DUBLIN and BRIDGEWATER, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) (“Amarin”), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, applauded the recommendation that the treatment of CV risk in patients with hypertriglyceridemia be part of a broader dyslipidemia management as discussed in the 2026 American College of Cardiology (ACC) / American Heart Association (AHA)/Multisociety Dyslipidemia Guideline Update.i These newly-issued, evid ...

Core Viewpoint - Amarin is in a precarious position due to restructuring efforts to cut costs and facing generic competition for its only drug, Vascepa, which may lead investors to prefer larger pharmaceutical companies [1][5]. Financial Position - Amarin has a strong financial position with no long-term debt, a cash balance of nearly $135 million, and short-term investments worth just under $168 million, allowing it to sustain operations for years [2]. - In 2025, Amarin reported product sales of nearly $183 million, and a restructuring effort is expected to generate positive free cash flow in 2026 [4]. Revenue Challenges - The company's sales have declined from $285 million two years ago, primarily due to generic competition affecting Vascepa, leading to concerns about the sustainability of its financial situation [5]. - The ongoing revenue decline poses a significant risk, as Amarin may need to further reduce spending to maintain its financial health [7]. Industry Comparison - The pharmaceutical sector typically experiences cycles, but Amarin's reliance on a single drug limits its operational strength compared to larger companies with diversified portfolios [8]. - Companies like Pfizer, despite facing challenges, have the ability to pivot and leverage a broader drug portfolio, positioning them more favorably in the market [9].

Core Insights - Amarin's shares have increased by 37.7% over the past year, significantly outperforming the industry's growth of 14.7%, driven by restructuring efforts, cost controls, and optimism regarding international expansion [1][7] Operational Restructuring & Cost Optimization - Amarin's revenue primarily comes from its drug Vascepa/Vazkepa and licensing agreements, with the drug available in over 20 countries. However, U.S. sales are pressured by generic competition [2] - To counteract competition, Amarin has implemented significant operational streamlining and cost reduction measures [2] - A global restructuring program was introduced in June 2025, aiming for $70 million in annual savings, which has positively impacted investor sentiment by extending the company's cash runway and reducing cash burn [3][7] International Growth of AMRN's Vascepa - Amarin is focusing on expanding Vascepa in international markets, particularly in Europe, where it is gaining market access and reimbursement approvals [4] - In June 2025, Amarin signed a long-term license and supply agreement with Recordati to commercialize Vazkepa in 59 European countries [5][7] - The company has established partnerships with seven regional partners, providing access to nearly 100 markets, which is expected to enhance international sales and offset declining U.S. revenues [8] Balance Sheet Strength - The restructuring initiatives have improved Amarin's balance sheet, maintaining a solid cash position and remaining debt-free throughout 2025, which reduces financial risk [9] - The company achieved positive cash flow in Q4 2025, ahead of its previous expectations for 2026 [9]

Company Overview - Amarin's shares have increased by approximately 22% over the past year, but its future prospects remain uncertain due to the presence of generics in the market for its sole product, Vascepa [6] - In fiscal 2025, Amarin reported a total revenue of $213.6 million, reflecting a year-over-year decrease of 6.5% [6] Financial Performance - Amarin's net loss per share improved to $0.09 in 2025, compared to a loss of $0.20 in 2024, indicating progress in cost-cutting measures despite declining sales [7] Legal and Strategic Developments - Amarin is currently involved in a legal dispute with Hikma Pharmaceuticals regarding the marketing of a generic version of Vascepa, with the case now at the U.S. Supreme Court [8] - The company has partnered with Recordati Industria Chimica e Farmaceutica to commercialize Vascepa in 59 countries, receiving an upfront payment of $25 million and potential earnings of up to $150 million based on milestones [9]

