DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 03, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the third quarter and nine months ended September 30, 2021 and provided an update on Company operations.
Recent Key Amarin Highlights:
- Topline Financial Results: Total net revenue for the three and nine months ended September 30, 2021 were $142.0 million and $438.7 million, respectively, compared to $156.5 million and $446.8 million in the corresponding periods of 2020, respectively, indicating decreases of 9% and 2%, respectively. Net product revenue for the three and nine months ended September 30, 2021 were $141.4 million and $436.6 million, respectively, compared to $155.2 million and $441.1 million in the corresponding periods of 2020, respectively, indicating decreases of 9% and 1%, respectively. In the U.S., based on data from Symphony Health, Amarin retained approximately 83% and 87% of the icosapent ethyl market in the three and nine months ended September 30, 2021, respectively, with approximately one year of generic presence in the market.
- Launched VAZKEPA (icosapent ethyl) in Europe: Amarin launched VAZKEPA in Germany as a treatment to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.i Amarin is deploying a distinct digitally native omnichannel approach to marketing VAZKEPA in Europe, which is supported by an approximately 150-person commercial field force in Germany and further Medical and Commercial teams in all major markets. In addition, the Company today announced the successful submission of market access dossiers for reimbursement in ten major countries in Europe.
- Introduced new Go-to-Market Strategy for VASCEPA® (icosapent ethyl) in U.S.: The new Go-to-Market strategy is designed to accelerate growth of VASCEPA in the U.S., with plans focused on expanding healthcare professional reach and engagement through a new digital omnichannel platform, driving further enhancements in managed care access and optimizing VASCEPA prescriptions for cardiovascular (CV) risk reduction.
- Executing International Expansion Strategy: Amarin announced plans to initiate regulatory filing and review processes and obtain approvals in several additional countries in 2022 as part of its global growth strategy to reach the top 50 cardiometabolic markets in the world.
- VASCEPA/VAZKEPA Added to Two Additional Medical Societies’ Clinical Treatment Guidelines or Position Statements: VASCEPA/VAZKEPA is now included in more than 20 medical societies’ clinical treatment guidelines or position statements. Click here for more information on the guidelines.
- New Senior Executive Further Strengthens Leadership Team: As of August 19, 2021, Jason Marks was appointed senior vice president, chief legal officer & corporate secretary, succeeding Joseph Kennedy who retired as general counsel, effective August 2021.
- Strong Balance Sheet: Ended third quarter 2021 with $517.9 million in total cash and investments and no debt.
Management Commentary
“During the third quarter we made important strides toward our goal to bring the CV risk reduction benefits of VASCEPA/VAZKEPA to at-risk patients around the world,” stated Karim Mikhail, president and chief executive officer of Amarin. “We are delighted with the launch of VAZKEPA in Germany in mid-September and to report that we have submitted market access dossiers for VAZKEPA in ten major countries in Europe ahead of our year end timeline. These filings form the foundation for pricing negotiations and, ultimately, for the launch of VAZKEPA in multiple other European countries throughout 2022.
“Importantly, we introduced a new Go-to-Market strategy in the U.S. that is designed to significantly expand reach and engagement with our target audiences through multiple digital omnichannels in order to increase awareness of and drive demand for VASCEPA in its CV risk reduction indication. In tandem, we are optimizing VASCEPA prescriptions in this indication by addressing factual errors by certain stakeholders in the prescribing ecosystem to reduce generic substitution for non-indicated uses. We have secured significant, positive managed care access for VASCEPA, but we continue working to enhance that access by further removing barriers and reducing patient out-of-pocket costs for VASCEPA prescriptions.
“Our global growth strategy in the near-term remains steadfast: expand the markets for VASCEPA/VAZKEPA in Europe and around the world and grow the U.S. market for VASCEPA through our new Go-to-Market initiatives. We are well positioned to deliver on our commitment to reduce the occurrence of the debilitating and deadly effects of cardiovascular disease by bringing the CV risk reduction benefits of VASCEPA/VAZKEPA to patients globally, while building value for our stakeholders,” concluded Mr. Mikhail.
