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Amicus Therapeutics (FOLD) investor relations material
Amicus Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary4 Nov, 2025
Executive summary
Achieved Q3 2025 revenue of $169.1 million, up 19% year-over-year (17% at constant exchange rates), with GAAP net income of $17.3 million, marking a shift to profitability and record demand for Galafold and Pombiliti + Opfolda.
Non-GAAP net income for Q3 2025 was $54.2 million ($0.18/share basic, $0.17 diluted), up from $30.8 million in Q3 2024.
Advanced late-stage pipeline with DMX-200 for FSGS, with pivotal Phase 3 study over 90% enrolled and exclusive U.S. license agreement including a $30 million upfront payment.
Reaffirmed confidence in reaching $1 billion combined sales for Galafold and Pombiliti + Opfolda by 2028.
Strategic priorities include double-digit revenue growth, advancing clinical programs, and maintaining profitability.
Financial highlights
Q3 2025 revenue reached $169.1 million, up from $141.5 million in Q3 2024.
GAAP net income was $17.3 million ($0.06/share), compared to a net loss of $6.7 million in Q3 2024.
Gross profit for Q3 2025 was $149.6 million, with gross margin approximately 88.5%.
Cash, cash equivalents, and marketable securities increased to $263.8 million as of September 30, 2025.
Non-GAAP operating expenses for Q3 2025 were $95.4 million, up 15% year-over-year.
Outlook and guidance
Reiterated 2025 full-year revenue growth guidance of 15%-22%, with Galafold growth of 10%-15% and Pombiliti + Opfolda at 50%-65%, all at constant exchange rates.
Gross margin projected in the mid-80% range, likely at the top end.
Non-GAAP operating expenses anticipated at the high end of $380M-$400M guidance, including a $30M DMX-200 license payment.
Positive GAAP net income expected for the second half of 2025.
Expects to surpass $1B in total sales by 2028, with continued double-digit growth anticipated.
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Next Amicus Therapeutics earnings date
UBS Global Healthcare Conference 202510 Nov, 2025
Next Amicus Therapeutics earnings date
UBS Global Healthcare Conference 202510 Nov, 2025
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Frequently asked questions
Amicus Therapeutics Inc. is a biotechnology company focused on developing and commercializing treatments for rare and orphan diseases. The company specializes in therapies for lysosomal storage disorders and other genetic conditions, leveraging proprietary technologies in protein engineering and gene therapy. Amicus Therapeutics Inc. is headquartered in Princeton, New Jersey, and its shares are listed on the NASDAQ.
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