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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 ...
Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress
GlobeNewswire News Room· 2024-08-22 12:30
Core Insights - Amarin Corporation announced new subgroup data from the REDUCE-IT cardiovascular outcomes trial with VASCEPA/VAZKEPA, to be presented at the ESC Congress 2024 in London [1][2] Group 1: REDUCE-IT Trial Insights - The REDUCE-IT trial assessed the effect of icosapent ethyl (IPE) on cardiovascular events in patients with controlled LDL-C levels (41-100 mg/dL) and elevated triglycerides (135-499 mg/dL) [5] - The trial included 8,179 patients over seven years, focusing on those with established cardiovascular disease or diabetes and additional risk factors [5] - The median baseline triglyceride level was 216 mg/dL, indicating a significant population at risk [5] Group 2: Abstracts and Presentations - Accepted abstracts for the ESC Congress include analyses on the impact of baseline small dense low-density lipoprotein cholesterol on IPE's effects, and the association of triglycerides with cardiovascular events in acute coronary syndrome patients [2] - Presentations will cover various topics, including the prognosis of patients eligible for IPE treatment and the effects of EPA on lipoprotein(a) oxidation under high glucose conditions [3] Group 3: Company Commitment and Research Focus - Amarin is dedicated to investing in research that addresses residual cardiovascular risk beyond traditional lipid management, emphasizing the clinical utility of VASCEPA/VAZKEPA [4] - The company aims to enhance understanding of the mechanisms of action for IPE/EPA and the prevalence of residual cardiovascular risk associated with elevated triglyceride levels [4]
Amarin (AMRN) Stock Down Despite Q2 Earnings & Revenues Beat
ZACKS· 2024-08-01 18:00
Core Viewpoint - Amarin Corporation reported break-even quarterly earnings for Q2 2024, surpassing the Zacks Consensus Estimate of a loss of 5 cents per share, but total revenues declined by 16% year-over-year to $67.5 million, primarily due to lower product revenues [1] Financial Performance - Net product revenues from Vascepa, Amarin's sole marketed drug, were $47.5 million, down 27.1% year-over-year [2] - U.S. product revenues from Vascepa were $43.8 million, a decline of 32.2% from the previous year, although it exceeded the model estimate of $32.1 million [2] - European product revenues from Vazkepa totaled $3.5 million, an increase from $1.9 million in the previous quarter, driven by growth in the UK and Spain [2] - Licensing and royalty revenues reached $20 million, up from $15 million in the year-ago period [2] Cost Management - Selling, general and administrative expenses were $38.5 million, down 24.3% year-over-year due to cost reduction and restructuring efforts [3] - Research and development expenses amounted to $4.7 million, a decrease of 16.1% year-over-year [3] - Amarin implemented an organizational restructuring plan in July 2023, resulting in $50 million in annual savings [3] Cash Position - Amarin ended Q2 with cash and investments of $306.7 million, slightly down from $308.2 million in the previous quarter, which is deemed sufficient to fund ongoing operations [4] Recent Developments - A pharmacy benefit manager has moved Vascepa to a blocked status on its formulary, which is expected to negatively impact revenues in the second half of 2024 [5] - In June 2024, Amarin appointed Aaron Berg as the new president and CEO following the resignation of Patrick Holt [5]
Amarin Corporation(AMRN) - 2024 Q2 - Earnings Call Transcript
2024-07-31 16:28
Financial Data and Key Metrics Changes - Amarin reported total net revenue of $67.5 million in Q2 2024, down from $80.2 million in Q2 2023, with U.S. product revenue declining to $43.8 million from $64.6 million due to lower net selling prices from generic competition [27][28][24] - Gross margin decreased to 48% in Q2 2024 from 64% in Q2 2023, primarily due to the decline in net selling price in the U.S. [30] - GAAP net income was $1.5 million in Q2 2024 compared to a loss of $17.6 million in the prior year [31] Business Line Data and Key Metrics Changes - U.S. product revenue was significantly impacted by generic competition, while European net product revenue increased to $3.5 million, driven by growth in Spain and the UK [27][28] - Licensing and royalty revenue rose to $20 million in Q2 2024 from $15 million in Q2 2023, including a $15 million milestone for cardiovascular risk reduction approval in China [28][29] Market Data and Key Metrics Changes - In the U.S., the company maintained IPE market leadership with approximately 50% market share, despite a decline in revenue due to the loss of a major exclusive contract [24][25] - In Europe, the company is focusing on key markets, with Spain showing robust growth following a successful launch [17][19] Company Strategy and Development Direction - The company is prioritizing execution and performance to maximize the impact of VASCEPA/VAZKEPA globally, with a focus on expanding access in Europe and other international markets [11][13] - A new strategy was implemented in Europe targeting a higher risk subset of patients to accelerate access and reimbursement [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in VASCEPA's potential to address cardiovascular disease, which remains a leading global health