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Agios Pharmaceuticals (AGIO) investor relations material

Agios Pharmaceuticals Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary30 Oct, 2025

Executive summary

  • Achieved $12.9 million in net revenue for Q3 2025, up 44% year-over-year and 3% sequentially, driven by PYRUKYND commercial execution in rare hematologic diseases.

  • Net loss of $103.4 million in Q3 2025, compared to net income of $947.9 million in Q3 2024, which included significant one-time milestone and royalty payments.

  • Maintains strong financial position with $1.3 billion in cash, cash equivalents, and marketable securities as of September 30, 2025, supporting commercial launches and pipeline investments.

  • Advanced regulatory milestones for PYRUKYND in thalassemia, including approval in Saudi Arabia, positive CHMP opinion in Europe, and ongoing FDA review with a PDUFA date of December 7, 2025.

  • Pipeline momentum with completed enrollment in phase II-B tebapivat trial for lower-risk MDS; topline data expected early 2026.

Financial highlights

  • Q3 2025 net revenue was $12.9 million, up from $9.0 million in Q3 2024 and $12.5 million in Q2 2025.

  • Net loss for Q3 2025 was $103.4 million, compared to net income of $947.9 million in Q3 2024, which included $889.1 million from the sale of royalty rights and a $200 million milestone payment.

  • R&D expenses rose to $86.8 million, up from $72.5 million year-over-year, mainly due to increased clinical trial costs.

  • SG&A expenses were $41.3 million, up from $38.5 million in Q3 2024, reflecting investments for potential U.S. launch.

  • Cash, cash equivalents, and marketable securities at $1.3 billion at Q3 2025, down from $1.5 billion at Q4 2024.

Outlook and guidance

  • Anticipates robust net revenue growth for 2025, with multiple high-value catalysts including potential FDA approval for PYRUKYND in thalassemia (PDUFA date December 7, 2025) and Phase 3 RISE UP data in SCD by year-end.

  • Topline results from the phase II-B tebapivat trial in lower-risk MDS expected in early 2026.

  • Ongoing launch preparations in the U.S., Europe, and GCC for thalassemia indications.

  • Cash position expected to fund operations for at least the next twelve months.

  • Anticipates increased expenses as clinical and commercial activities expand, especially for PYRUKYND in thalassemia and SCD.

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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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