Regulatory Approvals and Market Access - VASCEPA has received regulatory approval under the REDUCE-IT indication in 49 countries, including the U.S. and 27 EU Member States[445] - In Mainland China, VASCEPA received approval under the MARINE indication on June 1, 2023, and under the REDUCE-IT indication on June 28, 2024[460] - The company has filed 19 dossiers to gain market access in European countries, with reimbursement being a requisite for commercial success[454] - VASCEPA has been launched commercially in Canada since February 2020, with reimbursement obtained from all major private and public payors[462] - The company has received marketing authorization from the Medicines and Healthcare Products Regulatory Agency for VAZKEPA in England, Wales, and Scotland[445] - The company has filed for regulatory review in 22 countries and regions and received approval in 15 countries and regions outside of the U.S. and EMA, including Mainland China, Switzerland, Australia, New Zealand, and Israel[463] - The company entered into agreements with CSL Seqirus for commercialization in Australia and New Zealand, and with Lotus Pharmaceuticals for South Korea and Southeast Asia, expanding its market presence[464] - In the MENA region, VASCEPA has been launched in several countries, including Lebanon and the United Arab Emirates, with ongoing registration in additional countries[461] Sales and Revenue Performance - Approximately 27 million estimated normalized total prescriptions of VASCEPA have been reported since its commercial launch in 2013[447] - Product revenue is primarily derived from VASCEPA sales, with revenues recognized upon delivery to distributors, and the net price for direct sales being significantly higher than sales to commercial partners[475] - Total revenue, net decreased by $78.3 million, or 26%, to $228.6 million in 2024 from $306.9 million in 2023[499] - Product revenue, net fell by $80.7 million, or 28%, to $204.6 million in 2024, primarily due to a 39% decrease in VASCEPA sales in the U.S.[501] - U.S. product revenue, net decreased to $166.7 million in 2024 from $273.9 million in 2023, impacted by generic competition and a loss of a major Pharmacy Benefit Manager[502] - The overall icosapent ethyl market in the U.S. decreased by 2% in 2024, with the company's market share dropping to approximately 53% from 57%[503] - Product revenue, net from Europe increased to $13.7 million in 2024 from $3.3 million in 2023, primarily from the UK and Spain[504] - Licensing and royalty revenue includes upfront payments and milestone payments related to distribution agreements for VASCEPA outside the U.S.[476] - Licensing and royalty revenue increased by $2.4 million, or 11%, to $24.0 million in 2024[506] Financial Performance and Expenses - The Organizational Restructuring Program resulted in a 30% reduction in the total employee base, leading to an annual operating cost reduction of $50 million[467] - Research and development expenses include costs for clinical trials, independent monitoring, and salaries, with expenses recognized as incurred[479] - Selling, general and administrative expenses decreased by $47.6 million, or 24%, from $199.9 million in 2023 to $152.3 million in 2024[512] - Research and development expenses decreased by $1.4 million, or 6%, from $22.2 million in 2023 to $20.9 million in 2024[513] - Restructuring expenses from the July 2023 ORP included severance pay and other related costs[480] - Restructuring expenses were nil in 2024 compared to $11.0 million in 2023, reflecting a 100% decrease due to the implementation of the ORP[515] - Cost of goods sold rose by $5.9 million, or 4%, to $147.2 million in 2024, reflecting increased costs associated with supply management and inventory[508] - Approximately $8.0 million of inventory was expensed in 2024 due to unsellable inventory, compared to $5.1 million in 2023[509] - Overall gross margin on product sales decreased to 28% in 2024 from 50% in 2023, with a gross margin of 50% and 66% when excluding restructuring inventory and write-off charges[511] Cash Flow and Liquidity - Cash and cash equivalents and short-term investments totaled $294.5 million as of December 31, 2024[519] - Net cash used in operating activities was $(31.0) million in 2024, a decrease from $6.9 million provided in 2023[520] - The accumulated deficit as of December 31, 2024, was $1.7 billion, with expectations of variable quarterly net cash outflows due to various factors[524] - The company has no indebtedness and believes its liquidity will be sufficient to fund projected operations for at least one year[527] - A share repurchase program was announced to purchase up to $50.0 million of the company's ordinary shares, pending market conditions[526] Clinical and Research Developments - VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high-risk patients[445] - The REDUCE-IT study has been pivotal, with over 50 clinical treatment guidelines recognizing the use of icosapent ethyl for cardiovascular risk reduction[469] - The company continues to evaluate its deferred tax assets, concluding that they are not likely to be realizable as of December 31, 2024 and 2023[494] - Interest income, net, increased by $1.5 million, or 13%, from $11.9 million in 2023 to $13.4 million in 2024[516]

