sanctions for violations of any of these federal and state laws. Pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.
Risks Related to Intellectual Property
Our success depends upon our ability to obtain and maintain intellectual property protection for our products and technologies.
Our success will depend in significant part on our current or future licensors’, licensees’ or collaborators’ ability to establish and maintain adequate protection of our owned and licensed intellectual property covering the product candidates we plan to develop, and the ability to develop these product candidates and commercialize the products resulting therefrom, without infringing the intellectual property rights of others. In addition to taking other steps to protect our intellectual property, we hold issued patents, we have applied for patents, and we intend to continue to apply for, patents with claims covering our technologies, processes and product candidates when and where we deem it appropriate to do so. We have filed patent applications both in the United States and in certain non-U.S. jurisdictions to obtain patent rights to inventions we have developed, with claims directed to compositions of matter, methods of use and other technologies relating to our programs. In addition, as part of the first phase of the Board’s strategic review of our business focused on reformulating our portfolio of drug candidates targeting VEGF-C and/or VEGF-D, of which OPT-302 is one of these drug candidates, which was previously delivered to the eye via injection to treat wet AMD, to various other forms of delivery that may be appropriate for delivering our portfolio of drug candidates to other organs, we have already taken steps to apply for a patent in order to protect the use of OPT-302 in various delivery methods. There can be no assurance that any of these patent applications will issue as patents or, for those applications that do mature into patents, that the claims of the patents will exclude others from making, using or selling our product candidates or products that compete with or are similar to our product candidates. In countries where we have not sought and do not seek patent protection, third parties may be able to manufacture and sell our product candidates without our permission, and we may not be able to stop them from doing so.
With respect to patent rights, we do not know whether any of the pending patent applications for any of our product candidates will result in the issuance of patents that effectively protect our technologies, processes and product candidates, or if any of our issued patents or our current or future licensors’, licensees’ or collaborators’ issued patents will effectively prevent others from commercializing competitive technologies, processes and products. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or in some cases not at all, until they are issued as a patent. Therefore, we cannot be certain that we or our current or future licensors, licensees or collaborators were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our current or future licensors, licensees or collaborators were the first to file for patent protection of such inventions. For a description of our patent portfolio, see “Item 4B Business Overview” of this annual report.
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Any changes we make to any future product candidates to cause them to have what we view as more advantageous properties may not be covered by our existing patents and patent applications, and we may be required to file new applications and/or seek other forms of protection for any such altered product candidates. The patent landscape surrounding the technology underlying our product candidates is potentially crowded, and there can be no assurance that we would be able to secure patent protection that would adequately cover an alternative to any future product candidates.
The patent prosecution process is expensive and time-consuming, and we and our current or future licensors, licensees or collaborators may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we or our current or future licensors, licensees or collaborators will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection for them. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain or enforce the patents, covering technology that we license from or license to third parties and may be reliant on our current or future licensors, licensees or collaborators to perform these activities, which means that these patent applications may not be prosecuted, and these patents enforced, in a manner consistent with the best interests of our business. If our current or future licensors, licensees or collaborators fail to establish, maintain, protect or enforce such patents and other intellectual property rights, such rights may be reduced or eliminated. If our current or future licensors, licensees or collaborators are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.
Similar to the patent rights of other biotechnology companies, the scope, validity and enforceability of our owned and licensed patent rights generally are highly uncertain and involve complex legal and factual questions. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. In recent years, these areas have been the subject of much litigation in the industry. As a result, the issuance, scope, validity, enforceability and commercial value of our and our current or future licensors’, licensees’ or collaborators’ patent rights are highly uncertain. Our and our current or future licensors’, licensees’ or collaborators’ pending and future patent applications may not result in patents being issued that protect our technology or product candidates, or products resulting therefrom, in whole or in part, or that effectively prevent others from commercializing competitive technologies and products. The patent examination process may require us or our current or future licensors, licensees or collaborators to narrow the scope of the claims of pending and future patent applications, which would limit the scope of patent protection that is obtained, if any. Our and our current or future licensors’, licensees’ or collaborators’ patent applications cannot be enforced against third parties practicing the technology that is currently claimed in such applications unless and until a patent issues from such applications, and then only to the extent the claims that issue are broad enough to cover the technology being practiced by those third parties.
Furthermore, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after the resulting products are commercialized. As a result, our owned and in-licensed patents may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. We expect to seek extensions of patent terms for our issued patents, where available. This includes in the United States under the Hatch-Waxman Act, which permits a patent term extension of up to five years beyond the original expiration date of the patent as compensation for regulatory delays. However, such a patent term extension cannot lengthen the remaining term of a patent beyond a total of 14 years from the product’s approval date. Only one patent applicable to each regulatory review period may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended, with extended rights limited to the approved product, its approved uses and/or its manufacture. During the period of patent term extension, the claims of a patent are not enforceable for their full scope, but are instead limited to the scope of the approved product. In addition, the applicable authorities, including the FDA in the United States, and any comparable non-U.S. regulatory authorities, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. In addition, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to the expiration of relevant patents or otherwise failing to satisfy applicable requirements. If this occurs, any period during which we have the right to exclusively market our product will be shorter than we would otherwise expect, and our competitors may obtain approval of and launch products earlier than might otherwise be the case.
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We may not be able to protect our intellectual property rights throughout the world.
The legal protection afforded to inventors and owners of intellectual property in countries outside of the United States may not be as protective or effective as that in the United States and we may, therefore, be unable to acquire and enforce intellectual property rights outside the United States to the same extent as in the United States. Whether filed in the United States or abroad, our patent applications may be challenged or may fail to result in issued patents.
In addition, our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing or commercializing competing products. Furthermore, others may independently develop or commercialize similar or alternative technologies or drugs, or design around our patents. Our patents may be challenged, invalidated, circumvented or narrowed, or fail to provide us with any competitive advantages. In many non-U.S. countries, patent applications and/or issued patents, or parts thereof, must be translated into the native language. If our patent applications or issued patents are translated incorrectly, they may not adequately cover our technologies; in some countries, it may not be possible to rectify an incorrect translation, which may result in patent protection that does not adequately cover our technologies in those countries.
Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some non-U.S. countries do not protect intellectual property rights to the same extent as federal and certain state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with any future product candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in non-U.S. jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals. This could make it difficult for us to stop the infringement of our patents or the marketing of competing products in violation of our proprietary rights, generally. Proceedings to enforce our patent rights in non-U.S. jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could place our patent applications at risk of not issuing and could provoke third parties to assert claims against us or our collaborator. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.
The requirements for patentability differ and certain countries have heightened requirements for patentability, requiring more disclosure in the patent application. In addition, certain countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. Accordingly, our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license.
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect any future product candidates.
As is the case with other biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property rights, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves technological and legal complexity, and obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. The U.S. Supreme Court in recent years has issued rulings either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations or ruling that certain subject matter is not eligible for patent protection. In addition to
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increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts, the USPTO and equivalent bodies in non-U.S. jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce existing patents and patents we may obtain in the future.
Patent reform laws, such as the Leahy-Smith America Invents Act, or the Leahy-Smith Act, as well as changes in how patent laws are interpreted, could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith Act made a number of significant changes to U.S. patent law. These include provisions that affect the filing and prosecution strategies associated with patent applications, including a change from a “first-to-invent” to a “first-inventor-to-file” patent system, and a change allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first-inventor-to-file” provisions, became effective in 2013. The Leahy-Smith Act and its implementation may increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could harm our business, financial condition and results of operations.
We may be unable to obtain intellectual property rights or technology necessary to develop and commercialize any future product candidates.
The patent landscape around our programs is complex, and there may be one or more third-party patents and patent applications containing subject matter that might be relevant to any future product candidate we identify. Depending on what claims may ultimately issue from these patent applications, and how courts construe the issued patent claims, as well as depending on the ultimate formulation and method of use of any future product candidates, we may need to obtain a license to practice the technology claimed in such patents. There can be no assurance that such licenses will be available on commercially reasonable terms, or at all. If a third party does not offer us a necessary license or offers a license only on terms that are unattractive or unacceptable to us, we might be unable to develop and commercialize one or more of our product candidates, which would harm our business, financial condition and results of operations. Moreover, even if we obtain licenses to such intellectual property, but subsequently fail to meet our obligations under the relevant license agreements, or such license agreements are terminated for any other reasons, we may lose our rights to the technologies licensed under those agreements.
The licensing or acquisition of third-party intellectual property rights is an area in which many companies operate that have interests that are in conflict with ours, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment, or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could harm our business, financial condition, results of operations and prospects.
We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a negative effect on the success of our business.
Third parties may infringe our patents or misappropriate or otherwise violate our intellectual property rights. In the future, we may initiate legal proceedings to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity or scope of intellectual property rights we own or control. Also, third parties may initiate legal proceedings against us to challenge the validity or scope of intellectual property rights we own, control or to which we have rights. For example, generic or biosimilar drug manufacturers or other competitors or third parties may challenge the scope, validity or enforceability of our patents, requiring us to engage in complex, lengthy and costly litigation or other proceedings. These proceedings can be expensive and time-consuming and many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can. Accordingly, despite our efforts, we may not be
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able to prevent third parties from infringing upon or misappropriating intellectual property rights we own, control or have rights to, particularly in countries where the laws may not protect those rights as fully as in the United States. Litigation could result in substantial costs and diversion of management resources, which could harm our business and financial results. In addition, if we initiated legal proceedings against a third party to enforce a patent covering a product candidate, the defendant could counterclaim that such patent is invalid or unenforceable. In patent litigation in the United States, defendants usually assert counterclaims alleging invalidity or unenforceability. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. In an infringement or declaratory judgment proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable, or may refuse to stop the other party from using the subject matter alleged to be infringing on the grounds that our patents do not cover that subject matter. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that would not preclude third parties from entering the market with competing products.
Third-party pre-issuance submission of prior art to the USPTO, or opposition, derivation, revocation, reexamination, inter partes review or interference proceedings, or other pre-issuance or post-grant proceedings or other patent office proceedings or litigation in the United States or other jurisdictions provoked by third parties or brought by us, may be necessary to determine the inventorship, priority, patentability or validity of inventions with respect to our patents or patent applications. An unfavorable outcome could leave our technology or product candidates without patent protection, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or could require us to obtain license rights from the prevailing party in order to be able to manufacture or commercialize our product candidates without infringing third-party patent rights. Our business could be harmed if the prevailing party in such a case does not offer us a license on commercially reasonable terms, or at all. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates. Even if we successfully defend such litigation or proceeding, we may incur substantial costs and our defense may distract our management and other employees.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, many non-U.S. jurisdictions have rules of discovery that are different than those in the United States and that may make defending or enforcing our patents extremely difficult. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could negatively affect the price of the ADSs and our ordinary shares.
Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights, the outcome of which would be uncertain and could harm our business.
Our commercial success depends upon our ability to develop, manufacture, market and sell any future product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights. Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions, interferences, revocations, reexaminations, inter partes review or derivation proceedings before the USPTO or its counterparts in other jurisdictions. These proceedings can be expensive and time-consuming and many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can.
We could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a third party. A finding of infringement could prevent us from commercializing any future product candidates or force us to cease some of our business operations, which could materially harm our business.
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We may not be aware of all third-party intellectual property rights potentially relating to any future product candidates and technologies. We are not aware of any facts that would lead us to conclude that the valid and enforceable claims of any third-party patents would reasonably be interpreted to cover our product candidates. As to pending third-party applications, we cannot predict with any certainty which claims will issue, if any, or the scope of such issued claims. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and negatively affect our ability to commercialize any product candidates we may develop and any other product candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If any such third-party patents (including those that may issue from such applications) were successfully asserted against us or other commercialization partners and we were unable to successfully challenge the validity or enforceability of any such asserted patents, then we and other commercialization partners may be prevented from commercializing our product candidates, or may be required to pay significant damages, including treble damages and attorneys’ fees if we are found to willfully infringe the asserted patents, or obtain a license to such patents, which may not be available on commercially reasonable terms, or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Any of the foregoing would harm our business, financial condition and operating results.
Although we have reviewed certain third-party patents and patent filings that we believe may be relevant to our therapeutic candidates or products, we have not conducted a freedom-to-operate search or analysis for any of our therapeutic candidates or products, and we may not be aware of patents or pending or future patent applications that, if issued, would block us from commercializing our therapeutic candidates or products. Thus, we cannot guarantee that our therapeutic candidates or products, or our commercialization thereof, do not and will not infringe any third party’s intellectual property.
We may be subject to claims by third parties asserting misappropriation of intellectual property, or claiming ownership of what we regard as our own intellectual property.
Although we seek to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed confidential information or intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer, or that third parties have an interest in our patents as an inventor or co-inventor. Litigation may be necessary to defend against these claims. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or the services of personnel or sustain other damages. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms, or at all. Even if we successfully prosecute or defend against such claims, litigation could result in substantial costs and distract management.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could harm our business, financial condition, results of operations and prospects.
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Our inability to protect our confidential information and trade secrets would harm our business and competitive position.
In addition to seeking patents for some of our technology and product candidates, we also rely substantially on trade secrets, including unpatented know-how, technology and other proprietary materials and information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. However, these steps may be inadequate, we may fail to enter into agreements with all such parties or any of these parties may breach the agreements and disclose our trade secrets and there may be no adequate remedy available for such breach of an agreement. We cannot assure you that our trade secrets will not be disclosed or that we can meaningfully protect our trade secrets. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts both within and outside the United States may be less willing, or unwilling, to protect trade secrets. If a competitor lawfully obtained or independently developed any technology or information that we protect as trade secret, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.
Intellectual property rights do not necessarily address all potential threats.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:
Should any of these events occur, they could harm our business, financial condition, results of operations and prospects.
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If our trademarks and trade names are not maintained and adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be negatively affected.
Failure to obtain trademark registrations in the future, could limit our ability to protect and enforce our trademarks and impede our marketing efforts in the countries in which we operate. We may not be able to protect our rights to trademarks and trade names which we may need to build name recognition with potential partners or customers in our markets of interest. As a means to enforce any future trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings. This can be expensive and time consuming and can strain the financial resources of a company of our size, and we may not be successful in enforcing our trademark rights. In addition, our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks.
Future trademark applications in the United States and in other non-U.S. jurisdictions where we may file may not be allowed or may subsequently be opposed. Even if these applications result in registration of trademarks, third parties may challenge our use or registration of these trademarks in the future. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be negatively affected.
Our product candidates may face competition sooner than anticipated from biosimilar products.
Even if we are successful in achieving regulatory approval to commercialize a product candidate faster than our competitors, our product candidates may face competition from biosimilar products. In the United States, our product candidates are regulated by the FDA. The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our product candidates.
There is a risk that any exclusivity we may be afforded if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for generic or biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar product, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA after completing its own preclinical studies and clinical trials. In such cases, any exclusivity to which we may be eligible under the BPCIA would not prevent the competitor from marketing its product as soon as it is approved.
In Europe, the European Commission has granted marketing authorizations for several biosimilar products pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In Europe, a competitor may reference data supporting approval of an innovative biological product, but will not be able to market it until 10 years after the time of approval of the innovative product. This 10-year marketing exclusivity period may be extended to 11 years if, during the first eight of those 10 years, the marketing authorization holder obtains an approval for one or more new therapeutic indications that bring significant clinical benefits compared with existing therapies. In addition, companies may be developing biosimilar products in other countries that could compete with our products, if approved.
If competitors are able to obtain marketing approval for biosimilars referencing our product candidates, if approved, such products may become subject to competition from such biosimilars, with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete with us in each indication for which our product candidates may have received approval.
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Risks Related to Ownership of the ADSs
The trading price and volume of the ADSs may be volatile, and ADSs holders could incur substantial losses.
The price and trading volumes of our ordinary shares and ADSs may be significantly affected by events such as announcements regarding scientific and clinical results concerning product candidates currently being developed by us, our collaboration partners or our main competitors, changes in market conditions related to our sector of activity, announcements of new contracts, technological innovations and collaborations by us or our main competitors, developments concerning intellectual property rights, as well as the development, regulatory approval and commercialization of new products by us or our main competitors and changes in our financial results.
In addition, equity markets may be subject to considerable price and trading volume fluctuations, and often, these movements do not reflect the operational and financial performance of the listed companies concerned. In particular, biotechnology companies’ share prices have been highly volatile in the past and may continue to be highly volatile in the future. As we operate in a single industry, we are especially vulnerable to these factors to the extent that they affect our industry. Fluctuations in the stock market as well as the macroeconomic environment could significantly affect the price of the ADSs. As a result of this volatility, investors may not be able to sell their ADSs at or above the price originally paid for the security. The market price and trading volume for the ADSs may be influenced by many factors, including:
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These and other market and industry factors may cause the market price and demand for the ADSs to fluctuate, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs and may otherwise negatively affect the liquidity of the trading market for the ADSs.
We do not currently intend to pay dividends on our securities and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of the ADSs.
We have not declared or paid any cash dividends on our ordinary shares since February 2005 and do not currently intend to do so for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our operations and growth. Therefore, you are not likely to receive any dividends on your ADSs for the foreseeable future and the success of an investment in the ADSs will depend upon any future appreciation in its value. Consequently, investors may need to sell all or part of their holdings of the ADSs after price appreciation, which may never occur, as the only way to realize any future gains on their investment. There is no guarantee that the ADSs will appreciate in value or even maintain the price at which our shareholders have purchased them. Investors seeking cash dividends should consider not purchasing the ADSs.
While we do not anticipate paying any cash 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 negatively impact the value of your ADSs. In addition, exchange rate fluctuations may affect the amount of Australian dollars that we are able to distribute, and the amount in U.S. dollars that our shareholders receive upon the payment of cash dividends or other distributions we declare and pay in Australian dollars, if any. These factors could harm the value of the ADSs, and, in turn, the U.S. dollar proceeds that holders receive from the sale of the ADSs.
Future sales of ordinary shares or ADSs by existing holders could depress the market price of the ordinary shares or ADSs.
We had a total of 1,231,317,008 ordinary shares outstanding as of June 30, 2025. We issued an additional 136,661,003 ordinary shares to the DFA Investors in the DFA Settlement in August 2025. As of the date of this annual report, the exercise of all outstanding investor options/rights exercisable for ordinary shares would enable the subscription of new ordinary shares representing approximately 14% of the diluted share capital. The ordinary shares subject to subscription under outstanding options exercisable for ordinary shares will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the ordinary shares in the public market could depress the market price of the ADSs. If these additional ordinary shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of the ordinary shares and ADSs could decline substantially, which could impair our ability to raise additional capital through the issuance of ordinary shares, ADSs or other securities in the future.
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The dual listing of our ordinary shares and the ADSs may negatively impact the liquidity and value of the ADSs.
Our ADSs are listed on 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 negatively impact the development of an active trading market for the ADSs in the United States. The price of the ADSs could also be negatively impacted by trading in our ordinary shares on the ASX.
Our ADSs may be delisted from Nasdaq in the future which may negatively impact the liquidity and value of the ADSs
We may, in the future, fail to remain in compliance with the Nasdaq continued listing standards, and thus fail to maintain the listing of our ADSs on Nasdaq. If Nasdaq delists our securities from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect our securities could be quoted on an over-the-counter market. If this were to occur, we could face significant material adverse consequences, including:
We have incurred and will continue to incur significant increased costs as a result of operating as a company with ADSs that are publicly traded in the United States, and our management will be required to devote substantial time to new 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. In addition, the Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform and Consumer Protection Act and related rules implemented by the United States Securities and Exchange Commission, or SEC, and Nasdaq have imposed various requirements on public companies listed in the United States including requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need 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 will 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 listed in the United States, we could be subject to delisting of the ADSs, fines, sanctions and other regulatory action and potentially civil litigation.
U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of senior management and the experts named in this annual report.
Certain members of our senior management and board of directors named in this annual report are non-residents of the United States, and a substantial portion of the assets of such persons are located outside the United States. As a result, it may be impracticable 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 United States. 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 United States or elsewhere may be unenforceable in Australia or elsewhere outside the United States. An award for monetary damages under 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
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United States 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 may have more difficulty in protecting their interests through actions against us, our management or our directors than would shareholders of a corporation incorporated in a jurisdiction in the United States. In addition, as a company incorporated in Australia, the provisions of the Corporations Act 2001(Cth), or the Corporations Act, regulate the circumstances in which shareholder derivative actions may be commenced which may be different, and in many ways less permissive, than for companies incorporated in the United States.
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 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 and may further restrict the ability of our shareholders to obtain a premium from such transactions. See Exhibit 2.3 “Description of Securities” as well as our Constitution, which is included as an exhibit to this annual report.
Our Constitution and Australian laws and regulations applicable to us may adversely affect our ability to take actions that could be beneficial to our shareholders.
As an Australian company we are subject to different corporate requirements than a corporation organized under the laws of the United States. Our Constitution, as well as the Corporations Act, sets forth various rights and obligations that apply to us as an Australian company and which may not apply to a U.S. corporation. These requirements may operate differently than those of many U.S. companies. You should carefully review the summary of these matters set forth under Exhibit 2.3 “Description of Securities” as well as our Constitution, which is included as an exhibit to this annual report, prior to investing in our securities.
Your right as a holder of ADSs to participate in any future preferential subscription rights offering or to elect to receive dividends in ordinary shares may be limited, which may cause dilution to your holdings.
The deposit agreement provides that the depositary will not make rights available to you unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act of 1933, as amended, or the Securities Act or exempted from registration under the Securities Act. If we offer holders of our ordinary shares the option to receive dividends in either cash or shares, under the deposit agreement the depositary may require satisfactory assurances from us that extending the offer to holders of ADSs does not require registration of any securities under the Securities Act before making the option available to holders of ADSs. We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, we may not be able to establish an exemption from registration under the Securities Act. Accordingly, ADS holders may be unable to participate in our rights offerings or to elect to receive dividends in shares and may experience dilution in their holdings. In addition, if the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case you will receive no value for these rights.
You may not be able to exercise your right to vote the ordinary shares underlying your ADSs.
Holders of ADSs may exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the provisions of the deposit agreement. The deposit agreement provides that, upon receipt of notice of any meeting of holders of our ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the exercise of voting rights. Upon timely receipt of notice from us, if we so request, the depositary shall distribute to the holders as of the record date (i) the notice of the meeting or solicitation of consent or proxy sent by us and (ii) a statement as to the manner in which instructions may be given by the holders.
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You may instruct the depositary to vote the ordinary shares underlying your ADSs. Otherwise, you will not be able to exercise your right to vote, unless you withdraw the ordinary shares underlying the ADSs you hold. However, you may not know about the meeting far enough in advance to withdraw those ordinary shares. If we ask for your instructions, the depositary, upon timely notice from us, will notify you of the upcoming vote and arrange to deliver our voting materials to you and will try to vote ordinary shares as you instruct. We cannot guarantee you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your ordinary shares or to withdraw your ordinary shares so that you can vote them yourself. If we do not ask for your instructions, you can still send voting instructions to the depository and the depository may try to carry out those instructions, but it is not required to do so.
Under 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 in accordance with the terms of our Constitution. A poll may be demanded before a vote is taken, or, in the case of a vote taken on a show of hands, immediately before or immediately after, 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.
You may be subject to limitations on the transfer of your ADSs and the withdrawal of the underlying ordinary shares.
Your ADSs are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of your ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason subject to your right to surrender your ADSs and receive the underlying ordinary shares. Temporary delays in the surrendering of your ADSs and receipt of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares. In addition, you may not be able to surrender your ADSs and receive the underlying ordinary shares when you owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities. See “Item 12D —Description of American Depositary Shares.”
Holders of ADSs are not treated as holders of our ordinary shares.
Holders of ADSs are not treated as holders of our ordinary shares, unless they surrender the ADSs to receive the ordinary shares underlying their ADSs in accordance with the deposit agreement and applicable laws and regulations. The depositary is the holder of the ordinary shares underlying the ADSs. Holders of ADSs therefore do not have any rights as holders of our ordinary shares, other than the rights that they have pursuant to the deposit agreement. See “Item 12D —Description of American Depositary Shares.”
ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action.
The deposit agreement governing the ADSs provides that holders and beneficial owners of ADSs, including those holders and owners who acquired ADSs in secondary transactions, irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including in respect of claims under federal securities laws, against us or the depositary to the fullest extent permitted by applicable law. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. To our knowledge, the enforceability of a jury trial waiver under the federal securities laws has not been finally adjudicated by a federal court. However, we believe that a jury trial waiver provision is generally enforceable under the laws of the State of New York, which govern the deposit agreement, by a court of the State of New York or a federal court, which have non-exclusive jurisdiction over matters arising under the deposit agreement, applying such law. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor’s negligence in failing to liquidate collateral upon a
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guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs.
No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision of the federal securities laws. If you or any other holder or beneficial owner of ADSs brings a claim against us or the depositary in connection with such matters, you or such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and/or the depositary. If a lawsuit is brought against us and/or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the venue of the hearing.
As the jury trial waiver relates to claims arising out of or relating to the ADSs or the deposit agreement, we believe that the waiver would likely continue to apply to ADS holders or beneficial owners who withdraw the ordinary shares from the ADS facility with respect to claims arising before the cancellation of the ADSs and the withdrawal of the ordinary shares, and the waiver would likely not apply to ADS holders or beneficial owners who subsequently withdraw the ordinary shares represented by ADSs from the ADS facility with respect to claims arising after the withdrawal. However, to our knowledge, there has been no case law on the applicability of the jury trial waiver to ADS holders or beneficial owners who withdraw the ordinary shares represented by the ADSs from the ADS facility.
We currently report our financial results under IFRS, which differs in certain significant respect from U.S. generally accepted accounting principles, or 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, share-based compensation expense, and income tax. 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 exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company.
We are a foreign private issuer, as defined in the SEC’s rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to public companies organized within the United States. For example, we are exempt from certain rules under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our senior management and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we currently make annual and semi-annual filings with respect to our listing on the ASX and expect to file financial reports on an annual and semi-annual basis, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies and will not be required to file quarterly reports on Form 10-Q or current reports on Form 8-K under the Exchange Act. In addition, foreign private issuers are not required to file their annual report on Form 20-F until four months after the end of each fiscal year. Accordingly, there may be less publicly available information concerning our company than there would be if we were not a foreign private issuer.
As a foreign private issuer, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance listing standards and these practices may afford less protection to shareholders than they would enjoy if we complied fully with Nasdaq corporate governance listing standards.
As a foreign private issuer listed on Nasdaq, we are subject to its corporate governance listing standards. However, Nasdaq rules permit foreign private issuers to follow the corporate governance practices of their home
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country. Some corporate governance practices in Australia may differ from Nasdaq corporate governance listing standards. For example, we could include non-independent directors as members of our Remuneration and Nomination committees, and our independent directors may not necessarily hold regularly scheduled meetings at which only independent members of the board of directors are present. Currently, we follow home country practice to the maximum extent possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing standards applicable to U.S. domestic issuers. For an overview of our corporate governance practices, see “Item 16G—Corporate Governance.”
We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.
While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, our next determination will be made on December 31, 2025. In the future, we would lose our foreign private issuer status if we to fail to meet the requirements necessary to maintain our foreign private issuer status as of the relevant determination date. For example, if 50% or more of our securities are held by U.S. residents and more than 50% of our senior management or directors are residents or citizens of the United States, we could lose our foreign private issuer status.
The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly more than costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP rather than IFRS, and modify certain of our policies to comply with corporate governance practices required of U.S. domestic issuers. Such conversion of our financial statements to U.S. GAAP would involve significant time and cost. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers such as the ones described above and exemptions from procedural requirements related to the solicitation of proxies.
We are an “emerging growth company” under the JOBS Act and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our ordinary shares ADSs less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, and if we were to lose our foreign private issuer status, -exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
We cannot predict if investors will find the ordinary shares or ADSs less attractive because we may rely on these exemptions. If some investors find the ordinary shares or ADSs less attractive as a result, there may be a less active trading market for the ordinary shares or ADSs and the price of the ordinary shares or ADSs may be more volatile. We may take advantage of these exemptions until such time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earliest to occur of (i) the last day of the fiscal year in which we have more than US$1.235 billion in annual revenue; (ii) the last day of the fiscal year in which we qualify as a “large accelerated filer”; (iii) the date on which we have, during the previous three-year period, issued more than US$1.0 billion in non-convertible debt securities; and (iv)June 30, 2026.
It is likely that we will be classified as a passive foreign investment company, which could result in adverse U.S. federal income tax consequences for U.S. holders.
In general, a non-U.S. company will be considered a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for any taxable year in which (1) 75% or more of its gross income consists of passive income or (2) 50% or more of the average quarterly value of its assets is attributable to assets that produce, or are held for the production of, passive income. For purposes of these tests, passive income generally includes dividends, interest, gains from the sale or exchange of investment property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least
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25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets and received directly its proportionate share of the income of such other corporation.
We believe we were a PFIC for our taxable year ended June 30, 2025, and based on the nature and composition of our income, assets, activities and market capitalization, we may be a PFIC in future taxable years. However, our PFIC status is based on an annual determination and may change from year to year. Our status as a PFIC will depend on the composition of our income and the composition and value of our assets, which may be volatile, from time to time. Our status may also depend, in part, on how quickly we utilize the cash we raise in any offering of our securities. Our U.S. counsel expresses no opinion regarding our conclusions or our expectations regarding our PFIC status.
If we are a PFIC for any taxable year during which a U.S. holder (as defined below in the section titled “Item 10E – Taxation”) holds ADSs, the U.S. holder may be subject to adverse tax consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements. We will continue to be treated as a PFIC with respect to such U.S. holder in all succeeding years during which the U.S. holder owns the ADSs, regardless of whether we continue to meet the PFIC test described above, unless the U.S. holder makes a valid and timely qualified electing fund (QEF) or mark-to-market election, or makes a deemed sale election once we cease to be a PFIC; however, we do not currently intend to provide the information necessary for a U.S. holder to make a QEF election. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see “Item 10E—Taxation.”
If a United States person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
If a U.S. holder is treated as owning (directly, indirectly or constructively,) at least 10% of the value or voting power of our ordinary shares or ADSs, such U.S. holder may be treated, for U.S. federal income tax purposes, as a “United States shareholder” with respect to each “controlled foreign corporation” in our group, if any. Because our group includes a U.S. subsidiary (Opthea US Inc.), certain of our current and future non-U.S. subsidiaries will be treated as controlled corporations, regardless of whether we are treated as a controlled foreign corporation. A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro-rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. We cannot provide any assurances that we will furnish to any United States shareholder information that may be necessary to comply with the reporting and payment obligations described above. Failure to comply with such obligations may subject a United States shareholder to significant monetary penalties and stall the beginning of the statute of limitations period for relevant U.S. federal income tax returns. U.S. holders should consult their tax advisors regarding the potential application of these rules to their investment in the ADSs.
Future changes to tax laws could materially adversely affect our company and reduce net returns to our shareholders.
Our tax treatment is subject to the enactment of, or changes in, tax laws, regulations and treaties, or the interpretation thereof, tax policy initiatives and reforms under consideration and the practices of tax authorities in jurisdictions in which we operate, including those related to the Organization for Economic Co-Operation and Development’s Base Erosion and Profit Shifting Project, the European Commission’s state aid investigations and other initiatives. Such changes may include (but are not limited to) the taxation of operating income, investment income, dividends received or (in the specific context of withholding tax) dividends paid. We are unable to predict what tax reform may be proposed or enacted in the future or what effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our financial position and overall or effective tax rates in the future in countries where we have operations, reduce post-tax returns to our shareholders, and increase the complexity, burden and cost of tax compliance.
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Tax authorities may disagree with our position and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. For example, the U.S. Internal Revenue Service or another tax authority could challenge our allocation of income by tax jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangement and transfer pricing policies, including amounts paid with respect to our intellectual property development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, where applicable.
General Risk Factors
We may be subject to securities litigation, which is expensive and could divert management’s attention.
The market price of the ordinary shares or ADSs may be volatile and, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and their trading volume could decline.
The trading market for the ADSs depends in part on the research and reports that securities or industry analysts publish about us or our business. As a public listed company in Australia since 1985, our equity securities are currently subject to coverage by a number of analysts. If fewer securities or industry analysts cover our company, the trading price for the ADSs could be negatively impacted. If one or more of the analysts who covers us downgrades our equity securities or publishes incorrect or unfavorable research about our business, the price of the ADSs would likely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, or downgrades our securities, demand for the ADSs could decrease, which could cause the price of the ADSs or their trading volume to decline.
If our information technology systems or data, or those of the third-parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations' reputational harm' loss of revenue or profits; loss of customers or sales; and other adverse consequences.
In the ordinary course of our business, we and the third parties with whom we work, process confidential sensitive, and/or proprietary information, including intellectual property, business information, personal data, and health information (collectively, sensitive information).
Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties upon which we rely. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer "hackers," threat actors, "hacktivists," organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitations nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.
We and the third parties with whom we work are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing attacks, credential
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harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, attacks enhanced or facilitated by AI, adware, telecommunications failures, earthquakes, fires, floods and other similar threats. In particular, severe ransomware attacks are becoming increasingly prevalent, particularly for companies like ours in the biopharmaceutical space, and can lead to significant interruptions in our operations, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments
It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident. Our efforts to do so may not be successful. Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business. Threat actors may also gain access to other networks and systems after a compromise of our networks and systems.
Remote work has become more common and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations.
Future or past business transactions (such as acquisitions or integrations) could expose us to additional cyber security risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities' systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, as it may be difficult to integrate companies into our information technology environment and security program.
We rely on third parties and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitations, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, and other functions. Our ability to monitor these third parties' information security practices is limited, and these third parties may not have adequate information security measures in place. If the third parties with whom we work experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if these third parties fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties' infrastructure in our supply chain or that of the third-party with whom we work have not been compromised.
Any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information of our information technology systems, or those of the third parties with whom we work. A security incident or other interruptions could disrupt our ability (and that of third parties with whom we work) to develop and provide our products. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
We may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Certain data privacy and security obligations may require us to implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive information.
While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.
We take steps to detect and remediate vulnerabilities, but we may not be able to detect and remediate all vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties with whom we work). We may not, however, detect and remediate all such vulnerabilities including on a timely basis. Further, we may experience delays in developing and deploying remedial measures designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.
