Core Insights - Amarin Corporation plc has highlighted a new post hoc analysis from the REDUCE-IT study, demonstrating that icosapent ethyl significantly reduces cardiovascular events in high-risk patients, reinforcing its role in comprehensive cardiovascular risk management [1][3]. Summary by Sections Company Overview - Amarin is a global pharmaceutical company focused on reducing the burden of cardiovascular disease and advancing cardiovascular care, with a commitment to FDA-approved therapies like VASCEPA (icosapent ethyl) [6]. Clinical Findings - The post hoc analysis from the REDUCE-IT study indicates that icosapent ethyl provides cardiovascular protection beyond standard therapies, including statins and aspirin, without additional safety concerns [5]. - Among 8,179 statin-treated participants, 6,179 (75.5%) received aspirin at baseline. Icosapent ethyl reduced major adverse cardiovascular events by 28% in aspirin users, with an absolute risk reduction of 5.9% and a number needed to treat of 17 [4]. - In the subgroup of 4,867 aspirin users, icosapent ethyl reduced total primary endpoint events by 39% [4]. Regulatory Updates - The FDA updated the labeling for fibrates, indicating no cardiovascular benefit when used with statins, emphasizing the need for effective therapies like icosapent ethyl [2]. Market Position - VASCEPA has been prescribed over 25 million times since its launch in the U.S. in January 2020, and it is covered by most major medical insurance plans [7].

Core Insights - Amarin Corporation will present new findings at the American Heart Association's Scientific Sessions 2025, reinforcing the efficacy of VASCEPA®/VAZKEPA® in cardiovascular risk reduction and highlighting the pleiotropic mechanism of action of Eicosapentaenoic Acid (EPA) [1][2] Group 1: Study Findings - New analyses from the REDUCE-IT study will evaluate the clinical benefit of Icosapent Ethyl (IPE) on cardiovascular outcomes with or without baseline use of aspirin [2] - Mechanistic studies will explore the anti-oxidant effects of EPA on lipoprotein(a) [Lp(a)] and its anti-inflammatory and endothelial-protective properties [2] Group 2: Presentation Details - Featured abstracts will be presented by academic collaborators, including a session on the efficacy of Icosapent Ethyl for cardiovascular risk reduction by aspirin use in REDUCE-IT [7] - Additional presentations will cover the effects of EPA on endothelial cells during inflammation and its impact on lipoprotein oxidation [5][8] Group 3: Company Overview - Amarin is a global pharmaceutical company focused on reducing the cardiovascular disease burden and advancing cardiovascular care, with a direct sales approach in the U.S. and an indirect distribution strategy internationally [5] - VASCEPA (icosapent ethyl) is the first prescription treatment approved by the FDA solely comprising icosapent ethyl, launched in January 2020 for high-risk patients with persistent cardiovascular risk [6][9]

Core Insights - Amarin Corporation (AMRN) reported adjusted earnings of 1 cent per share for Q3 2025, missing the Zacks Consensus Estimate of 8 cents per share, compared to an adjusted loss of 5 cents per share in the same quarter last year [1][7] - Total revenues for Q3 were $49.7 million, exceeding the Zacks Consensus Estimate of $43 million, and representing a 17% increase year-over-year due to higher product sales in the U.S. [2][7] Financial Performance - The reported earnings excluded stock-based compensation and restructuring expenses; including these, the company incurred a loss of 2 cents per share in Q3 2025, an improvement from a loss of 6 cents per share in the prior year [2] - Net product revenues from Vascepa, the company's sole marketed drug, were $48.6 million, a 16% year-over-year increase, with U.S. product revenues totaling $40.9 million, surging 34% from the previous year [4][7] - Revenues from the European market for Vazkepa totaled $4.1 million, down 5% year-over-year, attributed to the transition to a fully partnered model with Recordati [5] - Revenues from the rest of the world were $3.6 million, down 48% year-over-year, while licensing and royalty revenues increased by 149% to $1.1 million [8] Cost Management - Selling, general, and administrative expenses decreased by 47% year-over-year to $19.7 million, reflecting the impact of recent restructuring and cost optimization efforts [8] - Research and development expenses totaled $4.2 million, down 7% year-over-year [9] Strategic Developments - Amarin signed a long-term license and supply agreement with Recordati to commercialize Vazkepa across 59 countries in the EU, which is expected to accelerate growth in the European market [10][11] - The company initiated a global restructuring expected to deliver approximately $70 million in cost savings over the next year [10] Market Reaction - Following the earnings announcement, Amarin's shares fell by 11.3% on October 29, although the stock has rallied 73.3% year-to-date compared to the industry's increase of 10.8% [3]

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 $6.7 million or 16% increase [21] - U.S. net product revenue reached $40.9 million, a significant increase of $10.3 million or 34%, driven by a change in customer mix and increased volume [22] - Operating loss for Q3 2025 was $11.1 million, which is $14.1 million or 56% lower than Q3 2024, indicating improved operational efficiency [25] - Operating margin improved to -22% from -60% in the prior year [25] - Cash and investments at the end of the quarter totaled $286.6 million, with no debt and working capital of $446 million [26] Business Line Data and Key Metrics Changes - The transition to a partnered model with Recordati has begun to show results, with product revenue from Europe at $4.1 million, consistent with the prior year [22][23] - Revenue from the rest of the world was $3.6 million, a decline from the prior year, attributed to variability in supply shipments and market demand [23][50] - SG&A expenses were reduced to $19.7 million, a decrease of $17.2 million or 47% compared to the prior year [24] Market Data and Key Metrics Changes - VASCEPA maintained over 50% market share in the IPE market in the U.S., demonstrating resilience five years post-generic entry [11] - The company anticipates that Recordati will fully manage European commercialization by the end of 2025, with sustained momentum in demand across all commercialized European markets [9][10] Company Strategy and Development Direction - The partnership with Recordati marks a strategic 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 globally, with a commitment to operational efficiency and cost savings of $70 million over the next year [8] - The transition to a partnered model is expected to enhance revenue generation and operational efficiency, with a focus on maximizing the clinical impact of VASCEPA [12][19] 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 [19] - The company is optimistic about achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [26] - The FDA's recent actions regarding fenofibrates are seen as an opportunity to shift clinical practice towards more effective therapies like VASCEPA [14][17] Other Important Information - Restructuring expenses totaled $9.4 million for the quarter, with a total of $32.2 million incurred to date [25] - The company is committed to advancing cardiovascular care through a strong presence at major medical meetings, including the European Society of Cardiology conference [12] Q&A Session Summary Question: U.S. net price trajectory for the back half of 2025 and into 2026 - Management anticipates U.S. net prices to remain consistent for the remainder of 2025, with ongoing negotiations for rebate percentages for 2026 [28][30] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [30] Question: Decline in rest of world revenue - The decline is attributed to variability in supply shipments and the absence of larger launches in the current quarter [48][50]

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]