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-- Amarin to Present at 41st Annual
Amarin Announces Preliminary (Unaudited) Fourth-Quarter and Full-Year 2022 Revenues and Cash Position
Revenues: For the fourth quarter and full year 2022, Amarin estimates total net revenue, subject to audit, to be between
Cash Position: Amarin ended 2022 with approximately
Management Commentary
“As we enter 2023, and continuing into the next chapter for Amarin, we will advance on our vision of becoming a global, diversified cardiometabolic player. We will do this with a clear focus on geographic expansion, operational excellence and portfolio diversification,” said
2022 Key Achievements & 2023 Priorities
- In 2022, Amarin secured positive pricing and reimbursement decisions in five European markets:
England &Wales ,Sweden ,Austria ,Denmark andFinland . - Reimbursement negotiations continue to progress in all remaining markets including
Spain ,Italy ,France ,Norway andthe Netherlands . - In 2023, we will focus on opportunities to accelerate revenues in
Europe in key launched markets includingEngland &Wales ,Northern Ireland ,Finland andSweden and further price negotiations in all markets.
- The Amarin team achieved four consecutive quarters of revenue stabilization in the
U.S. business despite additional generic competition. - In 2023, we will maintain our focus on profitability while evaluating and adapting to market conditions.
International
- Secured six International regulatory approvals, including
Hong Kong ,Bahrain ,Puerto Rico ,Saudi Arabia ,Australia andSwitzerland . - In 2023, we will continue to progress international regulatory filings and support approval processes in up to 9 countries, including
China andNew Zealand .
Data Evidence & Pipeline Advancement
- Amarin made progress with our fixed-dose combination (FDC) program for icosapent ethyl, including initiating the process to seek scientific advice from the
European Medicines Agency and we look forward to sharing additional updates in 2023.
J.P. Morgan Presentation Details
Amarin’s president and chief executive officer
41st Annual
Date/Time:
Webcast: https://jpmorgan.metameetings.net/events/healthcare23/sessions/43879-amarin-corporation-plc/webcast?gpu_only=true&kiosk=true
The conference presentation will be webcast live and archived on the Company’s website in the Investor Relations section under Upcoming Events and Latest Presentations.
2023 Financial Outlook
Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA capsules are the first prescription treatment approved by the
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
FULL
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in
Globally, prescribing information varies; refer to the individual country product label for complete information.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s key achievements in 2022 and the potential impact and outlook for achievements in 2023 and beyond; Amarin’s 2023 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs,
Amarin Contact Information
Investor Inquiries:
IR@amarincorp.com
Media Inquiries:
Mark Marmur
PR@amarincorp.com
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