Amicus Therapeutics(US:FOLD)2023-11-08 19:59Financial Data and Key Metrics Changes - Total revenue for Q3 2023 reached $103.5 million, a 27% increase year-over-year, with a 22% growth at constant exchange rates [41][42] - Galafold achieved over $100 million in quarterly revenue for the first time, representing a 19% growth from Q3 2022 at constant currency [30][34] - The net loss for Q3 2023 was reduced to $22 million, or $0.07 per share, compared to a net loss of $33 million, or $0.12 per share in the prior year [42] Business Line Data and Key Metrics Changes - Galafold reported a revenue growth of 17% year-over-year at constant exchange rates, with a strong demand from both naive and treated patient populations [20][30] - Pombiliti and Opfolda are expected to generate around $10 million in revenue for the full year 2023, aligning with consensus expectations [24][31] - The company has transitioned all expanded access and clinical trial patients to commercial products in Germany, with positive feedback from healthcare providers [38][64] Market Data and Key Metrics Changes - The company holds approximately 60% of the global market share of treated admissible patients for Galafold, with strong uptake in naive populations [21][62] - The demand for Galafold continues to be strong globally, with significant growth expected in the family market, potentially reaching $1 billion in annual revenue in about five years [62][63] - The company is actively engaged in pricing and reimbursement negotiations in various countries, including Hong Kong, Turkey, and Singapore [22][64] Company Strategy and Development Direction - The company aims to sustain double-digit growth for Galafold and expand into new geographies while maintaining a strong financial position [19][33] - The focus is on transitioning clinical trial and expanded access patients to commercial supply while ensuring physicians have the necessary information about Pombiliti and Opfolda [64][66] - The company is investing in next-generation therapies for Fabry and Pompe diseases, including gene therapy and next-generation chaperones [40][94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving non-GAAP profitability in Q4 2023, supported by strong revenue growth and careful expense management [18][42] - The company anticipates continued demand from newly diagnosed patients and aims to treat patients earlier in their disease progression [93] - Management highlighted the importance of generating new evidence and publications to support the launch of Pombiliti and Opfolda [6][9] Other Important Information - The company has submitted reimbursement dossiers in over a dozen countries and is focused on securing broad patient access throughout the EU [65] - The recent refinancing of debt under more favorable terms positions the company well for long-term growth [43] Q&A Session Questions and Answers Question: Can you provide more color on the cadence of the launch? - Management indicated that the goal is to convert existing patients first, with expectations for new patient starts to increase next year as the conversion process is completed [46][47] Question: What are the key regions for regulatory submissions in 2024? - Management noted that multiple regulatory submissions are planned for next year, with revenue contributions expected primarily in 2025 [50] Question: Can you clarify what PRFs are and the progress on commercial patients? - PRFs refer to patient referral forms, with 66% of clinical trial patients having submitted these forms for reimbursement [52][54] Question: How are physicians deciding between your product and Nixviazyme? - Approximately 75% of patients are reported by physicians as not improving on standard care, which drives the decision to consider switching to Pombiliti and Opfolda [87][88]