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Applicable data privacy and security obligations may require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents or to take other actions, such as providing credit monitoring and identity theft protection services. Such disclosures and related actions are costly, and the disclosure or the failure to comply with such applicable requirements could lead to adverse consequences.
If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.
In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position. Additionally, sensitive information of the Company could be leaked, disclosed, or revealed as a result of or in connection with our employees’, personnel’s, or vendors’ use of generative AI technologies.
Our insurance policies are expensive and only protect us from some business risks, leaving us exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. We believe that we maintain insurance customary for businesses of our size and type, including clinical trial liability insurance. However, there are types of losses we may incur that cannot be insured against or that we believe are not economically reasonable to insure. Moreover, any loss incurred could exceed policy limits and policy payments made to us may not be made on a timely basis. Such losses could negatively affect our business prospects, results of operations, cash flows and financial condition. We do not know if our current levels of coverage are adequate or if we will be able to obtain insurance with adequate levels of coverage in the future, if at all. Any significant uninsured liability may require us to pay substantial amounts, which could negatively impact our financial position and results of operations.
We have identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future or fail to implement and maintain an effective system of internal control over financial reporting, which may result in us being unable to accurately report our results of operations, meet our reporting obligations or prevent fraud, and investor confidence in our company and the market price of the ADSs may be negatively impacted.
Section 404(a) of the Sarbanes-Oxley Act of 2002, or 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. During the year ended June 30, 2025, we continued to identify a material weakness in our internal controls over financial reporting because we did not design and maintain effective controls in relation to accounting for non-routine transactions and its related note disclosures which resulted in our failure to prevent and detect material errors which were corrected in our consolidated financial statements as of and for the year ended June 30, 2025 related to the incorrect accounting and disclosures for the Development Funding Agreement obligations. During the year ended June 30, 2024 we identified a material weakness in our internal controls over financial reporting because we did not design and maintain effective controls in relation to accounting for non-routine transactions and its related note disclosures which resulted in our failure to prevent and detect material errors which were corrected in our consolidated financial statements as of and for the year ended June 30, 2024 related to the (1) the incorrect accounting of the Development Funding Agreement following the changes in the assumption relating to the timing of the
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repayments and (2) the accounting application and related disclosures of investor options in the prior year. Although we are taking certain measures to remediate this material weakness which continues to exist as of June 30, 2025, this material weakness will not be considered remediated until management completes the design and implementation of the remediation measures and the controls operate for a sufficient period of time and management concludes, through testing, that these controls are effective. If in the future, we fail to maintain effective internal controls, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404(a).
Section 404(b) also requires an attestation report on the effectiveness of internal control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following the date on which we are no longer an “emerging growth company”, which may be up to five fiscal years from the initial public offering of our ADSs. If we are unable to attest to the effectiveness of our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, and the market price of our ordinary shares and ADSs could decline. Failure to maintain effective internal control over financial reporting could also restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary and criminal liability. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expense and a diversion of management’s time and attention from revenue generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business, financial position, results and prospects may be adversely affected.
The presence of material weaknesses could result in financial statement errors which, in turn, could lead to errors in our financial reports or delays in our financial reporting, which could require us to restate our operating results or result in our auditors issuing a qualified audit report. In order to establish and maintain effective disclosure controls and procedures and internal controls over financial reporting, we will need to expend significant resources and provide significant management oversight. Developing, implementing and testing changes to our internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns. These changes may not, however, be effective in establishing and maintaining adequate internal controls.
If in the future we conclude that we have ineffective internal controls over financial reporting or when applicable, 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.
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Item 4. Information on the Company
4A. History and Development of Opthea Limited
We were incorporated under the laws of Australia in 1984 under the name Circadian Technologies Limited. In 1985, we completed an initial public offering of our ordinary shares and the listing of our ordinary shares on the Australian Securities Exchange, or the ASX. In December 2015, we changed the name of our company to Opthea Limited. In October 2020, we dual listed onto the NASDAQ. Our registered offices are located at C/- Prime Company Compliance, Level 9 505 Little Collins Street, Melbourne, VIC 3000, Australia. Our telephone number is +61 3 9826 0399. Our agent for service of process in the United States is Corporation Service Company, located at 1180 Avenue of the Americas, Suite 210, New York, NY 10036. Our website address is www.opthea.com. The reference to our website is an inactive textual reference only and information contained in, or that can be assessed through, our website is not part of this annual report. The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, such as us, that file electronically with the SEC.
For a description of our principal capital expenditures and divestitures for the three years ended June 30, 2025, and for those currently in progress, see Item 5 “Operating and Financial Review and Prospects”.
4B. Business Overview
Our Company
We are a clinical stage biopharmaceutical company publicly listed on the Australian Securities Exchange and Nasdaq. The principal activity of Opthea Limited is to research and develop novel therapeutic products based on targeting Vascular Endothelial Growth Factors (VEGF) C, D and R3.
Our lead asset, sozinibercept was being developed as a novel, first‑in‑class VEGF‑C/D ‘trap’ inhibitor designed to be used in combination with standard‑of‑care anti‑VEGF‑A therapies to improve vision in wet AMD patients, many of whom respond sub‑optimally or become refractory to existing therapies. Sozinibercept had the potential to become the first therapy in 20 years to improve visual outcomes in patients with wet AMD, enabling them to live more independently and have a better quality of life. Wet AMD is a chronic, progressive eye disease and the leading cause of vision loss for individuals over the age of 50. In a 366-patient Phase 2b clinical trial for the treatment of wet AMD, 2.0 mg sozinibercept, in combination with a standard of care anti-VEGF-A therapy, ranibizumab (Lucentis®), met the primary endpoint of a statistically significant superior mean gain in visual acuity over ranibizumab monotherapy at week 24. We initiated two pivotal Phase 3 clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab), in treatment-naive patients with wet AMD to evaluate the efficacy and safety of sozinibercept in combination with anti-VEGF-A therapies compared to anti-VEGF-A monotherapy. We completed patient recruitment for COAST in February 2024 and in ShORe in May 2024.
During 2024 through 2025 Opthea’s principal activities included progression of the Company’s Phase 3 registrational trials of sozinibercept for wet AMD through to top-line data read out. In March 2025 the company announced the Phase 3 trials did not meet their primary endpoints. Trading in our ordinary shares on the ASX and in our ADSs on Nasdaq have been halted since this announcement. Since March of 2025 the company has been closing all clinical, manufacturing, and regulatory activities associated with the Wet AMD program and exiting all contracts related to the clinical trials.
In March 2025, after the primary endpoints were not met in our COAST and ShORe Phase 3 trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD and agreed that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea to the DFA Investors. Following the discontinuation of the clinical trials we streamlined our operations, reduced our workforce and Board of Directors and exited all contracts related to our clinical trials. We also entered into negotiations with the DFA Investors to settle the DFA. On August 19, 2025, we reached a binding agreement with the DFA Investors to terminate the DFA, pursuant to which the DFA Investors received a cash payment of $20 million and 136,661,003 ordinary shares, equal to 9.99% of our then outstanding issued share capital on a fully diluted basis. Upon receipt of the cash payment and ordinary shares, the DFA Investors agreed to release all liens on the collateral and terminate the DFA.
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Our Strategy
Pivotal Phase 3 Clinical Trials in Wet AMD
Over the last several years we were focused on developing sozinibercept for patients with wet AMD. We initiated two concurrent pivotal Phase 3 clinical trials for the treatment of wet AMD. These double-masked, sham-controlled Phase 3 clinical trials enroll treatment-naive patients to assess the efficacy and safety of 2.0 mg sozinibercept in combination with anti-VEGF-A therapy for treatment-naive patients with wet AMD compared to a standard of care anti-VEGF-A monotherapy. In addition, each trial was comparing the clinical efficacy of sozinibercept, administered in combination with the applicable VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen to understand the durability of sozinibercept treatment effect with less frequent dosing. The primary endpoint of both trials was the mean change in visual acuity from baseline to week 52. Patients continued to be dosed until week 96 to further assess long-term safety at week 100. We completed patient recruitment for COAST in February 2024 and in ShORe in May 2024.
In March 2025, Opthea announced the COAST Phase 3 trial did not meet its primary or secondary endpoints. As a result of the COAST negative trial endpoints the management team and Board of Directors in consultation with the DFA Investors determined the most appropriate course of action for wet AMD patients and shareholders and other stakeholders was to accelerate the timing of the ShORE trial topline data.
In March 2025, Opthea announced the ShORE trial did not meet its primary or secondary endpoints. Following the negative topline data of both COAST & ShORE trials Opthea, in consultation with the DFA Investors determined to terminate the sozinibercept in wet AMD program.
Strategy Moving Forward
After our Phase 3 clinical trials in Wet AMD missed their primary endpoints the company has terminated the development of the Wet AMD program. The company has downsized the work force by 80% and reduced the Board of Directors by over 50%. As of September 11, 2025 there are 4 full time employees remaining with the company.
Our goal is to continue targeting Vascular Endothelial Growth Factors (VEGF”) and to reformulate our anti-VEGF compounds, including to treat diseases known to be mediated by VEGF-C and/or D. This signifies a shift from Opthea’s previous focus on the development and commercialization of existing compounds for the treatment of wet AMD (including through the COAST and ShORE clinical trials,) to the use of its existing compounds to potentially treat other diseases. We have previously explored the application of anti-VEGF compounds for diagnosing diseases where the elevation of VEGF-D serum levels correlated with disease severity. We believe OPT-302 has a promising application to the treatment of these diseases.
Following the DFA Settlement, the Board is conducting a full strategic review of our business. The first phase of the strategic review will be focused on reformulating our portfolio of drug candidates targeting VEGF-C and/or VEGF-D, of which OPT-302 is one of these drug candidates, which was previously delivered to the eye via injection to treat wet AMD, to various other forms of delivery that may be appropriate for delivering our portfolio of drug candidates to other organs. To implement phase one, we have already taken steps to apply for a patent in order to protect the use of OPT-302 in various delivery methods. Following completion of phase one and subject to the successful reformulation of one of our drug candidates targeting VEGF-C and/or VEGF-D, we will look to conduct clinical trials of any future drug candidate in treating VEGF-C and/or VEGF-D mediated disorders in other organs. Similar to previous clinical trials conducted for sozinibercept in wet AMD, we expect that any future clinical trials will be outsourced to third party providers.
Intellectual Property
As of June 30, 2025, we have rights to 16 issued U.S. patents, six U.S. patent applications, 68 issued non-U.S. patents and 23 pending non-U.S. applications. Our live issued patents and patent applications all are protected to expire between November 2026 and November 2034 although our most recent filing sin 22 countries do not expire until September 2043.
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With respect to soluble forms of VEGFR-3, we own and have licensed rights to patent families including issued patents in the United States and Europe (Switzerland, France, Germany and the UK) which began expiring in 2022 and are expect to continue expiring until 2031. These patents cover compositions of matter and/or method of use claims, including claims direct to at the treatment of eye diseases associated with abnormal blood vessel growth, such as wet AMD.
With respect to sozinibercept, we own a patent family with three issued U.S. patents, an issued European patent validated in 38 countries and non-U.S. patents granted in Australia, Brazil, Canada, China, Colombia, Indonesia, Israel, India, South Korea, Mexico, Malaysia (2), New Zealand, Philippines, Russia, Singapore and South Africa. Patent applications are pending in the United States and in Europe. The three issued U.S. patents have claims covering the composition of matter of sozinibercept and its uses in treating ocular disorders and/or nucleic acids, vectors, and host cells for producing it. These issued patents and pending patent applications, if issued, are expected to expire in 2034, not including any patent term extension. We also own a patent family with 23 pending applications with claims to formulations of sozinibercept with enhanced stability and shelf life.
The actual protection afforded by a patent, which can vary from country to country, depends on the type of patent, the scope of its coverage as determined by the patent office or courts in the country, and the availability of legal remedies in the country. The information in the above list is based on our current assessment of patents that we own or control or have exclusively licensed. The information is subject to revision, for example, in the event of changes in the law or legal rulings affecting our patents or if we become aware of new information. Significant legal issues remain unresolved as to the extent and scope of available patent protection for biotechnology products and processes in the United States and other important markets outside the United States. We expect that litigation will likely be necessary to determine the term, validity, enforceability and/or scope of certain of our patents and other proprietary rights. An adverse decision or ruling with respect to one or more of our patents could result in the loss of patent protection for a product and, in turn, the introduction of competitor products or follow-on biologics to the market earlier than anticipated.
Patents expire, on a country by country basis, at various times depending on various factors, including the filing date of the corresponding patent application(s), the availability of patent term adjustment, patent term extension and supplemental protection certificates and requirements for terminal disclaimers. In most countries, including the United States, the patent term is 20 years from the earliest claimed filing date of a non-provisional patent application or its foreign equivalent in the applicable country. In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date. In the United States, a patent may also be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process in the US. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to each regulatory review period may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended, with extended rights limited to the approved product, its approved uses, and/or its manufacture.
Although we believe our owned and licensed patents and patent applications provide us with a competitive advantage, the patent positions of biotechnology and pharmaceutical companies can be uncertain and involve complex legal and factual questions. We may not be able to develop patentable products or processes or obtain patents from pending patent applications. In the event of patent issuance, the patents may not be sufficient to protect the proprietary technology owned by or licensed to us or our partners. Our current patents, or patents that issue on pending applications, may be challenged, invalidated, infringed or circumvented. In addition, changes to patent laws in the United States or in other countries may limit our ability to defend or enforce our patents, or may apply retroactively to affect the term and/or scope of our patents. Our patents have been and may in the future be challenged by third parties in post-issuance administrative proceedings or in litigation as invalid, not infringed or unenforceable under U.S. or foreign laws, or they may be infringed by third parties. As a result, we have or may be from time to time involved in the defense and enforcement of our patent or other intellectual property rights in a court of law and administrative tribunals, such as in USPTO inter partes review or reexamination proceedings, foreign opposition proceedings or related legal and administrative proceedings in the United States and elsewhere. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings or litigation may be substantial and the outcome can be uncertain. An adverse outcome may allow third parties to use our proprietary technologies without a license from us.
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Furthermore, we rely upon trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information, in part, by using confidentiality and invention assignment agreements with its commercial partners, collaborators, employees and consultants. These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant it ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our commercial partners, collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Our commercial success will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the issuance of any third-party patent would require us to alter its development or commercial strategies for our product candidates or processes, or to obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license to proprietary rights that it may require to develop or commercialize its future products may have an adverse impact on us. If third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the USPTO to determine priority of invention.
As of June 30, 2025, we or our subsidiaries have registered and own “Opthea” as a trademark in ten jurisdictions, including the United States and Europe. Other than the registered trademark listed above, we currently rely on our unregistered trademarks, trade names and service marks, as well as our domain names and logos, as appropriate, to market our brands and to build and maintain brand recognition.
Government Regulation
The FDA and other regulatory authorities at federal, state, and local levels, as well as in non-U.S. countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record-keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of biologics such as those we are developing. We, along with third-party contractors, will be required to navigate the various nonclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of any future product candidate.
U.S. Biological Product Development
In the United States, the FDA regulates biologics under both the Federal Food, Drug and Cosmetic Act and the Public Health Service Act and their implementing regulations. Both drugs and biologics also are subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or post-market regulations may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, license revocation, a clinical hold, untitled or warning letters, product recalls or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
Our product candidates and any future biological product candidates we develop must be approved by the FDA through a biologics license application, or BLA, process before they may be legally marketed in the United States. The BLA is a request for approval to market the biologic for one or more specified indications and must contain proof of safety, purity and potency. The FDA review and approval process generally involves the following:
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Nonclinical Trials and IND
Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies.
Prior to beginning the first clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, PK, pharmacology, and PD characteristics of the product candidate; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold until the IND sponsor and the FDA resolve the outstanding concerns or questions. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
Clinical Trials
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. For new indications, a separate new IND may be required. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some trials also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical trials and clinical study results to public registries. For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.
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A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of a BLA. The FDA will accept a well-designed and well-conducted foreign clinical study not conducted under an IND if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.
In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 trials may be made a condition to approval of the BLA. Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
BLA Submission, Review and Approval
Assuming successful completion of the clinical trials, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from pertinent preclinical and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. The submission of a BLA requires payment of a substantial application user fee to FDA, unless a waiver or exemption applies.
Once a BLA has been submitted, the FDA’s goal is to review standard applications within ten months after it accepts the application for filing (a 60-day process), or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process can be significantly extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application 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 compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
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After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response letter will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.
If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.
Expedited Development and Review Programs
Any marketing application for a biologic submitted to the FDA for approval may be eligible for FDA programs intended to expedite the FDA review and approval process, such as Priority Review, Fast-Track, Breakthrough Therapy and Accelerated Approval.
A product is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition compared to marketed products. For products containing new molecular entities, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (compared with ten months under standard review).
In addition, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs or biologics designated as breakthrough therapies are also eligible for accelerated approval. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthrough therapy. The benefits of breakthrough therapy designation include the same benefits as Fast-Track designation, plus intensive guidance from the FDA to ensure an efficient drug development program.
Additionally, products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.
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Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review and approval will not be shortened. Furthermore, priority review, Fast-Track designation, breakthrough therapy designation, and accelerated approval do not change the standards for approval but may expedite the development or approval process.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan designation must be requested before submitting a BLA. After the FDA grants orphan designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or automatically shorten the duration of, the regulatory review or approval process.
If a product that has orphan designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee. A designated orphan product may not receive orphan exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
Post-Approval Requirements
Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to quality control and quality assurance, record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which FDA assesses an annual program fee for each product identified in an approved BLA. Biologic manufacturers and their subcontractors 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 cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
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The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.
Biosimilars and Reference Product Exclusivity
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or Affordable Care Act signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. To date, a number of biosimilars have been licensed under the BPCIA, and numerous biosimilars have been approved in Europe. The FDA has issued several guidance documents outlining its approach to the review and approval of biosimilars.
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 trial or trials. 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 in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.
Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.
The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.
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Other U.S. Healthcare Laws and Compliance Requirements
In the United States, our current and future operations are subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS other divisions of the U.S. Department of Health and Human Services, or HHS (such as the Office of Inspector General, Office for Civil Rights and the Health Resources and Service Administration), the U.S. Department of Justice, or DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments. For example, our clinical research, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, transparency and price reporting laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act, or HIPAA and similar state laws, each as amended, as applicable. Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors and customers may be subject to healthcare laws, regulations and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security, price reporting, and transparency laws. Some of our pre-commercial activities are subject to some of these laws.
The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between therapeutic product manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor.
Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard 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. Further, courts have found that if “one purpose” of remuneration is to induce referrals, the federal Anti-Kickback statute is violated. Violations of the Anti-Kickback Statute can result in significant civil and criminal fines and penalties for each violation, imprisonment, and exclusion from federal healthcare programs. In addition, the Affordable Care Act codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or the FCA, as discussed below.
The federal false claims laws, including the FCA, which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal government, including federal healthcare programs, such as Medicare and Medicaid, knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government, or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Pharmaceutical and other healthcare companies have been, and continue to be, prosecuted under these laws, among other things, for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product and for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, off-label, and thus generally non-reimbursable, uses.
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HIPAA created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, 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. Like the Anti-Kickback Statute, the Affordable Care Act amended the intent standard for certain healthcare fraud statutes under HIPAA 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. When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.
We may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates and their covered subcontractors relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, which are independent contractors or agents of covered entities that create, maintain, transmit, receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, many state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.
Additionally, the federal Physician Payments Sunshine Act, or the Sunshine Act, within the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians (defined to include (doctors, dentists, optometrists, podiatrists and chiropractors) certain other healthcare professionals (such as physicians assistants and nurse practitioners) and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members. Failure to report accurately could result in penalties.
Many states have similar statutes or regulations to the above federal laws that may be broader in scope and may apply regardless of payor. We may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, and/or state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, drug pricing or marketing expenditures. Certain state and local laws also require the registration of pharmaceutical sales representatives. We may be subject to state and foreign laws governing the privacy and security of health information, some of which may be more stringent than those in the United States (such as the GDPR, which was adopted by the EU and subsequently became effective in May 2018). These laws may differ from each other in significant ways and may not have the same effect, further complicating compliance efforts.
In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to 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 pharmacies and other healthcare entities from providing certain physician prescribing data to
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pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws. Additionally, to the extent that we have business operations in foreign countries or sell any of our products in foreign countries and jurisdictions, including Canada or the EU, we may be subject to additional regulation.
Ensuring business arrangements with third parties comply with applicable healthcare laws and regulations is a costly endeavor. If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other current or future governmental regulations that apply to us, we may be subject to penalties, including without limitation, significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect its ability to operate our business and results of operations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.
Coverage, Pricing and Reimbursement in the U.S.
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may obtain regulatory approval. In the United States and in foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage and establish adequate reimbursement levels for such products. In the United States, third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations. Third-party payors decide which medications they will pay for and establish reimbursement levels. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the United States, and commercial payors are critical to new product acceptance.
Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and reimbursement for these products and related treatments will be available from third-party payors, which decide which therapeutics they will pay for and establish reimbursement levels. In the United States, the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS. CMS decides whether and to what extent our products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a therapeutic is:
We cannot be sure that coverage or reimbursement will be available for any product that we commercialize and, if coverage and reimbursement are available, what the level of reimbursement will be. Coverage may also be more limited than the purposes for which the product is approved by the FDA or comparable foreign regulatory authorities. Reimbursement may impact the demand for, or the price of, any product for which we obtain regulatory approval.
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We may develop products that, once approved, may be administered by a physician. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization.
Third-party payors are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. Obtaining reimbursement for our products may be particularly difficult because of the higher prices often associated with branded drugs and drugs administered under the supervision of a physician. 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 FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our product on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on its investment in product development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any product candidate that we successfully develop.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care, the increasing influence of health maintenance organizations, and additional legislative changes in the United States has increased, and we expect will continue to increase, the pressure on healthcare pricing. The downward pressure on the rise in healthcare costs in general, particularly prescription medicines, medical devices and surgical procedures and other treatments, has become very intense. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
U.S. Healthcare Reform
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell product candidates for which marketing approval is obtained. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
For example, the Affordable Care Act has substantially changed healthcare financing and delivery by both governmental and private insurers. The Affordable Care Act among other things contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws.
Since its enactment, there have been executive, legal and political challenges to certain aspects of the Affordable Care Act. By way of example, the Tax Cuts and Jobs Act, or TCJA, included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care Act on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. On August 16, 2022, President Biden signed the IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible that the Affordable Care Act will be subject to
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judicial or Congressional challenges in the future. It is unclear how any such challenges and the healthcare reform measures of the Biden administration will impact the Affordable Care Act.
Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect until 2032 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. presidential executive orders, Congressional inquiries and proposed and enacted federal legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA directs the HHS Secretary to establish a Drug Price Negotiation Program (the “Program”) to lower prices for certain high-expenditure, single-source prescription drugs and biologics covered under Medicare Part B and Part D that have been approved by the FDA for at least 7 years for prescription drugs and at least 11 years for biologics. Under the Program, the HHS Secretary will publish a list of “selected drugs,” and will then negotiate maximum fair prices (“MFP”) with their manufacturers. The Program will be implemented in stages. Beginning in 2026, 10 Medicare Part D “selected drugs” will be subject to price negotiations. By 2029, and in subsequent years thereafter, the number will increase to 20 drugs and biologics covered under Medicare Part B and Part D. Agreements between HHS and manufacturers will remain in place until a drug or biologic is no longer considered a “selected drug” for negotiation purposes. Manufacturers who do not comply with the negotiated prices set under the Program will be subject to an excise tax based on a percentage of total sales of a “selected drug” up to 95% and potential civil monetary penalties. Further, beginning in October 2023, the IRA will require manufacturers that increase prices of certain Medicare Part B and Part D drugs or biologics at a rate greater than inflation to pay rebates to CMS or be subject to civil monetary penalties. HHS has and will continue to issue and update guidance as these programs are implemented, although the IRA may be subject to legal challenges. It is currently unclear how the IRA will be implemented but is likely to have significant impact on the pharmaceutical industry. In addition, in response to the Biden administration's October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control biopharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions on coverage or access could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates that we successfully commercialize or put pressure on our product pricing.
We expect that these and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. 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. Such reforms could have an adverse effect on anticipated revenue
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from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.
European Union Product Approval Process
Non-Clinical Studies and Clinical Trials
Similar to the United States, the various phases of non-clinical research in the EU are subject to significant regulatory controls.
Non-clinical studies are performed to demonstrate the health or environmental safety of new chemical or biological substances. In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded, reported, and archived in accordance with the GLP principles, as set forth in Directive 2004/10/EC, which define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These GLP standards reflect the Organization for Economic Co-operation and Development requirements.
The Clinical Trials Directive 2001/20/EC, the Directive 2005/28/EC on Good Clinical Practice, or GCP, and the related national implementing provisions of the individual EU member states currently govern the system for the approval of clinical trials in the EU.
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations of EU members states and the International Conference on Harmonization, or ICH, guidelines on GCP, as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If the sponsor of the clinical trial is not established within the EU, it must appoint an EU entity to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and increasingly in EU member states, the sponsor is liable to provide “no fault” compensation to any study subject injured in the clinical trial.
Under the applicable regulatory system, an applicant must obtain prior approval from the competent national authority of the EU member states in which the clinical trial is to be conducted. Furthermore, the applicant may only start a clinical trial at a specific study site after the competent ethics committee has issued a related favorable opinion. The application for authorization of a clinical trial must be accompanied by, among other documents, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation as prescribed by Directive 2001/20/EC, Directive 2005/28/EC, where relevant the related implementing national provisions of the individual EU member states, and further detailed in applicable guidance documents. Any substantial changes to the trial protocol or to other information submitted with the clinical trial application must be notified to and approved by the relevant competent national authorities and ethics committees. Medicinal products used in clinical trials must be manufactured in accordance with good manufacturing practice (GMP).
In April 2014, the new Clinical Trials Regulation, (EU) No 536/2014 (Clinical Trials Regulation) was adopted. The Regulation came into effect in the EU on January 31, 2022. The Clinical Trials Regulation is directly applicable in all the EU member states, repealing the Clinical Trials Directive 2001/20/EC. A three-year transition period is in place to move from the previous European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, SI No 190 of 2004 which transposed into law the provision of Council Directive 2001/20/EC. The transition period sets out the following key timelines:
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The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the EU. The main characteristics of the regulation include: a streamlined application procedure via a single-entry point, the "EU portal"; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed first by a single “reference” member state whose conclusions are then assessed by the competent authorities of all EU member states in which an application for authorization of a clinical trial has been submitted to “concerned” member states. Part II is assessed separately by each concerned EU member state. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU member state. However, overall related timelines will be defined by the Clinical Trials Regulation, which provides Sponsors a reliable timeline to evaluate the approval of the clinical trial throughout Europe.
Marketing Authorizations
To obtain a marketing authorization, or MA, for a product in the EU, an applicant must submit a Marketing Authorization Application, or MAA, either under a centralized procedure administered by the European Medicines Agency, or EMA, or one of the procedures administered by competent authorities in the EU member states (decentralized procedure, national procedure, or mutual recognition procedure). An MA may be granted only to an applicant established in the EU.
The centralized procedure provides for the grant of a single MA by the European Commission that is valid for all EU member states. Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) advanced therapy medicinal products (ATMPs), and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto-immune and other immune dysfunctions, and viral diseases. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional on the related approval of the EMA.
Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is responsible for conducting the assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.
Under the centralized procedure in the EU, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated assessment may be granted by the CHMP in exceptional cases, when a medicinal product targeting an unmet medical need is expected to be of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. If the CHMP accepts a request for accelerated assessment, the time limit of 210 days will be reduced to 150 days (not including clock stops). The CHMP can, however, revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
Unlike the centralized authorization procedure, the decentralized MA procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU member state in which the product is to be marketed. This application is identical to the application that would be submitted to the EMA for authorization through the centralized procedure. The reference EU member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned EU member states who, within 90 days of receipt, must decide whether to approve the assessment report and related materials. If a concerned EU member state cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may
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be referred to the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) for review. The subsequent decision of the European Commission is binding on all EU member states.
The mutual recognition procedure allows companies that have a medicinal product already authorized in one EU member state to apply for this authorization to be recognized by the competent authorities in other EU member states. Like the decentralized procedure, the mutual recognition procedure is based on the acceptance by the competent authorities of the EU member states of the MA of a medicinal product by the competent authorities of other EU member states. The holder of a national MA may submit an application to the competent authority of an EU member state requesting that this authority recognize the MA delivered by the competent authority of another EU member state.
In principle, an MA has an initial validity of five years. The MA may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the EU member state in which the original MA was granted. To support the application, the MA holder must provide the EMA or the competent authority with a consolidated version of the eCTD (Common Technical Document) providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced since the MA was granted, at least nine months before the MA ceases to be valid. The European Commission or the competent authorities of the EU member states may decide on justified grounds relating to pharmacovigilance, to proceed with one further five-year renewal period for the MA. Once subsequently definitively renewed, the MA shall be valid for an unlimited period. Any authorization which is not followed by the actual placing of the medicinal product on the EU market (in case of centralized procedure) or on the market of the authorizing EU member state within three years after authorization ceases to be valid (the so-called sunset clause).
Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines, or PRIME, scheme, which provides incentives similar to the breakthrough therapy designation in the U.S. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicinal products that target unmet medical needs. It permits increased interaction and early dialogue with companies developing promising medicinal products, to optimize their product development plans and speed up their evaluation to help the product reach patients earlier than normal. Product developers that benefit from PRIME designation are potentially eligible for accelerated assessment of their MAA although this is not guaranteed. Benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.
In the EU, a “conditional” MA may be granted in cases where all the required safety and efficacy data are not yet available. The conditional MA is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures. It is valid for one year and must be renewed annually until all related conditions have been fulfilled. Once any pending studies are provided, the conditional MA can be converted into a traditional MA. However, if the conditions are not fulfilled within the timeframe set by the EMA, the MA will cease to be renewed.
An MA may also be granted “under exceptional circumstances” where the applicant can show that it is unable to provide comprehensive data on efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced. These circumstances may arise in particular when the intended indications are very rare and, in the state of scientific knowledge at that time, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. Like a conditional MA, an MA granted in exceptional circumstances is reserved to medicinal products intended to be authorized for treatment of rare diseases or unmet medical needs for which the applicable does not hold a complete data set that is required for the grant of a standard MA. However, unlike the conditional MA, an applicant for authorization in exceptional circumstances is not subsequently required to provide the missing data. Although the MA “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually, and the MA is withdrawn in case the risk-benefit ratio is no longer favorable.
In addition to an MA, various other requirements apply to the manufacturing and placing on the EU market of medicinal products. Manufacture of medicinal products in the EU requires a manufacturing authorization, and import of medicinal products into the EU requires a manufacturing authorization allowing for import. The manufacturing authorization holder must comply with various requirements set out in the applicable EU laws,
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regulations and guidance. These requirements include compliance with EU GMP standards when manufacturing medicinal products and APIs, including the manufacture of APIs outside of the EU with the intention to import the APIs into the Union. Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU member states. MA holders and/or manufacturing and import authorization, or MIA holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU or EU member states’ requirements applicable to the manufacturing of medicinal products.
Data and Market Exclusivity
The EU provides opportunities for data and market exclusivity related to MAs. Upon receiving an MA, innovative medicinal products are generally entitled to receive eight years of data exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until 10 years have elapsed from the initial MA of the reference product in the EU. The overall ten-year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
Orphan Medicinal Products
Regulation (EC) No. 141/2000, as implemented by Regulation (EC) No. 847/2000 provides that a medicinal product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish that (1) the product 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 ten thousand 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; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, the product will be of significant benefit to those affected by that condition.
In the EU, an application for designation as an orphan product can be made any time prior to the filing of the MAA. Orphan medicinal product designation entitles an applicant to incentives such fee reductions or fee waivers, protocol assistance, and access to the centralized MA procedure. Upon grant of an MA, orphan medicinal products are entitled to a ten-year period of exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another MAA, or grant an MA, or accept an application to extend an MA for a similar product for the same indication for a period of ten years. The period of exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric trials for orphan indications. Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
The period of exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, an MA may be granted to a similar medicinal product with the same orphan indication during the 10 year period if: (i) if the applicant consents to a second original orphan medicinal product application, (ii) if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) if the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the original orphan medicinal product. A company may voluntarily remove a product from the register of orphan products.
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Post-Approval Requirements
Where an MA is granted in relation to a medicinal product in the EU, the holder of the MA is required to comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products.
Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory authorities of the individual EU member states. The holder of an MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.
Coverage, Pricing and Reimbursement outside the United States
Outside the U.S., pharmaceutical companies, products and distributors are also generally subject to extensive governmental price controls and other market regulations. We believe the increasing emphasis on cost-containment initiatives in EEA and other countries has and will continue to put pressure on the pricing and usage of our products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems that fund a large part of the cost of those products to consumers. Some countries operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of comparative trials that compare the cost effectiveness of a particular product candidate to currently available therapies. Other countries allow companies to fix their own prices for medical products, but monitor and control company profits. Additional price controls in foreign countries or other changes in pricing regulation could restrict the amount that we are able to charge for our products. Accordingly, in markets outside the U.S., the reimbursement for our products may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenue and profits.
Moreover, increasing efforts by governmental and third-party payors abroad, as in the U.S., to control healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our products. We expect to experience pricing pressures in connection with the sale of any of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.
If we are unable to establish or sustain coverage and adequate reimbursement for any of products from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved.
In various EEA countries, we expect to be subject to continuous cost-cutting measures, such as lower maximum prices, lower or lack of reimbursement coverage and incentives to use cheaper products as an alternative. Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EEA countries, including countries representing major markets. The HTA process, which is currently governed by the national laws of these countries, is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EEA Member States. On January 31, 2018, the European Commission adopted a proposal for a regulation on health technologies assessment. The proposed regulation is intended to boost cooperation among EEA Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at the EEA level for joint clinical assessments in these areas. In June 2021, the European Parliament and Council reached a provisional agreement on the draft regulation. Entry into application of the Regulation could impose stricter and
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more detailed procedures to be followed by MAHs concerning conduct of HTA in relation to their products which may influence related pricing and reimbursement decisions.
