Amicus Therapeutics Announces Second Quarter 2025 Financial Results and Corporate Updates

Core Insights - Amicus Therapeutics reported strong second quarter growth of 18% in total revenue, marking the seventeenth consecutive quarter of double-digit gains at constant exchange rates (CER) [3][4] - The company anticipates reaching GAAP profitability in the second half of 2025 and projects total revenue to exceed $1 billion by 2028 [3][4] Financial Performance - Total revenue for Q2 2025 was $154.7 million, up 18% at CER, with a currency tailwind contributing an additional $5 million or 4% [4] - Galafold generated revenue of $128.9 million, reflecting a year-over-year increase of 16% or 12% at CER [5][12] - Pombiliti + Opfolda revenue reached $25.8 million, representing a year-over-year increase of 63% or 58% at CER [5][12] - Total GAAP operating expenses for Q2 2025 were $148.9 million, an increase of 48% compared to $100.4 million in Q2 2024 [5][12] Product Insights - Galafold is an oral pharmacological chaperone for the treatment of Fabry disease, approved in over 40 countries [13] - Pombiliti + Opfolda is a two-component therapy for late-onset Pompe disease, recently granted regulatory approval in Japan for adult patients [16][12] Future Guidance - The company reiterates its 2025 financial guidance, expecting total revenue growth of 15% to 22%, with Galafold revenue growth projected at 10% to 15% and Pombiliti + Opfolda revenue growth at 50% to 65% [7] - Gross margin is expected to be in the mid-80% range, with non-GAAP operating expenses projected between $380 million and $400 million [7] Corporate Developments - The ACTION3 study of DMX-200 is on track for full enrollment by year-end, with the company having entered a licensing agreement with Dimerix for U.S. commercialization [12][3] - Cash, cash equivalents, and marketable securities totaled $231.0 million as of June 30, 2025, reflecting a decrease from $249.9 million at the end of 2024 [12]