Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $49.7 million, an increase of $7.4 million or 17% compared to the prior year, primarily due to higher U.S. sales [21] - Net product revenue was $48.6 million, reflecting a 16% increase [21] - U.S. net product revenue reached $40.9 million, a 34% increase driven by a change in customer mix and increased volume [22] - Operating loss for Q3 2025 was $11.1 million, a 56% improvement from the previous year [25] - Cash and investments at the end of the quarter totaled $286.6 million, with no debt [25] Business Line Data and Key Metrics Changes - U.S. business maintained over 50% share of the IPE market, demonstrating resilience five years post-generic entry [11] - European product revenue was $4.1 million, consistent with the prior year, reflecting the transition to a partnered model with Recordati [22][23] - Rest of world product revenue was $3.6 million, a decline from the prior year, attributed to variability in supply shipments [23][51] Market Data and Key Metrics Changes - The transition to a partnered model in Europe is expected to normalize by the end of 2025, with anticipated growth in revenue as operations stabilize [24][42] - The FDA's recent update on phenofibrates may influence prescribing practices globally, potentially benefiting VASCEPA's market position [16][44] Company Strategy and Development Direction - The partnership with Recordati marks a shift to a fully partnered commercial model in international markets, aiming to leverage expertise across nearly 100 markets [5][6] - The company is focused on reducing the cardiovascular disease burden and maximizing the clinical impact of VASCEPA [8][18] - A restructuring initiative aims to achieve $70 million in operational expense savings over the next year [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic actions taken and the potential for growth in both U.S. and international markets [19] - The company anticipates achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [19][26] - The management highlighted the importance of addressing cardiovascular disease through proven outcomes rather than solely improving biomarkers [17] Other Important Information - The company is committed to advancing cardiovascular care through a strong presence at major medical meetings, including the European Society of Cardiology 2025 conference [12] - Restructuring expenses totaled $9.4 million for the quarter, with expectations for lower costs moving forward [25] Q&A Session Summary Question: U.S. net price trajectory for the back half of 2025 and into 2026 - Management anticipates consistency in U.S. net pricing for the remainder of 2025, with ongoing negotiations for 2026 [29][32] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [30][31] Question: Decline in rest of world revenue compared to Q3 2024 - Revenue variability in the rest of the world is due to timing of supply shipments and market demand, with no significant launches in the current quarter [49][51]

Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $49.7 million, an increase of $7.4 million or 17% compared to the prior year period, primarily due to higher U.S. sales [18] - Net product revenue was $48.6 million, reflecting a 16% increase [18] - U.S. net product revenue reached $40.9 million, a 34% increase driven by a change in customer mix and increased volume [19] - Operating loss was $11.1 million, which is $14.1 million or 56% lower than Q3 2024, indicating improved operational efficiency [22] - Q3 2025 operating margin was negative 22%, a significant improvement from negative 60% in the prior year [22] Business Line Data and Key Metrics Changes - The U.S. business maintained over 50% share of the IPE market, demonstrating resilience five years post-generic entry [10] - European product revenue was $4.1 million, consistent with the prior year, reflecting the transition to a partnered model with Recordati [19] - Rest of world product revenue was $3.6 million, a decline from the prior year, attributed to variability in supply shipments [20] Market Data and Key Metrics Changes - The transition to a partnered commercial model with Recordati is progressing well, with expectations for full management of European commercialization by the end of 2025 [8] - The company is focused on expanding patient access in key growth geographies, leveraging partnerships to drive demand [9] Company Strategy and Development Direction - The partnership with Recordati marks a strategic shift to a fully partnered commercial model across international markets, aiming to enhance revenue generation [5] - The company is committed to reducing the cardiovascular disease burden and has implemented a global restructuring to achieve operational efficiency, targeting $70 million in OpEx savings [7] - The focus remains on maximizing the clinical impact of VASCEPA while ensuring financial strength in the U.S. market [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic actions taken and the potential for growth, particularly in underpenetrated markets [17] - The company anticipates achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [22] Other Important Information - The FDA's recent update on phenofibrates is expected to shift clinical practices, potentially benefiting VASCEPA as a preferred therapy for cardiovascular risk reduction [14][15] - The company ended the quarter with $286.6 million in cash and investments, no debt, and working capital of $446 million, indicating a stable capital structure [22] Q&A Session Summary Question: U.S. net price trajectory for the back half of 2025 and into 2026 - Management anticipates consistency in U.S. net prices for the remainder of 2025, with ongoing negotiations for 2026 [25][29] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [27] Question: Gross margin trajectory with a shift towards supply sales to partners - A decline in gross margin percentages is expected as the company moves to a partnered model, but lower operating expenses will benefit operating margins [30] Question: European sales dip due to the transition to Recordati - The transition is expected to normalize by 2026, with anticipated lower restructuring costs moving forward [43] Question: Impact of phenofibrate update on U.S. and Rest of World practices - The FDA's update is expected to influence prescribing practices globally, potentially benefiting VASCEPA as a preferred therapy [46][47] Question: Decline in rest of world revenue compared to Q3 2024 - The decline is attributed to variability in supply shipments and the absence of larger launches in the current quarter [50]