Advertising Regulation
In the EU, the advertising and promotion of medicinal products are subject to both EU and EU member states’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. Although general requirements for advertising and promotion of medicinal products are established under EU rules, the details are governed by regulations in individual EU member states and can differ from one country to another. Applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics, or SmPC, as approved by the competent authorities in connection with an MA, therefore all off-label promotion is prohibited. The SmPC is the document that provides information to physicians concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU. Direct-to-consumer advertising of prescription medicinal products is also prohibited in the EU.
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.
Rest of the World Regulation
For other countries outside of the EU and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally, the clinical trials must be conducted in accordance with GCP requirements 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.
The Foreign Corrupt Practices Act
The FCPA prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Additional Regulation
In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our business. These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business. We cannot predict, however, how changes in these laws may affect our future operations.
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Other Regulations
We are also subject to numerous federal, state and local laws and foreign laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future.
In addition to regulation in the United States and the EEA, a variety of foreign regulations govern clinical trials, commercial sales and distribution of drugs. Pharmaceutical firms who wish to market their medicinal drugs outside the EEA and the United States must submit marketing authorization application to the national authorities of the concerned countries, such as the Pharmaceutical and Medical Device Agency, or PMDA in Japan. The approval process varies from jurisdiction to jurisdiction and the time to approval may be longer or shorter than that required by the FDA or European Commission.
Manufacturing and Supply
We were dependent on specialized third parties, who are subject to cGMP requirements and regulations, for the supply and manufacture of sozinibercept drug substance and drug product. We do not have any internal manufacturing and control capabilities. We sourced the drug substance for OPT-302 and our clinical trials on a purchase order basis. However, we believe that competitive pricing was achieved because there are a number of potential long-term replacements for our suppliers of drug substance. We terminated all agreements with such third parties following the discontinuation of our clinical trials for sozinibercept. We expect that if we are successful in reformulating any of our drug candidates and identifying a product candidate we will similarly be dependent on specialized third parties for the supply and manufacture of the drug substance and drug product for any future product candidate.
Employees
As of September 11, 2025, we had 4 full-time employees in our administration department, all located in Australia. None of our employees are represented by collective bargaining agreements.
Legal Proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are currently not a party to any material legal proceedings.
4C. Organizational Structure
Opthea Limited is the parent company of two wholly-owned subsidiaries for which it holds 100% of the voting power: Vegenics Pty Ltd, incorporated in Australia in January 2006 and Opthea US Inc, incorporated in the United States in May 2021.
4D. Property and Equipment
We occupied approximately 1,938 square feet of office space in South Yarra, Victoria, Australia under a lease that expired in July 2025. With the expiry of the lease the Australian staff reverted to working remotely. We believe that this arrangement is adequate to meet our current needs and that suitable additional alternative facilities will be available in the future on commercially reasonable terms to meet our future needs.
Item 4A. Unresolved Staff Comments
Not applicable.
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Item 5. Operating and Financial Review and Prospects
The following “Operating and Financial Review and Prospects” should be read together with our consolidated financial statements and the accompanying notes included elsewhere in this annual report. The following discussion is based on our financial information prepared in accordance with IFRS, as issued by the IASB, which might differ in material respects from accounting principles generally accepted in other jurisdictions, including U.S. GAAP. This discussion includes both historical information and forward-looking information based upon current expectations that involve risk, uncertainties and assumptions. Our actual results may differ materially from management’s expectations as a result of various factors, including, but not limited to, those discussed in “Risk Factors” and elsewhere in this annual report.
Overview
We are a clinical stage biopharmaceutical company. The principal activity of Opthea Limited is to research and develop novel therapeutic products based on targeting Vascular Endothelial Growth Factors (VEGF) C, D and R3.
Our lead asset, sozinibercept was being developed as a novel, first‑in‑class VEGF‑C/D ‘trap’ inhibitor designed to be used in combination with standard‑of‑care anti‑VEGF‑A therapies to improve vision in wet AMD patients, many of whom respond sub‑optimally or become refractory to existing therapies. Sozinibercept had the potential to become the first therapy in 20 years to improve visual outcomes in patients with wet AMD, enabling them to live more independently and have a better quality of life. Wet AMD, a chronic, progressive eye disease and the leading cause of vision loss for individuals over the age of 50. In a 366-patient Phase 2b clinical trial for the treatment of wet AMD, 2.0 mg sozinibercept, in combination with a standard of care anti-VEGF-A therapy, ranibizumab (Lucentis®), met the primary endpoint of a statistically significant superior mean gain in visual acuity over ranibizumab monotherapy at week 24. We initiated two pivotal Phase 3 clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab), in treatment-naive patients with wet AMD to evaluate the efficacy and safety of sozinibercept in combination with anti-VEGF-A therapies compared to anti-VEGF-A monotherapy. We completed patient recruitment for COAST in February 2024 and in ShORe in May 2024.
During 2024- 2025 Opthea’s principal activities included progression of the Company’s Phase 3 registrational trials of sozinibercept for wet AMD through to top-line data read out. In March 2025 the company announced the Phase 3 trials did not meet their primary endpoints. Trading in our ordinary shares on the ASX and in our ADSs on Nasdaq have been halted since this announcement. Since March of 2025 the company has been closing all clinical, manufacturing, and regulatory activities associated with the Wet AMD program and exiting all contracts related to the clinical trials.
In March 2025, after the primary endpoints were not met in our COAST and ShORe Phase 3 trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD, and agreed that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea to the DFA Investors. Following the discontinuation of the clinical trials we streamlined our operations, reduced our workforce and Board of Directors and exited all contracts related to our clinical trials. We also entered into negotiations with the DFA Investors to settle the DFA. On August 19, 2025, we reached a binding agreement with the DFA Investors to terminate the DFA, pursuant to which the DFA Investors received a cash payment of $20 million and 136,661,003 ordinary shares, equal to 9.99% of our then outstanding issued share capital on a fully diluted basis. Upon receipt of the cash payment and ordinary shares, the DFA Investors agreed to release all liens on the collateral and terminate the DFA.
We were founded in 1984 and completed our initial public offering and listing of ordinary shares on the Australian Securities Exchange in 1985. In October 2020, we completed a U.S, initial public offering of ADSs on Nasdaq. In April 2007, we acquired intellectual property relating to VEGF receptor 3 and subsequently developed the intellectual property for our lead product candidate, sozinibercept. Our development focus on the treatment of retinal diseases began in 2013. Since then, we have devoted substantially all of our efforts to organizing and staffing our company, business planning, raising capital, developing and manufacturing our lead product candidate, sozinibercept, conducting research and development activities, including preclinical studies and clinical trials, and providing general and administrative support for these operations. Our operations relating to the development of sozinibercept have been financed primarily through the issuance and sale of new ordinary shares totaling US$377.3 million through June 30, 2024. We have also received an aggregate of US$36.1 million (A$44.4
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million) in cash tax incentives for the five fiscal years ended June 30, 2024 under the Research and Development, or R&D, Tax Incentive Scheme for the funding of the development of and clinical trials for sozinibercept.
We have incurred operating losses since 2013. Our ability to generate product revenue sufficient to achieve profitability will be dependent on the successful development and eventual commercialization of sozinibercept and any future product candidates. Our total comprehensive loss was US$142.5 million, US$220.2 million, and US$162.8 million for the years ended June 30, 2023, 2024 and 2025, respectively. As of June 30, 2025, we had an accumulated loss of US$742.5 million.
We expect to continue to spend, significant resources to fund our strategic review, including research and development of, and seeking regulatory approvals for, other future product candidates. As of June 30, 2025, we had cash and cash equivalents of US$48.4 million. Following the DFA Settlement, as of August 20, 2025 we have $20 million in cash on hand. We have no other committed external source of funds. We expect that our current cash balance will be sufficient to fund our operations into the fourth calendar quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect, requiring us to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. The estimate is also dependent on whether the reformulation process is successful and the nature and size of clinical trials to be conducted in the future. The various ways we could raise additional capital carry potential risks. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. See “—Liquidity and Capital Resources.” See Note 2, Going Concern of our consolidated financial statements for more information.
Due to uncertainties regarding our future operations following the strategic review, and the potential for future clinical trials to assess the efficacy of our drug candidates in other disorders, we may need to raise additional capital, the timing and amount of which is unknown at this time. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions as well as Australian research and development tax incentives. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If any potential product candidate is approved for commercial sale, our commercialization expenses will increase significantly as we seek a commercialization partner or establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure.
Because of the numerous risks and uncertainties associated with the development of biopharmaceutical product candidates, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may never become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to scale back or discontinue our operations.
5A. Operating Results
Components of Our Results of Operations
Revenue
Revenue consists of sales-based royalties in connection with the out-licensing of certain intellectual property assets that are unrelated to our core business and the development of our prior product candidate sozinibercept and are not currently under development. These licenses are primarily used by third-party licensees for research purposes, and we expect revenue from these out-licensing arrangements to be nominal in future periods. These are variable consideration amounts and are recognized when the sales by our license partners to third parties occur, as the performance obligation to transfer the intellectual property to the license partner is already satisfied.
To date, we have not generated any revenue from sales of approved products. Because of the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount, timing or whether we will be able to obtain revenue from sales of approved products, and we may never succeed in obtaining regulatory approval for any other future product candidate. If our development efforts for any future product candidates are successful and result in an approved and marketed product, or if we enter into additional collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements.
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Other Income
Other income primarily comprises funding under a one-time Australian government grant and the Australian Tax Office.
Operating Expenses
Research and Development Expenses. Research and development expenses comprise the research project costs related to the development programs, including clinical trials, for sozinibercept for the treatment of wet AMD and DME prior to the termination of our clinical program for sozinibercept. R&D expenses also include:
We expense R&D costs as incurred and have not capitalized any amounts of R&D costs as of June 30, 2024 and 2025. In the years ended June 30, 2023, 2024 and 2025, we have made payments for R&D activities that have been provided by our CROs for use in R&D activities.
Our direct R&D expenses are tracked on a program-by-program basis for our product candidate and consist primarily of R&D employee-based benefits, external costs, such as fees paid to CROs, CDMOs, research laboratories and outside consultants in connection with our process development, manufacturing and clinical development activities. We do not allocate laboratory supplies and facilities, including depreciation and other indirect costs, to specific programs because these costs are deployed across multiple development activities and indications for sozinibercept prior to the termination of the clinical program and, as such, are not separately classified. We use internal resources primarily to conduct our research activities as well as for managing our process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track these costs by program.
R&D expenses in fiscal years after June 30, 2025 are expected to decline as we have terminated our clinical program for sozinibercept and we will be in early stages of strategic review to reformulate our drug portfolio for clinical development. Product candidates in later stages of clinical development, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
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At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of clinical trials and development of any future product candidates will depend on a variety of factors, including:
A change in the outcome of any of these factors with respect to the development of any future product candidate could significantly change the duration, costs and timing associated with clinical trials and development of any future product candidate.
Patent and Intellectual Property Expenses. Patent and Intellectual Property expenses comprise the cost of outside patent attorneys to manage and prosecute our patent portfolio.- license and patent assignment costs in respect of our in-license agreements for certain technologies not currently under development and unrelated to our out-licensing arrangements under which we receive sales-based royalties.
Administrative Expenses. Administrative expenses comprise employee benefit expenses, including share-based payment expenses; investor relations expenses; insurance costs; audit, accountancy and legal fees; other personnel-related expenses; and depreciation expense. We anticipate that our administrative expenses will decline in the future as we have decreased our headcount following termination of our clinical program for sozinibercept.
Occupancy Expenses. Occupancy expenses represent the costs relating to our headquarters in Melbourne, Australia, including lease maintenance and incidental costs.
Finance Income – Interest income
Finance income primarily comprises of income from interest on bank deposits.
Net Foreign Exchange Gain (Loss)
Net foreign exchange gain (loss) represents the impact of the variance in exchange rates between the U.S. dollar and the Australian dollar, Euro, British Pound and Canadian dollar on our cash and cash equivalents, financial assets, financial liabilities and foreign currency denominated transactions.
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Income Tax Benefit
Income tax benefit represents the cash incentive amount receivable under the R&D Tax Incentive Scheme, an Australian Federal Government program under which eligible companies with annual aggregated revenue of less than A$20.0 million can receive cash amounts equal to 43.5% of eligible R&D expenditures from the Australian Taxation Office, or the ATO. The ATO may also make other changes to the eligibility of R&D expenditures, including placing a cap on the amount of non-clinical trial R&D expenses claimed under the scheme.
The R&D Tax Incentive Scheme incentive relates to eligible expenditures incurred in Australia and, under certain circumstances, in other countries in connection with the development of sozinibercept. The R&D tax incentive is applied annually to eligible expenditures incurred during the fiscal year following an annual application and subsequent filing of our income tax return subsequent to fiscal year end. We estimate the amount of R&D tax incentive after the completion of a fiscal year based on eligible Australia and overseas expenditures incurred during that year. We expect to continue applying for the R&D tax incentive as we further develop any future product candidate. In particular, if we are successful in our reformulation of one of our drug candidates targeting VEGF-C and/or VEGF-D we intend to apply for the costs expected to be incurred in Australia related to our clinical trials for any future product candidate to be eligible for the R&D tax incentive for future fiscal years once incurred. However, there can be no assurance that the ATO will allow these costs to be eligible for the tax incentive.
Results of Operations for the Fiscal Years Ended June 30, 2023, 2024 and 2025
The following table sets forth a summary of our consolidated statement of profit or loss and other comprehensive income for the periods presented.
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$ |
|
|
US$ |
|
|
US$ |
|
|||
|
|
(in thousands) |
|
|||||||||
Revenue |
|
|
25 |
|
|
|
125 |
|
|
|
108 |
|
Other income |
|
|
121 |
|
|
|
137 |
|
|
|
277 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|||
Research and development expenses (included amounts owed by related parties $10,021 (2024:$3,042, 2023: $900)) |
|
|
(126,832 |
) |
|
|
(176,326 |
) |
|
|
(128,829 |
) |
Administrative expenses (included amounts paid to related parties $275 (2024:$nil, 2023 $nil)) |
|
|
(29,076 |
) |
|
|
(15,778 |
) |
|
|
(21,582 |
) |
Total Operating expenses |
|
|
(155,908 |
) |
|
|
(192,104 |
) |
|
|
(150,411 |
) |
Operating loss |
|
|
(155,762 |
) |
|
|
(191,842 |
) |
|
|
(150,026 |
) |
Finance income |
|
|
5,532 |
|
|
|
3,395 |
|
|
|
3,228 |
|
Interest expense on DFA (includes amounts to related parties $32,792 (2024:$24,699, 2023:$13,462)) |
|
|
(46,457 |
) |
|
|
(30,263 |
) |
|
|
(13,462 |
) |
Gain on remeasurement of financial liability - DFA |
|
|
— |
|
|
|
387 |
|
|
|
12,302 |
|
Fair value gain/(loss) on derivative - investor options |
|
|
28,283 |
|
|
|
(11,224 |
) |
|
|
— |
|
Net foreign exchange loss |
|
|
(1,334 |
) |
|
|
(107 |
) |
|
|
(489 |
) |
Loss before income tax |
|
|
(169,738 |
) |
|
|
(229,654 |
) |
|
|
(148,447 |
) |
Income tax benefit |
|
|
6,947 |
|
|
|
9,412 |
|
|
|
5,926 |
|
Loss for the year |
|
|
(162,791 |
) |
|
|
(220,242 |
) |
|
|
(142,521 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|||
Other comprehensive income for the period, net of tax |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total comprehensive loss for the year |
|
|
(162,791 |
) |
|
|
(220,242 |
) |
|
|
(142,521 |
) |
Revenue
Revenue was US$25 thousand for the fiscal year ended June 30, 2025, compared to US$125 thousand for the fiscal year ended June 30, 2024. This decrease was due to lower sales-based royalties received under our out-licensing arrangements. Revenue for the years ended June 30, 2025 and 2024 consisted of sales-based royalties in connection with the out-licensing of certain intellectual property assets that are unrelated to our core business and the development of sozinibercept which are not currently under development following termination of our clinical program.
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Revenue was US$125 thousand for the fiscal year ended June 30, 2024, compared to US$108 thousand for the fiscal year ended June 30, 2023. This increase was due to higher sales-based royalties received under our out-licensing arrangements. Revenue for the years ended June 30, 2024 and 2023 consisted of sales-based royalties in connection with the out-licensing of certain intellectual property assets that are unrelated to our core business and the development of sozinibercept which are not currently under development.
Other Income
Other income was US$121 thousand for the fiscal year ended June 30, 2025, compared to US$137 thousand for the fiscal year ended June 30, 2024.
Other income was US$137 thousand for the fiscal year ended June 30, 2024, compared to US$277 thousand for the fiscal year ended June 30, 2023.
Research and Development Expenses
Research and development expenses were US$126.8 million for the fiscal year ended June 30, 2025, compared to US$176.3 million for the fiscal year ended June 30, 2024. This decrease was primarily due to termination costs relating to our Phase 3 clinical trial of sozinibercept, as a result of the discontinuation of the development program for sozinibercept in March 2025 following our Phase 3 clinical program and primary endpoints not being met in both our COAST and ShORe clinical trials, compared to the costs incurred during the fiscal year ended June 30, 2024.
Research and development expenses were US$176.3 million for the fiscal year ended June 30, 2024, compared to US$128.8 million for the fiscal year ended June 30, 2023. This increase was primarily due to costs relating to our Phase 3 clinical trial of sozinibercept in combination with anti-VEGF-A therapy for the treatment of wet AMD, particularly with the completion of enrollment of the global Phase 3 trials, the expansion of our clinical team, and chemistry, manufacturing and controls costs incurred during the fiscal year ended June 30, 2024 relative to costs incurred during the fiscal year ended June 30, 2023.
Our research and development expenses are broken down as set forth in the table below.
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$ |
|
|
US$ |
|
|
US$ |
|
|||
|
|
(in thousands) |
|
|
(in thousands) |
|
|
(in thousands) |
|
|||
Costs related to the ShORe Phase 3 clinical trial of sozinibercept in wet AMD |
|
|
47,733 |
|
|
|
77,788 |
|
|
|
59,472 |
|
Costs related to the COAST Phase 3 clinical trial of sozinibercept in wet AMD |
|
|
43,703 |
|
|
|
69,947 |
|
|
|
50,544 |
|
Costs related to the Phase 2b clinical trial of sozinibercept in wet AMD |
|
|
— |
|
|
|
— |
|
|
|
18 |
|
Costs related to the Phase 1b/2a clinical trial of sozinibercept in DME |
|
|
— |
|
|
|
— |
|
|
|
18 |
|
Chemistry manufacturing and controls |
|
|
13,017 |
|
|
|
19,394 |
|
|
|
12,062 |
|
Other direct non-clinical expenses |
|
|
22,379 |
|
|
|
9,197 |
|
|
|
6,715 |
|
Total research and development expenses |
|
|
126,832 |
|
|
|
176,326 |
|
|
|
128,829 |
|
Administrative Expenses
Administrative expenses were US$29.1 million for the fiscal year ended June 30, 2025, compared to US$15.8 million for the year ended June 30, 2024. This increase was primarily due to US$7.8 million in employee benefits that were incurred in fiscal year ended June 30, 2025 due to expansion of our headcount through to March 2025 and then the termination costs following our reduction in workforce following the failure to reach the primary endpoints in our two clinical trials and an increase of US$5.1 million for legal costs, consultancy and other costs in fiscal year ended June 30, 2025 resulting from the increased work to close out the clinical trials and all associated contracts.
Administrative expenses were US$15.8 million for the fiscal year ended June 30, 2024, compared to US$21.6 million for the year ended June 30, 2023. This decrease was primarily due to US$5.7 million in professional and
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advisory fees that were incurred in fiscal year ended June 30, 2023 and a decrease of US$1.2 million for insurance and consultancy costs in fiscal year ended June 30, 2024 offset by an US$1.1 million increase in personnel-related expenses, resulting from increased headcount as we built out the US management team in the fiscal year ended June 30, 2024.
Interest expense on DFA
Interest expense on the DFA was US$46.5 million for the fiscal year ended June 30, 2025, compared to US$30.3 million for the fiscal year ended June 30, 2024. This increase was due to the accretion of the financial liability recognized upon the receipt of payments under the DFA. The interest expense is a non-cash item.
Interest expense on the DFA was US$30.3 million for the fiscal year ended June 30, 2024, compared to US$13.5 million for the fiscal year ended June 30, 2023. This increase was due to the accretion of the financial liability recognized upon the receipt of payments under the DFA. The interest expense is a non-cash item.
Gain on remeasurement of financial liability - DFA
There was a US$nil million gain on remeasurement of the DFA for the fiscal year ended June 30, 2025, compared to US$0.4 million for the fiscal year ended June 30, 2024. The small gain in fiscal year ended June 30, 2024 was due to a remeasurement of the financial liability as a result of the additional $50.0 million option funding above the original committed funding under the DFA and Amended and Restated DFA. The gain on remeasurement on the DFA is a non-cash item.
There was a US$0.4 million gain on remeasurement of the DFA for the fiscal year ended June 30, 2024, compared to US$12.3 million for the fiscal year ended June 30, 2023. The small gain in fiscal year ended June 30, 2024 was due to a remeasurement of the financial liability as a result of the additional $50.0 million option funding above the original committed funding under the DFA and Amended and Restated DFA. The gain on remeasurement on the DFA is a non-cash item.
Fair value loss on investor options
There was a US$28.3 million fair value gain on investor options for the fiscal year ended June 30, 2025, compared to US$11.2 million loss for the fiscal year ended June 30, 2024. This gain was due to the fair value market assessment made by management at year end due to the current suspension in trading. The fair value adjustment on investor options is a non-cash item.
There was a US$11.2 million fair value loss on investor options for the fiscal year ended June 30, 2024, compared to US$nil loss for the fiscal year ended June 30, 2023. This increase was due to the new issues of options in the current financial year. The fair value adjustment on investor options is a non-cash item
Equity and Investor Options - 2024
On June 14, 2024, the Company offered approximately 139.5 million new shares at the offer price of A$0.40 per new share and approximately 46.5 million new options to eligible shareholders with an exercise price of A$1.00 on the basis of 1 new option for every 3 new shares issued under the retail offer of the 2024 ANREO; and approximately 142.9 million institutional and placement options with an exercise price of A$1.00 to participants in the placement and institutional offer of the 2024 ANREO on the basis of 1 Institutional option for every 3 new shares issued under the Placement (“2024 Investor Options”). Pursuant to the 2024 ANREO, the company raised gross proceeds of A$227.3 million. Each 2024 Investor Option entitles the holder to one ordinary share of the company.
Equity and Investor Options -2023
On August 28, 2023, the Company offered approximately 35.4 million new shares at the offer price of A$0.46 per new share and approximately 18.0 million new options to eligible shareholders with an exercise price of A$0.80 on the basis of 1 new option for every 2 new shares issued under the retail offer of the 2023 ANREO; and approximately 80.0 million institutional and placement options with an exercise price of A$0.80 to participants in the placement and institutional offer of the 2023 ANREO on the basis of 1 Institutional option for every 2 new
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shares issued under the Placement (“2023 Investor Options”). Pursuant to the 2023 ANREO, the company raised gross proceeds of A$90 million. Each Option entitles the holder to one ordinary share of the company.
Considering that the 2023 Investor Options are traded on the Australian Stock Exchange, we use the quoted price at the balance sheet date as the fair value of the options. The 2024 Investor Options are traded on the Australian Stock Exchange, we use the quoted price at the balance sheet date as the fair value of the options. At June 30, 2025 management assessed the fair value of the Investor options at US$nil due to the current trading suspension.
Net Foreign Exchange Loss
Net foreign exchange differences were a loss of US$1.3 million for the fiscal year ended June 30, 2025, compared to a loss of US$0.1 million for the fiscal year ended June 30, 2024. The increase was primarily the result of net variances of the exchange rate between the Australian dollar and U.S. dollar on Australian dollar-denominated cash and cash equivalents, financial assets, financial liabilities and foreign currency denominated transactions.
Net foreign exchange differences were a loss of US$0.1 million for the fiscal year ended June 30, 2024, compared to a loss of US$0.5 million for the fiscal year ended June 30, 2023. The decrease was primarily the result of net variances of the exchange rate between the Australian dollar and U.S. dollar on Australian dollar-denominated cash and cash equivalents, financial assets, financial liabilities and foreign currency denominated transactions
Income Tax Benefit
Income tax benefit was US$6.9 million for the fiscal year ended June 30, 2025, compared to US$9.4 million for the fiscal year ended June 30, 2024. This decrease was due to lower R&D tax incentive receivable recognized during the fiscal year ended June 30, 2025 based on eligible spend.
Income tax benefit was US$9.4 million for the fiscal year ended June 30, 2024, compared to US$5.9 million for the fiscal year ended June 30, 2023. This increase was due to higher R&D tax incentive receivable recognized during the fiscal year ended June 30, 2024 based on eligible spend.
5B. Liquidity and Capital Resources
The liquidity and capital resources discussion that follows contains certain estimates as of the date of this annual report of our estimated future sources and uses of liquidity (including estimated future capital resources and capital expenditures) and future financial and operating results. These estimates reflect numerous assumptions made by us with respect to industry performance, general business, economic, regulatory, market and financial conditions and other future events, and matters specific to our businesses, all of which are difficult or impossible to predict and many of which are beyond our control.
Sources and Uses of Liquidity
Our operations relating to the development of sozinibercept have been financed primarily through the issuance and sale of new ordinary shares totaling US$408.6 million in the five years ended June 30, 2025. We have also received an aggregate of US$170.0 million in the five years ended June 30, 2025, under the Development Funding Agreement, pursuant to which the DFA Investor agreed to provide funding to support our development of sozinibercept for the treatment of wet AMD. We have also received an aggregate of US$33.8 million (A$48.7 million) in the five fiscal years ended June 30, 2025, under the R&D Tax Incentive Scheme for the funding of the development and clinical trials of sozinibercept.
As of June 30, 2025, we had cash and cash equivalents of US$48.4 million, and we had an accumulated loss of US$742.5 million.
Funding Requirements
Following the DFA Settlement, as of August 20, 2025 we have $20 million in cash on hand. We have no other committed external source of funds. We expect to continue to spend significant resources to fund our
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strategic review, including research and development of, and seeking regulatory approvals for, other future product candidates. We expect that our current cash balance will be sufficient to fund our operations into the fourth calendar quarter of 2026, which includes completion of the strategic review process. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect, requiring us to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. The estimate is also dependent on whether the reformulation process is successful and the nature and size of clinical trials to be conducted in the future. The various ways we could raise additional capital carry potential risks. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all.
Due to uncertainties regarding our future operations following the strategic review, and the potential for future clinical trials to assess the efficacy of our drug candidates in other disorders, we may need to raise additional capital, the timing and amount of which is unknown at this time. If any potential product candidate is approved for commercial sale, our commercialization expenses will increase significantly as we seek a commercialization partner or establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure.
Conducting research and development and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, any future product candidate, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of any future product candidate that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. For more information as to the risks associated with our future funding needs, see “Item 3D—Risk Factors—Risks Related to Our Financial Position and Need for Capital.”
Until we can generate a sufficient amount of revenue from the sale of approved products, if ever, we expect to finance our operating activities through our existing liquidity, including future financing activities, including a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our equity holders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect your rights as a holder of ADSs. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, intellectual property, future revenue streams or product candidates. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We have in the past experienced delays in our research and development and our clinical trials, including the establishment of trial sites and patient recruitment delays, and incurred significantly increased costs in connection with the activities conducted by third-parties that assist us with clinical development, including CROs, CDMOs and other service providers to prepare for and progress our clinical trials. We may also experience further delays in our clinical development of commercialization of any future product candidate, including due to factors and conditions set forth above or other factors that we cannot presently anticipate. Our present and future funding requirements, both short and long-term will depend on many factors, including, among other things:
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Development Funding Agreement
On August 12, 2022, we entered into a Development Funding Agreement (as amended and restated, the “Funding Agreement” or “DFA”) with Ocelot SPV LP ("Ocelot"), an affiliate of Carlyle and Abingworth, in collaboration with Carlyle and Abingworth’s recently formed development company Launch Therapeutics (“Launch Tx”), pursuant to which Ocelot agreed to provide funding to support our development of sozinibercept for the treatment of wet AMD. On December 22, 2023, we entered into an Amended and Restated Development Funding Agreement with Ocelot as collateral agent, pursuant to which a new co-Investor (collectively with Ocelot, “DFA Investors”) provided an additional US$50.0 million in funding, bringing the total funding received under the Funding Agreement to US$170.0 million, the maximum amount under the terms of the Funding Agreement.
Pursuant to the Funding Agreement, we were required to use commercially reasonable efforts to develop sozinibercept for the treatment of wet AMD in accordance with the Funding Agreement, including pursuant to certain development timelines set forth therein
In return, Opthea was to pay to the DFA Investors (1) upon the first to occur of regulatory approval of sozinibercept for the treatment of wet AMD in the United States, United Kingdom or European Union (“Regulatory Approval”), fixed payments equal to a total of approximately two times the funding provided, consisting of seven payments, with the first payment due within 90 days after Regulatory Approval and the remaining six payments payable over a six-year period thereafter, and (2) variable payments equal to 7% of net sales of sozinibercept for the treatment of wet AMD for each calendar quarter.
At the time that the DFA Investors receive an aggregate of four times the funding provided (US$680.0 million as the DFA Investors have funded the full US$170.0 million under the Funding Agreement) (the “Cap”), Opthea’s payment obligations under the Funding Agreement were to be fully satisfied.
We granted the DFA Investors a security interest in all of our assets (other than intellectual property not related to sozinibercept). The security interest was to terminate when the DFA Investors receive payments and/or change of control acceleration payments equal to two times the funding provided or upon certain terminations of the Funding Agreement (the “Release Date”). The Funding Agreement also included customary representations and warranties and covenants, including certain negative covenants regarding limitations on incurrence of indebtedness, liens, investments, restricted payments, sales of assets, and royalty sales. The negative covenants will terminate upon the Release Date.
In certain instances, upon the termination of the Funding Agreement, we were obligated to pay the DFA Investors a multiple, which may vary based on the termination event of the amounts paid to us under the Funding Agreement, including specifically,
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In addition, if following certain events of termination of the Funding Agreement, Opthea continues to develop sozinibercept for the treatment of wet AMD and obtains Regulatory Approval, it was to make the payments to the DFA Investors as if the Funding Agreement had not been terminated, less any payments made upon termination.
In March 2025, after the primary endpoints were not met in our COAST and ShORe Phase 3 trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD, and agreed that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea to the DFA Investors. On August 19, 2025, we reached a binding agreement with the DFA Investors to terminate the DFA, pursuant to which the DFA Investors received a cash payment of US$20 million and 136,661,003 ordinary shares, equal to 9.99% of our then outstanding issued share capital on a fully diluted basis. Upon receipt of the cash payment and ordinary shares, the DFA Investors agreed to release all liens on the collateral and terminate the DFA (these transactions are referred to as the “DFA Settlement”).
Cash Flows
The following table summarizes our cash flows for the periods presented:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$ |
|
|
US$ |
|
|
US$ |
|
|||
|
|
(in thousands) |
|
|||||||||
Net cash used in operating activities |
|
|
(158,644 |
) |
|
|
(161,015 |
) |
|
|
(120,608 |
) |
Net cash provided by investing activities |
|
|
(13 |
) |
|
|
(33 |
) |
|
|
(22 |
) |
Net cash provided by financing activities |
|
|
34,767 |
|
|
|
243,729 |
|
|
|
167,285 |
|
Net increase/(decrease) in cash and cash equivalents |
|
|
(123,890 |
) |
|
|
82,681 |
|
|
|
46,655 |
|
Operating Activities
For the year ended June 30, 2025, net cash used in operating activities was US$158.6 million, attributable to a net loss of US$162.8 million adjusted for US$18.8 million in non-cash items as well as a net cash outflow from changes in operating assets and liabilities of US$24.7 million, and inflow of a R&D tax incentive of US$10.4 million received. Non-cash adjustments of US$18.8 million consisted of add back of US$6.9 million in income tax benefit recognized in profit and loss and the fair value gain on investor options US$28.3 million offset by positive US$1.3 million in net exchange differences, US$6.1 million in share-based payments, US$46.5 million of non-cash interest expense on the DFA, write off of property, plant and equipment of US$50 thousand, US$91 thousand in depreciation expense and US$3 thousand of net loss on disposal of non-current assets.
For the year ended June 30, 2024, net cash used in operating activities was US$161.0 million, attributable to a net loss of US$220.2 million adjusted for US$36.9 million in non-cash items as well as a net cash inflow from changes in operating assets and liabilities of US$17.3 million, and inflow of a R&D tax incentive of US$5.9 million received. Non-cash adjustments of US$36.9 million consisted of add back of US$9.4 million in income tax benefit recognized in profit and loss and the remeasurement gain on the DFA of US$0.4 million offset by positive US$0.1 million in net exchange differences, fair value loss add back on the investor options of US$11.2 million, US$5.1 million in share-based payments, US$30.3 million of non-cash interest expense on the DFA and US$103 thousand in depreciation expense.
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For the year ended June 30, 2023, net cash used in operating activities was US$120.6 million, attributable to a net loss of US$142.5 million adjusted for US$1.7 million in non-cash items as well as a net cash inflow from changes in operating assets and liabilities of US$13.9 million, and inflow of a R&D tax incentive of US$6.3 million received. Non-cash adjustments of US$1.7 million consisted of US$5.9 million in income tax benefit recognized in profit or loss and the gain on remeasurement of the DFA of US$12.3 million offset by US$0.5 million in net exchange differences, US$5.8 million in share-based payments, US$13.5 million of non-cash interest expense on the DFA and US$101 thousand in depreciation expense.
Investing Activities
For the years ended June 30, 2023, 2024 and 2025, net cash provided by investing activities was cash outflow of US$22 thousand, US$33 thousand and US$13 thousand, respectively, attributable to cash payments for the purchase of computer equipment.
