Agios Pharmaceuticals AGIO incurred a loss of $1.74 per share in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.73. In the year-ago quarter, the company had reported a loss per share of $1.72.
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AGIO reported revenues of $10.7 million for the fourth quarter, which marginally beat the Zacks Consensus Estimate of $10 million. Revenues increased 51% from the year-ago quarter’s figure of $7.1 million.
In the past year, shares of Agios have rallied 24.2% against the industry’s decline of 3.6%.
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More on AGIO's Q4 Earnings
In the fourth quarter, revenues were generated entirely from product revenues of Agios’ only marketed drug, Pyrukynd (mitapivat), which was approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States and the EU in 2022.
Pyrukynd revenues were up 20% sequentially, driven by year-end stocking and adjustments to certain revenue reserves. Per management, a total of 130 patients are on Pyrukynd therapy, up 2.4% from third-quarter 2024 levels.
Research & development expenses increased 6.8% year over year to $82.8 million, owing to higher workforce-related expenses.
Selling, general and administrative expenses increased 46.5% year over year to $51.7 million. The increase was due to the company’s commercial preparations for a potential launch of Pyrukynd in the thalassemia indication.
As of Dec. 31, 2024, cash, cash equivalents and marketable securities totaled $1.5 billion compared with $1.7 billion as of Sept. 30, 2024.
AGIO's Full-Year Results
For 2024, Agios generated revenues of $36.5 million, which reflected a 36.1% increase year over year.
For the same period, the company reported earnings of $11.64 per share against a loss of $6.33 per share in the year-ago period.
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.
Apart from 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 is expected by Sept. 7, 2025. If approved, Pyrukynd will become the first oral therapy for use in all thalassemia subtypes.
In October 2024, AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD. Top-line data from the study is expected in late 2025. A regulatory filing and a potential approval in the United States is 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.
In a separate press release, Agios 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. 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.
Besides Pyrukynd, Agios is developing a novel PK activator, tebapivat, 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 begin patient enrollment in a phase II study evaluating tebapivat for treating SCD in mid-2025.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote
AGIO's Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the biotech sector are Harmony Biosciences Holdings, Inc. HRMY and Pacira BioSciences, Inc. PCRX, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.16 for 2025. In the past year, shares of HRMY have risen 11.5%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Pacira BioSciences’ earnings per share have increased from $2.79 to $3.40 for 2025. In the past year, shares of PCRX have decreased 10.6%.
PCRX’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 7.13%.
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