Amarin Corporation(US:AMRN)2024-07-31 11:05Product Performance - VASCEPA has achieved approximately 25 million estimated normalized total prescriptions since its commercial launch in 2013[95]. - U.S. product revenue was $43.8 million in Q2 2024, down from $64.6 million in Q2 2023, attributed to a decline in net selling price due to generic competition[122]. - Product revenue decreased to $47.5 million in Q2 2024 from $65.2 million in Q2 2023, a decline of 27% primarily due to a 32% decrease in VASCEPA sales in the U.S.[122]. - The overall icosapent ethyl market in the U.S. decreased by 1% in Q2 2024 compared to Q2 2023, while the company's market share increased to approximately 59%[122]. - VASCEPA has been approved in 15 countries and regions outside of the United States and EMA, including Mainland China, Switzerland, Australia, New Zealand, and Israel[107]. - The company has filed for regulatory review in 22 countries and regions, aiming to ensure VASCEPA's availability in the top 50 cardiometabolic markets worldwide[107]. - VASCEPA received regulatory approval in Mainland China for the MARINE indication on June 1, 2023, and for the REDUCE-IT indication on June 28, 2024[103]. - VASCEPA has received reimbursement from all major private and public payors in Canada, gaining access to a majority of eligible patients[106]. Financial Performance - Total revenue decreased by $12.7 million, or 16%, to $67.5 million for the three months ended June 30, 2024, compared to $80.2 million for the same period in 2023[121]. - Product revenue, net, decreased by $47.2 million, or 31%, to $102.7 million for the six months ended June 30, 2024, compared to $149.8 million in 2023, primarily due to a 37% decrease in VASCEPA sales in the U.S.[135]. - Total revenue, net for the six months ended June 30, 2024 was $124.0 million, down from $166.1 million in the same period of 2023, a decrease of 25%[134]. - U.S. net product revenue decreased by $20.8 million, offset by a $3.1 million increase in net product revenue outside the United States and a $5.0 million increase in licensing and royalty revenue[121]. - Licensing and royalty revenue increased to $20.0 million in Q2 2024 from $15.0 million in Q2 2023, a rise of 33% driven by milestone payments related to the REDUCE-IT indication in China[123]. - Interest income, net increased to $3.3 million in Q2 2024 from $3.0 million in Q2 2023, a rise of 9% due to higher investment balances[132]. - The provision for income taxes increased to $2.7 million for the six months ended June 30, 2024, from $1.6 million in 2023, primarily due to a higher annualized estimated tax rate[146]. - The company incurred an accumulated deficit of $1.6 billion as of June 30, 2024[149]. Cost Management - The Organizational Restructuring Program resulted in a reduction of approximately 30% of the total employee base, leading to an annual operating cost reduction of $50 million[92]. - Selling, general and administrative expenses fell to $38.5 million in Q2 2024 from $51.0 million in Q2 2023, a decrease of 24% due to cost reduction initiatives[125]. - Research and development expenses decreased to $4.7 million in Q2 2024 from $5.6 million in Q2 2023, a decline of 16%[129]. - Cost of goods sold decreased to $24.7 million in Q2 2024 from $37.5 million in Q2 2023, a reduction of 34%, contributing to an increase in gross margin from 42% to 48%[124]. - Selling, general and administrative expenses decreased by $32.1 million, or 29%, to $78.4 million for the six months ended June 30, 2024, from $110.5 million in 2023[139]. - Cost of goods sold decreased by $26.2 million, or 35%, to $49.3 million for the six months ended June 30, 2024, compared to $75.5 million in 2023[138]. - Restructuring expenses were nil in Q2 2024 compared to $10.0 million in Q2 2023, a decrease of 100% following the implementation of the ORP[131]. Strategic Initiatives - The European redesign of the commercial infrastructure aims to align with pricing and reimbursement status, enhancing market access in key countries[94]. - The company is exploring additional partnerships in key international markets, including Canada, MENA, China, Australia, and New Zealand[102]. - The company aims to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets in 2024[135]. - The company has updated over 40 clinical treatment guidelines recommending the use of icosapent ethyl in at-risk patients based on REDUCE-IT results[109]. - The company is in the final year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries[107]. - The company entered into agreements to commercialize VASCEPA in Australia, New Zealand, South Korea, and several Southeast Asian countries[107]. - The company continues to advance pricing and reimbursement activities to drive access in remaining geographies, optimizing a hybrid commercial model[101]. Cash Flow and Liquidity - As of June 30, 2024, the company had cash and cash equivalents of $215.9 million and short-term investments of $90.7 million[149]. - Net cash used in operating activities for the six months ended June 30, 2024, was $(15.4) million, compared to $0.2 million provided in the same period in 2023[148]. - Net cash provided by investing activities increased to $33.4 million for the six months ended June 30, 2024, from $14.7 million in the same period in 2023[148]. - The company believes its cash and cash equivalents, along with short-term investments, will be sufficient to fund projected operations for at least one year[149]. - The company has no indebtedness and maintains a conservative investment policy to ensure liquidity and capital preservation[147]. - A share repurchase program was announced on January 10, 2024, to buy up to $50.0 million of the company's ordinary shares, pending market conditions[147]. - The company anticipates variable quarterly net cash outflows due to API purchases, generic competition, and pricing and reimbursement of VAZKEPA in Europe[147].