PRINCETON, N.J. — November 4, 2025 — Leads & Copy — Amicus Therapeutics (Nasdaq: FOLD) reported its Q3 2025 financial results, with total revenue reaching $169 million, a 17% increase at CER. The company also announced positive GAAP net income of $17 million and a cash position of $264 million, a $33 million increase in Q3 2025.
According to Amicus Therapeutics Inc. President and CEO Bradley Campbell, the company achieved revenue growth of 17 percent and reached GAAP profitability, serving more patients than ever before, driven by new Galafold starts and growing adoption for Pombiliti + Opfolda. Enrollment in the Phase 3 study of DMX-200 remains on track for completion by year-end, and the company is well positioned to achieve its 2025 strategic objectives and deliver sustainable double-digit growth in the years ahead.
Third Quarter 2025 Financial Highlights:
Total revenues for the third quarter 2025 were $169.1 million, reflecting strong operational growth measured at constant exchange rates (CER)1 of 17% and a currency tailwind of ~$4 million.
Galafold (migalastat) net product sales for the third quarter 2025 were $138.3 million, representing a year-over-year increase of 15%, or 12% at CER1, driven by continued commercial execution in all markets, net new patient starts, and strong compliance.
Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales for the third quarter 2025 were $30.7 million, representing a year-over-year increase of 45%, or 42% at CER1, driven by high commercial demand and new launch countries.
Total GAAP operating expenses of $115.3 million for the third quarter 2025 increased by 8% as compared to $106.6 million for the third quarter 2024. Total non-GAAP operating expenses2 were up 15% to $95.4 million for the third quarter 2025 as compared to $82.6 million for the third quarter 2024.
GAAP net income of $17.3 million, or $0.06 per share basic and diluted, was achieved in the third quarter 2025, compared to a GAAP net loss of $6.7 million, or $0.02 per share basic and diluted, for the third quarter 2024. Non-GAAP net income2,3 was $54.2 million, or $0.18 per share basic and $0.17 diluted, for the third quarter 2025, compared to non-GAAP net income of $30.8 million, or $0.10 per share basic and diluted, for the third quarter 2024.
Cash, cash equivalents, and marketable securities increased to $263.8 million at September 30, 2025, as compared to $249.9 million at December 31, 2024.
Corporate Updates:
Pombiliti + Opfolda pricing and reimbursement agreements recently completed in four countries, including Japan and Belgium. The Company remains on track for up to 10 new launch countries in 2025.
New 4-year data from the PROPEL open-label extension (OLE) adds to growing body of evidence for Pombiliti + Opfolda. As previously announced, in this new analysis presented at the International Congress of Inborn Errors of Metabolism (ICIEM), patients within the ERT-experienced group showed stability or improvement on measures of muscle function, muscle strength, and biomarkers out to 4 years.
During the third quarter, our manufacturing partner, WuXi Biologics, announced that its Dundalk, Ireland facility has received approval from European Medicines Agency (EMA) as a commercial manufacturing site for Pombiliti.
ACTION3 Study of DMX-200 is on track for full enrollment by end of year. DMX-200 is a first in class treatment for Focal Segmental Glomerulosclerosis (FSGS), a rare and fatal kidney disease with no approved therapies and significant market potential. The ongoing Phase 3 study (ACTION3), funded and executed by Dimerix, continues to be on track for full enrollment by end of 2025.
Amicus is focused on delivering significant long-term revenue growth and anticipates surpassing $1 billion in total sales in 2028. The Company anticipates continuing to grow its current commercial business with Galafold and Pombiliti + Opfolda resulting in strong total revenue growth.
2025 Financial Guidance
Amicus reiterates its financial guidance for 2025, as follows:
Contact:
Investors:
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809
Media:
Brendan McEvoy
Executive Director, External Communications
bmcevoy@amicusrx.com
(609) 662-5005
Source: Amicus Therapeutics