Product Performance and Market Presence - VASCEPA has approximately 27 million estimated normalized total prescriptions reported since its commercial availability in 2013[160]. - VAZKEPA has received marketing authorization in the EU, England, Wales, and Scotland, with product availability in several countries starting from March 2022[166][171]. - The company has filed for regulatory review in 22 countries and regions, receiving approval in 15 countries outside the U.S. and EMA[173]. - VAZKEPA is under registration in additional countries in the MENA region and ASEAN region, with ongoing efforts to secure partnerships for international markets[175]. - The company has entered into exclusive long-term licensing agreements with Recordati for the commercialization of VAZKEPA in 59 countries[167]. - The company has received regulatory approval for VAZKEPA in Switzerland, with individual reimbursement starting in January 2023[171]. - The company has faced competition from generic versions of icosapent ethyl, with multiple companies obtaining FDA approval for the MARINE indication[160]. - The company has made 19 filings for market access in European countries, focusing on securing product reimbursement as a prerequisite for commercial success[169]. - The company has a patent extending exclusivity for VAZKEPA to 2039, providing a competitive advantage in the European market[172]. Financial Performance - Total revenue, net, increased by $7.4 million, or 17%, to $49.7 million for the three months ended September 30, 2025, compared to $42.3 million for the same period in 2024[198]. - Product revenue, net, rose by $6.7 million, or 16%, to $48.6 million for the three months ended September 30, 2025, from $41.9 million in 2024[199]. - U.S. product revenue, net, increased to $40.9 million in Q3 2025 from $30.6 million in Q3 2024, attributed to a higher net selling price and increased volume[200]. - The overall icosapent ethyl market in the U.S. grew by 2% for the three months ended September 30, 2025, with the company's market share increasing to approximately 51%[201]. - Europe product revenue, net, was $4.1 million for the three months ended September 30, 2025, compared to $4.3 million in the same period of 2024[202]. - Total revenue for the nine months ended September 30, 2025, was $164.4 million, a decrease of 1% from $166.3 million in 2024[220]. - U.S. product revenue for the nine months ended September 30, 2025, was $113.0 million, down 8% from $122.5 million in 2024[222]. - Licensing and royalty revenue for the nine months ended September 30, 2025, increased to $28.2 million, up 30% from $21.8 million in 2024[225]. - Overall gross margin for the nine months ended September 30, 2025, was 51%, compared to 48% in 2024[227]. Cost Management and Expenses - The company expects annual cost savings of approximately $70 million from the Global Restructuring Plan following the Recordati Licensing Agreement[167]. - Cost of goods sold rose to $27.5 million for the three months ended September 30, 2025, up from $26.0 million in 2024, an increase of 6%[207]. - Selling, general and administrative expenses decreased to $19.7 million for the three months ended September 30, 2025, down 47% from $36.9 million in 2024[210]. - Research and development expenses for the three months ended September 30, 2025, were $4.2 million, a decrease of 7% from $4.5 million in 2024[213]. - Restructuring expense for the nine months ended September 30, 2025, was $32.2 million, compared to nil in 2024, due to the Global Restructuring Plan related to the Recordati Licensing Agreement[231]. - Selling expenses decreased by $22.8 million, or 38%, to $36.9 million for the nine months ended September 30, 2025, due to cost reductions from the Global Restructuring Plan[234]. - General and administrative expenses increased by $5.8 million, or 13%, to $49.9 million for the nine months ended September 30, 2025, primarily due to fees related to the ADS Ratio Change and Recordati Licensing Agreement[234]. Cash Flow and Financial Position - As of September 30, 2025, the company had cash and cash equivalents of $122.8 million and short-term investments of $163.8 million, totaling $286.6 million[243]. - Net cash used in operating activities improved to $(8.5) million for the nine months ended September 30, 2025, compared to $(17.7) million in 2024[238]. - The accumulated deficit as of September 30, 2025, was $1.7 billion, with expectations of variable quarterly net cash outflows due to API purchases and generic competition[242]. - The company announced a share repurchase program of up to $50.0 million, with approval received in April and May 2024, but no repurchases have commenced to date[241]. Research and Development - The company anticipates continued publication of additional details from the REDUCE-IT study, which involved over 35,000 patient years of study experience[177]. - More than 55 clinical treatment guidelines have recognized the use of icosapent ethyl for cardiovascular risk reductions as of the filing date[178]. - The company is pursuing additional indicated uses for VASCEPA in the U.S. and globally based on the positive results of the REDUCE-IT study[177]. Other Income and Expenses - Net interest income decreased by $1.8 million, or 17%, to $8.3 million for the nine months ended September 30, 2025, primarily due to lower interest rates[232]. - Other income, net, fell by $1.6 million, or 81%, to $0.4 million for the nine months ended September 30, 2025, mainly from foreign exchange transactions and sublease income[233]. - Licensing and royalty revenue increased to $1.1 million for the three months ended September 30, 2025, compared to $0.4 million in 2024, marking a 149% increase[205].

