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[10-Q] AMARIN CORP PLC\UK Quarterly Earnings Report

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Amarin Corporation plc reported Q3 2025 results. Total revenue was $49.7 million (up from $42.3 million a year ago), driven by product revenue of $48.6 million and licensing and royalty revenue of $1.1 million. The company posted a net loss of $7.7 million, a significant improvement from a $25.1 million loss in Q3 2024, as operating expenses declined, particularly selling, general and administrative costs.

Gross margin was $22.2 million on cost of goods sold of $27.5 million. Amarin recorded $9.4 million of restructuring expense in the quarter and $32.2 million year‑to‑date tied to its June 24, 2025 global restructuring plan associated with its Recordati agreement, with expected total charges of $30.0–$37.0 million, substantially all cash.

Liquidity remains solid with $122.8 million in cash and cash equivalents and $163.8 million in short‑term investments as of September 30, 2025, and no outstanding debt. Year‑to‑date, revenue was $164.4 million and net loss $37.6 million. U.S. product revenue led the quarter at $40.9 million, with Europe at $4.1 million and Rest of World at $3.6 million.

Amarin Corporation plc ha riportato i risultati del terzo trimestre 2025. Il fatturato totale è stato di 49,7 milioni di dollari (in aumento rispetto a 42,3 milioni di dollari dell'anno precedente), trainato dal ricavo di prodotto di 48,6 milioni di dollari e da ricavi da licenze e royalty di 1,1 milione di dollari. L'azienda ha registrato una perdita netta di 7,7 milioni di dollari, un significativo miglioramento rispetto a una perdita di 25,1 milioni di dollari nel Q3 2024, poiché i costi operativi sono diminuiti, in particolare i costi di vendita, generali e amministrativi.

Il margine lordo è stato di 22,2 milioni di dollari su costi di vendita di 27,5 milioni di dollari. Amarin ha registrato 9,4 milioni di dollari di oneri di ristrutturazione nel trimestre e 32,2 milioni di dollari da inizio anno legati al piano di ristrutturazione globale del 24 giugno 2025 associato all'accordo con Recordati, con oneri totali attesi tra 30,0–37,0 milioni di dollari, sostanzialmente in contanti.

La liquidità rimane solida con 122,8 milioni di dollari in contanti e equivalenti e 163,8 milioni di dollari in investimenti a breve termine al 30 settembre 2025, e nessun debito pendente. Nel periodo da inizio anno, i ricavi sono stati 164,4 milioni di dollari e la perdita netta 37,6 milioni di dollari. I ricavi statunitensi da prodotto hanno guidato il trimestre con 40,9 milioni di dollari, seguiti dall'Europa con 4,1 milioni di dollari e il resto del mondo con 3,6 milioni di dollari.

Amarin Corporation plc informó los resultados del tercer trimestre de 2025. Los ingresos totales fueron de $49.7 millones (frente a $42.3 millones del año pasado), impulsados por ingresos de productos de $48.6 millones y por ingresos de licencias y regalías de $1.1 millones. La empresa registró una pérdida neta de $7.7 millones, una mejora significativa frente a una pérdida de $25.1 millones en el tercer trimestre de 2024, ya que los gastos operativos disminuyeron, especialmente los gastos de venta, generales y administrativos.

El margen bruto fue de $22.2 millones sobre costos de ventas de $27.5 millones. Amarin registró $9.4 millones de gastos de reestructuración en el trimestre y $32.2 millones en lo que va del año ligados a su plan de reestructuración global del 24 de junio de 2025 asociado a su acuerdo con Recordati, con cargos totales esperados de $30.0–$37.0 millones, con casi toda la caja.

La liquidez se mantiene sólida con $122.8 millones en efectivo y equivalentes y $163.8 millones en inversiones a corto plazo al 30 de septiembre de 2025, y ninguna deuda pendiente. En lo que va del año, los ingresos fueron $164.4 millones y la pérdida neta $37.6 millones. Los ingresos por productos en Estados Unidos lideraron el trimestre con $40.9 millones, seguido de Europa con $4.1 millones y Resto del Mundo con $3.6 millones.

Amarin Corporation plc는 2025년 3분기 실적을 발표했습니다. 총매출은 금액 4970만 달러로 지난해 같은 기간 4230만 달러에서 증가했으며, 제품 매출이 4860만 달러, 라이선스 및 로열티 매출이 110만 달러였습니다. 회사는 7.7백만 달러의 순손실을 기록했으며, 이는 2024년 3분기의 2510만 달러 손실에 비해 크게 개선된 수치로, 주로 판매비 및 일반관리비의 감소로 인해 영업비용이 감소했습니다.

매출총이익은 2220만 달러이고 매출원가가 2750만 달러였습니다. Amarin은 2025년 6월 24일 글로벌 구조조정 계획과 Recordati 계약과 관련하여 분기 동안 940만 달러의 구조조정 비용과 연초부터 3220만 달러의 비용을 기록했으며, 총 비용은 3000–3700만 달러로 예상되며 거의 현금으로 지출될 예정입니다.

유동성은 양호하며 2025년 9월 30일 기준 현금 및 현금등가물 1억2280만 달러와 단기투자 1억6380만 달러, 그리고 부채 미해당를 보유하고 있습니다. 연초부터의 누적 매출은 1억6440만 달러, 순손실은 3천760만 달러였습니다. 미국의 제품 매출이 분기를 주도했고 4,090만 달러, 유럽이 410만 달러, 나머지 세계가 360만 달러였습니다.

Amarin Corporation plc a publié les résultats du troisième trimestre 2025. Le chiffre d'affaires total s'est élevé à 49,7 millions de dollars (contre 42,3 millions de dollars l'année précédente), porté par un chiffre d'affaires produits de 48,6 millions de dollars et des revenus de licences et de redevances de 1,1 million de dollars. L'entreprise affiche une perte nette de 7,7 millions de dollars, une amélioration significative par rapport à une perte de 25,1 millions de dollars au T3 2024, les frais opérationnels ayant diminué, en particulier les coûts de vente, généraux et administratifs.

La marge brute était de 22,2 millions de dollars sur un coût des ventes de 27,5 millions de dollars. Amarin a enregistré 9,4 millions de dollars de charges de restructuration au cours du trimestre et 32,2 millions de dollars pour l'année en cours liés au plan mondial de restructuration du 24 juin 2025 associé à l'accord Recordati, avec des charges totales attendues entre 30,0–37,0 millions de dollars, quasi entièrement en espèces.

La liquidité reste solide avec 122,8 millions de dollars en espèces et équivalents et 163,8 millions de dollars en investissements à court terme au 30 septembre 2025, et pas de dette en cours. Sur l'année, le chiffre d'affaires s'élevait à 164,4 millions de dollars et la perte nette à 37,6 millions de dollars. Le chiffre d'affaires produit américain a mené le trimestre à 40,9 millions de dollars, l'Europe à 4,1 millions de dollars et le reste du monde à 3,6 millions de dollars.

Amarin Corporation plc berichtete die Ergebnisse des dritten Quartals 2025. Der Gesamtumsatz belief sich auf 49,7 Mio. USD (gegenüber 42,3 Mio. USD im Vorjahr), getragen von Produktumsätzen von 48,6 Mio. USD und Lizenz- und Lizenzgebühren von 1,1 Mio. USD. Das Unternehmen verzeichnete einen Nettverlust von 7,7 Mio. USD, eine deutliche Verbesserung gegenüber einem Verlust von 25,1 Mio. USD im Q3 2024, da die operativen Ausgaben zurückgingen, insbesondere Vertriebs-, Allgemeine Verwaltungs- und Verwaltungskosten.

Die Bruttomarge betrug 22,2 Mio. USD bei Kosten der verkauften Waren von 27,5 Mio. USD. Amarin wies im Quartal 9,4 Mio. USD Restrukturierungsaufwendungen aus und 32,2 Mio. USD year-to-date im Zusammenhang mit dem globalen Restrukturierungsplan vom 24. Juni 2025 in Verbindung mit der Recordati-Vereinbarung aus, mit voraussichtlichen Gesamtkosten von 30,0–37,0 Mio. USD, überwiegend in bar.

Die Liquidität bleibt solide mit 122,8 Mio. USD in Barmitteln und Äquivalenten und 163,8 Mio. USD an kurzfristigen Investitionen zum 30. September 2025 und keine Verbindlichkeiten. Year-to-date lagen die Umsätze bei 164,4 Mio. USD und der Nettverlust bei 37,6 Mio. USD. Der Umsatz aus US-Produkten führte das Quartal an mit 40,9 Mio. USD, gefolgt von Europa mit 4,1 Mio. USD und Rest der Welt mit 3,6 Mio. USD.

اعلنت شركة أمارين كابيتال بي إل سي عن نتائج الربع الثالث من 2025. بلغ إجمالي الإيرادات 49.7 مليون دولار (ارتفاعًا من 42.3 مليون دولار قبل عام)، مدفوعًا بإيرادات المنتجات قدرها 48.6 مليون دولار وإيرادات الرخص والحقوق 1.1 مليون دولار. سجلت الشركة خسارة صافية قدرها 7.7 مليون دولار، وهو تحسن مهم من خسارة 25.1 مليون دولار في الربع الثالث 2024، مع انخفاض المصروفات التشغيلية، لا سيما تكاليف البيع والإدارة العامة والسرية.

الهامش الإجمالي كان 22.2 مليون دولار على تكلفة البضاعة المباعة 27.5 مليون دولار. سجلت أمارين 9.4 مليون دولار من تكاليف إعادة الهيكلة في الربع و32.2 مليون دولار منذ بداية السنة مرتبط بخطة إعادة الهيكلة العالمية المقررة في 24 يونيو 2025 المرتبطة باتفاقها مع Recordati، مع تكبد إجمالي متوقع يتراوح بين 30.0–37.0 مليون دولار، ومعظمها نقداً.

السيولة لا تزال قوية مع 122.8 مليون دولار من النقد النقدي وما يعادله و 163.8 مليون دولار من الاستثمارات قصيرة الأجل حتى 30 سبتمبر 2025، ولا توجد ديون مستحقة. حتى تاريخه لعام، بلغت الإيرادات 164.4 مليون دولار والخسارة الصافية 37.6 مليون دولار. قادت الإيرادات من المنتجات الأمريكية الربع بقيمة 40.9 مليون دولار، في حين جاءت أوروبا بـ 4.1 مليون دولار وباقي العالم بـ 3.6 مليون دولار.

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Amarin Corporation plc ha riportato i risultati del terzo trimestre 2025. Il fatturato totale è stato di 49,7 milioni di dollari (in aumento rispetto a 42,3 milioni di dollari dell'anno precedente), trainato dal ricavo di prodotto di 48,6 milioni di dollari e da ricavi da licenze e royalty di 1,1 milione di dollari. L'azienda ha registrato una perdita netta di 7,7 milioni di dollari, un significativo miglioramento rispetto a una perdita di 25,1 milioni di dollari nel Q3 2024, poiché i costi operativi sono diminuiti, in particolare i costi di vendita, generali e amministrativi.

Il margine lordo è stato di 22,2 milioni di dollari su costi di vendita di 27,5 milioni di dollari. Amarin ha registrato 9,4 milioni di dollari di oneri di ristrutturazione nel trimestre e 32,2 milioni di dollari da inizio anno legati al piano di ristrutturazione globale del 24 giugno 2025 associato all'accordo con Recordati, con oneri totali attesi tra 30,0–37,0 milioni di dollari, sostanzialmente in contanti.

La liquidità rimane solida con 122,8 milioni di dollari in contanti e equivalenti e 163,8 milioni di dollari in investimenti a breve termine al 30 settembre 2025, e nessun debito pendente. Nel periodo da inizio anno, i ricavi sono stati 164,4 milioni di dollari e la perdita netta 37,6 milioni di dollari. I ricavi statunitensi da prodotto hanno guidato il trimestre con 40,9 milioni di dollari, seguiti dall'Europa con 4,1 milioni di dollari e il resto del mondo con 3,6 milioni di dollari.

Amarin Corporation plc informó los resultados del tercer trimestre de 2025. Los ingresos totales fueron de $49.7 millones (frente a $42.3 millones del año pasado), impulsados por ingresos de productos de $48.6 millones y por ingresos de licencias y regalías de $1.1 millones. La empresa registró una pérdida neta de $7.7 millones, una mejora significativa frente a una pérdida de $25.1 millones en el tercer trimestre de 2024, ya que los gastos operativos disminuyeron, especialmente los gastos de venta, generales y administrativos.

El margen bruto fue de $22.2 millones sobre costos de ventas de $27.5 millones. Amarin registró $9.4 millones de gastos de reestructuración en el trimestre y $32.2 millones en lo que va del año ligados a su plan de reestructuración global del 24 de junio de 2025 asociado a su acuerdo con Recordati, con cargos totales esperados de $30.0–$37.0 millones, con casi toda la caja.

La liquidez se mantiene sólida con $122.8 millones en efectivo y equivalentes y $163.8 millones en inversiones a corto plazo al 30 de septiembre de 2025, y ninguna deuda pendiente. En lo que va del año, los ingresos fueron $164.4 millones y la pérdida neta $37.6 millones. Los ingresos por productos en Estados Unidos lideraron el trimestre con $40.9 millones, seguido de Europa con $4.1 millones y Resto del Mundo con $3.6 millones.

Amarin Corporation plc는 2025년 3분기 실적을 발표했습니다. 총매출은 금액 4970만 달러로 지난해 같은 기간 4230만 달러에서 증가했으며, 제품 매출이 4860만 달러, 라이선스 및 로열티 매출이 110만 달러였습니다. 회사는 7.7백만 달러의 순손실을 기록했으며, 이는 2024년 3분기의 2510만 달러 손실에 비해 크게 개선된 수치로, 주로 판매비 및 일반관리비의 감소로 인해 영업비용이 감소했습니다.

매출총이익은 2220만 달러이고 매출원가가 2750만 달러였습니다. Amarin은 2025년 6월 24일 글로벌 구조조정 계획과 Recordati 계약과 관련하여 분기 동안 940만 달러의 구조조정 비용과 연초부터 3220만 달러의 비용을 기록했으며, 총 비용은 3000–3700만 달러로 예상되며 거의 현금으로 지출될 예정입니다.

유동성은 양호하며 2025년 9월 30일 기준 현금 및 현금등가물 1억2280만 달러와 단기투자 1억6380만 달러, 그리고 부채 미해당를 보유하고 있습니다. 연초부터의 누적 매출은 1억6440만 달러, 순손실은 3천760만 달러였습니다. 미국의 제품 매출이 분기를 주도했고 4,090만 달러, 유럽이 410만 달러, 나머지 세계가 360만 달러였습니다.

