DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today 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. These incremental initiatives include direct-to-consumer advertisement, which launched for the new cardiovascular risk reduction indication in the third quarter of 2020. Such promotion builds on the important outreach to healthcare professionals made by our direct sales team, the size of which doubled near the start of 2020. Amarin’s strategy and initiatives to further expand the market despite likely generic competition reflect the large number of at-risk patients who could potentially benefit from VASCEPA and survey data indicating that most healthcare professionals and at-risk patients are not yet aware of the benefits of VASCEPA in the cardiovascular risk reduction indication, which launched in early 2020. Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand.
• 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.

Management Commentary

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. Thero, president and chief executive officer. “We believe the key court decisions regarding VASCEPA patents related to the triglyceride lowering indication have been wrong and we plan to continue to pursue this matter to the highest level. Moreover, we believe that because of numerous factors, including that VASCEPA was only recently launched as the first and only drug for its cardiovascular risk reduction indication, that continued investment is justified in market expansion with the expectation that increased revenue and profit can accumulate for Amarin by doing so. We remain focused on bringing this potentially life-saving drug to at-risk patients in the United States, Europe and elsewhere in the world.”

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. Launching on our own in major markets in Europe allows us to create the greatest value as Amarin would not have to share profits with a partner. Importantly, we can leverage the knowledge and experience gained from the tremendous progress made by our U.S. commercial team.

“In the coming months, we expect to achieve a number of key milestones including the topline data readout from the Phase 3 clinical trial of VASCEPA in China with our partner, Eddingpharm; a recommendation from the Committee for Medicinal Products for Human Use (CHMP) relating to our European regulatory review and approval process; and presentation of numerous data in support of VASCEPA in the cardiovascular risk reduction indication at the upcoming Annual Scientific Sessions of the American Heart Association,” added Mr. Thero.

Prescription Growth

Normalized prescriptions for VASCEPA (prescription of 120 grams of VASCEPA representing a one-month supply) increased by approximately 36% and 37% in the third quarter of 2020 compared to the same period in 2019 based on data from Symphony Health and IQVIA, respectively. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 1,174,000 and 1,081,000 in the third quarter of 2020. Year to date, estimated normalized prescriptions for VASCEPA increased by approximately 49% and 51%, compared to the first nine months of 2019 based on data from Symphony Health and IQVIA, respectively. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 3,325,000 and 3,050,000 in the first nine months of 2020, respectively.

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. Amarin temporarily suspended in-person promotional activities in March 2020 and beginning in June 2020 in a phased approach, resumed face-to-face interactions with healthcare providers, to the extent such healthcare providers allow, and recently substantially all sales force personnel are permitted to resume face-to-face interaction. This has been done in a manner consistent with guidelines from local, state and government health officials in the United States, although such permission may be further restricted if geographies continue to experience a resurgence of the pandemic. Due to various state and local shelter in place and other travel restrictions, reports from IQVIA indicated that patient visits to medical offices in April were down approximately 70% compared to pre-COVID-19 levels. Similarly, IQVIA reported a significant drop in the number of routine lab tests, including blood tests, being conducted. Physicians typically require office visits, including physical examinations and blood tests, prior to prescribing new medications such as VASCEPA.

Commencing in September 2020, weekly normalized prescriptions reached levels consistent with, or slightly higher than, pre-COVID-19 levels. According to IQVIA data, in September 2020 the number of patient visits to health care providers increased meaningfully over the lows of April 2020 but remained below the volume levels reported prior to mid-March 2020 when the impact of COVID-19 began to significantly affect the United States. Amarin is optimistic that the worst period of impact from COVID-19 on the levels of patients seeking ordinary course doctor visits and lab tests may be behind it. Amarin expects, however, that the COVID-19 dynamic will continue to have an unfavorable impact on revenue, at least in the near term. Accordingly, the degree and timing for potential reacceleration of VASCEPA revenue growth is uncertain, particularly if there are resurgences in the spread of the infection in various geographies and a reinforcement of social distancing and other protocols.

While Amarin’s field team continues to utilize, as necessary, various means to interact with healthcare professionals virtually, such interactions tend to be less frequent and potentially less impactful than in-person communications. This is particularly the case because VASCEPA is being newly introduced to many healthcare professionals as a treatment for cardiovascular risk reduction based on its second FDA indication, launched in January 2020.

Increasing Promotion in the United States

To augment Amarin’s ongoing activities to educate healthcare professionals and in parallel with the sales team getting back into the field, Amarin launched its first ever direct-to-consumer campaign focused on the use of VASCEPA for cardiovascular risk reduction in indicated patients in mid-July 2020. The campaign highlights persistent cardiovascular risk and the benefit of VASCEPA to reduce risk of a heart attack or stroke by 25% when added to a statin. The campaign is intended to raise awareness of VASCEPA among both healthcare professionals and consumers and encourages patients to ask their providers about VASCEPA. As healthcare professionals and patients learn more about VASCEPA, Amarin anticipates expanded VASCEPA prescriptions and revenue. However, the timing and magnitude of such increases remain difficult to predict due to the challenges of quantifying the pace and stability of COVID-19 recovery and the unprecedented nature and limited history of VASCEPA’s approved indication.

