Amicus Therapeutics, Inc.

For Q3 2025, total revenue was $169.1 million, up 19% year over year, or 17% at constant exchange rates. Galafold revenue was $138.3 million, up 15% reported and 12% at constant exchange rates, while Pombiliti and Opfolda revenue was $30.7 million, up 45% reported and 42% at constant exchange rates. GAAP net income was $17.3 million, or $0.06 per share, versus a GAAP net loss of $6.7 million, or $0.02 per share, in Q3 2024. Gross margin was not stated directly, but cost of goods sold was 12% of net sales versus 9% last year. Cash, cash equivalents and marketable securities were $263.8 million at September 30, 2025, up $32.8 million sequentially and above $249.9 million at year-end 2024. For full-year 2025, management reiterated guidance for total revenue growth of 15% to 22%, Galafold growth of 10% to 15%, Pombiliti and Opfolda growth of 50% to 65% at constant exchange rates, gross margin in the mid-80s and likely at the top end of 83% to 87%, non-GAAP operating expense of $380 million to $400 million with a likely high-end outcome, and positive GAAP net income for the second half of 2025.

Bradley Campbell framed the quarter as another strong execution period, emphasizing growth in both commercial products, GAAP profitability and a growing cash position. He highlighted record demand for Galafold and Pombiliti/Opfolda, confidence in sustaining momentum into 2026, and the company’s longer-term goal of $1 billion in combined sales in 2028. His tone was upbeat and confident, but he also noted that label expansion, especially in Pompe, remains important to broaden the patient base.

Simon Harford focused on the financial step-up: $169.1 million in revenue, $17.3 million in GAAP net income, and $54.2 million in non-GAAP net income for Q3. He said COGS were 12% of net sales, operating expenses rose year over year, and cash increased to $263.8 million, with the company also generating cash in the quarter. He reiterated full-year 2025 guidance and said gross margin should be in the mid-80s, likely near the top of the 83% to 87% range, while non-GAAP opex should land near the high end of $380 million to $400 million.

Analysts focused on what is driving Pombiliti/Opfolda switching behavior, the role of real-world evidence, and whether physicians are changing their threshold to switch patients. Management said the label has been well received, but that they want further label expansion, particularly into pediatric Pompe, and that long-term data, indirect comparisons, and case studies are increasingly important in physician discussions. On Pompe growth, management said U.S. new patient starts and breadth of prescribing improved materially, and that momentum from new launches and real-world evidence should support 2026. On DMX-200, management said higher MCP-1 levels appear correlated with stronger response, but no MCP-1 entry threshold was used in Phase III; ACTION3 remains over 90% enrolled and on track for year-end completion.