Financing Activities
For the year ended June 30, 2025, net cash provided by financing activities was US$34.8 million, attributable to $34.8 million from capital entitlement raise and US$31 thousand from exercise of options under LTIP and US$20 thousand from exercise of investor options. Net cash provided by financing activities also included US$93 thousand in respect of the payment of lease liabilities.
For the year ended June 30, 2024, net cash provided by financing activities was US$243.7 million, attributable to $158.8 million from capital placement, and US$85.0 million under the Development Funding agreement. Net cash provided by financing activities also included US$89 thousand in respect of the payment of lease liabilities.
For the year ended June 30, 2023, net cash provided by financing activities was US$167.3 million, attributable to $81.8 million from capital placement, US$1.0 million received on the exercise of options granted to employees and US$84.5 million under the Development Funding agreement. Net cash provided by financing activities also included US$71 thousand in respect of the payment of lease liabilities.
5C. 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 5A—Operating Results – Results of Operations.”
For a description of our research and development process, see “Item 4B—Business Overview.”
5D. Trend Information
For a discussion of trends, see “Item 4B—Business Overview,” “Item 5A—Operating Results” and “Item 5B—Liquidity and Capital Resources.”
5E. Critical Accounting Estimates
Critical Accounting Estimates
We believe that the following accounting policies involve a high degree of estimation and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our consolidated financial condition and results of our operations. See note 3 to our consolidated financial statements appearing elsewhere in this annual report for a description of our other significant accounting policies. The preparation of our consolidated financial statements in conformity with IFRS requires us to make estimates and judgments that affect the amounts reported in those financial statements and accompanying notes. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making those estimates, actual results reported in future periods could differ from those estimates.
Development Funding - Financial liability
The Group evaluated the Funding Agreement and determined it to be a research and development funding
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arrangement with the characteristics of a debt instrument, as the transfer of financial risk to DFA Investors was not considered substantive and genuine.
Accordingly, the Group has recorded payments received under the Funding Agreement as part of a development financing liability in its consolidated balance sheet. The Group measures the overall development financing liability at amortized cost which is the amount at which the financial liability is measured at initial recognition minus principal repayments, plus or minus the cumulative amortization using the effective interest method of any difference between the initial amount and the maturity amount. The financial liability is based on contractual cash flows which includes estimated timing of regulatory approval and attainment of certain sales milestones and the contractual success fee payments expected to be due therefrom, as discounted using an imputed interest rate. The development financing liability will be accreted as interest expense to its expected future repayment amount over the expected life of the agreement using the effective interest rate method.
At each reporting date, the Group reassess the contractual cash flows based on the estimated timing of regulatory approval and attainment of sales milestones and the expected fixed and variable contractual success fee payments due therefrom. If the timing and/or amount of such expected payments is materially different from the estimates used on the initial recognition date, the Group will adjust the accretion of the development financing liability using the previously determined imputed interest rate.
At June 30, 2023 the Group performed a remeasurement of the carrying amount of the Financial Liability. The expected timeline for approval and commercial launch have been delayed by twelve months, thus extending date of expected repayments. As the Group has more time to repay the amounts owed, the carrying value of the Financial Liability at June 30, 2023 was adjusted downward to reflect this delay. The remeasurement resulted in a non‑cash gain on revaluation of $12.3 million. This change is recorded on the Profit or Loss statement as a gain on remeasurement of financial liability.
At June 30, 2024 the Group performed a remeasurement of the carrying amount of the Financial Liability. The expected timeline for approval and commercial launch have been delayed, thus extending date of expected repayments. As the Group has more time to repay the amounts owed, the carrying value of the Financial Liability at June 30, 2024 was adjusted downward to reflect this delay. The remeasurement resulted in a non‑cash gain on revaluation of $0.4 million. This change is recorded on the Profit or Loss statement as a gain on remeasurement of financial liability.
Following the phase 3 trial results not meeting their primary endpoint, the Group in consultation with the DFA investors agreed to discontinue the development of sozinibercept in wet AMD with immediate effect and agreed that this decision did not constitute a termination event under the DFA under sections 13.4.2 Termination for Fundamental Material Breach, 13.4.3 Termination for Material Breach, 13.4.8 Termination for Safety Concerns or 13.4.10 Termination for JSC Decision. Following the termination of the sozinibercept wet AMD program, the Company reduced its work force, exited all contracts related to the clinical trials and commenced active discussions with the DFA Investors on a potential settlement of the DFA agreement. These settlement discussions were ongoing at June 30, 2025.
At June 30, 2025, the DFA Investors had right to terminate the agreement in the event of development product failure. Section 13.4.5.2 Development Product Failure of the DFA does not contemplate the obligations of the Group where the agreement is terminated following negative trial results achieved and the Group does not elect to continue development of the product where the primary endpoint in such trial is not achieved. The Group exercised significant judgment in the estimation of the DFA obligation at June 30, 2025 and evaluated that, in the absence of a termination event, the contractual obligation of the Group in terms of the DFA were not discharged, cancelled or modified at June 30, 2025. Accordingly, the Group continued to account for the development funding liability at amortized cost being the funds invested of US$170 million and interest accreted at the original interest rate of approximately 23%, which reflects the estimated return on the instrument. The Group considered this to be the best estimate of the contractual obligation in the absence of the specific terms in the DFA of the amounts repayable where the primary endpoint in such trial is not achieved. Although the DFA Investors have not called a termination event, the right to terminate under section 13.4.5.2 Development Product Failure remained with the Investors at June 30, 2025 and therefore the Group did not have a right to defer settlement of the liability for at least 12 months after the reporting period. The liability was reclassified from non‑current to current as of June 30, 2025.
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Derivative Financial Liability - Investor options
The Group accounts for investor options as a derivative financial liability. Such derivatives are measured at fair value with subsequent changes in fair value accounted for through profit and loss. For the investor options that are traded on the Australian Securities Exchange, the Group use the quoted price at the balance sheet date as the fair value of the options. For the investor options issued on June 14, 2024, fair values were determined internally using Binomial models as a quoted price was not available as at year end. Key inputs to the valuation include the share price at grant date, expected term, volatility, dividend yield, risk free rate and exercise price. Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects of non‑transferability, exercise restrictions (including the probability of meeting market conditions attached to the option), and behavioral considerations. Expected volatility is based on the historical share price volatility over the past two years. These investor options were listed for trading on the Australian Securities Exchange in July 2024. Should the quoted price differ from the internally determined fair value, this could have a material impact on the amounts recognized in derivative financial liabilities and in the profit and loss. At June 30, 2025 the Group determined that a fair value of $nil was to apply due to current trading suspension.
Share-based Payment Transactions
We provide benefits to our directors and employees (including key management personnel) in the form of share-based payments, whereby employees render services in exchange for ordinary shares or rights over ordinary shares (equity-settled transactions). The cost of these equity-settled transactions with employees is measured by reference to the fair value at the date at which they are granted. Binomial, Black Scholes or Monte Carlo models are used to value the options issued, with key assumptions being the listed price per ordinary share on the grant date, the option exercise price, expected volatility of the underlying ordinary shares based on the historical share price volatility and the risk-free interest rate.
The cost of the equity-settled transactions is recognized, together with a corresponding increase in equity, over the period in which the performance conditions are fulfilled (the vesting period), ending on the date on which the relevant employees become fully entitled to the award (the vesting date). The charge to profit or loss for the period is the cumulative amount less the amounts already charged in previous periods. There is a corresponding credit to equity.
Until an award has vested, any amounts recorded are contingent and will be adjusted if more or fewer awards vest than were originally anticipated to do so. Should one or more of the assumptions and estimates used in estimating the fair value of share‑based payments change, this could have a material impact on the amounts recognized in equity and employee‑related expenses.
Recently Adopted Accounting Pronouncements relating to the Financial Statements
Amendments to Accounting Standards that are Mandatorily Effective for the Current Year
We have adopted all of the new and revised Standards and Interpretations issued by the IASB that are relevant to our operations and effective for the current year.
During the fiscal year ended June 30, 2025, we applied a number of amendments to IFRS and Interpretations issued by the IASB that are effective for an annual period that begins on or after January 1, 2023. Their adoption has not had any material impact on the disclosures or on the amounts reported in our consolidated financial statements.
New and Revised International Financial Reporting Standards and Interpretations on Issue But not Yet Effective
The new and revised International Financial Reporting Standards, Interpretations and amendments that have been issued but are not yet effective, are not expected to have a material impact on the amounts recognized or disclosures included in our consolidated financial statements.
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Qualitative and Quantitative Disclosures about Market Risk
We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in interest rates and foreign currency exchange rate risk.
Interest Rate Risk
As of June 30, 2025, we had cash and cash equivalents of US$48.4 million, including US$34.4 million in short term deposit accounts. We have limited exposure to interest rate risk. Our exposure to market interest rates relates primarily to the short-term deposits. The deposits are held with two of Australia’s largest banks. Our cash and cash equivalents are not locked into long-term deposits at fixed rates so as to mitigate the risk of earning interest below the current floating rate. We do not have any credit facilities bearing variable interest rates.
Foreign Currency Exchange Rate Risk
As a result of services provided by non-related entities in the United States, Canada, United Kingdom and Europe, part of our financial assets and liabilities and foreign currency denominated transactions are affected by movements in the applicable exchange rate. We do not enter into any hedging transactions. We enter into forward rate foreign exchange rate contracts in respect of the settlement of supplier invoices denominated in U.S. dollars to mitigate the risk of movements in the Australian dollar and U.S dollar exchange rates. As of June 30, 2025 and June 30, 2024, we had US$10.8 million and US$141.4 million, respectively, in net exposure to the Australian dollar and U.S. dollar, primarily in payables and cash. An increase or decrease of the Australian dollar to U.S. dollar exchange rate by 10% would increase our after-tax loss by US$299 thousand (2024: US$9.0 million) or decrease our after tax loss by US$365 thousand (2024: US$11 million), respectively. As we continue our development activities, we expect to face continued exposure to exchange rate risk from the U.S. dollar. There was minimal or insignificant exposure to the British Pound, Euro and Canadian dollar during the years ended June 30, 2024 and 2025.
Emerging Growth Company Status
As a company with less than US$1.235 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:
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We may take advantage of these exemptions until such time that we are no longer an emerging growth company. Accordingly, the information that we provide shareholders and holders of the ADSs may be different than you might obtain from other public companies. We will cease to be an emerging growth company upon the earliest to occur of (i) the last day of the fiscal year in which we have more than US$1.235 billion in annual revenue; (ii) the last day of the fiscal year in which we qualify as a “large accelerated filer”; (iii) the date on which we have, during the previous three-year period, issued more than US$1.0 billion in non-convertible debt securities; and (iv) June 30, 2026.
Foreign Private Issuer Status
We are also considered a “foreign private issuer” under U.S. securities laws. In our capacity as a foreign private issuer, we are exempt from certain rules under the Securities Exchange Act of 1934, as amended, that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our senior management, the members of our board of directors and our principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.
We may take advantage of these exemptions until such time as we are no longer a foreign private issuer. We will remain a foreign private issuer until such time that 50% or more of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (i) the majority of the members of board of directors or our senior management are U.S. citizens or residents; (ii) more than 50% of our assets are located in the United States; or (iii) our business is administered principally in the United States.
We have taken advantage of certain reduced reporting and other requirements in this annual report. Accordingly, the information contained herein may be different from the information you receive from other public companies.
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Item 6. Directors, Senior Management and Employees
6A. Directors and Senior Management
The following table sets forth information relating to our directors, senior management and key employees as of June 30, 2025.
Name |
|
|
Age |
|
|
Position |
Senior Management and Key Employees |
|
|
|
|
|
|
Fred Guerard (1) |
|
|
53 |
|
|
Chief Executive Officer |
Megan Baldwin, Ph.D.(2) |
|
|
50 |
|
|
Chief Innovation Officer and Founder |
Thomas Reilly (3) |
|
|
53 |
|
|
Chief Financial Officer |
Peter Lang (1) |
|
|
53 |
|
|
Former Chief Financial Officer |
Karen Adams |
|
|
54 |
|
|
Vice President Finance and Company Secretary |
Judith Robertson (4) |
|
|
65 |
|
|
Chief Commercial Officer |
Parisa Zamiri (5) |
|
|
60 |
|
|
Chief Medical Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Employee Directors |
|
|
|
|
|
|
Julia Haller, M.D. (6) |
|
|
70 |
|
|
Director |
Jeremy Levin, D.Phil, MB BChir (6) |
|
|
71 |
|
|
Chairperson |
Lawrence Gozlan |
|
|
46 |
|
|
Director |
Sujal Shah (6) |
|
|
52 |
|
|
Director |
Susan Orr(6) |
|
|
63 |
|
|
Director |
Anshul Thakral (6) |
|
|
47 |
|
|
Director |
Kathy Connell |
|
|
58 |
|
|
Director |
Quinton Oswald (6) |
|
|
74 |
|
|
Director |
(1) Dr. Guerard and Mr. Lang were appointed October 27, 2023, Mr. Lang, the Company's former Chief Financial Officer was terminated September 5, 2024. Dr. Guerard departed from the Company on September 1, 2025
(2) Dr. Baldwin resigned as Chief Innovation Officer and Founder, on July 1, 2025 and as Executive Director on November 15, 2024.
(3) Mr. Reilly was appointed October 28, 2024 and will be departing from the Company on September 15, 2025.
(4) Judith Robertson resigned on September 9, 2024.
(5) Parisa Zamiri was appointed October 4, 2024 and resigned on July 15, 2025.
(6) Susan Orr, Anshul Thakral, Julia Haller, and Quinton Oswald resigned as a director in June 2025. Sujal Shah will be resigning as a director effective September 15, 2025. Jeremy Levin is acting as Chief Executive effective September 1, 2025.
The business addresses for our senior management and board of directors is Opthea Limited, C/- Prime Company Compliance, Level 9, 505 Little Collins Street, Melbourne, VIC 3000, Australia.
Senior Management and Key Employees
Frederic Guerard, PharmD, MS served as our Chief Executive Officer from October 2023 until September 1, 2025. Dr. Guerard’s career in the pharmaceutical industry spans over 25 years and includes multiple leadership, strategic and commercial roles. Dr.Guerard served as the Chief Executive Officer of Graybug Vision, Inc., a clinical-stage pharmaceutical company developing potentially transformative therapies for ocular diseases. He led the clinical development of a late-stage wet AMD product candidate. Dr.Guerard led the merger of Graybug with CalciMedica, Inc. and remains a non-executive Board member of CalciMedica. Before Graybug, Dr.Guerard acted as the Worldwide Business Franchise Head of Ophthalmology at Novartis. In this role, he successfully led the integration of Novartis retina and Alcon Pharmaceuticals and accelerated the rejuvenation of the product pipeline through strategic acquisitions and licensing transactions in dry-eye, presbyopia, and inherited retinal diseases.
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Prior to this role, he served as Global Franchise Head of Pharmaceuticals at Alcon. He has also held multiple leadership positions at Novartis, including Head of United Kingdom and Ireland, Head and Country President of Australia and New Zealand, Head of Marketing and Sales for Emerging Growth Markets Region, Head and Country President Egypt, and Cluster Head North and West Africa. He has served on the Board of the Association of the British Pharmaceutical Industry (ABPI) and on the Board of Medicines Australia.
Megan Baldwin, Ph.D., served as our Founder, Chief Executive Officer and Executive Director since October 2023. From October 2023 until July 1, 2025, Dr. Baldwin served as our Founder and Chief Innovation Officer and from October 2023 until November 15, 2024, as Executive Director. Since joining our company in 2008, Dr. Baldwin has held various positions, including Head of Preclinical R&D from February 2009 to November 2012 and Chief Executive Officer of Opthea Pty Ltd., previously a wholly-owned subsidiary, from November 2012 to December 2015. Dr. Baldwin has over 20 years of experience focusing on angiogenesis and therapeutic strategies for ophthalmic and cancer indications. Prior to joining our company, Dr. Baldwin was employed at Genentech, Inc. (now a subsidiary of the Roche Group), a leader in the field of angiogenesis-based therapies for cancer and other diseases. Dr. Baldwin earned a Bachelor of Science with Honours and a Ph.D. in Medicine from the University of Melbourne. We believe that Dr. Baldwin’s business expertise and her daily insight into corporate matters as our Chief Innovation Officer qualified her to serve on our board of directors.
Thomas Reilly, has served as our Chief Financial Officer since October 2024 and will be departing from the Company on September 15, 2025. Mr. Reilly comes to Opthea with over 25 years of experience. He has held leadership roles at biopharmaceutical companies and well-recognized global and boutique investment banks. In addition, Mr. Reilly served as Chief Financial Officer and Head of Human Resources of Amarin Corporation, supporting the commercial expansion of the company's lead asset in cardiovascular disease. Mr. Reilly also served as Chief Financial Officer for Cara Therapeutics and Head of Finance for the Allergan General Medicines business supporting several commercial launches in neuroscience. Mr. Reilly spent 14 years with Novartis serving in roles of increasing responsibility, including Finance Head for the Oncology development unit, Chief Financial Officer for Novartis Pharma Austria, and Financial Controller for Novartis Pharmaceuticals US. He earned his bachelor's degree in finance from Manhattan College, an MBA in accounting from Seton Hall University, and is a certified public accountant.
Peter Lang, served as our Chief Financial Officer from October 2023 until September 2024. Mr. Lang comes to Opthea with over 25 years of experience delivering strategic, operational, and financial solutions, with deep expertise in the healthcare and biopharmaceutical sectors. He has held leadership roles at biopharmaceutical companies and well-recognized global and boutique investment banks. In addition, Mr. Lang has a long track record of working with management teams and boards to optimize companies’ growth plans, capital structures, and return on capital. Prior to joining Opthea, Mr. Lang served as the Chief Financial Officer of Aerie Pharmaceuticals, Inc., a fully integrated pharmaceutical company focused on the discovery, development, and commercialization of first-in-class ophthalmic therapies for the treatment of patients with eye diseases. He co-led the successful strategic and financial repositioning of Aerie, including reinvigorating its commercial glaucoma franchise, refocusing the R&D pipeline, and improving the financial and operation results of the Company, ultimately resulting in a ~$950 million cash acquisition of Aerie by Alcon AG. Before Aerie, Peter was Managing Director and Partner at Ridge Advisory, LLC, a boutique advisory and banking firm. Prior to his work at Ridge Advisory, Mr. Lang served in various leadership roles in the healthcare investment banking divisions of well-respected firms, including HSBC, Bank of America Merrill Lynch, UBS Investment Bank, and Leerink Partners.
Karen Adams, has served as our Vice President Finance since May 2021 and as our Company Secretary since June 2021. Prior to joining Opthea, Ms. Adams was the Chief Financial Officer of the Victor Smorgon Group, an investment management company, from December 2018 to May 2021. From February 2014 to August 2018, she served as the Director of Finance of Nexvet Biopharma Pty Ltd, a veterinary biologic therapeutics company. Karen holds a Graduate Degree in Business from Swinburne University and is a member of the Australian Society of Chartered Accountant, Graduate of Australian Institute of Company Directors and a Fellow of the Institute of Company Secretaries.
Judith Robertson served as our Chief Commercial Officer since January 1, 2022 until September 2024. Ms. Robertson served as a member of our board of directors from June 2021 to January 1, 2022. Since 2019, Ms. Robertson has served as a member of the board of directors of Durect Corporation, a biotechnology company. From December 2020 to April 2021, Ms. Robertson served as the Chief Commercial Officer of Eleusis Ltd. From December 2016 she served as the Chief Commercial Officer of Aerie Pharmaceuticals Inc., a publicly held biotechnology company. Prior to Aerie, Ms. Robertson was Vice President Immunology and Ophthalmology Global Commercial Strategy Leader at Johnson and Johnson, Janssen Pharmaceuticals, and Vice President,
100
Ophthalmology Global Business Franchise Head at Novartis (formerly Alcon). Ms. Robertson’s prior experience also includes sales and marketing roles at Novartis, Bristol Myers Squibb and Searle USA. Ms. Robertson received Bachelor of Arts from Ryerson University and a Master of Business Administration from Kellogg School of Management at Northwestern University.
Parisa Zamiri MD, Ph.D served as our Chief Medical Officer from October 2024 until July 2025, is an ophthalomologist by training with clinical experience in medial retina, immunology and inflammation. Dr. Zamiri prior to joining Opthea, served as the Chief Medical Officer at Complement Therapeutics and previously at Graybug Vision, where she oversaw clinical, regulatory, medical affairs and biostatitics. Prior to that, she served as Vice President, Global Head of Clinical Development and Therapeutic Area Head of Ophthalmology at Novartis Pharmaceuticals leading a group of clinical scientists and ophthalmologists that designed and executed Phase 1 to Phase 4 clinical trials with novel biologics, gene therapies, small molecules, and digital therapeutics for ophthalmic indications, such as wet AMD, geographic atrophy, retinitis pigmentosa and dry eye.
Non-Employee Directors
Jeremy Levin, D.Phil., MB Bchir has served as the Chairperson of our board of directors since October 2020 and as Chief Executive since September 1, 2025. Since March 2015, Dr. Levin has served as the Chief Executive Officer, and since April 2014, as the chairperson of the board of directors, of Ovid Therapeutics Inc., a biopharmaceutical company. From May 2012 to October 2013, Dr. Levin served as the President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd., a publicly held pharmaceutical company. From September 2007 to December 2012, Dr. Levin held several roles at Bristol-Myers Squibb Company, a publicly held pharmaceutical company, ultimately serving as the Senior Vice President of Strategy, Alliances and Transactions. Dr. Levin also served as a member of the executive committee at Bristol-Myers Squibb Company. Dr. Levin earned a Bachelor of Arts in Zoology, Master of Arts in Cell Biology and D.Phil. in Chromatin Structure, all from University of Oxford, and a Bachelor of Medicine, Bachelor of Surgery from the University of Cambridge. We believe Dr. Levin’s extensive experience in the global biotechnology and pharmaceutical industry qualify him to serve on our board of directors.
Lawrence Gozlan has served as a member of our board of directors since July 2020. Since 2007, Mr. Gozlan has served as the Life Sciences Investment Manager of Jagen Pty Ltd., an international investment organization. Mr. Gozlan has also served as a member of the board of directors of Alterity Therapeutics Ltd., a drug development company, since 2011. Mr. Gozlan earned a Bachelor of Science in Microbiology and Immunology from the University of Melbourne. We believe Mr. Gozlan’s extensive investment experience in biotechnology and life sciences companies qualify him to serve on our board of directors.
Julia Haller, M.D. has served as a member of our board of directors since June 2021 until her resignation in June 2025. Since 2007, Dr. Haller has served as Ophthalmologist-in-Chief and William Tasman, ME Endowed Chair at Wills Eye Hospital in Philadelphia. Dr. Haller is Professor and Chair of the Department of Ophthalmology at the Sidney Kimmel Medical College at Thomas Jefferson University as well as a director of Bristol Myers Squibb, a biopharmaceutical company and Outlook Therapeutics, a biopharmaceutical company. She is also a member of the National Academy of Medicine, the Chair of the College of Physicians of Philadelphia, Chair of the Heed Ophthalmic Society, past president of the Women in Medicine Legacy Foundation, and serves on several prestigious boards including John Hopkins Medical and Surgical Association (immediate past president), the Association of University Professors of Ophthalmology, and the Society of Heed Fellows. Dr. Haller received a Bachelor of Arts from Princeton University and an M.D. from Harvard Medical School. We believe Dr. Haller’s extensive experience as an internationally recognized ophthalmologist and vitreoretinal surgeon qualified her to serve on our board of directors.
Susan Orr, OD has served as a member of our board of directors since April 2022 until her resignation in June 2025. Dr. Orr is an experienced medical and business leader with specialization in identifying, developing, and commercializing ophthalmic therapeutic product candidates. Since February 2020, Dr. Orr has served as the Chief Medical Officer at Claris Biotherapeutics, a biotechnology firm, and is a member of the Retina Global Board of Directors. From October 2018 to November 2019, Dr. Orr was the Chief Executive Officer at Notal Vision, an ophthalmic remote monitoring service provider. From July 2016 to September 2018, Dr. Orr served as Notal Vision’s Chief Medical Officer and Vice President of Medical Affairs. Prior to joining Notal Vision, Dr. held leadership roles at Alcon and Janssen across Marketing, Strategy, Business Development, and multiple Development functions, following 10 years in private practice in Canada. Dr. Orr earned a Bachelor of Science and a Doctor of Optometry from the University of Waterloo. We believe Dr. Orr’s extensive experience in ophthalmology and leadership qualified her to serve on our board of directors.
101
Quinton Oswald has served as a member of our board of directors since April 2022 until his resignation in June 2025. Mr. Oswald brings over 25 years of international general management experience, including onsite assignments in the U.S, Europe and South Africa. From April 2016 to December 2018, Mr. Oswald was the Chief Executive Officer of Notal Vision, a commercial stage ophthalmic home monitoring services provider with a focus on both wet and dry AMD. From April 2013 to April 2016, Mr. Oswald served as the President and Chief Executive Officer of Neurotech Pharmaceuticals, a biotechnology research company, and from September 2010 to April 2013, as the Chief Executive Officer of SARcode Bioscience, an ophthalmic biopharmaceutical company. We believe Mr. Oswalds extensive leadership experience in biotechnology companies qualified him to serve on our board of directors.
Sujal Shah has served as a member of our board of directors since April 2024 and will be resigning as a director effective September 15, 2025. Mr. Shah is an accomplished biopharmaceutical executive with extensive leadership and product development experience and a track record in capital formation that complements the deep expertise in retinal disease, especially wet AMD, of the Opthea Board. Most recently, Mr. Shah served as President and Chief Executive Officer of CymaBay Therapeutics which was acquired by Gilead Sciences for approximately $4.3 billion in total equity value in March 2024
Kathy Connell has served as a member of our board of directors since November 2024. Is an internationally recognized healthcare and life sciences leader with deep and broad investment and licensing expertise, delivering a solid track record of value creating deals across pharmaceutical, medtech, vaccines consumer and digital healthcare for some of the world's largest companies. For the past 20 years, Kathy has held senior executive leadership positions in biotechnology, pharmaceutical, medical device and consumer health sectors specializing in business development, licensing, acquisition and venture investment, as well as having worked in healthcare and Life sciences executive search and management consulting with Korn Ferry. During her tenure at Johnson & Johnson and Sanofi, Kathy led external innovation investment, licensing and acquisition across ANZ, with more that $US1 billion of capital being deployed in Australian with industry, academia, VCs and government organizations. . We believe Ms. Connell's extensive leadership in supporting Australia's high priority strategic growth sectors of biotech companies qualify her to serve on our board of directors.
Anshul Thakral has served as a member of our board of directors since June 2023 until his resignation in June 2025. Mr. Thakral is Chief Executive Officer and Board Member of Launch Therapeutics, a clinical development company backed by funds managed by global investment firm Carlyle and its life sciences franchise, Abingworth. Mr. Thakral has worked for over 20 years in the pharmaceutical and biotechnology industry and is an experienced executive, management consultant and entrepreneur. Mr. Thakral was previously Chief Commercial Officer and Executive Vice President of Peri and Post-Approval Services at PPD, and prior to that was Global Head of PPD Biotech. Before PPD, Mr. Thakral ran the global life sciences business unit at Gerson Lehrman Group and worked at McKinsey & Company as an associate principal in the health care practice, where he provided strategic advice to global pharmaceutical and biotechnology companies on growth, research and development, business development and commercialization. He currently serves on the boards of TriNetX, Saama Technologies, Orsini Specialty Pharmacy, is an Operating Executive at Carlyle and is a Venture Partner at Abingworth. Mr. Thakral holds a Master’s degree in Biomedical Engineering from Johns Hopkins University and a Masters Business Administration (MBA) from the Wharton School at the University of Pennsylvania. We believe Mr. Thakral’s extensive experience in the global biotechnology and pharmaceutical industry qualified him to serve on our board of directors.
Family Relationships
There are no family relationships among any of the members of our board of directors and our senior management.
102
6B. Compensation
Overview
Our remuneration policy is to align director and senior management objectives with shareholder and business objectives by providing a fixed remuneration component and typically offering long-term incentives based on key performance areas. Our board of directors believes the remuneration policy to be appropriate and effective in its ability to attract and retain the best executives and directors to run and manage the consolidated entity, as well as create goal congruence between directors, executives and shareholders. Our board of directors and the Remuneration Committee are responsible for determining the appropriate remuneration package for our senior management, including our Chief Executive Officer.
Australian executives and directors receive a superannuation guarantee contribution required under Australian law and do not receive any other retirement benefits.
Remuneration of Senior Management
For the fiscal year ended June 30, 2025, the aggregate cash remuneration paid to our senior management was US$4,231 thousand (2024:US$2,805 thousand).
Our senior management receive fixed compensation and performance-linked remuneration. The level of fixed remuneration is set to provide a base level of compensation which is both appropriate to the applicable position and is competitive in the marketplace. The Remuneration Committee accesses external advice independent of senior management if required. Fixed compensation is comprised of base salary and superannuation contribution and is reviewed every 12 months by the Remuneration Committee.
Performance-linked remuneration consists of short-term and long-term incentives. The objective of short-term incentives is to link the achievement of our operational targets with the remuneration received by our senior management charged with meeting those targets. Total potential short-term incentives are set at a level that we believe provides sufficient incentive to our senior management to achieve the operational targets at a cost to us that is reasonable under the circumstances. Short-term incentives may include cash bonuses based on the extent to which specific targets set at the beginning of each fiscal year are met. The targets consist of a number of key performance indicators covering corporate objectives and individual measures of performance. Individual performance indicators are linked to our development plans. Our Remuneration Committee determines, on an annual basis and after consideration of performance against the key performance indicators, the amount, if any, of short-term incentives payable to our senior management. Payments of short-term incentive bonuses are made in the following reporting period.
We also provide long-term incentives through option grants under our Long-Term Incentive Plan. The objective of the Long-Term Incentive Plan is to reward our management and key employees in a manner that aligns this element of compensation with the creation of shareholder wealth. Long Term Incentive Plan grants are made to senior management and employees who are able to influence the generation of shareholder wealth and have a direct impact on our performance and development. Option vesting conditions are based on continued service to us.
In making remuneration determinations for our senior management, the Remuneration Committee considers operational contributions by our senior management as well as the following performance indicators: revenue, loss before tax, tax benefit, loss after tax, basic loss per ordinary share, net tangible assets per share and changes in prevailing trading prices of our ordinary shares on the ASX.
Remuneration of Non-Employee Directors
Our non-employee directors receive a fixed fee annually, which is reviewed by our board of directors on an annual basis. Dr. Orr and Mses. Haller, and Messrs. Oswald, Thakral were each and Mr. Gozlan is entitled to an annual fixed fee of US$50,000/A$65,700. Mr. Shah was entitled to an annual fix fee of US$70,000 (inclusive of fees for his service as chairperson of the audit and risk committee). Dr. Levin is entitled to an annual fixed fee of US$75,000 (for his service as chairperson of the board of directors). Board members are entitled to an annual fixed fee of US$10,000/A$13,140 for service as Chair of any other committees and US$5,000/A$6,570 for service on any other committee in a non-Chair role. Unless otherwise noted, the fixed fees cover both service on the board of directors and committees of the board of directors. The remuneration of our non-employee directors is reviewed by our board of directors on an annual basis. Non-employee directors are not provided with retirement benefits
103
apart from statutory superannuation, which is only applicable to Australian resident directors. Non-employee directors are reimbursed for costs directly related to conducting business related to their service on our board of directors.
We implemented a non-executive director share and option plan, or the NED Plan, in 2014. Under the NED Plan, present and future non-executive directors may:
The NED Plan is designed to assist us in preserving our cash for use toward advancing the clinical development of our product candidate and provide our non-employee directors an opportunity to demonstrate their commitment and support for us through sacrificing some or all of their cash fees for ordinary shares or options. The NED Plan also provides us with further flexibility in the design of the directors’ remuneration packages and in turn assists us with retaining existing directors and attracting new additional directors with the relevant experience and expertise.
For the fiscal year ended June 30, 2025, the aggregate cash remuneration paid to our non-employee directors was US$744 thousand (2024:US$715 thousand), including Nil in cash reimbursements.
Employment Agreements with Senior Management
The key provisions of the employment agreements are set out below for each member of our senior management. None of these employment agreements have termination dates. The base salary under the employment agreements may be increased by the board of directors from time to time.
Officer |
|
Date of |
|
Base Salary |
|
Termination without Cause |
|
Benefits upon Termination without |
Fred Guerard Chief Executive Officer (from October 27, 2023 until September 1, 2025) |
|
October 27, 2023 |
|
US$600,000 per year |
|
Not less than twelve months' notice or payment in lieu of notice period (if by us) |
|
Upon notice of termination by us any options that have vested or will vest during the notice period will be released, all other options will lapse at the discretion of our board of directors |
|
|
|
|
|
|
|
|
|
Megan Baldwin, Ph.D. |
|
April 23, 2014 |
|
A$609,500 per year |
|
Not less than three months’ notice (if by employee) Not less than twelve months’ notice or payment in lieu of notice period (if by us) |
|
Upon notice of termination by us, any options that have vested or will vest during the notice period will be released; all other options will lapse at the discretion of our board of directors. |
|
|
|
|
|
|
|
|
|
Karen Adams |
|
June 15, 2021 |
|
A$353,510 per year |
|
Not less than three months’ notice (if by employee) Not less than three months’ notice or payment in lieu of notice period (if by us |
|
Not applicable. |
104
|
|
|
|
|
|
|
|
|
Thomas Reilly Chief Financial Officer (from October 28, 2024 until September 15, 2025) |
|
October 28, 2024 |
|
US$500,000 per year |
|
Not less than twelve months' notice or payment in lieu of notice period (if by us) |
|
Upon notice of termination by us any options that have vested or will best during the notice period will be released, all other options will lapse at the discretion of our board of directors |
|
|
|
|
|
|
|
|
|
Peter Lang Chief Financial Officer (until September 5, 2024) |
|
October 27, 2023 |
|
US$500,000 per year |
|
Not less than twelve months’ notice or payment in lieu of notice period (if by us) |
|
Upon notice of termination by us, any options that have vested or will vest during the notice period will be released; all other options will lapse at the discretion of our board of directors |
|
|
|
|
|
|
|
|
|
Judith Robertson Chief Commercial Officer (until September 9, 2024) |
|
January 1, 2022 |
|
US$413,400 per year |
|
Not less than twelve months’ notice or payment in lieu of notice period (if by us |
|
Upon notice of termination by us, any options that have vested or will vest during the notice period will be released; all other options will lapse at the discretion of our board of directors |
Upon termination of employment, our senior management are entitled to receive their statutory entitlements of accrued annual and long service leave, together with any superannuation benefits.
