Agios Pharmaceuticals, Inc. (AGIO) Q2 2026 Earnings: Revenue $45M (+259.3%)
AGIO — Q2 2026 Financial Report Analysis
Q2 · Fiscal year 2026 · Published by Pham Hop
Agios's revenue more than tripled to $44.7M in AQVESME's first full U.S. quarter for thalassemia, while the net loss narrowed to $100.7M despite a $25M licensing upfront.
Revenue
$45M
+259.3% YoY
Net income
-$101M
-10.1% YoY
Diluted EPS
$-1.69
-12.4% YoY
Operating margin
-247.1%
This period vs a year ago
Same period last year
This period
Revenue▲+259.3%
≈$12M
$45M
Year-ago figures (≈) are worked out from the growth rate the company reported. Each row has its own scale.
Overview
Agios sells one drug, mitapivat, under two brand names: PYRUKYND for pyruvate kinase (PK) deficiency, a rare inherited disorder in which red blood cells break down early and cause chronic anemia, and AQVESME for adults with alpha- or beta-thalassemia, a much larger inherited blood disorder in which the body makes too little working hemoglobin. The FDA approved AQVESME on December 23, 2025, and Agios began selling it in the U.S. in late January 2026. Q2 2026 is the first full quarter that shows what that launch is worth.
Net product revenue was $44.7 million, up from $12.5 million a year earlier and more than double Q1 2026's $20.7 million. The 10-Q attributes the $28.8 million jump in U.S. revenue "primarily" to AQVESME sales. Agios still lost $100.7 million in the quarter (-$1.69 per share), only modestly better than the $112.0 million loss a year earlier. The quarter's research spending included a one-time $25.0 million upfront payment to license a new drug, cevidoplenib, from South Korea's Oscotec.
At a glance
$44.7M revenue (+259% YoY, +116% vs Q1): the thalassemia launch is adding sales quickly. U.S. revenue was $40.9M and ex-U.S. revenue $3.8M.
-$100.7M net loss: the loss would have been about $75.7M without the $25.0M licensing payment. Revenue is growing but still covers less than a third of operating costs.
$964.8M cash and investments: down $199.6M from $1,164.4M at December 31, 2025. There is no debt, and management says this cash plus expected revenue funds the launch, the sickle cell launch preparation and the pipeline.
Results
Metric
Q2 2026
Q2 2025
YoY Change
Net product revenue
$44.7M
$12.5M
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+259.3%
— U.S.
$40.9M
$12.2M
+236.7%
— Rest of world
$3.8M
$0.3M
n/m
Cost of sales
$3.0M
$1.7M
+76.0%
R&D expense
$100.8M
$91.9M
+9.6%
— of which in-process R&D (licensing upfronts)
$25.0M
$10.0M
+150.0%
SG&A expense
$51.5M
$45.9M
+12.4%
Operating loss
-$110.6M
-$127.1M
loss 13.0% smaller
Operating margin
-247.1%
-1,020.1%
+773 pts
Interest income, net
$9.7M
$14.5M
-33.0%
Net loss
-$100.7M
-$112.0M
loss 10.1% smaller
Diluted EPS
-$1.69
-$1.93
loss 12.4% smaller
Cumulative AQVESME prescriptions (as of Jun 30)
442
—
—
Operating margin is operating profit or loss as a share of revenue. For a company still spending heavily to build its business it is deeply negative, and the useful signal is how quickly it moves toward zero. It went from about -10x revenue to about -2.5x in a year.
Year-to-date, revenue was $65.5M (vs $21.2M) and the net loss was $199.8M (vs $201.3M).
What drove the quarter
The thalassemia launch accounts for most of the growth. Q1 2026 U.S. revenue was $18.9M, which includes only a partial quarter of AQVESME, and U.S. revenue then reached $40.9M in Q2. The 10-Q credits the year-over-year increase primarily to AQVESME and, for the half-year, also to higher PYRUKYND volume. It does not report revenue for each brand separately. The only launch figure disclosed is 442 cumulative prescriptions written by U.S. doctors certified under the REMS as of June 30. REMS stands for Risk Evaluation and Mitigation Strategy, an FDA-required safety program. For AQVESME it requires liver tests before the first dose and every four weeks for the first 24 weeks, because five trial patients had liver injury while taking mitapivat. That monitoring burden is the main practical obstacle to faster uptake. A prescription is also not the same as a patient on paid therapy.
Ex-U.S. revenue is still small. The $3.8M came from Europe, where PYRUKYND was approved for thalassemia in May 2026 and is sold through distributor Avanzanite, and from Gulf countries through distributor NewBridge. Because both markets run through distributors, Agios records sales to the partner rather than to patients.
