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 compared to Q3 2024, with a 17% growth at constant exchange rates [23] - GAAP net income for Q3 2025 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][25] - Non-GAAP net income for Q3 2025 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 [25] 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 year-over-year patient demand increase of 13% [10] - 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 [14] Market Data and Key Metrics Changes - Approximately 69% of the global market share of treated Fabry patients with amenable mutations is held by Galafold [10] - The U.S. represented approximately 43% of Pombiliti and Opfolda revenue, while ex-U.S. accounted for 57% [15] Company Strategy and Development Direction - The company aims to achieve combined sales of $1 billion for its two commercial products by 2028, supported by growing diagnostic rates and patient access [7] - The company is advancing the development of DMX-200, a therapy for FSGS, with over 90% enrollment in the ACTION3 pivotal study expected to complete by year-end [8][21] Management's 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 robust new patient starts [5] - The company anticipates positive GAAP net income for the second half of 2025 and reiterated full-year financial guidance for 2025, projecting total revenue growth of 15%-22% [26][27] Other Important Information - The company highlighted the significant unmet need in Fabry disease, with over 6,000 diagnosed patients remaining untreated, indicating a larger market opportunity for Galafold [12] - The company is focused on expanding its market presence and increasing patient compliance and adherence rates above 90% [16] Q&A Session Summary Question: Reception of Pombiliti in the U.S. and real-world evidence impact - Management noted that the label for Pombiliti has been well received, with ongoing studies expected to support label expansion for pediatric patients [32] - Real-world evidence is increasingly important in discussions with physicians, and the company plans to continue supporting publications and presentations [33][34] Question: U.S. new patient starts and revenue trajectory for 2026 - Management reported significant increases in new patient starts in Q3 and expressed confidence in continued momentum into 2025 [42] - The company is focused on expanding its sales force and enhancing real-world evidence to drive revenue growth [43] Question: Galafold patient adds from core vs. emerging countries - The growth in patient adds is primarily driven by core countries, with a significant number of naive patients being diagnosed [48][49] Question: DMX-200 candidate selection based on MCP-1 levels - Management indicated that higher MCP-1 levels correlate with more robust responses to DMX-200, and they are measuring MCP-1 throughout the phase three study [54][55] Question: Impact of Biosecure 2.0 on Pombiliti usability in the U.S. - Management expressed confidence in maintaining a stable supply from the Ireland facility and highlighted the importance of providing evidence to physicians regarding Pombiliti [59][60] Question: Timing for infantile onset Pompe disease label expansion - Management anticipates a submission for adolescent patients mid-next year, with further progress expected for infantile onset patients thereafter [66][68] Question: Commercial trajectory of Pombiliti and market share expectations - Management is confident in continued growth and aims for over 50% market share at peak for Pombiliti, with a target of exceeding $1 billion in revenue [71][72]