The material terms of Dr. Jeremy Levin's engagement to fulfill the role and responsibilities of chief executive officer following Dr. Guerard’s departure as follows:
as Chairman, AUD$150 thousand per annum;
as a Board Committee member, AUD$6,500 per annum per Board Committee;
to fulfil the roles and responsibilities of the CEO, AUD$210 thousand per annum, excluding statutory entitlement (if applicable) plus a 30% retention bonus.
105
Remuneration of Our Non-Employee Directors and Senior Management During the Fiscal Year Ended June 30, 2025
Details of the remuneration of our non-employee directors and senior management for the fiscal year ended June 30, 2025 are set forth below in US$.
|
|
|
|
|
Short-Term |
|
|
Post- |
|
|
|
|
|
|
|
|||||||||||||
|
|
Salary/ |
|
|
Cash |
|
|
Benefits |
|
|
Superannuation/401k plan |
|
|
Termination |
|
|
Share- |
|
|
Total |
|
|||||||
Non-Employee Directors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Anshul Thakral (3) |
|
$ |
63,694 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
551,403 |
|
|
$ |
615,097 |
|
Jeremy Levin |
|
|
80,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
453,568 |
|
|
|
533,568 |
|
Julia Haller (3) |
|
|
50,722 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
244,885 |
|
|
|
295,607 |
|
Kathy Connell (4) |
|
|
25,888 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
58,384 |
|
|
|
84,272 |
|
Lawrence Gozlan |
|
|
330,552 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
479,485 |
|
|
|
810,037 |
|
Quinton Oswald (3) |
|
|
59,944 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
467,199 |
|
|
|
527,143 |
|
Sujal Shah |
|
|
70,778 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
222,813 |
|
|
|
293,591 |
|
Susan Orr (3) |
|
|
59,944 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
467,199 |
|
|
|
527,143 |
|
Senior Management |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
||||||
Fred Guerard (5) |
|
|
584,028 |
|
|
|
360,000 |
|
|
|
51,046 |
|
|
|
20,326 |
|
|
|
— |
|
|
|
485,967 |
|
|
|
1,501,367 |
|
Megan Baldwin, Ph.D. |
|
|
394,938 |
|
|
|
199,651 |
|
|
|
— |
|
|
|
62,302 |
|
|
|
— |
|
|
|
527,402 |
|
|
|
1,184,293 |
|
Thomas Reilly (6) |
|
|
365,278 |
|
|
|
563,000 |
|
|
|
35,216 |
|
|
|
12,438 |
|
|
|
— |
|
|
|
— |
|
|
|
975,932 |
|
Peter Lang (5) |
|
|
337,500 |
|
|
|
45,500 |
|
|
|
27,913 |
|
|
|
15,209 |
|
|
|
181,370 |
|
|
|
(656,204 |
) |
|
|
(48,712 |
) |
Karen Adams |
|
|
247,787 |
|
|
|
71,563 |
|
|
|
— |
|
|
|
33,457 |
|
|
|
— |
|
|
|
148,758 |
|
|
|
501,565 |
|
Judith Robertson (7) |
|
|
147,195 |
|
|
|
31,700 |
|
|
|
15,634 |
|
|
|
7,126 |
|
|
|
333,536 |
|
|
|
83,028 |
|
|
|
618,219 |
|
Parisa Zamiri (8) |
|
|
352,727 |
|
|
|
211,500 |
|
|
|
26,192 |
|
|
|
12,167 |
|
|
|
— |
|
|
|
(4,054 |
) |
|
|
598,532 |
|
106
Details of options held by our non-employee directors and senior management as of June 30, 2025 are set forth below.
|
|
Number of |
|
|
Grant |
|
Exercise |
|
|
Percentage |
|
|
Last Vesting |
|
Expiration |
|||
Non-Employee Directors(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Lawrence Gozlan |
|
|
2,000,000 |
|
|
10/12/2020 |
|
$ |
3.24 |
|
|
|
100 |
% |
|
10/11/2023 |
|
10/11/2024 |
Lawrence Gozlan |
|
|
500,000 |
|
|
11/16/2022 |
|
Nil |
|
|
|
100 |
% |
|
11/15/2032 |
|
11/16/2032 |
|
Lawrence Gozlan |
|
|
2,000,000 |
|
|
11/16/2022 |
|
|
0.444 |
|
|
|
86 |
% |
|
11/15/2032 |
|
11/16/2032 |
Lawrence Gozlan |
|
|
500,000 |
|
|
11/30/2023 |
|
|
0.382 |
|
|
|
53 |
% |
|
11/30/2026 |
|
11/30/2033 |
Lawrence Gozlan |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Julia Haller |
|
|
2,000,000 |
|
|
10/19/2021 |
|
|
0.948 |
|
|
|
100 |
% |
|
10/19/2024 |
|
10/18/2025 |
Julia Haller |
|
|
1,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Jeremy Levin |
|
|
3,000,000 |
|
|
01/19/2021 |
|
|
1.56 |
|
|
|
100 |
% |
|
01/19/2024 |
|
01/18/2025 |
Jeremy Levin |
|
|
3,000,000 |
|
|
11/30/2023 |
|
|
0.38 |
|
|
|
53 |
% |
|
11/30/2026 |
|
11/30/2033 |
Jeremy Levin |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.43 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Michael Sistenich |
|
|
1,500,000 |
|
|
11/16/2022 |
|
|
0.444 |
|
|
|
86 |
% |
|
11/16/2025 |
|
11/15/2032 |
Daniel Spiegelman |
|
|
2,000,000 |
|
|
10/12/2020 |
|
|
2.16 |
|
|
|
100 |
% |
|
10/11/2023 |
|
10/11/2024 |
Daniel Spiegelman |
|
|
2,000,000 |
|
|
11/16/2022 |
|
|
0.454 |
|
|
|
94 |
% |
|
11/15/2032 |
|
11/16/2032 |
Daniel Spiegelman |
|
|
150,000 |
|
|
11/16/2022 |
|
Nil |
|
|
|
100 |
% |
|
11/15/2032 |
|
11/16/2032 |
|
Susan Orr |
|
|
1,000,000 |
|
|
04/21/2022 |
|
|
0.948 |
|
|
|
100 |
% |
|
04/21/2025 |
|
04/20/2026 |
Susan Orr |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Quinton Oswald |
|
|
1,000,000 |
|
|
04/21/2022 |
|
|
0.948 |
|
|
|
100 |
% |
|
04/21/2025 |
|
04/20/2026 |
Quinton Oswald |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Sujal Shah |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Anshul Thakral |
|
|
1,000,000 |
|
|
11/30/2023 |
|
|
0.382 |
|
|
|
53 |
% |
|
11/30/2026 |
|
11/30/2033 |
Anshul Thakral |
|
|
2,000,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
19 |
% |
|
11/15/2027 |
|
11/14/2034 |
Kathy Connell |
|
|
500,000 |
|
|
11/15/2024 |
|
|
0.426 |
|
|
|
25 |
% |
|
11/15/2028 |
|
11/14/2034 |
Senior Management |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Fred Guerard (3) |
|
|
1,400,000 |
|
|
10/27/2023 |
|
1.66 |
|
|
|
50 |
% |
|
10/27/2026 |
|
11/26/2033 |
|
Fred Guerard(3) |
|
|
600,000 |
|
|
10/27/2023 |
|
1.66 |
|
|
|
0 |
% |
|
|
|
11/26/2033 |
|
Fred Guerard (3) |
|
|
400,000 |
|
|
9/16/2024 |
|
3.15 |
|
|
|
25 |
% |
|
9/16/2027 |
|
9/15/2034 |
|
Fred Guerard (3) |
|
|
200,000 |
|
|
9/16/2024 |
|
3.15 |
|
|
|
0 |
% |
|
|
|
9/15/2034 |
|
Megan Baldwin, Ph.D. (4) |
|
|
3,000,000 |
|
|
11/16/2022 |
|
|
0.658 |
|
|
|
86 |
% |
|
11/29/2019 |
|
11/29/2022 |
Megan Baldwin, Ph.D. (4) |
|
|
1,600,000 |
|
|
10/19/2021 |
|
Nil |
|
|
|
87 |
% |
|
09/30/2024 |
|
10/18/2031 |
|
Megan Baldwin, Ph.D. (4) |
|
|
500,000 |
|
|
11/16/2022 |
|
Nil |
|
|
|
100 |
% |
|
11/15/2032 |
|
11/16/2032 |
|
Megan Baldwin, Ph.D. (4) |
|
|
3,000,000 |
|
|
11/30/2023 |
|
|
0.261 |
|
|
|
53 |
% |
|
11/30/2026 |
|
11/30/2033 |
Peter Lang (3) |
|
|
1,300,000 |
|
|
10/27/2023 |
|
|
1.660 |
|
|
|
0 |
% |
|
10/27/2028 |
|
11/26/2033 |
Peter Lang (3) |
|
|
300,000 |
|
|
10/27/2023 |
|
|
1.660 |
|
|
|
0 |
% |
|
|
|
11/26/2033 |
Thomas Reilly (3) |
|
|
770,000 |
|
|
11/4/2024 |
|
|
4.340 |
|
|
|
0 |
% |
|
11/4/2027 |
|
11/3/2034 |
Karen Adams (4) |
|
|
800,000 |
|
|
06/06/2022 |
|
|
1.460 |
|
|
|
100 |
% |
|
06/06/2025 |
|
06/05/2032 |
Karen Adams (4) |
|
|
150,000 |
|
|
11/16/2022 |
|
Nil |
|
|
|
100 |
% |
|
11/15/2032 |
|
11/16/2032 |
|
Karen Adams (4) |
|
|
800,000 |
|
|
10/10/2023 |
|
|
0.205 |
|
|
|
25 |
% |
|
10/10/2027 |
|
10/9/2033 |
Karen Adams (4) |
|
|
600,000 |
|
|
9/16/2024 |
|
|
0.418 |
|
|
|
25 |
% |
|
9/16/2027 |
|
9/15/2034 |
Judith Robertson (3) |
|
|
2,000,000 |
|
|
10/19/2021 |
|
|
0.948 |
|
|
|
100 |
% |
|
10/19/2024 |
|
10/19/2025 |
Judith Robertson (3) |
|
|
62,500 |
|
|
9/16/2024 |
|
|
3.150 |
|
|
|
100 |
% |
|
12/09/2024 |
|
12/9/2026 |
Parisa Zamiri (3) |
|
|
830,000 |
|
|
11/4/2024 |
|
|
4.340 |
|
|
|
0 |
% |
|
10/7/2028 |
|
10/6/2034 |
Parisa Zamiri (3) |
|
|
27,000 |
|
|
4/1/2024 |
|
|
4.140 |
|
|
|
39 |
% |
|
10/1/2025 |
|
3/31/2034 |
107
6C. Board Practices
Board of Directors
Our board of directors currently consists of four members. Effective September 15, 2025, Sujal Shah will resign as a director. Directors are elected at our annual general meeting of shareholders. Under our Constitution, at the close of each annual general meeting one-third of the directors, other than the Managing Director, or if their number is not a multiple of three, then the number nearest to but not more than one-third of the directors must retire. In addition, a director, other than the managing director, must retire from office at the conclusion of the third annual general meeting of shareholders after the director was last elected, even if his or her retirement results in more than one-third of all directors retiring from office. A retiring director remains in office until the end of such shareholder meeting and will be eligible for re-election at that meeting.
The membership of our board of directors is directed by the following requirements as set forth in our Constitution and our Board Charter, as applicable:
Our board of directors has delegated responsibility for the management of our businesses to the Chief Executive Officer but remains responsible for overseeing the performance of management. The principal roles and responsibilities of our board of directors include the following:
Our board of directors has established delegated limits of authority, which define the matters that are delegated to management and those that require board of director approval. Under the Corporations Act, at least two of our directors must be resident Australians. None of our non-employee directors have any service contracts with us that provide for benefits upon termination of employment. Under our Board Charter, the board of directors is required to meet at least six times per year.
108
Board Committees
To assist with the effective discharge of its duties, the board of directors has established an Audit and Risk Committee, a Remuneration Committee, Research and Development Committee and a Nomination and Governance Committee. Each committee operates under a charter approved by our board of directors, which sets forth the purposes and responsibilities of the committees as well as qualifications for committee membership, committee structure and operations and committee reporting to the board of directors.
Audit and Risk Committee
The members of our Audit and Risk Committee are Messrs. Shah, Oswald (till June 2025), Dr. Orr (till June 2025, Gozlan (from June 2025) and Connell (from June 2025). Our board of directors has determined that each of Messrs. Shah, Oswald and Dr. Orr and Ms. Connell satisfies the independence requirements under Nasdaq listing standards and Rule 10A-3(b)(1) under the Exchange Act. The chairperson of our Audit and Risk Committee is Mr. Shah. Our board of directors has determined that Mr. Shah is an “audit committee financial expert” within the meaning of SEC regulations. Each member of our Audit and Risk Committee can read and understand fundamental financial statements in accordance with applicable requirements. In arriving at these determinations, our board of directors has examined each member’s scope of experience and the nature of his or her employment.
The charter for our Audit and Risk Committee requires the committee to consist of at least three directors, each of whom must be non-employee directors and a majority of which must be independent directors. The chairperson of our Audit and Risk Committee must be an independent director and cannot be the chairperson of our board of directors. The Audit and Risk Committee is required to hold at least one regular meeting per fiscal quarter and must review its charter at least annually.
The role of the Audit and Risk Committee is to advise our board of directors in discharging responsibilities of our board of directors with respect to our financial reporting including accounting standards, internal control integrity and compliance, external audit activities including auditor appointment, independence, terms of engagement and fees and business risk management. Specific responsibilities of our Audit and Risk Committee include:
109
Remuneration Committee
The members of our Remuneration Committee are Messrs. Gozlan Thakral (till June 2025) and Oswald (till June 2025), Ms. Connell (from June 2025) and Mr. Levin (from June 2025). The chairperson of our Remuneration Committee is Mr. Gozlan. The objectives of the Remuneration Committee are to link remuneration to the creation of shareholder value, to offer competitive and appropriate remuneration for the business performance delivered and to put into place a remuneration framework that reflects the responsibilities of senior management while being sufficiently competitive to attract and retain high caliber performers. The charter of our Remuneration Committee requires the committee to consist of at least three directors, a majority of whom must be independent. The chairperson of our Remuneration Committee must be an independent director. The Remuneration Committee is required to hold at least one regular meeting each year. Specific responsibilities of our Remuneration Committee include:
Nomination and Governance Committee
The members of our Nomination and Governance Committee are Messrs. Thakral (till June 2025), Gozlan, and Levin and Ms. Connell (from June 2025). The chairperson of our Nomination and Governance Committee is Mr. Gozlan. The role of the Nomination and Governance Committee is to assist our board of directors by identifying, reviewing and evaluating individuals qualified to become members of our board of directors, reviewing and recommending the nomination of directors and assisting the board of directors with other related tasks. The charter of our Nomination and Governance Committee requires the committee to consist of at least three directors, the majority of whom must meet the independence recommendations of the ASX Corporate Governance Council (as well as all applicable laws and regulations) and each of whom must be free of any relationship that, in the opinion of the board of directors, would interfere with his or her exercise of independent judgment. The members of the Nomination and Governance Committee will be appointed annually by the board of directors. The Nomination and Governance Committee is required to hold at least one regular meeting each year. Specific responsibilities of our Nomination and Governance Committee include:
110
Research and Development Committee
The members of our Research and Development Committee are Messrs. Thakral (till June 2025), Oswald (till June 2025), and Dr. Haller (till June 2025 and Dr. Orr (till June 2025). The chairperson of our Research and Development Committee is Dr. Orr. The role of the Research and Development Committee is to guide and oversee and implement Opthea's Research and Development strategy of and recommend or make such changes to the strategy as the Committee may deem to be appropriate, including by not limited to the clinical development strategy, including the planning and design of clinical studies, Opthea's interactions with regulatory authorities and over all regulatory strategy and processes for products and the manufacture and supply of Opthea's product candidates. The charter of our Research and Development committee requires the committee to consist of at least three directors, the majority of whom must meet the independence recommendations of the ASX Corporate Governance Council (as well as all applicable laws and regulations) and each of whom must be free of any relationship that, in the opinion of the board of directors, would interfere with his or her exercise of independent judgment. The members of the Research and Development Committee will be appointed annually by the board of directors. The Research and Development Committee is required to hold at least one regular meeting each year. Specific responsibilities of our Research and Development Committee include:
Code of Conduct
We have adopted a Code of Conduct applicable to all of our directors, officers and employees. Our Code of Conduct is available on our website at www.opthea.com. We post on our website all disclosures that are required by law or the listing standards of Nasdaq concerning any amendments to, or waivers from, any provision of the Code of Conduct. The reference to our website address does not constitute incorporation by reference of the information contained at or available through our website, and you should not consider it to be a part of, this annual report.
6D. Employees
As of June 30, 2025, we had ten full-time employees, five of whom had an M.D. or Ph.D. degree. None of our employees are represented by collective bargaining agreements. We believe that our management maintains good relations with our employees. As of June 30, 2025, our employees were based in Australia (4) and the United States (6), with five (5) employees in our research and development and commercialization department and five employees in our general and administrative department.
6E. Share Ownership
For information regarding the share ownership of our directors and executive officers, see “Item 6B—Compensation” and “Item 7A—Major Shareholders.”
111
6F. Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation
Not applicable. The Company adopted a clawback policy in compliance with the Dodd-Frank Wall Street Reform and Consumer Protection Act, Exchange Act Rule 10D-1 and Nasdaq Listing Rule 5608, effective October 2, 2023. The clawback policy is attached as Exhibit 97.1 to this annual report.
Item 7. Major Shareholders and Related Party Transactions
7A. Major Shareholders
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of September 5, 2025, for:
To our knowledge, as of the date of this annual report, 99,442,576 of our ordinary shares (12,430,322 ADRs) were held by one record holder in the United States, representing approximately 8.1% of our total outstanding shares. The record holder is The Bank of New York Mellon, the depositary of our ADS program. The number of beneficial owners of our ADSs in the United States is likely to be much larger than the number of record holders of our ordinary shares in the United States.
Beneficial ownership is determined in accordance with the rules and regulations of the SEC. In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person, we have included ordinary shares that the person has the right to acquire within 60 days of September 5, 2025, including through the exercise of any option, warrant or other right or the conversion of any other security. These ordinary shares, however, are not included in the computation of the percentage ownership of any other person.
The calculations of the percentage of beneficial ownership are based on 1,367,978,173 ordinary shares (including ordinary shares in the form of ADSs) issued and outstanding as of September 5, 2025.
112
Unless otherwise indicated, the address of each beneficial owner listed below is c/o Opthea Limited, C/- Prime Company Compliance, Level 9 505 Little Collins Street, Melbourne Vic 3000, Australia.
|
|
Shares Beneficially Owned |
|
|||||
Name of Beneficial Owner |
|
Number |
|
|
Percent |
|
||
Principal Shareholders |
|
|
|
|
|
|
||
Funds affiliated with Regal Funds Management Pty Ltd.(1) |
|
|
344,394,283 |
|
|
|
25.2 |
% |
Directors and Senior Management |
|
|
|
|
|
|
||
Megan Baldwin, Ph.D.(2) |
|
|
8,095,299 |
|
|
* |
|
|
Fred Guerard(3) |
|
|
799,999 |
|
|
|
— |
|
Tom Reilly |
|
|
— |
|
|
|
— |
|
Parisa Zamiri |
|
|
— |
|
|
|
— |
|
Karen Adams(4) |
|
|
1,150,000 |
|
|
|
— |
|
Julia Haller(5) |
|
|
3,000,000 |
|
|
|
— |
|
Lawrence Gozlan(6) |
|
|
2,375,000 |
|
|
* |
|
|
Jeremy Levin, DPhil, MB BChir(7) |
|
|
1,972,222 |
|
|
* |
|
|
Susan Orr (8) |
|
|
3,000,000 |
|
|
|
— |
|
Quinton Oswald (9) |
|
|
3,000,000 |
|
|
|
— |
|
Judith Robertson(10) |
|
|
2,000,000 |
|
|
|
— |
|
Judith Robertson(10) |
|
|
62,500 |
|
|
|
— |
|
Anshul Thakral(11) |
|
|
3,000,000 |
|
|
|
— |
|
Kathy Connell (12) |
|
|
500,000 |
|
|
|
— |
|
Sujal Shah (13) |
|
|
2,000,000 |
|
|
|
— |
|
All directors and senior management as a group (fourteen persons) |
|
|
29,592,521 |
|
|
|
2.2 |
% |
* Represents beneficial ownership of less than 1%.
- Represents unexercised options
113
7B. Related Party Transactions
Following the appointment of Anshul Thakral (who is the CEO of Launch Tx, Operation Executive of Carlyle and on the board of Saama Technologies) as a Director of Opthea on June 7, 2023, Launch, Ocelot (an affiliate of Carlyle and Abingworth), Carlyle and Saama Technologies became related parties of Opthea.
Trading transactions
During the year, the Company entered into the following transactions with related parties:
|
|
Consolidated |
|
|||||||||
|
|
Purchase of Service |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
32,793 |
|
|
|
24,699 |
|
|
|
— |
|
Launch Tx |
|
|
9,900 |
|
|
|
2,700 |
|
|
|
900 |
|
Mr Lawrence Gozlan |
|
|
275 |
|
|
|
— |
|
|
|
— |
|
Saama Technologies |
|
|
121 |
|
|
|
343 |
|
|
|
— |
|
Transactions with Launch TX relate to the purchase of services assisting Opthea with the management and oversight of trials under the Service Agreement with Launch Tx.
114
Transactions with Saama Technologies relate to the purchase of services assisting Opthea with analytical work on clinical trials.
|
|
Consolidated |
|
|||||||||
|
|
Amounts owed to related parties |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
— |
|
|
|
141,554 |
|
|
|
85,660 |
|
Launch Tx |
|
|
2,250 |
|
|
|
— |
|
|
|
900 |
|
Lawrence Gozlan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Saama Technologies |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Amounts owed to Ocelot and Co Investor relate to the Development Funding Agreement and carry an effective rate of 23%. Included in the interest expense on DFA for the year is an amount due to related parties of US$3,793 thousand (2024:US424,699 thousand)) Amounts paid to Launch Tx relate to the purchase of services assisting Opthea with the management and oversight of trials under the Service Agreement with Launch Tx which were in a payable position at June 30, 2025.
|
|
Consolidated |
|
|||||||||
|
|
Amounts owed by related parties* |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Launch Tx |
|
|
— |
|
|
|
3,150 |
|
|
|
— |
|
Mr. Lawrence Gozlan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Saama Technologies |
|
|
— |
|
|
|
24 |
|
|
|
— |
|
*The above amounts represent prepayments.
Amounts due to related parties relates to the services assisting Opthea with the management and oversight of trials under the Service Agreement with Launch Tx which was entered into in March 2023. Amounts due to Saama Technologies relate to subscription fees for the use of analytical platform, which were in a prepayment position at June 30, 2024.
On August 28,2023 Mr. Lawrence Gozlan, a director of the Company, and the Company entered into a Consultancy Agreement of up to US$300,000 in respect of the provision of services associated with managing, overseeing and coordinating the conduct and implementation of the 2023 Equity Offering. The consultancy agreement was effective for the financial year June 30, 2024 and ended at the completion of the 2023 Equity Offering in September 2023. In the opinion of the Directors, these duties are outside the scope of the ordinary duties of a Non-Executive Director. Included in equity are transaction costs paid under this consulting agreement of US$125,000 for the year ended June 30, 2024.
On September 19, 2024, Mr. Lawrence Gozlan, a Director of the Company, and the Company entered into a Consultancy Agreement of up to US$275 thousand in respect to the provision of services associated with managing, overseeing and coordinating the conduct and implementation of Capital Raising. The consultancy agreement was effective for the financial year June 30, 2025. in the opinion of the Directors, these duties are outside the scope of the ordinary duties of a Non-Executive Director. Included in the Statement of Profit or Loss under Administrative expense are consultancy costs of US$275 thousand for the year ended June 30, 2025.
Other than compensation arrangements which are described under “Item 6B—Compensation” or as disclosed below, from July 1, 2023 through the date of this annual report, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) key management personnel and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.
115
Director and Senior Management Compensation
See “Item 6B—Compensation” for information regarding compensation of our senior management and directors.
Indemnification Agreements
Our Constitution provides that, except to the extent prohibited by law including under the Corporations Act and, to the extent that an officer is not otherwise indemnified by us pursuant to an indemnity, we will indemnify every person who is or has been an officer of the company against any liability (other than legal costs that are unreasonable) incurred by that person as an officer. This includes any liability incurred by that person in their capacity as an officer of our subsidiaries where we requested that person to accept that appointment.
We have entered into Deeds of Indemnity, Insurance and Access, or Indemnity Deeds, with Megan Baldwin, Ph.D., Fred Guerard, Thomas Reilly, Karen Adams, Lawrence Gozlan, Julia Haller, Jeremy Levin, Susan Orr, Quinton Oswald, Anshul Thakral, Sujal Shah and Kathy Connell, each a non-employee director , or executive officer. Under the Indemnity Deeds, we have agreed to indemnify (to the maximum extent permitted under Australian law and our Constitution, subject to certain specified exceptions) each director and executive officer against all liabilities incurred in their capacity as our or our subsidiaries’ director or officer and any and all costs and expenses relating to such a claim or to any notified event incurred by such director or executive officer, including costs and expenses reasonably and necessarily incurred to mitigate any liability for such a claim or any claim which may arise from such a notified event. The Indemnity Deeds provide that the indemnities are unlimited as to amount, continuous and irrevocable.
Separately, we have obtained insurance for our directors and executive officers, as required by the Indemnity Deeds.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
Related Person Transaction Policy
We comply with Australian law and the rules and regulations of the ASX regarding approval of transactions with related parties. We have also adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions, which became effective in connection with the listing of our ADSs on Nasdaq. For purposes of our policy, a related person transaction is a transaction, arrangement or similar contractual relationship, or any series of similar transactions, arrangements or relationships, in which we and any related person are, were or will be participants and the amount involved in the transaction exceeds US$120,000, with the exception of usual transactions concluded under normal conditions. A related person is any member of our board of directors, our senior management or any beneficial owner of more than 5% of any class of our ordinary shares, including any of their immediate family members and any entity owned or controlled by such persons.
Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, our senior management must present information regarding the related person transaction to the board of directors for review, consideration and approval or ratification. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information that we deem reasonably necessary from each member of our board of directors and, to the extent feasible, significant shareholder to enable us to identify any existing or potential related-person transactions and to effectuate the terms of the policy.
All of the transactions described above were entered into prior to the adoption of the written policy, but our board of directors evaluated and approved all transactions that were considered to be related party transactions under Australian law and the rules and regulations of the ASX at the time at which they were consummated.
116
7C. Interests of Experts and Counsel
Not applicable.
Item 8. Financial Information
8A. Consolidated Statements and Other Financial Information
Consolidated Financial Statements
See “Item 18—Financial Statements.”
Legal Proceedings
See “Item 4B—Business Overview—Legal Proceedings.”
Dividend Policy
We have not declared or paid any dividends on our ordinary shares since February 2005. 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 the ADSs, subject to the terms of the deposit agreement.
8B. Significant Changes
No significant change, other than as otherwise described in this annual report, has occurred in our operations since the date of our financial statements included in this annual report.
Item 9. The Offer and Listing
9A. Offer and Listing Details
Our ADSs have been listed on the Nasdaq Global Select Market under the symbol “OPT” since October 16, 2020. Our ordinary shares are listed on the ASX under the symbol “OPT.”
9B. Plan of Distribution
Not applicable.
9C. Markets
See “—Offer and Listing Details.”
9D. Selling Shareholders
Not applicable.
9E. Dilution
Not applicable.
9F. Expenses of the Issue
Not applicable.
117
Item 10. Additional Information
10A. Share Capital
Not applicable.
10B. Constitution
See Exhibit 2.3 “Description of Securities,” which is incorporated herein by reference.
10C. Material Contracts
For information on our material contracts, see “Item 4B—Business Overview,” “Item 5B—Liquidity and Capital Resources—Sources and Uses of Liquidity,” and “Item 5B–Liquidity and Capital Resources–Development Funding Agreement .”
10D. 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 (or "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.
10E. Taxation
The following summary of the material Australian and U.S. federal income tax considerations relating to an investment in the ADSs or ordinary shares is based upon laws and relevant interpretations thereof in effect as of the date of this annual report, 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 the ADSs or ordinary shares, such as the tax consequences under U.S. state, local and other tax laws other than U.S. federal income tax laws and certain Australian tax laws.
Material United States Federal Income Tax Considerations
The following discussion is a summary of U.S. federal income tax considerations generally applicable to the ownership and disposition of the ADSs or ordinary shares by a U.S. holder (as defined below). This summary applies only to U.S. holders that hold such ADSs or ordinary shares as capital assets (generally, property held for investment) for U.S. federal income tax purposes. This summary does not address all U.S. federal income tax considerations that may be relevant to a particular U.S. holder and does not represent a detailed discussion of all of the U.S. federal income tax considerations applicable to a holder of our ordinary shares or ADSs that may be subject to special tax rules including, without limitation:
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Holders of the ADSs or ordinary shares who fall within one of the categories above are advised to consult their tax advisor regarding the specific tax consequences which may apply to their particular situation.
If a partnership (or any other entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds the ADSs or ordinary shares, the tax consequences relating to an investment in the ADSs or ordinary shares will depend in part upon the status of the partner and the activities of the partnership. Such a partner or partnership should consult its tax advisor regarding the U.S. federal income tax considerations of owning and disposing of the ADSs or ordinary shares in its particular circumstances.
The discussion in this section is based on the U.S. Internal Revenue Code of 1986, as amended, or the Code, existing, proposed and temporary U.S. Treasury Regulations promulgated thereunder, administrative and judicial interpretations thereof, and the Convention 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, signed on August 6, 1982, as amended and currently in force, or the Treaty, in each case as in effect and available on the date hereof. Such authorities are subject to change, which change could apply retroactively, and to differing interpretations, all of which could affect the tax considerations described below. There can be no assurances that the U.S. Internal Revenue Service, or the IRS, will not take a position concerning the tax consequences of the ownership and disposition of ADSs or ordinary shares or that such a position would not be sustained by a court. U.S. holders should consult their own tax advisors concerning the U.S. federal, state, local and non-U.S. tax consequences of owning and disposing of ADSs or ordinary shares in their particular circumstances.
This summary does not address the estate tax considerations, alternative minimum tax considerations, the potential application of the Medicare contribution tax on net investment income, the special tax accounting rules under Section 451(b) of the Code, or any U.S. state, local, or non-U.S. tax considerations applicable to the acquisition, ownership and disposition of ordinary shares or ADSs or ordinary shares.
For the purposes of this description, a “U.S. holder” is a beneficial owner of the ADSs or ordinary shares that is (or is treated as), for U.S. federal income tax purposes:
The discussion in this section is based in part upon the representations of the depositary and the assumption that each obligation in the amended and restated deposit agreement and any related agreement will be performed in accordance with its terms.
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In general, and taking into account the earlier assumptions, for U.S. federal income tax purposes, a U.S. holder holding ADSs will be treated as the owner of the ordinary shares represented by the ADSs. Exchanges of ordinary shares for ADSs, and ADSs for ordinary shares, generally will not be subject to U.S. federal income tax.
ALL HOLDERS AND POTENTIAL HOLDERS OF THE ADSs SHOULD CONSULT THEIR OWN TAX ADVISORS AS TO THE PARTICULAR TAX CONSEQUENCES APPLICABLE TO THEM RELATING TO THE ACQUISITION, OWNERSHIP AND DISPOSITION OF THE ADSs OR ORDINARY SHARES, INCLUDING THE APPLICABILITY OF U.S. FEDERAL, STATE AND LOCAL TAX LAWS, AUSTRALIAN TAX LAWS AND OTHER NON-U.S. TAX LAWS.
Passive Foreign Investment Company Considerations.
If we are classified as a PFIC in any taxable year, during which a U.S. holder holds the ADSs or ordinary shares, such U.S. holder will be subject to special rules generally intended to reduce or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. holder could derive from investing in a non-U.S. company that does not distribute all of its earnings on a current basis.
We will be classified as a PFIC for U.S. federal income tax purposes in any taxable year in which, after applying certain look-through rules with respect to the income and assets of our subsidiaries, either: (1) at least 75% of the gross income is “passive income” or (2) at least 50% of the average quarterly value of our total gross assets (which would generally be measured by fair market value of our assets, and for which purpose the total value of our assets may be determined in part by the market value of the ADSs and our ordinary shares, which are subject to change) is attributable to assets that produce “passive income” or are held for the production of “passive income.”
Passive income for this purpose generally includes dividends, interest, royalties, rents, gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income, and includes amounts derived by reason of the temporary investment of funds raised in offerings of our securities. If a non-U.S. corporation owns directly or indirectly at least 25% by value of the stock of another corporation or the partnership interests in a partnership, the non-U.S. corporation is treated for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation or partnership and as receiving directly its proportionate share of the other corporation’s or partnership’s income.
We believe we were a PFIC for our taxable year ended June 30, 2025, and based on the nature and composition of our income, assets, activities and market capitalization, we may be a PFIC in future taxable years. However, our PFIC status is based on an annual determination and may change from year to year. Our status as a PFIC will depend on the composition of our income and the composition and value of our assets, which may be determined in large part by reference to the market value of the ADSs and our ordinary shares, which may be volatile, from time to time. Our status may also depend, in part, on how quickly we utilize the cash we raise in any offering of our securities. Our U.S. counsel expresses no opinion regarding our conclusions or our expectations regarding our PFIC status.
