Agios Pharma (AGIO) Q3 2026 Earnings Report
MX:AGIO Q3 2026 EPS Results
- Actual EPS
- -MXN 20.23
- Consensus EPS
- -MXN 23.08
- Beat/Miss
- Beat by +MXN 2.86
- One Year Ago EPS
- -MXN 33.03
MX:AGIO Q3 2026 Revenue Results
- Actual Revenue
- MXN 1.03B
- Expected Revenue
- MXN 958.36M
- Beat/Miss
- Beat by +MXN 69.36M
- YoY Revenue Growth
- +330.01%
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/05/2026
- Time
- Before Open
- Conference Call
- Thursday, November 5, 2026
Agios Pharma's next earnings date is estimated for February 25, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
Q3 2026 Earnings Slide Deck
Q3 2026 Earnings Call Summary
The call was strongly positive overall. Agios reported record revenue, rapid AQVESME launch adoption, 75% six-month persistence, international growth, a strong cash position, readiness for a potential sickle cell launch, and encouraging pipeline data. The main challenges were the three-month FDA review extension and uncertainty around a potential REMS, along with higher SG&A, a continuing net loss, and a planned one-time headcount reduction charge.
Agios said full year operating expenses are expected to remain approximately flat versus 2025 excluding the $25 million upfront payment associated with the cevidoplenib in licensing and an approximately $11 million onetime expense associated with the headcount reduction to be recognized in the fourth quarter; over the course of 2026, R&D headcount will have reduced by more than 35 percent compared with 2025, or more than 100 roles, with associated cost savings expected to be realized in 2027, and the company is targeting non GAAP profitability in 2028, including the potential launch of sickle cell in 2027. Agios plans to initiate a phase 3 program for AG-236 in polycythemia vera by year end, a phase 3 trial for cevidoplenib in immune thrombocytopenia in the first half of 28, and expects Phase 1b proof-of-concept data for AG-181 before the end of the year; it also expects Phase 2/3 initiation for AG-236 by the end of this year, with every-6-month dosing as the goal of Phase 2, and described 177 prescriptions as probably the more run rate for AQVESME as it continues to penetrate the thalassemia markets.
- Record Third-Quarter RevenueAgios delivered record total net revenue of $55.4 million in the third quarter, more than 4x the $12.9 million reported in the third quarter of 2025. The company generated more total revenue in a single quarter than it generated in all of 2025.
- Strong U.S. Thalassemia LaunchU.S. net revenue was $48.7 million, driven by the continued launch of AQVESME in thalassemia. The company added 177 prescriptions from REMS-certified physicians with completed start forms in the quarter, bringing the cumulative total to 619 since launch, or roughly 15% of the approximately 4,000-patient target launch population.
- Additional Thalassemia Demand in ProcessAn additional 48 prescriptions had started the support process and were still in process at quarter end. Management said demand is broadening into community practices and non-transfusion-dependent patients.
- Patient Persistence and Market AccessApproximately 75% of patients remained on AQVESME therapy at about six months, with strong persistence reported across transfusion-dependent and non-transfusion-dependent segments. The company also reported payer coverage policies for 75% of the market within six months of launch, with no major restrictions described.
- Direct-to-Consumer Campaign EngagementAgios launched its first direct-to-consumer campaign, Level Up with AQVESME, in August and expanded it with multilingual assets. Following the campaign launch, engagement on the patient website increased by 65%.
- International Revenue GrowthRevenue outside the U.S. increased 74% sequentially to $6.6 million, driven by early access programs in Europe following European Commission approval for thalassemia in the second quarter. Agios is pursuing international expansion through a capital-efficient model with Avanzanite in Europe and Newbridge Pharmaceuticals in the GCC.
- Sickle Cell Launch ReadinessAgios stated that its commercial, medical, market access, patient, sales, manufacturing, and supply-chain teams are prepared for a potential mitapivat launch in sickle cell disease. The initial U.S. launch target is approximately 25,000 actively treated or therapy-needing patients with a hemolytic profile, compared with approximately 4,000 patients in the thalassemia launch population.
- Sickle Cell Clinical DifferentiationIn the RISE UP open-label extension, 62.7% of patients achieved hemoglobin improvement, including 39.7% who were initially nonresponders, with hemoglobin response lasting up to 115 weeks. In patients with hyperfiltration, mitapivat reduced eGFR by a mean of 14.7 versus 4.9 with placebo at week 52. Hemoglobin responders also showed a mean reduction in left ventricular mass index of 5.9 grams per meter squared, compared with increases of 5.8 in nonresponders and 4.6 with placebo.
- Progress Across Rare Hematology PipelineAgios plans to initiate a phase 3 program for AG-236 in polycythemia vera by year end and a phase 3 trial for cevidoplenib in immune thrombocytopenia in the first half of 2028. The company described both programs as having clinically validated and derisked mechanisms of action.
- Positive AG-236 Phase 1 FindingsA single dose of AG-236 increased hepcidin by up to 24 micrograms per liter at day 29 versus a decrease with placebo. Effects on iron, transferrin saturation, hemoglobin, and hematocrit were sustained through month six. The program was well tolerated, with all adverse events graded 1 or 2, no serious adverse events, and no discontinuations.
- AG-181 PKU Program ProgressIn a preclinical model of classical severe PKU, AG-181 produced dose-response reductions in blood phenylalanine and reached the clinical target of below 360 micromolar at 300 milligrams per kilogram without diet modification. In healthy volunteers, it had no serious or grade 3 or higher adverse events or discontinuations, and its pharmacokinetic profile supported twice-daily dosing in the ongoing phase 1b study.
- Reduced Research and Development SpendingResearch and development expense was $73.5 million in the third quarter compared with $86.8 million in the prior-year period, primarily reflecting lower spending on mitapivat and tebapivat process development and certain clinical trials.
- Operating Model Rightsizing and Profitability TargetAgios expects to reduce R&D headcount by more than 35% compared with 2025, representing more than 100 roles, with associated cost savings expected to be realized in 2027. The company is targeting non-GAAP profitability in 2028 while prioritizing commercial launches and rare hematology pipeline opportunities.
- Strong Cash PositionAgios ended the quarter with $907 million in cash equivalents and marketable securities, which management said supports the AQVESME launch, a potential sickle cell launch, and progression of the focused pipeline toward non-GAAP profitability in 2028.
MX:AGIO Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Feb 25, 2027 | 2026 (Q4) | -21.40- | -34.51 | ― | ― |
| Nov 05, 2026 | 2026 (Q3) | -23.08-20.23 | -33.03 | 38.76% (+12.80) | |
| Jul 30, 2026 | 2026 (Q2) | -30.71-31.36 | -35.81 | 12.44% (+4.45) | |
| Apr 29, 2026 | 2026 (Q1) | -33.46-31.36 | -28.76 | -9.03% (-2.60) | |
| Feb 12, 2026 | 2025 (Q4) | -36.26-34.51 | -26.72 | -29.17% (-7.79) | |
| Oct 30, 2025 | 2025 (Q3) | -35.20-33.03 | 300.98 | -110.97% (-334.01) | |
| Jul 31, 2025 | 2025 (Q2) | -33.53-35.81 | -31.36 | -14.20% (-4.45) | |
| May 01, 2025 | 2025 (Q1) | -32.86-28.76 | -26.91 | -6.90% (-1.86) | |
| Feb 13, 2025 | 2024 (Q4) | -31.38-26.72 | -31.73 | 15.79% (+5.01) | |
| Oct 31, 2024 | 2024 (Q3) | 282.35300.98 | -30.43 | 1089.02% (+331.41) |
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
