Core Viewpoint - The U.S. Supreme Court's decision to hear a patent dispute involving Amarin Pharma's cardiovascular drug Vascepa may significantly impact generic drug manufacturers and the "skinny label" strategy [1] Group 1: Patent Dispute - The case centers around Amarin Pharma's Vascepa, which is a cardiovascular drug [1] - The outcome of this dispute could set a precedent affecting the generic drug market [1] Group 2: Implications for Generic Drug Makers - The ruling may influence how generic drug makers approach the development and marketing of their products [1] - The "skinny label" strategy, which allows generics to avoid patent infringement by omitting certain indications, could be affected by the court's decision [1]

Financial Performance - Amarin Corporation plc reported a year-end 2025 cash balance of $303 million, reflecting a growth of $16 million compared to $287 million in Q3 2025 [3] - The company expects its fiscal Q4 2025 net revenue to be in the range of $48 to $53 million, with fiscal year 2025 net revenue projected to be between $212 to $217 million [3] Operational Highlights - The company achieved positive cash flow in fiscal Q4 2025 earlier than previously forecasted, driven by a significant reduction in operating expenses and a long-term partnership with Recordati S.p.A. to commercialize VAZKEPA® across 59 countries, focusing on Europe [1] - Amarin believes it is on track for sustainable positive annual cash flow in 2026, supported by a full year of cost savings from its restructuring plan, with most expenses related to the plan already incurred in 2025 [2] Company Overview - Amarin Corporation plc is a pharmaceutical company focused on the development and commercialization of therapeutics targeting cardiovascular health, specifically developing and commercializing Vascepa capsules [4]

Core Insights - Amarin's shares increased nearly 17% following the release of preliminary sales numbers for Q4 and full-year 2025, which exceeded expectations [1][6] Financial Performance - Preliminary total revenues for Q4 2025 are expected to be between $48 million and $53 million, surpassing the Zacks Consensus Estimate of $43 million [3] - For full-year 2025, preliminary total revenues are projected to be between $212 million and $217 million, above the Zacks Consensus Estimate of $207 million [3] - The company achieved positive cash flow in Q4 2025, earlier than the previously expected timeline of 2026 [5][6] - Amarin ended 2025 with approximately $303 million in cash and investments, an increase from $287 million in Q3 2025, and remains debt-free [5][6] Cost Management and Restructuring - Restructuring costs for full-year 2025 are expected to range from $37 million to $40 million, up from the prior estimate of $30 million to $37 million [4] - Amarin has achieved approximately 50% of its planned $70 million operating expense reductions, with full benefits expected by June 2026 [4] Market Expansion - Amarin signed an exclusive long-term license and supply agreement with Recordati to commercialize Vazkepa in 59 countries, primarily in the European Union [7] - The company has established partnerships with seven experienced partners, providing access to nearly 100 markets [7] - Vascepa/Vazkepa is approved in over 50 countries and is protected by patents in Europe until 2039 [8] Stock Performance - Over the past year, Amarin's shares have risen 48.6%, compared to the industry's growth of 19.2% [5]

Core Insights - Amarin Corporation emphasizes the importance of recent innovations in therapies for patients with elevated triglycerides, particularly highlighting the role of VASCEPA/VAZKEPA in expanding treatment options and patient access [1][3][4] Company Overview - Amarin Corporation is focused on advancing cardiovascular therapeutics globally, with VASCEPA/VAZKEPA being a key product that has been prescribed over 25 million times worldwide [1][11] - The company has secured a long-term license and supply agreement with Recordati S.p.A. to commercialize VAZKEPA across 59 countries, enhancing its global reach [6] Product Efficacy - VASCEPA is FDA approved for reducing triglyceride levels in patients with severe hypertriglyceridemia (≥500 mg/dL) and for reducing cardiovascular risks in patients with elevated triglyceride levels [5][14] - The REDUCE-IT trial demonstrated a 25% reduction in cardiovascular events when VASCEPA was used alongside statin therapy in patients with elevated triglyceride levels [5] Market Dynamics - The emergence of new therapies targeting elevated triglycerides is expected to increase the utilization of existing treatments like VASCEPA, as payor-driven step-therapy programs may favor established, cost-effective options [8][9] - Historical data from the launch of PCSK9 inhibitors indicates that similar step-therapy requirements could lead to sustained growth in prescriptions for VASCEPA, as seen with ezetimibe [9] Clinical Significance - Advances in treating severe hypertriglyceridemia and related conditions are crucial for addressing the unmet needs of millions of cardiovascular disease patients globally [4][2] - VASCEPA's unique formulation and proven efficacy position it favorably against other triglyceride-lowering agents that have not demonstrated similar cardiovascular outcomes [5]

Financial Highlights - Amarin Corporation announced preliminary unaudited financial highlights for 2025 on January 8, 2026[4]. Operational Accomplishments - The company outlined key operational accomplishments for 2025 and set priorities for 2026 in its press release[4]. Regulatory Information - The press release is furnished as Exhibit 99.1 and is not deemed "filed" under the Securities Exchange Act[5]. Company Information - The company is listed on the Nasdaq Stock Market under the symbol AMRN, representing American Depositary Shares[2]. Leadership Commitment - The report was signed by Aaron Berg, President and CEO, indicating leadership's commitment to transparency[9].

Core Insights - Amarin Corporation has achieved significant operational milestones in 2025, including a positive cash flow in Q4 2025, ahead of expectations, and is on track for sustainable positive annual cash flow in 2026 [2][3]. Financial Highlights - The year-end 2025 cash balance was $303 million, an increase of $16 million from $287 million in Q3 2025 [6]. - Q4 2025 net revenue is expected to range between $48 - $53 million, while FY 2025 net revenue is projected to be between $212 - $217 million [6]. - The company realized approximately 50% of the estimated $70 million in OPEX savings from its restructuring plan, with full savings expected by June 30, 2026 [6]. Operational Accomplishments - VASCEPA maintained market leadership with over 50% share of IPE prescriptions by year-end 2025 [6]. - Amarin entered into a long-term partnership with Recordati S.p.A. to commercialize VAZKEPA in 59 countries, focusing on Europe [3][6]. - The company secured pricing and reimbursement in Austria and Slovenia, enhancing market access [6]. Strategic Outlook - In 2026, Amarin aims to maintain its IPE leadership in the U.S. and expand its therapeutic reach across Europe and other international markets [9]. - The company is actively pursuing additional strategic opportunities to unlock shareholder value [3][9]. - Amarin's commercialization strategy is now asset-light, leveraging partnerships to enhance efficiency and market reach [9].

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]