If we are classified as a PFIC in any year with respect to which a U.S. holder owns the ADSs or ordinary shares, we will continue to be treated as a PFIC with respect to such U.S. holder in all succeeding years during which the U.S. holder owns the ADSs or ordinary shares, regardless of whether we continue to meet the tests described above unless we cease to be a PFIC and the U.S. holder has made a “deemed sale” election under the PFIC rules. If the “deemed sale” election is made, a U.S. holder will be deemed to have sold the securities the U.S. holder holds at their fair market value as of the date of such deemed sale and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the U.S. holder’s securities with respect to which such election was made will not be treated as shares in a PFIC and the U.S. holder will not be subject to the rules described below with respect to any “excess distribution” the U.S. holder receives from us or any gain from an actual sale or other disposition of the securities. U.S. holders should consult their tax advisors as to the possibility and consequences of making a deemed sale or other “purging” election if such election becomes available.
If we are a PFIC, and you are a U.S. holder that does not make one of the elections described herein, a special tax regime will apply to both (a) any “excess distribution” by us to you (generally, your ratable portion of distributions in any year, other than the taxable year in which your holding period in the shares or ADSs begins, which are greater than 125% of the average annual distribution received by you in the shorter of the three preceding years or the portion of your holding period for the ADSs or ordinary shares that preceded the year of
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the distribution) and (b) any gain realized on the sale or other disposition of the ADSs or ordinary shares. Under this regime, any excess distribution and realized gain will be treated as ordinary income and will be subject to tax as if (a) the excess distribution or gain had been realized ratably over your holding period, (b) the amount deemed realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for such year (other than income allocated to the current period or any taxable period before we became a PFIC, which would be subject to tax at the U.S. holder’s regular ordinary income rate for the current year and would not be subject to the interest charge discussed below) and (c) the interest charge generally applicable to underpayments of tax had been imposed on the taxes deemed to have been payable in those years. In addition, dividend distributions made to you will not qualify for the lower rates of taxation applicable to qualified dividends discussed above under “Distributions.”
Certain elections may alleviate some of the adverse consequences of PFIC status and would result in an alternative treatment of our ordinary shares or ADSs.
If a U.S. holder makes a mark-to-market election, with respect to our ordinary shares or ADSs, the U.S. holder generally will recognize as ordinary income any excess of the fair market value of our ordinary shares or ADSs at the end of each taxable year over their adjusted tax basis, and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of our ordinary shares or ADSs over their fair market value at the end of the taxable year (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. holder makes the election, the U.S. holder’s tax basis in our ordinary shares or ADSs will be adjusted to reflect these income or loss amounts. Any gain recognized on the sale or other disposition of our ordinary shares or ADSs in a year in which 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 of income previously included as a result of the mark-to-market election). The mark-to-market election is available only if we are a PFIC and our ordinary shares or ADSs are “regularly traded” on a “qualified exchange.” Our ordinary shares or ADSs will be treated as “regularly traded” in any calendar year in which more than a de minimis quantity of our ordinary shares or ADSs are traded on a qualified exchange on at least 15 days during each calendar quarter (subject to the rule that trades that have as one of their principal purposes the meeting of the trading requirement are disregarded). Nasdaq is a qualified exchange for this purpose and, consequently, if the ADSs are regularly traded, the mark-to-market election will be available to a U.S. holder. It should be noted that only the ADSs and not our ordinary shares are listed on Nasdaq. Consequently, our ordinary shares may not be marketable if the ASX (where our ordinary shares are currently listed) does not meet the applicable requirements. U.S. holders should consult their tax advisors regarding the availability of the mark-to-market election for ordinary shares that are not represented by ADSs.
However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower-tier PFIC are themselves “marketable.” As a result, even if a U.S. holder validly makes a mark-to-market election with respect to our ordinary shares or ADSs, the U.S. holder may continue to be subject to the PFIC rules (described above) with respect to its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. U.S. holders should consult their tax advisors as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.
We do not currently intend to provide the information necessary for U.S. holders to make qualified electing fund elections if we were treated as a PFIC for any taxable year. U.S. holders should consult their tax advisors to determine whether any of the other elections described above would be available and if so, what the consequences of the alternative treatments would be in their particular circumstances.
For years in which we are determined to be a PFIC, the general tax treatment for U.S. holders described in this section would apply to indirect distributions and gains deemed to be realized by U.S. holders in respect of any of our subsidiaries that also may be determined to be PFICs. U.S. holders should consult their tax advisors regarding the application of the PFIC rules to our subsidiaries.
If a U.S. holder owns ordinary shares or ADSs during any taxable year in which we are a PFIC, the U.S. holder may be required to file an IRS Form 8621 (Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund) with respect to the company, generally with the U.S. holder’s federal income tax return for that year. You should consult your tax advisor concerning any filing requirements arising from the PFIC rules.
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The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urged to consult their own tax advisors with respect to the acquisition, ownership and disposition of our ordinary shares or ADSs, the consequences to them of an investment in a PFIC, any elections available with respect to ordinary shares and ADSs and the IRS information reporting obligations with respect to the acquisition, ownership and disposition of ordinary shares and ADSs.
Distributions
We do not expect to make any distributions in respect of the ADSs or ordinary shares. Subject to the discussion under “—Passive Foreign Investment Company Considerations” above, the gross amount of any distribution (including any amounts withheld in respect of foreign tax) actually or constructively received by a U.S. holder with respect to the ADSs or ordinary shares will generally be taxable to the U.S. holder as a dividend to the extent of the U.S. holder’s pro rata share of our current or accumulated earnings and profits as determined under U.S. federal income tax principles. Distributions in excess of earnings and profits will generally be non-taxable to the U.S. holder to the extent of, and will be applied against and reduce (but not below zero), the U.S. holder’s adjusted tax basis in the ADSs or ordinary shares. Distributions in excess of earnings and profits and such adjusted tax basis will generally be taxable to the U.S. holder as either long-term or short-term capital gain depending upon whether the U.S. holder has held the ADSs or ordinary shares for more than one year as of the time such distribution is received. However, since we do not calculate our earnings and profits under U.S. federal income tax principles, it is expected that any distribution will be reported as a dividend, even if that distribution would otherwise be treated as a non-taxable return of capital or as capital gain under the rules described above.
Non-corporate U.S. holders may qualify for the preferential rates of taxation with respect to dividends on the ADSs or ordinary shares applicable to long-term capital gains (i.e., gains from the sale of capital assets held for more than one year) and “qualified dividend income” (as discussed below) if we are a “qualified foreign corporation” and certain other requirements (discussed below) are met. A non-U.S. corporation generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange of information provision, or (b) with respect to any dividend it pays on ADSs or ordinary shares which are readily tradable on an established securities market in the United States. The ADSs are listed on Nasdaq, which is an established securities market in the United States, and we expect the ADSs to be readily tradable on Nasdaq. However, there can be no assurance that the ADSs will be considered readily tradable on an established securities market in the United States in later years. The Company, which is incorporated under the laws of Australia, believes that it qualifies as a resident of Australia for purposes of, and is eligible for the benefits of, the Treaty, although there can be no assurance in this regard. Further, the IRS has determined that the Treaty is satisfactory for purposes of the qualified dividend rules and that it includes an exchange-of-information program. However, the preferential tax rates available for qualified dividend income do not apply if we are a PFIC in the taxable year in which such dividends are paid or in the preceding taxable year. As discussed above under “—Passive Foreign Investment Company Considerations”, we believe that we were a PFIC for our taxable year ended June 30, 2025 and we may be a PFIC in future taxable years. In addition, the dividends will not be eligible for the dividends-received deduction generally allowed to corporate U.S. holders.
A U.S. holder generally may claim the amount of any Australian withholding tax as either a deduction from gross income or a credit against its U.S. federal income tax liability. The foreign tax credit is subject to numerous complex limitations that must be determined and applied on an individual basis. In addition, the creditability of foreign taxes could be affected by actions taken by intermediaries in the chain of ownership between the holders of the ADSs and our company if, as a result of such actions, the holders of the ADSs are not properly treated as beneficial owners of the underlying ordinary shares. Each U.S. holder should consult its own tax advisors regarding the foreign tax credit rules.
In general, the amount of a distribution paid to a U.S. holder in a foreign currency will be the U.S. dollar value of the foreign currency calculated by reference to the spot exchange rate on the day the depositary receives the distribution, in the case of the ADSs, or on the day the distribution is received by the U.S. holder, in the case of ordinary shares, regardless of whether the foreign currency is converted into U.S. dollars at that time. Any foreign currency gain or loss a U.S. holder realizes on a subsequent conversion of foreign currency into U.S. dollars will be U.S. source ordinary income or loss. If dividends received in a foreign currency are converted into U.S. dollars on the day they are received, a U.S. holder should not be required to recognize foreign currency gain or loss in respect of the dividend.
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Sale, Exchange or Other Taxable Disposition
A U.S. holder will generally recognize gain or loss for U.S. federal income tax purposes upon the sale, exchange or other taxable disposition of the ADSs or ordinary shares in an amount equal to the difference between the U.S. dollar value of the amount realized from such sale or exchange and the U.S. holder’s adjusted tax basis in those securities, determined in U.S. dollars. Subject to the discussion under “—Passive Foreign Investment Company Considerations” above, this gain or loss will generally be a capital gain or loss. The adjusted tax basis in the ADSs or ordinary shares generally will be equal to the cost of such ADSs or ordinary shares. Capital gain from the sale, exchange or other taxable disposition of the ADSs or ordinary shares by a non-corporate U.S. holder is generally eligible for a preferential rate of taxation applicable to capital gains if the non-corporate U.S. holder’s holding period determined at the time of such sale, exchange or other taxable disposition for such securities exceeds one year (i.e., such gain is long-term taxable gain). The deductibility of capital losses for U.S. federal income tax purposes is subject to limitations. Any such gain or loss that a U.S. holder recognizes generally will be treated as U.S. source gain or loss for foreign tax credit limitation purposes.
For a cash basis taxpayer, units of foreign currency paid or received are translated into U.S. dollars at the spot rate on the settlement date of the purchase or sale. In that case, no foreign currency exchange gain or loss will result from currency fluctuations between the trade date and the settlement date of such a purchase or sale.
An accrual basis taxpayer, however, may elect the same treatment required of cash basis taxpayers with respect to purchases and sales of our ordinary shares or ADSs that are traded on an established securities market, provided the election is applied consistently from year to year. Such election may not be changed without the consent of the IRS. For an accrual basis taxpayer who does not make such election, units of foreign currency paid or received are translated into U.S. dollars at the spot rate on the trade date of the purchase or sale. Such an accrual basis taxpayer may recognize exchange gain or loss based on currency fluctuations between the trade date and the settlement date. Any foreign currency gain or loss a U.S. holder realizes will be U.S. source ordinary income or loss.
Backup Withholding and Information Reporting.
U.S. holders generally will be subject to information reporting requirements with respect to distributions on the ordinary shares or ADSs and on the proceeds from the sale, exchange, or disposition of the ordinary shares or ADSs that are paid within the United States or through U.S.-related financial intermediaries, unless the U.S. holder is an “exempt recipient.” In addition, U.S. holders may be subject to backup withholding on such payments, unless the U.S. holder provides a taxpayer identification number and a duly executed IRS Form W-9 or otherwise establishes an exemption. Backup withholding is not an additional tax, and the amount of any backup withholding will be allowed as a credit against a U.S. holder’s U.S. federal income tax liability and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.
Foreign Asset Reporting.
Certain individual U.S. holders are required to report information relating to an interest in the ordinary shares or ADSs, subject to certain exceptions (including an exception for shares held in accounts maintained by U.S. financial institutions) by filing IRS Form 8938 (Statement of Specified Foreign Financial Assets) with their federal income tax return. U.S. holders are urged to consult their tax advisors regarding their information reporting obligations, if any, with respect to their ownership and disposition of the ordinary shares or ADSs.
THE DISCUSSION ABOVE IS A SUMMARY OF THE U.S. FEDERAL INCOME TAX CONSEQUENCES OF AN INVESTMENT IN THE ORDINARY SHARES OR ADSs AND IS BASED UPON LAWS AND RELEVANT INTERPRETATIONS THEREOF IN EFFECT AS OF THE DATE OF THIS ANNUAL REPORT, ALL OF WHICH ARE SUBJECT TO CHANGE, POSSIBLY WITH RETROACTIVE EFFECT. EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN THE ORDINARY SHARES OR ADSs IN LIGHT OF THE INVESTOR’S OWN CIRCUMSTANCES.
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Material Australian Tax Considerations
In this section, we discuss the material Australian income tax, stamp duty and goods and services tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ADSs or ordinary shares represented by ADSs. It is based upon existing Australian tax law as of the date of this registration statement, 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 ADSs or shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any non-Australian or state tax considerations, other than stamp duty and goods and services tax.
Prospective investors are urged to consult their tax advisors regarding the Australian and non-Australian income and other tax considerations of the acquisition, ownership and disposition of the ADSs or shares. This summary is based upon the premise that the holder of an ADS is not an Australian tax resident for Australian income tax purposes and is not carrying on business in Australia through a permanent establishment (referred to as a “Non-Australian Holder” in this summary). This summary is also based on the assumption that a Non-Australian Holder is “absolutely entitled” to the ordinary shares represented by an ADS (see “—Nature of ADSs for Australian Taxation Purposes” below).
Nature of ADSs for Australian Taxation Purposes
Non-Australian Holders of ADSs should obtain specialist Australian tax advice regarding their rights and obligations under the deposit agreement with the depositary, including whether the deposit arrangement constitutes a “bare trust” which results in the holders of an ADS being “absolutely entitled” to the underlying shares represented by the ADS for Australian taxation purposes. Apart from certain aspects of the Australian tax legislation (for example, the Australian capital gains tax and withholding tax provisions, which are discussed below), there is no express legislative basis for disregarding “bare trusts” for Australian tax purposes generally.
This summary proceeds on the assumption that the deposit arrangement results in holders of ADSs being “absolutely entitled” to the underlying shares. On this basis, holders of ADSs can be treated as the owners of the underlying ordinary shares for Australian capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends derived by the holders of ADSs as the persons presently 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 they are paid out of company profits that have been subject to income tax. Fully franked dividends are not subject to dividend withholding tax. To the extent that they are unfranked, dividends payable to Non-Australian Holders will be subject to dividend withholding tax except to the extent they are declared to be “conduit foreign income”, or CFI. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country with which Australia has a double taxation treaty and qualifies for the benefits of the treaty. Under the provisions of the current Double Taxation Convention between Australia and the United States, the Australian tax withheld on unfranked dividends that are not declared to be CFI paid by us to which a resident of the United States is beneficially entitled is limited to 15%.
Under the Double Taxation Convention between Australia and the United States, if a U.S. resident company that is a Non-Australian Holder directly owns 10% or more of the voting interests in us, the Australian tax withheld on unfranked dividends that are not declared to be CFI paid by us to which the company is beneficially entitled is limited to 5%.
Character of ADSs or Shares for Australian Taxation Purposes
The Australian tax treatment of a sale or disposal of the ADSs or underlying shares will depend on whether they are held on revenue or capital account. ADSs may be held on revenue rather than capital account, for example, where they are held by share traders or any profit arises from a profit-making undertaking or scheme entered into by the holder. Non-Australian Holders of ADSs should obtain specialist Australian tax advice regarding the characterization of any gain or loss on a sale or disposal of the ADSs or underlying shares as revenue or capital in nature.
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Tax on Sales or other Dispositions of Shares or ADSs—Capital Gains Tax
Non-Australian Holders who are treated as the owners of the underlying shares on the basis that they are absolutely entitled to those shares will not be subject to Australian capital gains tax on the gain made on a sale or other disposal of ordinary shares, provided the shares are not “taxable Australian property.” Taxable Australian property includes “indirect Australian real property interests,” which are interests in a company where:
Australian capital gains tax applies to net capital gains at a taxpayer’s marginal tax rates. Net capital gains are calculated after reduction for capital losses, which may only be offset against capital gains.
If a Non-Australian Holder of ADSs was not absolutely entitled to the underlying shares, and the ADSs were held on capital account, the same principles would apply in determining whether a gain on the sale or disposal of the ADSs would be subject to Australian capital gains tax. That is, a Non-Australian Holder should not be subject to Australian capital gains tax provided the ADSs are not taxable Australian property.
The 50% capital gains tax discount is not available to Non-Australian Holders on gains from assets acquired after May 8, 2012 where they were non-Australian residents during the entire holding period. Companies are not entitled to a capital gains tax discount.
In the 2024-2025 Federal Budget, the Federal Government of Australia announced that it will be strengthening the foreign resident capital gains tax rules in respect of disposal of assets occurring on or after July 1, 2025. There is limited detail on the proposed changes and they will be subject to consultation. Non-Australian Holders should monitor any developments in relation to these proposed changes and obtain specialist Australian tax advice regarding the Australian tax implications made on a sale or other disposal of the ADSs or underlying shares if and when the changes to the foreign resident capital gains tax rules become effective.
Tax on Sales or other Dispositions of ADSs—Revenue Account
Non-Australian Holders who hold their ADSs on revenue account may have the gains made on the sale or other disposal of the ADSs included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia. In the case of gains which are ordinary income, there are no express provisions which treat holders of ADSs as the owners of the underlying shares where they are absolutely entitled to those shares under a bare trust.
Non-Australian Holders assessable under these ordinary income provisions in respect of gains made on ADSs held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which currently start at a marginal rate of 32.5% for individuals and would be required to file an Australian tax return. Some relief from Australian income tax may be available to a Non-Australian Holder who is resident of a country with which Australia has a double taxation treaty, qualifies for the benefits of the treaty and does not, for example, derive the gain in carrying on business through a permanent establishment in Australia.
To the extent an amount would be included in a Non-Australian Holder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount may be reduced, so that the holder may not be subject to double Australian tax on any part of the gain.
Dual Residency
If a holder of ADSs is a resident of both Australia and the United States under those countries’ domestic taxation laws, that holder may be subject to tax as an Australian resident. If, however, the holder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia and qualifies for the benefit of that treaty, the Australian tax may be subject to limitation by the Double Taxation Convention. Holders should obtain specialist taxation advice in these circumstances.
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Stamp Duty
No Australian stamp duty is payable by Australian residents or non-Australian residents on the issue, transfer and/or surrender of the ADSs or ordinary shares, provided that the securities issued, transferred and/or surrendered do not represent 90% or more of our issued shares.
Australian Death Duty
Australia does not have estate or death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a deceased person’s shares. The disposal of inherited shares by beneficiaries may, however, give rise to a capital gains tax liability if the gain falls within the scope of Australia’s jurisdiction to tax.
Goods and Services Tax
No Australian goods and services tax will be payable on the supply of the ADSs or ordinary shares.
THE DISCUSSION ABOVE IS A SUMMARY OF THE AUSTRALIAN TAX CONSEQUENCES OF AN INVESTMENT IN OUR ORDINARY SHARES OR ADSs AND IS BASED UPON LAWS AND RELEVANT INTERPRETATIONS THEREOF IN EFFECT AS OF THE DATE OF THIS ANNUAL REPORT, ALL OF WHICH ARE SUBJECT TO CHANGE, POSSIBLY WITH RETROACTIVE EFFECT. EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN OUR ORDINARY SHARES OR ADSs IN LIGHT OF THE INVESTOR’S OWN CIRCUMSTANCES.
10F. Dividends and Paying Agents
Not applicable.
10G. Statement by Experts
Not applicable.
10H. Documents on Display
We are subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers and under those requirements will file reports with the SEC. Those reports may be inspected without charge at the locations described below. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing 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. In addition, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as United States companies whose securities are registered under the Exchange Act. Nevertheless, we will file with the SEC an Annual Report on Form 20-F containing financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting firm.
The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, such as us, that file electronically with the SEC. With respect to references made in this annual report to any contract or other document of our company, such references are not necessarily complete and you should refer to the exhibits attached or incorporated by reference to this annual report for copies of the actual contract or document.
We maintain a corporate website at www.opthea.com. Information contained on, or that can be accessed through, our website does not constitute a part of this annual report and our website address is included herein as an inactive textual reference only.
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10I. Subsidiary Information
Not required.
10J. Annual Report to Security Holders
Pursuant to Item 10J of Form 20-F, exhibit 15.2 to this annual report on Form 20-F includes our annual report to security holders. None of such annual report is incorporated by reference into this annual report on Form 20-F. Such annual report is not deemed to be filed as part of this annual report on Form 20-F.
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 5E—Critical Accounting Estimates— Qualitative and Quantitative Disclosures about Market Risk.”
Item 12. Description of Securities Other than Equity Securities
12A. Debt Securities
Not applicable.
12B. Warrants and Rights
Not applicable.
12C. Other Securities
Not applicable.
12D. American Depositary Shares
The Bank of New York Mellon, as depositary, registers and delivers American Depositary Shares, or ADSs. Each ADS represents eight ordinary shares (or a right to receive eight ordinary shares) deposited with HSBC Bank Australia Limited, as custodian for the depositary in Australia. Each Ads also represents any other securities, cash or other property that may be held by the depositary. The deposited shares together with any other securities, cash or other property held by the depositary are referred to as the deposited securities. The depositary’s office at which the ADSs are administered, and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.
You may hold ADSs either (A) directly (i) by having an ADR, which is a certificate evidencing a specific number of ADSs, registered in your name, or (ii) by having uncertificated ADSs registered in your name, or (B) indirectly by holding a security entitlement in ADSs through your broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, or DTC. If you hold ADSs directly, you are a registered ADS holder, or an ADS holder. This description assumes you are an ADS holder. If you hold the ADSs indirectly, you must rely on the procedures of your broker or other financial institution to assert the rights of ADS holders described in this section. You should consult with your broker or financial institution to find out what those procedures are.
Registered holders of uncertificated ADSs receive statements from the depositary confirming their holdings.
As an ADS holder, you are not treated as one of our shareholders and you do not have shareholder rights. Australian law governs shareholder rights. The depositary is the holder of the shares underlying your ADSs. As a registered holder of ADSs, you have ADS holder rights. The amended and restated deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs.
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Fees and Expenses
The following table shows the fees and charges that a holder of our ADSs may have to pay, either directly or indirectly. The majority of these costs are set by the depositary bank and are subject to change:
Persons depositing or withdrawing shares or ADS holders must pay: |
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For: |
US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs) |
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Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates |
US$0.05 (or less) per ADS |
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Any cash distribution to ADS holders |
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs |
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Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders |
US$0.05 (or less) per ADS per calendar year |
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Depositary services |
Registration or transfer fees |
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Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares |
Expenses of the depositary |
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Cable (including SWIFT) and facsimile transmissions (when expressly provided in the deposit agreement) Converting foreign currency to U.S. dollars |
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes |
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As necessary |
Any charges incurred by the depositary or its agents for servicing the deposited securities |
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As necessary |
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the depositary and that may earn or share fees, spreads or commissions.
The depositary may convert currency itself or through any of its affiliates, or the custodian or we may convert currency and pay U.S. dollars to the depositary. Where the depositary converts currency itself or through any of its affiliates, the depositary acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary makes no representation that the exchange rate used or obtained by it or its affiliate in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or that the method by which
128
that rate will be determined will be the most favorable to ADS holders, subject to the depositary’s obligation to act without negligence or bad faith. The methodology used to determine exchange rates used in currency conversions made by the depositary is available upon request. Where the custodian converts currency, the custodian has no obligation to obtain the most favorable rate that could be obtained at the time or to ensure that the method by which that rate will be determined will be the most favorable to ADS holders, and the depositary makes no representation that the rate is the most favorable rate and will not be liable for any direct or indirect losses associated with the rate. In certain instances, the depositary may receive dividends or other distributions from the United States in U.S. dollars that represent the proceeds of a conversion of foreign currency or translation from foreign currency at a rate that was obtained or determined by us and, in such cases, the depositary will not engage in, or be responsible for, any foreign currency transactions and neither it nor we make any representation that the rate obtained or determined by us is the most favorable rate and neither it nor we will be liable for any direct or indirect losses associated with the rate.
Payment of Taxes
ADS holders are responsible for any taxes or other governmental charges payable on your ADSs or on the deposited securities represented by any of your ADSs. The depositary may refuse to register any transfer of your ADSs or allow you to withdraw the deposited securities represented by your ADSs until those taxes or other charges are paid. It may apply payments owed to you or sell deposited securities represented by your ADSs to pay any taxes owed and you will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to ADS holders any proceeds, or send to ADS holders any property, remaining after it has paid the taxes. Your obligation to pay taxes and indemnify us and the depository against any tax claims will survive the transfer or surrender of your ADSs, the withdrawal of the deposited ordinary shares as well as the termination of the deposit agreement.
See Exhibit 2.3 -Description of Securities” for additional information on the ADSs.
129
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
E. Use of Proceeds
Not applicable
Item 15. Controls and Procedures
A. Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to provide reasonable assurance that information required to be disclosed in reports filed under the Exchange Act is recorded, processed, summarized and reported within the specified time periods and accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2025. Based on such evaluation, our Principal Executive Officer and Principal Financial Officer have concluded that, as of June 30, 2025, our disclosure controls and procedures were not effective because of the material weakness in our internal control over financial reporting as described below.
B. Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the effectiveness of our internal control over financial reporting. Under the supervision and with the participation of our Principal Executive Officer and our Principal Financial Officer, management assessed our internal control over financial reporting based upon the framework in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, our management has concluded that our internal control over financial reporting was not effective as of June 30, 2025 because we did not design and maintain effective controls in relation to accounting for non-routine transactions and its related note disclosures which resulted in our failure to prevent and detect material errors which were corrected in our consolidated financial statements as of and for the year ended June 30, 2025 related to (1) the accounting and disclosures of the financial liabilities in connection with our Funding Agreement and (2) the accounting application and related disclosures of investor options in the prior year.
We will continue to take certain measures to remediate the material weakness described above including implementing key mitigating controls to address the risk associated with accurately accounting for and disclosing non-routing transactions, such as the Funding Agreement and investor options. The material weakness will not be considered remediated until management completes the design and implementation of the measures described above and the controls operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. We are working to remediate the material weakness as efficiently and effectively as possible.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, and can only provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. 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.
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C. Attestation Report of the Registered Public Accounting Firm
This annual report does not include an attestation report of the company’s registered public accounting firm due to a transition period established by the SEC’s rules for emerging growth companies.
D. Changes in Internal Control Over Financial Reporting
Other than as discussed above in Management's Annual Report on Internal Control Over Financial Reporting, there have been no changes to our internal control over financial reporting during the fiscal year ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 16. [Reserved]
Item 16A. Audit Committee Financial Expert
The members of our Audit and Risk Committee are Messrs. Quinton Oswald (till his resignation June 2025), Mr. Sujal Shah (appointed April 2024), Dr. Susan Orr (till her resignation June 2025), Ms. Connell and Messr Gozlan. Our board of directors has determined that each of Messrs. Oswald, Gozlan and Dr. Orr and Ms. Connell satisfies the independence requirements under Nasdaq listing standards and Rule 10A-3(b)(1) of the Exchange Act. The chairperson of our Audit and Risk Committee is Mr. Shah. Our board of directors has determined that Mr. Shah is an “audit committee financial expert” within the meaning of SEC regulations. Each member of our Audit and Risk Committee can read and understand fundamental financial statements in accordance with applicable requirements. In arriving at these determinations, our board of directors has examined each member’s scope of experience and the nature of his or her employment.
Item 16B. Code of Ethics
We have adopted a Code of Conduct applicable to all of our directors, officers and employees. Our Code of Conduct is available on our website at www.opthea.com. We post on our website all disclosures that are required by law or the listing standards of Nasdaq concerning any amendments to, or waivers from, any provision of the Code of Conduct. The reference to our website address does not constitute incorporation by reference of the information contained at or available through our website, and you should not consider it to be a part of, this annual report.
Item 16C. Principal Accountant Fees and Services
Fees Paid to Independent Public Accountants
The following table sets forth, for each of the years indicated, the fees billed by Deloitte Touche Tohmatsu.
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2025 |
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2024 |
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2023 |
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(in thousands A$) |
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Audit Fees |
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A$555 |
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A$563 |
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A$357 |
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Audit-Related Fees |
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— |
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— |
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— |
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Tax Fees |
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— |
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— |
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— |
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Other Fees |
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— |
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— |
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— |
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Total |
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A$555 |
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A$563 |
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A$357 |
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“Audit Fees” are the aggregate fees billed for the audit of our annual financial statements. This category also includes services that Deloitte Touche Tohmatsu provides, such as consents and assistance with and review of documents filed with the SEC.
“Audit-Related Fees” are the aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit, including fees related to our public offering, and are not reported under Audit Fees.
“Tax Fees” are the aggregate fees billed for professional services rendered by Deloitte Touche Tohmatsu for tax compliance, tax advice and tax planning related services.
131
“Other Fees” are any additional amounts billed for products and services provided by Deloitte Touche Tohmatsu.
There were no “Audit-Related Fees,” or “Tax Fees” billed or paid during the fiscal years ended June 30, 2025, 2024 or 2023.
Pre-Approval of Audit and Non-Audit Services
The Audit and Risk Management Committee’s pre-approval is required for all services provided by
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. In order to rely on this exception, we are required to disclose each Nasdaq Stock Market Rule that we do not follow and describe the home country practice we do follow in lieu thereof. In accordance with this exception, we intend to follow Australian corporate governance practices in lieu of the following Nasdaq corporate governance standards:
132
Item 16H. Mine Safety Disclosure
Not applicable.
Item 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
Item 16J. Insider Trading Policies
Our board of directors has
Item 16K. Cybersecurity
Risk Management and Strategy
133
Governance
134
PART III
Item 17. Financial Statements
See “Item 18—Financial Statements.”
Item 18. Financial Statements
The consolidated financial statements and the related notes required by this Item are included in this annual report beginning on page F-1.
Item 19. Exhibits
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Incorporated by Reference |
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Exhibit Number |
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Exhibit Description |
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Form |
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File No. |
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Exhibit |
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Filing Date |
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Filed Herewith |
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1.1 |
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Certificate of Registration of Opthea Limited. |
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F-1 |
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333-249020 |
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3.1 |
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9/24/20 |
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1.2 |
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Constitution of Opthea Limited. |
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F-1 |
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333-249020 |
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3.2 |
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9/24/20 |
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2.1 |
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Form of Amended and Restated Deposit Agreement. |
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F-1/A |
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333-249020 |
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4.1 |
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10/9/20 |
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2.2 |
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Form of American Depositary Receipt evidencing American Depositary Shares. |
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F-1/A |
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333-249020 |
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4.1 |
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10/9/20 |
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2.3 |
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Description of Securities. |
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20-F |
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001-39621 |
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2.3 |
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10/28/21 |
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4.1* |
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Amended and Restated Long Term Incentive Plan Rules. |
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6-K |
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001-39621 |
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99.3 |
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9/13/21 |
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4.2* |
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Non-Executive Directors Share and Option Plan Rules. |
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F-1 |
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333-249020 |
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10.6 |
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9/24/20 |
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4.3* |
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Executive Employment Contract, dated May 3, 2021, between the Registrant and Karen Adams. |
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20-F |
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001-39621 |
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4.4 |
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10/28/21 |
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4.6* |
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Form of Non-Executive Director Agreement. |
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F-1/A |
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333-249020 |
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10.9 |
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10/9/20 |
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4.9 |
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Form of Deed of Indemnity, Insurance and Access. |
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F-1 |
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333-249020 |
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10.3 |
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9/24/20 |
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4.14 |
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Sales Agreement by and between the Registrant and Jefferies LLC, dated February 1, 2022. |
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F-3 |
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333-262444 |
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1.2 |
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2/1/22 |
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4.16 |
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Consultancy Agreement by and between Opthea Limited and Lawrence Gozlan, dated as of August 28, 2023 |
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20-F |
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001-39621 |
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4.16 |
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9/30/23 |
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4.17* |
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Executive Employment Contract dated October 27, 2023 between Opthea US Inc and Fred Guerard |
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20-F |
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001-39621 |
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4.17 |
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8/30/24 |
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4.18#
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Amended and Restated Development Funding Agreement by and between Opthea Limited, Ocelot SPV LP, as Collateral Agent, and the Investors from Time to Time Party Thereto, dated December 22, 2023
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20-F |
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001-39621 |
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4.19 |
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8/30/24 |
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135
4.19*
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Executive Employment Contract dated October 28, 2024 between Opthea US, Inc. and Thomas Reilly
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X
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4.20*
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Executive Employment Contract dated October 4, 2024 between Opthea US, Inc. and Parisa Zamiri
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X
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4.21#
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Settlement Agreement |
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X
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4.22#
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Subscription Agreement |
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X
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8.1 |
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List of subsidiaries. |
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20-F |
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001-39621 |
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8.1 |
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10/28/21 |
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11.1 |
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Securities Trading Policy |
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20-F |
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001-39621 |
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11.1 |
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8/30/24 |
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12.1 |
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Certification of the Principal 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. |
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X |
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12.2 |
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Certification of the Principal 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. |
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X |
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13.1† |
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Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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15.1 |
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Consent of Deloitte Touche Tohmatsu, independent registered public accounting firm. |
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X |
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15.2 |
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Annual Report 2024-2025 |
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6-K |
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001-39621 |
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99.1 |
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9/15/2025 |
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97.1 |
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Opthea Limited Incentive Compensation Recoupment Policy. |
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20-F |
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001-39621 |
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97.1 |
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8/30/24 |
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101.INS |
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Inline XBRL Instance Document—this instance document does not appear in the Interactive Data File because its XBRL tags embedded within the Inline XBRL document |
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X |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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X |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Indicates management contract or compensatory plan or arrangement.
# 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 of the type that the Company treats as private or confidential. The registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.
† The certification attached as Exhibit 13.1 accompanying this Annual Report on Form 20-F is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Opthea Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 20-F, irrespective of any general incorporation language contained in such filing.
136
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.
