Agios Pharmaceuticals, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 30 July 2026: press release. Guidance figures: 4 new. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue rose to $44.7 million: Worldwide product revenue was $44.7 million, up from $12.5 million a year earlier. Six-month product revenue was $65.5 million against $21.2 million. Source
• AQVESME prescriptions reached 442: Cumulative AQVESME thalassemia prescriptions from REMS-certified U.S. physicians reached 442 at June 30, 2026, up from 242 at March 31, 2026. Source
• R&D rose on Oscotec upfront payment: R&D expense rose to $100.8 million from $91.9 million, driven mainly by a $25.0 million up-front payment to Oscotec for cevidoplenib. Source
• Sickle cell sNDA accepted with Priority Review: FDA accepted the mitapivat sNDA for sickle cell disease, submitted under the accelerated approval pathway, with Priority Review. Source
• PDUFA date set for November 1: The FDA goal date for the sickle cell sNDA is November 1, 2026, under the accelerated approval pathway. Source
• Cevidoplenib licensed from Oscotec: Agios licensed exclusive global rights to cevidoplenib, an oral SYK inhibitor for immune thrombocytopenia. The company cites up to $1.0 billion in peak U.S. sales potential. Source
• Tebapivat ended in two indications: Phase 2b results led the company not to advance tebapivat in LR-MDS. Phase 2 results also led it to stop development in sickle cell disease. Source
• Cash balance declined to $964.8 million: Cash, cash equivalents and marketable securities were $964.8 million at June 30, 2026, down from $1.2 billion at December 31, 2025. Source

“Our second-quarter performance reflects continued execution across the key priorities that will drive sustainable growth for Agios”

Brian Goff, Chief Executive Officer, Agios

Guidance

What changed from last quarter

• New: Agios licensed exclusive global rights to cevidoplenib from Oscotec, an oral SYK inhibitor for immune thrombocytopenia. Source
• New: AG-236 moves into a Phase 2/3 polycythemia vera program after Phase 1 healthy-volunteer results. Source
• New: FDA accepted the mitapivat sickle cell sNDA with Priority Review; the prior release had planned submission in the second quarter of 2026. Source
• Ended: Tebapivat will not advance in lower-risk myelodysplastic syndromes after Phase 2b results. Source
• Guidance withdrawn: Tebapivat Phase 2 sickle cell topline readout, previously guided for the second half of 2026, is replaced by the decision not to advance the program. Source

Results and growth drivers

• Revenue rose to $44.7 million: Worldwide product revenue was $44.7 million, up from $12.5 million a year earlier. Six-month product revenue was $65.5 million against $21.2 million. Source
• Net loss narrowed to $100.7 million: Net loss was $100.7 million against $112.0 million a year earlier. Net loss per share was $1.69, against $1.93. Six-month net loss was $199.8 million. Source
• Operating loss and interest income fell: Loss from operations was $110.6 million against $127.1 million. Interest income, net was $9.7 million against $14.5 million a year earlier. Source

Segments and regions

• U.S. revenue rose to $40.9 million: U.S. net product revenue from mitapivat was $40.9 million against $12.2 million a year earlier, with the AQVESME thalassemia launch as the driver. Source
• Ex-U.S. revenue reflects Europe and Gulf demand: Ex-U.S. net product revenue was $3.8 million against $0.3 million. Management tied it to early European demand after the May 2026 approval and continued GCC demand. Source
• PYRUKYND approved across EU states: The European Commission authorized PYRUKYND for adults with transfusion-dependent and non-transfusion-dependent thalassemia, with orphan designation. Management said it is the only approved medicine in all EU member states for this population. Source

“Beyond these milestones, we strengthened our hematology pipeline with the licensing of cevidoplenib and advancement of AG-236 into Phase 2/3 development, while maintaining disciplined capital allocation.”

