Amarin Corporation(AMRN) - 2024 Q4 - Annual Report

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]