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Opthea Limited |
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By: |
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/s/ Jeremy Levin |
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Name: |
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Jeremy Levin. |
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Title: |
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Chairman and Chief Executive Officer
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Dated: September 15, 2025
137
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 0 |
F-2 |
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Consolidated Statements of Profit or Loss and Other Comprehensive Income |
F-3 |
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Consolidated Statements of Financial Position |
F-4 |
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Consolidated Statements of Changes in Equity |
F-5 |
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Consolidated Statements of Cash Flows |
F-6 |
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Notes to Consolidated Financial Statements |
F-7 |
F-1
Report of Independent Registered Public Accounting Firm
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Opthea Limited
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of Opthea Limited and subsidiaries (the “Company”) as of June 30, 2025 and 2024, the related consolidated statements of profit or loss and other comprehensive income, changes in equity, and cash flows, for each of the three years in the period ended June 30, 2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2025, in conformity with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB).
Substantial Doubt related to Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company incurred a net loss of $162.8 million, had a net cash outflow from operating activities of $158.6 million during the year and, as of June 30, 2025, the Company had an equity deficit of $201.1 million. The Company has discontinued the development of sozinibercept in wet AMD and is undergoing a full strategic review of the business. These matters raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte Touche Tohmatsu
DELOITTE TOUCHE TOHMATSU
September 15, 2025
We have served as the Company’s auditor since 2012.
F-2
OPTHEA LIMITED
Consolidated Statements of Profit or Loss and Other Comprehensive Income
For the Years ended June 30, 2025, and 2024, and 2023
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Years ended June 30, |
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2025 |
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2024 |
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2023 |
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US$(000's) |
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US$(000's) |
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Revenue |
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Other income |
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Operating expenses: |
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Research and development (includes amounts paid to related parties $ |
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Administration expenses (includes amounts paid to related parties $ |
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Total operating expenses |
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Operating Loss |
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Finance income |
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Interest expense on DFA* (includes amounts to related parties $ |
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Gain on remeasurement of financial liability - DFA |
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Fair value gain/(loss) on derivatives - investor options |
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Net foreign exchange loss |
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Loss before income tax |
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Income tax benefit |
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Loss for the year |
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Other comprehensive income |
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Other comprehensive income for the period, net of tax |
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— |
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— |
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— |
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Total comprehensive loss for the year |
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Loss for the year is attributable to: |
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Owners of the Company |
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Net loss |
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Total comprehensive loss for the year is attributable to: |
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Owners of the Company |
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Comprehensive loss |
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Loss per share attributable to the owners of the Company: |
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- Basic and diluted loss per share (cents) |
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(13.29 |
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(34.51 |
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(32.20 |
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*
The above consolidated statements of profit or loss and other comprehensive income should be read in conjunction with the accompanying notes.
F-3
OPTHEA LIMITED
Consolidated Statements of Financial Position
as of June 30, 2025, and 2024
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June 30, |
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June 30, |
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2025 |
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2024 |
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US$(000's) |
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US$(000's) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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Current tax receivable |
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Receivables |
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Prepayments (includes amounts owed by related parties $ |
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Total current assets |
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Non-current assets: |
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Equipment |
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Right-of-use assets |
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Prepayments (includes amounts owed by related party $ |
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Total non-current assets |
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Total assets |
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Liabilities |
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Current liabilities: |
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Payables |
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Lease liabilities |
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Derivative financial liabilities - investor options |
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Financial liabilities - DFA (includes amounts due to a related party $ |
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Provisions |
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Total current liabilities |
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Non-current liabilities: |
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Financial liabilities - DFA (includes amounts due to a related party $ |
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Provisions |
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Total non-current liabilities |
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Total liabilities |
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Net Assets |
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( |
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Equity |
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Contributed equity |
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Accumulated Loss |
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Reserves |
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Total Equity |
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The above consolidated statements of financial position should be read in conjunction with the accompanying notes.
F-4
OPTHEA LIMITED
Consolidated Statements of Changes in Equity
for the Years ended June 30, 2025, and 2024, and 2023
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Contributed |
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Share-based |
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Fair value of |
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FX translation |
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Accumulated |
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Total |
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equity |
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payment |
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Investment |
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Reserve |
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Deficit |
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Equity |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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Balance at June 30, 2022 |
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( |
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Net loss for the year |
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— |
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— |
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— |
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— |
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( |
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( |
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Total Comprehensive income and expense for the period |
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— |
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— |
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— |
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( |
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Issuance of ordinary shares net of issuance costs $ |
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— |
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— |
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— |
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— |
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Exercise of options granted under LTIP and NED plan |
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( |
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— |
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— |
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— |
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Recognition of share-based payment |
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— |
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— |
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— |
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Balance at June 30, 2023 |
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( |
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( |
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Net loss for the year |
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— |
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— |
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— |
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( |
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( |
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Total Comprehensive income and expense for the period |
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— |
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— |
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— |
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( |
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( |
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Issuance of ordinary shares in September 2023 net of issuance costs $ |
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— |
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— |
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— |
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— |
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Issuance of ordinary shares in June 2024 net of issuance cost of $ |
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— |
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— |
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— |
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— |
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Issuance of ordinary shares on exercise of options from equity financing |
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— |
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— |
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— |
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— |
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Recognition of share-based payment |
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-— |
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— |
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— |
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— |
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Balance at June 30, 2024 |
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( |
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( |
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Net loss for the year |
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— |
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— |
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— |
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— |
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( |
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( |
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Total Comprehensive income and expense for the period |
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— |
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— |
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— |
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( |
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( |
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Issuance of ordinary shares in July 2024 (net of issuance costs US$ |
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— |
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— |
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— |
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— |
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Issuance of ordinary shares on exercise of options from equity financing |
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— |
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— |
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— |
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— |
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Exercise of options granted under LTIP and NED plan |
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— |
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— |
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— |
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— |
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Recognition of share-based payment |
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— |
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— |
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— |
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— |
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Balance at June 30, 2025 |
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( |
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( |
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The above consolidated statements of change in equity should be read in conjunction with the accompanying notes.
F-5
OPTHEA LIMITED
Consolidated Statements of Cash Flows
for the Years ended June 30, 2025, and 2024, and 2023
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Year ended June 30, |
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2025 |
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2024 |
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2023 |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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Cashflow from operating activities |
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Interest received |
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Royalty and license income received |
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Grant and other income |
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Payment of lease interest |
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( |
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( |
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( |
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Payments to suppliers, employees and for research & development and intellectual property costs (inclusive of GST) |
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( |
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( |
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( |
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Taxes paid to US |
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— |
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— |
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Research and development tax incentive scheme credit received in cash |
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Net cash flows used in operating activities |
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( |
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Cash flow from investing activities: |
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Purchase of equipment |
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( |
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( |
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Net cash used in investing activities |
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( |
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( |
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( |
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Cash flows from financing activities: |
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Payment of lease liabilities |
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( |
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Proceeds on issue of shares, net of issuance costs |
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Net proceeds under the DFA |
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— |
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Cash received for ordinary shares issued on exercise of investor options |
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— |
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— |
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Cash received for ordinary shares issued on exercise of options LTIP |
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— |
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Net cash provided by financing activities |
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Net (decrease)/increase in cash and cash equivalents |
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( |
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Effects of exchange rate changes on the balance of cash held in foreign currencies |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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The above consolidated statements of cash flows should be read in conjunction with the accompanying notes.
F-6
OPTHEA LIMITED
Notes to Consolidated Financial Statements
Note 1 Reporting Entity
Opthea Limited (the Company) is a listed public company incorporated in Australia. The address of its registered office and principal place of business is: C/- Prime Company Compliance Level 9, 505 Little Collins Street, Melbourne, Victoria 3000, Australia. These consolidated financial statements comprise the Company and its subsidiaries (together referred to as the Group). The Group’s principal activity is the research and development phase of new drugs for novel therapeutic products based on targeting Vascular Endothelial Growth Factors (VEGF) C, D and R3.
Note 2. Basis of Accounting
These financial statements are general purpose financial statements which have been prepared in accordance with International Financial Reporting Standards (“or IFRS Accounting Standards”) as issued by the International Accounting Standards Board (the “IASB”).
The financial statements comprise the consolidated financial statements of the Group. For the purposes of preparing the consolidated financial statements, the Company is a for‑profit entity.
The financial statements were authorized for issue by the directors on September 15, 2025.
Going Concern
The consolidated financial statements have been prepared on the going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
For the full year ended June 30, 2025, the Group recorded a loss after income tax of $
On March 24, 2025, the Group announced topline data results for the Combination OPT‑302 with Aflibercept Study (COAST) phase three clinical trial. It was announced that the primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 was not met. Following the negative results of the COAST Phase 3 trial, Opthea determined that the most appropriate course of action for wet aged‑related macular degeneration (wet AMD) patients, shareholders, and other stakeholders was to accelerate the Study of OPT‑302 in combination with Ranibizumab (ShORe) trial topline data readout. On March 31, 2025 the Group announced that the ShORE phase three clinical trial also did not meet the primary endpoint of mean change in BCVA from baseline to week 52.
Following consultation with Ocelot SPV LP and Sanba II Investment Group (together, the “DFA Investors”), the Group agreed to discontinue the development of sozinibercept in wet AMD. Trading in the Group’s shares on the Australian Stock Exchange (ASX) and Nasdaq have been suspended since this announcement and remain suspended.
Following the discontinuation of the clinical trials, Opthea’s overall strategy has been to streamline its operations, which has resulted in the Group reducing its workforce by over
The Group also entered negotiations with DFA Investors to settle the Development Funding Agreement (DFA). Under the terms of the DFA, in certain instances the Group may obligated to pay the DFA Investors up to four multiples of the amounts paid to Opthea under the DFA. Termination can be triggered by a range of events including if Opthea fails to use commercially reasonable efforts to develop and commercialize sozinibercept, if positive trial results are not achieved or if regulatory approval is not obtained. The agreement also includes termination clauses relating to change of control, disagreement with DFA Investors, inability to fund development costs, safety, bankruptcy and other material breaches, as defined in the DFA. Each termination trigger has a
F-7
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
corresponding percentage to be paid, with possible outcomes requiring the Group to repay an amount equal to
On August 19, 2025, Opthea and the DFA Investors reached a binding agreement to terminate the DFA. As part of the settlement arrangements, all parties have entered into an agreement of settlement and release (Settlement Agreement) and an equity subscription deed (Subscription Deed). Under these arrangements, the DFA Investors received from the Group a one‑off cash payment of $
Following the DFA settlement, the Directors will continue to focus on maximizing shareholder value through the completion of a full strategic review of the business. The first phase of the strategic review will be focused on reformulating its portfolio of drug candidates targeting VEGF‑C and/or VEGF‑D, of which OPT‑302 is one of these drug candidates, which was previously delivered to the eye via injection to treat wet AMD, to various other forms of delivery that may be appropriate for delivering its portfolio of drug candidates to other organs. To implement phase one, Opthea has already taken steps to apply for a patent in order to protect the use of OPT‑302 in various delivery methods. The Directors and management have forecast that the first phase of the strategic review, together with ongoing operating costs and finalization of operations streamlining in the first half of FY2026, will cost up to $
Following completion of phase one and subject to the successful reformulation of one of its drug candidates targeting VEGF‑C and/or VEGF‑D, Opthea will look to conduct clinical trials of its drug candidate in treating VEGF‑C and/or VEGF‑D mediated disorders in other organs. Similar to previous clinical trials conducted for sozinibercept in wet AMD, it is expected that any future clinical trials would be outsourced to third party providers. The forecast cost of the second phase of the strategic review is variable, depending on whether the reformulation process is successful and the nature and size of clinical trials to be conducted. At present, the Directors and management’s best estimate of the costs associated with phase two is in the range of $
The Group expects that it has sufficient funds to continue its operations into the fourth calendar quarter of 2026.
Based on this assessment, the Directors and management believe that the Group has adequate funding through its existing cash and cash equivalents balance to continue operations, realize its assets, and settle its liabilities in the normal course of business.
However, there remains uncertainty on the potential product and future operations of the Group which is dependent on the strategic review and its outcomes. Furthermore, the Group may incur additional costs to those estimated and it may need to raise additional funds of which the timing and amount is unknown at this time. The Group does not have any committed external source of funds and expects to finance future cash needs through public or private equity financings. The Group cannot be certain that additional funding will be available to it on acceptable terms, or at all. Furthermore, the Group remains suspended as it engages with the listing authorities on its product and operations of the Group. Therefore, a material uncertainty exists that may cast significant doubt as whether the Group will continue as a going concern and, therefore, that it may be unable to realize its assets and discharge its liabilities in the normal course of business.
The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or to the amounts and classification of liabilities that might be necessary should the Group not continue as a going concern.
F-8
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 3. Summary of Accounting Policies
The consolidated financial statements have been prepared using the material accounting policies and measurement bases summarized below.
Basis of measurement
The consolidated financial statements have been prepared on a historical cost basis, except for certain financial liabilities, which have been measured at fair value. All amounts are presented in United States dollars unless otherwise stated.
Basis of Consolidation
The consolidated financial statements incorporate the financial statements of the Company and its subsidiaries. Control is achieved when the Company:
Consolidation of a subsidiary begins when the Company obtains control over the subsidiary and ceases when the Company loses control of the subsidiary.
All intragroup assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group are eliminated in full on consolidation.
Foreign currency translation
i. Functional and presentation currency
The functional and presentation currency of the Group is the United States dollars (US$).
ii. Transactions and balances
Transactions in foreign currencies are initially recorded in the functional currency by applying the exchange rates ruling in place at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are retranslated at the rate of exchange ruling in place at the reporting date.
Non‑monetary items that are measured in terms of historical cost in a foreign currency are translated using the exchange rate as of the date of the initial transaction. Non‑monetary items measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined.
Financial assets and liabilities
Recognition and derecognition of financial assets
Purchases and sales of financial assets that require delivery of assets within the time frame generally established by regulation or convention in the marketplace are recognized on the trade date, i.e., the date that the Group commits to purchase the asset. Financial assets are derecognized when the right to receive cash flows from the financial assets has expired or when the entity transfers substantially all the risks and rewards of the financial assets. If the entity neither retains nor transfers substantially all of the risks and rewards, it derecognizes the asset if it has transferred control of the assets.
When financial assets are recognized initially, they are measured at fair value, plus directly attributable transaction costs.
F-9
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Cash and cash equivalents
Cash and cash equivalents in the statement of financial position comprise cash at bank and in hand and short‑term deposits with an original maturity 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.
For the purposes of the statement of cash flows, cash and cash equivalents consist of cash and cash equivalents as defined above.
Finance income
Almost all of the Group’s finance income is earned on short‑term bank deposits, and as such, finance income is recognized when the Group’s right to receive the payment is established.
Payables
Payables are carried at amortized cost and due to their short‑term nature, they are not discounted. They represent liabilities for goods and services provided to the Group prior to the end of the financial year that are unpaid and arise when the Group becomes obliged to make future payments in respect of the purchase of these goods and services.
The amounts are unsecured and are usually paid within
Financial liabilities - DFA
Financial liabilities are recognized in the Group’s statement of financial position when the Group becomes a party to the contractual provisions of the instrument. Financial liabilities are initially measured at fair value. Transaction costs that are directly attributable to the acquisitions or issue of financial liabilities (other than financial liabilities at fair value through profit or loss) are deducted from the fair value of the financial liabilities, as appropriate, on initial recognition. Subsequent measurement of the liability will be at its amortized cost, subject to any re-measurement of the obligation for changes in assumptions, which would be recognized through the consolidated statement of profit or loss and other comprehensive income.
Amortized cost and effective interest method
The effective interest method is a method of calculating the amortized cost of an instrument and of allocating interest expense over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through the expected life of the financial liability, or (where appropriate) a shorter period, to the amortized cost of the financial liability.
Interest expense is recognized in profit and loss and is included in the “Interest expense on DFA” line item.
Derivative financial liabilities -investor options
Derivative financial liabilities relate to investor options and are recognized in the Group’s statement of financial position when the Group becomes a party to the contractual provisions of the instrument. These options are considered a derivative as these are options with an exercise price denominated in a currency that differs from an entity’s functional currency and where certain existing equity investors were not offered to participate in the equity raise on a pro rata basis. Such derivatives are measured at fair value with subsequent changes in fair value accounted for through profit and loss Transaction costs that are directly attributable to the issue of derivative financial liabilities at fair value through profit or loss are recognized immediately in profit or loss. Transaction costs are allocated between the instruments issued based on the proportionate fair value.
At every reporting period, the Company reviews the fair value of the investor options which can be measured against the current trading value of the options on ASX. It is expected that a revaluation will result in a non‑cash gain or loss depending on the closing trading price of the options. Revaluation gains or losses are recognized on the Profit and Loss statement with a corresponding adjustment recorded to the liability. The gains or losses are unrealized.
F-10
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Equipment
Equipment is stated at historical cost less accumulated depreciation and any accumulated impairment losses. Depreciation is calculated on a straight‑line basis over their useful economic lives as follows:
The assets’ residual values, useful lives and amortization methods are reviewed, and adjusted if appropriate, at each financial year end.
An item of equipment is derecognized upon disposal or when no further economic benefits are expected from its use or disposal.
Research and development costs
Research costs are expensed as incurred. An intangible asset arising from the development expenditure on an internal project will only be recognized when the Group can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale, its intention to complete and its ability to use or sell the asset, how the asset will generate future economic benefits, the availability of resources to complete the development and the ability to measure reliably the expenditure attributable to the intangible asset during its development. The Company considers that the capitalization may only be considered after regulatory approval.
As of June 30, 2025, 2024 and 2023, the Group is in the research phase and has not capitalized any development costs to date.
Provisions and employee benefits
i. Wages, salaries, annual leave and sick leave
Liabilities for wages and salaries, including non‑monetary benefits and annual leave expected to be settled within 12 months of the reporting date are recognized in current provisions in respect of employees’ services up to the reporting date. They are measured at the amounts expected to be paid when the liabilities are settled. Expenses for non‑accumulating sick leave are recognized when the leave is taken and are measured at the rate paid or payable.
ii. Long service leave
The liability for long service leave is recognized in the provision for employee benefits and measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date. Consideration is given to expected future wage and salary levels, experience of employee departures, and periods of service. Expected future payments are discounted using market yields at the reporting date on bonds with terms to maturity that match, as closely as possible, the estimated future cash outflows.
Share‑based payment transactions
The Group provides benefits to directors and employees (including key management personnel) of the Group in the form of share‑based payments, whereby employees render services in exchange for shares or rights over shares (equity‑settled transactions).
The cost of these equity‑settled transactions with employees is measured by reference to the fair value at the date at which they are granted. Binomial, Black Scholes and Monte Carlo models are used to value the options issued.
F-11
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
The cost of the equity‑settled transactions is recognized, together with a corresponding increase in equity, over the period in which the performance conditions are fulfilled (the vesting period), ending on the date on which the relevant employees become fully entitled to the award (the vesting date).
The charge to profit or loss for the period is the cumulative amount less the amounts already charged in previous periods. There is a corresponding credit to equity.
Until an award has vested, any amounts recorded are contingent and will be adjusted if more or fewer awards vest than were originally anticipated to do so.
Contributed equity
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds. Transaction costs are allocated between the instruments issued based on the proportionate fair value.
Revenue recognition
License revenue in connection with licensing of the Group’s intellectual property (including patents) to customers is recognized as a right to use the Group’s intellectual property as it exists at the point in time in which the license is granted. This is because the contracts for the license of intellectual property are distinct and do not require, nor does the customer reasonably expect, that the Group will undertake further activities that significantly affect the intellectual property to which the customer has the rights. Although the Group is entitled to sales‑based royalties from the eventual sales of goods and services to third parties using the intellectual property licensed, these royalty arrangements do not in themselves indicate that the customer would reasonably expect the Group to undertake such activities, and no such activities are undertaken or contracted in practice. Accordingly, the promise to provide rights to the Group’s intellectual property is accounted for as a performance obligation satisfied at a point in time.
The following consideration is received in exchange for licenses of intellectual property:
During the years ended June 30, 2025, 2024 and 2023, the Group’s only revenue related to sales‑based royalties.
Income tax
Current tax
Current tax assets and liabilities for the current and prior periods are measured at the amount expected to be recovered from or paid to the taxation authorities based on the current period’s taxable income.
The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted by the reporting date.
Research and development tax incentive
The Research and Development (R&D) Tax Incentive Scheme is an Australian Federal Government program under which eligible companies with annual aggregated revenue of less than A$
F-12
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
application to AusIndustry, an Australian governmental agency, and subsequent filing of its Income Tax Return with the ATO after the financial year end.
The Group estimates the amount of R&D tax incentive after the completion of the financial year based on eligible Australia and overseas expenditures incurred during that year.
The Group has presented incentives in respect of the R&D Tax Incentive Scheme within income tax benefit in the Statements of Profit or Loss and Other Comprehensive Income by analogizing with IAS 12 “Income Taxes”.
Deferred tax
Deferred income tax is provided on all temporary differences at the reporting date between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.
Deferred income tax liabilities are recognized for all taxable temporary differences except when the deferred income tax liability arises from the initial recognition of goodwill or of an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, does not give rise to equal taxable and deductible temporary differences.
Deferred income tax assets are recognized for all deductible temporary differences, carry forward of unused tax assets (or credits) and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary differences, and the carry forward of unused tax credits and unused tax losses can be utilized, except when the deferred income tax asset relating to the deductible temporary differences arises from the initial recognition of an asset or liability in a transaction that is not a business combination and, at the time of the transaction, affects neither the accounting profit or taxable profit or loss.
The carrying amount of deferred income tax assets is reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred income tax asset to be utilized.
Unrecognized deferred income tax assets are reassessed at each reporting date and are recognized to the extent that it has become probable that future taxable profit will allow the deferred tax asset to be recovered.
Deferred income tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at balance date.
Income taxes relating to items recognized directly in equity are recognized directly in equity and not in profit or loss.
Tax consolidation legislation
Tax consolidation is a system adopted by the ATO that treats a group of entities as a single entity for tax purposes. Opthea Limited and its
The head entity which is the parent entity, in assuming the net unused tax losses and unused relevant tax credits, has recognized reductions to investments in subsidiaries and where the amount of tax losses assumed is in excess of the carrying value of the investment, the parent has recognized the difference as a distribution from subsidiaries in profit or loss.
F-13
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Other taxes
Revenues, expenses, assets and liabilities are recognized net of the amount of GST except:
The net amount of GST recoverable from, or payable to the taxation authority is included as part of receivables or payables in the statement of financial position.
Cash flows are included in the statement of cash flows on a gross basis and the GST component of cash flows arising from investing and financing activities, which is recoverable from, or payable to, the taxation authority is classified as part of operating cash flows.
Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the taxation authority.
Note 4. Critical Accounting Judgments and Key Sources of Estimation Uncertainty
In applying the Group’s accounting policies, management continually evaluates judgments, estimates and assumptions based on experience and other factors, including expectations of future events that may have an impact on the Group. All judgments, estimates and assumptions made are believed to be reasonable based on the most current set of circumstances available to management. Actual results may differ from the judgments, estimates and assumptions.
Significant judgments, estimates and assumptions made by management in the preparation of these financial statements are outlined below:
4.1 Critical judgments in applying accounting policies
Research and development costs
The majority of Opthea’s expenditure is incurred as a result of clinical trials for sozinibercept. During the years ended June 30, 2025, 2024 and 2023, Opthea progressed Phase 3 wet age‑related macular degeneration (wet AMD) trials. A key measure of Opthea’s performance is the level of expenditure incurred on the research of sozinibercept.
Judgment is required in relation to:
The directors have determined that the Group is still in a research phase and accordingly,
DFA
The Group’s accounting policy for DFA requires judgment around the determination of it having the characteristics of a debt instrument. The payments received under the DFA have been recorded as a financial liability in the Group’s consolidated statement of financial position.
F-14
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Following the discontinuation of the clinical trials, the Group exercised significant judgment in the valuation of the DFA at reporting date, including consideration of whether the loan has been discharged, suspended or modified. In the absence of a termination event, judgment was applied in determining the best estimate for the value of the liability being the funds received accreted with interest at the reporting date, as this represents the best estimate of the contractual cash flows. Refer to Note 13 and 27 for further information.
Derivative financial liabilities – investor options
The Group’s accounting for investor options requires judgment as these are options with an exercise price denominated in a currency that differs from an entity’s functional currency and are treated as a derivative where certain existing equity investors were not offered to participate in the equity raise on a pro rata basis. Judgment is required in determining whether the offer was made on a pro rata basis, which impacts the accounting of the options. Such derivatives measured at fair value with subsequent changes in fair value accounted for through profit and loss. Refer to Note14 and 25 for further information.
Taxation
Research and development tax incentive
The Research and Development (R&D) Tax Incentive Scheme is an Australian Federal Government program under which eligible companies can receive cash refunds of
For the years ended June 30, 2025, and 2024, the Group has recognized an R&D tax incentive receivable of US$
The R&D tax incentive receivable as of June 30, 2025 and 2024 is based on the legislation as currently enacted as of June 30, 2025 and 2024, respectively. Any proposed changes to the legislation, such as rate changes and eligibility requirements, may have a retrospective impact if the legislation is passed. During the years ended June 30, 2025 and 2024, no such legislative changes have occurred.
Investment tax credits such as the R&D tax incentive are outside of the scope of IAS 12 “Income Taxes” and IAS 20 “Accounting for Government Grants and Disclosure of Government Assistance.” Based on the guidance in IAS 8 “Accounting Policies, Changes in Accounting Estimates and Errors,” companies need to make an accounting policy choice on how to present these incentives, which in practice is done by either analogizing with IAS 12 or with IAS 20. In the Group’s opinion, the R&D tax incentive should be presented by analogizing to IAS 12 because the nature of the incentive is considered to be more closely aligned to income taxes, based on the following considerations:
F-15
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Functional currency
Significant judgment is required in determining the currency of the primary economic environment in which the Group operates, which requires an evaluation of various indicators related to the Group’s underlying transactions, events and conditions as they relate to generating and expending cash.
4.2 Key sources of estimation uncertainty
Development funding - financial liability
The Group evaluated the Funding Agreement and determined it to be a research and development funding arrangement with the characteristics of a debt instrument, as the transfer of financial risk to DFA Investors was not considered substantive and genuine. Accordingly, the Group has recorded payments received under the Funding Agreement as part of a development financing liability in its consolidated balance sheet. The Group measures the overall development financing liability at amortized cost which is the amount at which the financial liability is measured at initial recognition minus principal repayments, plus or minus the cumulative amortization using the effective interest method of any difference between that initial amount and the maturity amount. Refer to Note 27 for further information.
Derivative financial liabilities - investor options
The Group accounts for investor options as a derivative financial liability. Such derivatives are measured at fair value with subsequent changes in fair value accounted for through profit and loss. For the investor options that are traded on the Australian Securities Exchange, the Group uses the quoted price at the balance sheet date as the fair value of the options. For the investor options issued on June 14, 2024, fair values were determined internally using Binomial models as a quoted price was not available as at year end. Key inputs to the valuation include the share price at grant date, expected term, volatility, dividend yield, risk free rate and exercise price. Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects of non‑transferability, exercise restrictions (including the probability of meeting market conditions attached to the option), and behavioral considerations. Expected volatility is based on the historical share price volatility over the past 2 years. These investor options were listed for trading on the Australian Securities Exchange in July 2024. Should the quoted price differ from the internally determined fair value, this could have a material impact on the amounts recognized in derivative financial liabilities and in the profit and loss. Refer to Note 14 and 25 for further information.
Share‑based payment transactions
The Group measures the cost of equity‑settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. Fair values are determined internally using Binomial, Black Scholes and Monte Carlo models. The related assumptions are detailed in note 37. The accounting estimates and assumptions relating to equity‑settled share‑based payments have no impact on the carrying amounts of assets and liabilities in future reporting periods but may impact expenses and equity. Should one or more of the assumptions and estimates used in estimating the fair value of share‑based payments change, this could have a material impact on the amounts recognized in equity and employee‑related expenses. Refer to Note 37 for further information.
Note 5. Application of New and Revised Accounting Standards
New and amended Accounting Standards that are effective for the current year
The Group has adopted all of the new and revised Standards and Interpretations issued by the International Accounting Standards Board (the IASB) that are relevant to its operations and effective for the current year.
F-16
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Their adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements.
New and revised International Accounting Standards and Interpretations on issue but not yet effective
At the date of authorization of the financial statements, certain new accounting standard and interpretations have been published that are not mandatory for June 30, 2025 reporting periods and have not been early adopted by the Company.
The Directors have not yet evaluated the impact that the new and revised Accounting Standards, Interpretations and amendments will have on the Group's financial statements.
Note 6. Segment Information
The Group operates in
The Group is focused primarily on developing novel therapeutic products based on targeting Vascular Endothelial Growth Factors (VEGF) C, D and R3.
The chief financial officer regularly reviews entity wide information that is compliant with International Financial Reporting Standards. There is only
The Group’s only revenue stream in the current and previous financial year is royalty income generated from licenses granted in respect of the Group’s intellectual property that are unrelated to the Group’s core business and the development novel therapeutic products based on targeting Vascular Endothelial Growth Factors (VEGF) C, D and R3. These licenses are primarily used by third‑party licensees for research purposes. All of the royalty income of US$
Note 7. Revenue
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2025 |
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2024 |
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|
2023 |
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|||
|
|
US$(000's) |
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|
US$(000's) |
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US$(000's) |
|
|||
Sales-based royalties |
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|||
Total Revenue |
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|||
Note 8. Other Income
|
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2025 |
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2024 |
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2023 |
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|||
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|
US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Grant and other income |
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|||
Total other income |
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|||
F-17
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 9. Research and Development Expenses
|
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2025 |
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2024 |
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2023 |
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|||
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US$(000's) |
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US$(000's) |
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US$(000's) |
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|||
Employee benefits expenses: |
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|||
Salaries and fees |
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|||
Severance |
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— |
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— |
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Cash bonuses |
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Superannuation |
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Share-based payments expense |
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Total employee benefits expense |
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Payroll tax |
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Research Insurance |
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Research project costs1 |
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Total research and development expenses |
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1. The research project costs relate to the research programs in respect to the treatment of eye diseases by sozinibercept.
Note 10. Administrative expenses
|
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2025 |
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2024 |
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2023 |
|
|||
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|
US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Administrative expenses |
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Employee benefits expenses: |
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|||
Salaries and fees |
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|||
Severance |
|
|
|
|
|
— |
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|
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— |
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Cash bonuses |
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Superannuation |
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Share-based payments expense |
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Total employee benefits expense |
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Other expenses: |
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Insurance |
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Investor relations costs |
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Audit and accounting |
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Travel expenses |
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Payroll tax |
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Legal fees |
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Advisory fees |
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Consultancy costs |
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Other expenses |
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Total other expenses |
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Depreciation of: |
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Equipment and furniture |
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Right-of-use assets |
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Total depreciation expense |
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Total administrative expenses |
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Note 11. Finance Income
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2025 |
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2024 |
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2023 |
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US$(000's) |
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US$(000's) |
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US$(000's) |
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|||
Interest income |
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Total finance income |
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F-18
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 12. Interest expense on DFA
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2025 |
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2024 |
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2023 |
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|||
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US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Interest expense on DFA |
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Total interest expense on DFA |
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The interest expense on DFA is non-cash interest at the imputed rate of
Note 13. Gain on remeasurement of financial liability -DFA
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2025 |
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2024 |
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2023 |
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|||
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US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Gain on remeasurement of financial liability - DFA |
|
|
— |
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Total gain on remeasurement of financial liability - DFA |
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|
— |
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||
Refer to disclosures in Notes 4.1, 4.2 and 27
Note 14. Fair value (gain)/loss on derivative - investor options
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2025 |
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2024 |
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2023 |
|
|||
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US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Fair value (gain)/loss on derivative - investor options in September 2023 (2023 Investor options) |
|
|
( |
) |
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— |
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Fair value (gain)/loss on derivative - investor options in June/July 2024 (2024 Investor options) |
|
|
( |
) |
|
|
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|
|
— |
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Fair value (gain)/loss - investor options converted to shares |
|
|
( |
) |
|
|
— |
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— |
|
Total fair value (gain)/loss on derivative - investor options |
|
|
( |
) |
|
|
|
|
|
— |
|
|
Refer to Note 25
Note 15. Net Foreign Exchange loss
|
|
2025 |
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|
2024 |
|
|
2023 |
|
|||
|
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US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Net foreign exchange loss |
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|||
Total net foreign exchange loss |
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|
|||
Exchange differences arising on the translation of monetary items are recognized in the consolidated statements of profit and loss and other comprehensive income.
F-19
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 16. Income Taxes
|
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2025 |
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2024 |
|
|
2023 |
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|
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US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
(a) Income tax benefit |
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The major components of income tax benefit are: |
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Statement of Profit or Loss and Other Comprehensive Income |
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Current income tax credit |
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( |
) |
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( |
) |
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— |
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Deferred tax |
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Deferred tax |
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In respect of the current year |
|
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— |
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— |
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— |
|
Total income tax benefit recognized in the Statement of Profit or Loss and Other Comprehensive Income |
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(b) Current tax receivable |
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US$ |
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US$ |
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US$ |
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Research and Development Tax Incentive Credit receivable |
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(c) Numerical reconciliation between aggregate income tax benefit recognized in the Statement of Profit of Loss and Other Comprehensive Income and benefit calculated per the statutory income tax rate
A reconciliation between income tax benefit and the product of accounting loss before income tax multiplied by the Group’s applicable income tax rate is as follows:
|
|
2025 |
|
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2024 |
|
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2023 |
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|||
|
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US$(000's) |
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US$(000's) |
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US$(000's) |
|
|||
Accounting loss before tax |
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( |
) |
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( |
) |
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( |
) |
At the Company's statutory income tax rate of |
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R&D tax incentive on eligible expenses |
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Non-deductible R&D expenditure |
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( |
) |
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( |
) |
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( |
) |
Other non-deductible expenses - share-based payment expense |
|
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( |
) |
|
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( |
) |
|
|
( |
) |
Amount of temporary differences and carried forward tax losses not recognized |
|
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( |
) |
|
|
( |
) |
|
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( |
) |
Income tax benefit reported in the Statement of Profit or Loss and Other Comprehensive Income |
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F-20
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
|
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June 30, 2025 |
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June 30, 2024 |
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June 30, 2023 |
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(d) Recognized deferred tax assets and liabilities in statement of financial position |
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Deferred income tax at June 30 relates to the following: |
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Deferred tax liabilities: |
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Interest and royalty income receivable (future assessable income) |
|
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( |
) |
|
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( |
) |
|
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( |
) |
|
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( |
) |
|
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( |
) |
|
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( |
) |
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Deferred tax assets related to temporary differences: |
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Accrued expenses and other liabilities |
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Employee provisions |
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Other miscellaneous items |
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Net deferred tax assets |
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|
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Less: temporary differences not recognized |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net deferred tax recognized in the statement of financial position |
|
|
— |
|
|
|
— |
|
|
|
— |
|
(d) Carry forward unrecognized tax losses
The Group had income tax losses of US$
(e) Franking credit balance
Franking credits are a type of tax credit in Australia that is available to the Group’s shareholder to reduce double taxation on any dividends paid by the Group. The franking account balance at the end of the financial year at
F-21
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 17. Earnings per Share
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
The following reflects the income used in the basic and diluted earnings per share computations: |
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|
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(a) Earnings used in calculating earnings per share |
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|
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Net loss attributable to ordinary equity holders of the parent |
|
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( |
) |
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( |
) |
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( |
) |
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(b) Weighted average number of shares |
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|
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Weighted average number of ordinary shares on issue for basic earnings per share |
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|
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Effect of dilution: |
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|
|||
Share options |
|
|
— |
|
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|
— |
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— |
|
Weighted average number of ordinary shares adjusted for the effect of dilution |
|
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|
|||
Loss per share (basic and diluted in cents) |
|
|
(13.29 |
) |
|
|
(34.51 |
) |
|
|
(32.20 |
) |
On August 24 and 28, 2023 the company announced a capital raising which involved an additional
On June 14, 2024 the company announced a capital raising which involved an additional
Diluted earnings per share is calculated as net loss divided by the weighted average number of ordinary shares and dilutive potential ordinary shares. Options granted under the Long Term Incentive (LTIP) and Non‑Executive Director Share and Option (NED Plan) plans would generally be included in the calculation due to the conditions of the issuance being satisfied.