Product Approval and Market Expansion - VASCEPA was first approved by the U.S. FDA in July 2012 for severe hypertriglyceridemia and received a label expansion in December 2019 for reducing cardiovascular risk in high-risk patients [455]. - The company has received marketing authorization for VAZKEPA in the EU, England, Wales, and Scotland in 2021, with various reimbursement approvals across multiple countries [465][468]. - The Recordati Licensing Agreement allows Recordati to commercialize VAZKEPA in 59 countries, with the potential for future product reimbursements and approvals [466]. - The company has filed for regulatory review in 22 countries and regions, receiving approval in 17 countries outside of the U.S. and EMA [471]. - VAZKEPA has been launched in several European countries, with national reimbursement secured in Sweden, England, and Spain among others [468]. - The company has established partnerships with seven commercial partners for VASCEPA and VAZKEPA, focusing on regulatory approval and commercialization [457]. - The company anticipates that the success of reimbursement negotiations will significantly impact the commercial opportunity of VAZKEPA in Europe [467]. - A patent issued in April 2024 extends VAZKEPA's market exclusivity to 2039, providing a competitive advantage in the European market [470]. - VASCEPA is under registration in additional countries in the MENA region, Israel, and ASEAN, with revenue from Israel recorded within European revenue [472]. Financial Performance - Total revenue, net decreased by $15.0 million, or 7%, to $213.6 million in 2025 from $228.6 million in 2024 [507]. - Product revenue, net fell by $21.8 million, or 11%, to $182.8 million in 2025, primarily due to an 8% decrease in VASCEPA sales in the U.S. [508]. - U.S. product revenue, net was $154.1 million in 2025, down from $166.7 million in 2024, attributed to a decline in net selling price due to generic competition [509]. - Licensing and royalty revenue increased by $6.9 million, or 29%, to $30.9 million in 2025, driven by a $25.0 million upfront payment from the Recordati Licensing Agreement [513]. - Cost of goods sold decreased by $54.5 million, or 37%, to $92.8 million in 2025, reflecting cost management and supplier agreement amendments [515]. - Overall gross margin on product sales improved to 49% in 2025 from 28% in 2024, with a gross margin of 49% excluding restructuring inventory charges [517]. - Product revenue from Europe increased to $18.4 million in 2025 from $13.7 million in 2024, primarily from the UK and Spain [511]. - Revenue from collaboration partners in the Rest of the World (RoW) decreased to $10.2 million in 2025 from $24.2 million in 2024, reflecting variability in early-stage market development [512]. Expenses and Cost Management - Selling, general and administrative expenses decreased by $37.3 million, or 24%, from $152.3 million in 2024 to $115.0 million in 2025 [518]. - Research and development expenses decreased by $1.1 million, or 5%, from $20.9 million in 2024 to $19.8 million in 2025 [519]. - Restructuring expenses increased by $36.2 million, or 100%, due to the Global Restructuring Plan associated with the Recordati Licensing Agreement [520]. - The Global Restructuring Plan is expected to reduce operating costs by approximately $70 million annually through the elimination of commercial roles in European operations [474]. Cash Flow and Investments - Cash and cash equivalents and short-term investments totaled $302.8 million as of December 31, 2025 [525]. - Net cash provided by operating activities was $6.7 million in 2025, compared to a net cash used of $31.0 million in 2024 [526]. - Interest income, net, decreased by $2.6 million, or 19%, from $13.4 million in 2024 to $10.8 million in 2025 [521]. - Other income, net, increased from $1.2 million in 2024 to $3.3 million in 2025 [522]. - Provision for income taxes decreased by $2.2 million, or 44%, from $5.0 million in 2024 to $2.8 million in 2025 [523]. Research and Clinical Studies - The REDUCE-IT study has been pivotal for VASCEPA, with over 35,000 patient years of study experience, leading to additional indicated uses being pursued globally [475]. - More than 70 global medical societies have recognized the use of icosapent ethyl (IPE) for cardiovascular risk reduction, with significant findings from the REDUCE-IT study showing a 25% reduction in major cardiovascular events [476].

Core Insights - The peer-reviewed analysis indicates that icosapent ethyl (IPE) is associated with fewer total hospitalizations and reduced days lost due to hospitalization and death, highlighting its impact on patient-centered measures of disease burden [1][6]. Study Overview - The analysis involved 8,179 participants who were randomized to receive either IPE 2 g twice daily or a placebo, followed for a median of five years to assess the impact on hospitalization frequency and duration [2][4]. Key Findings - IPE treatment resulted in a 9% reduction in total hospitalizations (HR = 0.91, P = 0.017) and increased the likelihood of surviving without hospitalization (OR = 1.12, P = 0.016) [5]. - Participants treated with IPE experienced fewer days lost due to hospitalization or death, with a relative risk reduction of 7% (RR = 0.93, P < 0.001) [5]. Clinical Significance - The findings emphasize the real-world relevance of IPE for patients, potentially allowing them to maintain independence and spend more time at home, thus reducing the overall burden on healthcare systems [3][6]. - The results extend the benefits of IPE beyond cardiovascular prevention, indicating its role in improving quality of life for patients with heart disease or diabetes [3]. Background on IPE - IPE, marketed as VASCEPA/VAZKEPA, is the first prescription treatment approved by the FDA solely comprising icosapent ethyl, aimed at high-risk patients with persistent cardiovascular risk despite statin therapy [12][17]. - The REDUCE-IT study, which evaluated IPE, was a global cardiovascular outcomes study that included patients with controlled LDL-C levels and elevated triglycerides, demonstrating significant efficacy in reducing cardiovascular events [8][9]. Company Profile - Amarin Corporation is dedicated to reducing the cardiovascular disease burden and advancing cardiovascular care globally, with a commercialization model that includes direct sales in the U.S. and indirect distribution internationally [7].

