Amarin Corporation plc (NASDAQ:AMRN) Q3 2021 Earnings Conference Call November 3, 2021 7:30 AM ET Company Participants Michael Kalb - CFO Karim Mikhail - President, CEO & Director Conference Call Participants Yasmeen Rahimi - Piper Sandler & Co. Roanna Ruiz - SVB Leerink Michael Yee - Jefferies Louise Chen - Cantor Fitzgerald & Co. Paul Choi - Goldman Sachs Group Jessica Fye - JPMorgan Chase & Co. Operator Welcome to Amarin Corporation's conference call to discuss its third quarter and 9 months 2021 financ ...

Summary of Amarin Corporation plc Conference Call Company Overview - **Company**: Amarin Corporation plc (NASDAQ:AMRN) - **Industry**: Biopharmaceuticals, specifically focusing on cardiovascular disease treatment Key Points and Arguments 1. **Market Context**: Cardiovascular disease is a significant global health issue, with a long-standing burden on healthcare systems, comparable to the COVID-19 pandemic [2][3] 2. **Unique Positioning**: Amarin's VASCEPA is the first and only approved medication that reduces cardiovascular risk beyond LDL lowering, as demonstrated in the REDUCE-IT study [5][6] 3. **Clinical Evidence**: The REDUCE-IT study showed that the majority of the benefits from VASCEPA come from anti-inflammatory effects rather than triglyceride lowering, challenging previous assumptions [7] 4. **Comparison with Competitors**: VASCEPA requires fewer patients to treat to achieve cardiovascular benefits compared to other therapies, highlighting its efficacy and cost-effectiveness [8] 5. **Regulatory Approvals**: VASCEPA received unanimous FDA approval and EMA approval, with a broad label aligned with REDUCE-IT findings [6] 6. **Market Strategy**: Amarin is focusing on expanding its presence in the U.S. and Europe, with a new go-to-market strategy to reignite growth in the U.S. market [10][21] 7. **Revenue Performance**: In the first half of 2021, Amarin generated approximately $300 million in revenue in the U.S., despite challenges from generic competition [12] 8. **Generic Competition**: Limited penetration of generics in the cardiovascular risk indication, with ongoing legal efforts to protect VASCEPA's market position [15][19] 9. **Digital Engagement**: The company is enhancing its marketing strategy by incorporating digital channels to reach physicians more effectively, especially post-COVID [18][20] 10. **International Expansion**: Amarin is launching VASCEPA in Europe and targeting additional international markets, with a focus on regulatory approvals in countries like Canada, China, and various Latin American nations [13][26][27] 11. **Pricing Strategy**: The price for VASCEPA in Europe is set at €200 or $240 per month, with expectations for net pricing to be comparable or higher than in the U.S. [22][28] 12. **Long-term Vision**: Amarin aims to create value through portfolio diversification and partnerships, leveraging its commercial infrastructure and R&D capabilities [11][30] Additional Important Content - **Physician Engagement**: The company is working to improve physician access and education, recognizing that many physicians were inaccessible during the pandemic [17] - **Market Exclusivity**: Amarin has a 10-year regulatory exclusivity in Europe for the cardiovascular risk indication, which is crucial for pricing and market positioning [13][22] - **Scientific Leadership**: Engagement with leading medical societies is critical for building awareness and support for VASCEPA [25][29] This summary encapsulates the key insights from the conference call, highlighting Amarin's strategic positioning, market challenges, and growth opportunities in the biopharmaceutical landscape focused on cardiovascular health.

Financial Data and Key Metrics Changes - The company reported net total revenue for Q2 2021 of $154.5 million, an increase from $135.3 million in Q2 2020, representing a growth of approximately 14.5% [10] - For the first six months of 2021, net product revenue was $295.2 million, a 3% increase compared to the same period in 2020 [39] - The U.S. VASCEPA franchise remains profitable, supporting growth and expansion plans despite the ongoing impact of the COVID-19 pandemic and generic competition [10][39] Business Line Data and Key Metrics Changes - The majority of revenue growth is attributed to U.S. product sales of VASCEPA, which is the only FDA-approved product for cardiovascular risk reduction in at-risk patients [10][39] - The company noted that generic penetration in the market is around 12%, which is lower than expected for a typical product facing generic competition [18] Market Data and Key Metrics Changes - A Harris Poll indicated that approximately one-third of the general adult population avoided in-person healthcare visits due to COVID-19, impacting new prescriptions for VASCEPA [11] - The company anticipates significant opportunities for growth as vaccinations increase and COVID-19 recedes, allowing for greater patient engagement [12] Company Strategy and Development Direction - The overarching goal is to drive profitable growth by unlocking the potential of VASCEPA and VAZKEPA to reduce cardiovascular risk globally [9] - The company plans to enhance its digital omnichannel platforms to improve customer engagement and drive awareness of VASCEPA [13] - In Europe, the company aims to establish a presence in 15 countries and has submitted market access dossiers in key markets including the UK, France, Italy, and Denmark [19][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of VASCEPA in the U.S. despite the entry of generics, emphasizing the need for continued education about the product's benefits [18] - The company is preparing for a launch in Germany in September 2021, with a focus on maximizing VAZKEPA's reach and profitability on a country-by-country basis [20][24] - Management acknowledged the challenges posed by COVID-19 but remains optimistic about the recovery and growth opportunities in the second half of 2021 [12][39] Other Important Information - The company has a strong balance sheet with aggregate cash investments of $523.1 million as of June 30, 2021, which is deemed sufficient to fund projected operations and the European launch [41] - The company is actively pursuing partnerships for international expansion, particularly in markets outside the U.S. and Europe [62] Q&A Session Summary Question: Can you discuss the proposed list price and the timing of securing it in various regions? - Management indicated that the proposed list price is a starting point for negotiations in Europe, with specific mechanics varying by country [45][46] Question: How is the company performing against generics, and what are the supply chain dynamics? - Management noted that the U.S. team has retained 88% of the market despite two generics, attributing this to inconsistent supply from generic competitors and effective educational efforts [46][48] Question: Can you provide details on the additional dossiers filed and the pricing negotiations? - Four dossiers have been submitted, with the German dossier ready for submission prior to the launch, and different countries have varying negotiation timelines [51][53] Question: Where will the incremental $1 billion in revenues come from? - The incremental revenue is expected from pursuing additional markets outside the U.S. and Europe, including Australia, New Zealand, and select Latin American and Asian countries [60][62] Question: What are the expectations for expenses in the U.S. moving forward? - Management emphasized the need for selective investments and a focus on profitability while balancing growth initiatives in the U.S. and Europe [68][69] Question: Will the net selling price decline in the second half of the year? - Management indicated that while the net price has been stable, there may be opportunistic adjustments to protect managed care access, but this is not expected to be a consistent trend [70][72]