Financial Update

Net total revenue for the three and nine months ended September 30, 2020 were $156.5 million and $446.8 million, respectively, compared to $112.4 million and $286.5 million in the corresponding periods of 2019, respectively, indicating increases of 39% and 56%, respectively. Net product revenue for the three and nine months ended September 30, 2020 were $155.2 million and $441.1 million, respectively, compared to $112.3 million and $285.3 million in the corresponding periods of 2019, respectively, indicating increases of 38% and 55%, respectively. The increase in net product revenue was 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 $0.5 million and $8.9 million during the three and nine months ended September 30, 2020 as compared to nil and $0.3 million during the three and nine months ended September 30, 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 that partner).

In addition, Amarin recognized 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 United States. This compares with licensing and royalty revenue of $0.2 million and $1.1 million in the same periods of 2019, respectively.

Cost of goods sold for the three and nine months ended September 30, 2020 was $33.1 million and $96.7 million, respectively, compared to $25.4 million and $65.4 million in the corresponding periods of 2019, respectively. Amarin’s overall gross margin on net product revenue for the three and nine months ended September 30, 2020 was 79% and 78%, respectively, compared to 77% for the three and nine months ended in 2019. This increase in gross margin on net product sales is driven by gross margin on U.S. product sales of 79% for the three and nine months ended September 30, 2020, partially offset by the gross margin on product sales to Amarin’s partners outside the United States to which, under contractual agreements, we generally sell product on a cost-plus basis with licensing and royalty revenue separately recorded.

Selling, general and administrative (SG&A) expense for the three and nine months ended September 30, 2020 were $120.2 million and $346.5 million, respectively, compared to $82.6 million and $227.6 million, respectively, in the corresponding periods of 2019, representing increases of 46% and 52%. This increase is primarily due to personnel costs related to the sales force expansion as well as an increase in promotional activity following the launch of VASCEPA, including consumer-focused promotion which was augmented in July 2020 when Amarin launched its first television advertisement of VASCEPA focused on cardiovascular risk reduction based on the product’s new label.

Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2 million and $30.5 million, respectively, compared to $8.9 million and $23.3 million, respectively, in the corresponding periods of 2019, representing increases of 14% and 31%, respectively. The increase in expense was primarily driven by costs beyond the conduct of the REDUCE-IT study to further analyze samples collected from REDUCE-IT patients as well as costs associated with the achievement of certain milestones under Amarin’s strategic collaboration agreement with Mochida and costs to support various publications and pilot studies.

Under U.S. GAAP, 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. In comparison, Amarin reported a net loss of $3.5 million for the third quarter of 2019, or basic and diluted loss per share of $0.01, which included $8.0 million in non-cash stock-based compensation expense.

Under U.S. GAAP, Amarin reported a net loss of $22.9 million for the nine months ended September 30, 2020, or basic and diluted loss per share of $0.06, which included $34.3 million in non-cash stock-based compensation expense. In comparison, Amarin reported a net loss of $29.7 million, or basic and diluted loss per share of $0.09 for the nine months ended September 30, 2019, which 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 $4.8 million for the third quarter of 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.01, compared to non-GAAP adjusted net income of $4.5 million for the third quarter of 2019, or non-GAAP adjusted basic and diluted earnings per share of $0.01.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $11.4 million for the nine months ended September 30, 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.03, compared to non-GAAP adjusted net loss of $7.0 million for the nine months ended September 30, 2019, or non-GAAP adjusted basic and diluted loss per share of $0.02.

As of September 30, 2020, Amarin reported aggregate cash and investments of $608.0 million, consisting of cash and cash equivalents of $207.2 million and liquid short-term and long-term investments of $354.7 and $46.1 million, respectively. As of September 30, 2020, Amarin reported $147.3 million in net accounts receivable ($223.6 million in gross accounts receivable before allowances and reserves) and $148.5 million in inventory. Further, Amarin plans to pay the remaining $9.5 million of its debt during the fourth quarter of 2020. Once repaid, Amarin will have no debt obligations.

As previously expressed, until uncertainties regarding the effects and duration of the COVID-19 pandemic and the scope of potential generic competition are better understood, Amarin is not providing an estimate of expected 2020 revenue results. Based on its current plans and expectations, Amarin believes that its current capital resources are sufficient to achieve sustained positive cash flows from VASCEPA, including commercial launch of VASCEPA in Europe. Results are anticipated to vary significantly on a quarterly basis including some likely negative net cash flow periods. Factors that are expected to contribute to this variability include the cost and response to, Amarin’s educational and promotional initiatives to advance its launch in the United States of VASCEPA in its new cardiovascular risk reduction indication; the continued and varied impact of the COVID-19 pandemic on Amarin’s business and society; the potential launch of generic versions of VASCEPA in the United States; and the cost and response to Amarin’s efforts toward the further development and launch of VASCEPA in Europe. While Amarin believes that it has adequate supply to support likely near-term sales demand, the company intends to continue to purchase supply as needed to support anticipated VASCEPA growth in the United States and globally.

As of September 30, 2020, Amarin had approximately 388.8 million American Depository Shares (ADSs) and ordinary shares outstanding, 2.4 million common share equivalents of Series A Convertible Preferred Shares outstanding, approximately 17.5 million equivalent shares underlying stock options at a weighted-average exercise price of $7.84, and 7.7 million equivalent shares underlying restricted or deferred stock units.

About Amarin

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA^® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. VASCEPA is not yet approved and available in any other countries. Amarin, on its own or together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, Europe and the Middle East. For more information about Amarin, visit www.amarincorp.com.

About Cardiovascular Risk

The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.¹ In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

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

About REDUCE-IT^®

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.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

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 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 eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.