Amarin Corporation(US:AMRN)2025-10-29 11:05Product 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].