AMRN 7Jan2021 PR "AMARIN PROVIDES PRELIMINARY 2020 RESULTS AND 2021 OUTLOOK"
Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019
Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® (icosapent ethyl) Expected in Late January or February 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided a business update, including preliminary unaudited full-year 2020 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 39th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present on Tuesday, January 12, 2020, at 2:00 pm Eastern time.
Preliminary (unaudited) 2020 Financial Results
Record Revenue Levels: Full-year 2020 total net revenue, subject to audit, are expected to be approximately $610 million. Despite the impact of COVID-19, this estimated 2020 net revenue expectation represents an increase of approximately 42% compared with full-year 2019 results. This growth was primarily driven by increased prescription levels of VASCEPA® in the United States.
Liquid Assets: Amarin ended 2020 with more than $550 million in cash and investments, approximately $150 million in net accounts receivable and approximately $180 million in inventory.
No Debt: At year-end 2020, Amarin had no debt, having fully repaid its prior royalty-like debt instrument in the fourth quarter of 2020, which from 2013 through most of 2020 required approximately 10% of net revenue to be paid against this prior obligation.
Management Commentary
“Amarin has the people, product and resources to expand globally starting with anticipated 2021 VASCEPA regulatory approval and commercial launch in Europe. Our expected growth in Europe and elsewhere overseas will build on our growth and experience in the United States,” commented John F. Thero, president and chief executive officer. “We intend to build on our strong scientific foundation and medical experience. As patients begin to return for medical care beyond the COVID-19 era, we aim to ensure that VASCEPA is increasingly prescribed to help at-risk patients. While 2020 was a challenging year, I am thankful to our employees for the progress they made in countless areas. Their hard work and passion provide a strong foundation from which we will further launch VASCEPA to reduce persistent cardiovascular risk in appropriate patients, or P-CVR, in the United States, Europe and around the world.”
Highlights from 2020 and Outlook
U.S. Commercial
Amarin achieved a number of important commercial milestones in 2020, despite the challenges Amarin faced with COVID-19 and the November launch of generic icosapent ethyl in the United States.
U.S. commercial highlights from 2020 include:
Record levels of VASCEPA revenues, prescriptions, prescribers and patients
Faster prescription growth for VASCEPA as compared to most other cardiovascular drugs that reported positive outcomes studies in recent years, despite VASCEPA having a lower level of promotional spend than many such drugs
VASCEPA growth in 2020 due to COVID-19 was slower than initially expected but compares well with the growth in 2020 of peer drugs
The P-CVR indication has quickly garnered the largest part of the market as approximately 93% of VASCEPA prescriptions based on the most recent data reported to us by IQVIA were for patients with triglyceride (TG) levels below 500 mg/dL
Further expanded managed care coverage for VASCEPA during 2020 with additional improvements agreed for 2021
Such increases are consistent with third-party analysis, which found VASCEPA to be cost effective, and with medical guidelines or recommendations from six leading U.S. medical societies
Doubled size of sales force (training for this expanded group was completed in March 2020 just before Amarin’s customer-facing team was temporarily prohibited from conducting in-person meetings due to COVID-19)
Adapted to COVID-19 protocols with various tele-sales, tele-marketing and virtual education initiatives as well as training representatives to safely interact with healthcare professionals where possible
U.S. commercial outlook includes:
Confidence that millions of at-risk patients remain untreated for P-CVR and could benefit from VASCEPA
Recognition that many at-risk patients ceased doctor visits for ordinary care in 2020 but are likely to return to their doctors for needed care as COVID-19 risk recedes
According to IQVIA, patient visits to medical offices for non-emergency medical care were down approximately 70% in April 2020 during the height of COVID-19, with visits steadily increasing thereafter. In December 2020, as a result of a spike in COVID-19 cases, patient visits have decreased approximately 50% compared to pre-COVID levels
Following a resurgence of COVID-19 in recent months, Amarin intends to reduce spending levels for certain forms of promotion (e.g., television advertisements) in early 2021
U.S. promotional spending likely to be variable with adjustments upward or downward in response to the changing impact from COVID-19 and generic competition
As COVID-19 vaccine progress is made, along with other mitigating approaches, Amarin plans to increasingly resume its promotion of VASCEPA for P-CVR while continuing to adapt to market changes
Generic competition launched in November 2020 only for the original indication (TG >500 mg/dL) and is expected to continue to face supply limits, despite stockpiles of generic product likely created prior to launch
Variability is expected as patients, pharmacies and payers adjust to the availability, pricing and label of this generic competition
Due to the uncertainties regarding COVID-19 and potential generic supply, Amarin will continue to withhold 2021 revenue guidance for VASCEPA in the U.S. until there is greater clarity on the impact of these issues
Amarin intends to continue to manage its U.S. commercial operations to expand patient care and enhance profits from U.S. operations
Europe
Europe highlights from 2020 include:
Reached Day 180 of the European Medicines Agency, or EMA, centralized regulatory review of VASCEPA assuring that the United Kingdom is grandfathered into a facilitated review process despite its withdrawal from the European Union
An expanded recommendation was issued by the European Society of Cardiology regarding use of icosapent ethyl (U.S. brand name VASCEPA)
