DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the quarter and year ended December 31, 2020 and provided an update on company operations.
Recent Key Amarin Achievements:
- Record revenue led by increased VASCEPA® (icosapent ethyl) use in the United States: Annual net total revenue of $614.1 million in 2020, an increase of 43% compared with 2019, consistent with guidance provided at the beginning of 2021. Fourth quarter of 2020 net total revenue was $167.3 million, an increase of 17% compared with the fourth quarter of 2019 and the highest quarterly net total revenue to date.
- Europe launch on-track for 2021: Received a positive opinion from the Committee on Human Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending market authorization in Europe for icosapent ethyl (brand name VAZKEPA® in Europe) for cardiovascular risk reduction.
- Mainland China and Hong Kong approval expected near the end of 2021: As submitted by our partner, Edding, in Mainland China the Chinese National Medical Products Administration (NMPA) has accepted for review icosapent ethyl. On a separate track, in Hong Kong, the Hong Kong Department of Health is evaluating icosapent ethyl. Medical guidelines of the Chinese Society of Cardiology (CSC) updated to recommend use of icosapent ethyl in China.
- Strong balance sheet: Ended 2020 with $563.4 million in total cash and investments and no debt.
“We entered 2021 well positioned to further grow VASCEPA revenue in the U.S. while expanding internationally as we continue to lead the creating of an important new paradigm in preventative cardiovascular care beyond cholesterol management for at-risk patients,” stated John F. Thero, president and chief executive officer. “Our record revenue for the fourth quarter and full year of 2020, despite the headwinds we faced from the COVID-19 pandemic, underscores the large, untapped market need for VASCEPA in its new indication of persistent cardiovascular risk (P-CVR) reduction in the United States. We continue to focus our efforts on increasing awareness and education of P-CVR and VASCEPA’s demonstrated benefits in reducing that risk as proven in the landmark REDUCE-IT® study.”
“The positive CHMP opinion, as recently announced, leads us to expect the European Commission to render its formal approval of VAZKEPA in April 2021. The CHMP opinion and anticipated approval are significant milestones for Amarin that brings us closer to making this important drug available in Europe to millions of patients at high risk of cardiovascular events such as heart attacks and strokes. Our growing commercial team in Europe is advancing commercial launch plans with unbranded engagement, and preliminary market access discussions are underway in certain key markets.”
“Our global expansion plans are being further advanced by the progress of our partner in the China region, Edding, which includes Mainland China, Hong Kong, Macau and Taiwan. Edding is making tremendous progress across several key initiatives critical to the successful approval and launch of VASCEPA in the region, including the positive readout from their pivotal Phase 3 clinical study, inclusion of icosapent ethyl in the treatment guidelines of the CSC, the acceptance of the regulatory filing related to Mainland China with the NMPA and the introduction of VASCEPA in the Hainan Boao Lecheng International Medical Tourism Pilot Zone program. The China region represents a very significant market opportunity and we continue to work closely with Edding in support of their efforts to bring this important therapeutic to the millions of patients in the China region with high triglycerides who are at risk of cardiovascular events.”
“Amarin has a very dynamic year ahead and we expect to achieve a number of potentially value-creating milestones and to advance our leadership in cardiovascular risk reduction,” concluded Mr. Thero.
U.S. Prescription Growth
Normalized prescriptions for VASCEPA (prescription of 120 grams of VASCEPA representing a one-month supply) in the United States increased by approximately 39% and 41% in 2020 compared to the same period in 2019 based on data from Symphony Health and IQVIA, respectively, and increased by 17% and 18% in the fourth quarter of 2020 compared to the same period in 2019, respectively. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 1,159,000 and 1,076,000 in the fourth quarter of 2020, respectively. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 4,484,000 and 4,126,000 in 2020, respectively. While there is no other drug which has the same labeled clinical effects as VASCEPA, prescription growth of VASCEPA in 2020 compared well to the other branded cardiovascular drugs which reported positive cardiovascular outcomes study results in recent years.
Following a temporary suspension of in-person promotional activities in March 2020 due to the COVID-19 pandemic and quarantine in the United States, in June 2020 Amarin resumed field-based, face-to-face interactions with healthcare providers, to the extent such healthcare providers allow. For the second half of 2020, substantially all of the company’s field force personnel had the ability to resume face-to-face customer interactions, though such interactions became more challenging in the fourth quarter of 2020 with the resurgence of COVID-19. While Amarin utilizes various means to interact with healthcare professionals virtually and digitally, such interactions tend to be less impactful than frequent in-person communications. This is particularly true for VASCEPA, as it is being newly introduced to many healthcare professionals as a treatment for cardiovascular risk reduction based on its second FDA indication, which had launched in January 2020.