Europe
In September 2021, Amarin launched VAZKEPA in Germany with a scientific conference that was led by eleven internationally renowned cardiovascular specialists and was attended by more than 200 healthcare professionals from Germany, with a live stream to many more physicians across the continent. The commercial team has made great strides introducing the cardioprotective benefits of VAZKEPA to the German market with 60 events hosted to date and more than 50 events approved and ready to execute before year-end. As Germany is the largest economy in Europe, and there are more than 300,000 deaths due to cardiovascular disease (CVD) in Germany every yearii, it represents both a significant market need and opportunity.
Amarin has filed market access dossiers for reimbursement in ten European countries, including Germany, the United Kingdom, France, Italy, Spain, Denmark, Sweden, Finland, Norway and the Netherlands. Amarin expects to file several additional dossiers in various other European countries throughout 2022. The submitted filings include health economic data demonstrating the uniqueness of VAZKEPA from a scientific perspective, various country-specific demographic data sets to define the eligible patient population based on the drug’s approved label, and proposed pricing of approximately €200 or U.S. $240 per month. Amarin is seeking pricing it believes is well justified based on the demonstrated clinical effectiveness of VAZKEPA and the high economic burden of heart attacks, strokes and other adverse cardiovascular events, the risk of which VAZKEPA is proven to reduce.
U.S. Icosapent Ethyl Market
The icosapent ethyl market in aggregate, consisting of branded and generic product, increased for the three months ended September 30, 2021 by approximately 11% as compared to the same period in 2020, based on data from Symphony Health. Based on data from Symphony Health, VASCEPA captured approximately 83% of the total icosapent ethyl normalized prescriptions for the three months ended September 30, 2021.
Two generic versions of VASCEPA have launched in the U.S., both of which are indicated only as an adjunct to diet for lowering triglyceride levels in adult patients with severe hypertriglyceridemia (TG ≥500 mg/dL), which represents a limited patient population. Amarin has filed a lawsuit to defend its cardiovascular risk reduction patent rights against what it believes to be unlawful infringement by a company sponsoring a generic product and a healthcare insurance company that Amarin believes has likewise infringed on its rights.
The COVID-19 Delta Variant caused a resurgence of positive COVID cases, which peaked in the third quarter of 2021. According to IQVIA, this resulted in a decrease in patient office visits of approximately 6% and lab tests of approximately 7% as compared with the same period of 2020. We expect that continued recovery from COVID-19 will further contribute to future market growth.
International Market Expansion
Amarin is gaining traction in its goal to unlock the potential of VASCEPA/VAZKEPA internationally. The Company plans to file three waves of regulatory submissions for approval of VASCEPA/VAZKEPA in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA/VAZKEPA. Amarin today announced plans to initiate the first wave of regulatory filings in several countries in 2022, including Australia, New Zealand and Israel. With approvals in the U.S. and Europe, and backed by the results from the global REDUCE-IT® long-term CV outcomes study, Amarin has significant clinical data to support these filings. In total, this expansion across an additional 20 markets has the potential to add a significant number of patients who can benefit from VASCEPA, which Amarin believes represents a market opportunity in excess of $1 billion.1
In early 2021, in Mainland China, the Chinese National Medical Products Administration (NMPA) accepted for review the New Drug Application (NDA) for VASCEPA. In addition, the medical guidelines of the Chinese Society of Cardiology were updated to recommend use of icosapent ethyl in China as a treatment consideration to further lower atherosclerotic cardiovascular disease ASCVD in the appropriate patient population. Edding, Amarin’s marketing partner in China, expects to receive a decision on the NDA in Mainland China and, separately, in Hong Kong near the end of 2021. Following approval, Edding will undertake the process 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 use based on VASCEPA’s demonstrated clinical results.
In August 2021, Amarin’s partner in Canada, HLS Therapeutics (HLS), announced a promotional agreement with Pfizer, which addresses the expansion of VASCEPA promotion to the primary care physician (PCP) audience in Canada. HLS will retain responsibility over VASCEPA’s commercialization and will continue to record all revenue related to VASCEPA sales in Canada.