Core Insights - Amarin Corporation (AMRN) reported adjusted earnings of 1 cent per share for Q4 2025, surpassing the Zacks Consensus Estimate of a loss of $1.27, and improved from an adjusted loss of 2 cents per share in the same quarter last year [1][6] - Total revenues for Q4 were $49.2 million, falling short of the Zacks Consensus Estimate of $51 million, and representing a 21% decline from the previous year due to lower sales volume and pricing issues [2][6] - The company's stock declined by 9% following the earnings announcement, although shares have increased by 22.5% over the past year compared to the industry growth of 19.2% [2] Revenue Breakdown - Net product revenues from Vascepa in Q4 were $46.5 million, down 23% year over year, and missed the Zacks Consensus Estimate of $48.7 million [4][6] - U.S. product revenues from Vascepa decreased by 7% year over year to $41.1 million, attributed to lower net selling prices [4] - European product revenues from Vazkepa totaled $2.3 million, a 42% decrease from the previous year, due to the transition to a partnered model with Recordati [7] - Revenues from the Rest of the World were $3.1 million, down 74% year over year, while licensing and royalty revenues increased by 20% to $2.7 million [7] Cost Management and Cash Flow - Selling, general and administrative expenses declined by 46% year over year to $20.1 million, reflecting restructuring and cost-optimization efforts [8] - Research and development expenses remained consistent at $5.4 million compared to the prior year [8] - The company achieved positive cash flow in Q4 2025, earlier than previously expected in 2026 [9] Full-Year Performance - For the full year 2025, Amarin reported total revenues of $213.6 million, a decrease of 6.5% year over year [10] - Adjusted net earnings for the full year were 4 cents per share, compared to a net loss of 7 cents per share in 2024 [10] - The company incurred $36.2 million in restructuring charges for the year and anticipates total charges of $37 million to $40 million, with remaining costs expected in early 2026 [10] Strategic Developments - In 2025, Amarin entered into a long-term license and supply agreement with Recordati to commercialize Vazkepa across 59 European countries [11] - The company launched a global restructuring program aimed at achieving $70 million in annual cost savings, with $31 million already realized [11] - Management believes that the fully partnered ex-U.S. business model will help reduce costs and maintain positive cash flow in 2026 [12]

Core Insights - Amarin is undergoing a strategic pivot towards a partnered international commercial model and has executed a global restructuring to lower operating expenses, with 2025 being marked as a "substantial achievement" year [2] Group 1: Strategic Partnerships and Restructuring - The exclusive long-term partnership with Recordati, starting in Q3 2025, is a key driver for Amarin's operational review and restructuring initiative [3] - The license and supply agreement with Recordati covers 59 countries, focusing on Europe, and transfers European promotional activities to Recordati [3] - The agreement provides immediate financial value, including a $25 million upfront cash payment and potential future milestone payments up to $150 million, contingent on Recordati achieving $100 million in annual net sales [4] Group 2: Market Performance and Sales Dynamics - Early commercial indicators show growth in volume and demand in launch markets, particularly in Italy, where pricing and reimbursement have been secured [5] - In the U.S., VASCEPA has maintained market leadership among icosapent ethyl products five years post-generic launch, retaining major managed care exclusives through 2025 [6] - U.S. sales for Q4 2025 declined by 7% due to a decrease in net selling price, attributed to proactive pricing strategies [6]

