Amicus Therapeutics(FOLD) - 2025 Q3 - Quarterly Results

Financial Performance - Q3 2025 total revenue reached $169.1 million, reflecting a 17% increase at constant exchange rates (CER) and a currency tailwind of approximately $4 million[3] - GAAP net income for Q3 2025 was $17.3 million, compared to a net loss of $6.7 million in Q3 2024, marking a significant turnaround[4] - Galafold net product sales were $138.3 million in Q3 2025, a 15% year-over-year increase, while Pombiliti + Opfolda sales reached $30.7 million, up 45% year-over-year[4] - Net product sales for Q3 2025 reached $169.1 million, a 19.5% increase from $141.5 million in Q3 2024[26] - Gross profit for Q3 2025 was $149.6 million, compared to $128.2 million in Q3 2024, reflecting a gross margin improvement[26] - Non-GAAP net income for Q3 2025 was $54.2 million, significantly higher than $30.8 million in Q3 2024[32] Expenses and Liabilities - Total GAAP operating expenses for Q3 2025 were $115.3 million, an 8% increase from $106.6 million in Q3 2024[4] - Research and development expenses decreased to $23.4 million in Q3 2025 from $26.2 million in Q3 2024, indicating a 10.6% reduction[26] - Selling, general, and administrative expenses increased to $90.0 million in Q3 2025, up from $75.1 million in Q3 2024, representing a 19.9% rise[26] - The company’s total liabilities rose to $638.4 million as of September 30, 2025, compared to $591.0 million at the end of 2024[28] Cash Position and Assets - Cash position increased to $263.8 million as of September 30, 2025, up from $249.9 million at the end of 2024[4] - Cash and cash equivalents decreased to $190.6 million from $213.8 million at the end of 2024[28] - Total assets increased to $868.8 million as of September 30, 2025, up from $785.0 million at the end of 2024[28] - The weighted-average common shares outstanding for Q3 2025 were 308.5 million, slightly up from 304.7 million in Q3 2024[32] Future Projections - Amicus anticipates total revenue growth of 15% to 22% for 2025, with Galafold revenue growth projected at 10% to 15% and Pombiliti + Opfolda revenue growth expected between 50% to 65%[6] - The company aims to achieve positive GAAP net income during the second half of 2025[6] - Amicus is focused on surpassing $1 billion in total sales by 2028, driven by growth in Galafold and Pombiliti + Opfolda[12] - Enrollment in the Phase 3 study of DMX-200 is on track for completion by year-end 2025, targeting a rare kidney disease with significant market potential[12] Market Expansion - New pricing and reimbursement agreements for Pombiliti + Opfolda were completed in four countries, including Japan and Belgium, with plans for up to 10 new launch countries in 2025[12]