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]

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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].

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 ...

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]

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]

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]

| --- | --- | --- | --- | --- | |--------------------------------|---------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 ...

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]

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].