DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the three and six months ended June 30, 2020, and provided an update on company operations.

Key Amarin achievements since its last quarterly report include:

• Maintaining favorable revenue progress amid COVID-19 challenges: Reported $135.3 million in net total revenue in Q2 2020, an increase of 34% over Q2 2019, resulting in H1 2020 net total revenue of $290.3 million, an increase of 67% over H1 2019.
• Progressing VASCEPA^® development in Europe towards expected approval in early 2021: Continued to support review of VASCEPA by the European Medicines Agency in anticipation of expected approval of VASCEPA for commercial sale in Europe in early 2021 while advancing commercial plans for VASCEPA reimbursement and related commercial launch in Europe.
• Decision made on commercialization in Europe: As announced separately today, Amarin plans to maximize the blockbuster potential of VASCEPA in Europe through its own dedicated European commercial organization. Amarin’s plan retains for shareholders substantially all of the economic upside to participate in the multi-billion-dollar cardiovascular risk reduction market in Europe while preserving strategic optionality and enabling later partnering of VASCEPA in smaller countries in Europe. To help execute on this European strategy Amarin appointed industry veteran, Mr. Karim Mikhail, as senior vice president, commercial head Europe. As detailed in today’s separate press release, Mr. Mikhail has extensive cardiovascular and international experience and a track-record of success to rely on in building multi-billion-dollar brands.
• Results of VASCEPA clinical trial in China nearing reporting: VASCEPA clinical trial results on-track to be reported by Amarin’s partner in China before end of 2020.
• Patent appeal progressing: Substantive briefing completed with two supporting amicus briefs submitted and September 2, 2020 hearing date scheduled in Amarin’s appeal to the U.S. Court of Appeals for the Federal Circuit of the March 30, 2020 adverse district court decision on patents covering the first FDA-approved indication for VASCEPA.
• Strong cash and investments balance: As of June 30, 2020, Amarin reported total cash and investments of $611.3 million with its only debt remaining to be paid being a maximum of $23.0 million on its royalty-like instrument.

“The second quarter of 2020 was a challenging but productive quarter for Amarin. Despite headwinds brought on by the adverse patent judgment and the onset of COVID-19 related societal restrictions at the end of the first quarter, the Amarin team continues to be productive with an increasingly positive outlook. We recently resumed a substantial level of in-person interactions with healthcare professionals in various geographies to build on the January launch of VASCEPA for its new and differentiated cardiovascular risk reduction indication. Amarin’s employees are working diligently to succeed driven by our mission to bring the promise of VASCEPA to millions of cardiovascular disease patients in need in the United States and internationally,” stated John F. Thero, president and chief executive officer, Amarin.

Prescription Growth

Normalized prescriptions for VASCEPA (prescription of 120 grams of VASCEPA representing a one-month supply) increased by approximately 44% and 47% in Q2 2020 compared to Q2 2019 based on data from Symphony Health and IQVIA, respectively. Estimated normalized VASCEPA prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 1,090,000 and 1,007,000 in the second quarter of 2020. Year to date, estimated normalized prescriptions for VASCEPA increased by approximately 57% and 59%, compared to the first half 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 2,151,000 and 1,969,000 in the first half of 2020, respectively. As is typically true, prescription and net revenue growth values are rarely the same in any quarter. In Q2 2020, the estimates of prescriptions made by these third parties reflected slightly stronger growth than Amarin experienced in shipments of product to customers upon which revenues are recognized. Such differences are likely due to the estimated nature of these prescription growth numbers and the timing of purchases by customers. In Q1 2020, the inverse was true with the rate of growth in net revenue exceeding the third-party estimates of prescription growth.

VASCEPA revenue and prescription growth in Q2 2020 were adversely impacted by actions taken to slow the spread of COVID-19 infections. 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. Further impacting VASCEPA growth in Q2 2020, for safety reasons Amarin reduced face-to-face interactions between Amarin sales personnel and healthcare professionals. While Amarin’s field team utilized various means to virtually interact with healthcare professionals in Q2 2020, such interactions were less frequent and potentially less impactful than in-person communications, in particular as VASCEPA is being newly introduced to many healthcare professionals.

Per IQVIA data, patient visits to physicians increased in June compared to the lows of April indicating encouraging signs of recovery. However, per data from IQVIA for the week ending July 3, 2020, patient visits to physicians remained approximately 35% below pre-COVID-19 levels¹. Similarly, the number of lab tests in June also remained well below pre-COVID-19 levels. This data is independent of VASCEPA and reflects continued patient cautiousness in the COVID-19 era.

