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Agios (AGIO) Q4 Earnings Beat Estimates, Revenues Miss

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Agios Pharmaceuticals, Inc. (AGIO - Free Report) announced fourth-quarter 2022 earnings per share of 67 cents, beating both Zacks Consensus Estimate of a loss of $1.59 per share and our estimate of a loss of $1.72.

Revenues were $4.3 million during the quarter, which slightly missed the Zacks Consensus Estimate of $4.42 million but beat our estimate of $3.9 million.

The revenues comprised entirely of U.S. revenues from Agios’ only marketed drug, Pyrukynd (mitapivat), which was approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency in February 2022.

Pyrukynd was granted approval for adults with PK deficiency in the European Union (EU) in November 2022.

Agios’ shares were down 10.5% compared with the industry’s 38% decline in the past year.

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Quarter in Details

Research & development expenses were $70.3 million for the fourth quarter, down 4.1% year over year.

Selling, general and administrative expenses were up 4.1% year over year to $32.8 million, primarily due to an increase in workforce-related expenses.

As of Dec 31, 2022, cash, cash equivalents and marketable securities were $1.1 billion compared with $1 billion as of Sep 30, 2022. This cash position will help Agios execute its planned development projects for mitapivat, AG-946 and PAH stabilization. It will also help in commercializing mitapivat outside the United States.  

Pipeline Updates

The company has two ongoing phase III studies in PK deficiency — ACTIVATE-kids and ACTIVATE-kidsT — evaluating Pyrukynd in non-regularly transfused and regularly transfused pediatric patients respectively. Agios anticipates to enroll at least half of the patients in these studies by the year end.

Apart from PK deficiency, Agios is also evaluating Pyrukynd for SCD and thalassemia indications.

AGIO is enrolling people in phase III studies, namely ENERGIZE and ENERGIZE-T, to evaluate Pyrukynd for thalassemia in adults, with one segment being not regularly transfused while the other being regularly transfused. Agios plans to complete the patient enrollment by mid-2023.

AGIO also completed enrollment in phase II portion of RISE UP study, evaluating Pyrukynd for sickle cell disease (SCD). Till date, the data from trail suggests that Pyrukynd reduces red blood cell sickling in adults with SCD, similar to the observation in PK deficiency and thalassemia. Agios plans to announce data from phase II and a go/no go decision for phase III by mid-2023.

Agios also expects to complete patient enrollment in a phase II study of AG-946 by year-end. The study of its next-generation pyruvate kinase-R activator is for treating adults with low-risk myelodysplastic syndromes (MDS).

AGIO is also evaluating the candidate AG-946 in a phase I study to treat hemolytic anemia.

Results 2022

For 2022, Agios generated revenues of $11.7 million from its only marketed drug, Pyrukynd (mitapivat).

The company reported a loss of $4.23 per share for the same period.

Zacks Rank & Other Stocks to Consider

Currently, Agios has a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the overall healthcare sector include Haemonetics (HAE - Free Report) , TerrAscend Corp. and Akerna . Haemonetics and TerrAscend both sport a Zacks Rank #1, while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Haemonetics’ stock has risen 42.1% in the past year. Earnings Estimates for Haemonetics have increased from $2.87 per share to 2.91 for 2023, and from $3.02 per share to $3.28 for 2024 in the past 30 days.

HAE’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 10.98%. In the last reported quarter, it reported an earnings surprise of 7.59%.

Estimates for TerrAscend in 2023 have remained constant at a loss of 10 cents per share in the past 30 days. Shares of TerrAscend have declined 70.6% in the past year.

TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.

Akerna’s stock declined 95.7% in the past year. Its estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.

Akerna missed earnings estimates in each of the last four quarters, delivering a negative earnings surprise of 15.49%, on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.


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