Revenue Growth - For the three months ended March 31, 2025, net product sales increased by $14.8 million to $125.2 million compared to the same period in the prior year, driven by growth in Galafold and Pombiliti + Opfolda[87]. - Galafold revenue for the same period was $104.2 million, reflecting an increase of $4.9 million year-over-year, indicating strong commercial momentum[79]. - Pombiliti + Opfolda generated $21.0 million in revenue, with approvals in multiple regions including the U.S., E.U., and U.K.[79]. Financial Position - Total cash, cash equivalents, and marketable securities as of March 31, 2025, amounted to $250.6 million[80]. - The net loss attributable to common stockholders improved to $21.7 million from $48.4 million in the prior year, representing a reduction of 26.7%[87]. - The current cash position is believed to be sufficient to fund operations and ongoing research programs for at least the next 12 months[101]. Expenses - Research and development expenses for the three months ended March 31, 2025, were $27.8 million, a slight decrease from $28.3 million in the prior year[88]. - Selling, general, and administrative expenses increased by $3.8 million, primarily due to higher personnel costs and facility-related expenses[89]. Cash Flow - Net cash provided by operations for Q1 2025 was $7.8 million, reflecting a net loss of $21.7 million adjusted for non-cash expenses of $23.4 million[95]. - Net cash used in operations for Q1 2024 was $29.7 million, with a net loss of $48.4 million and a decrease in operating assets and liabilities of $22.3 million[96]. - Net cash used in investing activities for Q1 2025 was $32.9 million, primarily due to $38.8 million for the purchase of marketable securities[97]. - Net cash provided by investing activities for Q1 2024 was $7.5 million, reflecting $38.9 million from the sale and redemption of marketable securities[98]. - Net cash used in financing activities for Q1 2025 was $11.7 million, mainly from withholding taxes paid on vested restricted stock units of $11.8 million[99]. - Net cash used in financing activities for Q1 2024 was $13.3 million, primarily due to withholding taxes of $16.7 million on vested restricted stock units[100]. Future Outlook - The company expects to incur significant costs in the foreseeable future primarily due to research and development expenses, including clinical trials[101]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory approvals for drug candidates[102]. Agreements and Commitments - The company entered into an exclusive license agreement with Dimerix for DMX-200, with an upfront payment of $30 million and potential milestone payments totaling up to $75 million[77]. - The company has established reimbursement agreements for Pombiliti + Opfolda in multiple E.U. countries, enhancing market access[79]. - The company is committed to developing next-generation therapies for Fabry and Pompe diseases, focusing on innovative genetic medicines[85]. Accounting Policies - There have been no significant changes to the company's accounting policies and estimates during Q1 2025[104].
Amicus Therapeutics(FOLD) - 2025 Q1 - Quarterly Report