Brian Goff, Chief Executive Officer, Agios

Products and customers

• AQVESME prescriptions reached 442: Cumulative AQVESME thalassemia prescriptions from REMS-certified U.S. physicians reached 442 at June 30, 2026, up from 242 at March 31, 2026. Source
• Launch began in late January: The AQVESME thalassemia launch began in late January 2026 and is the stated driver of U.S. net revenue for the quarter. Source
• Physician and patient engagement continues: Management described the launch as continuing to draw engagement from physicians and patients. Source

Costs and margins

• R&D rose on Oscotec upfront payment: R&D expense rose to $100.8 million from $91.9 million, driven mainly by a $25.0 million up-front payment to Oscotec for cevidoplenib. Source
• SG&A rose on launch activity: SG&A expense rose to $51.5 million from $45.9 million, reflecting higher activity for the AQVESME thalassemia launch. Source
• Cost of sales rose to $3.0 million: Cost of sales was $3.0 million against $1.7 million a year earlier. Six-month cost of sales was $4.3 million. Source

Pipeline and regulatory milestones

• Sickle cell sNDA accepted with Priority Review: FDA accepted the mitapivat sNDA for sickle cell disease, submitted under the accelerated approval pathway, with Priority Review. Source
• PDUFA date set for November 1: The FDA goal date for the sickle cell sNDA is November 1, 2026, under the accelerated approval pathway. Source
• Confirmatory Phase 3 trial dosed first patient: The first patient was dosed in REIGNITE, a global Phase 3 trial aimed at reducing transfusion burden in sickle cell patients aged 12 and older. Source
• AG-236 advances to Phase 2/3: Phase 1 healthy-volunteer results showed sustained hepcidin control and possible dosing up to every six months. The Phase 2/3 polycythemia vera program follows. Source
• AG-181 Phase 1b trial began: The first patient was dosed in a Phase 1b trial testing AG-181 safety and tolerability in adults with PKU. Data are expected in the second half of 2026. Source

Business development and portfolio

• Cevidoplenib licensed from Oscotec: Agios licensed exclusive global rights to cevidoplenib, an oral SYK inhibitor for immune thrombocytopenia. The company cites up to $1.0 billion in peak U.S. sales potential. Source
• Cevidoplenib Phase 3 timing set: Phase 3 development in ITP is expected to start in the first half of 2028, after additional chemistry, manufacturing and controls work. Source
• Tebapivat ended in two indications: Phase 2b results led the company not to advance tebapivat in LR-MDS. Phase 2 results also led it to stop development in sickle cell disease. Source

Capital, cash and balance sheet

• Cash balance declined to $964.8 million: Cash, cash equivalents and marketable securities were $964.8 million at June 30, 2026, down from $1.2 billion at December 31, 2025. Source
• Cash to fund launches and pipeline: Management said cash, anticipated product revenue and interest income are expected to fund the AQVESME launch, sickle cell launch preparation, clinical programs and pipeline expansion. Source
• Receivables and inventory rose: Accounts receivable were $20.1 million, up from $10.6 million at December 31, 2025. Inventory was $35.8 million, including $5.6 million of long-term inventory. Source

Coming up, as management said on 30 July 2026

• FDA decision on sickle cell sNDA: The FDA goal date for the mitapivat sickle cell sNDA under accelerated approval is November 1, 2026. Source
• Saudi Arabia sickle cell filing pending: The company has filed for approval of mitapivat in sickle cell disease in Saudi Arabia. The release gives no decision date. Source
• Preparing a sickle cell launch: Management said its cash will be used in part to prepare for a potential U.S. launch of mitapivat in sickle cell disease. Source

Figures management reported

Risks management discussed

• Operational: Tebapivat did not show clinical benefit in enough LR-MDS patients to meet the company's predefined threshold for advancement, so the program stopped. Source
• Demand: Management said tebapivat lacked a sufficiently differentiated profile against other PK activators in sickle cell disease, which ended its development there. Source
• Regulatory: The sickle cell approval pathway requires a confirmatory trial, REIGNITE, to be conducted after accelerated approval. Source

Earlier plans management reported on

• Not stated: The prior release planned the sNDA submission for the second quarter; the current release reports FDA acceptance with Priority Review.
• Not stated: The prior release guided to topline results in the first half of 2026; the current release reports the outcome and the decision not to advance.
• Not stated: The prior release guided to second-half 2026 results; the current release says the program will not advance in this indication.
• Not stated: The prior release said the application was under review; the current release reports EC marketing authorization in May 2026.

Other quarters

• Q3 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.