Financial Performance - Total net revenue for Q3 2025 was $49.7 million, an increase of 17% compared to $42.3 million in Q3 2024[4] - U.S. product revenue increased by 34% to $40.9 million in Q3 2025, up from $30.6 million in Q3 2024[7] - Total revenue for Q3 2025 was $49.67 million, a 17.5% increase from $42.30 million in Q3 2024[36] - Product revenue for Q3 2025 reached $48.56 million, up from $41.85 million in Q3 2024, representing a 15.5% increase[36] - Net loss for Q3 2025 was $7.74 million, compared to a net loss of $25.13 million in Q3 2024, indicating a significant improvement[36] - The company reported a non-GAAP net income of $4.02 million for Q3 2025, compared to a non-GAAP net loss of $20.44 million in Q3 2024[38] Operating Expenses - Operating expenses decreased by 20% to $33.3 million in Q3 2025, down from $41.4 million in Q3 2024[11] - Operating expenses decreased to $33.31 million in Q3 2025 from $41.44 million in Q3 2024, a reduction of 19.6%[36] - The restructuring plan recognized $9.4 million in charges during Q3 2025, impacting overall operating expenses[13] Cash and Investments - Cash and investments at the end of Q3 2025 totaled $286.6 million, down from $298.7 million at the end of Q2 2025[17] - Cash and cash equivalents as of September 30, 2025, were $122.80 million, slightly up from $121.04 million at the end of 2024[34] - Total current assets increased to $628.33 million as of September 30, 2025, compared to $595.40 million at the end of 2024, a growth of 5.5%[34] Loss Improvement - The operating loss improved by 56% to $11.1 million in Q3 2025, compared to a loss of $25.2 million in Q3 2024[16] - Net loss for Q3 2025 was $7.7 million, significantly reduced from $25.1 million in Q3 2024[17] Revenue Sources - Licensing and royalties increased by 149% to $1.1 million in Q3 2025, compared to $0.4 million in Q3 2024[10] Future Outlook - The company is targeting sustainable positive free cash flow in 2026[2] - The transition to a fully partnered commercialization model is expected to enhance market presence across nearly 100 countries[4] - The company anticipates expanding access and reimbursement for VAZKEPA across global markets, with potential strategic collaborations in the pipeline[30] Research and Development - Research and development expenses for Q3 2025 were $4.21 million, consistent with $4.54 million in Q3 2024[36] Gross Margin - Gross margin for Q3 2025 was $22.21 million, compared to $16.28 million in Q3 2024, reflecting a 36.4% increase[36]

Core Insights - Amarin Corporation has transitioned to a fully partnered commercialization model across all international markets, which is expected to enhance its operational efficiency and market reach [1][3] - The Q3 2025 financial results indicate a positive trend with a 17% increase in total net revenue compared to Q3 2024, driven primarily by strong U.S. sales [4][6] - The company aims to achieve sustainable positive free cash flow by 2026, reflecting confidence in its strategic actions and operational improvements [1][4] Financial Performance - Total net revenue for Q3 2025 was $49.7 million, up from $42.3 million in Q3 2024, marking a 17% increase [4][6] - Product revenue, net increased by 16% to $48.6 million, primarily due to higher U.S. sales, which rose by 34% to $40.9 million [5][7] - Operating expenses decreased by 20% to $33.3 million, largely due to a restructuring plan implemented in June 2025 [9][12] Operating Metrics - The operating loss for Q3 2025 was $11.1 million, significantly improved from a loss of $25.2 million in Q3 2024, reflecting a 56% reduction [4][14] - The net loss for Q3 2025 was $7.7 million, compared to a net loss of $25.1 million in the same quarter of the previous year, indicating a 69% improvement [15][34] - Cash and investments at the end of Q3 2025 totaled $286.6 million, down from $305.7 million in Q3 2024 [15] Strategic Initiatives - The company has established partnerships with seven parties across nearly 100 countries to leverage regional expertise and infrastructure for the commercialization of VASCEPA/VAZKEPA [3][17] - Amarin is focused on enhancing shareholder value through strategic actions and is optimistic about its global business potential [3][4]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Viewpoint - The FDA's recent update to fenofibrate drug labeling highlights the lack of cardiovascular benefits and aims to shift clinical practices towards therapies that are clinically proven to reduce cardiovascular events [1][2][3] Company Perspective - Amarin Corporation supports the FDA's decision, emphasizing the need for healthcare practitioners to stop prescribing fibrates for cardiovascular risk reduction, particularly in combination with statins, as this approach is outdated and ineffective [5][6] - The company advocates for the use of FDA-approved therapies like VASCEPA (icosapent ethyl) to reduce cardiovascular risks in patients with elevated triglycerides [6][10] Industry Context - Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 900,000 deaths annually in the U.S. and nearly 20 million worldwide [2] - Despite evidence from major clinical trials (FIELD, ACCORD Lipid, PROMINENT) showing that fenofibrates do not reduce cardiovascular event risks, over 11 million prescriptions were written in the U.S. in 2023, indicating a significant gap in clinical practice [3][4] - In Europe, fibrates are the third most commonly used lipid management agents, with an estimated two million patients treated with fibrates in Western Europe [4] Clinical Evidence - The FDA's labeling change is based on decades of clinical data demonstrating that fenofibrates do not provide cardiovascular benefits, even when used with statins [3] - The company highlights the importance of aligning treatment decisions with current scientific understanding to improve patient outcomes in cardiovascular health [7]

