Workflow
Amarin Corporation(AMRN)
icon
Search documents
Amarin Receives National Reimbursement for VAZKEPA® in Austria
GlobeNewswire· 2025-02-25 13:00
Core Insights - Austrian Health Authorities have approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular event risks in eligible patients, effective April 1, 2025, marking the 10th national reimbursement approval in Europe for this product [1][4]. Group 1: Company Overview - Amarin Corporation is an innovative pharmaceutical company focused on cardiovascular disease management, with a commitment to advancing treatment options for patients worldwide [5]. - The company has offices in multiple locations, including Bridgewater, New Jersey, Dublin, Ireland, and Zug, Switzerland, and collaborates with commercial partners globally [5]. Group 2: Industry Context - Cardiovascular diseases accounted for approximately 35% of all deaths in Austria in 2023, highlighting the urgent need for effective treatment options [2]. - More than 100,000 hospitalizations in Austria in 2023 were due to cardiovascular diseases, with direct and indirect costs estimated at around 4.7 billion euros in 2015 [2]. Group 3: Reimbursement Impact - The reimbursement of VAZKEPA® is seen as a significant advancement in addressing the unmet needs of patients with established cardiovascular disease whose triglycerides remain elevated despite statin treatment [3]. - This decision is expected to alleviate the burden on the healthcare system and improve patient outcomes in secondary prevention of cardiovascular diseases [3].
Amarin to Report Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call on March 12, 2025
GlobeNewswire· 2025-02-19 13:30
Group 1 - Amarin Corporation will host a conference call on March 12, 2025, at 8:00 a.m. ET to discuss its fourth quarter and full year 2024 results [1] - The financial results will be released in the pre-market hours on the same day [1] - The call will include a Q&A session with the management team [1] Group 2 - Amarin is an innovative pharmaceutical company focused on cardiovascular disease management, with offices in multiple countries including the United States, Ireland, and Switzerland [3] - The company aims to enhance the scientific understanding of cardiovascular risks that persist beyond traditional therapies [3] Group 3 - Amarin provides various channels for investor communication, including its website and investor relations section, where material information is regularly posted [4] - The company encourages stakeholders to review the information available on these channels [4]
Amarin Receives National Reimbursement for VAZKEPA® in Italy
Newsfilter· 2024-12-16 12:00
-- Italian Health Authorities Approve VAZKEPA® (icosapent ethyl) for National Reimbursement to Reduce Cardiovascular Risk in Eligible High-Risk Patients1 -- -- Italy is the Third EU5 Market to Grant National Reimbursement; Ninth National Reimbursement for VAZKEPA® Overall in Europe -- -- European Progress Has Advanced Patient Access: Countries That Have Provided Access to VAZKEPA Now Account for More Than 50% of the Total Established Cardiovascular Disease (eCVD) Population in Western Europe -- -- Italy Ap ...
Amarin Appoints Peter Fishman Chief Financial Officer
Newsfilter· 2024-12-13 14:00
Core Points - Amarin Corporation has appointed Peter Fishman as Chief Financial Officer, effective immediately [1] - Fishman has nearly 20 years of experience in finance, including roles in accounting, financial reporting, treasury, tax, and audit [2] - He has been with Amarin since 2019, serving as the principal financial and accounting officer since October 2024 and as Vice President & Global Controller since October 2022 [2] - Fishman holds a Bachelor of Arts in accounting and an MBA, and is a certified public accountant [3] Company Strategy - The CEO, Aaron Berg, expressed confidence in Fishman's ability to lead the company's financial and business strategy moving forward [2] - Fishman has been integral to Amarin's financing efforts and current cash management strategy [2]
After Plunging -19.13% in 4 Weeks, Here's Why the Trend Might Reverse for Amarin (AMRN)
ZACKS· 2024-11-19 15:35
Amarin (AMRN) has been beaten down lately with too much selling pressure. While the stock has lost 19.1% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that measu ...
Amarin's Q3 Earnings In Line, Revenues Fall Shy of Estimates
ZACKS· 2024-10-31 14:36
Core Viewpoint - Amarin Corporation plc reported an adjusted loss of 5 cents per share for Q3 2024, aligning with estimates, but total revenues of $42.3 million fell short of expectations and declined 36% year-over-year due to lower product revenues [1][2]. Financial Performance - The net product revenues from Vascepa, Amarin's sole marketed drug, were $41.9 million, down 36% year-over-year, with U.S. product revenues at $30.6 million, a nearly 51% decline from the previous year [3]. - Licensing and royalty revenues decreased to $0.4 million from $1.2 million in the year-ago period [4]. - Selling, general and administrative expenses were $36.9 million, down almost 18.9% year-over-year, attributed to cost optimization efforts [5]. - Research and development expenses totaled $4.5 million, down almost 11.7% year-over-year [5]. Cash Position - Amarin ended Q3 with cash and investments of $305.7 million, slightly down from $306.7 million in the previous quarter, indicating sufficient funds for ongoing operations [6]. Organizational Restructuring - In July 2023, Amarin implemented a restructuring plan aimed at strengthening its cash runway and reducing cash burn, which included workforce reductions and projected annual savings of $50 million [7]. Stock Performance - Following the earnings announcement, Amarin's shares fell 2.9% in after-hours trading, with a year-to-date decline of 30.8%, contrasting with the industry's decline of 3.2% [2].
