Amarin Reports Second Quarter and Six Month 2021 Financial Results and Provides Business Update

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the second quarter and six months ended June 30, 2021 and provided an update on company operations.

Recent Key Amarin Highlights:

  • Second Quarter Revenue: Net total revenue in the second quarter of 2021 was $154.5 million, an increase of 14% when compared with $135.3 million in total net revenue during the prior year period. Net product revenue for the three months ended June 30, 2021 was $153.8 million, an increase of 15% when compared with the net product revenue in the prior year’s second quarter. In the U.S., based on data from Symphony Health, Amarin retained approximately 89% of the icosapent ethyl market in the first half of 2021, with approximately eight months of generic presence in the market.
  • On Track for European Launch: Amarin plans to launch VAZKEPA in Germany in September and has filed several market access dossiers in Europe with proposed pricing of approximately €200 per month.
  • Received Marketing Authorization for VAZKEPA in Great Britain: Amarin received market authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) for VAZKEPA in Great Britain as a treatment to reduce the risk of cardiovascular (CV) events in high CV risk statin-treated adult patients.
  • Executing Global Expansion Strategy: Amarin plans to initiate regulatory approval processes in approximately 20 additional countries in order to reach the top 50 cardiometabolic markets in the world.
  • VASCEPA®/VAZKEPA Added to Four Medical Societies’ Clinical Treatment Guidelines or Position Statements: VASCEPA is now included in 19 medical societies’ clinical treatment guidelines or position statements, including the recent addition of VASCEPA to the “2021 Expert Consensus Decision Pathway on the Management of Patients with Persistent Hypertriglyceridemia for Atherosclerotic Cardiovascular Disease (ASCVD) Risk Reduction” issued by the American College of Cardiology. Click here for more information on the guidelines.
  • New Senior Leadership to Support Further Growth: As of August 1, 2021, Karim Mikhail succeeded to the president and chief executive officer position following the planned retirement of his predecessor, John F. Thero. In addition, the company appointed Laurent Abuaf as senior vice president, president of Europe.
  • Strong Balance Sheet: Ended second quarter 2021 with $523.1 million in total cash and investments and no debt.

Management Commentary

“Amarin enters the second half of 2021 well positioned to deliver on our goals to reignite growth of branded VASCEPA in the U.S., to successfully launch VAZKEPA in Europe and to undertake initiatives to expand its growth in other important geographies,” stated Karim Mikhail, president and chief executive officer of Amarin. “We believe that this additional expansion represents an incremental market potential in excess of $1 billion that we are confident we can access as there are millions of at-risk patients who could benefit from VASCEPA/VAZKEPA.”

“There continues to be a steady flow of scientific and clinical evidence in support of the cardioprotective benefits of VASCEPA/VAZKEPA presented at key global medical meetings.  Later this month, we look forward to the European Society of Cardiology, where VAZKEPA will be featured in a series of oral and poster presentations by key opinion leaders before an audience of leading cardiologists. We are particularly pleased that our product launch in Germany will take place shortly after this important congress.

“Our strategy for reducing the occurrence of the debilitating and deadly effects of cardiovascular disease is sound and we are executing our global plans to efficiently reach physicians, payors, pharmacists and patients. We are transforming our go-to-market model to enhance customer engagement while executing a variety of promotional and educational programs to increase awareness of the cardiovascular risk reduction benefits of our unique therapy. We expect these efforts will build demand for and drive adoption of VASCEPA/VAZKEPA in the U.S. and Europe,” concluded Mr. Mikhail.

U.S. Prescription Growth

Normalized prescriptions for VASCEPA (prescription of 120 grams of VASCEPA representing a one-month supply) in the United States were flat according to data from Symphony Health and increased by approximately 2% during the second quarter 2021 compared to the same period in 2020 based on data from IQVIA. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 1,086,000 and 1,015,000 in the second quarter of 2021, respectively, compared with 1,089,000 and 998,000 in the second quarter of 2020, respectively. The icosapent ethyl market in aggregate, consisting of branded and generic product, increased for the three months ended June 30, 2021 by approximately 13% as compared to the three months ended June 30, 2020, based on data from Symphony Health. Revenue recognition, which is based on control of the product transferring to customers, and levels of prescriptions as estimated by third parties, often do not directly correlate, particularly over relatively short periods of time such as a fiscal quarter.

Amarin remains confident that the patient need for VASCEPA in the United States remains high and that, as the negative impact of COVID-19 on patient visits and lab tests recedes, 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.

Two generic versions of VASCEPA have launched in the United States, 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 the Company believes has likewise infringed on its rights. Based on data from Symphony Health, VASCEPA captured approximately 88% of the total icosapent ethyl normalized prescriptions for the three months ended June 30, 2021.

Europe

After receiving marketing authorization for VAZKEPA in Europe by the European Commission and in Great Britain by the MHRA, Amarin has filed market access dossiers in four out of ten planned first wave European country submissions. The dossiers were filed in the United Kingdom, France, Italy and Denmark. The German dossier is ready for submission just prior to the launch date in September 2021. These dossiers are an important component for successful product launch as they support pricing and reimbursement, a key determining factor in market penetration. The submitted filings include 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 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 cardiovascular events, which VAZKEPA can help avoid.