Core Viewpoint - Amarin Corporation plc will report its third quarter 2025 financial results on October 29, 2025, followed by a conference call with senior management [1]. Group 1: Financial Reporting - The company will issue a press release detailing its third quarter 2025 financial results in the pre-market hours on October 29, 2025 [1]. - A conference call is scheduled for 8:00 a.m. ET on the same day to discuss the financial results [1]. Group 2: Participation Information - Investors can access the live call via telephone or online, with specific dial-in numbers provided for both U.S. and international participants [2]. - A replay of the conference call will be available shortly after the call and accessible until March 29, 2026 [2]. Group 3: Company Overview - Amarin is a global pharmaceutical company focused on reducing the burden of cardiovascular disease (CVD) and advancing cardiovascular care [3]. - The company has a global branded product approved by multiple regulatory authorities, supported by robust clinical trial evidence [3]. - Amarin employs a direct sales approach in the U.S. and an indirect distribution strategy internationally, covering over 90 markets worldwide [3].

Core Insights - Amarin Corporation, in collaboration with HLS Therapeutics, will present scientific data on Icosapent Ethyl (IPE) at the Canadian Cardiovascular Congress (CCC) from October 23 to 26, 2025, emphasizing their commitment to advancing cardiovascular care [1][2] Group 1: Scientific Presentations - Data presented at CCC 2025 will highlight the clinical value of IPE for cardiometabolic conditions and explore the mechanistic effects of EPA on atherogenic lipoproteins and endothelial cells during inflammation when combined with a GLP-1 receptor agonist [2] - Featured abstracts include a poster presentation on the ENCORE study, which indicates that Icosapent Ethyl reduces cardiovascular disease risk in patients with cardiovascular-kidney-metabolic syndrome [2][3] - An oral presentation will discuss the effects of Icosapent Ethyl on the risk and duration of hospitalizations and death in the REDUCE-IT study [3] Group 2: Product Information - VASCEPA (icosapent ethyl) is the first prescription treatment approved by the FDA solely comprising IPE, launched in the U.S. in January 2020 for high-risk patients with persistent cardiovascular risk despite statin therapy [7] - Since its launch, VASCEPA has been prescribed over 25 million times and is covered by most major medical insurance plans [7] - VASCEPA is approved and sold in multiple countries, including Canada, China, Australia, and various European nations under the brand name VAZKEPA [7]

Company Overview - Amarin (AMRN) shares increased by 12.5% to close at $18.84, supported by high trading volume, compared to an 11.4% gain over the past four weeks [1] - The price surge is linked to rising investor confidence in Vascepa, Amarin's sole marketed drug, which treats severe hypertriglyceridemia [1] Earnings Expectations - Amarin is projected to report quarterly earnings of $0.31 per share, reflecting a year-over-year increase of 131% [2] - Expected revenues are $42.36 million, showing a slight increase of 0.2% from the same quarter last year [2] Stock Performance Insights - The consensus EPS estimate for Amarin has remained stable over the last 30 days, indicating that stock price movements may not sustain without earnings estimate revisions [3] - The stock currently holds a Zacks Rank of 2 (Buy), suggesting positive market sentiment [4] Industry Comparison - Amarin operates within the Zacks Medical - Biomedical and Genetics industry, where Fortrea Holdings Inc. (FTRE) has seen a decline of 1.6% to $9.45, with a monthly return of -8.7% [4] - Fortrea's consensus EPS estimate has decreased by 13.3% over the past month to $0.15, representing a 34.8% decline from the previous year [5]