AMICUS THERAPEUTICS, INC. (FOLD) FY2025 10-K Annual Report
AMICUS THERAPEUTICS, INC. (FOLD) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Feb 20, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
AMICUS THERAPEUTICS, INC. FY2025 10-K Analysis
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
AMICUS THERAPEUTICS, INC. FY2025 Key Financial MetricsXBRL
Revenue
$634M
▲ +20.0% YoY
Net Income
-$27M
▲ +51.7% YoY
Gross Margin
88.5%
▼ -148bp YoY
Operating Margin
5.2%
▲ +46bp YoY
Net Margin
-4.3%
▲ +635bp YoY
ROE
-9.9%
▲ +1903bp YoY
Total Assets
$950M
▲ +21.0% YoY
EPS (Diluted)
$-0.09
▲ +50.0% YoY
Operating Cash Flow
$33M
▲ +197.8% YoY
Source: XBRL data from AMICUS THERAPEUTICS, INC. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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