Complications in 2020 from COVID-19 were exacerbated as many at-risk patients in 2020 delayed doctors’ visits and blood tests. In the United States, public reports from IQVIA showed patient visits to medical offices for non-emergency medical care were down approximately 70% in April 2020 during the height of the COVID-19 quarantine, with visits increasing thereafter until the resurgence of COVID-19 in the fourth quarter of 2020 when, for example, patient visits in December 2020 again decreased to approximately 50% of pre-COVID-19 levels. As a result of fewer doctors’ visits, fewer lab tests and prioritization of COVID-19 safety, reports in 2020 showed an increase in heart attacks and other urgent cardiovascular events which might have been avoided through preventative cardiovascular risk management. Amarin remains confident that the patient need for VASCEPA in the United States remains high and that as COVID-19 begins to recede, VASCEPA growth will be positioned to accelerate as more patients seek routine doctor visits and lab tests and as our promotional activities become less restricted.
In November 2020, a generic version of VASCEPA was launched in the United States, and that generic drug is indicated only as an adjunct to diet for lowering triglyceride levels in adult patients with severe hypertriglyceridemia (TG ?500 mg/dL), which based on industry data, represents no more than approximately 7% of recent VASCEPA usage and a smaller proportion of the overall market opportunity for VASCEPA. The “skinny label” of this generic product represents no more than approximately $40 million of Amarin’s net product revenue at 2020 prescription levels. The indication for this generic product is limited and we have filed a lawsuit to protect our cardiovascular risk reduction patent rights against what we believe is unlawful infringement by Hikma Pharmaceuticals PLC and a representative healthcare insurance company. Thus far, growth of the generic product has reportedly been limited by lack of qualified supply capacity. Other generic versions of VASCEPA have FDA approval to launch in the United States but have thus far not done so.
In late 2020 and early 2021, various managed care companies improved their insurance coverage of branded VASCEPA. In addition, many insurance companies and patients have reported that branded VASCEPA is less expensive to them than the generic version and the wholesale acquisition cost of branded VASCEPA continues to be lower than that of other branded drugs with positive outcomes study results. In these and other ways, this is an atypical generic launch in the United States. Amarin believes the untapped market opportunity in the cardiovascular risk reduction indication is large and that more patients will be helped by VASCEPA with continued investment in market education regarding its benefits. Amarin’s goal is to grow the market faster than generic competition can take share. Amarin intends to vigorously defend its intellectual property rights.
European Market Expansion
Amarin is seeking to commence commercial sale of VAZKEPA in one or more countries of Europe before the end of 2021. On January 28, 2021, Amarin received a positive CHMP opinion, which recommended marketing authorization be granted for icosapent ethyl in the European Union for cardiovascular risk reduction under the brand name VAZKEPA. Approval of VAZKEPA for marketing and sale by the European Commission is expected in April 2021. The need for preventative cardiovascular care beyond cholesterol management is potentially as large or larger in Europe than the United States.
Market access in Europe is managed on a country-by-country basis and, consequently, the timing for receiving market access for each European country will vary significantly. Amarin is planning a staged launch in Europe, including likely launch in 2021 in Germany, Europe’s largest market. In preparation for commercial launch, Amarin’s team in Europe has increased to approximately 50 experienced professionals and is targeted to increase to approximately 200 employees by the end of 2021. Additional information regarding securing market access in Europe and Amarin’s commercialization plans in Europe can be found in the FAQ section under investor relations at www.amarincorp.com.
Rest of World
In November 2020, Amarin’s partner in the China region, Edding, shared positive, statistically significant top line results from their Phase 3 clinical trial of VASCEPA. In December 2020, the CSC included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. In January 2021, VASCEPA was accepted for introduction into the Hainan Boao Lecheng International Medical Tourism Pilot Zone program. Most recently, in Mainland China, the Chinese National Medical Products Administration (NMPA) accepted for review the New Drug Application for VASCEPA. Edding currently anticipates receiving a decision in Mainland China and, separately in Hong Kong, near the end of 2021, followed by steps to ensure that this unique therapy is reimbursed in the major provinces of Mainland China as the first and only drug for its important potential indication for use based on VASCEPA’s demonstrated clinical results. With approximately 180.4 million hypertriglyceridemia (HTG) patients in Mainland China in 2019, representing approximately 20.2% of the adult population and broad use of statin therapy in the country, the medical need for VASCEPA in Mainland China is believed to be high creating a meaningful market opportunity for Amarin and its partner, Edding.
