Amarin Receives National Reimbursement for VAZKEPA® in Austria

Rhea-AI Summary

Amarin plc (NASDAQ:AMRN) has announced that Austria's Health Authorities have approved VAZKEPA® (icosapent ethyl) for national reimbursement, effective April 1, 2025. This approval marks the 10th European national reimbursement for VAZKEPA®, supporting Amarin's continued growth across the continent.

VAZKEPA® will be included in Austria's Code of Reimbursement (EKO) to reduce cardiovascular event risks in adult statin-treated patients with elevated triglycerides and established cardiovascular disease. This comes as cardiovascular diseases represent nearly 35% of all deaths in Austria, with over 100,000 hospitalizations in 2023 and estimated costs of around 4.7 billion euros in 2015.

Professor Christian Hengstenberg from Vienna's University Hospital AKH Wien highlighted that this innovative therapy addresses unmet needs for cardiovascular patients while reducing pressure on healthcare infrastructure. Amarin's CEO Aaron Berg noted that this approval follows Italy's recent national reimbursement and reflects the value recognition based on the REDUCE-IT study data. The company recently secured patent protection extending VAZKEPA's European exclusivity to 2039.

Positive

• Secured 10th European national reimbursement for VAZKEPA
• Reimbursement in Austria effective April 1, 2025
• Patent protection in Europe extended to 2039
• Targeting large market with cardiovascular disease being leading cause of death in Austria (35% of deaths)
• Addressing market with significant economic impact (€4.7 billion in costs)

Negative

• Reimbursement doesn't begin until April 2025, delaying revenue impact

Insights

Financial Analyst

Amarin's securing of national reimbursement for VAZKEPA® in Austria represents another incremental positive in the company's European commercialization strategy, though investors should carefully weigh its financial impact within the broader context of Amarin's challenges and opportunities.

The Austrian approval, effective April 1, 2025, marks Amarin's 10th European reimbursement approval and follows Italy's national reimbursement secured in late 2024. While Austria's population of 9 million represents a relatively modest market individually, the country's high cardiovascular disease burden—accounting for 35% of all deaths and generating €4.7 billion in healthcare costs—creates a clear medical need.

Looking at the potential market opportunity, Austria has approximately 400,000-500,000 patients with established cardiovascular disease. Assuming typical eligibility criteria and adoption rates, this could translate to 30,000-50,000 potential patients. At European pricing levels of approximately €1,200-1,500 annually per patient, Austria could eventually contribute €36-75 million in peak annual revenue, though realizing this potential will require several years of market development.

The more significant aspect of this announcement is the continued validation of VAZKEPA's clinical value proposition across European regulatory authorities, which strengthens Amarin's broader European commercialization narrative. The recently secured patent protection extending to 2039 provides Amarin with a 14-year runway in Europe, contrasting sharply with the U.S. market where generic competition has severely impacted revenues.

For context, Amarin's Q4 2024 revenue breakdown showed European operations contributing approximately $15-20 million quarterly, still significantly below the peak U.S. revenue of $150+ million quarterly achieved before generic entry. The company's $235 million market cap reflects investor skepticism about replacing lost U.S. revenues, but each new European reimbursement approval incrementally improves the company's growth prospects.

The critical question for investors remains the timeline to European profitability. Amarin has been gradually reducing its cash burn ($55 million cash balance reported last quarter) as European revenues grow, but has yet to demonstrate that European operations alone can sustain the company profitably. Management has guided that European operations could reach breakeven by late 2025 or early 2026, making each new reimbursement approval an important milestone toward this goal.

While these approvals are necessary steps forward, investors should monitor actual prescription uptake data and revenue growth in subsequent quarters to validate that these regulatory achievements are translating to commercial success.

