Amicus Therapeutics(FOLD) - 2024 Q4 - Annual Results

Revenue Growth - Total revenue for FY 2024 reached approximately $528 million, representing a 32$2.1 billion in 2024 to over $3 billion by 2029, driven by improved diagnosis and treatment rates[10][11] - The global Pompe disease market is projected to grow from approximately$1.5 billion in 2024 to over $2 billion by 2029, driven by increased diagnosis and treatment[29] Patient Demographics - The number of patients treated for Fabry disease has more than doubled since 2015, with approximately 12,000 currently treated in the U.S.[13][22] - The company has identified over 100,000 undiagnosed individuals with Fabry disease in the U.S., highlighting a significant unmet need in the market[21] - The company serves over 3,000 patients living with rare diseases[52] Product Performance - Galafold continues to be the leading oral treatment for Fabry disease, capturing over 60$70.3 million in revenue in FY 2024, with expectations of 65-85% growth in FY 2025[49] Clinical Development - Ongoing clinical studies are focused on expanding the label for Pombiliti and Opfolda, with evidence generation supporting their differentiated mechanism of action[46] Geographic Expansion - The company anticipates launching in up to 10 new countries in 2025, expanding access to therapies for over 650 late-onset Pompe disease patients[44] - The company has expanded access to 40 patients across 16 countries as of November 2024[60] Financial Considerations - A 4% variance in USD exchange rates could negatively impact total revenue by approximately $15 million in 2025[57] - Approximately 60$1,980,516 to U.S. community programs[60] Revenue Distribution - The average quarterly distribution of Galafold revenue over the past 5 years shows Q4 at 28%[58]