Third Quarter 2026
Filed Nov 5, 2026Agios Reports Third Quarter 2026 Financial Results and Provides Business Update
Mitapivat product revenue increased substantially from the prior-year quarter, led by the U.S. launch of AQVESME, while net loss narrowed. The company reported continued commercial investment, a lower cash balance than at December 31, 2025, and a three-month extension of the mitapivat sickle cell disease PDUFA goal date.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Product revenue, net, three months ended September 30, 2026GAAP | $55.38M | – | – |
| Total revenue, three months ended September 30, 2026GAAP | $55.38M | – | – |
| Cost of sales, three months ended September 30, 2026GAAP | $2.52M | – | – |
| Research and development, three months ended September 30, 2026GAAP | $73.49M | – | – |
| Selling, general and administrative, three months ended September 30, 2026GAAP | $56.53M | – | – |
| Total operating expenses, three months ended September 30, 2026GAAP | $132.5M | – | – |
| Loss from operations, three months ended September 30, 2026GAAP | −$77.16M | – | – |
| Royalty income from gain on sale of oncology business, three months ended September 30, 2026GAAP | $2.97M | – | – |
| Interest income, net, three months ended September 30, 2026GAAP | $8.88M | – | – |
| Other income, net, three months ended September 30, 2026GAAP | $266K | – | – |
| Net loss, three months ended September 30, 2026GAAP | −$65.05M | – | – |
| Net loss per share - basic and diluted, three months ended September 30, 2026GAAP | $(1.09) | – | – |
| Weighted-average number of common shares used in computing net loss per share – basic and diluted, three months ended September 30, 2026GAAP | 59,707,904 | – | – |
| Product revenue, net, nine months ended September 30, 2026GAAP | $120.9M | – | – |
| Total revenue, nine months ended September 30, 2026GAAP | $120.9M | – | – |
| Cost of sales, nine months ended September 30, 2026GAAP | $6.84M | – | – |
| Research and development, nine months ended September 30, 2026GAAP | $255.4M | – | – |
| Selling, general and administrative, nine months ended September 30, 2026GAAP | $156.4M | – | – |
| Total operating expenses, nine months ended September 30, 2026GAAP | $418.6M | – | – |
| Loss from operations, nine months ended September 30, 2026GAAP | −$297.7M | – | – |
| Royalty income from gain on sale of oncology business, nine months ended September 30, 2026GAAP | $2.97M | – | – |
| Interest income, net, nine months ended September 30, 2026GAAP | $29.41M | – | – |
| Other income, net, nine months ended September 30, 2026GAAP | $504K | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$264.9M | – | – |
| Net loss per share - basic and diluted, nine months ended September 30, 2026GAAP | $(4.46) | – | – |
| Weighted-average number of common shares used in computing net loss per share – basic and diluted, nine months ended September 30, 2026GAAP | 59,329,729 | – | – |
| Cash, cash equivalents, and marketable securities, September 30, 2026GAAP | $907.0M | – | – |
| Accounts receivable, net, September 30, 2026GAAP | $25.25M | – | – |
| Inventory, September 30, 2026GAAP | $37.84M | – | – |
| Total assets, September 30, 2026GAAP | $1.06B | – | – |
| Stockholders' equity, September 30, 2026GAAP | $979.3M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| U.S. net product revenue from mitapivat (PYRUKYND and AQVESME), third quarter of 2026Driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026. | $48.7M | increased 20% sequentially | – |
| Ex-U.S. net product revenue from mitapivat (PYRUKYND), third quarter of 2026Driven primarily by early access programs in Europe following the late May 2026 approval of PYRUKYND (mitapivat) in thalassemia in the European Union. | $6.6M | increased 74% sequentially | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
2026-2028 outlook
- NoteAgios’ goal is to achieve non-Generally Accepted Accounting Principles (GAAP) profitability in 2028.
- NoteAgios will have reduced its R&D headcount by over 100 roles by year-end, representing a more than 35% decrease compared with 2025.
- NoteThe company expects the associated cost savings of these reductions to be realized in 2027.
- NoteNew PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027.
What drove it
- The U.S. commercial launch of AQVESME in thalassemia drove U.S. net revenue.
- Early access programs in Europe following late May 2026 European Union approval of PYRUKYND in thalassemia drove ex-U.S. net revenue.
- R&D expense was driven lower primarily by reductions in spend associated with mitapivat and tebapivat process development and certain clinical trials.
- SG&A expense increased due to activities supporting the U.S. commercial launch of AQVESME in thalassemia and preparation for the potential U.S. commercial launch of mitapivat in sickle cell disease.
- Approximately 75% of patients remain on AQVESME after six months of treatment.
