Short answer
AMICUS THERAPEUTICS, INC. (FOLD) filed its fiscal 2025 10-K annual report with the SEC on Feb 20, 2026. It reported revenue of $634M (+20.0% year over year) and net income of −$27M.
- Top risk flagged: Regulatory risk: Pending merger requires Hart-Scott-Rodino Act antitrust approval and clearance from EU and Japanese authorities, risking delays or termination
FY2025 key financial metrics · XBRL
- Revenue
- $634M
- +20.0% YoY
- Net income
- −$27M
- +51.7% YoY
- Operating margin
- 5.2%
- +0.5 pp YoY
- Gross margin
- 88.5%
- −1.5 pp YoY
- EPS (diluted)
- −$0.09
- +50.0% YoY
- ROE
- -9.9%
- +19.0 pp YoY
- Operating cash flow
- $33M
- +197.8% YoY
Source: XBRL data from the AMICUS THERAPEUTICS, INC. (FOLD) FY2025 10-K on SEC EDGAR. USD.
AMICUS THERAPEUTICS, INC. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Global biotechnology company focused on developing transformative rare disease medicines including Fabry and Pompe disease therapies
- New emphasis: Licensed exclusive U.S. commercialization rights to Phase 3 FSGS drug candidate DMX-200 in April 2025
- Strategic shift: Definitive merger agreement with BioMarin announced December 2025, $14.50/share cash, expected Q2 2026 close, going private
- Quantitative highlight: 2025 revenue increased to $521.7M for Galafold (+$63.6M YoY) and $112.5M for Pombiliti+Opfolda (+$42.3M YoY)
- Noteworthy fact: Patent litigation resolved with generic challengers Teva, Aurobindo, Lupin, with licensing agreements allowing generics from January 30, 2037
Management Discussion & Analysis
- Revenue $634.2M, up $105.9M YoY from $528.3M driven by Galafold and Pombiliti+Opfolda growth plus $13.5M currency impact
- Gross profit $561.3M vs $475.4M; cost of goods sold $72.9M vs $52.9M; operating loss narrowed with net loss $27.1M vs $56.1M
- Best segment: Pombiliti+Opfolda third-party R&D expenses $48.6M up $3.3M; worst: SG&A expenses $383.5M up $60.1M due to litigation and merger costs
- Operating cash flow positive $33.1M vs negative $33.9M; investing cash used $46.4M mostly in marketable securities and capex $3.3M; no share issuances under ATM in 2025
- Management highlights Merger Agreement with BioMarin, expects ongoing R&D expenses, and notes risks from clinical trial outcomes, regulatory environment, and market acceptance
Risk Factors
- Regulatory risk: Pending merger requires Hart-Scott-Rodino Act antitrust approval and clearance from EU and Japanese authorities, risking delays or termination
- Geopolitical risk: Transaction contingent on foreign direct investment approvals in European and Japanese markets, exposing reliance on international regulatory outcomes
- Operational risk: Business restricted under merger agreement, limiting indebtedness, asset transactions, share issuance, potentially stifling strategic opportunities
- Competitive risk: Market erosion threat from competitors’ oral, enzyme replacement, and gene therapies against Galafold® and Pombiliti® + Opfolda®
- Financial risk: $175 million termination fee payable to BioMarin if merger agreement is terminated under specified circumstances, affecting liquidity and operations
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