Total Revenue Increased 39% in Third Quarter 2020 and 56% in First Nine Months of 2020 Compared to Same Periods of 2019 Despite COVID-19 Headwinds
Progress Continues Towards VASCEPA® (icosapent ethyl) Approval and Commercialization in Europe
#AMRN "announced financial results for the three and nine months ended September 30, 2020 and provided an update on company operations.
Key Achievements in Third Quarter 2020 (and recent weeks)
Achieved record quarterly and nine-month revenue levels: Reported $156.5 million in net total revenue in the third quarter of 2020, an increase of 39% compared to the third quarter of 2019, resulting in net total revenue for the first nine months of $446.8 million, an increase of 56% compared to the same period in 2019.
Reaffirmed strategy to continue increasing U.S. promotion of VASCEPA: As reported, the U.S. Court of Appeals for the Federal Circuit upheld the March 2020 U.S. District Court ruling in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to VASCEPA capsules in its initial triglyceride lowering indication. While generic competition could potentially launch in the United States at any time, Amarin continues to expect that with enhanced education and promotional initiatives there is an opportunity to meaningfully grow revenue for VASCEPA in the United States.
Progressed European regulatory review and commercial preparations: Continued to support regulatory review of VASCEPA by the European Medicines Agency (EMA) with the expectation of an early 2021 approval of VASCEPA for commercial sale in Europe. In the process of hiring select people with extensive commercial experience in Europe and preparing for post-approval market access negotiations.
Expanded medical society recommendations in support of the efficacy and safety of VASCEPA: The European Society of Cardiology expanded their guidelines to recommend use of VASCEPA in treating acute coronary syndrome patients. Previously they had recommended use of VASCEPA for treating patients with established cardiovascular disease.
Reported additional VASCEPA clinical results and other data that further define VASCEPA’s multifactorial mechanisms of action, clinical need and effects in reducing cardiovascular risk: EVAPORATE study results reported in August 2020 showed a 17% reduction in coronary plaque over 18 months in patients with established coronary plaque. REDUCE-IT® PCI results presented in October 2020 showed through post hoc subgroup analyses that patients in the REDUCE-IT study who had stenting, bypass or other forms of percutaneous cardiovascular intervention (PCI) experienced significantly reduced rates of ischemic events when treated with VASCEPA. REDUCE-IT RENAL results presented in October 2020 showed, through prespecified and post hoc subgroup analyses, that patients in the REDUCE-IT study who had compromised renal function at baseline prior to treatment with VASCEPA or placebo, experienced higher rates of cardiovascular events than the overall population studied in REDUCE-IT. Additionally, VASCEPA use in the treatment of such patients with baseline decreased renal function resulted in similarly favorable relative risk reductions and numerically greater absolute risk reductions versus placebo in comparison with the overall patient population.
Reaffirmed clinical trial results from study of VASCEPA in China are expected by year end 2020: Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter.
Advanced enrollment in three COVID-19 related pilot studies: Clinical studies of VASCEPA in Argentina, Canada and the United States each reported substantial patient enrollment. These are investigator-initiated studies which Amarin supports but does not manage, and the clinical data being collected from these studies are blinded. Final results from these studies are expected to be available some time in 2021. Mechanistic data continues to provide reasons to believe that VASCEPA could potentially be beneficial to lessen the impact of COVID-19.
Maintained strong cash balance and reduced debt: As of September 30, 2020, Amarin reported total cash and investments of $608.0 million and $9.5 million remaining debt on its royalty-like instrument, which Amarin plans to pay in full during the fourth quarter of 2020.
See press release HERE.
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