issue [10][34] - The company is prepared for ongoing challenges from generic competition and is considering launching an authorized generic to maintain market leadership [26][38] Other Important Information - The company has a strong cash position of $307 million as of June 30, 2024, providing a foundation for future growth [31] - A conditional share repurchase program was established, but no repurchases have been initiated due to current market conditions [32][40] Q&A Session Summary Question: Outlook for U.S. revenues against additional generic competition - Management believes branded VASCEPA will remain the market leader despite the loss of a major exclusive plan, with positive feedback received for 2025 formulary coverage [36][37] Question: Market conditions impacting share repurchase decisions - The decision not to commence share repurchases is due to business and market conditions, with ongoing monitoring of cash generation [39][40] Question: Update on potential delisting from NASDAQ - The company received notice of potential delisting due to trading below $1, but believes operational improvements can help regain compliance [41][42] Question: Recent decision in skinny label litigation - The Federal Circuit reversed a previous decision, allowing the case against Hikma to proceed in District Court [43][44] Question: Market opportunity in China - The cardiovascular risk reduction indication presents a significant market opportunity, with expectations for inclusion in the NRDL by January 1, 2025 [66][67] Question: OpEx flexibility and future spending - The company plans to continue investing in European expansion while monitoring operating expenses, expecting a slight decline in cash for the next quarters [68][69]
Amarin Corporation(AMRN) - 2024 Q2 - Earnings Call Presentation
2024-07-31 15:30
| --- | --- | --- | --- | --- | |--------------------------------|---------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Second Quarter 2024 Business Update & Financial Results Conference Call | | | | | Aaron Berg CEO & President CFO | Tom Reilly | | | | | July 31, 2024 | | | | | Forward Looking Statements & Disclaimer This presentation contains forward-looking statements, such as those relating to ...
Amarin Corporation(AMRN) - 2024 Q2 - Quarterly Results
2024-07-31 11:05
Financial Performance - Total net revenue for Q2 2024 was $67.5 million, a decrease of 16% compared to $80.2 million in Q2 2023[4] - Net product revenue for Q2 2024 was $47.5 million, down 27% from $65.2 million in Q2 2023, primarily due to U.S. generic competition[4] - Total revenue for the three months ended June 30, 2024, was $67.491 million, a decrease of 16% compared to $80.167 million for the same period in 2023[27] - Product revenue for the same period was $47.514 million, down from $65.187 million year-over-year, reflecting a decline of 27%[27] - Licensing and royalty revenue for Q2 2024 was $20.0 million, including a $15.0 million milestone payment for CVRR approval in China[5] - Licensing and royalty revenue increased to $19.977 million, up 33% from $14.980 million in the prior year[27] - Net income for the three months ended June 30, 2024, was $1.522 million, compared to a net loss of $17.560 million in the same period of 2023[27] - Adjusted net income for EPS (non-GAAP) for the three months ended June 30, 2024, was $5.909 million, down from $8.607 million in the prior year[28] - Basic earnings per share (non-GAAP) for the three months ended June 30, 2024, was $0.01, compared to $0.02 in the same period last year[28] Expenses and Cost Management - Operating expenses for Q2 2024 were $43.3 million, a reduction of 24% from $56.6 million in Q2 2023, attributed to organizational restructuring[4] - Operating expenses decreased to $43.293 million from $66.627 million year-over-year, a reduction of 35%[27] - The company achieved $50 million in annual savings from the workforce reduction announced in July 2023[6] Cash and Assets - Cash position as of June 30, 2024, was $306.7 million, reflecting a 2% decrease from $313.0 million in the same period last year[4] - Total assets as of June 30, 2024, were $799.855 million, a decrease from $831.684 million as of December 31, 2023[26] Strategic Initiatives - The company is focused on cash preservation and plans to invest prudently to accelerate revenues in Europe and maximize cash generation from the U.S. and RoW markets[9] - A share repurchase program of up to $50 million was approved, although no repurchases have been initiated yet[8] - Amarin has entered into a conditional share repurchase agreement to purchase up to $50 million of its ordinary shares in the form of ADSs[22] Product Development - Gross margin on net product revenue improved to 48% in Q2 2024, compared to 42% in Q2 2023[5] - A new patent for VAZKEPA was granted, extending exclusivity until 2039, enhancing the product's market position[3]
Amarin Corporation(AMRN) - 2024 Q2 - Quarterly Report
2024-07-31 11:05
