Short answer
AGIOS PHARMACEUTICALS, INC. (AGIO) filed its fiscal 2025 10-K annual report with the SEC on Feb 12, 2026. It reported revenue of $54M (+48.0% year over year) and net income of −$413M.
- Top risk flagged: Regulatory risk: FDA REMS requirements for AQVESME™ due to boxed warning on hepatocellular injury risk
FY2025 key financial metrics · XBRL
- Revenue
- $54M
- +48.0% YoY
- Net income
- −$413M
- −161.3% YoY
- Operating margin
- -873.9%
- +292.6 pp YoY
- EPS (diluted)
- −$7.12
- −161.2% YoY
- ROE
- -34.6%
- −78.3 pp YoY
- Operating cash flow
- −$373M
- +4.3% YoY
Source: XBRL data from the AGIOS PHARMACEUTICALS, INC. (AGIO) FY2025 10-K on SEC EDGAR. USD.
AGIOS PHARMACEUTICALS, INC. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Commercial-stage biopharma focused on rare hematology diseases via PK activator small molecules
- New regulatory approvals for mitapivat: FDA approval of AQVESME™ for thalassemia anemia (Dec 2025), Saudi Arabia approval for PYRUKYND®, EMA positive opinion pending final decision early 2026
- Strategic shift: Divested oncology business in 2021, monetized vorasidenib milestone and royalty rights for total $1.1B cash inflow by 2024
- R&D investment milestone: $10M milestone payment to Alnylam in 2025 under license for siRNA candidate AG-236 in polycythemia vera
- Noteworthy metric: Completed phase 3 SCD trial with mitapivat, 40.6% hemoglobin response vs 2.9% placebo, launched U.S. commercial thalassemia product in Jan 2026
Management Discussion & Analysis
- Revenue from PYRUKYND® and AQVESME™ product sales began in 2022 and 2026 respectively; milestone income $200M in 2024 from Vorasidenib FDA approval
- Net income $673.7M in 2024 driven by $1.09B total gain from Vorasidenib royalty rights sale and milestone payment, net loss $412.8M in 2025, net loss $352.1M in 2023
- Best segment: Oncology contingent payments, $889.1M gain in 2024 from contingent payments sale; Worst segment: ongoing R&D and commercialization expenses driving net losses in 2025
- Cash inflows include $905M from sale of Vorasidenib Royalty Rights in 2024; R&D expenses include $17.5M upfront license payment plus $10M milestone payment to Alnylam in 2025
- Future outlook: FDA pre-sNDA meeting Q1 2026 for mitapivat in sickle cell disease; EU approval expected early 2026; continued investment in clinical trials and commercialization expansion
Risk Factors
- Regulatory risk: FDA REMS requirements for AQVESME™ due to boxed warning on hepatocellular injury risk
- Macroeconomic risk: geopolitical events like war impacting patient enrollment and clinical trial site operations internationally
- Supply chain risk: reliance on third-party CROs and contractors with limited control over compliance and timelines
- Market disruption risk: competition for patient enrollment from other companies’ clinical trials in same indications
- Financial risk: $130M potential milestone and royalty payments under license agreement with Alnylam for siRNA candidate targeting TMPRSS6
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