Amarin Corporation(AMRN) - 2024 Q3 - Earnings Call Transcript
2024-10-31 00:50
Financial Data and Key Metrics Changes - In Q3 2024, Amarin reported total net revenue of $42.3 million, a decrease from $66.1 million in Q3 2023, with net product revenue of $41.9 million and licensing and royalty revenue of $400,000 [38] - U.S. product revenue was $30.6 million in Q3 2024, down from $62.4 million in Q3 2023, attributed to lower net selling prices due to generic competition and decreased volume from CVS's coverage changes [39] - Gross margin declined to 38% in Q3 2024 from 64% in the prior year, primarily due to reduced net selling prices in the U.S. [41] - The company reported a GAAP net loss of $25.1 million for Q3 2024, compared to a $19.3 million loss in the prior year [42] Business Line Data and Key Metrics Changes - European net product revenue increased to $4.3 million in Q3 2024, a $3.5 million increase year-over-year, driven by growth in Spain and the UK [40] - Total operating expenses in Q3 2024 were $41.4 million, a reduction of approximately $10 million compared to the prior year, due to ongoing cost optimization initiatives [42] Market Data and Key Metrics Changes - The U.S. market continues to be the main revenue source, maintaining over 50% market share despite increased generic competition [27] - In Europe, the company has launched in eight countries, representing about half of the market access opportunity, with ongoing efforts to expand access [19] Company Strategy and Development Direction - The company aims to maximize the value of VASCEPA and VAZKEPA by expanding access to at-risk patients globally, particularly in Europe where there is significant untapped potential [21][22] - Amarin is focused on executing strategies to drive access and use of its products, supported by strong scientific validation and a commitment to patient care [22][45] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing global unmet need to reduce cardiovascular disease, which remains the leading cause of death worldwide, emphasizing the importance of expanding access to VASCEPA and VAZKEPA [10][46] - The company remains committed to regaining NASDAQ compliance while focusing on operational performance and maximizing product value [47][48] Other Important Information - Amarin has secured pricing and reimbursement in Greece and Portugal, with ongoing efforts in Italy [26] - The company reported aggregate cash and investments of $306 million as of September 30, 2024, with no debt [43] Q&A Session Summary Question: Expectations for net pricing pressure for VASCEPA - Management expects rebates to continue to increase due to the competitive generic market but believes they can maintain volume and compete profitably [51] Question: Additional trials or data points for reimbursement coverage in the EU and China - Ongoing subgroup analyses in high-risk patient populations may support reimbursement efforts, with a focus on acute coronary syndrome patients [53][55] Question: Momentum in revenue from the rest of the world - Growth is driven by early launches and partnerships in various regions, with positive signs from Australia and China [60] Question: Growth dynamics in Europe - Encouraging growth in the UK and Spain attributed to strategic changes and effective execution [61] Question: Future of net pricing for VASCEPA in the U.S. - Pricing pressure is expected to continue due to the generic environment and a shift towards Medicare Part D [63] Question: Status of share repurchase program and business development opportunities - No shares have been repurchased yet; the focus remains on executing with VAZKEPA and VASCEPA before considering additional assets [68][71]
Amarin Corporation(AMRN) - 2024 Q3 - Earnings Call Presentation
2024-10-30 23:28
| --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------------|-------|--------------------------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Third Quarter 2024 Business Update & Financial Results Conference Call | | | | | | | | | | | | | | | | | | October 30, 2024 | | | | | | | | Forward Looking Statements & Discl ...
