| --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------------|-------|--------------------------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Third Quarter 2024 Business Update & Financial Results Conference Call | | | | | | | | | | | | | | | | | | October 30, 2024 | | | | | | | | Forward Looking Statements & Discl ...

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 ...

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced new supported and/or funded subgroup data from the landmark REDUCE-IT® cardiovascular outcomes trial with VASCEPA®/VAZKEPA® (icosapent ethyl), as well as abstracts showcasing the mechanistic activity of eicosapentaenoic acid (EPA) that will be presented at the European Society of Cardiology (ESC) Congress in London, United Kingdom, August 30 – September 2, 2024. The accepted abstract ...

Amarin Corporation plc (AMRN) reported break-even quarterly earnings in second-quarter 2024 against the Zacks Consensus Estimate of a loss of 5 cents per share. The company recorded an adjusted loss of 4 cents per share in the year-ago quarter.Total revenues were $67.5 million, which beat the Zacks Consensus Estimate of $46 million. However, revenues declined 16% from the year-ago quarter’s levels, owing to lower product revenues.Despite the better-than-expected results, shares of Amarin were down 12.9% on ...

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].

-- 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 ...