Agios' Q1 Loss Narrower Than Expected, Revenues Lag Estimates

Agios Pharmaceuticals AGIO incurred a loss of $1.55 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.80. In the year-ago quarter, the company had reported a loss per share of $1.45.

AGIO reported revenues of $8.7 million for the first quarter, which missed the Zacks Consensus Estimate of $10 million. Revenues increased 6.1% from the year-ago quarter’s figure of $8.2 million. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)

Year to date, shares of Agios have declined 5.8% compared with the industry’s decrease of 1.7%.

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AGIO's Q1 Earnings in Detail

In the first quarter, revenues were generated entirely from product revenues of Agios’ only marketed drug, Pyrukynd (mitapivat), which is approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States and the EU.

Pyrukynd revenues declined 19% sequentially. In the fourth quarter of 2024, revenues had increased due to the benefit of year-end stocking and adjustments to certain revenue reserves, which did not happen in the first quarter.

Per management, a total of 136 patients are on Pyrukynd therapy, up 4.6% from fourth-quarter 2024 levels.

Research & development expenses increased around 6% year over year to $72.7 million, owing to higher workforce-related expenses.

Selling, general and administrative expenses increased 33.9% year over year to $41.5 million. The increase was due to the company’s commercial preparations for a potential approval and subsequent launch of Pyrukynd in the thalassemia indication.

As of March 31, 2025, cash, cash equivalents and marketable securities totaled $1.4 billion compared with $1.5 billion as of Dec. 31, 2024.

AGIO's Recent Pipeline Development Activities

Agios’ lead PK activator, Pyrukynd, is the first disease-modifying therapy approved to treat adults with PK deficiency, a rare and debilitating blood disorder.

Besides PK deficiency, Pyrukynd is also being developed for other hemolytic anemias, including sickle cell disease (SCD) and thalassemia, in several label expansion studies.

The FDA accepted AGIO’s supplemental new drug application (sNDA) seeking label expansion for Pyrukynd for treating adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia in January 2025.

A final decision from the FDA is expected by Sept. 7, 2025. If approved, Pyrukynd will become the first oral therapy for use in all thalassemia subtypes.

AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD last October. Top-line data from the study is expected in late 2025. A regulatory filing and a potential approval in the United States are expected in 2026.

Agios is also conducting two phase III studies, namely ACTIVATE-Kids and ACTIVATE-KidsT, on Pyrukynd for PK deficiency in pediatric patients who are not regularly transfused and those who are regularly transfused, respectively.

The company reported top-line data from the phase III ACTIVATE-Kids study evaluating Pyrukynd in children aged one to less than 18 years with PK deficiency who are not regularly transfused in February. The study met the primary endpoint of hemoglobin response.

Per management, the ACTIVATE-Kids is the first study to demonstrate the efficacy of an oral therapy for children with PK deficiency who are not regularly transfused.

Meanwhile, Agios is developing tebapivat, a novel PK activator, for the treatment of myelodysplastic syndromes, a rare type of blood cancer.

The company has initiated patient enrollment in the phase IIb study on tebapivat for treating lower-risk myelodysplastic syndromes. Enrollment of patients in the study is likely to be completed in late 2025.

Agios also plans to initiate a phase II study evaluating tebapivat for treating SCD in mid-2025.

AGIO's Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ADMA Biologics Inc. ADMA, Beam Therapeutics Inc. BEAM and Immunocore Holdings PLC IMCR, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 35.7%.

ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.

In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.45 to $4.27 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.94 to $4.80. Year to date, shares of BEAM have lost 20.1%.

BEAM’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.92%.

In the past 60 days, estimates for Immunocore’s loss per share have narrowed from $1.63 to $1.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.83 to $1.68. Year to date, shares of IMCR have gained 2.3%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 31.91%.

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This article originally published on Zacks Investment Research (zacks.com).

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