Amarin Corporation(US:AMRN)2024-07-31 16:28Financial Data and Key Metrics Changes - Amarin reported total net revenue of $67.5 million in Q2 2024, down from $80.2 million in Q2 2023, with U.S. product revenue declining to $43.8 million from $64.6 million due to lower net selling prices from generic competition [27][28][24] - Gross margin decreased to 48% in Q2 2024 from 64% in Q2 2023, primarily due to the decline in net selling price in the U.S. [30] - GAAP net income was $1.5 million in Q2 2024 compared to a loss of $17.6 million in the prior year [31] Business Line Data and Key Metrics Changes - U.S. product revenue was significantly impacted by generic competition, while European net product revenue increased to $3.5 million, driven by growth in Spain and the UK [27][28] - Licensing and royalty revenue rose to $20 million in Q2 2024 from $15 million in Q2 2023, including a $15 million milestone for cardiovascular risk reduction approval in China [28][29] Market Data and Key Metrics Changes - In the U.S., the company maintained IPE market leadership with approximately 50% market share, despite a decline in revenue due to the loss of a major exclusive contract [24][25] - In Europe, the company is focusing on key markets, with Spain showing robust growth following a successful launch [17][19] Company Strategy and Development Direction - The company is prioritizing execution and performance to maximize the impact of VASCEPA/VAZKEPA globally, with a focus on expanding access in Europe and other international markets [11][13] - A new strategy was implemented in Europe targeting a higher risk subset of patients to accelerate access and reimbursement [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in VASCEPA's potential to address cardiovascular disease, which remains a leading global health issue [10][34] - The company is prepared for ongoing challenges from generic competition and is considering launching an authorized generic to maintain market leadership [26][38] Other Important Information - The company has a strong cash position of $307 million as of June 30, 2024, providing a foundation for future growth [31] - A conditional share repurchase program was established, but no repurchases have been initiated due to current market conditions [32][40] Q&A Session Summary Question: Outlook for U.S. revenues against additional generic competition - Management believes branded VASCEPA will remain the market leader despite the loss of a major exclusive plan, with positive feedback received for 2025 formulary coverage [36][37] Question: Market conditions impacting share repurchase decisions - The decision not to commence share repurchases is due to business and market conditions, with ongoing monitoring of cash generation [39][40] Question: Update on potential delisting from NASDAQ - The company received notice of potential delisting due to trading below $1, but believes operational improvements can help regain compliance [41][42] Question: Recent decision in skinny label litigation - The Federal Circuit reversed a previous decision, allowing the case against Hikma to proceed in District Court [43][44] Question: Market opportunity in China - The cardiovascular risk reduction indication presents a significant market opportunity, with expectations for inclusion in the NRDL by January 1, 2025 [66][67] Question: OpEx flexibility and future spending - The company plans to continue investing in European expansion while monitoring operating expenses, expecting a slight decline in cash for the next quarters [68][69]