Financial Data and Key Metrics Changes - For the full year 2025, total net revenue was $49.2 million, down from $62.3 million in the previous year’s fourth quarter, reflecting a 21% decline [21] - U.S. sales declined by 7% due to a decrease in net selling price, driven by proactive pricing adjustments [21] - Total operating expenses decreased by 31%, or $13.5 million, with cost of goods sold declining by 63% [23] - The operating loss in the fourth quarter narrowed to $2.3 million from an operating loss of $16 million in the previous year’s fourth quarter [25] - The company ended 2025 with $303 million in cash and investments, no debt, and working capital of $455 million [25] Business Line Data and Key Metrics Changes - Product revenue for Europe was $2.3 million, including $900,000 in supply shipments to Recordati, significantly lower than the $4 million of direct sales in the fourth quarter of 2024 [21][22] - Rest of World revenues were $3.1 million, down from $11.9 million in the previous year’s fourth quarter, impacted by $7.8 million in stocking orders in the last quarter of 2024 [22] Market Data and Key Metrics Changes - VASCEPA maintained clear market leadership in the U.S. across all available icosapent ethyl products, both branded and generic, five years after the introduction of the first generic product [8] - The partnership with Recordati aims to capitalize on the growing awareness of lipid management protocols in Europe, where cardiovascular disease is a leading cause of death [9] Company Strategy and Development Direction - The company established a long-term partnership with Recordati to commercialize VAZKEPA across Europe, aiming to enhance the global market for its franchise [4] - The strategy includes a focus on operational efficiencies and a global restructuring plan expected to yield approximately $70 million in annualized savings by mid-2026 [5][26] - The company is committed to enhancing long-term shareholder value by addressing cardiovascular disease as a leading cause of death [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of the VASCEPA franchise and its global growth potential, supported by extensive scientific evidence [7] - The company anticipates 2026 to be a pivotal year, focusing on defending its U.S. franchise and expanding its global presence through the international partnership model [19][25] - Management highlighted the importance of maintaining exclusivity in the U.S. market and expressed confidence in sustaining it through 2026 [38] Other Important Information - The company reported generating positive cash flow from operations of $7 million in 2025, earlier than anticipated [25] - The partnership model will result in revenue variability quarter-to-quarter, influenced by market demand and launch timing [23] Q&A Session Summary Question: Could you provide more color on the volume versus price dynamics in 4Q? - Management noted that volume and price remained consistent compared to Q3, with typical volume declines expected in Q1 [31][32] Question: How confident are you in sustaining exclusivity with your existing exclusive formulary in 2026? - Management expressed confidence in maintaining exclusivity through 2026, despite the dynamic nature of the market [38]

Financial Data and Key Metrics Changes - For the fourth quarter of 2025, total net revenue was $49.2 million, down from $62.3 million in the same quarter of the previous year, reflecting a 21% decline [21] - U.S. sales declined by 7% due to a decrease in net selling price, driven by proactive pricing adjustments [21] - Total operating expenses decreased by 31%, or $13.5 million, with cost of goods sold declining by 63% [24] - The operating loss narrowed to $2.3 million from an operating loss of $16 million in the previous year's fourth quarter [26] - The company ended 2025 with $303 million in cash and investments, no debt, and working capital of $455 million [26] Business Line Data and Key Metrics Changes - Product revenue for Europe was $2.3 million, including $900,000 in supply shipments to Recordati, significantly lower than the $4 million of direct sales in Q4 2024 [22] - Rest of World revenues were $3.1 million, down from $11.9 million in the previous year's fourth quarter, impacted by $7.8 million in stocking orders in Q4 2024 [23] - SG&A expenses declined by 46%, representing 41% of total net sales compared to 59% in the previous year [25] Market Data and Key Metrics Changes - VASCEPA maintained clear market leadership in the U.S. across all available icosapent ethyl products, both branded and generic [7] - The company has established a partnership with Recordati to commercialize VAZKEPA across 59 countries, focusing on Europe, which is expected to enhance market access [9] Company Strategy and Development Direction - The company aims to transform its business model and expand the global market for its VASCEPA/VAZKEPA franchise through strategic partnerships and operational efficiencies [4] - The partnership with Recordati is expected to generate substantial economies of scale and significant revenue opportunities while providing extensive infrastructure [9] - The company is focused on maintaining exclusivity in the U.S. market and expanding its global presence through a partnered international commercial strategy [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of the VASCEPA franchise and its global growth potential, supported by a strong body of scientific evidence [6] - The company anticipates a pivotal year in 2026, focusing on defending its U.S. franchise and expanding its global presence [19] - Management highlighted the importance of proven therapies like VASCEPA in the evolving treatment landscape for cardiovascular disease [16] Other Important Information - The company achieved approximately half of the estimated $70 million in total operating expense savings from its global restructuring plan by the end of 2025 [5] - The company expects to incur the last of the restructuring expenses in early 2026 [25] Q&A Session Summary Question: Could you provide more color on the volume versus price dynamics in 4Q? - Management noted that volume and price remained consistent compared to Q3, with typical volume declines expected in Q1 [31][32] Question: How confident are you in sustaining exclusivity with your existing exclusive formulary in 2026? - Management expressed confidence in maintaining exclusivity through the year, citing past successes in regaining exclusives [37]