Amarin Corporation(AMRN) - 2024 Q3 - Quarterly Report
2024-10-30 20:10
Regulatory Approvals and Market Access - VASCEPA has received FDA approval for the MARINE indication to reduce triglyceride levels in patients with severe hypertriglyceridemia and for the REDUCE-IT indication to reduce cardiovascular risk in high-risk patients[76]. - The company has filed 15 dossiers for market access in European countries, with national reimbursement being a prerequisite for commercial success[83]. - VAZKEPA has received national reimbursement and launched in several European countries, including England/Wales in October 2022 and Spain in September 2023[84]. - Regulatory approval for VASCEPA in Mainland China was received for both the MARINE and REDUCE-IT indications, with launches expected in 2024[86]. - VASCEPA received approval from the NMPA in Mainland China under the MARINE indication on June 1, 2023, and was launched commercially in October 2023[88]. - The company entered into agreements to commercialize VASCEPA in Australia, New Zealand, South Korea, and several countries in Southeast Asia[91]. Financial Performance - Total revenue decreased to $42.3 million for the three months ended September 30, 2024, down 36% from $66.1 million in the same period of 2023[105]. - U.S. product revenue fell to $30.6 million, a 51% decrease compared to $62.4 million in the prior year, primarily due to generic competition and loss of a major pharmacy benefit manager[106]. - Total revenue for the nine months ended September 30, 2024, was $166.3 million, a decrease of 28% from $232.2 million in the same period of 2023[116]. - Product revenue decreased to $144.5 million for the nine months ended September 30, 2024, down 33% from $214.7 million in 2023, primarily due to a 41% decrease in VASCEPA sales in the U.S.[117]. - U.S. product revenue was $122.5 million for the nine months ended September 30, 2024, compared to $209.0 million in 2023, attributed to a decline in net selling price and volume loss from a major national PBM.[117]. - Licensing and royalty revenue decreased by 61% to $0.4 million, down from $1.2 million, due to the recognition of prior milestone payments[107]. - Licensing and royalty revenue increased by 25% to $21.8 million for the nine months ended September 30, 2024, from $17.5 million in 2023, driven by milestone payments related to VASCEPA licensing agreements.[118]. Cost Management and Restructuring - The Organizational Restructuring Program resulted in a 30% reduction in the total employee base and an annual operating cost reduction of $50 million[78]. - The company incurred restructuring expenses related to its July 2023 ORP, including severance pay and stock-based compensation[99]. - Selling, general and administrative expenses decreased by 19% to $36.9 million, attributed to reduced promotional costs and a reduction in workforce[109]. - Selling, general and administrative expenses decreased by 26% to $115.3 million for the nine months ended September 30, 2024, down from $156.0 million in 2023, due to cost reduction initiatives.[122]. - Cost of goods sold decreased by 28% to $26.0 million, resulting in a gross margin of 38%, down from 44% in the previous year[108]. - Cost of goods sold decreased by 33% to $75.4 million for the nine months ended September 30, 2024, from $111.8 million in 2023, reflecting a reduction in restructuring charges and improved supply chain management.[121]. Leadership Changes - A new CEO, Aaron Berg, was appointed effective June 4, 2024, following the resignation of Patrick Holt[77]. Research and Development - The REDUCE-IT study has led to updates in over 40 clinical treatment guidelines recommending the use of icosapent ethyl in at-risk patients[92]. - The company anticipates continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results[92]. - Research and development expenses decreased by 11% to $4.5 million, reflecting ongoing evaluations of spending commitments[112]. - Research and development expenses decreased by 9% to $14.9 million for the nine months ended September 30, 2024, compared to $16.4 million in 2023, reflecting a strategic focus on essential projects.[124]. Cash Flow and Investments - As of September 30, 2024, the company had cash and cash equivalents of $157.5 million and short-term investments of $148.8 million, with no indebtedness.[129]. - Net cash used in operating activities increased to $(17.7) million for the nine months ended September 30, 2024, compared to $7.5 million provided in the same period in 2023[130]. - Net cash used in investing activities decreased to $(23.1) million, with purchases of $208.9 million offset by proceeds from the maturity of $185.8 million in investment grade interest-bearing instruments[130]. - Financing activities showed a net cash outflow of $(1.5) million, primarily due to decreased proceeds from stock option exercises[130]. - Cash and cash equivalents as of September 30, 2024, were $156.9 million, with short-term investments of $148.8 million, expected to fund operations for at least one year[130]. Market Challenges - The company has faced challenges with generic competition, with several companies receiving FDA approval for generic versions of icosapent ethyl[80]. - The overall icosapent ethyl market in the U.S. saw a 1% decline, with the company's market share dropping to approximately 50% from 58% year-over-year[106]. - The company anticipates variable quarterly net cash outflows due to timing of purchases and competition in the market[130].
Amarin Corporation(AMRN) - 2024 Q3 - Quarterly Results
2024-10-30 20:10
Exhibit 99.1 Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update -- Strong Cash Position of $306 Million; 9 th Consecutive Quarter of Positive or Neutral Cash Balance -- -- Total Net Revenue of $42 Million Represents Continued Source of Cash from the U.S., RoW Partnerships and Early Phases of European Launches -- -- Positive European Momentum Continues with Progress from Pricing & Reimbursement Efforts and Incremental Revenue Growth Driven Primarily by Spain and the UK -- -- Com ...