Increased the size of the Amarin team in Europe to approximately 50 experienced professionals to support pre-approval and pre-launch preparations for VASCEPA in select countries
Commenced interactions with authorities in select countries regarding VASCEPA market access assuming approval, noting that more formal proceedings cannot progress until after the product is approved and the label is established
Made major advances in expanding company-wide systems to support expected commercial launch of VASCEPA in Europe in 2021
Europe outlook includes:
Millions of at-risk patients could benefit from VASCEPA in Europe
There are more patients on statins in Europe in aggregate compared to the U.S. and the rate of death from cardiovascular disease is higher
Regulatory approval expected in early 2021
CHMP opinion expected in late January or February 2021
EMA approval decision expected within 67 days of CHMP decision
Market access negotiations anticipated on a country-by-country basis promptly after approval
Seeking net pricing that equals or exceeds U.S. net pricing with focus on P-CVR indication based on outcomes data in Europe, whereas pricing in the U.S was based on original TG lowering indication
Launch timing by country dependent on market access (i.e., insurance coverage)
At a minimum, launch expected in Germany in 2021 after initial product awareness campaign
Launch in Germany and other countries is anticipated to give priority to specialists (e.g., cardiologists) and to also include substantial digital educational and promotional initiatives
Target of approximately 200 employees (or contractors) in the European commercial team by end of 2021
Rest of World
Rest of world, or ROW, highlights from 2020 include:
China positive clinical study results reported
Canada commercial launch of VASCEPA initiated (just prior to slowdown from COVID-19)
Canada reimbursement levels for VASCEPA established within six months of product regulatory approval to facilitate treating patients with established cardiovascular disease
ROW outlook includes:
Large at-risk patient opportunities
In China 290 million people are reported to have cardiovascular disease, a number which has been increasing rapidly in recent years, including approximately 52 million reported to have high TG levels, a substantial portion of whom might be able to benefit from VASCEPA
Plans to submit application for regulatory approval through Amarin’s commercial partner in the People's Republic of China
Anticipate inclusion of VASCEPA in the treatment guidelines in Chinese medical societies
Pursue opportunities for VASCEPA in untapped countries after approval and market access in Europe is secured, with such approval and market access expected to enhance ROW positioning
R&D and Medical Advancement
R&D and medical advancement highlights from 2020 include:
EVAPORATE exploratory study results, as previously reported, reported 17% reduction in plaque volume in patients with coronary atherosclerosis treated with VASCEPA
Numerous other studies presented in support of the potential unique mechanism of action of VASCEPA
In aggregate, Amarin supported over 40 scientific publications and presentations in 2020
CardioLink-19 exploratory study results, as previously reported, evaluated a higher initial dose of VASCEPA and suggested VASCEPA could potentially have utility as a therapeutic option for mitigating COVID-19 effects in an out-patient setting
This pilot study was rapidly commenced and completed with results that exceeded expectations
Additional COVID-19 investigational studies of VASCEPA were also commenced in 2020
Witnessed an increase to twelve (12) the number of medical societies globally that now include icosapent ethyl in their guidelines or have otherwise recommended its use
R&D and medical outlook includes:
Supporting approval of VASCEPA in Europe and regulatory review processes initiated by Amarin’s commercial partner in the People's Republic of China
Supporting cost-effectiveness studies and market access for VASCEPA wherever it is approved
Support completion of COVID-19 investigational studies and, based on the results, decide on appropriate next steps
Continue to study and differentiate the unique clinical and biological effects of VASCEPA
In concert with Amarin’s business development and other efforts, prioritize and execute on potential opportunities to expand indications for VASCEPA or develop new products
Financial Resources
Amarin reiterates that it believes its current cash resources are adequate to support the European launch and its planned operations and priorities in the United States and globally. Such guidance included anticipated resources likely needed to further expand its VASCEPA supply capacity in anticipation of launches of VASCEPA in Europe, China and other countries as well as the opportunity to continue to grow prescription levels in the United States after COVID-19 recedes, continuing the launch of VASCEPA for P-CVR as commenced in 2020.
Currently, Amarin anticipates 2021 operating expenses of approximately $550 million to $600 million which represents an increase of approximately 10% to 20%, compared with 2020 levels. Included in these anticipated expenses are increased costs associated with Amarin’s commercial launch preparations and initial launch in Europe as well as continued U.S. promotional activities, including increased face to face interactions between Amarin’s sales professionals and health care providers and direct-to-consumer advertising in the U.S. after the impact of COVID-19 becomes less pronounced and at-risk patients begin returning to their doctors for non-urgent medical care. With continued investment in consumer and in-person marketing, Amarin expects VASCEPA revenue growth in the U.S. As described above, these spending levels may vary from quarter to quarter. Further these operating expense levels assume substantial societal recovery in 2021 from COVID-19 and the continued limited availability of supply to the generic companies. Amarin will re-evaluate its planned spend in 2021 if any of these assumptions change.
More Information to Follow
Amarin expects to provide further details regarding its 2020 results and perspective regarding its future outlook in the company's annual report on Form 10-K.