Amarin Corporation plc a publié les résultats du troisième trimestre 2025. Le chiffre d'affaires total s'est élevé à 49,7 millions de dollars (contre 42,3 millions de dollars l'année précédente), porté par un chiffre d'affaires produits de 48,6 millions de dollars et des revenus de licences et de redevances de 1,1 million de dollars. L'entreprise affiche une perte nette de 7,7 millions de dollars, une amélioration significative par rapport à une perte de 25,1 millions de dollars au T3 2024, les frais opérationnels ayant diminué, en particulier les coûts de vente, généraux et administratifs.

La marge brute était de 22,2 millions de dollars sur un coût des ventes de 27,5 millions de dollars. Amarin a enregistré 9,4 millions de dollars de charges de restructuration au cours du trimestre et 32,2 millions de dollars pour l'année en cours liés au plan mondial de restructuration du 24 juin 2025 associé à l'accord Recordati, avec des charges totales attendues entre 30,0–37,0 millions de dollars, quasi entièrement en espèces.

La liquidité reste solide avec 122,8 millions de dollars en espèces et équivalents et 163,8 millions de dollars en investissements à court terme au 30 septembre 2025, et pas de dette en cours. Sur l'année, le chiffre d'affaires s'élevait à 164,4 millions de dollars et la perte nette à 37,6 millions de dollars. Le chiffre d'affaires produit américain a mené le trimestre à 40,9 millions de dollars, l'Europe à 4,1 millions de dollars et le reste du monde à 3,6 millions de dollars.

Amarin Corporation plc berichtete die Ergebnisse des dritten Quartals 2025. Der Gesamtumsatz belief sich auf 49,7 Mio. USD (gegenüber 42,3 Mio. USD im Vorjahr), getragen von Produktumsätzen von 48,6 Mio. USD und Lizenz- und Lizenzgebühren von 1,1 Mio. USD. Das Unternehmen verzeichnete einen Nettverlust von 7,7 Mio. USD, eine deutliche Verbesserung gegenüber einem Verlust von 25,1 Mio. USD im Q3 2024, da die operativen Ausgaben zurückgingen, insbesondere Vertriebs-, Allgemeine Verwaltungs- und Verwaltungskosten.

Die Bruttomarge betrug 22,2 Mio. USD bei Kosten der verkauften Waren von 27,5 Mio. USD. Amarin wies im Quartal 9,4 Mio. USD Restrukturierungsaufwendungen aus und 32,2 Mio. USD year-to-date im Zusammenhang mit dem globalen Restrukturierungsplan vom 24. Juni 2025 in Verbindung mit der Recordati-Vereinbarung aus, mit voraussichtlichen Gesamtkosten von 30,0–37,0 Mio. USD, überwiegend in bar.

Die Liquidität bleibt solide mit 122,8 Mio. USD in Barmitteln und Äquivalenten und 163,8 Mio. USD an kurzfristigen Investitionen zum 30. September 2025 und keine Verbindlichkeiten. Year-to-date lagen die Umsätze bei 164,4 Mio. USD und der Nettverlust bei 37,6 Mio. USD. Der Umsatz aus US-Produkten führte das Quartal an mit 40,9 Mio. USD, gefolgt von Europa mit 4,1 Mio. USD und Rest der Welt mit 3,6 Mio. USD.

اعلنت شركة أمارين كابيتال بي إل سي عن نتائج الربع الثالث من 2025. بلغ إجمالي الإيرادات 49.7 مليون دولار (ارتفاعًا من 42.3 مليون دولار قبل عام)، مدفوعًا بإيرادات المنتجات قدرها 48.6 مليون دولار وإيرادات الرخص والحقوق 1.1 مليون دولار. سجلت الشركة خسارة صافية قدرها 7.7 مليون دولار، وهو تحسن مهم من خسارة 25.1 مليون دولار في الربع الثالث 2024، مع انخفاض المصروفات التشغيلية، لا سيما تكاليف البيع والإدارة العامة والسرية.

الهامش الإجمالي كان 22.2 مليون دولار على تكلفة البضاعة المباعة 27.5 مليون دولار. سجلت أمارين 9.4 مليون دولار من تكاليف إعادة الهيكلة في الربع و32.2 مليون دولار منذ بداية السنة مرتبط بخطة إعادة الهيكلة العالمية المقررة في 24 يونيو 2025 المرتبطة باتفاقها مع Recordati، مع تكبد إجمالي متوقع يتراوح بين 30.0–37.0 مليون دولار، ومعظمها نقداً.

السيولة لا تزال قوية مع 122.8 مليون دولار من النقد النقدي وما يعادله و 163.8 مليون دولار من الاستثمارات قصيرة الأجل حتى 30 سبتمبر 2025، ولا توجد ديون مستحقة. حتى تاريخه لعام، بلغت الإيرادات 164.4 مليون دولار والخسارة الصافية 37.6 مليون دولار. قادت الإيرادات من المنتجات الأمريكية الربع بقيمة 40.9 مليون دولار، في حين جاءت أوروبا بـ 4.1 مليون دولار وباقي العالم بـ 3.6 مليون دولار.

Amarin Corporation plc 报告了 2025 第三季度业绩。 总收入为4970万美元(较上一年同期的4230万美元上涨),其中产品收入为4860万美元,许可与特许经营收入为110万美元。公司实现净亏损770万美元,较2024年第三季度的2500万美元亏损有显著改善,因为运营支出下降,特别是销售、一般与管理费用下降。

毛利为2220万美元,销售成本为2750万美元。Amarin 本季度记入940万美元的重组费用,年初至今记入3220万美元,与其 2025 年 6 月 24 日全球重组计划及与 Recordati 的协议相关,预计总费用为3000–3700万美元,几乎全部以现金支付。

流动性依然稳健,截至 2025 年 9 月 30 日,拥有1.228 亿美元的现金及现金等价物,以及1.638 亿美元的短期投资,且无未偿债务。年初至今,收入为164.4 百万美元,净亏损为37.6 百万美元。美国的产品收入在本季度领先,为40.9 百万美元,欧洲为4.1 百万美元,其他地区为3.6 百万美元

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File No. 000-21392

 

Amarin Corporation plc

(Exact Name of Registrant as Specified in its Charter)

 

England and Wales

 

Not applicable

(State or Other Jurisdiction of

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

8th Floor, One Central Plaza,

Dame Street

Dublin 2, Co. Dublin,

D02 K7K5, Ireland

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s telephone number, including area code: +353 (0) 1 6699 020

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol

Name of each exchange on which registered

American Depositary Shares (ADS(s)), each ADS
representing the right to receive twenty (20) Ordinary Share of

Amarin Corporation plc

AMRN

Nasdaq Stock Market LLC

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. YesNo

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). YesNo

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

Emerging growth company

 

 

 

 

If an emerging growth company, 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). YesNo

415,853,680 Ordinary Shares, 50 pence par value per share, were outstanding as of October 24, 2025, including 20,352,521 Ordinary Shares held as American Depositary Shares (ADSs), each representing 20 Ordinary Shares.

 

 

 


 

INDEX TO FORM 10-Q

 

 

 

 

Page

 

 

 

PART I – Financial Information

 

 

 

Item 1.

 

Financial Statements (unaudited):

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024

 

3

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the nine months ended September 30, 2025 and 2024

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024

 

6

 

 

Notes to Condensed Consolidated Financial Statements

 

7

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

26

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

38

Item 4.

 

Controls and Procedures

 

38

 

 

 

PART II – Other Information

 

 

 

Item 1.

 

Legal Proceedings

 

39

Item 1A.

 

Risk Factors

 

39

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

40

Item 5.

 

Other Information

 

41

Item 6.

 

Exhibits

 

42

 

SIGNATURES

 

43

 

2


 

PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

September 30, 2025

 

 

December 31, 2024

 

ASSETS

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

122,802

 

 

$

121,038

 

Restricted cash

 

 

301

 

 

 

300

 

Short-term investments

 

 

163,785

 

 

 

173,182

 

Accounts receivable, net

 

 

127,309

 

 

 

122,279

 

Inventory

 

 

184,703

 

 

 

166,048

 

Prepaid and other current assets

 

 

29,434

 

 

 

12,552

 

Total current assets

 

 

628,334

 

 

 

595,399

 

Property, plant and equipment, net

 

 

13

 

 

 

16

 

Long-term inventory

 

 

9,106

 

 

 

64,740

 

Operating lease right-of-use asset

 

 

7,186

 

 

 

7,592

 

Other long-term assets

 

 

1,109

 

 

 

1,213

 

Intangible asset, net

 

 

14,066

 

 

 

16,389

 

TOTAL ASSETS

 

$

659,814

 

 

$

685,349

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

36,712

 

 

$

40,366

 

Accrued expenses and other current liabilities

 

 

145,521

 

 

 

139,583

 

Total current liabilities

 

 

182,233

 

 

 

179,949

 

Long-Term Liabilities:

 

 

 

 

 

 

Long-term operating lease liability

 

 

6,731

 

 

 

7,723

 

Other long-term liabilities

 

 

11,956

 

 

 

11,501

 

Total liabilities

 

 

200,920

 

 

 

199,173

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Ordinary Shares, £0.50 par value per share, unlimited authorized; 429,597,419 shares issued, 415,965,977 shares outstanding as of September 30, 2025; 422,256,900 shares issued, 411,584,851 shares outstanding as of December 31, 2024

 

 

310,019

 

 

 

305,298

 

Additional paid-in capital

 

 

1,922,351

 

 

 

1,914,750

 

Treasury stock; 13,631,442 shares as of September 30, 2025; 10,672,049 shares as of December 31, 2024

 

 

(67,356

)

 

 

(65,326

)

Accumulated deficit

 

 

(1,706,120

)

 

 

(1,668,546

)

Total stockholders’ equity

 

 

458,894

 

 

 

486,176

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

659,814

 

 

$

685,349

 

 

See notes to condensed consolidated financial statements.

3


 

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except per share amounts)

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Product revenue, net

$

48,558

 

 

$

41,852

 

 

$

136,210

 

 

$

144,522

 

Licensing and royalty revenue

 

1,112

 

 

 

446

 

 

 

28,217

 

 

 

21,786

 

Total revenue, net

 

49,670

 

 

 

42,298

 

 

 

164,427

 

 

 

166,308

 

Less: Cost of goods sold

 

27,462

 

 

 

26,022

 

 

 

66,728

 

 

 

75,359

 

Gross margin

 

22,208

 

 

 

16,276

 

 

 

97,699

 

 

 

90,949

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

19,697

 

 

 

36,904

 

 

 

94,944

 

 

 

115,340

 

Research and development

 

4,208

 

 

 

4,540

 

 

 

14,435

 

 

 

14,884

 

Restructuring

 

9,406

 

 

 

 

 

 

32,165

 

 

 

 

Total operating expenses

 

33,311

 

 

 

41,444

 

 

 

141,544

 

 

 

130,224

 

Operating loss

 

(11,103

)

 

 

(25,168

)

 

 

(43,845

)

 

 

(39,275

)

Interest income, net

 

2,783

 

 

 

3,374

 

 

 

8,277

 

 

 

10,028

 

Other income, net

 

205

 

 

 

265

 

 

 

372

 

 

 

1,954

 

Loss from operations before taxes

 

(8,115

)

 

 

(21,529

)

 

 

(35,196

)

 

 

(27,293

)

Benefit from (provision for) income taxes

 

377

 

 

 

(3,605

)

 

 

(2,378

)

 

 

(6,272

)

Net loss

$

(7,738

)

 

$

(25,134

)

 

$

(37,574

)

 

$

(33,565

)

Loss per Ordinary Share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.02

)

 

$

(0.06

)

 

$

(0.09

)

 

$

(0.08

)

Diluted

$

(0.02

)

 

$

(0.06

)

 

$

(0.09

)

 

$

(0.08

)

Weighted average Ordinary Shares:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

415,531

 

 

 

411,150

 

 

 

414,607

 

 

 

410,786

 

Diluted

 

415,531

 

 

 

411,150

 

 

 

414,607

 

 

 

410,786

 

See notes to condensed consolidated financial statements.

4


 

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share amounts)

 

 

Ordinary
Shares

 

 

Treasury
Shares

 

 

Ordinary
Shares

 

 

Additional
Paid-in
Capital

 

 

Treasury
Stock

 

 

Accumulated
Deficit

 

 

Total

 

December 31, 2024

 

 

422,256,900

 

 

 

(10,672,049

)

 

 

305,298

 

 

 

1,914,750

 

 

 

(65,326

)

 

 

(1,668,546

)

 

 

486,176

 

Vesting of restricted stock units

 

 

4,585,679

 

 

 

(1,805,341

)

 

 

2,854

 

 

 

(2,854

)

 

 

(1,119

)

 

 

 

 

 

(1,119

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

4,327

 

 

 

 

 

 

 

 

 

4,327

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,697

)

 

 

(15,697

)

March 31, 2025

 

 

426,842,579

 

 

 

(12,477,390

)

 

$

308,152

 

 

$

1,916,223

 

 

$

(66,445

)

 

$

(1,684,243

)

 

$

473,687

 

Issuance of common stock under employee stock purchase plan

 

 

 

 

 

97,520

 

 

 

 

 

 

 

 

 

57

 

 

 

 

 

 

57

 

Vesting of restricted stock units

 

 

1,872,240

 

 

 

(933,452

)

 

 

1,269

 

 

 

(1,269

)

 

 

(720

)

 

 

 

 

 

(720

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

6,039

 

 

 

 

 

 

 

 

 

6,039

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,139

)

 

 

(14,139

)

June 30, 2025

 

 

428,714,819

 

 

 

(13,313,322

)

 

$

309,421

 

 

$

1,920,993

 

 

$

(67,108

)

 

$

(1,698,382

)

 

$

464,924

 

Vesting of restricted stock units

 

 

882,600

 

 

 

(318,120

)

 

 

598

 

 

 

(598

)

 

 

(248

)

 

 

 

 

 

(248

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

1,956

 

 

 

 

 

 

 

 

 

1,956

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,738

)

 

 

(7,738

)

September 30, 2025

 

 

429,597,419

 

 

 

(13,631,442

)

 

$

310,019

 

 

$

1,922,351

 

 

$

(67,356

)

 

$

(1,706,120

)

 

$

458,894

 

 

 

 

Ordinary
Shares

 

 

Treasury
Shares

 

 

Ordinary
Shares

 

 

Additional
Paid-in
Capital

 

 

Treasury
Stock

 

 

Accumulated
Deficit

 

 

Total

 

December 31, 2023

 

 

418,141,295

 

 

 

(9,317,202

)

 

$

302,756

 

 

$

1,899,456

 

 

$

(63,752

)

 

$

(1,586,363

)

 

$

552,097

 

Exercise of stock options

 

 

9,500

 

 

 

 

 

 

6

 

 

 

4

 

 

 

 

 

 

 

 

 

10

 

Vesting of restricted stock units

 

 

3,119,637

 

 

 

(1,217,450

)

 

 

1,980

 

 

 

(1,980

)

 

 

(1,436

)

 

 

 

 

 

(1,436

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

5,218

 

 

 

 

 

 

 

 

 

5,218

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,953

)

 

 

(9,953

)

March 31, 2024

 

 

421,270,432

 

 

 

(10,534,652

)

 

$

304,742

 

 

$

1,902,698

 

 

$

(65,188

)

 

$

(1,596,316

)

 

$

545,936

 

Issuance of common stock under employee stock purchase plan

 

 

139,982

 

 

 

 

 

 

89

 

 

 

33

 

 

 

 

 

 

 

 

 

122

 

Vesting of restricted stock units

 

 

340,936

 

 

 

(102,928

)

 

 

215

 

 

 

(215

)

 

 

(88

)

 

 

 

 

 

(88

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

4,387

 

 

 

 

 

 

 

 

 

4,387

 

Income for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,522

 

 

 

1,522

 

June 30, 2024

 

 

421,751,350

 

 

 

(10,637,580

)

 

$

305,046

 

 

$

1,906,903

 

 

$

(65,276

)

 

$

(1,594,794

)

 

$

551,879

 

Vesting of restricted stock units

 

 

243,081

 

 

 

(95,173

)

 

 

156

 

 

 

(156

)

 

 

(68

)

 

 

 

 

 

(68

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

4,698

 

 

 

 

 

 

 

 

 

4,698

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,134

)

 

 

(25,134

)

September 30, 2024

 

 

421,994,431

 

 

 

(10,732,753

)

 

$

305,202

 

 

$

1,911,445

 

 

$

(65,344

)

 

$

(1,619,928

)

 

$

531,375

 

 

See notes to condensed consolidated financial statements.

