Amicus Therapeutics (FOLD) Q1 2025 earnings summary

Executive summary

• Achieved Q1 2025 total revenue of $125.2M, up 15% year-over-year at constant exchange rates, driven by strong demand for Galafold and rapid growth in Pombiliti + Opfolda sales.

• Strategic U.S. licensing agreement for DMX-200, a Phase 3 asset for FSGS, with $30M upfront and up to $560M in milestones, expanding the rare disease pipeline.

• Net loss narrowed to $21.7M from $48.4M in Q1 2024; non-GAAP net income was $9.0M, marking a return to non-GAAP profitability.

• Cash, cash equivalents, and marketable securities totaled $250.6M as of March 31, 2025.

• On track to achieve GAAP profitability in the second half of 2025 and targeting $1B+ in total sales by 2028.

Financial highlights

• Galafold Q1 2025 revenue reached $104.2M, up 6% at constant exchange rates, with 14% global patient demand growth and 69% share of treated amenable Fabry patients.

• Pombiliti + Opfolda Q1 2025 revenue was $21.0M, up 92% at constant exchange rates, with strong U.S. growth and expanding prescriber base.

• Cost of goods sold was 9.3% of net sales, down from 12.3% last year; gross margin improved to 90.7%.

• GAAP net loss narrowed to $21.7M ($0.07/share) from $48.4M ($0.16/share) last year; non-GAAP net income was $9.0M ($0.03/share) vs. a loss of $4.6M ($0.02/share) last year.

• Cash and equivalents stood at $250.6M at quarter end.

Outlook and guidance

• Updated 2025 total revenue growth guidance to 15–22% at constant exchange rates, reflecting timing of new patient starts and DMX-200 licensing impact.

• Galafold revenue growth guidance maintained at 10–15% at CER; Pombiliti + Opfolda guidance revised to 50–65% at CER.

• Non-GAAP operating expenses expected at $380M–$400M, including $30M DMX-200 upfront payment; gross margin expected in mid-80% range.

• On track to achieve GAAP profitability in H2 2025.

• Current cash position expected to fund operations and research for at least 12 months.