Financial Data and Key Metrics Changes - Total revenue for Q3 2025 grew 69% year over year to $87.3 million [4][18] - U.S. net product revenue increased 31% year over year to $40.7 million [4][18] - Collaboration revenue rose approximately 128% to $46.7 million compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - U.S. prescription growth saw nearly double-digit sequential growth, contributing to the overall revenue increase [4] - Average approval rate for Medicare coverage reached 87%, with out-of-pocket costs reduced significantly [10][11] - Total retail prescription equivalents increased by 9% from Q2 2025, with a 7% increase in the number of healthcare professionals prescribing Nexletol and Nexlizet [12] Market Data and Key Metrics Changes - The company outpaced the broader adjunct lipid-lowering market, achieving growth that exceeded all other non-statin products [6] - Royalty revenue from Daiichi Sankyo Europe increased 21% sequentially to $16.4 million [14] Company Strategy and Development Direction - The company is focused on expanding patient access programs and enhancing marketing strategies to drive future growth [4][5] - Strategic agreements with four generic manufacturers were finalized to protect the long-term value of its products [5] - The inclusion of bempedoic acid in ESC/EAS guidelines is expected to support expanded utilization and reinforce the company's market position [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustainable profitability by Q1 2026, despite one-time costs impacting net income [24] - The company anticipates continued growth momentum driven by strong execution and strategic investments [21][31] Other Important Information - The company closed a $75 million follow-on equity offering to ensure adequate capital for future developments [20] - The launch of Nexletol in Japan is expected to occur shortly after final pricing approval, which is anticipated within weeks [31][15] Q&A Session Summary Question: What were the drivers behind the gross margins for this quarter? - Gross margin drivers included low-margin tablet sales to partners, with expectations for improvement in 2026 as manufacturing is transferred [22] Question: Can you comment on achieving sustainable profitability in Q1 of 2026? - Management confirmed tracking in line with forecasts for sustainable ongoing profitability, with many Q3 expenses being one-time or non-recurring [24] Question: Regarding reimbursement per script, why were U.S. revenues flat despite a 9% increase in scripts? - One-time investments were made to secure preferred access with Medicare plans, impacting short-term revenue but expected to benefit future growth [25][27] Question: What feedback has been received regarding the ESC/EAS guidelines? - Positive feedback from partners indicates excitement among physicians regarding the guidelines, which are expected to enhance market reception [30] Question: What is the status of the 340B utilization of Nexletol and Nexlizet? - 340B utilization is minimal and not expected to impact revenue outlook [33] Question: What is the plan for the PSC pipeline and IND filing? - The company is in the planning phase for the PSC pipeline and aims to move quickly due to the high unmet need [34]

Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $49.7 million, an increase of $7.4 million or 17% compared to the prior year period, primarily due to higher U.S. sales [18] - Net product revenue was $48.6 million, reflecting a 16% increase [18] - U.S. net product revenue reached $40.9 million, a 34% increase driven by a change in customer mix and increased volume [19] - Operating loss was $11.1 million, which is $14.1 million or 56% lower than Q3 2024, indicating improved operational efficiency [22] - Q3 2025 operating margin was negative 22%, a significant improvement from negative 60% in the prior year [22] Business Line Data and Key Metrics Changes - The U.S. business maintained over 50% share of the IPE market, demonstrating resilience five years post-generic entry [10] - European product revenue was $4.1 million, consistent with the prior year, reflecting the transition to a partnered model with Recordati [19] - Rest of world product revenue was $3.6 million, a decline from the prior year, attributed to variability in supply shipments [20] Market Data and Key Metrics Changes - The transition to a partnered commercial model with Recordati is progressing well, with expectations for full management of European commercialization by the end of 2025 [8] - The company is focused on expanding patient access in key growth geographies, leveraging partnerships to drive demand [9] Company Strategy and Development Direction - The partnership with Recordati marks a strategic shift to a fully partnered commercial model across international markets, aiming to enhance revenue generation [5] - The company is committed to reducing the cardiovascular disease burden and has implemented a global restructuring to achieve operational efficiency, targeting $70 million in OpEx savings [7] - The focus remains on maximizing the clinical impact of VASCEPA while ensuring financial strength in the U.S. market [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic actions taken and the potential for growth, particularly in underpenetrated markets [17] - The company anticipates achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [22] Other Important Information - The FDA's recent update on phenofibrates is expected to shift clinical practices, potentially benefiting VASCEPA as a preferred therapy for cardiovascular risk reduction [14][15] - The company ended the quarter with $286.6 million in cash and investments, no debt, and working capital of $446 million, indicating a stable capital structure [22] Q&A Session Summary Question: U.S. net price trajectory for the back half of 2025 and into 2026 - Management anticipates consistency in U.S. net prices for the remainder of 2025, with ongoing negotiations for 2026 [25][29] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [27] Question: Gross margin trajectory with a shift towards supply sales to partners - A decline in gross margin percentages is expected as the company moves to a partnered model, but lower operating expenses will benefit operating margins [30] Question: European sales dip due to the transition to Recordati - The transition is expected to normalize by 2026, with anticipated lower restructuring costs moving forward [43] Question: Impact of phenofibrate update on U.S. and Rest of World practices - The FDA's update is expected to influence prescribing practices globally, potentially benefiting VASCEPA as a preferred therapy [46][47] Question: Decline in rest of world revenue compared to Q3 2024 - The decline is attributed to variability in supply shipments and the absence of larger launches in the current quarter [50]

Strategic Partnerships & Financial Restructuring - Amarin has entered into an exclusive license and supply agreement with Recordati to commercialize VAZKEPA in 59 countries, primarily in Europe[13] - The Recordati agreement includes $25 million in upfront cash[9] and up to $150 million in milestone payments based on net sales levels[9] - Global restructuring is expected to generate approximately $70 million in cost savings over the next 12 months[6, 16, 24] VAZKEPA/VAZKEPA Market & Growth - VAZKEPA has CVRR indication regulatory approvals in 49 global markets[7] - Demand for VASCEPA/VAZKEPA has grown by 77% in aggregate, comparing Q1 2025 to Q1 2024[22] - The company maintains over 40% share of the IPE market in the U S [21] US Market & Global Expansion - The refined commercial strategy in the U S focuses on payer coverage post-loss of exclusivity[21] - Partnerships in Rest of World are focused on maximizing patient access to VASCEPA globally, with commercialization across 11 countries and regulatory submissions pending in 8 additional markets[23]

Financial Performance - Total revenue for Q1 2025 was $42.0 million[14, 21] - U S revenue was $35.7 million, a ~26% year-over-year reduction[21] - Europe revenue was $5.4 million, a ~284% year-over-year increase[14, 21] - Operating expenses for Q1 2025 were $41.9 million, an 8% reduction year-over-year[14, 19] - The company maintained a strong cash position with $281.8 million and no debt[14, 24] Business Updates - Achieved sequential growth in in-market demand across all European markets where VAZKEPA was launched, particularly in Spain, the UK, and CEE[13] - Secured pricing and reimbursement in Austria and continued progress in other EU markets[13] - CSL's efforts led to VAZKEPA's inclusion in the National Heart Foundation/Cardiac Society Acute Coronary Syndrome guidelines in Australia[13] - Edding continued CVRR launch in the private pay market in China, working towards National Reimbursement Drug List (NRDL) review for 2026[13] Strategic Priorities - Drive growth in access and revenue in Europe and Rest of World markets[30] - Drive efficient VASCEPA U S revenue generation[30] - Support research that reinforces VASCEPA science and therapeutic value[30] - Maintain fiscal and operational discipline while pursuing all avenues to maximize shareholder value[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]