5


 

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(37,574

)

 

$

(33,565

)

Adjustments to reconcile loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

3

 

 

 

90

 

Accretion of investments

 

 

(3,019

)

 

 

(4,163

)

Stock-based compensation

 

 

12,322

 

 

 

14,303

 

Amortization of intangible asset

 

 

2,323

 

 

 

2,186

 

Changes in assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

(5,030

)

 

 

20,921

 

Inventory

 

 

36,979

 

 

 

38,208

 

Prepaid and other current assets

 

 

(17,260

)

 

 

4,471

 

Other long-term assets

 

 

104

 

 

 

110

 

Interest receivable

 

 

449

 

 

 

(250

)

Deferred revenue

 

 

 

 

 

(4,850

)

Accounts payable and other current liabilities

 

 

2,284

 

 

 

(55,382

)

Other long-term liabilities

 

 

(131

)

 

 

211

 

Net cash used in operating activities

 

 

(8,550

)

 

 

(17,710

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Maturities of securities

 

 

162,300

 

 

 

185,800

 

Purchases of securities

 

 

(149,955

)

 

 

(208,937

)

Net cash provided by (used in) investing activities

 

 

12,345

 

 

 

(23,137

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from issuance of common stock under employee stock purchase plan

 

 

57

 

 

 

122

 

Proceeds from exercise of stock options

 

 

 

 

 

10

 

Taxes paid related to stock-based awards

 

 

(2,087

)

 

 

(1,592

)

Net cash used in financing activities

 

 

(2,030

)

 

 

(1,460

)

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND
   RESTRICTED CASH

 

 

1,765

 

 

 

(42,307

)

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD

 

 

121,338

 

 

 

199,777

 

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD

 

$

123,103

 

 

$

157,470

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Cash paid during the year for:

 

 

 

 

 

 

Income taxes

 

$

(148

)

 

$

(2,045

)

Supplemental disclosure of non-cash transactions:

 

 

 

 

 

 

Initial recognition of operating lease right-of-use asset

 

$

856

 

 

$

1,068

 

 

See notes to condensed consolidated financial statements.

6


 

AMARIN CORPORATION PLC

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(1) Nature of Business and Basis of Presentation

Nature of Business

Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. The Company is commercialized in the United States, or the U.S., under the brand name VASCEPA® (icosapent ethyl), or VASCEPA. VASCEPA, under the brand name VAZKEPA, hereinafter along with VASCEPA, collectively referred to as VASCEPA is also commercialized in various European countries, including the United Kingdom, or the UK, and Spain. The Company’s operations outside of the U.S. are in varying stages of development and commercialization with reliance on third-party commercial partners in select geographies, including Europe, China, Australia and Canada.

VASCEPA was first approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, or the MARINE indication. In January 2013, the Company launched 1-gram size VASCEPA in the U.S. and in October 2016, introduced a 0.5-gram capsule size. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of the Company’s long-term cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.

On March 30, 2020, following conclusion of a trial in late January 2020, the U.S. District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or, collectively, the Defendants, that declared as invalid several of the Company's patents covering the MARINE indication. The Company sought appeals of the Nevada Court judgment up to the U.S. Supreme Court, but the Company was unsuccessful. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market:

Company

 

FDA MARINE Indication Approval

 

1-gram Launch Date

 

0.5-gram Launch Date

Hikma Pharmaceuticals USA Inc.

 

May 2020

 

November 2020

 

March 2023

Dr. Reddy’s Laboratories, Inc.

 

August 2020

 

June 2021

 

June 2023

Teva Pharmaceuticals USA, Inc.

 

September 2020

 

January 2023

 

September 2022

Apotex, Inc.

 

June 2021

 

January 2022

 

Zydus Lifesciences

 

April 2023

 

 

June 2024

Strides Pharma (1)

 

September 2023

 

April 2024

 

April 2024

Epic Pharma

 

December 2023

 

March 2024

 

Ascent Pharmaceuticals, Inc. (2)

 

December 2023

 

April 2024

 

April 2024

Qilu Pharmaceutical Co Ltd

 

November 2024

 

 

Spriaso LLC

 

December 2024

 

 

(1) Strides Pharma licensed its rights to the generic version of icosapent ethyl to Amneal Pharmaceuticals.

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc. and XL Care Pharmaceuticals, Inc.

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (>150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk. Collectively, CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

On June 24, 2025, the Company announced the execution of an exclusive long-term license and supply agreement with Recordati Industria Chimica e Farmaceutica S.p.A., or Recordati, to develop and commercialize VAZKEPA in 59 countries, focused in Europe.

On June 1, 2023, the Company announced that the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and the Company's partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, launched commercially in October 2023. On June 28, 2024, Edding received NMPA approval for VASCEPA in Mainland China for the REDUCE-IT indication. On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.

7


 

Amarin is responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product. The Company operates in one business segment.

Basis of Presentation

The condensed consolidated financial statements included herein have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information in the footnote disclosures of the financial statements has been condensed or omitted where it substantially duplicates information provided in the Company’s latest audited consolidated financial statements, in accordance with the rules and regulations of the SEC. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or the Form 10-K, filed with the SEC. The balance sheet amounts in this report were derived from the Company’s audited consolidated financial statements included in the Form 10-K.

The condensed consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated. The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results for any future period. Certain numbers presented throughout this document may not add precisely to the totals provided due to rounding. Absolute and percentage changes are calculated using the underlying amounts in thousands. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Effective as of April 11, 2025, the Company implemented an adjustment to the ratio of its American Depository Shares, or ADSs, to Ordinary Shares from one ADS representing one Ordinary Share to one ADS representing 20 Ordinary Shares, or the ADS Ratio Change. The ADS Ratio Change does not change the Ordinary Shares outstanding. Holders of fractional ADSs resulting from the ADS Ratio Change received a cash payment in lieu of such fractional ADSs. The rate for the cash payment was set when the depositary bank aggregated the fractional ADSs and sold them in one or more market trades. All references to ADSs in the accompanying notes to the financial statements give retroactive effect to the per-share and share amounts for the ADS Ratio Change for all periods presented herein, unless otherwise specified. In addition, the exercise prices and the numbers of ADSs issuable upon the exercise of any outstanding options or restricted stock units, or RSUs, were proportionately adjusted.

The accompanying condensed consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

As of September 30, 2025, the Company had total assets of $659.8 million, of which $286.6 million consisted of cash and short-term investments. More specifically, the Company had current assets of $628.3 million, including cash and cash equivalents of $122.8 million, short-term investments of $163.8 million, accounts receivable, net, of $127.3 million and current inventory of $184.7 million. In addition, as of September 30, 2025, the Company had long-term inventory of $9.1 million. As of September 30, 2025, the Company had no outstanding debt.

(2) Significant Accounting Policies

Revenue Recognition

In accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 7—Revenue Recognition.

8


 

Cash and Cash Equivalents and Restricted Cash

Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees.

Accounts Receivable, net

Accounts receivable, net, comprised of trade receivables, are generally due within 45 days and are stated at amounts due from customers. The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable credit losses net of any recoveries. The allowance is based primarily on assessment of specific identifiable customer accounts considered at risk or uncollectible, as well as an analysis of current receivables aging and expected future write-offs. The expense associated with the allowance for doubtful accounts is recognized as selling, general, and administrative expense. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.

The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of September 30, 2025 and December 31, 2024:

In thousands

 

September 30, 2025

 

 

December 31, 2024

 

Gross trade accounts receivable

 

$

141,296

 

 

$

133,072

 

Trade allowances

 

 

(12,774

)

 

 

(9,433

)

Chargebacks

 

 

(1,213

)

 

 

(1,360

)

Accounts receivable, net

 

$

127,309

 

 

$

122,279

 

Inventory

The Company states inventory at the lower of cost or net realizable value. Cost is determined based on actual cost using the average cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company classifies inventory as long-term inventory when consumption of the inventory is expected beyond the next 12 months. The Company classifies finished goods expected to be sold within the next 12 months, and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected net realizable value due to obsolescence, damage or quantities in excess of expected demand, changes in price levels or other causes, the Company will reduce the carrying value of such inventory to net realizable value and recognize the difference as a component of cost of goods sold in the period in which it occurs. The Company capitalizes inventory purchases of saleable product from approved suppliers while inventory purchases from suppliers prior to regulatory approval are included as a component of research and development expense. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of VASCEPA API.

Income Taxes

Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other tax attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. Deferred tax assets and liabilities are classified as non-current in the condensed consolidated balance sheet.

The Company provides reserves for potential payments of tax to various tax authorities and does not recognize tax benefits related to uncertain tax positions and other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy is to record interest and penalties in the benefit from (provision for) income taxes, as applicable.

The Company regularly assesses its ability to realize deferred tax assets. Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed.

Excess tax benefits and deficiencies that arise upon vesting or exercise of stock-based payments are recognized as an income tax benefit and expense, respectively, in the condensed consolidated statement of operations. Excess income tax benefits are classified as cash flows from operating activities and cash paid to taxing authorities arising from the withholding of Ordinary Shares from employees are classified as cash flows from financing activities.

9


 

The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and state tax authorities. The Company is currently under audit by the IRS for its 2018 and 2019 U.S. income tax returns. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its condensed consolidated financial position or results of operations.

Loss per Share

Basic net loss per share is determined by dividing net loss by the weighted average number of Ordinary Shares outstanding during the period. Diluted net loss per share is determined by dividing net loss by diluted weighted average number of Ordinary Shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive Ordinary Shares, such as from the exercise of stock options and vesting of RSUs calculated using the treasury stock method. In periods with reported net losses, all stock options and RSUs outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.

The calculation of net loss and the number of Ordinary Shares and ADSs used to compute basic and diluted net loss per Ordinary Share and ADS for the three and nine months ended September 30, 2025 and 2024 are as follows:

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

In thousands

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net loss—basic and diluted

 

$

(7,738

)

 

$

(25,134

)

 

$

(37,574

)

 

$

(33,565

)

Weighted average Ordinary Shares outstanding—basic and diluted

 

 

415,531

 

 

 

411,150

 

 

 

414,607

 

 

 

410,786

 

Loss per Ordinary Share—basic and diluted (1)

 

$

(0.02

)

 

$

(0.06

)

 

$

(0.09

)

 

$

(0.08

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average ADS outstanding—basic and diluted

 

 

20,776

 

 

 

20,557

 

 

 

20,730

 

 

 

20,539

 

Loss per ADS—basic and diluted (1)

 

$

(0.37

)

 

$

(1.22

)

 

$

(1.81

)

 

$

(1.63

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Excluding the licensing revenue change in estimates, discussed in Note 7 – Revenue Recognition, net loss per ordinary share, basic and diluted, for the nine months ended September 30, 2024 would have been net loss per share of $(0.09) and net loss per ADS, basic and diluted for the nine months ended September 30, 2024 would have been net loss per share of $(1.84).

For the three and nine months ended September 30, 2025 and 2024, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

In thousands

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Stock options

 

 

30,769

 

 

 

29,071

 

 

 

30,769

 

 

 

29,071

 

Restricted stock units

 

 

14,726

 

 

 

14,926

 

 

 

14,726

 

 

 

14,926

 

 

Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying securities on the last day of the reporting period. RSUs are anti-dilutive during periods of net earnings when underlying performance-based vesting requirements were not achieved as of the last day of the reporting period.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term investments, and accounts receivable. The Company maintains substantially all of its cash and cash equivalents and short-term investments in financial institutions believed to be of high credit quality.

A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry. The Company monitors the creditworthiness of customers to whom it grants credit terms and has not experienced any credit losses. The Company does not require collateral or any other security to support credit sales. Three customers individually accounted for 10% or more of the Company’s gross product sales. Customers A, B, and C accounted for 31%, 29%, and 28%, respectively, of gross product sales for the nine months ended September 30, 2025, and represented 40%, 23%, and 15%, respectively, of the gross accounts receivable balance as of September 30, 2025. Customers A, B, and C accounted for 29%, 34%, and 28%, respectively, of gross product sales for the nine months ended September 30, 2024, and represented 41%, 30%, and 17%, respectively, of the gross accounts receivable balance as of September 30, 2024. The Company has not experienced any significant write-offs of its accounts receivable. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.

10


 

Concentration of Suppliers

The Company has contractual freedom to source the API for VASCEPA and to procure other services supporting its supply chain and has entered into supply agreements with multiple suppliers. The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.

The Company cannot provide assurance that its efforts to procure uninterrupted supply of VASCEPA to meet market demand will continue to be successful or that it will be able to renew current supply agreements on favorable terms or at all. Significant alteration to or disruption or termination of the Company’s current supply chain or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations.

