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 16% increase [21] - U.S. net product revenue reached $40.9 million, a 34% increase driven by a change in customer mix and increased volume [22] - Operating loss for Q3 2025 was $11.1 million, a 56% improvement from the previous year [25] - Cash and investments at the end of the quarter totaled $286.6 million, with no debt [25] Business Line Data and Key Metrics Changes - U.S. business maintained over 50% share of the IPE market, demonstrating resilience five years post-generic entry [11] - European product revenue was $4.1 million, consistent with the prior year, reflecting the transition to a partnered model with Recordati [22][23] - Rest of world product revenue was $3.6 million, a decline from the prior year, attributed to variability in supply shipments [23][51] Market Data and Key Metrics Changes - The transition to a partnered model in Europe is expected to normalize by the end of 2025, with anticipated growth in revenue as operations stabilize [24][42] - The FDA's recent update on phenofibrates may influence prescribing practices globally, potentially benefiting VASCEPA's market position [16][44] Company Strategy and Development Direction - The partnership with Recordati marks a 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 and maximizing the clinical impact of VASCEPA [8][18] - A restructuring initiative aims to achieve $70 million in operational expense savings over the next year [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic actions taken and the potential for growth in both U.S. and international markets [19] - The company anticipates achieving positive free cash flow by 2026, supported by a rightsized operating footprint and improved operating margins [19][26] - The management highlighted the importance of addressing cardiovascular disease through proven outcomes rather than solely improving biomarkers [17] Other Important Information - The company is committed to advancing cardiovascular care through a strong presence at major medical meetings, including the European Society of Cardiology 2025 conference [12] - Restructuring expenses totaled $9.4 million for the quarter, with expectations for lower costs moving forward [25] 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 pricing for the remainder of 2025, with ongoing negotiations for 2026 [29][32] Question: Future milestone payments from Recordati - Milestone payments are based on sales performance, triggered as Recordati surpasses $100 million in sales [30][31] Question: Decline in rest of world revenue compared to Q3 2024 - Revenue variability in the rest of the world is due to timing of supply shipments and market demand, with no significant launches in the current quarter [49][51]