Amarin Provides Preliminary 2020 Results and 2021 Outlook
January 07, 2021 at 06:05 AM EST
Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019
Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® (icosapent ethyl) Expected in Late January or February 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided a business update, including preliminary unaudited full-year 2020 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 39th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present on Tuesday, January 12, 2020, at 2:00 pm Eastern time.
Preliminary (unaudited) 2020 Financial Results
Record Revenue Levels: Full-year 2020 total net revenue, subject to audit, are expected to be approximately $610 million. Despite the impact of COVID-19, this estimated 2020 net revenue expectation represents an increase of approximately 42% compared with full-year 2019 results. This growth was primarily driven by increased prescription levels of VASCEPA® in the United States.
Liquid Assets: Amarin ended 2020 with more than $550 million in cash and investments, approximately $150 million in net accounts receivable and approximately $180 million in inventory.
No Debt: At year-end 2020, Amarin had no debt, having fully repaid its prior royalty-like debt instrument in the fourth quarter of 2020, which from 2013 through most of 2020 required approximately 10% of net revenue to be paid against this prior obligation.
Highlights from 2020 and Outlook
Amarin achieved a number of important commercial milestones in 2020, despite the challenges Amarin faced with COVID-19 and the November launch of generic icosapent ethyl in the United States.
U.S. commercial highlights from 2020 include:
U.S. commercial outlook includes:
Europe highlights from 2020 include:
Europe outlook includes:
Rest of World
Rest of world, or ROW, highlights from 2020 include:
ROW outlook includes:
R&D and Medical Advancement
R&D and medical advancement highlights from 2020 include:
R&D and medical outlook includes:
Amarin reiterates that it believes its current cash resources are adequate to support the European launch and its planned operations and priorities in the United States and globally. Such guidance included anticipated resources likely needed to further expand its VASCEPA supply capacity in anticipation of launches of VASCEPA in Europe, China and other countries as well as the opportunity to continue to grow prescription levels in the United States after COVID-19 recedes, continuing the launch of VASCEPA for P-CVR as commenced in 2020.
Currently, Amarin anticipates 2021 operating expenses of approximately $550 million to $600 million which represents an increase of approximately 10% to 20%, compared with 2020 levels. Included in these anticipated expenses are increased costs associated with Amarin’s commercial launch preparations and initial launch in Europe as well as continued U.S. promotional activities, including increased face to face interactions between Amarin’s sales professionals and health care providers and direct-to-consumer advertising in the U.S. after the impact of COVID-19 becomes less pronounced and at-risk patients begin returning to their doctors for non-urgent medical care. With continued investment in consumer and in-person marketing, Amarin expects VASCEPA revenue growth in the U.S. As described above, these spending levels may vary from quarter to quarter. Further these operating expense levels assume substantial societal recovery in 2021 from COVID-19 and the continued limited availability of supply to the generic companies. Amarin will re-evaluate its planned spend in 2021 if any of these assumptions change.
More Information to Follow
Amarin expects to provide further details regarding its 2020 results and perspective regarding its future outlook in the company's annual report on Form 10-K.
About Cardiovascular Risk
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4,5
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Availability of Other Information About Amarin
Amarin Contact Information