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, primarily due to higher U.S. sales [21] - Net product revenue was $48.6 million, reflecting a $6.7 million or 16% increase [21] - U.S. net product revenue reached $40.9 million, a significant increase of $10.3 million or 34%, driven by a change in customer mix and increased volume [22] - Operating loss for Q3 2025 was $11.1 million, which is $14.1 million or 56% lower than Q3 2024, indicating improved operational efficiency [25] - Operating margin improved to -22% from -60% in the prior year [25] - Cash and investments at the end of the quarter totaled $286.6 million, with no debt and working capital of $446 million [26] Business Line Data and Key Metrics Changes - The transition to a partnered model with Recordati has begun to show results, with product revenue from Europe at $4.1 million, consistent with the prior year [22][23] - Revenue from the rest of the world was $3.6 million, a decline from the prior year, attributed to variability in supply shipments and market demand [23][50] - SG&A expenses were reduced to $19.7 million, a decrease of $17.2 million or 47% compared to the prior year [24] Market Data and Key Metrics Changes - VASCEPA maintained over 50% market share in the IPE market in the U.S., demonstrating resilience five years post-generic entry [11] - The company anticipates that Recordati will fully manage European commercialization by the end of 2025, with sustained momentum in demand across all commercialized European markets [9][10] Company Strategy and Development Direction - The partnership with Recordati marks a strategic shift to a fully partnered commercial model in international markets, aiming to leverage expertise across nearly 100 markets [5][6] - The company is focused on reducing the cardiovascular disease burden globally, with a commitment to operational efficiency and cost savings of $70 million over the next year [8] - The transition to a partnered model is expected to enhance revenue generation and operational efficiency, with a focus on maximizing the clinical impact of VASCEPA [12][19] 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 [19] - The company is optimistic about achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [26] - The FDA's recent actions regarding fenofibrates are seen as an opportunity to shift clinical practice towards more effective therapies like VASCEPA [14][17] Other Important Information - Restructuring expenses totaled $9.4 million for the quarter, with a total of $32.2 million incurred to date [25] - The company is committed to advancing cardiovascular care through a strong presence at major medical meetings, including the European Society of Cardiology conference [12] Q&A Session Summary Question: U.S. net price trajectory for the back half of 2025 and into 2026 - Management anticipates U.S. net prices to remain consistent for the remainder of 2025, with ongoing negotiations for rebate percentages for 2026 [28][30] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [30] Question: Decline in rest of world revenue - The decline is attributed to variability in supply shipments and the absence of larger launches in the current quarter [48][50]

Core Viewpoint - The FDA's recent update to fenofibrate drug labeling highlights the lack of cardiovascular benefits and aims to shift clinical practices towards therapies that are clinically proven to reduce cardiovascular events [1][2][3] Company Perspective - Amarin Corporation supports the FDA's decision, emphasizing the need for healthcare practitioners to stop prescribing fibrates for cardiovascular risk reduction, particularly in combination with statins, as this approach is outdated and ineffective [5][6] - The company advocates for the use of FDA-approved therapies like VASCEPA (icosapent ethyl) to reduce cardiovascular risks in patients with elevated triglycerides [6][10] Industry Context - Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 900,000 deaths annually in the U.S. and nearly 20 million worldwide [2] - Despite evidence from major clinical trials (FIELD, ACCORD Lipid, PROMINENT) showing that fenofibrates do not reduce cardiovascular event risks, over 11 million prescriptions were written in the U.S. in 2023, indicating a significant gap in clinical practice [3][4] - In Europe, fibrates are the third most commonly used lipid management agents, with an estimated two million patients treated with fibrates in Western Europe [4] Clinical Evidence - The FDA's labeling change is based on decades of clinical data demonstrating that fenofibrates do not provide cardiovascular benefits, even when used with statins [3] - The company highlights the importance of aligning treatment decisions with current scientific understanding to improve patient outcomes in cardiovascular health [7]