VASCEPA/VAZKEPA
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Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ESC 2025
Globenewswire· 2025-08-31 12:30
Core Insights - Amarin Corporation presented in vitro data on the effects of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)] oxidation and its potential anti-inflammatory mechanisms at the European Society of Cardiology Congress 2025 [1][2] Mechanisms of Action - The in vitro analyses suggest that EPA may reduce inflammation in atherosclerotic cardiovascular disease (ASCVD) and impact cardiovascular events in at-risk patients with elevated Lp(a) [2][6] - EPA modulates inflammasome activation in monocyte-derived macrophages (MDMs), which may be linked to cardiovascular risk reduction beyond triglyceride lowering [3][5] - Key findings indicate that EPA may reduce extracellular ATP release and caspase 1 activation in stimulated MDMs, providing preliminary evidence of its protective role against inflammation in ASCVD [5][6] Effects on Lipoprotein(a) - Elevated Lp(a) is associated with increased ASCVD risk, and EPA has been shown to inhibit Lp(a) oxidation and its effects on oxidative stress and pro-inflammatory protein expression in endothelial cells [7][8] - The analysis indicates that EPA's lipid-centric scavenging mechanism may inhibit lipoprotein oxidation, thereby reducing its impact on endothelial dysfunction and inflammation [9] Company Overview - Amarin is focused on advancing cardiovascular disease management and increasing scientific understanding of persistent cardiovascular risk beyond traditional therapies [10][11] - VASCEPA (icosapent ethyl) is the first FDA-approved prescription treatment solely comprising this active ingredient, launched in the U.S. in January 2020 for high-risk patients [12][13]
Amarin Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-07 11:00
Core Insights - Amarin Corporation reported a 26% decrease in total net revenue for Q1 2025, amounting to $42.0 million compared to $56.5 million in Q1 2024, primarily due to lower net selling prices and reduced volume amid U.S. generic competition [6][8][19] - The company continues to focus on maximizing the global value of its products VASCEPA and VAZKEPA, with strategic initiatives aimed at enhancing revenue streams and managing operating expenses [2][3] - Amarin regained compliance with Nasdaq listing standards following a 1-for-20 ADS ratio change, which was completed on April 11, 2025 [13][14] Financial Performance - Total net revenue for Q1 2025 was $42.0 million, a decrease of 26% from $56.5 million in Q1 2024 [6] - Net product revenue for Q1 2025 was $41.0 million, down from $55.2 million in the same period of 2024 [6][19] - Operating expenses decreased by 8% to $41.9 million in Q1 2025 from $45.5 million in Q1 2024 [6][10] - The company reported a net loss of $15.7 million for Q1 2025, compared to a net loss of $10.0 million in Q1 2024 [11][32] Market Performance - In the U.S., the company generated $35.7 million from branded VASCEPA, despite competition from generics [7][19] - In Europe, VAZKEPA's in-market demand grew 16% sequentially quarter over quarter, with significant contributions from Spain, the UK, and Central Eastern European markets [7] - In Italy, patient access was secured in 14 of 21 regions, representing over 85% of the eligible population [7] - In China, the partner Edding is advancing commercialization efforts, targeting top private hospitals and planning for National Reimbursement Drug Listing submission in 2026 [7] Strategic Initiatives - The company is focused on capitalizing on opportunities in Europe and efficiently generating revenue in the U.S. and Rest of World markets while managing operating expenses [2][3] - Amarin is preparing to introduce an authorized generic version of VASCEPA when advantageous [7] - The company continues to evaluate opportunities to expand the impact of VASCEPA/VAZKEPA in addressing cardiovascular risk globally [2][3]
Amarin Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-04-29 20:15
Core Points - Amarin Corporation has regained compliance with Nasdaq's continued listing standards for minimum share price, confirming an average closing share price of at least $1.00 over the last 10 consecutive business days as of April 28, 2025 [2][3] - The company is now fully compliant with all Nasdaq listing requirements and will continue to be listed and traded on the Nasdaq Capital Market [3] - Amarin's focus remains on maximizing the global value of its products VASCEPA and VAZKEPA for patients [3] Company Overview - Amarin is an innovative pharmaceutical company specializing in cardiovascular disease management, with offices in Bridgewater, New Jersey, Dublin, Ireland, and Zug, Switzerland, among other locations [3] - The company is committed to enhancing the scientific understanding of cardiovascular risk that persists beyond traditional therapies and advancing treatment options [3]
Amarin Corporation(AMRN) - 2024 Q4 - Earnings Call Transcript
2025-03-12 14:30
Financial Data and Key Metrics Changes - In Q4 2024, Amarin reported total net revenue of $62.3 million, a decrease from $74.7 million in Q4 2023, with U.S. product revenue dropping to $44.2 million from $64.9 million due to lower net selling prices and decreased volume [33][34] - The company ended 2024 with a strong cash position of $294 million and no debt, reflecting prudent cash management and a focus on strengthening the financial foundation [28][39] Business Line Data and Key Metrics Changes - U.S. product revenue decline was attributed to the loss of CVS commercial exclusivity, leading to a shift in business mix and higher rebates [34][74] - European product revenue increased to $4 million, driven by growth in Spain and the UK, while partnership revenue from the rest of the world rose to $11.9 million, a $7.7 million increase year-over-year [34][35] Market Data and Key Metrics Changes - VASCEPA revenues in Europe gradually increased throughout 2024, with significant contributions from Spain, the UK, and Central Eastern Europe [19] - The company secured pricing and reimbursement in 10 European markets, with ongoing efforts to expand access in various regions [19][20] Company Strategy and Development Direction - The company aims to maintain its NASDAQ listing through an ADS ratio change, which is intended to increase the per-share market price to comply with NASDAQ's minimum bid price requirement [14][43] - Amarin is focused on driving momentum in Europe and the rest of the world, leveraging patent protection until 2039 and exploring opportunities for additional products in the cardiovascular and cardiometabolic areas [63][80] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in generating further momentum in 2025, emphasizing the importance of addressing cardiovascular disease, which remains a leading global health challenge [66][68] - The company acknowledged the challenges posed by the generic market but highlighted the resilience of the U.S. business and the significant untapped potential for VASCEPA globally [30][34] Other Important Information - The company successfully extended its intellectual property position in Europe, enhancing exclusivity for VASCEPA through 2039 [15] - Amarin has supported over 500 publications to advance the understanding of icosapent ethyl's clinical benefits, which has driven regulatory progress globally [11][48] Q&A Session Summary Question: Factors influencing U.S. net price in Q4 - Management noted that the U.S. market is increasingly generic, with a mix of business changing over time, impacting net prices [72] - The shift in business mix due to CVS commercial moving from exclusive to not covered was a significant driver of the revenue changes [74] Question: Outlook on building the pipeline - Management indicated a focus on executing with VASCEPA while remaining opportunistic regarding business development, particularly in cardiovascular and cardiometabolic areas [78][80] Question: Driving rest of the world revenue growth - Management highlighted that they are early in most regions, with ongoing efforts to establish medical advocacy and access, particularly in China and Australia [84][90]