Amarin Corporation(AMRN) - 2021 Q2 - Earnings Call Transcript

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]