Product Performance - VASCEPA has achieved approximately 25 million estimated normalized total prescriptions since its commercial launch in 2013[95]. - U.S. product revenue was $43.8 million in Q2 2024, down from $64.6 million in Q2 2023, attributed to a decline in net selling price due to generic competition[122]. - Product revenue decreased to $47.5 million in Q2 2024 from $65.2 million in Q2 2023, a decline of 27% primarily due to a 32% decrease in VASCEPA sales in the U.S.[122]. - The overall icosapent ethyl market in the U.S. decreased by 1% in Q2 2024 compared to Q2 2023, while the company's market share increased to approximately 59%[122]. - VASCEPA has been approved in 15 countries and regions outside of the United States and EMA, including Mainland China, Switzerland, Australia, New Zealand, and Israel[107]. - The company has filed for regulatory review in 22 countries and regions, aiming to ensure VASCEPA's availability in the top 50 cardiometabolic markets worldwide[107]. - VASCEPA received regulatory approval in Mainland China for the MARINE indication on June 1, 2023, and for the REDUCE-IT indication on June 28, 2024[103]. - VASCEPA has received reimbursement from all major private and public payors in Canada, gaining access to a majority of eligible patients[106]. Financial Performance - Total revenue decreased by $12.7 million, or 16%, to $67.5 million for the three months ended June 30, 2024, compared to $80.2 million for the same period in 2023[121]. - Product revenue, net, decreased by $47.2 million, or 31%, to $102.7 million for the six months ended June 30, 2024, compared to $149.8 million in 2023, primarily due to a 37% decrease in VASCEPA sales in the U.S.[135]. - Total revenue, net for the six months ended June 30, 2024 was $124.0 million, down from $166.1 million in the same period of 2023, a decrease of 25%[134]. - U.S. net product revenue decreased by $20.8 million, offset by a $3.1 million increase in net product revenue outside the United States and a $5.0 million increase in licensing and royalty revenue[121]. - Licensing and royalty revenue increased to $20.0 million in Q2 2024 from $15.0 million in Q2 2023, a rise of 33% driven by milestone payments related to the REDUCE-IT indication in China[123]. - Interest income, net increased to $3.3 million in Q2 2024 from $3.0 million in Q2 2023, a rise of 9% due to higher investment balances[132]. - The provision for income taxes increased to $2.7 million for the six months ended June 30, 2024, from $1.6 million in 2023, primarily due to a higher annualized estimated tax rate[146]. - The company incurred an accumulated deficit of $1.6 billion as of June 30, 2024[149]. Cost Management - The Organizational Restructuring Program resulted in a reduction of approximately 30% of the total employee base, leading to an annual operating cost reduction of $50 million[92]. - Selling, general and administrative expenses fell to $38.5 million in Q2 2024 from $51.0 million in Q2 2023, a decrease of 24% due to cost reduction initiatives[125]. - Research and development expenses decreased to $4.7 million in Q2 2024 from $5.6 million in Q2 2023, a decline of 16%[129]. - Cost of goods sold decreased to $24.7 million in Q2 2024 from $37.5 million in Q2 2023, a reduction of 34%, contributing to an increase in gross margin from 42% to 48%[124]. - Selling, general and administrative expenses decreased by $32.1 million, or 29%, to $78.4 million for the six months ended June 30, 2024, from $110.5 million in 2023[139]. - Cost of goods sold decreased by $26.2 million, or 35%, to $49.3 million for the six months ended June 30, 2024, compared to $75.5 million in 2023[138]. - Restructuring expenses were nil in Q2 2024 compared to $10.0 million in Q2 2023, a decrease of 100% following the implementation of the ORP[131]. Strategic Initiatives - The European redesign of the commercial infrastructure aims to align with pricing and reimbursement status, enhancing market access in key countries[94]. - The company is exploring additional partnerships in key international markets, including Canada, MENA, China, Australia, and New Zealand[102]. - The company aims to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets in 2024[135]. - The company has updated over 40 clinical treatment guidelines recommending the use of icosapent ethyl in at-risk patients based on REDUCE-IT results[109]. - The company is in the final year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries[107]. - The company entered into agreements to commercialize VASCEPA in Australia, New Zealand, South Korea, and several Southeast Asian countries[107]. - The company continues to advance pricing and reimbursement activities to drive access in remaining geographies, optimizing a hybrid commercial model[101]. Cash Flow and Liquidity - As of June 30, 2024, the company had cash and cash equivalents of $215.9 million and short-term investments of $90.7 million[149]. - Net cash used in operating activities for the six months ended June 30, 2024, was $(15.4) million, compared to $0.2 million provided in the same period in 2023[148]. - Net cash provided by investing activities increased to $33.4 million for the six months ended June 30, 2024, from $14.7 million in the same period in 2023[148]. - The company believes its cash and cash equivalents, along with short-term investments, will be sufficient to fund projected operations for at least one year[149]. - The company has no indebtedness and maintains a conservative investment policy to ensure liquidity and capital preservation[147]. - A share repurchase program was announced on January 10, 2024, to buy up to $50.0 million of the company's ordinary shares, pending market conditions[147]. - The company anticipates variable quarterly net cash outflows due to API purchases, generic competition, and pricing and reimbursement of VAZKEPA in Europe[147].
Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update
Newsfilter· 2024-07-31 11:00
-- Cash Position of $307 Million Provides Stable and Strong Capital Foundation –-- Total Net Revenue of $68 Million ($124 Million Year-To-Date) Reflecting Continuing Efforts to Maximize VASCEPA/VAZKEPA Performance Globally -- -- Leadership Transition Completed with Appointment of Aaron Berg as President and CEO -- DUBLIN and BRIDGEWATER, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today reported financial results for the second quarter ended June 30, 2024, and provided a b ...
Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-07-31 11:00
Core Insights - Amarin Corporation reported a total net revenue of $68 million for the second quarter of 2024, reflecting a 16% decrease compared to the same period in 2023, primarily due to U.S. generic competition impacting net selling prices [3][4] - The company completed a leadership transition with Aaron Berg appointed as President and CEO, focusing on operational execution and expanding the impact of VASCEPA/VAZKEPA globally [1][2] - Amarin's cash position stands at $307 million, providing a stable capital foundation for ongoing operations and strategic investments [1][8] Financial Performance - Total net revenue for Q2 2024 was $67.5 million, down from $80.2 million in Q2 2023, marking a 16% decline [3] - Net product revenue decreased by 27% to $47.5 million in Q2 2024 from $65.2 million in Q2 2023, with U.S. net product revenue falling from $64.6 million to $43.8 million [3] - Licensing and royalty revenue increased to $20 million in Q2 2024, including a $15 million milestone payment for regulatory approval in China [4] Cost Management - Operating expenses were reduced by 24% to $43.3 million in Q2 2024 from $56.6 million in Q2 2023, largely due to a restructuring plan implemented in July 2023 [3][4] - The company achieved $50 million in annual savings from workforce reductions announced in July 2023 [2][5] Product Developments - EDDINGPHARM, Amarin's partner, received regulatory approval for VASCEPA in China for cardiovascular risk reduction [2] - A new patent for VAZKEPA was granted by the European Patent Office, extending exclusivity until 2039 [2] Market Position - VASCEPA/VAZKEPA is positioned as a significant treatment for cardiovascular risk, supported by strong scientific evidence and intellectual property [1][2] - The company is focused on maximizing cash generation from U.S. and international markets while preserving cash for strategic opportunities [8]
3 Breakthrough Stocks Under $10 Set for Massive Upside
Investor Place· 2024-07-29 18:26
Core Insights - The article highlights three breakthrough stocks under $10, each demonstrating strong fundamentals and high upside potential in their respective sectors. Group 1: Arq (ARQ) - Arq produces activated carbon and environmentally efficient carbon products, reporting Q1 2024 revenue of $21.7 million, a 4% increase year-over-year despite a 6% reduction in volumes due to higher average selling prices and a favorable product mix [3][4] - The company's gross margin improved significantly to 37% from 17% in the previous year, indicating a focus on profitability over volume and effective operational cost management [3][4] - Arq secured a strategic supply contract for its GAC product, forecasting 5 million pounds per year, which represents approximately 20% of its Red River facility's capacity, with deliveries expected to start in Q1 2025 [4] Group 2: Amarin (AMRN) - Amarin specializes in cardiovascular disease treatments, achieving a 65% increase in in-market sales in Europe in Q1 2024 compared to Q4 2023, with significant contributions from Spain and the UK [5][6] - In Spain, the number of patients on VAZKEPA therapy increased by 91%, while the UK saw a 28% growth in patient numbers during the same period, indicating strong market acceptance and demand [5][6] - European net product revenue grew by 35% from Q4 2023, reflecting successful market access and reimbursement efforts, positioning Amarin as a top pick among breakthrough stocks under $10 [6] Group 3: OppFi (OPFI) - OppFi is a financial tech company that has improved its credit performance, with the net charge-off rate decreasing by 1.1 percentage points to 47.9% of total revenue in Q1 2024, indicating better credit quality [7][8] - Recoveries of previously charged-off loan balances increased by 33.5% annually, showcasing OppFi's enhanced ability to recover funds and contributing to its financial health [7] - The company's total expenses as a percentage of consolidated top-line increased by 1.1% annually to 45.5%, but adjusted expenses dropped by 2.7% to 40.6%, highlighting a focus on operational efficiency and cost control [8]