The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing. Each of these API manufacturers, encapsulators and packagers is U.S. FDA-approved and certain of these API manufacturers, encapsulators and packagers are also approved by the European Regulatory Authorities for manufacturing VAZKEPA in Europe. These suppliers are also used by the Company to source supply to meet the clinical trial and commercial demands of its partners in other countries. Each of these suppliers has qualified and validated its manufacturing processes. There can be no guarantee that these or other suppliers with which the Company may contract in the future to manufacture VASCEPA or VASCEPA API will remain qualified to do so to its specifications or that these and any future suppliers will have the manufacturing capacity to meet potential global demand for VASCEPA.

Fair Value of Financial Instruments

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:

Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates, yield curves) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The following tables present information about the estimated fair value of the Company’s assets and liabilities as of September 30, 2025 and December 31, 2024, and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:

 

 

September 30, 2025

 

In thousands

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Asset:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury Securities

 

$

172,822

 

 

$

172,822

 

 

$

 

 

$

 

Money Market Fund

 

 

38,765

 

 

 

38,765

 

 

 

 

 

 

 

Repo Securities

 

 

5,000

 

 

 

 

 

 

5,000

 

 

 

 

Total

 

$

216,587

 

 

$

211,587

 

 

$

5,000

 

 

$

 

 

 

 

December 31, 2024

 

In thousands

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Asset:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury Securities

 

$

174,722

 

 

$

174,722

 

 

$

 

 

$

 

Money Market Fund

 

 

67,456

 

 

 

67,456

 

 

 

 

 

 

 

Repo Securities

 

 

5,000

 

 

 

 

 

 

5,000

 

 

 

 

Total

 

$

247,178

 

 

$

242,178

 

 

$

5,000

 

 

$

 

 

11


 

 

The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature. The cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of purchase of 90 days or less.

The Company’s investments are stated at amortized cost, which approximates fair value. The Company does not intend to sell these investment securities and the contractual maturities are not greater than 12 months. Those with original maturities greater than 90 days and maturities less than 12 months are included in short-term investments on its condensed consolidated balance sheet.

Unrealized gains or losses are not recognized until maturity, except other-than-temporary unrealized losses, which are recognized in earnings in the period incurred. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. The unrealized gain for both the nine months ended September 30, 2025 and 2024 were $0.1 million and $0.3 million, respectively. Interest on investments is reported in interest income in our condensed consolidated statement of operations. Interest receivable in investment securities is reported in prepaid and other current assets in our condensed consolidated balance sheet.

The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature.

Segment and Geographical Information

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or CODM, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company currently operates in two business segments, U.S. and Europe, which are aggregated into a single reportable segment, for the development and commercialization of VASCEPA. A single management team that reports to the Company’s CODM, who is the Chief Executive Officer, comprehensively manages the business on an integrated basis for the purpose of allocating resources. The Company’s CODM does not currently assess segment performance or allocate resources based on a measure of total assets nor is it practical for the Company to disaggregate assets based on geography. Accordingly, a total asset measure has not been provided for segment disclosure. Therefore, the Company does not have separate reportable segments.

The table below is a summary of the reportable segment profit or loss, including significant reportable segment expenses:

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

In thousands

2025

 

 

2024

 

 

2025

 

 

2024

 

US product revenue, net

$

40,866

 

 

$

30,601

 

 

$

113,028

 

 

$

122,471

 

Europe product revenue, net

 

4,095

 

 

 

4,332

 

 

 

16,060

 

 

 

9,732

 

RoW product revenue, net

 

3,597

 

 

 

6,919

 

 

 

7,122

 

 

 

12,319

 

Total product revenue, net

 

48,558

 

 

 

41,852

 

 

 

136,210

 

 

 

144,522

 

Licensing and royalty revenue

 

1,112

 

 

 

446

 

 

 

28,217

 

 

 

21,786

 

Total revenue, net

 

49,670

 

 

 

42,298

 

 

 

164,427

 

 

 

166,308

 

Less: Cost of goods sold

 

27,462

 

 

 

26,022

 

 

 

66,728

 

 

 

75,359

 

Gross margin

 

22,208

 

 

 

16,276

 

 

 

97,699

 

 

 

90,949

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling

 

2,722

 

 

 

9,107

 

 

 

18,582

 

 

 

29,579

 

General and administrative

 

9,012

 

 

 

9,693

 

 

 

32,185

 

 

 

28,498

 

Research and development

 

1,289

 

 

 

1,425

 

 

 

5,216

 

 

 

5,268

 

Payroll and payroll related expense

 

8,528

 

 

 

16,521

 

 

 

43,250

 

 

 

52,576

 

Non-cash stock-based compensation expense

 

2,354

 

 

 

4,698

 

 

 

10,146

 

 

 

14,303

 

Restructuring

 

9,406

 

 

 

 

 

 

32,165

 

 

 

 

Total operating expenses

 

33,311

 

 

 

41,444

 

 

 

141,544

 

 

 

130,224

 

Operating loss

 

(11,103

)

 

 

(25,168

)

 

 

(43,845

)

 

 

(39,275

)

Interest income, net

 

2,783

 

 

 

3,374

 

 

 

8,277

 

 

 

10,028

 

Other income, net

 

205

 

 

 

265

 

 

 

372

 

 

 

1,954

 

Loss from operations before taxes

 

(8,115

)

 

 

(21,529

)

 

 

(35,196

)

 

 

(27,293

)

Benefit from (provision for) income taxes

 

377

 

 

 

(3,605

)

 

 

(2,378

)

 

 

(6,272

)

Segment & consolidated net loss

$

(7,738

)

 

$

(25,134

)

 

$

(37,574

)

 

$

(33,565

)

Restructuring

The Company identifies a restructuring event as a program that is planned and controlled by management, and materially changes either the scope of the Company's business or the manner in which that business is conducted. The accounting for involuntary

12


 

termination benefits that are provided pursuant to a one-time benefit arrangement are accounted for under ASC 420 – Exit or Disposal Cost Obligations, whereas involuntary termination benefits that are part of an ongoing written or substantive plan are accounted for under ASC 712 – Compensation – Nonretirement Postemployment Benefits. The Company accrues a liability for termination benefits under ASC 712 when it is probable that a liability has been incurred and the amount can be reasonably estimated and under ASC 420 when the termination benefits are communicated.

On June 24, 2025, the Company announced a global restructuring plan, the Global Restructuring Plan, in connection with the execution of an exclusive long-term license and supply agreement with Recordati, with the vast majority of estimated cost savings to come from the elimination of commercial roles in the Company’s European operations. The Company anticipates that it will incur between approximately $30.0 million and $37.0 million in charges related to the Global Restructuring Plan, substantially all of which will be cash expenditures. During the three and nine months ended September 30, 2025, the Company recognized approximately $9.4 million and $32.2 million, respectively, of restructuring expense reflected on the condensed consolidated statement of operations related to the reduction in force, substantially all of which are cash expenditures.

The following table sets forth the components of the Company's restructuring charges for the three and nine months ended September 30, 2025 (none in 2024):

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

In thousands

 

2025

 

 

2025

 

Restructuring expense

 

$

10,714

 

 

$

23,428

 

Vendor contract charges

 

 

(1,308

)

 

 

8,737

 

    Total restructuring expense

 

 

9,406

 

 

 

32,165

 

Forfeited (accelerated) stock vesting

 

 

399

 

 

 

(2,176

)

    Total restructuring costs incurred

 

$

9,805

 

 

$

29,989

 

The following table shows the change in restructuring liability, which is included within accrued expenses and other current liabilities:

 

In thousands

 

Restructuring Liability

 

Balance at December 31, 2024

 

$

 

   Costs incurred

 

 

29,989

 

   Payments

 

 

(17,190

)

Balance at September 30, 2025

 

$

12,799

 

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted early by the Company or adopted as of the specified effective date.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, which provides more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This change is effective for annual periods beginning after December 15, 2024. The Company expects adoption of this ASU will result in additional annual disclosures in line with the requirements of ASU 2023-09.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires a public business entity to disclose specific information about certain costs and expenses in the notes to its financial statements for interim and annual reporting periods beginning after December 15, 2026. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on the Company’s consolidated financial statements.

The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

(3) Intangible Asset

Intangible asset consists of internal-use software, website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for the MARINE indication in 2012, the REDUCE-IT indication in 2019 and marketing approval in Europe in 2021. In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization. As of September 30, 2025, the

13


 

intangible assets have an estimated weighted-average remaining useful life of 5.4 years. The carrying value as of September 30, 2025 and December 31, 2024 is as follows:

 

In thousands

 

September 30, 2025

 

 

December 31, 2024

 

Technology rights

 

$

33,188

 

 

$

33,188

 

Accumulated amortization

 

 

(19,122

)

 

 

(16,799

)

Intangible asset, net

 

$

14,066

 

 

$

16,389

 

 

(4) Inventory

The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA and other global regulatory agencies. Inventories as of September 30, 2025 and December 31, 2024 consist of the following:

In thousands

 

September 30, 2025

 

 

December 31, 2024

 

Raw materials

 

$

96,154

 

 

$

91,421

 

Work in process

 

 

9,211

 

 

 

30,482

 

Finished goods

 

 

88,444

 

 

 

108,885

 

Total inventory 1

 

$

193,809

 

 

$

230,788

 

(1) Total inventory consists of both current inventory and long-term inventory. During the nine months ended September 30, 2025, approximately $0.4 million of inventory was expensed through cost of goods sold for product dating inventory. During the nine months ended September 30, 2024, approximately $1.5 million of inventory was expensed through cost of goods sold for product dating inventory.

As of September 30, 2025 and December 31, 2024, the Company had $9.1 million and $64.7 million of long-term inventory, respectively, as consumption is expected beyond the Company's operating cycle of 12 months.

(5) Commitments and Contingencies

The Company accrues a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Company reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Company's views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Company's accrued liabilities would be recorded in the period in which such determination is made. For the matters referenced below, the amount of liability is not probable nor can the amount be reasonably estimated; therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for matters in which the likelihood of material loss is at least reasonably possible, the Company provides disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, the Company will provide disclosure to that effect.

Litigation Updates

The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of such lawsuits or other proceedings described in the Company's Form 10-K. Except as described below, there have been no material updates to our litigation as reported in the Company’s Form 10-K.

On November 30, 2020, the Company filed a patent infringement lawsuit against Hikma for making, selling, offering to sell, and importing generic icosapent ethyl capsules in and into the U.S. in a manner that the Company alleges induced the infringement of patents covering the use of VASCEPA to reduce specified CV risk. On January 4, 2022, the district court for the District of Delaware granted a motion to dismiss the Company's lawsuit for failure to state a claim. Thereafter, the Company appealed to the Court of Appeals for the Federal Circuit. On June 25, 2024, the Federal Circuit issued a decision reversing the district court, finding that the Company's allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents. Hikma filed a petition for rehearing en banc on August 22, 2024, which was denied on October 17, 2024. On February 14, 2025, Hikma filed a petition for a writ of certiorari with the Supreme Court of the U.S. seeking review of the Federal Circuit decision reversing the district court. The infringement case continues to proceed within the district court during the pendency of the petition.

On March 31, 2023, the Company’s former chief executive officer, Karim Mikhail, filed a complaint against the Company and certain of its affiliates in the Superior Court of New Jersey, Law Division – Somerset County, captioned Mikhail v. Amarin Corporation, plc (Docket No. SOM-L-000366-23), concerning Mr. Mikhail’s alleged “constructive termination” from the Company. The complaint seeks unspecified damages arising from claims for breaches of his employment agreement, Executive Severance and Change of Control Plan, and the implied covenant of good faith and fair dealing. On April 3, 2023, the case moved to the U.S. District Court for

14


 

the District of New Jersey (Civ. No. 3:23-cv-01856). On June 30, 2023, all defendants moved to dismiss this case without prejudice due to lack of jurisdiction. On March 4, 2024, the District Court granted the motion in part and denied the motion in part, permitting the parties to pursue limited discovery on the issue of personal jurisdiction. On March 20, 2025, the Company filed a new motion to dismiss for failure of plaintiff to state a claim. The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome. The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.

In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters.

Milestone and Supply Purchase Obligations

The Company currently has long-term supply agreements with multiple API suppliers and encapsulators. The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.

These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities, including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers.

The Company continues to negotiate with contract suppliers to align its supply arrangements with current and future global demand, which may result in additional costs to the Company. As of the date of filing of this Quarterly Report, the Company has a total of approximately $190.8 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.

Under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each such former shareholder) of £5.0 million (approximately $6.7 million as of September 30, 2025).

The Company has no provision for any of these obligations since the amounts are either not paid or payable as of September 30, 2025.

(6) Equity

ADSs

On April 11, 2025, the Company effected its ADS Ratio Change on its ADSs from one ADS representing one Ordinary Share, to the new ratio of one ADS representing 20 Ordinary Shares.

During the nine months ended September 30, 2025 and 2024, except as described above, the Company did not engage in any transactions involving its ADSs. Refer to Incentive Equity Awards below for discussions of Ordinary Shares issued as a result of stock option exercises and vesting of RSUs.

Ordinary Shares

There was no Ordinary Share activity during the nine months ended September 30, 2025 and 2024, except as described in Incentive Equity Awards below.

Incentive Equity Awards

The following table summarizes the aggregate number of Ordinary Shares underlying stock options and RSUs outstanding under the Amarin Corporation plc 2020 Stock Incentive Plan, as amended, or the 2020 Plan, as of September 30, 2025:

 

 

September 30, 2025

 

Outstanding stock options

 

30,768,706

 

% of outstanding on a fully-diluted basis

 

7

%

Outstanding RSUs

 

14,726,029

 

% of outstanding on a fully-diluted basis

 

4

%

The following table represents equity awards activity during the nine months ended September 30, 2025 and 2024:

 

15


 

 

Nine months ended September 30,

 

 

2025

 

 

2024

 

Ordinary Shares issued for stock option exercises

 

 

 

 

9,500

 

Gross and net proceeds from stock option exercises

$

 

 

$

10,260

 

Ordinary Shares issued in settlement of vested RSUs

 

7,083,019

 

 

 

3,218,757

 

Ordinary Shares retained for settlement of employee tax obligations  RSUs

 

2,939,015

 

 

 

1,188,171

 

Ordinary Shares issued in settlement of vested Performance-based RSUs (1)

 

257,500

 

 

 

484,897

 

Ordinary Shares retained for settlement of employee tax obligations ─ Performance-based RSUs

 

117,898

 

 

 

227,380

 

(1)
Performance-based RSUs vested in connection with the achievement of certain performance conditions during the year.