As the Group is in a loss position, the options are anti‑dilutive and, accordingly, the basic loss per share is the same as the diluted loss per share.
At June 30, 2025, a total number of
Fully paid ordinary shares have
Ordinary Options |
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
NED Plan |
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|
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LTIP |
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|
|
2025 |
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2024 |
|
|
2023 |
|
|||
Performance Rights |
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|
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NED Plan |
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LTIP |
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F-22
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
ADS Options |
|
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|
|||
NED Plan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
LTIP - Extended terms |
|
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|
|
|
|
|
— |
|
||
LTIP |
|
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|||
|
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|
|||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Investor Options |
|
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|
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|
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|
|||
2023 investor options - listed |
|
|
|
|
|
|
|
|
— |
|
||
2024 investor options- listed |
|
|
|
|
|
|
|
|
— |
|
||
|
|
|
|
|
|
|
|
|
— |
|
||
As of June 30, 2025,
Note 18. Current Assets – Cash and Cash Equivalents
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Cash at bank and in hand |
|
|
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|
|
|
||
Short-term deposits |
|
|
|
|
|
|
||
Total cash and cash equivalents |
|
|
|
|
|
|
||
Cash at bank earns interest at floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents represent fair value.
Short term‑deposits are with
Note 19. Current Assets - Receivables
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Interest receivable |
|
|
|
|
|
|
||
GST receivable1 |
|
|
|
|
|
|
||
Other receivable1 |
|
|
|
|
|
|
||
Total current receivables |
|
|
|
|
|
|
||
1
Note 20. Current Assets - Prepayments
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Launch Service Agreement |
|
|
|
|
|
|
||
R&D Contract Research Organization |
|
|
|
|
|
|
||
Insurance |
|
|
|
|
|
|
||
Other prepayments |
|
|
|
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|
||
Total current prepayments |
|
|
|
|
|
|
||
The insurance amount predominantly relates to directors and officers insurance.
F-23
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 21. Non-Current Assets - Right of Use Assets
The Group has a three- year lease contract for its head office premises in Melbourne, Australia, which commenced on 15 July 2022. The agreement does not contain any extension options. The lease term ended on
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Right-of-Use Asset Cost |
|
|
|
|
|
|
||
Opening balance as at July 1 |
|
|
|
|
|
|
||
Additions |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
||
Right-of-Use-Asset Depreciation |
|
|
|
|
|
|
||
Opening balance as at July 1 |
|
|
( |
) |
|
|
( |
) |
Charge to the period |
|
|
( |
) |
|
|
( |
) |
|
|
|
( |
) |
|
|
( |
) |
Net carrying amount at June 30 |
|
|
— |
|
|
|
|
|
Note 22. Non-Current Assets - Prepayments
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Prepayments |
|
|
— |
|
|
|
|
|
Total non-current prepayments |
|
|
— |
|
|
|
|
|
Note 23. Current Liabilities – Payables
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Creditors (unsecured)1 |
|
|
|
|
|
|
||
Payroll related tax liability |
|
|
— |
|
|
|
|
|
Total current payables |
|
|
|
|
|
|
||
1 Creditors are non‑interest bearing and are normally settled on
Note 24. Current Liabilities - Provisions
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Annual leave |
|
|
|
|
|
|
||
Long service leave |
|
|
|
|
|
|
||
Total current provisions |
|
|
|
|
|
|
||
Note 25. Current Liabilities - Derivative Financial Liabilities Investor Options
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||||
|
|
Number outstanding |
|
|
Number outstanding |
|
|
US$(000's) |
|
|
US$(000's) |
|
||||
Carrying amount at July 1 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Fair valuation upon listing in September -2023 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Fair value upon issuance in June 2024 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Fair valuation upon issuance in July 2024 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Fair value on conversions of options to shares |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Fair value loss on investor options at reporting date-2023 Investor options |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
Fair value loss on investor options at reporting date-2024 Investor options |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
Total financial liabilities investor options |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
F-24
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Equity and Investor options -2023
On August 28, 2023, the Company offered
Equity and Investor options - 2024
On June 14, 2024, the Company offered approximately
Under IFRS 9 Financial Instruments and IAS 32 Financial Instruments: Presentation, options with an exercise price denominated in a currency that differs from an entity’s functional currency are treated as a derivative where not all existing equity investors are offered to participate in the equity raise on a pro rata basis. Such derivatives are measured at fair value with subsequent changes in fair value accounted for through profit and loss. Options with an exercise price of A$
At June 30, 2024, the 2024 options were fair valued using a Black Scholes model and are level 2 inputs. Key inputs to the valuation include the share price at grant date, expected term, volatility, dividend yield, risk free rate and exercise price. Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects of non‑transferability, exercise restrictions (including the probability of meeting market conditions attached to the option), and behavioral considerations. Expected volatility is based on the historical share price volatility over the past
At June 30, 2025, management assessed the fair value of the 2024 options at $
F-25
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 26. Current Liabilities - Lease Liabilities
Lease liabilities are as indicated below.
At the commencement date of the lease of its office premises, the Group recognizes lease liabilities measured at the present value of lease payments to be made over the lease term ending on
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Carrying amount at July 1 |
|
|
|
|
|
|
||
New lease |
|
|
— |
|
|
|
— |
|
Payments |
|
|
( |
) |
|
|
( |
) |
Carrying amount at June 30 |
|
|
— |
|
|
|
|
|
Maturity analysis: |
|
|
|
|
|
|
||
Year 1 |
|
|
— |
|
|
|
|
|
Year 2 |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
Less: unearned interest |
|
|
— |
|
|
|
( |
) |
|
|
|
— |
|
|
|
|
|
Analyzed into: |
|
|
|
|
|
|
||
Current portion |
|
|
— |
|
|
|
|
|
Non-current portion |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Amounts recognized in profit or loss: |
|
|
|
|
|
|
|
|
|
|||
Depreciation expense on right-of-use asset |
|
|
|
|
|
|
|
|
|
|||
Lease finance costs |
|
|
|
|
|
|
|
|
|
|||
Expense relating to leases of low value assets |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Note 27. Current and Non-Current Liabilities - Financial Liabilities - DFA
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Carrying amount at July 1 |
|
|
|
|
|
|
||
Funding at fair value |
|
|
— |
|
|
|
|
|
Interest expense on DFA (includes amounts to related parties $ |
|
|
|
|
|
|
||
Gain on remeasurement of financial liability - DFA |
|
|
— |
|
|
|
( |
) |
Total non-current financial liabilities |
|
|
— |
|
|
|
|
|
Total current financial liabilities |
|
|
|
|
|
— |
|
|
In August 2022, Ocelot, an affiliate of Carlyle and Abingworth, committed to provide Opthea no less than US$
F-26
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
In return, Opthea was to pay to the DFA Investors (1) upon the first to occur of regulatory approval of sozinibercept for the treatment of wet AMD in the United States, United Kingdom or European Union (“Regulatory Approval”), fixed payments equal to a total of approximately two times the funding provided, consisting of seven payments, with the first payment due shortly after Regulatory Approval and the remaining six annual payments payable over a six-year period thereafter, and (2) variable payments equal to
The DFA contains terms that require compliance by the Company to maintain a minimum cash balance and to provide a notice to Ocelot in the event it anticipates that it does not have sufficient cash to fund its operations for the next six months. At June 30, 2025, the Group remains in compliance with the DFA and no such instances have occurred or are expected to occur.
Pursuant to the DFA, Opthea granted the DFA Investors a security interest in all its assets (other than intellectual property not related to sozinibercept), provided that the Group is permitted to incur certain indebtedness. The security interest will terminate when the Group has paid the DFA Investors the required payment amounts or upon certain termination events under the DFA.
Accordingly, the Company had recorded payments received under the DFA as part of a development financing liability in its consolidated balance sheet. The Group accounted for the overall development financing liability at amortized cost based on the estimated timing of regulatory approval and attainment of certain sales milestones and the contractual success fee payments expected to be due therefrom, as discounted using an imputed interest rate at inception. The development financing liability was to be accreted as interest expense to its expected future repayment amount over the expected life of the agreement using the effective interest rate method. Certain legal and financial advisory fees incurred specifically to complete the DFA were capitalized and recorded as a reduction to the carrying amount of the development funding liability and was also to be amortized to interest expense using the effective interest method.
In certain instances which may result upon the termination of the DFA, the Group will be obligated to pay the DFA Investors up to four multiples of the amounts paid to Opthea under the DFA. Termination can be triggered by a range of events including if Opthea fails to use commercially reasonable efforts to develop and commercialize sozinibercept, if positive trial results are not achieved or if Regulatory Approval is not obtained. The DFA also includes termination clauses relating to change of control, disagreement with DFA Investors, inability to fund development costs, safety, bankruptcy and other material breaches, as defined in the DFA. Each termination trigger has a corresponding percentage to be paid, with possible outcomes requiring the Group to repay an amount equal to
On March 31, 2025, the Company announced that following the negative results of the COAST Phase 3 trial, the Company determined that the most appropriate course of action for wet AMD patients, shareholders and other stakeholders of the Company was to accelerate the ShORe trial topline data readout. Both Phase 3 trials did not meet their primary endpoint and following the negative results of both the COAST and ShORE trials, the Company in consultation with the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD with immediate effect and agreed that this decision did not constitute a termination event under the DFA under sections 13.4.2 Termination for Fundamental Material Breach, 13.4.3 Termination for Material Breach, 13.4.8 Termination for Safety Concerns or 13.4.10 Termination for JSC Decision. Following the termination of the sozinibercept wet AMD program, the Company reduced its work force, exited all contracts related to the clinical trials and commenced active discussions with the DFA Investors on a potential settlement of the DFA agreement. These settlement discussions were ongoing at June 30, 2025.
At June 30, 2025, the DFA Investors had right to terminate the agreement in the event of development product failure. Section 13.4.5.2 Development Product Failure of the DFA does not contemplate the obligations of the Company where the agreement is terminated following negative trial results achieved and the Company does not elect to continue development of the product where the primary endpoint in such trial is not achieved. The Company exercised significant judgment in the estimation of the DFA obligation at June 30, 2025 and evaluated that, in the absence of a termination event, the contractual obligation of the Company in terms of the DFA were
F-27
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
not discharged, cancelled or modified at June 30, 2025. Accordingly, the Group continued to account for the development funding liability at amortized cost being the funds invested of US$
On August 19, 2025, the Company and the DFA Investors agreed to a settlement, with the DFA Investors receiving a cash payment of US$
Note 28. Non-Current Liabilities - Provisions
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
Long service leave |
|
|
— |
|
|
|
|
|
Total non-current provisions |
|
|
— |
|
|
|
|
|
F-28
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 29. Contributed Equity
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
|
June 30, 2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
(a) Ordinary shares |
|
|
|
|
|
|
|
|
|
|||
Issued and fully paid at June 30 |
|
|
|
|
|
|
|
|
|
|||
Movement in ordinary shares: |
|
|
|
|
|
|
|
|
|
|||
Opening balance |
|
|
|
|
|
|
|
|
|
|||
Issue of shares on exercise of options granted under the LTIP |
|
|
|
|
|
— |
|
|
|
|
||
Issue of shares on exercise of options granted from Entitlement Offer |
|
|
|
|
|
|
|
|
— |
|
||
Issue of shares net of issuance costs from Placement and Institutional Offer $ |
|
|
— |
|
|
|
— |
|
|
|
|
|
Issue of shares in September 2023, net of issuance costs $ |
|
|
— |
|
|
|
|
|
|
— |
|
|
Issue of shares in June 2024, net of issuance costs of $ |
|
|
— |
|
|
|
|
|
|
— |
|
|
Issue of shares in July 2024, net of issuance costs $ |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|||
Ordinary shares on issue: |
|
No: |
|
|
No: |
|
|
No: |
|
|||
Opening balance |
|
|
|
|
|
|
|
|
|
|||
Issue of shares on exercise of options granted under the LTIP |
|
|
|
|
|
— |
|
|
|
|
||
Issue of share on exercise of options from Entitlement offer |
|
|
|
|
|
|
|
|
— |
|
||
Issue of shares from Placement and Institutional offer |
|
|
|
|
|
|
|
|
— |
|
||
Issue of shares from Entitlement Offer |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Fully paid ordinary shares carry
Equity and Investor options - 2023
On August 28, 2023, the Company offered approximately
Equity and Investor options – 2024
On June 14, 2024, the Company offered approximately
F-29
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Issued capital at June 30, 2024 amounted to US$
During the year ended June 30, 2024 the Company issued
Issued capital at June 30, 2023 amounted to US$
During the year ended June 30, 2023 the Company issued
Options granted to directors and employees.
The Company has
The Company granted
The Company granted
The Company granted
At June 30, 2025 the Company has
At June 30, 2024, the Company had
At June 30, 2023, the Company had
F-30
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Capital management
The Group is not subject to any externally imposed capital requirements. The DFA contains terms that require compliance by the Company to maintain a minimum cash balance and to provide a notice to Ocelot in the event it anticipates that it does not have sufficient cash to fund its operations for the next six months. Refer to Notes 27 and 39 for additional information. When managing share capital, management’s objective is to ensure the entity continues as a going concern as well as to provide benefits to shareholders and for other stakeholders. In order to maintain or achieve an appropriate capital structure, the Company may issue new shares or reduce its share capital, subject to the provisions of the Company’s constitution. The Group only commits to significant R&D expenditure when this is fully funded either by existing funds, the DFA or further equity raises.
Note 30. Accumulated Losses and Reserves
|
|
2025 |
|
|
2024 |
|
||
|
|
US$(000's) |
|
|
US$(000's) |
|
||
(a) Movements in accumulated losses were as follows: |
|
|
|
|
|
|
||
Balance at July 1 |
|
|
( |
) |
|
|
( |
) |
Net loss for the period |
|
|
( |
) |
|
|
( |
) |
Balance at June 30 |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
(b) Reserves |
|
|
|
|
|
|
||
Fair value of Investments reserve (i) |
|
|
|
|
|
|
||
Share-based payments reserve (ii) |
|
|
|
|
|
|
||
Foreign translation reserve (iii) |
|
|
|
|
|
|
||
Total reserves |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
(i) Movement in fair value of investments reserve: |
|
|
|
|
|
|
||
Opening balance |
|
|
|
|
|
|
||
Closing balance |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
(ii) Movement in share-based payments reserve: |
|
|
|
|
|
|
||
Opening balance |
|
|
|
|
|
|
||
Share-based payments expense |
|
|
|
|
|
|
||
Exercise of options |
|
|
— |
|
|
|
— |
|
Closing balance |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
(iii) Movement in foreign translation reserve: |
|
|
|
|
|
|
||
Opening balance |
|
|
|
|
|
|
||
(Gains)/loss on translation |
|
|
— |
|
|
|
— |
|
Closing balance |
|
|
|
|
|
|
||
Nature and purpose of reserves
Fair value of investments reserve
This reserve records fair value changes on listed investments. As at June 30, 2025 and 2024, no remaining investments are held by the Group. Management's accounting policy is to not reclassify the realized fair value to accumulated loss upon disposal.
Share‑based payment reserve
This reserve is used to record the value of equity benefits provided to executives and employees as part of their remuneration.
F-31
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Foreign currency translation reserve
The reserve records the value of foreign currency movements on the initial translation of financial statements from A$ to US$ that was completed in 2021.
Note 31. Financial Risk Management Objectives and Policies
The Group’s principal financial assets comprise cash, receivables and short‑term deposits.
The Group manages its exposure to key financial risks, including interest rate and currency risk in accordance with the Group’s financial risk management practices. The objective is to support the delivery of the Group’s financial targets whilst protecting future financial security.
The Group’s other various financial assets and liabilities, such as receivables and payables, arise directly from its operations. The main risks arising from the Group’s financial assets and liabilities are interest rate risk, foreign currency risk, and liquidity risk.
The Group uses different methods to measure and manage different types of risks to which it is exposed. These include monitoring levels of exposure to interest rate and foreign exchange risk and assessments of market forecasts for interest rates and foreign exchange rates. Liquidity risk is monitored through future rolling cash flow forecasts.
The board reviews and agrees policies for managing each of these risks as summarized below.
Risk exposures and responses
The Group has investigated the main financial risk areas which could impact on its financial assets and determined the impact on post tax (losses) or profits for a range of sensitivities. These can be seen in the post-tax (loss)/profit impact for each risk area.
For each risk area, the equity impact relates solely to reserve movements and excludes movements in accumulated losses as the impact of these can be seen within the post-tax (loss)/profit impact.
The Group’s exposure to market interest rates relates primarily to the short‑term deposits. The deposits are held with two of Australia’s largest banks.
The objective of managing interest rate risk is to minimize the Group’s exposure to fluctuations in interest rates that might impact its interest income and cash flow. To manage interest rate risk, the Group invests the majority of its cash in short‑term deposits for varying periods of between
The Group currently has borrowings under the DFA with the DFA Investors. Due to the structure of the DFA Agreement, the Group has determined that there is
The following sensitivity analysis (an annual effect) is based on the interest rate risk exposures at June 30, 2025 and 2024.
F-32
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
At June 30, 2025, 2024 and 2023, if interest rates moved, with all variables held constant, post tax (loss)/profit and equity would have been affected as illustrated in the following table:
|
|
Post tax (loss)/profit impact |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Judgments of reasonably possible movements |
|
|
|
|
|
|
|
|
|
|||
+ |
|
|
|
|
|
|
|
|
|
|||
-0.50% (50 basis points) (2024:-0.50%, 2023:-0.50%) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
The post-tax figures include an offset for tax losses (bringing the tax effect to
Significant assumptions used in the interest rate sensitivity analysis include:
As a result of services provided by non‑related entities in Australia, Canada, United Kingdom and Europe, part of the Group’s monetary assets and liabilities are affected by movements in the exchange rate.
The Group does not enter into any hedging transactions.
At the reporting date, the Group has the following exposure to foreign currencies. :
|
|
Consolidated |
|
|||||||||||||
|
|
AUD |
|
|
EURO |
|
|
GBP |
|
|
CAD |
|
||||
2025 |
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
||||
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Receivables |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Financial liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Payables |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Other financial liabilities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net exposure |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Consolidated |
|
|||||||||||||
|
|
AUD |
|
|
EURO |
|
|
GBP |
|
|
CAD |
|
||||
2024 |
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
||||
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Receivables |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Financial liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Payables |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other financial liabilities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net exposure |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
The following sensitivity is based on the foreign currency risk exposures in existence at June 30, 2025, 2024 and 2023.
F-33
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
At June 30, 2025, 2024 and 2023, had the United States dollar moved with all other variables held constant, post-tax (loss) profit and equity would have been affected as illustrated in the table below:
|
|
Post tax (loss)/profit impact |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Judgments of reasonably possible movements |
|
|
|
|
|
|
|
|
|
|||
Consolidated |
|
|
|
|
|
|
|
|
|
|||
AUD/USD + |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
AUD/USD -10% (2024:-10%, 2023:-10%) |
|
|
|
|
|
|
|
|
|
|||
The reasonably possible movements at June 30, 2025 are lower than at June 30, 2024 and June 30, 2023 due mainly to net exposure to the Australian dollar due to cash at bank deposits. There was minimum or insignificant exposure to the GBP, Euro and CAD during the current financial year.
Significant assumptions used in the foreign currency exposure sensitivity analysis include:
Credit risk is associated with those financial assets of the Group which comprise cash and cash equivalents and, receivables. The Group’s exposure to credit risk arises from default of the counter party, with a maximum exposure equal to the carrying amount of these investments. Credit risk is considered minimal as the Group transacts with reputable recognized Australian banks.
Liquidity risk arises from the financial liabilities of the Group and the Group’s subsequent ability to meet their obligations to repay their financial liabilities as and when they fall due.
As outlined in Note 2, the Group expects that the cash on hand at June 30, 2025 will be sufficient to fund its operations into the fourth calendar quarter of 2026, which includes completion of the strategic review process. Due to uncertainties regarding future operations of the Group following the strategic review, and the potential for future clinical trials of OPT‑302 in other disorders, the Group may need to raise additional funds, the timing and amount of which is unknown at this time.
The Group’s objective is to maintain an appropriate cash asset balance to fund its operations.
F-34
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
The table below reflects undiscounted cash flows of the financial liabilities.
|
|
Consolidated |
|
|
|
|
||||||||||||||
|
|
Carrying |
|
|
Less than 3 |
|
|
Between 3 |
|
|
1 year and |
|
|
Total |
|
|||||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||||
June 30, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Non-derivative liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Payables |
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
Accrued expenses |
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
Financial liability - DFA1 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Total |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
Consolidated |
|
|
|
|
||||||||||||||
|
|
Carrying |
|
|
Less than 3 |
|
|
Between 3 |
|
|
1 year and |
|
|
Total |
|
|||||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||||
June 30, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Non-derivative liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Payables |
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
Accrued expenses |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
||||
Financial liability - DFA |
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
1. Following the termination of the clinical trials, the Group did not have a right to defer settlement of the liability for at least twelve months after the reporting period and therefore the liability is reflected in the period between 3 months and 1 year. Refer to Note 27.
Note 32. Related Party Disclosures
The consolidated financial statements include the financial statements of Opthea Limited and its subsidiaries in the following table:
|
|
Parent entity % equity interest |
|
|||||||
|
|
June 30, 2025 |
|
June 30, 2024 |
|
|
June 30, 2023 |
|
||
|
|
|
|
% |
|
|
% |
|
||
Vegenics Pty Ltd1 |
|
|
|
|
|
|
|
|||
Opthea US Inc2 |
|
|
|
|
|
|
|
|||
(1) Opthea Limited is the ultimate parent entity. Vegenics Pty Ltd is incorporated in Australia and has the same financial year as Opthea Limited.
(2) Opthea Limited is the ultimate parent entity. Opthea US Inc was incorporated in the United States in May 2021 and has the same financial year as Opthea Limited.
Balances and transactions between the Company and its subsidiaries, a related party of the Company, have been eliminated on consolidation and are not disclosed in this note. Transactions between the Group and its associates are disclosed below:
Following the appointment of Anshul Thakral (who is the CEO of Launch Tx, Operation Executive of Carlyle and on the board of Saama Technologies) as a Director of Opthea on June 7, 2023, Launch, Ocelot (an affiliate of
F-35
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Carlyle and Abingworth), Carlyle and Saama Technologies became related parties of Opthea. Anshul Thakral resigned from the Opthea Board of Directors effective June 2, 2025 and therefore Ocelot, Launch Tx and SaamaTechnologies are no longer entities related to the Group at year end.
Trading transactions
During the year, group entities entered into the following transactions with related parties who are not members of the Group.
|
|
Consolidated |
|
|||||||||
|
|
Purchase of Service |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
|
|
|
|
|
|
— |
|
||
Launch Tx |
|
|
|
|
|
|
|
|
|
|||
Mr Lawrence Gozlan |
|
|
|
|
|
— |
|
|
|
— |
|
|
Saama Technologies |
|
|
|
|
|
|
|
|
— |
|
||
Transactions with Saama Technologies relate to the purchase of services assisting Opthea with analytical work on clinical trials.
Transaction with Mr. Lawrence Gozlan, a director of the Company, related to Consultancy fees for the provision of services associated with managing, overseeing and coordinating the conduct and implementation of Capital raises. In the
|
|
Consolidated |
|
|||||||||
|
|
Amounts owed to related parties |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
— |
|
|
|
|
|
|
|
||
Launch Tx |
|
|
|
|
|
— |
|
|
|
|
||
Lawrence Gozlan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Saama Technologies |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Amounts owed to Ocelot relate to the DFA and carry an effective rate of
|
|
Consolidated |
|
|||||||||
|
|
Amounts owed by related parties* |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Ocelot |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Launch Tx |
|
|
— |
|
|
|
|
|
|
— |
|
|
Mr. Lawrence Gozlan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Saama Technologies |
|
|
— |
|
|
|
|
|
|
— |
|
|
Amounts paid to Launch Tx relate to the purchase of services assisting Opthea with the management and oversight of trials under the Service Agreement with Launch Tx which were in a prepayment position at June 30, 2024.
Amounts paid to Saama Technologies in regard to subscription fees for the use of analytical platform, which were in a prepayment position at June 30, 2024.
F-36
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
On August 28, 2023, Mr. Lawrence Gozlan, a director of the Company, and the Company entered into a Consultancy Agreement of up to US$
On September 19, 2024, Mr. Lawrence Gozlan, a director of the Company, and the Company entered into a Consultancy Agreement of up to US$
Note 33. Cash Flow Statements Reconciliation
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
(a) Reconciliation to cash at the end of the year |
|
|
|
|
|
|
|
|
|
|||
Cash at bank and in hand (Note 18) |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
(b) Reconciliation of net loss after tax to net cash flows from operations |
|
|
|
|
|
|
|
|
|
|||
Net loss for the year |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|||
Income tax benefit recognized in profit or loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss of disposal of non-current assets |
|
|
|
|
|
— |
|
|
|
— |
|
|
Write off of Property Plant and Equipment |
|
|
|
|
|
— |
|
|
|
— |
|
|
Depreciation of non-current assets |
|
|
|
|
|
|
|
|
|
|||
Depreciation of right-of-use assets |
|
|
|
|
|
|
|
|
|
|||
Interest expense on DFA* (includes amounts to related parties $ |
|
|
|
|
|
|
|
|
|
|||
Gain on remeasurement of financial liability - DFA |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Fair value (gain)/loss on Investor options |
|
|
( |
) |
|
|
|
|
|
— |
|
|
Share-based payments expense |
|
|
|
|
|
|
|
|
|
|||
Net foreign exchange differences |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Changes in: |
|
|
|
|
|
|
|
|
|
|||
Payables |
|
|
( |
) |
|
|
|
|
|
|
||
Receivables |
|
|
|
|
|
( |
) |
|
|
|
||
Prepayments |
|
|
|
|
|
( |
) |
|
|
|
||
Provisions |
|
|
|
|
|
|
|
|
|
|||
Net cash flows used in operating activities before tax |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
R&D tax incentive received |
|
|
|
|
|
|
|
|
|
|||
Current US tax paid |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
Net cash flows used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
F-37
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 34. Commitments
The Group has entered into research and development contracts and intellectual property license agreements with various third parties in respect of services for the Phase 3 wet AMD clinical trial and the clinical grade manufacture of sozinibercept.
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Within one year |
|
|
|
|
|
|
|
|
|
|||
After one year but not more than five years |
|
|
|
|
|
|
|
|
|
|||
After more than five years |
|
|
— |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|||
Currently, the biggest research contract has a
The Group has entered into commercial agreements with various third parties in respect of services for preparation of OPT‑302 for launch and pre‑marketing phase. Expenditure commitments relating to these activities are payable as follows:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Within one year |
|
|
— |
|
|
|
|
|
|
|
||
After one year but not more than five years |
|
|
— |
|
|
|
— |
|
|
|
— |
|
After more than five years |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
||
Note 35. Contingencies
The Group is party to various research agreements with respect to which a commitment to pay is contingent on the achievement of research milestones. Assuming all milestones are achieved within the time‑frames stipulated in the contracts, those which could become payable in less than one year total US$
Under these license/collaboration agreements, payments are to be made only if certain research and clinical development milestones are achieved and royalties may become payable on any eventual sales of products developed under these agreements.
The group had a bank guarantee outstanding at June 30, 2025 in respect of a rental deposit for its office premises of AU$
F-38
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Note 36. Key Management Personnel
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000's) |
|
|
US$(000's) |
|
|
US$(000's) |
|
|||
Short-term employee benefits |
|
|
|
|
|
|
|
|
|
|||
Post-employment benefits |
|
|
|
|
|
|
|
|
|
|||
Termination benefits |
|
|
|
|
|
|
|
|
— |
|
||
Share-based payments expense |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
There were
Note 37. Share-Based Payments
The expense recognized for share‑based payments during the year is shown in the table below:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
|
|
US$(000s) |
|
|
US$(000s) |
|
|
US$(000s) |
|
|||
Expense arising from equity-settled share-based payment transactions: |
|
|
|
|
|
|
|
|
|
|||
Director and employee services received |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
During the 2015 financial year, the Group introduced an ownership‑based compensation scheme for non‑executive directors, executives and senior employees, the Long-Term Incentive Plan (LTIP) and Non‑Executive Directors Share and Option Plan (NED Plan). In accordance with the terms of the plans, as approved by shareholders at the 2014 annual general meeting, eligible non‑executive directors, executives and senior employees with the Group may be granted options to purchase ordinary shares.
Each employee share option converts into
The number of options granted is subject to approval by the board and rewards executives and senior employees to the extent of the Group’s and the individual’s achievement judged against both qualitative and quantitative criteria as determined by the board on a case by case basis.
F-39
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
The vesting condition of options granted under the LTIP and NED Plan is continuous service.
Options/Rights services |
|
Grant date |
|
Grant date |
|
|
Exercise |
|
|
Expiry date |
|
Vesting date |
||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
F-40
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2023 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2023 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2023 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2024 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2024 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2024 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
|||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
F-41
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
There has been no alteration of the terms and conditions of the above share‑based payment arrangements since the grant date.
ADS Options |
|
Grant date |
|
Grant date |
|
|
Exercise |
|
|
Expiry date |
|
Vesting date |
||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|||||
F-42
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects of non‑transferability, exercise restrictions (including the probability of meeting conditions attached to the option), and behavioral considerations. Expected volatility is based on the historical share price volatility over the past
Options/Rights services |
|
Grant date |
|
|
Exercise |
|
|
Fair value |
|
|
Expected |
|
|
Option life |
|
Dividend |
|
|
Risk free |
|
|
Model |
||||||
LTIP - director FY2019 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2018 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2019 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2022 |
|
|
|
|
nil |
|
|
|
|
|
na |
|
|
|
|
% |
|
n/a |
|
|
||||||||
LTIP - employees FY2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2023 |
|
|
|
|
nil |
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
NED Plan FY2016 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2019 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Play FY2021 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2021 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2023 |
|
|
|
|
nil |
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
NED Plan FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
% |
|
|||||||||
F-43
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Fair value of ADS options granted
Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects of non‑transferability, exercise restrictions (including the probability of meeting conditions attached to the option), and behavioral considerations. Expected volatility is based on the historical share price volatility over the past
ADS Options |
|
Grant |
|
|
Exercise |
|
|
Fair |
|
|
Expected |
|
|
ADS |
|
Dividend |
|
|
Risk free |
|
|
Model |
||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2022 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2023 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2025 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employee 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
LTIP - employees FY2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
||||||||||
Contractor - 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
Contractor - 2024 |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
% |
|
|
% |
|
||||||||
F-44
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
The following reconciles the share/rights options outstanding at the beginning and end of the year:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||||||||||||||
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
||||||
Balance at beginning of year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Granted during the year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
To employees and directors under the LTIP and NED Plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercised during the year |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Expired during the year |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Balance at end of the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable at end of year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The share options outstanding at the end of the year had a weighted average exercise price of US $
Movements in ADS options during the year
The following reconciles the ADS options outstanding at the beginning and end of the year:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||||||||||||||
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
||||||
Balance at beginning of year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Granted during the year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
To employees and directors under the LTIP and NED Plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercised during the year |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Expired during the year |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|||
Balance at end of the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable at end of year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The ADS options outstanding at the end of the year has a weighted average exercise price of US$
F-45
OPTHEA LIMITED
Notes to Consolidated Financial Statements — Continued
Movements in contractor ADS options during the year
The following reconciles the contractor ADS options outstanding at the beginning and end of the year:
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||||||||||||||
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
||||||
Balance at beginning of year |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Granted during the year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
To contractors under additional terms |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Exercised during the year |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Expired during the year |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Balance at end of the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||||
Exercisable at end of year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||||
Note 38. Events After the Balance Sheet Date
On August 19, 2025, Opthea announced the successful completion of a settlement agreement with the Development Funding Agreement investors. This settlement includes a payment of US$
Besides the above-mentioned subsequent events, no matters or circumstances have arisen since the end of the reporting period, which significantly affected, or may significantly affect, the operations of the Group, the results of those operations, or the state of affairs of the Group in future financial years.
F-46
FAQ
What cash position did Opthea (CKDXF) report after the DFA resolution?
What was the Development Funding Agreement outcome disclosed in the 20-F?
Did Opthea report any material internal control findings?
Does Opthea have any products approved or revenue from product sales?
What contingent support does Opthea reference for R&D spending?
Were there leadership changes disclosed in the 20-F?
