Amarin Corporation(AMRN) - 2025 Q3 - Earnings Call Transcript

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]