In June 2025, the Company granted to Aaron Berg (i) RSUs for 1,500,000 Ordinary Shares that vested upon the date of grant; and (ii) stock options and RSUs of 750,000 and 250,000 Ordinary Shares that vest 50% on both June 26, 2026 and December 26, 2026, respectively.

In January 2025, the Company granted RSUs for a total of 10,646,844 Ordinary Shares and stock options for a total of 3,313,059 Ordinary Shares to employees under the 2020 Plan. The RSUs and stock options vest 50% on both January 1, 2026 and July 1, 2026, respectively.

In July 2024, the Company granted stock options for 5,000,000 Ordinary Shares to Aaron Berg in connection with his appointment as President and Chief Executive Officer, which will vest upon achievement of specified stock price conditions for the Company.

In April 2024, the Company granted RSUs for a total of 492,296 Ordinary Shares and stock options for a total of 1,438,360 Ordinary Shares to members of the Company's Board of Directors. The RSUs vest annually over a three-year period and the stock options vest quarterly over a four-year period with a one-year cliff vesting.

In February 2024, the Company granted RSUs for a total of 6,800,500 Ordinary Shares and stock options for a total of 2,662,000 Ordinary Shares to employees under the 2020 Plan. The RSUs vest annually over a three-year period and the stock options vest quarterly over a four-year period with a one-year cliff vesting.

(7) Revenue Recognition

The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty retail pharmacy providers in the U.S., or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Patients are required to have a prescription in order to purchase VASCEPA. In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.

Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor and in certain instances upon shipment. Payments from distributors are generally received 45 days from the date of sale. The Company evaluates the creditworthiness of each of its distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements, or whether recognition is required to be delayed until receipt of payment. The Company calculates gross product revenues generally based on the wholesale acquisition cost or list price that the Company charges its distributors for VASCEPA.

Reserves for Variable Consideration

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the distributor) or as a current liability (if the amount is payable to a party other than a distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a

16


 

significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors in the U.S. and Europe generally include a 2-3% discount for prompt payment; while the fees for U.S. and global distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.

Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors. We have withdrawn from the Medicaid Drug Rebate program and the 340B drug pricing program effective October 1, 2024. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.

Product Returns: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently four years and three years, respectively, after being converted into capsule form, which is the last step in the manufacturing process for VASCEPA and generally occurs within a few months before VASCEPA is delivered to distributors. The Company estimates future product returns on sales of VASCEPA based on (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets.

Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed.

17


 

The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the nine months ended September 30, 2025 and 2024:

 

In thousands

 

Trade
Allowances

 

 

Rebates,
Chargebacks
and Discounts

 

 

Product
Returns

 

 

Other
Incentives

 

 

Total

 

Balance as of December 31, 2024

 

$

9,433

 

 

$

97,526

 

 

$

4,734

 

 

$

1,548

 

 

$

113,241

 

Provision related to current period sales

 

 

56,169

 

 

 

504,168

 

 

 

1,301

 

 

 

9,897

 

 

 

571,535

 

Provision related to prior period sales

 

 

 

 

 

562

 

 

 

 

 

 

 

 

 

562

 

Credits/payments made for current period sales

 

 

(44,049

)

 

 

(411,114

)

 

 

(81

)

 

 

(8,496

)

 

 

(463,740

)

Credits/payments made for prior period sales

 

 

(8,779

)

 

 

(96,717

)

 

 

(3,232

)

 

 

(1,703

)

 

 

(110,431

)

Balance as of September 30, 2025

 

$

12,774

 

 

$

94,425

 

 

$

2,722

 

 

$

1,246

 

 

$

111,167

 

 

In thousands

 

Trade
Allowances

 

 

Rebates,
Chargebacks
and Discounts

 

 

Product
Returns

 

 

Other
Incentives

 

 

Total

 

Balance as of December 31, 2023

 

$

18,834

 

 

$

143,033

 

 

$

7,732

 

 

$

1,902

 

 

$

171,501

 

Provision related to current period sales

 

 

62,211

 

 

 

589,133

 

 

 

1,459

 

 

 

8,667

 

 

 

661,470

 

Provision related to prior period sales

 

 

 

 

 

(2,111

)

 

 

 

 

 

 

 

 

(2,111

)

Credits/payments made for current period sales

 

 

(50,145

)

 

 

(484,127

)

 

 

(167

)

 

 

(7,912

)

 

 

(542,351

)

Credits/payments made for prior period sales

 

 

(18,383

)

 

 

(136,588

)

 

 

(3,152

)

 

 

(1,986

)

 

 

(160,109

)

Balance as of September 30, 2024

 

$

12,517

 

 

$

109,340

 

 

$

5,872

 

 

$

671

 

 

$

128,400

 

 

Such net product revenue allowances and reserves are included within accrued expenses and other current liabilities within the condensed consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within accounts receivable, net, as discussed above.

Licensing Revenue

The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing and royalty revenues.

In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company.

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. During the three months ended June 30, 2024, the Company adjusted the measure of performance and recognized an additional $4.0 million of license revenue relating to Edding. Excluding this change in estimate, net loss per share basic and diluted for the nine months ended September 30, 2024 would have been $(0.09). Refer to Note 8—Development, Commercialization and Supply Agreements for further details.

Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not

18


 

occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.

Royalty Payments: At the inception of each arrangement that includes royalty-based payments, the Company evaluates whether the royalties relate to the license of intellectual property, in which case they are accounted for under the royalty constraint within ASC 606 and recognized when the later of the subsequent sale or usage occurs or when the performance obligations have been satisfied. If the royalties do not relate to the licensing of intellectual property, the royalties are accounted for under the variable consideration constraint within ASC 606 and are recognized in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue will not occur when the uncertainty around the variable consideration is subsequently resolved. Royalty payments that fall within the variable consideration constraint take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The royalties that are considered variable consideration are recognized when the uncertainty related to the variable consideration is subsequently resolved. At the end of each subsequent reporting period, the Company reevaluates the circumstances and recognizes royalties that are no longer constrained.

The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

(8) Development, Commercialization and Supply Agreements

In-licenses

Mochida Pharmaceutical Co., Ltd.

In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the U.S. and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the U.S. and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.

Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.

In February 2025 and January 2024, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million in each of such periods to Mochida, which was recorded as research and development expense in the condensed consolidated statement of operations.

Out-licenses

Eddingpharm (Asia) Macao Commercial Offshore Limited

In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or collectively, the China Territory. Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.

19


 

Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company; (2) the obligation to participate in various steering committees; and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.

The transaction price is comprised of the following upfront payments and milestones:

In thousands

 

 

 

 

 

Transaction Price Components

 

Achieved

 

Amount

 

Upfront fee

 

February 2015

 

$

15,000

 

Submission of the CTA for the MARINE indication

 

March 2016

 

 

1,000

 

Approval of VASCEPA under the MARINE indication

 

March 2017

 

 

5,000

 

Submission of the CTA for the REDUCE-IT indication

 

October 2023

 

 

3,000

 

Approval of VASCEPA under the REDUCE-IT indication

 

June 2024

 

 

15,000

 

Regulatory Development Support

 

Various

 

 

1,081

 

Total Transaction Price

 

 

 

$

40,081

 

In addition to the non-refundable, upfront and regulatory milestone payments described above, the Company is entitled to receive tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The achievement of sales-based milestone events occurs when annual aggregate net sales of VASCEPA in the China Territory equals or exceeds certain specified thresholds, and range from $5.0 million to $50.0 million, for a total of $120.0 million. Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the second quarter of 2024, Edding received approval in China under the REDUCE-IT indication. The REDUCE-IT indication approval concludes the Company's support for regulatory activities and, as noted above, pursuit of additional indications was deemed to be not probable. As a result, the Company reevaluated the performance period and determined that all remaining performance obligations were satisfied as of June 30, 2024, resulting in a decrease of the previous performance period of two years. The effect of this change in estimate from the previously received upfront payment and prior year milestone payments was an increase of $4.0 million in licensing revenue and a related reduction in net loss by $4.0 million in the nine months ended September 30, 2024. In addition, the Company also recognized $15.0 million in the second quarter related to the REDUCE-IT indication approval milestone. The Company fully recognized the transaction price as of June 30, 2024.

In thousands

 

Amount

 

Licensing revenue recognized during the nine months ended September 30, 2025 (1)

 

$

 

Licensing revenue recognized during the nine months ended September 30, 2024 (1)

 

 

19,450

 

Licensing revenue recognized from contract inception through both September 30, 2025 and December 31, 2024

 

$

40,081

 

(1)
Licensing revenue under the DCS Agreement is recognized concurrent with the input measure of support hours provided by the Company to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

The Company recognized net product revenue of $4.8 million and $8.2 million for the three and nine months ended September 30, 2024, respectively, related to sales to Edding (none in 2025). The Company also recognized royalties of $0.4 million and $1.3 million for the three and nine months ended September 30, 2025, respectively, and nil and $0.4 million for the three and nine months ended September 30, 2024, respectively.

20


 

Biologix FZCo

In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, the Company granted Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Upon closing of the agreement, the Company received a non-refundable upfront payment, which has been fully recognized as of June 30, 2024. The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.

The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries:

Country

 

MARINE

 

REDUCE-IT

 

Launch Date

Lebanon

 

March 2018

 

August 2021

 

June 2018

United Arab Emirates

 

July 2018

 

October 2021

 

February 2019

Qatar

 

December 2019

 

April 2021

 

May 2022

Bahrain

 

April 2021

 

April 2022

 

September 2023

Kuwait

 

December 2021

 

March 2023

 

September 2023

Saudi Arabia

 

March 2022

 

June 2023

 

September 2023

The Company recognized net product revenue of $1.8 million and $4.5 million for the three and nine months ended September 30, 2025, respectively, and $1.3 million for both the three and nine months ended September 30, 2024, related to sales to Biologix.

HLS Therapeutics, Inc.

In September 2017, the Company entered into an agreement with HLS Therapeutics, Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada; (2) support general development and regulatory activities; and (3) participate in various steering committees. Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.

The transaction price is comprised of the following upfront payments and milestones:

In thousands

 

 

 

 

 

Transaction Price Components

 

Achieved

 

Amount

 

Upfront fee

 

September 2017

 

$

5,000

 

Achievement of the REDUCE-IT trial primary endpoint

 

September 2018

 

 

2,500

 

Approval from Health Canada

 

December 2019

 

 

2,500

 

Regulatory exclusivity from the Office of Patented Medicines and Liaison

 

January 2020

 

 

3,800

 

Total Transaction Price

 

 

 

$

13,800

 

In addition to the non-refundable, upfront and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada. None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price.

The Company fully recognized the transaction price as of June 30, 2023.

The Company recognized net product revenue of $1.8 million for both the three and nine months ended September 30, 2025 and nil and $1.9 million for the three and nine months ended September 30, 2024, respectively, related to sales to HLS. The Company also recognized royalties of $0.7 million and $1.9 million for the three and nine months ended September 30, 2025, respectively, and $0.6 million and $1.6 million for the three and nine months ended September 30, 2024, respectively.

 

21


 

CSL Seqirus

In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. The Company received an upfront payment of $0.5 million, which was fully recognized during the first quarter of 2023. In October 2024, CSL obtained listing of VAZKEPA on the Pharmaceutical Benefits Scheme, or PBS, in Australia, as a result the Company received a non-refundable $1.2 million milestone payment. In addition to the upfront payment, the Company will be eligible to receive event-related milestone payments of approximately $6.0 million and additional product-related milestone payments of approximately $4.0 million. The Company will be responsible for supplying finished product to CSL Seqirus at a price that is the greater of (i) a fixed transfer price, or (ii) a fixed percentage of the net selling price, as defined in the CSL agreement.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, CSL, is a customer. The Company identified the following distinct performance obligations at the inception of the contract: an exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.

The transaction price includes the $0.5 million upfront consideration as well as the $1.2 million milestone payment received related to the listing of VAZKEPA on the PBS in Australia. Any consideration related to event-based or product-based milestones will be recognized when the related milestone events occur and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company recognized net product revenue of nil and $0.8 million for the three and nine months ended September 30, 2025, respectively, and $0.8 million for both the three and nine months ended September 30, 2024 related to sales to CSL.

Recordati Industria Chimica e Farmaceutica S.p.A.

In June 2025, the Company entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VASCEPA in 59 countries focused in Europe, or the Recordati Territory. Under the terms of the Recordati Licensing Agreement, the Company granted Recordati an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the Recordati Territory for uses that are currently commercialized and under development by the Company based on the Company’s REDUCE-IT clinical trials of VASCEPA. The Company has received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently made VASCEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

 

Country

 

Individual Reimbursement

 

National Reimbursement

 

Product Availability

 

Launch Date

Sweden

 

 

March 2022

 

March 2022

 

March 2022

Finland

 

 

October 2022

 

December 2022

 

December 2022

England/Wales

 

 

July 2022

 

October 2022

 

October 2022

Spain

 

 

July 2023

 

September 2023

 

September 2023

Netherlands

 

 

August 2023

 

September 2023

 

September 2023

Scotland

 

 

August 2023

 

August 2023

 

September 2023

Greece (1)

 

 

May 2024

 

June 2024

 

June 2024

Portugal

 

 

August 2024

 

August 2024

 

September 2024

Italy

 

 

December 2024

 

December 2024

 

January 2025

Slovenia (2)

 

 

September 2025

 

October 2025

 

October 2025

Austria

 

September 2022

 

February 2025

 

September 2022

 

Denmark

 

June 2022

 

 

June 2022

 

(1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.

(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Recordati, is a customer. The Company identified the following distinct performance obligations at the inception of the contract: an exclusive license to use its intellectual property; regulatory approvals; and regulatory documents in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Recordati Territory. The Company will be responsible for supplying finished product to Recordati at a set price, as defined in the Recordati Licensing Agreement.

22


 

The Company received an upfront payment of $25.0 million, which was fully recognized during the second quarter of 2025. In addition to the upfront payment, the Company will be eligible to receive sales-based milestone payments and royalties on net sales of VASCEPA in the Recordati Territory. The achievement of sales-based milestone events occurs when annual aggregate net sales of VASCEPA in the Recordati Territory equals or exceeds certain specified thresholds resulting in total payments of up to $150.0 million. Each such milestone payment will be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

The transaction price includes the $25.0 million upfront consideration. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur or uncertainty related to the consideration resolved, and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the nine months ended September 30, 2025, the Company recognized $25.0 million as licensing revenue related to the upfront payment received in connection with the Recordati Licensing Agreement (none in 2024).

The Company recognized net product revenue of $1.7 million for both the three and nine months ended September 30, 2025, related to sales to Recordati (none in 2024). The Company also recognized royalties of less than $0.1 million for both the three and nine months ended September 30, 2025, respectively (none in 2024).