Concerns
- The FDA extended the mitapivat sickle cell disease sNDA PDUFA goal date by three months, from November 1, 2026, to February 1, 2027, after classifying the company's response to an information request regarding a potential REMS as a major amendment.
- The company remained loss-making, reporting net loss of $65.0 million for the quarter ended September 30, 2026.
- Cash, cash equivalents and marketable securities were $907.0 million as of September 30, 2026, compared to $1.2 billion as of December 31, 2025.
- SG&A expenses were $56.5 million for the third quarter of 2026, compared to $41.3 million for the third quarter of 2025.
What to watch
- The February 1, 2027 PDUFA goal date and continuing labeling discussions with the FDA, including elements of a potential REMS.
- AQVESME prescription growth, including the 48 cumulative prescriptions with Agios start forms in process as of September 30, 2026.
- The realization in 2027 of cost savings associated with R&D headcount reductions.
- The company's progress toward its goal of non-GAAP profitability in 2028.
- New clinical data for mitapivat in sickle cell disease and AG-236 in polycythemia vera scheduled for ASH 2026, taking place December 12-15, 2026.
Balance sheet and cash flow
- Cash, cash equivalents, and marketable securities were $907.0 million as of September 30, 2026, compared to $1.2 billion as of December 31, 2025.
- Accounts receivable, net was $25,254 (in thousands) as of September 30, 2026, compared to $10,577 (in thousands) as of December 31, 2025.
- Inventory was $37,841 (in thousands) as of September 30, 2026, compared to $32,920 (in thousands) as of December 31, 2025.
- Total assets were $1,064,040 (in thousands) as of September 30, 2026, compared to $1,297,225 (in thousands) as of December 31, 2025.
- Stockholders' equity was $979,336 (in thousands) as of September 30, 2026, compared to $1,193,114 (in thousands) as of December 31, 2025.
Analysis
Third-quarter product revenue was $55,385 (in thousands), compared with $12,880 (in thousands) in the third quarter of 2025. Mitapivat worldwide net revenues were $55.4 million, comprising $48.7 million of U.S. net revenue and $6.6 million of ex-U.S. net revenue. The filing attributes U.S. growth to the late-January 2026 AQVESME launch in thalassemia and ex-U.S. momentum to European early-access programs following late-May 2026 European Union approval.
Commercial demand indicators continued to build. During the third quarter, 177 AQVESME prescriptions with completed Agios start forms were written by REMS-certified U.S. physicians, bringing cumulative prescriptions to 619 as of September 30, 2026. A further 48 cumulative prescriptions had start forms in process. Management cited deeper penetration among transfusion-dependent patients and expansion into the larger non-transfusion dependent population, while approximately 75% of patients remained on AQVESME after six months of treatment.
The loss narrowed as revenue increased. Net loss was $(65,045) (in thousands), versus $(103,433) (in thousands) in the prior-year quarter, and loss from operations was $(77,160) (in thousands), versus $(116,869) (in thousands). R&D was $73,487 (in thousands), below $86,796 (in thousands), primarily reflecting lower spend associated with mitapivat and tebapivat process development and certain clinical trials. SG&A was $56,533 (in thousands), above $41,274 (in thousands), reflecting AQVESME launch support and preparation for a potential sickle cell disease launch.
The balance sheet reported $907,018 (in thousands) of cash, cash equivalents and marketable securities at September 30, 2026, compared with $1,164,438 (in thousands) at December 31, 2025. The company plans to reduce R&D headcount by over 100 roles by year-end, representing a more than 35% decrease compared with 2025, with associated savings expected in 2027. Agios is targeting non-GAAP profitability in 2028.
The key regulatory development was the three-month extension of the mitapivat sickle cell disease sNDA PDUFA goal date from November 1, 2026, to February 1, 2027. The FDA requested additional information to assess whether a REMS is necessary and treated the company's response as a major amendment. The company said it is launch-ready and remains in labeling discussions with the FDA, including elements of a potential REMS.
Management, verbatim
The third quarter was a record for our product revenue, outperforming our entire 2025 total in just three months. This growth was driven by the U.S. commercial launch of AQVESME in thalassemia, where broadening demand is translating into a durable base of patients on therapy.
Brian Goff, Chief Executive Officer, Agios
Not in the filing
stated, not guessed- Gross margin.
- Operating cash flow.
- Free cash flow.
- Debt balances.
- Share repurchases.
- Dividends.
- Non-GAAP earnings, non-GAAP operating income, and non-GAAP EPS for the reported period.
- Forward revenue guidance.
- Forward gross-margin guidance.
- Forward operating-expense guidance.
- Forward tax-rate guidance.
- Prior-quarter comparatives for the income-statement metrics.
- Percentage year-over-year changes for the income-statement metrics and U.S. and ex-U.S. mitapivat revenue segments.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.