In June, Amarin initiated a phased redeployment of sales representatives in a manner consistent with federal, Centers for Disease Control and Prevention, and state and local regulations. Amarin’s redeployment expanded in July although not all healthcare professionals will currently allow sales representatives into their offices, particularly in some of the densely populated areas including New York City and Los Angeles where VASCEPA is best known, and historically most highly prescribed. Amarin intends to remain flexible and responsible in its promotion of VASCEPA while seeking effective ways to ensure that prescribers and at-risk patients are increasingly aware of the demonstrated positive efficacy and safety of VASCEPA.

Increasing Promotion in the United States

As society begins to emerge from COVID-19 restrictions, albeit partially and inconsistently, Amarin views the need for VASCEPA to be greater than ever. Cardiovascular disease is among the most significant underlying conditions that could lead to less favorable outcomes in patients infected by COVID-19. Therefore, patients’ need for preventative cardiovascular care is greater than ever. Amarin is confident that its branded commercial launch activities, medical education, and other efforts will help patients and healthcare providers understand the value of VASCEPA for cardiovascular protection in appropriate patients.

Amarin’s launch of VASCEPA for its new cardiovascular risk reduction indication remains in its infancy. Based on a recent survey of approximately 300 randomly sampled cardiologists, endocrinologists and primary care physicians, unaided awareness of VASCEPA for cardiovascular risk was just 32%. And among 302 statin-treated patients with triglycerides above 150 mg/dL and other relevant factors, unaided awareness was less than 1%.

To augment Amarin’s ongoing activities to educate healthcare professionals and in parallel with our sales team getting back into the field, in mid-July Amarin began to launch its first ever direct-to-consumer campaign for VASCEPA focused on the use of VASCEPA for cardiovascular risk reduction in indicated patients. The campaign focuses on 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, which informs healthcare professionals as well as consumers, 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 of COVID-19 recovery and the unprecedented nature and limited history of VASCEPA’s approved indication.

International Update

In Europe, EMA review of Amarin’s application remains active. Based on the pace of the review, Amarin anticipates the timing of completion of EMA’s review to support early 2021 European Community approval of VASCEPA for marketing and sale in Europe. Amarin is rapidly preparing for the commercial launch of VASCEPA in Europe with an emphasis on pursuing reasonable reimbursement for VASCEPA on a country-by-country basis. Amarin is confident that it has the resources to be successful in launching VASCEPA in Europe without having to share a significant portion of the economics from such launch with a commercial partner, except perhaps in certain of the smaller countries of Europe. Notably, the physician targets to be educated about VASCEPA in Europe tend to be more concentrated than in the United States as high-risk patients in Europe are more likely to be treated by a specialist. Therefore, targeting European physicians for education should be a more efficient process than in the United States where primary care physicians continue to manage most statin-treated patients. While Amarin has been preparing for an extended period of time for certain aspects of commercializing VASCEPA in Europe, Amarin recently began to expand its commercialization team for Europe including hiring an experienced head of commercialization for Europe with a core group of other key hires anticipated to be added before the end of 2020.

In Canada, Amarin’s partner appears to have had early success in getting VASCEPA recommended for reimbursement for a significant patient population, patients with established cardiovascular disease consistent with VASCEPA’s approved label, and aims to pursue further expansion of such reimbursement to other at-risk patient groups over time. VASCEPA was launched in Canada in February 2020. Receiving a positive reimbursement recommendation this quickly is a credit to Amarin’s partner and to the demonstrated clinical effectiveness of VASCEPA.

In China, results of the study of VASCEPA in treating patients with severe hypertriglyceridemia (TG >500 mg/dL) is anticipated to be reported by Amarin’s partner before the end of 2020. Based on the results of this study, Amarin and its partner in China will evaluate how to best proceed toward regulatory approval of VASCEPA in China.

ANDA Update

Substantive legal briefs have been filed with the U.S. Court of Appeals for the Federal Circuit in Amarin’s appeal of the previously announced district court’s decision in favor of two filers of abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA capsules in the United States based on the MARINE indication. The oral hearing date for this appeal is September 2, 2020. More information regarding this appeal can be found in this FAQ on the Amarin website.

Amarin believes strongly that the lower court judgment was seriously flawed and that it has strong arguments on appeal that could result in a victory for Amarin. If generic companies ultimately succeed at this effort, Amarin anticipates that for an extended period of time a significant portion of the icosapent ethyl market may remain branded due to potential supply volume constraints for high quality, generic versions of VASCEPA. At this time, Amarin is increasing promotion of VASCEPA with the expectation that Amarin will benefit from such promotion under these conditions with or without the launch of generic VASCEPA.