Financial Performance - Total revenues for Q4 2024 were $62.3 million, a decrease of 17% compared to $74.7 million in Q4 2023[8] - Operating expenses for Q4 2024 were $43.0 million, down 18% from $49.7 million in Q4 2023[8] - The company reported a net loss of $48.6 million for Q4 2024, compared to a net loss of $5.8 million in Q4 2023[11] - Adjusted net loss for Q4 2024 was $8.7 million, compared to an adjusted net loss of $0.9 million in Q4 2023[12] - Non-GAAP adjusted net loss for Q4 2024 was $8.744 million, compared to a loss of $0.906 million in Q4 2023[36] - Product revenue for the year ended December 31, 2024, was $204.590 million, a decrease of 28.3% from $285.299 million in 2023[34] - Gross margin for the year ended December 31, 2024, was $81.382 million, down from $165.541 million in 2023[34] - Net loss for the year ended December 31, 2024, was $82.183 million, compared to a loss of $59.112 million in 2023[34] - Operating loss for Q4 2024 was $52.522 million, compared to a loss of $4.837 million in Q4 2023[34] Cash Position and Assets - The company ended 2024 with a cash position of $294.2 million, an 8% decrease from $320.7 million at the end of 2023[8] - Cash and cash equivalents decreased to $121.038 million as of December 31, 2024, from $199.252 million a year earlier[32] - Total assets as of December 31, 2024, were $685.349 million, down from $831.684 million in 2023[32] - Total stockholders' equity decreased to $486.176 million as of December 31, 2024, from $552.097 million in 2023[32] Revenue Breakdown - U.S. net product revenue for Q4 2024 was $44.2 million, compared to $64.9 million in Q4 2023, reflecting a significant decline[14] - European net product revenue increased to $4.0 million in Q4 2024 from $1.5 million in Q4 2023, showing growth in that market[14] - Total revenue for Q4 2024 was $62.306 million, down 16.5% from $74.713 million in Q4 2023[34] Strategic Plans - The company plans to implement a 1-for-20 ADS ratio change to maintain its Nasdaq listing, effective around April 11, 2025[4] - The VASCEPA/VAZKEPA franchise is expanding into six additional global markets, including Italy, China, and Australia[3] - The company aims to capitalize on the significant opportunity in Europe, targeting over 5 million high-risk patients with established cardiovascular disease[15] - The company plans to expand access and reimbursement for VAZKEPA across global markets, with expectations for strategic collaborations in 2025[27]

Core Points - Amarin Corporation plans to change the ratio of its American Depositary Shares (ADS) from 1:1 to 1:20 to comply with Nasdaq's minimum bid price requirement of $1.00 per share [1][3] - The effective date for this ratio change is expected to be around April 11, 2025 [1] - The adjustment will not affect the ordinary shares of Amarin, and the ADSs will continue to trade under the symbol "AMRN" on The Nasdaq Capital Market [2] Summary by Sections Ratio Change Details - The ratio change aims to increase the per share market price of the Company's ADSs to maintain its listing on Nasdaq [3] - Holders of uncertificated ADSs will not need to take action as the exchange will occur automatically, while registered holders of certificated ADSs must surrender their shares for the new ratio [3][4] - No fractional new ADSs will be issued; instead, fractional entitlements will be aggregated and sold, with net cash proceeds distributed to ADS holders [4] Market Impact - The trading price of the Company's ADSs is expected to increase proportionally due to the ratio change, although there is no assurance that the price will be equal to or greater than twenty times the pre-adjustment price [5] Company Overview - Amarin is an innovative pharmaceutical company focused on cardiovascular disease management and aims to enhance the understanding and treatment of cardiovascular risks [6]

