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Agios Pharmaceuticals
Agios Pharmaceuticals (AGIO) investor relations material
Agios Pharmaceuticals Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary12 Feb, 2026
Executive summary
Achieved strong commercial execution in Q4 and FY 2025, with PYRUKYND delivering $20M in Q4 and $54M for the year, reflecting robust year-over-year growth and successful launches in rare hematology indications.
FDA approval and U.S. launch of ACTIVASE/AQVESME (mitapivat) for thalassemia in December 2025, with early positive physician and patient engagement and 44 prescriptions through January 2026.
Advanced pipeline with key milestones, including completion of enrollment in Phase 2 tebapivat trial for sickle cell disease, pre-sNDA meeting for mitapivat in sickle cell disease scheduled for Q1 2026, and anticipated data readouts for tebapivat, AG-236, and AG-181 in 2026.
Maintained robust financial discipline, ending 2025 with $1.2B in cash, cash equivalents, and marketable securities, providing flexibility for launches and pipeline advancement.
Clear path to profitability based on thalassemia and PK deficiency franchises, with disciplined capital allocation and operational efficiency.
Financial highlights
Q4 2025 PYRUKYND net revenue was $20M, up 86% year-over-year and 55% sequentially; FY 2025 net revenues were $54M, up 48% from FY 2024.
U.S. Q4 PYRUKYND revenue was $16M; ex-U.S. Q4 revenue was $4M, mainly from inventory stocking in Europe.
FY 2025 net loss was $(412.8)M, compared to net income of $673.7M in FY 2024, which included significant one-time gains.
Cost of sales for Q4 2025 was $1.9M; R&D expenses were $88.1M in Q4 and $339.5M for FY 2025; SG&A expenses were $51.6M in Q4 and $180.3M for FY 2025.
Cash, cash equivalents, and marketable securities at $1.2B at year-end 2025.
Outlook and guidance
2026 U.S. PK deficiency revenue expected in the range of $45–$50M.
Operating expenses in 2026 anticipated to be roughly flat with 2025, with potential for greater efficiencies beyond 2026.
Anticipate strong catalyst flow in 2026, including regulatory milestones and topline data readouts for multiple pipeline assets.
Ex-U.S. revenue expected to decrease in Q1 2026 due to prior inventory stocking.
Cash position expected to support commercial launches and pipeline expansion.
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Next Agios Pharmaceuticals earnings date
Q1 202630 Apr, 2026
Agios Pharmaceuticals
Next Agios Pharmaceuticals earnings date
Q1 202630 Apr, 2026
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Frequently asked questions
Agios Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering and developing therapies for genetically defined diseases. The company leverages its expertise in cellular metabolism and genetic pathways to create treatments for rare and severe conditions, including metabolic and hematologic disorders. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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