Amicus Therapeutics reported a total revenue of $154.7 million in Q2 2025, up 18% at constant exchange rates (CER). Galafold® revenue was $128.9 million, up 12% at CER, while Pombiliti® + Opfolda® revenue was $25.8 million, up 58% at CER. The company expects GAAP profitability in H2 2025.
Galafold® net product sales for Q2 2025 were $128.9 million, up 16% year-over-year, driven by new patient starts and strong compliance. Pombiliti® + Opfolda® net product sales for Q2 2025 were $25.8 million, up 63% year-over-year, due to high commercial demand and new launches in five countries. Total GAAP operating expenses increased to $148.9 million for Q2 2025.
Amicus Therapeutics anticipates exceeding $1 billion in total revenue in 2028 and reaching GAAP profitability in the second half of 2025. The company’s cash position at June 30, 2025, was $231.0 million. Regulatory approval was granted in Japan for Pombiliti + Opfolda in June, and the ACTION3 study of DMX-200 is on track for full enrollment by the end of the year.
Amicus reiterates its 2025 financial guidance, expecting total revenue growth of 15% to 22%, Galafold revenue growth of 10% to 15%, and Pombiliti + Opfolda revenue growth of 50% to 65%. Gross margin is expected to be in the mid-80s, with non-GAAP operating expenses of $380M to $400M, including a $30M upfront license payment. Amicus Therapeutics reported second quarter 2025 financial results, with a full reconciliation of GAAP results to non-GAAP adjusted measures available in the press release. The company defines non-GAAP Net Income as excluding specific expenses like share-based compensation and depreciation. A reconciliation of non-GAAP expectation to corresponding GAAP measure is not feasible due to high variability.
To discuss these results, Amicus Therapeutics will host a conference call and webcast on July 31, 2025, at 8:30 a.m. ET. Interested participants can register online to access the call. Galafold, an oral treatment for Fabry disease, stabilizes the body’s dysfunctional enzyme. Approximately 35 to 50 percent of Fabry disease patients may have amenable GLA variants.
Galafold is approved in over 40 countries, including the U.S. and EU, for adults with Fabry disease and amenable GLA variants. Adverse reactions to Galafold include headache and nausea. Galafold is not recommended for those with severe renal impairment or pediatric patients. Amicus Therapeutics focuses on developing medicines for rare diseases with a patient-centered approach. Amicus Therapeutics, Inc. provides non-GAAP financial measures alongside U.S. GAAP data to assist in evaluating operational performance and trends. These adjusted financial measures are considered in addition to GAAP information and are used for internal assessments. The company excludes certain GAAP items that do not impact basic operations.
The press release from Amicus Therapeutics, Inc. also contains forward-looking statements regarding regulatory approvals, commercialization plans, collaborations, and financial projections. The company acknowledges that these statements may not come to fruition due to inaccurate assumptions or unforeseen risks. Factors such as regulatory delays, unsuccessful negotiations, and financial needs could impact actual results. 1. The stock market saw a sharp decline today, with the Dow Jones Industrial Average dropping 500 points due to concerns over rising inflation and interest rates. The S&P 500 and Nasdaq also experienced losses, with tech stocks taking a hit.
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Read more at GlobeNewswire: Amicus Therapeutics Announces Second Quarter 2025 Financial