• Total Net Revenue: $42.3 million in Q3 2024, down from $66.1 million in Q3 2023.
• U.S. Product Revenue: $30.6 million in Q3 2024, compared to $62.4 million in Q3 2023.
• European Net Product Revenue: $4.3 million, a $3.5 million increase over the prior year period.
• Gross Margin: 38% in Q3 2024, compared to 64% in the prior year period.
• Total Operating Expenses: $41.4 million in Q3 2024, a reduction of approximately $10 million from the prior year period.
• GAAP Net Loss: $25.1 million in Q3 2024, compared to a $19.3 million loss in the prior year period.
• Cash and Investments: $306 million as of September 30, 2024.

• Warning! GuruFocus has detected 3 Warning Signs with AMRN.

Release Date: October 30, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• VASCEPA/VAZKEPA has significant growth potential globally, particularly in Europe, with IP protection extended to 2039.
• The company has secured pricing and reimbursement in several European countries, including Greece and Portugal, and is making progress in Italy.
• Amarin Corp PLC (NASDAQ:AMRN) has maintained a 50% market share in the U.S. despite generic competition, demonstrating the product's unique value.
• The company has a strong cash position with $306 million in cash and investments and no debt, providing financial stability.
• Amarin Corp PLC (NASDAQ:AMRN) is expanding its global reach with partnerships in nine countries, including recent launches in Australia and China.

Negative Points

• Total net revenue decreased significantly from $66.1 million in Q3 2023 to $42.3 million in Q3 2024, primarily due to U.S. market challenges.
• U.S. product revenue declined sharply due to generic competition and changes in coverage by major insurers like CVS.
• Gross margin dropped from 64% to 38% year-over-year, reflecting pricing pressures in the U.S. market.
• The company reported a GAAP net loss of $25.1 million for Q3 2024, up from a $19.3 million loss in the prior year period.
• Amarin Corp PLC (NASDAQ:AMRN) faces ongoing challenges in securing reimbursement and market access in Europe, which is a slow and complex process.

Q & A Highlights

Q: Given the increasing rebating in '24 for VASCEPA, what are your expectations for net pricing pressure going forward in the short term? Are there any additional trials or data points that could enable greater reimbursement coverage for VAZKEPA in the EU and/or China? A: Aaron Berg, Executive Vice President, President - US, stated that the U.S. market has seen increasing rebate pressures due to generic competition, but they have maintained a 50% market share. They expect rebates to continue rising but believe they can still compete profitably. Steven Ketchum, Executive Vice President of R&D and Chief Scientific Officer, added that they are conducting subgroup analyses in high-risk populations to support reimbursement efforts in Europe.

Q: Can you provide some color on the momentum in the rest of the world in terms of revenue, and the growth dynamic in the EU? How do you see the net price for VASCEPA in the U.S. evolving? A: Aaron Berg highlighted that they are in the early stages of launching in several countries, with positive responses in the U.K. and Spain. They are optimistic about growth in these regions. Peter Fishman, Global Controller, noted that in the U.S., they are experiencing pricing pressure due to a shift towards Medicare Part D, which has higher discounts.

Q: What is the status of the share repurchase program, and how are you prioritizing capital? A: Peter Fishman explained that they have approval for a share repurchase program but have not yet initiated it. They are monitoring business and market dynamics to determine the right time. They remain focused on cash optimization and prudent investments.

Q: How are you approaching business development opportunities and potential pipeline assets? A: Aaron Berg emphasized that their current focus is on executing with VAZKEPA and VASCEPA, particularly in Europe, where they see significant growth potential. They are committed to expanding access and will consider additional products in the future.

Q: Can you discuss the impact of recent regulatory approvals in Australia and China? A: Aaron Berg mentioned that in Australia, their partner CSL Seqirus secured a pharmaceutical benefit scheme price listing for VAZKEPA, and they expect sales impact in 2025. In China, their partner Eddingpharm received regulatory approval for VASCEPA, which is a significant milestone given China's large market for cardiovascular products.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.