Global Market Expansion

Amarin’s goal is to unlock the potential of VASCEPA by bringing the cardioprotective benefits of VASCEPA/VAZKEPA to patients worldwide. The Company plans to access 20 additional countries to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA. In these territories which include Australia, New Zealand, key Latin American markets, and select Asian markets, Amarin will initiate regulatory filing processes in the coming months and year. With approvals in the U.S. and Europe and backed by the global REDUCE-IT study outcomes, Amarin has the clinical data to support these filings and expects regulatory submissions and approval decision times to range from six to eighteen months depending on the region. This expansion 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.

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 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 indication for use based on VASCEPA’s demonstrated clinical results.

New Leadership to Support Further Growth

Amarin significantly enhanced its senior leadership team with the promotion of Mr. Mikhail to president and chief executive officer on August 1, 2021. Mr. Mikhail has a successful track-record of leading significant growth of cardiovascular and other franchises with Merck for 22 years, where he served in leadership roles in seven countries across three continents and where he led Merck’s multibillion-dollar lipid franchise among other senior management positions.

In addition, the Company announced the appointment of Laurent Abuaf as the new senior vice president and president of Europe to fill the opening left by Mr. Mikhail’s promotion to president and chief executive officer. He will join Amarin and assume the role on August 23, 2021. Mr. Abuaf joins Amarin with nearly 20 years of global pharmaceutical commercialization experience, primarily with AstraZeneca, where he most recently served as President, United Kingdom. He brings a wealth of European marketing management experience across small, medium and large markets. Mr. Abuaf has significant cardiometabolic launch experience having contributed to the successful launch of Crestor® and Farxiga®. He also has significant entrepreneurial and strategic project management experience, having led and managed commercial activities in multiple countries in Asia. Prior to his career in pharmaceuticals, Mr. Abuaf spent nearly five years with Boston Consulting Group.

Financial Update

Net total revenue for the three and six months ended June 30, 2021 were $154.5 million and $296.7 million, respectively, compared to $135.3 million and $290.3 million in the corresponding periods of 2020, respectively, indicating increases of 14% and 2%, respectively. Net product revenue for the three and six months ended June 30, 2021 were $153.8 million and $295.2 million, respectively, compared to $133.7 million and $285.9 million in the corresponding periods of 2020, respectively, indicating increases of 15% and 3%, respectively. The increase in net product revenue and net total revenue was driven primarily by increased volume of VASCEPA sales to customers in the United States.

In addition, net total revenue includes licensing and royalty revenue of approximately $1.5 million and $4.4 million in the six months ended June 30, 2021 and 2020, respectively, under agreements for the commercialization of VASCEPA outside the United States.

Cost of goods sold for the three and six months ended June 30, 2021 was $32.2 million and $60.5 million, respectively, compared to $28.8 million and $63.6 million in the corresponding periods of 2020, respectively. Amarin’s overall gross margin on net product revenue for the three and six months ended June 30, 2021 and was 79% and 80%, respectively, compared to 78% for both the three and six months ended June 30, 2020.

Selling, general and administrative (SG&A) expense for the three and six months ended June 30, 2021 were $107.2 million and $213.0 million, respectively, compared to $92.4 million and $226.3 million, respectively, in the corresponding periods of 2020, representing an increase of 16% for the same three month period and a decrease of 6% for the same six month period. The increase for the same three month period in 2021 and 2020, was due primarily to personnel costs related to preparation for expansion into the European market as well as increased promotional activity in connection with the resumption of marketing and direct-to-consumer promotions. The decrease for the same six month period in 2021 and 2020, was due primarily to a decrease in promotional activity as a result of the COVID-19 pandemic, which included reduced marketing and direct-to-consumer promotions, travel, and a slower hiring process to replace open positions due to ordinary turnover.

Research and development (R&D) expense for the three and six months ended June 30, 2021 were $6.4 million and $15.7 million, respectively, compared to $10.0 million and $20.2 million, respectively, in the corresponding periods of 2020, representing decreases of 36% and 22%, respectively. These decreases were primarily driven by the completion of certain analyses performed beyond 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 net income of $7.8 million in the three months ended June 30, 2021, or basic and diluted earnings per share of $0.02. This net income included $2.5 million in non-cash stock-based compensation expense. Amarin reported net income of $4.4 million in the second quarter of 2020, or basic and diluted earnings per share of $0.01. This net income included $12.1 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.

Under U.S. GAAP, Amarin reported net income of $6.2 million in the six months ended June 30, 2021, or basic and diluted earnings per share of $0.02. This net income included $16.4 million in non-cash stock-based compensation expense. For the six months ended June 30, 2020, Amarin reported a net loss of $16.1 million, or basic and diluted loss per share of $0.04. This net loss included $22.7 million in non-cash stock-based compensation expense.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $10.3 million for the second quarter of 2021, or non-GAAP adjusted basic and diluted earnings per share of $0.03, compared to non-GAAP adjusted net income of $16.5 million for the second quarter of 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.04.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $22.6 million for the six months ended June 30, 2021, or non-GAAP adjusted basic and diluted earnings per share of $0.06, compared to non-GAAP adjusted net income of $6.6 million for the six months ended June 30, 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.02.

As of June 30, 2021, Amarin reported aggregate cash and investments of $523.1 million, consisting of cash and cash equivalents of $327.0 million and liquid short-term and long-term investments of $181.9 million and $14.2 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 June 30, 2021, Amarin had approximately 395.2 million American Depository Shares (ADSs) and ordinary shares outstanding approximately 19.7 million equivalent shares underlying stock options at a weighted-average exercise price of $7.54 and 10.4 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 primarily has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland 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.