Amicus Therapeutics(US:FOLD)2025-11-04 21:03Revenue Performance - For the nine months ended September 30, 2025, Galafold revenue was $371.5 million, an increase of $40.9 million compared to the same period in the prior year[85]. - For the same period, Pombiliti + Opfolda revenue was $77.5 million, with approvals in multiple countries including the U.S., E.U., and Japan[85]. - Net product sales for the three months ended September 30, 2025, were $169.1 million, an increase of $27.5 million from $141.5 million in the same period of 2024[94]. - Net product sales increased by $70.4 million to $448.998 million for the nine months ended September 30, 2025, compared to $378.589 million in the same period of 2024[98]. - Gross profit rose to $402.616 million, reflecting a $62.13 million increase from $340.482 million in the prior year[98]. Expenses - The cost of goods sold increased by $6.2 million to $19.5 million, primarily due to the increase in net product sales[95]. - Research and development expenses for the three months ended September 30, 2025, were $23.4 million, a decrease of $2.7 million from $26.2 million in 2024[95]. - Research and development expenses increased by $32.9 million to $112.102 million, primarily due to a $30.0 million upfront license payment to Dimerix[98]. - Selling, general, and administrative expenses increased by $14.9 million to $90.0 million, driven by higher professional fees and increased personnel costs[96]. - Selling, general, and administrative expenses rose by $29.7 million to $266.406 million, driven by higher personnel costs and professional fees[99]. Cash and Investments - Total cash, cash equivalents, and marketable securities as of September 30, 2025, was $263.8 million[90]. - Cash, cash equivalents, and marketable securities totaled $263.8 million as of September 30, 2025[104]. - Net cash provided by operations was $16.9 million for the nine months ended September 30, 2025, compared to a net cash used of $30.0 million in the same period of 2024[105][106]. - Net cash used in investing activities was $39.9 million, primarily for the purchase of marketable securities[107]. - The company has $164.2 million available under its at-the-market equity program as of September 30, 2025[103]. Future Outlook - An exclusive license agreement was entered into with Dimerix for the U.S. commercialization rights of DMX-200, with an upfront payment of $30 million and potential milestone payments totaling up to $590 million[83]. - DMX-200 is currently in a pivotal Phase 3 study for the treatment of Focal Segmental Glomerulosclerosis, with positive interim results reported[88]. - The company is committed to developing next-generation genetic medicines for Fabry and Pompe diseases[92]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory approvals for drug candidates[111]. Net Loss - Net loss attributable to common stockholders decreased by 42.04% to $28.800 million from $70.845 million in the previous year[98].