Amicus Therapeutics(FOLD) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $169.1 million, a 19% increase year-over-year, with a 17% growth at constant exchange rates [22] - GAAP net income was $17.3 million, or $0.06 per share, compared to a net loss of $6.7 million, or $0.02 per share, in Q3 2024, marking the first quarter of positive GAAP net income in 2025 [24] - Non-GAAP net income was $54.2 million, or $0.18 per share, compared to $30.8 million, or $0.10 per share, in the same quarter last year [24] Business Line Data and Key Metrics Changes - Galafold revenue reached $138.3 million, up 12% at constant exchange rates and 15% in reported terms, with a 13% year-over-year increase in patient demand [8][22] - Pombiliti and Opfolda generated $30.7 million in revenue for Q3, a 42% increase at constant exchange rates and 45% in reported terms, with year-to-date growth of 59% at CER [12][22] Market Data and Key Metrics Changes - Approximately 69% of the global market share of treated Fabry patients with amenable mutations is held by Galafold, with a significant opportunity for further market penetration [8] - The U.S. represented approximately 43% of Pombiliti and Opfolda revenue, while ex-U.S. accounted for 57% [13] Company Strategy and Development Direction - The company aims to achieve combined sales of $1 billion for its two commercial products by 2028, supported by strong growth in Galafold and Pombiliti and Opfolda [5][6] - The company is advancing the development of DMX-200, a late-stage therapy for FSGS, with over 90% enrollment in the ACTION3 pivotal study [6][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth in the Fabry and Pompe core business, driven by record demand and new patient starts [4][5] - The company anticipates positive GAAP net income for the second half of 2025 and reiterated full-year financial guidance for total revenue growth of 15%-22% [25][24] Other Important Information - The company is focused on expanding its market presence and improving patient access, with ongoing efforts to enhance awareness and diagnosis of Fabry disease [10][11] - The company has secured reimbursement in 15 countries for Pombiliti and Opfolda, with plans to launch in up to 10 new countries in 2024 [16] Q&A Session Summary Question: Can you discuss the reception of Pombiliti's label and real-world evidence? - Management noted that the label has been well received, with ongoing studies expected to support label expansion, particularly for pediatric patients [30] Question: What is the status of new patient starts in the U.S. for Pompe? - Management reported significant increases in new patient starts and improved time to reimbursement, contributing to strong growth [38] Question: How should we think about the commercial trajectory of Pombiliti in 2026? - Management expressed confidence in continued momentum and expects strong growth, aiming for over 50% market share at peak [64]