 

The following table presents changes in the balances of the Company’s contract assets and liabilities during the nine months ended September 30, 2025 and 2024:

 

In thousands

Balance at Beginning of Period

 

 

Additions

 

 

Deductions

 

 

Balance at
End of Period

 

Nine months ended September 30, 2025:

 

 

 

 

 

 

 

 

 

 

 

Contract assets

$

 

 

$

 

 

$

 

 

$

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

$

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended September 30, 2024:

 

 

 

 

 

 

 

 

 

 

 

Contract assets

$

 

 

$

 

 

$

 

 

$

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue (1)

$

4,850

 

 

$

 

 

$

(4,850

)

 

$

 

 

(1)
The approximately $4.9 million reduction consists primarily of recognition of $4.0 million relating to the change in estimate for Edding during the three months ended June 30, 2024.

During the nine months ended September 30, 2025 and 2024, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods:

 

In thousands

Nine months ended September 30,

 

Revenue recognized in the period from:

2025

 

 

2024

 

Amounts included in contract liability at the beginning of the period

$

 

 

$

1,180

 

Performance obligations satisfied in previous periods

$

 

 

$

3,670

 

 

(9) Leases

Lessee

The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842.

23


 

The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1% would not result in a material change to the Company’s condensed consolidated financial statements.

On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease. The Lease commenced on August 15, 2019, or the Commencement Date, for an 11-year period, with two five-year renewal options. Subject to the terms of the Lease, Amarin will have a one-time option to terminate the agreement effective on the first day of the 97th month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company paid monthly rent of approximately $0.1 million for the first year following the Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease.

On November 17, 2021, the Company entered into a lease agreement for office space in Zug Switzerland, or the Zug Lease. The Zug Lease commenced on February 1, 2022, or the Zug Commencement Date, for a five-year period, with one five-year renewal option. Under the Zug Lease, the Company will pay annual rent of approximately $0.2 million for the first year following the Zug Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Zug Commencement Date.

On September 13, 2022, the Company entered into a lease agreement for office space in Dublin, Ireland, or the Dublin Lease. The Dublin Lease commenced on October 1, 2022, or the Dublin Commencement Date, for a two-year period. Under the Dublin Lease, the Company paid annual rent of approximately $0.4 million during the duration of the lease term, which ended on September 30, 2024.

On April 26, 2024, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Subsequent Dublin Lease. The Subsequent Dublin Lease commenced on September 1, 2024, or the Subsequent Dublin Commencement Date, for a two-year period. Under the Subsequent Dublin Lease, the Company paid annual rent of approximately $0.5 million during the duration of the lease term, which was terminated effective on February 28, 2025.

On February 11, 2025, the Company entered into an amended lease agreement, which amended the Subsequent Dublin Lease, for additional office space in Dublin, Ireland, or the Amended Subsequent Dublin Lease. The Amended Subsequent Dublin Lease commenced on March 1, 2025, or the Amended Subsequent Dublin Commencement Date, for a two-year period. Under the Amended Subsequent Dublin Lease, the Company will pay annual rent of approximately $0.9 million during the duration of the lease term.

Prior to the licensing agreement with Recordati, the Company had lease agreements for various vehicles with terms ranging from month-to-month up to 36 months within Europe.

The total operating lease liability is $9.0 million and $9.7 million and the total operating lease right-of-use asset is $7.2 million and $7.6 million, as of September 30, 2025 and December 31, 2024, respectively.

The lease expense for the three and nine months ended September 30, 2025 is approximately $0.8 million and $2.6 million, respectively. The lease expense for the three and nine months ended September 30, 2024 is approximately $0.8 million and $2.7 million, respectively.

The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of September 30, 2025:

 

In thousands

 

Undiscounted lease payments

 

Remainder of 2025

 

$

793

 

2026

 

 

3,220

 

2027

 

 

2,142

 

2028

 

 

1,978

 

2029

 

 

2,011

 

2030 and thereafter

 

 

1,262

 

Total undiscounted payments

 

$

11,406

 

Discount Adjustments

 

$

(2,374

)

Current operating lease liability

 

$

2,301

 

Long-term operating lease liability

 

$

6,731

 

 

24


 

Lessor

The Company classifies contractual lease arrangements entered as a lessor as a sales-type, direct financing or operating lease as described in ASC 842. For sales-type leases, the Company derecognizes the leased asset and recognizes the lease investment on the balance sheet.

On January 20, 2023, the Company entered into a sublease agreement, or the Sublease, for 50,000 square feet of the 67,747 square foot Lease and included within the sublease are furniture, fixtures and equipment, collectively the Sublease. The Sublease commenced on February 1, 2023, or the Sublease Commencement Date, for a 7.5-year period. Under the Sublease, the Company will be paid monthly rent of approximately $0.1 million for the first year following the Sublease Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date. In addition, the Company will provide certain abatements subject to the limitations in the Lease.

The components of lease income are as follows:

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

In thousands

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Interest income from sales-type leases

 

$

14

 

 

$

15

 

 

$

42

 

 

$

47

 

Operating lease income

 

 

249

 

 

 

249

 

 

 

746

 

 

 

746

 

Total

 

$

263

 

 

$

264

 

 

$

788

 

 

$

793

 

Future minimum sales-type lease and operating lease receivables as of September 30, 2025 are as follows:

In thousands

 

Sales-Type Leases

 

 

Operating Leases

 

Remainder of 2025

 

$

30

 

 

$

258

 

2026

 

 

122

 

 

 

1,051

 

2027

 

 

125

 

 

 

1,073

 

2028

 

 

127

 

 

 

1,096

 

2029

 

 

130

 

 

 

1,118

 

2030 and thereafter

 

 

88

 

 

 

759

 

Total

 

$

622

 

 

$

5,355

 

 

25


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements reflect our plans, estimates and beliefs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or our Annual Report, and under Part II, Item IA, “Risk Factors” of this Quarterly Report.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise.

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report, and the audited consolidated financial statements and accompanying notes, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report.

Overview

We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.

Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of our long-term cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication.

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA®, hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk statin-treated adult patients who have elevated triglycerides (>150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

We and our seven commercial partners are in various stages; seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization. VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S. New Drug Application, or NDA, core dossier or the EMA core dossier.

VASCEPA (U.S. NDA Core Dossier)

 

VAZKEPA (EMA Core Dossier)

Amarin (US)

 

Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1)

HLS Therapeutics Inc. "HLS" (Canada)

 

CSL Seqirus "CSL"(Australia/New Zealand)

Biologix FZCo "Biologix" (MENA)

 

Lotus Pharmaceuticals, "Lotus" (Southeast Asia)

Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory)

 

Neopharm (Israel) 1996 Ltd. "Neopharm" (Israel)

(1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) will be transitioned to Recordati.

We are responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate us for such supply. We are not responsible for providing any generic company with drug product. The Company operates in one business segment.

26


 

United States

VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 27 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:

Company

 

FDA MARINE Indication Approval

 

1-gram Launch Date

 

0.5-gram Launch Date

Hikma Pharmaceuticals USA Inc.

 

May 2020

 

November 2020

 

March 2023

Dr. Reddy’s Laboratories, Inc.

 

August 2020

 

June 2021

 

June 2023

Teva Pharmaceuticals USA, Inc.

 

September 2020

 

January 2023

 

September 2022

Apotex, Inc.

 

June 2021

 

January 2022

 

Zydus Lifesciences

 

April 2023

 

 

June 2024

Strides Pharma (1)

 

September 2023

 

April 2024

 

April 2024

Epic Pharma

 

December 2023

 

March 2024

 

Ascent Pharmaceuticals, Inc. (2)

 

December 2023

 

April 2024

 

April 2024

Qilu Pharmaceutical Co Ltd

 

November 2024

 

 

Spriaso LLC

 

December 2024

 

 

(1) Strides Pharma licensed its rights to the generic version of icosapent ethyl to Amneal Pharmaceuticals.

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc. and XL Care Pharmaceuticals, Inc.

We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to determine the actual number of total prescriptions for products like VASCEPA during such periods. The vendor's estimate utilizes a proprietary projection methodology and is based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable. Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S.

img154162028_0.jpg

Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients, calculated on a normalized basis (i.e., one month’s supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams). Inventory levels at wholesalers tend to fluctuate based on seasonal factors, prescription trends and other factors.

The previous calculations of prescription levels by this vendor can change between periods and can be significantly affected by lags in data reporting from various sources or by changes in pharmacies and other distributors providing data. Such methods can from time to time result in significant inaccuracies in information when ultimately compared with actual results. These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use. Further, data for a single and limited period may not be representative of a trend or otherwise predictive of future results.

27


 

Europe

In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland.

In June 2025, we entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe, or the Recordati Territory. As a result of the Recordati Licensing Agreement, we implemented a global restructuring plan, or the Global Restructuring Plan, which we estimate will result in annual cost savings of approximately $70.0 million primarily from the elimination of commercial roles in our European operations.

As a result of the Recordati Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory. Recordati may sell VAZKEPA pursuant to the product reimbursements we have already obtained in Europe and will use commercially reasonable efforts to pursue future approvals in the Recordati Territory.

Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 19 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement varies from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Quarterly Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

 

Country

 

Individual Reimbursement

 

National Reimbursement

 

Product Availability

 

Launch Date

Sweden

 

 

March 2022

 

March 2022

 

March 2022

Finland

 

 

October 2022

 

December 2022

 

December 2022

England/Wales

 

 

July 2022

 

October 2022

 

October 2022

Spain

 

 

July 2023

 

September 2023

 

September 2023

Netherlands

 

 

August 2023

 

September 2023

 

September 2023

Scotland

 

 

August 2023

 

August 2023

 

September 2023

Greece (1)

 

 

May 2024

 

June 2024

 

June 2024

Portugal

 

 

August 2024

 

August 2024

 

September 2024

Italy

 

 

December 2024

 

December 2024

 

January 2025

Slovenia (2)

 

 

September 2025

 

October 2025

 

October 2025

Austria

 

September 2022

 

February 2025

 

September 2022

 

Denmark

 

June 2022

 

 

June 2022

 

(1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.

(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.

In addition, we received regulatory approval in Switzerland by the Swiss Agency for Therapeutic Products, or Swissmedic. VAZKEPA has been made available in Switzerland under individual reimbursement since January 2023.

Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists, rather than by general practitioners. Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies than in the U.S. However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S. In Europe, VAZKEPA has the benefit of 10 years of market protection, and in April 2024 we were issued a patent that extended our exclusivity to 2039.

Rest of World (RoW)

One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets, outside the Recordati Territory. We and our RoW partners have obtained varying levels of indication approvals and initiated or are in the process of initiating commercial launches in various territories where our partners have access. Through the date of this Quarterly Report, we have filed for regulatory review in 22 countries and regions and have received approval in 15 countries and regions outside

28


 

of the U.S. and EMA regulatory approval authority. We have agreements in place with the following partners within the respective territories:

 

Partner

 

Agreement Date

 

Country

 

MARINE Approval

 

REDUCE-IT Approval

 

Launch Date

Edding (1)

 

February 2015

 

Mainland China

 

June 2023

 

June 2024

 

October 2023

Hong Kong

 

 

February 2023

 

May 2024

Biologix

 

March 2016

 

Lebanon

 

March 2018

 

August 2021

 

June 2018

United Arab Emirates

 

July 2018

 

October 2021

 

February 2019

Qatar

 

December 2019

 

April 2021

 

May 2022

Bahrain

 

April 2021

 

April 2022

 

September 2023

Kuwait

 

December 2021

 

March 2023

 

September 2023

Saudi Arabia

 

March 2022

 

June 2023

 

September 2023

HLS

 

September 2017

 

Canada

 

 

December 2019

 

February 2020

CSL

 

February 2023

 

Australia

 

 

November 2022

 

October 2024

New Zealand

 

 

January 2023

 

Neopharm

 

August 2023

 

Israel

 

 

March 2023

 

May 2024

 Lotus

 

August 2023

 

South Korea

 

 

May 2025

 

 

(1) - VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.

(2) - VASCEPA is under registration in additional countries in the MENA region with Biologix.

(3) - VASCEPA is under registration in additional countries in the Israel territory with Neopharm. Revenue earned from sales of VASECPA within the Israel territory are recorded within European revenue.

(4) - VASCEPA is under registration in additional countries in the ASEAN region with Lotus.

The Company will be responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.

Research and Development

Since its inception in 2011, the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development as well as the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S. and continue to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study.

Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 55 clinical treatment guidelines, consensus statements or scientific statements from global medical or scientific societies or within peer reviewed journals have recognized the use of icosapent ethyl, or IPE, in appropriate at-risk patients for CV risk reductions, including those statements which we were informed of by our global partners as well as guidelines which were newly received during the third quarter of 2025 as listed below:

In August 2025, the European Society of Cardiology and the European Atherosclerosis Society, or ESC and EAS, respectively, issued a focused update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. The following information was included regarding IPE:
o
High-dose IPE (2 × 2 g/day) should be considered in combination with a statin in high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135–499 mg/dL or 1.52–5.63 mmol/L) to reduce the risk of cardiovascular events (Class IIa recommendation; Level B evidence).
o
Proposed mechanisms of action of how eicosapentaenoic acid, or EPA, specifically reduces cardiovascular risk are the distinct effects on lipid oxidation, inflammation, membrane structure/organization, cholesterol domain formation, and endothelial function. In view of the newer evidence from the STRENGTH trial, this Focused Update revised the respective recommendation for polyunsaturated fatty acids, or PUFAs, by explicitly stating that high-dose IPE (as in the REDUCE-IT trial) should be considered for high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135-499 mg/dL [1.52-5.63 mmol/L]) despite statin therapy to lower cardiovascular disease, or CVD, events.
In September 2025, a consensus statement by the American Association of Clinical Endocrinologists, or AACE, on the

29


 

Algorithm for Management of Adults with Dyslipidemia 2025 Update, was released. A multidisciplinary task force with representatives from AACE and several international co-sponsoring organizations (Canadian Cardiovascular Society, European Association for the Study of Diabetes, and the Latin American Academy for the Study of Lipids and Cardiometabolic Risk) were appointed to determine the scope and breadth of the algorithm and the areas in need of updated guidance. The specific update regarding IPE in the new guidance includes the following:
o
For those with mild to moderate hypertriglyceridemia (TG 150-499 mg/dL; 1.75.6 mmol/L), the primary concern is excess atherosclerotic cardiovascular disease, or ASCVD, risk, and the primary target must be Low-Density Lipoprotein Cholesterol, or LDL-C. This may also expand to individuals with TG in the 500 to 884 mg/dL (5.6-9.9 mmol/L) range in whom the presence of atherogenic lipoproteins predisposes them to ASCVD.
o
If ASCVD risk is high or intermediate, medications with proven cardiovascular benefit, such as statins, ezetimibe, and EPA monotherapy (IPE) are preferred.

