AGIOS PHARMACEUTICALS, INC. (AGIO) FY2025 10-K Annual Report
AGIOS PHARMACEUTICALS, INC. (AGIO) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Feb 12, 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.
AGIOS PHARMACEUTICALS, INC. FY2025 10-K Analysis
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
AGIOS PHARMACEUTICALS, INC. FY2025 Key Financial MetricsXBRL
Revenue
$54M
▲ +48.0% YoY
Net Income
-$413M
▼ -161.3% YoY
Operating Margin
-873.9%
▲ +29260bp YoY
Net Margin
-764.0%
▼ -260994bp YoY
ROE
-34.6%
▼ -7832bp YoY
Total Assets
$1.3B
▼ -22.0% YoY
EPS (Diluted)
$-7.12
▼ -161.2% YoY
Operating Cash Flow
-$373M
▲ +4.3% YoY
Source: XBRL data from AGIOS PHARMACEUTICALS, INC. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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