Financial Update
Total net revenue for the three and nine months ended September 30, 2021 were $142.0 million and $438.7 million, respectively, compared to $156.5 million and $446.8 million in the corresponding periods of 2020, respectively, indicating decreases of 9% and 2%, respectively. Net product revenue for the three and nine months ended September 30, 2021 were $141.4 million and $436.6 million, respectively, compared to $155.2 million and $441.1 million in the corresponding periods of 2020, respectively, indicating decreases of 9% and 1%, respectively. The decrease in net product revenue and total net revenue for the three months ended September 30, 2021 was driven primarily by decreased volume of VASCEPA sales to customers in the U.S.
In addition, total net revenue includes licensing and royalty revenue of approximately $0.6 million and $2.1 million in the three and nine months ended September 30, 2021, which compares with licensing and royalty revenue of approximately $1.3 million and $5.7 million in the three and nine months ended September 30, 2020, respectively, under agreements for the commercialization of VASCEPA outside the U.S.
Cost of goods sold for the three and nine months ended September 30, 2021 was $30.2 million and $90.7 million, respectively, compared to $33.1 million and $96.7 million in the corresponding periods of 2020, respectively. Amarin’s overall gross margin on net product revenue for both the three and nine months ended September 30, 2021 was 79%, compared to 79% and 78% for the three and nine months ended September 30, 2020, respectively.
Selling, general and administrative (SG&A) expense for the three and nine months ended September 30, 2021 were $103.0 million and $316.0 million, respectively, compared to $120.2 million and $346.5 million, respectively, in the corresponding periods of 2020, representing a decrease of 14% and 9% for the same three and nine month periods one year ago. The decreases were due primarily to reduced promotional initiatives when compared to the same periods in the prior year.
Research and development (R&D) expense for the three and nine months ended September 30, 2021 were $7.8 million and $23.6 million, respectively, compared to $10.2 million and $30.5 million, respectively, in the corresponding periods of 2020, representing decreases of 23%, respectively. These decreases were primarily driven by the completion of certain activities related to the REDUCE-IT cardiovascular outcomes trial and the reversal of expense for certain performance-based awards that were no longer deemed probable.
Under U.S. GAAP, Amarin reported a net loss of $13.2 million in the three months ended September 30, 2021, or basic and diluted loss per share of $0.03, which included $10.4 million in non-cash stock-based compensation expense and $14.1 million in restructuring expense. In comparison, Amarin reported a net loss of $6.8 million in the three months ended September 30, 2020, or basic and diluted loss per share of $0.02, which included $11.6 million in non-cash stock-based compensation expense. The company expects financial results regarding net income or net loss to be variable through the balance of 2021 and into 2022.
Under U.S. GAAP, Amarin reported a net loss of $7.0 million in the nine months ended September 30, 2021, or basic and diluted loss per share of $0.02, which included $26.8 million in non-cash stock-based compensation expense and $14.1 million in restructuring expense. For the nine months ended September 30, 2020, Amarin reported a net loss of $22.9 million, or basic and diluted loss per share of $0.06, which included $34.3 million in non-cash stock-based compensation expense.
Excluding non-cash gains or losses for stock-based compensation and restructuring expense, non-GAAP adjusted net income was $11.4 million for the third quarter of 2021, or non-GAAP adjusted basic and diluted earnings per share of $0.03, compared to non-GAAP adjusted net income of $4.8 million for the third quarter of 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.01.
Excluding non-cash gains or losses for stock-based compensation and restructuring expense, non-GAAP adjusted net income was $34.0 million for the nine months ended September 30, 2021, or non-GAAP adjusted basic and diluted earnings per share of $0.09 and $0.08, respectively, compared to non-GAAP adjusted net income of $11.4 million for the nine months ended September 30, 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.03.
As of September 30, 2021, Amarin reported aggregate cash and investments of $517.9 million, consisting of cash and cash equivalents of $222.9 million and liquid short-term and long-term investments of $256.3 million and $38.8 million, respectively. The Company believes its current resources are sufficient to fund projected operations including ongoing promotion of VASCEPA in the U.S. and a successful commercial launch of VAZKEPA in Europe.
As of September 30, 2021, Amarin had approximately 395.6 million American Depository Shares (ADSs) and ordinary shares outstanding approximately 19.1 million equivalent shares underlying stock options at a weighted-average exercise price of $7.38 and 10.3 million equivalent shares underlying restricted or deferred stock units.
About Amarin
Amarin is an 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 rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as 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.