In July 2025, at the Heart UK meeting in Coventry, England, we provided, along with our collaborators, support for a REDUCE-IT poster presentation analyzing the efficacy of IPE by burden of standard modifiable CV risk factors. This same data analysis was later presented in August of 2025 as an ENCORE poster presentation at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand, or CSANZ, with support from our partners in Australia, CSL.

In August 2025, at the Australasian Diabetes Congress, or ADC, in Queensland, Australia, we along with CSL and our collaborators supported an ENCORE poster presentation analyzing the reduction in ischemic events with IPE in patients with diabetes and prior coronary artery bypass graft, or CABG.

At the European Society of Cardiology, or ESC, scientific session which occurred from August 29 to Sept. 1, 2025, in Madrid, Spain, we supported along with out and global collaborators five separate presentations ranging from the effect of IPE on risk and duration of hospitalizations and death in REDUCE-IT to mechanistic data looking at the antioxidant effects of EPA on Lp(a).

In September 2025, at the European Association for the Study of Diabetes, or EASD, congress in Vienna, Austria, we supported, along with our global collaborators an oral presentation analyzing the efficacy of IPE across the spectrum of baseline triglyceride to glucose index.

In the third quarter of 2025, we and global medical and scientific collaborators supported sixteen publications inclusive of accepted abstracts, posters, and manuscripts.

Commercial and Clinical Supply

We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise in the U.S. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of September 30, 2025, we had inventory of $193.8 million, of which 49% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand.

30


 

Financial Operations Overview

Product revenue, net. All of our product revenue is derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. In the U.S., VASCEPA is sold to three major wholesalers, several regional wholesalers along with mail order pharmacy providers that in turn resell the product to retail pharmacies, as well as directly to select regional retail pharmacy chains, or collectively, our distributors or our customers. Most of these customers resell VASCEPA to retail pharmacies for purposes of dispensing VASCEPA to patients. Revenues from VASCEPA sales are recognized upon delivery to the distributor or customer. Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period. Our product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the U.S.

Outside of the U.S., currently the majority of our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly. We also derive product revenue from sales of our product to a limited number of wholesalers in Europe, most of whom in turn resell the product to pharmacies for purposes of their reselling the product to fill patient prescriptions.

Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized when the uncertainty related to the consideration is resolved.

Cost of goods sold. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country.

Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our sales, marketing, executive, business development, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

Research and development expense. Research and development expense consists primarily of fees paid to professional service providers in conjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid to independent researchers, costs of qualifying contract manufacturers, services expenses incurred in developing and testing products and product candidates, salaries and related expenses for personnel, including stock-based compensation expense, costs of materials, depreciation, rent, utilities and other facilities costs. In addition, research and development expenses include the cost to support current development efforts, costs of product supply received from suppliers when such receipt by us is prior to regulatory approval of the supplier, as well as license fees related to our strategic collaboration with Mochida. We expense research and development costs as incurred.

Restructuring expense. Restructuring expense consists of restructuring costs incurred under our June 2025 Global Restructuring Plan, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs.

Interest income, net and other income (expense), net. Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term and long-term investments. Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income.

Benefit from (provision for) income taxes. Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes

31


 

in both the U.S. and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2025 and 2024 are not more likely than not to be realized.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the U.S., or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies, significant judgments and estimates is presented in Part II, Item 7 of our Annual Report. There have been no material changes to our critical accounting policies, significant judgments and estimates described in our Annual Report.

Recent Accounting Pronouncements

For a discussion of recent accounting pronouncements, see Note 2—Significant Accounting Policies in the accompanying Notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.

Effects of Inflation

We believe the impact of inflation on operations has been minimal during the past three years.

Results of Operations

Comparison of Three Months Ended September 30, 2025 and September 30, 2024

Total revenue, net. We recorded total revenue, net, of $49.7 million and $42.3 million during the three months ended September 30, 2025 and 2024, respectively, an increase of $7.4 million, or 17%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the three months ending September 30, 2025, we also sold VASCEPA by prescription in certain countries outside of the U.S., through collaborations with third-party companies. As further discussed below, the aforementioned increase is due primarily to a $10.3 million increase in U.S. net product revenue and a $0.7 million increase in licensing and royalty revenue, offset by a $3.6 million decrease in net product revenue outside of the U.S.

Product revenue, net. We recorded product revenue, net, of $48.6 million and $41.9 million during the three months ended September 30, 2025 and 2024, respectively, an increase of $6.7 million, or 16%. This increase was due primarily to an increase in VASCEPA sales within the U.S., offset by a decrease in VASCEPA sales outside the U.S.

We recorded U.S. product revenue, net, of $40.9 million and $30.6 million during the three months ended September 30, 2025 and 2024, respectively. This increase was due to increased net selling price as a result of our exit from the Medicaid and 340B programs on October 1, 2024, as well as an increase in volume primarily related to regaining a large national pharmacy benefit manager, or PBM, which transitioned from no longer covering VASCEPA to being exclusive.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased by 2% for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. Our share of the icosapent ethyl market has increased to approximately 51% in the three months ended September 30, 2025 compared to approximately 50% in the three months ended September 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 3% in the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended September 30, 2025, we recorded Europe product revenue, net, of $4.1 million compared to $4.3 million during the three months ended September 30, 2024.

For the three months ended September 30, 2025, we recorded RoW product revenue, net, of $3.6 million from our six collaboration partners, comprising multiple distinct geographies, compared to $6.9 million during the three months ended September 30, 2024.

Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. For the remainder of 2025, we will continue to (i) competitively manage our market leadership in the U.S., and (ii) drive expanded access and

32


 

increased patient uptake of VASCEPA through ongoing support of our commercialization partners and their pricing, reimbursement and licensure initiatives in non-U.S. geographies around the world.

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended September 30, 2025 and 2024 was $1.1 million and $0.4 million, respectively, an increase of $0.7 million, or 149%. This increase was primarily due to higher royalties as a result of increased partner sales within their respective territories.

As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. Royalty payments are recognized based on revenue reported by our partners. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.

Cost of goods sold. Cost of goods sold during the three months ended September 30, 2025 and 2024 was $27.5 million and $26.0 million, respectively, an increase of $1.4 million, or 6%. This increase in cost of goods sold is due to increased product volumes. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.

The API included in the calculation of the average cost of goods sold during the quarters ended September 30, 2025 and 2024 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.

Our overall gross margin on product sales for the three months ended September 30, 2025 and 2024 was 43% and 38%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended September 30, 2025 and 2024 was $19.7 million and $36.9 million, respectively, a decrease of $17.2 million, or 47%. Selling, general and administrative expenses for the three months ended September 30, 2025 and 2024 are summarized in the table below:

 

 

 

Three months ended September 30,

 

In thousands

 

2025

 

 

2024

 

Selling expense (1)

 

$

5,354

 

 

$

18,777

 

General and administrative expense (2)

 

 

12,584

 

 

 

14,298

 

Non-cash stock-based compensation expense (3)

 

 

1,759

 

 

 

3,829

 

Total selling, general and administrative expense

 

$

19,697

 

 

$

36,904

 

(1)
Selling expense for the three months ended September 30, 2025 and 2024 was $5.4 million and $18.8 million, respectively, a decrease of $13.4 million, or 71%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan.
(2)
General and administrative expense for the three months ended September 30, 2025 and 2024 was $12.6 million and $14.3 million, respectively, a decrease of $1.7 million, or 12%. This decrease is primarily due to decrease in employee-related costs as a result of the reduction in force from the Global Restructuring Plan.
(3)
Non-cash stock-based compensation expense for the three months ended September 30, 2025 and 2024 was $1.8 million and $3.8 million, respectively, a decrease of $2.1 million, or 54%. Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions.

Subsequent to the Recordati Licensing Agreement, we will continue to manage our spending commitments to support our partners advancing commercialization and pricing and reimbursement efforts, as well as maintaining market leadership in the U.S.

33


 

Research and development expense. Research and development expense for the three months ended September 30, 2025 and 2024 was $4.2 million and $4.5 million, respectively, a decrease of $0.3 million, or 7%. Research and development expenses for the three months ended September 30, 2025 and 2024 are summarized in the table below:

 

 

 

Three months ended September 30,

 

In thousands

 

2025

 

 

2024

 

REDUCE-IT study and presentations (1)

 

$

209

 

 

$

124

 

Regulatory filing fees and expenses (2)

 

 

249

 

 

 

548

 

Non-clinical research activities (3)

 

 

245

 

 

 

669

 

Internal staffing, overhead and other (4)

 

 

2,910

 

 

 

2,330

 

Research and development expense, excluding non-cash expense

 

 

3,613

 

 

 

3,671

 

Non-cash stock-based compensation expense (5)

 

 

595

 

 

 

869

 

Total research and development expense

 

$

4,208

 

 

$

4,540

 

 

(1)
REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and to provide data to be published in medical journals.
(2)
Regulatory and quality filing fees are primarily related to the preparation, submission and review defense of regulatory filings as well as assistance with securing and maintaining regulatory approvals for qualifying suppliers for VASCEPA in the U.S. and Europe as well as regulatory expansion in the rest of the world.
(3)
Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
(4)
Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research, development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated to specific projects. Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida.
(5)
Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to personnel supporting our research and development and regulatory functions.

We continuously evaluate all of our research and development investment commitments and priorities and are prepared to adjust such investment levels based on various factors, including the impact of U.S. generic competition, as well as timing of pricing reimbursements throughout the world.

Restructuring expense. Restructuring expense for the three months ended September 30, 2025 and 2024 was $9.4 million and nil, respectively. The charge in the current year is due to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net. Interest income, net, for the three months ended September 30, 2025 and 2024 was $2.8 million and $3.4 million, respectively, a decrease of $0.6 million, or 18%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.

Other income, net. Other income, net, for the three months ended September 30, 2025 and 2024 was $0.2 million and $0.3 million, respectively, a decrease of $0.1 million, or 23%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the three months ended September 30, 2025 and 2024 was a benefit of $0.4 million and a provision of $3.6 million, respectively. The benefit for the three months ended September 30, 2025 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full-year estimated U.S. and foreign income tax liability.

34


 

Comparison of Nine Months Ended September 30, 2025 and September 30, 2024

Total revenue, net. We recorded total revenue, net, of $164.4 million and $166.3 million during the nine months ended September 30, 2025 and 2024, respectively, a decrease of $1.9 million, or 1%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the nine months ended September 30, 2025, we also sold VASCEPA by prescription in certain countries in Europe, as well as in certain countries outside of the U.S. and Europe, through collaborations with third-party companies. As further discussed below, the aforementioned decrease is due primarily to a $9.4 million decrease in U.S. net product revenue, offset in part by a $1.1 million increase in net product revenue outside of the U.S. and a $6.4 million increase in licensing and royalty revenue.

Product revenue, net. We recorded product revenue, net, of $136.2 million and $144.5 million during the nine months ended September 30, 2025 and 2024, respectively, a decrease of $8.3 million, or 6%. This decrease was due primarily to a 8% decrease in VASCEPA sales in the U.S..

We recorded U.S. product revenue, net, of $113.0 million and $122.5 million during the nine months ended September 30, 2025 and 2024, respectively. This decrease was due to a decrease in volume primarily related to a large national PBM not covering VASCEPA during the first half of the year.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the nine months ended September 30, 2025 by 2% as compared to the nine months ended September 30, 2024. Our share of the icosapent ethyl market has decreased to approximately 45% in the nine months ended September 30, 2025 compared to approximately 55% in the nine months ended September 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 17% in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

In Europe, we recorded product revenue, net, of $16.1 million and $9.7 million during the nine months ended September 30, 2025 and 2024, respectively.

For the nine months ended September 30, 2025, we recorded RoW product revenue, net, of $7.1 million from our six collaboration partners, comprising multiple distinct geographies, compared to $12.3 million during the nine months ended September 30, 2024.

Licensing and royalty revenue. Licensing and royalty revenue during the nine months ended September 30, 2025 and 2024 was $28.2 million and $21.8 million, respectively, an increase of $6.4 million, or 30%. This increase was primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement and higher royalties as a result of an increase in partner sales within their respective territories. During the nine months ended September 30, 2024, we recognized a $15.0 million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.

Cost of goods sold. Cost of goods sold during the nine months ended September 30, 2025 and 2024 was $66.7 million and $75.4 million, respectively, a decrease of $8.6 million, or 11%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.

The API included in the calculation of the average cost of goods sold during the nine months ended September 30, 2025 and 2024 was sourced from multiple API suppliers.

Our overall gross margin on product sales for the nine months ended September 30, 2025 and 2024 was 51% and 48%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.

Selling, general and administrative expense. Selling, general and administrative expense for the nine months ended September 30, 2025 and 2024 was $94.9 million and $115.3 million, respectively, a decrease of $20.4 million, or 18%. Selling, general and administrative expenses for the nine months ended September 30, 2025 and 2024 are summarized in the table below:

 

 

 

Nine months ended September 30,

 

In thousands

 

2025

 

 

2024

 

Selling expense (1)

 

$

36,862

 

 

$

59,669

 

General and administrative expense (2)

 

 

49,924

 

 

 

44,102

 

Non-cash stock-based compensation expense (3)

 

 

8,158

 

 

 

11,569

 

Total selling, general and administrative expense

 

$

94,944

 

 

$

115,340

 

 

35


 

 

(1)
Selling expense for the nine months ended September 30, 2025 and 2024 was $36.9 million and $59.7 million, respectively, a decrease of $22.8 million, or 38%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan, as well as decreased promotional and marketing initiatives and other cost optimization initiatives.
(2)
General and administrative expense for the nine months ended September 30, 2025 and 2024 was $49.9 million and $44.1 million, respectively, an increase of $5.8 million, or 13%. This increase is primarily due to fees associated with the ADS Ratio Change and Recordati Licensing Agreement. This increase is offset by a decrease in branded pharma fees as a result of lower sales and the reduction of costs associated with the Global Restructuring Plan.
(3)
Non-cash stock-based compensation expense for the nine months ended September 30, 2025 and 2024 was $8.2 million and $11.6 million, respectively, a decrease of $3.4 million, or 29%. Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions.

