Agios Pharmaceuticals, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 2 new. The quarter’s numbers.

Read the filing

Key takeaways

• Product revenue more than quadrupled: Worldwide mitapivat net revenue was $55.4 million, more than four times the $12.9 million in the same quarter of 2025. Source
• U.S. net revenue up 20% sequentially: U.S. net revenue reached $48.7 million, driven by the AQVESME thalassemia launch that began in late January 2026. Source
• Cumulative prescriptions reached 619: REMS-certified U.S. physicians wrote 177 AQVESME prescriptions with completed start forms in the quarter, up from 442 at June 30, 2026. A further 48 are excluded from the metric. Source
• SG&A rose on AQVESME launch: SG&A was $56.5 million, up from $41.3 million, due to launch activity for AQVESME and preparation for a potential sickle cell disease launch. Source
• RISE UP data extend to 115 weeks: Phase 3 RISE UP data show hemoglobin improvements lasting up to 115 weeks, with post-hoc analyses on kidney function and cardiac remodeling. Source
• Cash down to $907.0 million: Cash, cash equivalents and marketable securities were $907.0 million at September 30, 2026, down from $1.2 billion at December 31, 2025. Source
• R&D headcount cut over 100 roles: Following a 2026 operating model review, R&D headcount is to fall by over 100 roles by year-end, more than 35% below 2025. Source

“The third quarter was a record for our product revenue, outperforming our entire 2025 total in just three months.”

Brian Goff, Chief Executive Officer, Agios

Guidance

What changed from last quarter

• New: The FDA review of the mitapivat sickle cell sNDA was extended three months, moving the PDUFA goal date from November 1, 2026 to a later date. Source
• New: The company reviewed its operating model during 2026 and reduced R&D headcount, a change not present in the prior-quarter release. Source
• New guidance: A non-GAAP profitability target for 2028 was introduced this quarter. Source

Results and growth drivers

• Product revenue more than quadrupled: Worldwide mitapivat net revenue was $55.4 million, more than four times the $12.9 million in the same quarter of 2025. Source
• Net loss narrowed year on year: Net loss was $65.0 million, or $1.09 per basic and diluted share, against $103.4 million, or $1.78 per share, a year earlier. Source

Segments and regions

• U.S. net revenue up 20% sequentially: U.S. net revenue reached $48.7 million, driven by the AQVESME thalassemia launch that began in late January 2026. Source
• Ex-U.S. net revenue up 74%: Ex-U.S. net revenue was $6.6 million, mainly from early access programs in Europe after the thalassemia approval in the European Union. Source
• Partners extend mitapivat abroad: Ex-U.S. commercialization runs through partnerships with Avanzanite Bioscience B.V. in Europe and NewBridge Pharmaceuticals in the GCC region. Source

“Our conviction in mitapivat for patients with sickle cell disease is grounded in the robust efficacy and safety data generated to date”

Brian Goff, Chief Executive Officer, Agios

AQVESME prescriptions and demand

• Cumulative prescriptions reached 619: REMS-certified U.S. physicians wrote 177 AQVESME prescriptions with completed start forms in the quarter, up from 442 at June 30, 2026. A further 48 are excluded from the metric. Source
• About 75% stay on therapy at six months: Management said roughly three in four patients remain on AQVESME after six months of treatment. Source
• Demand broadens into wider population: Demand is deepening among transfusion-dependent patients and expanding into the larger non-transfusion-dependent population. Source

Costs and operating expenses

• R&D spend fell year on year: R&D expense was $73.5 million, down from $86.8 million, reflecting lower mitapivat and tebapivat process development and certain clinical trial spend. Source
• SG&A rose on AQVESME launch: SG&A was $56.5 million, up from $41.3 million, due to launch activity for AQVESME and preparation for a potential sickle cell disease launch. Source
• Cost of sales at $2.5 million: Cost of sales was $2.5 million in the quarter, compared with $3.0 million in the second quarter of 2026 per the prior release. Source

Regulatory timing and pipeline

• Sickle cell review extended three months: FDA extended the mitapivat sickle cell sNDA review by three months after classifying Agios’ response on a possible REMS as a major amendment. Source
• Labeling talks cover possible REMS: Labeling discussions with FDA continue as part of the sNDA review and include elements of a potential REMS. Source
• RISE UP data extend to 115 weeks: Phase 3 RISE UP data show hemoglobin improvements lasting up to 115 weeks, with post-hoc analyses on kidney function and cardiac remodeling. Source
• AG-236 Phase 1 supports six-month dosing: Phase 1 data for AG-236 in healthy volunteers support dosing as infrequently as every six months in polycythemia vera. Source

Cash and funding

• Cash down to $907.0 million: Cash, cash equivalents and marketable securities were $907.0 million at September 30, 2026, down from $1.2 billion at December 31, 2025. Source
• Cash expected to fund launches: Management expects cash, product revenue and interest income to provide financial independence for the AQVESME launch, the sickle cell launch preparation and the pipeline. Source

Operating model and headcount

• R&D headcount cut over 100 roles: Following a 2026 operating model review, R&D headcount is to fall by over 100 roles by year-end, more than 35% below 2025. Source
• Savings expected from 2027: The company expects savings from these reductions to be realized in 2027. Source

Coming up, as management said on 5 November 2026

• ASH 2026 presentations in December: Fourteen abstracts are accepted for ASH 2026 in New Orleans, with presentation dates of December 12-15, 2026. Source
• Sickle cell decision date set: The FDA goal date for the mitapivat sickle cell sNDA is set for February 1, 2027, and the company says it is launch-ready. Source

Figures management reported

Risks management discussed

• Regulatory: FDA asked for more information to decide whether a REMS is needed for mitapivat in sickle cell disease, which could add conditions to the label. Source

Earlier plans management reported on

• Ahead: Management says the company is launch-ready ahead of the sickle cell disease PDUFA goal date. Source

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.