Costs rose, but less than the headline R&D figure suggests. Excluding in-process R&D, R&D was $75.8M against $81.9M a year earlier, down 7.5%. Spending on the mitapivat program fell $4.0M on lower process-development work. SG&A (selling, general and administrative costs) rose $5.7M, or 12.4%, which the 10-Q attributes to the AQVESME launch.
Interest income fell by a third to $9.7M because the cash pile is smaller. This is a real headwind: Operating loss improved by $16.5M, but $4.8M of that was given back through lower interest income.
What the headline numbers hide
One-offs in both years. Q2 2026 R&D includes the $25.0M Oscotec upfront. Q2 2025 included a $10.0M upfront, which the cash flow statement records under "Payments associated with license agreement". Excluding both, net loss would have been about $75.7M vs about $102.0M, a 26% improvement. That is a better measure of the operating trend than the reported 10% improvement.
Cash burn. Operating cash outflow was $176.2M in H1 2026, compared with a net loss of $199.8M. The difference is mostly $31.5M of non-cash stock compensation and the $25.0M Oscotec payment, which Agios records as an investing cash flow rather than an operating one. Including that payment, total cash and investments fell $199.6M in six months, about $100M per quarter. At that pace the $964.8M balance would last roughly nine to ten quarters before any further revenue growth, so the company is not under near-term funding pressure.
Receivables grew faster than cash collections. Accounts receivable nearly doubled, from $10.6M to $20.1M. Cash received from product sales in H1 was $56.2M, against $65.5M of recorded revenue. This fits a fast-growing launch, since sales made late in a quarter are collected the next quarter, but it should level off as growth slows.
Gross margin is very high but slightly flattered. Cost of sales was $3.0M, about 6.7% of revenue. Some inventory was manufactured before approval and expensed as R&D at the time, so it never passes through cost of sales. Agios says the amounts involved were "not significant".
Stock compensation is rising. It was $31.5M in H1 2026, up from $26.1M, and both R&D and SG&A cite it as a driver. It is a real cost to shareholders even though it uses no cash. The diluted share count also rose 2.7% to 59.5M.
No financial guidance. Agios does not give revenue guidance, so there is no earlier forecast to measure this quarter against.
Takeaway: In its first full quarter, AQVESME more than doubled Agios's revenue quarter over quarter. Excluding the licensing upfronts in both years, the loss narrowed about 26% year over year. Excluding the licensing fee, the business still spends about $2.90 in operating costs for every $1 of revenue, so the investment case depends on thalassemia sales keeping this pace and on the sickle cell decision due November 1, 2026, rather than on anything already in the income statement.
Pipeline and what comes next
Sickle cell disease (SCD): the FDA granted Priority Review to Agios's request to add SCD to mitapivat's U.S. label under accelerated approval, with a decision date of November 1, 2026. SCD is the largest potential market for mitapivat. Accelerated approval requires a confirmatory trial, and Agios dosed the first patient in the Phase 3 REIGNITE trial (about 159 patients, primary endpoint: transfusion-free status over weeks 4-52). It has also filed for SCD approval in Saudi Arabia.
Pipeline changes: Agios stopped developing tebapivat, its second-generation PK activator, in both lower-risk myelodysplastic syndromes and sickle cell disease after Phase 2 results that it said did not meet its bar for advancement. To replace it, Agios licensed cevidoplenib, an oral pill for immune thrombocytopenia (ITP, an autoimmune disorder that destroys blood-clotting platelets). Agios will owe up to $140.0M in development and regulatory milestones plus royalties, and plans to start Phase 3 in the first half of 2028. It is also moving AG-236, an injected drug that targets iron regulation, into a Phase 2/3 program in polycythemia vera (a bone marrow disorder that produces too many red blood cells), with Phase 2 starting in the second half of 2026. AG-181, for the metabolic disorder phenylketonuria (PKU), has Phase 1b data expected in the second half of 2026.
Earn-out: Agios keeps a 3% earn-out on Servier's U.S. vorasidenib royalties only above $1.0B in annual U.S. sales. Agios itself says it cannot estimate these payments, so it is best treated as zero.
Our read: Q3 2026 will be the second full launch quarter, and revenue growth from Q2 to Q3 will show whether demand is building steadily or whether Q2 was boosted by initial wholesaler stocking. The 10-Q does not say how much of the increase was stocking. Operating costs are around $130M per quarter excluding one-off licensing fees. At a gross margin above 90%, quarterly revenue probably needs to reach well above $100M before Agios could fund itself without its cash reserves. An SCD approval on November 1 would make that achievable, while a delay or rejection would leave thalassemia as the only growth driver. The main risk to watch is the liver-monitoring requirement: any post-launch safety reports could tighten the label for all indications.