Research and development expense. Research and development expense for the nine months ended September 30, 2025 and 2024 was $14.4 million and $14.9 million, respectively, a decrease of $0.4 million, or 3%. Research and development expenses for the nine months ended September 30, 2025 and 2024 are summarized in the table below:

 

 

 

Nine months ended September 30,

 

In thousands

 

2025

 

 

2024

 

REDUCE-IT study and presentations (1)

 

$

719

 

 

$

1,122

 

Fixed-dose combination (2)

 

 

 

 

 

44

 

Regulatory filing fees and expenses (3)

 

 

1,517

 

 

 

1,818

 

Non-clinical research activities (4)

 

 

581

 

 

 

1,372

 

Internal staffing, overhead and other (5)

 

 

9,630

 

 

 

7,794

 

Research and development expense, excluding non-cash expense

 

 

12,447

 

 

 

12,150

 

Non-cash stock-based compensation expense (6)

 

 

1,988

 

 

 

2,734

 

Total research and development expense

 

$

14,435

 

 

$

14,884

 

 

(1)
REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and to provide data to be published in medical journals.
(2)
Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 but was subsequently deprioritized during 2023.
(3)
Regulatory and quality filing fees are primarily related to the preparation, submission and review defense of regulatory filings as well as assistance with securing and maintaining regulatory approvals for qualifying suppliers for VASCEPA in the U.S. and Europe as well as regulatory expansion in the rest of the world.
(4)
Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
(5)
Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research, development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated to specific projects. Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida.
(6)
Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to personnel supporting our research and development and regulatory functions.

Restructuring expense. Restructuring expense for the nine months ended September 30, 2025 and 2024 was $32.2 million and nil, respectively. The charge in the current year is due to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net. Interest income, net, for the nine months ended September 30, 2025 and 2024 was $8.3 million and $10.0 million, respectively, a decrease of $1.8 million, or 17%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.

Other income, net. Other income, net, for the nine months ended September 30, 2025 and 2024 was $0.4 million and $2.0 million, respectively, a decrease of $1.6 million, or 81%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

36


 

Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the nine months ended September 30, 2025 and 2024 were provisions of $2.4 million and $6.3 million, respectively. The provision for income taxes for the nine months ended September 30, 2025 is the result of income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full-year estimated U.S. and foreign income tax liability.

Liquidity and Capital Resources

As of September 30, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $123.1 million and short-term investments of $163.8 million, aggregating $286.6 million. We have no indebtedness. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities of less than 90 days. Our short-term investments consist of securities that will be due in one year or less. We invest cash in excess of our immediate requirements in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.

Our cash flows from operating, investing and financing activities, as reflected in the condensed consolidated statements of cash flows, are summarized in the following table:

 

 

 

Nine months ended September 30,

 

In millions

 

2025

 

 

2024

 

Cash (used in) provided by:

 

 

 

 

 

 

Operating activities

 

$

(8.5

)

 

$

(17.7

)

Investing activities

 

 

12.3

 

 

 

(23.1

)

Financing activities

 

 

(2.0

)

 

 

(1.5

)

Increase (decrease) in cash and cash equivalents and restricted cash

 

$

1.8

 

 

$

(42.3

)

Net cash used in operating activities decreased during the nine months ended September 30, 2025 as compared to the same period in 2024. This is primarily as a result of timing and payment of invoices and accruals in 2024.

Net cash provided by investing activities during the nine months ended September 30, 2025 decreased due primarily to proceeds from the maturity of $162.3 million in investment grade interest-bearing instruments offset by the purchases of $150.0 million of investment grade interest-bearing instruments as compared to the same period in 2024 where proceeds from the maturity of investment grade interest-bearing instruments were $185.8 million, partially offset by $208.9 million in purchases of investment-grade interest bearing instruments.

Net cash used in financing activities during the nine months ended September 30, 2025 as compared to the same period in 2024 was primarily as a result of taxes paid on stock-based awards.

On January 10, 2024, we announced plans to initiate a share repurchase program to purchase up to $50.0 million of the Company's Ordinary Shares held in the form of American Depository Shares, or ADS. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively. The share repurchase program has a five-year approval window and can be deployed at any point until the second quarter of 2029. The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions.

As of September 30, 2025, we had net accounts receivable of $127.3 million, current inventory of $184.7 million and long-term inventory of $9.1 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of September 30, 2025. We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API and the generic competition in the U.S. and the efforts of our licensee of VAZKEPA in Europe.

As of September 30, 2025, we had cash and cash equivalents of $122.8 million and short-term investments of $163.8 million, aggregating $286.6 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

37


 

Contractual Obligations

Except for our contractual obligations related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office space as set forth in Note 5 – Commitments and Contingencies and Note 9 – Leases, respectively, in our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes from the contractual obligations and commitments as of December 31, 2024 previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2025.

We do not have any special purpose entities or other off-balance sheet arrangements.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

There have been no material changes with respect to the information appearing in Part II, Item 7A “Quantitative and Qualitative Disclosures about Market Risk” of our Annual Report.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

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 of September 30, 2025. Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of September 30, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the quarter ended September 30, 2025, there were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three months ended September 30, 2025, and updates to any descriptions of previously reported legal proceedings in which there have been material developments during such period. The discussion of legal proceedings included within Note 5 – Commitments and Contingencies is incorporated into this Item 1 by reference.

Item 1A. Risk Factors

This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA and VAZKEPA, collectively referred to as VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties effects of tax reform, and other risks set forth below.

There have been no material changes to the risk factors presented under Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 other than as set forth below. See Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 for a detailed discussion of risk factors affecting the Company.

Risks Related to the Commercialization and Development of VASCEPA

We are dependent on our collaboration partner for the commercialization of VAZKEPA® in 59 countries focused in Europe. If the collaboration is not successful, we may not be able to capitalize on the full market potential for VAZKEPA® in those countries.

On June 20, 2025, we licensed the rights to VAZKEPA® in the Recordati Territory to Recordati. Our ability to receive payments from these arrangements will depend on Recordati’s ability to successfully commercialize VAZKEPA® in the Recordati Territory. The Recordati Licensing Agreement may pose many risks to us, including that:

marketing authorizations for VAZKEPA in certain countries in the Recordati Territory have not yet been obtained and certain other authorizations will need to be transitioned to Recordati subject to approval by the relevant regulatory authorities;
Recordati has discretion in determining the efforts, resources and strategies they will apply to commercializing VAZKEPA® in the Recordati Territory and may not apply sufficient efforts or resources to or otherwise may pursue sub-optimal strategies for the commercialization of VAZKEPA;
Recordati may mismanage its supply chain (including by ordering too many or too few units of VAZKEPA® from us) and also may not or may not be able to set favorable pricing for VAZKEPA® due to regulations, generic entry or other factors, all of which could negatively impact payments owed to us;
Recordati may be subject to changes in key personnel or strategic focus, have limited available funding or be subject to other external factors diverting resources or competing priorities, all of which could negatively impact the commercialization of VAZKEPA® in the Recordati Territory;
Recordati may use our intellectual property rights or our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or otherwise expose us to potential litigation; and
Recordati could be involved in a business combination and the continued pursuit and emphasis on VAZKEPA® could be delayed, diminished or terminated.

If our ability to generate revenue under the Recordati Licensing Agreement is adversely impacted by these or any other risks, our right to receive additional payments from the thereunder, including our share of the revenues generated by net sales of VAZKEPA®, could be insufficient to achieve or maintain profitability or may result in VAZKEPA® being less valuable to us than if we had not entered into the Recordati Licensing Agreement.

Our reduction in force related to our Recordati Licensing Agreement with Recordati, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our business and establishing a more significant international footprint.

If we are not successful in our efforts to continue to market and sell VASCEPA in the U.S., including following our Global Restructuring Plan announced in June 2025, which reduced our headcount in Europe, primarily Europe's commercial operations, as a

39


 

result of our exclusive license agreement with Recordati, our anticipated revenues or our expenses could be materially adversely affected, and we may not maintain profitability in the U.S. or obtain profitability internationally. Further, we may need to cut back on research and development activities or we may need to implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business.

Risks Related to Ownership of our ADSs and Ordinary Shares

If we are unable to meet the listing requirements of the Nasdaq Stock Market, our ADS may be delisted.

Our ADSs are listed and traded on Nasdaq, which has listing requirements that include a $1.00 minimum closing bid price requirement, or the Minimum Bid Requirement. Nasdaq will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 business consecutive days. Such deficiency letter does not result in the immediate delisting of an issuer as there is a period of 180 calendar days from the deficiency notice to regain compliance with Nasdaq's minimum bid price requirement. If an issuer is unable to comply with Nasdaq's minimum bid price requirement after this 180-day calendar period, Nasdaq may elect, subject to any potential additional cure periods, to initiate a process that could delist the issuer from trading on the Nasdaq. We received a deficiency letter from Nasdaq in October 2023, as our ADSs had traded below $1.00 for 30 consecutive business days. In January 2024, we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days. We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days. On November 22, 2024, we received notice Nasdaq granted the Company an additional 180 calendar days, or until May 19, 2025, to regain compliance with the Minimum Bid Requirement. Effective as of April 11, 2025, we implemented an adjustment of the ratio of our ADSs to Ordinary Shares from one ADS representing one Ordinary Share to one ADS representing 20 Ordinary Shares, or the ADS Ratio Change. The ADS Ratio Change resulted in a 1-for-20 reverse split of issued and outstanding ADSs, and it had no effect on the Ordinary Shares. On April 29, 2025, we received written confirmation from Nasdaq that we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days. While we have regained compliance with the Minimum Bid Requirement, there is no guarantee that we will be able to maintain such compliance, and we may receive additional deficiency letters in the future.

Should such a delisting occur, it would adversely impact the liquidity and price of our ADSs and would impede our ability to raise capital.

General Risk Factors

Our business may be adversely affected by tariffs, trade sanctions or similar government actions.

The recent imposition and ongoing discussions regarding certain trade restrictions, sanctions and tariffs on goods exported from the U.S. or imported into the U.S., as well as retaliatory measures enacted in response to such actions and related market volatility, could have a material adverse impact on our business, financial condition, results of operations and cash flows. In light of these events, there continues to exist significant uncertainty about the future relationship between the U.S. and other countries with respect to such trade policies. These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the U.S. Any of these factors could depress economic activity, lower product demand and restrict our access to potential partners, suppliers or other third parties we seek to do business with and, in turn, have a material adverse effect on the business and financial condition of such third parties, which in turn would negatively impact us.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuer Purchases of Equity Securities

ADSs purchased in the third quarter of 2025 are as follows:

Period

 

Total Number of
ADSs Purchased
(1)

 

 

Average Price
Paid per ADS

 

July 1 - 31, 2025

 

 

6,611

 

 

$

13.24

 

August 1 - 31, 2025

 

 

7,013

 

 

 

12.06

 

September 1 - 30, 2025

 

 

2,282

 

 

 

13.40

 

Total

 

 

15,906

 

 

$

12.74

 

(1) Represents ADSs withheld to satisfy tax withholding amounts due from employees related to the receipt of ADS which resulted from the exercise or vesting of equity awards.

40


 

Item 5. Other Information

None of our officers or directors, as defined in Rule 16a-1(f), adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Item 408 of Regulation S-K, during the three months ended September 30, 2025.

41


 

Item 6. Exhibits

The following exhibits are incorporated by reference or filed or furnished as part of this report.

Exhibit
Number

 

Description

 

Incorporated by Reference Herein

 

 

Form

 

Date

 

 

 

 

 

 

 

4.1

 

Form of Second Amended and Restated Deposit Agreement among Amarin Corporation plc, JPMorgan Chase Bank, N.A., as depositary (the “Depositary”), and all Holders and Beneficial Owners from time to time of American Depositary Receipts (“ADRs”) issued thereunder, including the Form of ADR attached as Exhibit A thereto

 

Registration Statement on Form F-6, Exhibit (a)

 

July 23, 2025

 

 

 

 

 

 

 

10.1

 

Employment Agreement, between David Keenan and Amarin Pharmaceuticals Ireland Limited, dated February 25, 2022*†

 

Current Report on Form 8-K as Exhibit 10.1

 

October 22, 2025

 

 

 

 

 

 

 

10.2

 

First Amendment to the Employment Agreement, between David Keenan and Amarin Pharmaceuticals Ireland Limited, dated July 17, 2023*†

 

Current Report on Form 8-K as Exhibit 10.2

 

October 22, 2025

 

 

 

 

 

 

 

10.3

 

Second Amendment to the Employment Agreement, between David Keenan and Amarin Pharmaceuticals Ireland Limited, dated October 6, 2025*†

 

Current Report on Form 8-K as Exhibit 10.3

 

October 22, 2025

 

 

 

 

 

 

 

31.1

 

Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002

 

Filed herewith

 

 

 

 

 

 

 

 

 

31.2

 

Certification of Vice President and Global Controller (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002

 

Filed herewith

 

 

 

 

 

 

 

 

 

32.1

 

Certification of President and Chief Executive Officer (Principal Executive Officer) and Vice President and Global Controller (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002

 

Filed herewith

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

Filed herewith

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

Filed herewith

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

Filed herewith

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

Filed herewith

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

Filed herewith

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File

(formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)

 

Filed herewith

 

 

 

* Management contract or compensatory plan or arrangement.

† Certain personal information in this exhibit has been omitted in accordance with Regulation S-K Item 601(a)(6).

 

 

 

42


 

SIGNATURE

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

AMARIN CORPORATION PLC

 

 

 

By:

 

/s/ Aaron Berg

 

 

Aaron Berg

 

 

 

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

(On behalf of the Registrant)

 

Date: October 29, 2025

 

AMARIN CORPORATION PLC

 

 

 

By:

 

/s/ Peter Fishman

 

 

Peter Fishman

 

 

 

 

 

Senior Vice President and Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

 

(On behalf of the Registrant)

 

Date: October 29, 2025

43


FAQ

What were AMRN’s Q3 2025 revenues and net loss?

Total revenue was $49.7 million and net loss was $7.7 million, improving from $42.3 million and $25.1 million, respectively, in Q3 2024.

How did revenue break down by region for AMRN in Q3 2025?

U.S. product revenue was $40.9 million, Europe $4.1 million, and Rest of World $3.6 million.

What restructuring charges did AMRN record in 2025?

Amarin recorded $9.4 million in Q3 and $32.2 million year‑to‑date, within the expected total of $30.0–$37.0 million, substantially all cash.

What is AMRN’s cash position and debt as of September 30, 2025?

Cash and cash equivalents were $122.8 million, short‑term investments $163.8 million, and the company had no outstanding debt.

What were AMRN’s year‑to‑date results through Q3 2025?

Year‑to‑date revenue was $164.4 million and net loss was $37.6 million.

How did operating expenses change for AMRN in Q3 2025?

Selling, general and administrative expense was $19.7 million, down from $36.9 million in Q3 2024; total operating expenses were $33.3 million.

How many Ordinary Shares of AMRN were outstanding recently?

415,853,680 Ordinary Shares were outstanding as of October 24, 2025.

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