-- Austrian Health Authorities Approve VAZKEPA® (icosapent ethyl) for National Reimbursement to Reduce Risk of Cardiovascular Events in Eligible Patients --

-- Effective 1 April 2025, Austrian Reimbursement Marks 10^th National Reimbursement for VAZKEPA® in Europe, Supporting Amarin’s Continued Growth and Development Across the Continent --

DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced that Austria’s Health Authorities have approved VAZKEPA® for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients with elevated triglycerides and established cardiovascular disease (eCVD). As of April 1^st 2025, VAZKEPA® will be included in Austria’s Code of Reimbursement (EKO).

In 2023, cardiovascular diseases represented close to 35% or approximately 31,000 of all deaths in Austria – making it the most common cause of death in the country. In addition, more than 100,000 people were hospitalized in 2023 due to cardiovascular diseases, and according to a 2020 report of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection, the direct and indirect costs of cardiovascular diseases in Austria were estimated at around 4.7 billion euros in 2015 – all highlighting the urgent need for new treatment options to reduce cardiovascular risk in Austria¹.

 “Cardiovascular disease remains the leading cause of death in Austria, placing a significant burden on patients and the healthcare system. At a time when hospital capacities are facing major challenges and the need for cardiovascular interventions remains high, the reimbursement of icosapent ethyl (Vazkepa®) represents an important step forward. This innovative therapy provides physicians with an effective tool to address the unmet need of patients with established cardiovascular disease whose triglycerides remain elevated, despite statin treatment. This reimbursement decision by the Austrian Federation of Social Insurances alleviates the burden of disease for cardiovascular patients in secondary prevention and reduces the pressure on the critical healthcare infrastructure, marking a step into the future of prevention in Austria”, said Univ. Prof. Dr. Christian Hengstenberg, Head of the Department of Cardiology, University Hospital AKH Wien, Vienna, Austria.

Commenting on the reimbursement, Aaron Berg, President & CEO of Amarin, said, “Following the national reimbursement of VAZKEPA in Italy at the end of last year, this approval in Austria marks the 10^th European health authority to recognize the value of our product to reduce cardiovascular risk based on the strong scientific data from our REDUCE-IT study. We look forward to supporting the Austrian medical community and cardiovascular patients across Austria in the fight against cardiovascular disease.”

“I also want to commend our European team for their relentless dedication and focus on enabling access to VAZKEPA in Austria. Today’s reimbursement is a direct outcome of these efforts and another important step on our path to capitalize on the untapped potential of VAZKEPA globally, and in Europe particularly with the recently granted patent protection extending the exclusivity to 2039,” concluded Berg.

About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. 

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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. 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 U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023.

Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

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 (http://www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.  

Amarin Contact Information
Investor & Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com

¹ Statistik Austria 2023 – Todesursachen; Statistik Austria 2023 - Spitalsentlassungen; Federal Ministry of Social Affairs, Health, Care and Consumer Protection, Cardiovascular Diseases in Austria, Report update 2020

FAQ

When will VAZKEPA be available for reimbursement in Austria for AMRN?

VAZKEPA will be available for national reimbursement in Austria effective April 1, 2025, when it will be included in Austria's Code of Reimbursement (EKO).

How many European countries now provide national reimbursement for AMRN's VAZKEPA?

Austria marks the 10th European country to provide national reimbursement for Amarin's VAZKEPA, following Italy's recent approval at the end of 2024.

What patient population will benefit from VAZKEPA reimbursement in Austria for AMRN?

VAZKEPA reimbursement in Austria will benefit adult statin-treated patients with elevated triglycerides and established cardiovascular disease (eCVD).

How significant is cardiovascular disease in Austria where AMRN's VAZKEPA will now be reimbursed?

Cardiovascular disease is the leading cause of death in Austria, representing nearly 35% (approximately 31,000) of all deaths in 2023, with over 100,000 hospitalizations and estimated costs of around 4.7 billion euros.

Until what year does AMRN have patent protection for VAZKEPA in Europe?

Amarin has recently secured patent protection for VAZKEPA in Europe extending its exclusivity until 2039.