Core Insights - Amarin Corporation reported a total revenue of $62.3 million for Q4 2024, a decrease of 17% compared to $74.7 million in Q4 2023, primarily due to lower net selling prices and reduced volume from U.S. generic competition [5][8][10] - The company ended 2024 with nearly $300 million in cash and no debt, reflecting a disciplined approach to capital management [2][5] - A 1-for-20 ADS ratio change was announced to maintain the company's Nasdaq listing, effective around April 11, 2025 [3][5] Financial Performance - Q4 2024 operating expenses were $43.0 million, down 18% from $49.7 million in Q4 2023 [5][12] - The net loss for Q4 2024 was $48.6 million, compared to a net loss of $5.8 million in Q4 2023, resulting in a basic and diluted loss per share of $0.12 [13][14] - Adjusted net loss for Q4 2024, excluding non-cash expenses, was $8.7 million, compared to an adjusted net loss of $0.9 million in Q4 2023 [14][35] Market Expansion and Product Performance - The company successfully launched VASCEPA/VAZKEPA in six additional global markets, including Italy, China, and Australia, and is progressing in 16 more countries [2][6] - In Italy, national reimbursement for VAZKEPA was secured, with access unlocked in over 50% of the eligible population [6] - U.S. net product revenue for Q4 2024 was $44.2 million, down from $64.9 million in Q4 2023, while European revenue increased to $4.0 million from $1.5 million [10][11] Research and Development - In 2024, Amarin's R&D team published 45 additional studies supporting the benefits of VASCEPA/VAZKEPA, enhancing the understanding of its cardiovascular risk reduction capabilities [7] - The company plans to present further data at the ACC.25 conference in March 2025, focusing on the antioxidant effects of EPA and its role in reducing cardiovascular events [9]

Core Insights - Amarin Corporation reported total revenues of $62.3 million for Q4 2024, a decrease of 17% compared to $74.7 million in Q4 2023, primarily due to lower net selling prices and reduced volume from U.S. generic competition [7][9] - The company ended 2024 with a cash position of $294.2 million and no debt, reflecting a disciplined approach to capital management [3][16] - Amarin announced a 1-for-20 ADS ratio change to maintain its Nasdaq listing, effective around April 11, 2025 [4] Financial Performance - Total net revenue for Q4 2024 was $62.3 million, down from $74.7 million in Q4 2023, marking a 17% decline [9] - Operating expenses decreased by 18% to $43.0 million in Q4 2024 from $49.7 million in Q4 2023 [7][13] - The net loss for Q4 2024 was $48.6 million, compared to a net loss of $5.8 million in Q4 2023, resulting in a basic and diluted loss per share of $0.12 [14][36] Product and Market Developments - The VASCEPA/VAZKEPA franchise continues to expand, with significant growth in global markets, including Italy, China, and Australia [3][10] - In Europe, VAZKEPA secured national reimbursement in Italy and Austria, enhancing market access [5][11] - The company reported U.S. net product revenue of $44.2 million for Q4 2024, down from $64.9 million in Q4 2023, while European and Rest of World revenues showed growth [11] Strategic Outlook - Amarin aims to capitalize on opportunities in Europe, targeting over 5 million high-risk patients with established cardiovascular disease [17] - The company is focused on efficient revenue generation in the U.S. and expanding its presence in Rest of World markets [17] - Ongoing cost optimization efforts are expected to support the company's financial health and operational efficiency [13][17]

Core Insights - The recent post-hoc analysis of the REDUCE-IT study indicates that icosapent ethyl (IPE) significantly reduces composite cardiovascular (CV) endpoint events by 34% among patients with very well-controlled low-density lipoprotein cholesterol (LDL-C) levels (<55 mg/dL) [1][4] - IPE is positioned as a complementary therapy to existing LDL-C lowering treatments, enhancing cardiovascular outcomes and potentially saving lives [1][2] Company Insights - Amarin Corporation emphasizes the efficacy and safety profile of VASCEPA (icosapent ethyl), advocating its use alongside standard care to mitigate cardiovascular disease risk, which remains the leading cause of death globally [1][2] - The company has a commitment to advancing treatment options for patients with persistent cardiovascular risk despite statin therapy, as evidenced by the incorporation of IPE into multiple global guidelines [2][4] Industry Insights - Elevated LDL-C is recognized as a major cardiovascular risk factor, with recent guidelines recommending LDL-C levels be lowered to <55 mg/dL for high-risk patients [1][2] - The cardiovascular disease landscape shows a pressing need for additional evidence-based therapies beyond standard treatments, particularly for patients with elevated triglycerides who remain at significant risk for cardiovascular events [2][11]