Financial Update

Net total revenue for the three and six months ended June 30, 2020 were $135.3 million and $290.3 million, respectively, compared to $100.8 million and $174.1 million in the corresponding periods of 2019, respectively, indicating increases of 34% and 67%, respectively. Net product revenue for the three and six months ended June 30, 2020 were $133.7 million and $285.9 million, respectively, compared to $100.4 million and $173.1 million in the corresponding periods of 2019, respectively, indicating increases of 33% and 65%, 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. In addition, the increase was also driven by VASCEPA sales outside of the United States of approximately $1.8 million and $8.5 million during the three and six months ended June 30, 2020 as compared to nil and $0.3 million during the three and six months ended June 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 $4.4 million and $1.0 million in the six months ended June 30, 2020 and 2019, 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, 2020 was $28.8 million and $63.6 million, respectively, compared to $22.8 million and $39.9 million in the corresponding periods of 2019, respectively. Amarin’s overall gross margin on net product revenue for the three and six months ended June 30, 2020 and 2019 was 78% and 77%, respectively. This increase in gross margin on net product sales is driven by gross margin on U.S. product sales of 79% and 80% for the three and six months ended June 30, 2020, partially offset by the gross margin on product sales to Amarin’s partners outside the United States as per contractual arrangements. Net product revenue to Amarin’s partners does not include licensing and royalty revenue.

Selling, general and administrative (SG&A) expense for the three and six months ended June 30, 2020 were $92.4 million and $226.3 million, respectively, compared to $73.4 million and $145.0 million, respectively, in the corresponding periods of 2019, representing increases of 26% and 56%. This increase is due primarily to personnel costs related to the sales force expansion. This increase was offset during the three months ended June 30, 2020 compared to the corresponding period in 2019 by a decrease in consumer-focused promotion. Such consumer-focused promotion 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. While there was a decrease in promotional activities in the second quarter of 2020, in early 2020 there was an increase in promotional activities to support the launch of VASCEPA for its new cardiovascular risk reduction indication resulting in an increase in year-to-date costs for such promotional activities compared to the same prior year period. Primarily driven by the increase in educational and marketing initiatives described above, Amarin anticipates SG&A expense to be approximately $10 million to $20 million higher in the second half of 2020 compared to the first half of 2020.

Research and development (R&D) expense for the three and six months ended June 30, 2020 were $10.0 million and $20.2 million, respectively, compared to $7.1 million and $14.4 million, respectively, in the corresponding periods of 2019, representing increases of 40% and 41%, 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 net income of $4.4 million in the three months ended June 30, 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. Amarin reported a net loss of $1.8 million in the second quarter of 2019, or basic and diluted loss per share of $0.01. This net loss included $7.9 million in non-cash stock-based compensation expense.

Under U.S. GAAP, Amarin reported a net loss of $16.1 million in the six months ended June 30, 2020, or basic and diluted loss per share of $0.04. This net loss included $22.7 million in non-cash stock-based compensation expense. For the six months ended June 30, 2019, Amarin reported a net loss of $26.3 million, or basic and diluted loss per share of $0.08. This net loss included $14.8 million in non-cash stock-based compensation expense.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $16.5 million for the second quarter of 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.04, compared to non-GAAP adjusted net income of $6.1 million for the second quarter of 2019, or non-GAAP adjusted basic and diluted earnings per share of $0.02.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $6.6 million for the six months ended June 30, 2020, or non-GAAP adjusted basic and diluted earnings per share of $0.02, compared to non-GAAP adjusted net loss of $11.5 million for the six months ended June 30, 2019, or non-GAAP adjusted basic and diluted loss per share of $0.03.

As of June 30, 2020, Amarin reported aggregate cash and investments of $611.3 million, consisting of cash and cash equivalents of $214.0 million and liquid short-term investments and long-term investments of $336.3 and $61.0 million, respectively. As of June 30, 2020, Amarin reported $125.0 million in net accounts receivable ($173.2 million in gross accounts receivable before allowances and reserves) and $124.8 million in inventory. As previously expressed, until uncertainties regarding the effects and duration of the COVID-19 pandemic and patent litigation 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 Amarin’s efforts to continue with a robust launch of VASCEPA in its new cardiovascular risk reduction indication, further developments from the influence of the COVID-19 pandemic on Amarin’s business and society, the potential launch of generic versions of VASCEPA in the United States and Amarin’s efforts toward the further development and launch of VASCEPA in Europe.

As of June 30, 2020, Amarin had approximately 385.8 million American Depository Shares (ADSs) and ordinary shares outstanding, 5.2 million common share equivalents of Series A Convertible Preferred Shares outstanding, approximately 17.2 million equivalent shares underlying stock options at a weighted-average exercise price of $7.87, and 7.6 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. Amarin, 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.