Canada, Middle East and Other
Cardiovascular disease is a growing public health burden globally. Amarin has elected to pursue VASCEPA approval in limited countries initially with plans to seek regulatory approvals in other geographies after the product is launched and has market access in Europe. Limited exceptions are in select countries of the Middle East and in Canada where promotion of VASCEPA has commenced in a phased manner.
Net total revenue for the three and twelve months ended December 31, 2020 were $167.3 million and $614.1 million, respectively, compared with $143.3 million and $429.8 million in the corresponding periods of 2019, indicating increases of 17% and 43%, respectively. Net product revenue for the three and twelve months ended December 31, 2020 were $165.9 million and $607.0 million, respectively, compared to $142.0 million and $427.4 million in the corresponding periods of 2019, indicating increases of 17% and 42%, respectively. The increases in net product revenue were driven primarily by increased volume of VASCEPA sales to customers in the United States, as well as a modest increase in VASCEPA’s net selling price in the United States, reflecting various factors including managed care coverage improvements. The increase was also driven by VASCEPA sales outside of the United States of approximately nil and $8.9 million during the three and twelve months ended December 31, 2020 as compared to $0.4 million and $0.7 million during the three and twelve months ended December 31, 2019, primarily as a result of an initial order in the first half of 2020 to ensure adequate product supply for Amarin’s commercial partner’s launch of VASCEPA in Canada (recognized upon shipment by Amarin to our partner).
Amarin recognized licensing and royalty revenue of approximately $7.0 million and $2.4 million for the years ended December 31, 2020 and 2019, respectively, from VASCEPA-related commercial progress of our partners in Canada, the China region and the Middle East.
Cost of goods sold for the three and twelve months ended December 31, 2020 was $34.8 million and $131.4 million, respectively, compared to $30.7 million and $96.0 million in the corresponding periods of 2019. Amarin’s overall gross margin on net product revenue for the quarter and year ended December 31, 2020 was 79% and 78%, respectively, compared to 78% in the quarter and year ended December 31, 2019, respectively.
Selling, general and administrative expenses for the year ended December 31, 2020 was $463.3 million compared with $323.6 million, in the prior year. This increase was primarily due to personnel costs related to the U.S. sales force expansion and European commercial launch preparations. The increase also included an increase in other promotional activities in the United States focused on cardiovascular risk reduction based on VASCEPA’s new label. The level of such promotional activities varied from quarter-to-quarter in 2020 with decreases resulting when the impact of COVID-19 was most pronounced.
Research and development expenses for the years ended December 31, 2020 and 2019 were $39.0 million and $34.4 million, respectively. This increase reflects support of numerous publications regarding results of the REDUCE-IT cardiovascular outcomes study, costs and fees related to regulatory reviews of VASCEPA, particularly in Europe, together with costs associated with exploratory development, including costs of pilot studies of VASCEPA for other potential uses such as the potential use of VASCEPA as a therapy to help mitigate patient risks and symptoms of COVID-19.
Under U.S. GAAP, Amarin reported a net loss of $18.0 million for the year ended December 31, 2020, or basic and diluted loss per share of $0.05. This net loss included $45.8 million in non-cash stock-based compensation expense. For the year ended December 31, 2019, Amarin reported a net loss of $22.6 million, or basic and diluted loss per share of $0.07. This net loss included $30.9 million in non-cash stock-based compensation expense.
Excluding non-cash stock-based compensation expense, non-GAAP adjusted net income was $27.8 million for the year ended December 31, 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.07, compared to non-GAAP adjusted net income of $8.3 million for the year ended December 31, 2019, or non-GAAP adjusted basic and diluted earnings per share of $0.02.
As of December 31, 2020, Amarin reported aggregate cash and investments of $563.4 million, consisting of cash and cash equivalents of $187.0 million and liquid short-term and long-term investments of $314.0 million and $62.5 million, respectively. As of December 31, 2020, Amarin reported $154.6 million in net accounts receivable ($203.9 million in gross accounts receivable before allowances and reserves) and $188.9 million in inventory. Furthermore, the final royalty-like debt payment was made during the fourth quarter of 2020, which previously had been 10% of net product revenue since VASCEPA was launched, resulting in Amarin having no debt.
As of December 31, 2020, Amarin had approximately 392.5 million ADSs and ordinary shares outstanding, nil common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 16.7 million equivalent shares underlying stock options at a weighted-average exercise price of $8.00, as well as 7.7 million equivalent shares underlying restricted or deferred stock units.
Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
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.1 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.3 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
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (?500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, approval is anticipated in April 2021 following the January 28, 2021 favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA®.