Core Insights - Austrian Health Authorities have approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular event risks in eligible patients, effective April 1, 2025, marking the 10th national reimbursement approval in Europe for this product [1][4]. Group 1: Company Overview - Amarin Corporation is an innovative pharmaceutical company focused on cardiovascular disease management, with a commitment to advancing treatment options for patients worldwide [5]. - The company has offices in multiple locations, including Bridgewater, New Jersey, Dublin, Ireland, and Zug, Switzerland, and collaborates with commercial partners globally [5]. Group 2: Industry Context - Cardiovascular diseases accounted for approximately 35% of all deaths in Austria in 2023, highlighting the urgent need for effective treatment options [2]. - More than 100,000 hospitalizations in Austria in 2023 were due to cardiovascular diseases, with direct and indirect costs estimated at around 4.7 billion euros in 2015 [2]. Group 3: Reimbursement Impact - The reimbursement of VAZKEPA® is seen as a significant advancement in addressing the unmet needs of patients with established cardiovascular disease whose triglycerides remain elevated despite statin treatment [3]. - This decision is expected to alleviate the burden on the healthcare system and improve patient outcomes in secondary prevention of cardiovascular diseases [3].

Group 1 - Amarin Corporation will host a conference call on March 12, 2025, at 8:00 a.m. ET to discuss its fourth quarter and full year 2024 results [1] - The financial results will be released in the pre-market hours on the same day [1] - The call will include a Q&A session with the management team [1] Group 2 - Amarin is an innovative pharmaceutical company focused on cardiovascular disease management, with offices in multiple countries including the United States, Ireland, and Switzerland [3] - The company aims to enhance the scientific understanding of cardiovascular risks that persist beyond traditional therapies [3] Group 3 - Amarin provides various channels for investor communication, including its website and investor relations section, where material information is regularly posted [4] - The company encourages stakeholders to review the information available on these channels [4]

Core Insights - Italy's National Health Service has approved VAZKEPA® (icosapent ethyl) for national reimbursement aimed at reducing cardiovascular risk in eligible high-risk patients, marking Italy as the third EU5 market to grant such reimbursement and the ninth overall in Europe [1][4] - The approval is part of a broader strategy by Amarin Corporation to enhance reimbursement, access, and commercialization in Europe, which has resulted in securing national reimbursement in three EU5 markets and nine European markets overall, covering more than 50% of the established cardiovascular disease population in Western Europe [4][6] - The intellectual property for VAZKEPA in Europe has been extended to 2039, eliminating the risk of early competitive entry prior to patent expiration [5] Industry Context - Cardiovascular disease is the leading cause of death and hospitalization in Italy, with over 217,000 deaths and more than 107,000 hospitalizations annually due to myocardial infarction, indicating a significant need for effective treatment options [2][3] - The approval of VAZKEPA addresses a critical clinical need for patients with established cardiovascular disease and elevated triglycerides, who are at a higher risk of subsequent cardiovascular events despite well-managed LDL-C levels [3] - The endorsement of VAZKEPA by over 50 medical societies globally and its approval in 46 countries for cardiovascular risk reduction highlight the significant potential to benefit millions of patients worldwide [6]

Core Points - Amarin Corporation has appointed Peter Fishman as Chief Financial Officer, effective immediately [1] - Fishman has nearly 20 years of experience in finance, including roles in accounting, financial reporting, treasury, tax, and audit [2] - He has been with Amarin since 2019, serving as the principal financial and accounting officer since October 2024 and as Vice President & Global Controller since October 2022 [2] - Fishman holds a Bachelor of Arts in accounting and an MBA, and is a certified public accountant [3] Company Strategy - The CEO, Aaron Berg, expressed confidence in Fishman's ability to lead the company's financial and business strategy moving forward [2] - Fishman has been integral to Amarin's financing efforts and current cash management strategy [2]