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AGIO's Q3 Earnings Miss Mark, Revenues In Line, Stock Down
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Agios Pharmaceuticals, Inc. (AGIO - Free Report) reported earnings of $16.22 per share for the third quarter of 2024, which missed the Zacks Consensus Estimate of $16.69. In the year-ago quarter, the company had reported a loss of $1.64 per share.
The abovementioned earnings included a gain on the sale of contingent payments and a milestone payment from a gain on the sale of the oncology business. Excluding these items, the company incurred a loss of 15 cents per share.
Earnings grew significantly year over year owing to a $1.1 billion payment from Servier and Royalty Pharma, following the FDA approval for vorasidenib for the treatment of IDH-mutant diffuse glioma.
In August 2024, the FDA approved vorasidenib for a brain tumor called IDH-mutant diffuse glioma. Per the terms of the sale executed between Agios and Servier, the latter was to pay a milestone payment of $200 million to Agios for this approval. In May 2024, Agios entered into a deal with Royalty Pharma to sell its royalty rights on potential net sales of vorasidenib in exchange for an upfront payment of $905 million.
In the third quarter, AGIO reported revenues of $9 million, which came in line with the Zacks Consensus Estimate. In the year-ago quarter, the company had recorded revenues of $7.4 million.
Shares of Agios were down 4% on Oct. 31 following the announcement of the results.
The stock is up 99.5% in the year-to-date period compared with the industry’s rise of 14.3%.
Image Source: Zacks Investment Research
Stay up-to-date with all quarterly releases:See Zacks Earnings Calendar.
More on AGIO's Q3 Earnings
In the reported 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 4% sequentially, driven primarily by increased patient demand. Per management, a total of 127 patients are on Pyrukynd therapy, down 0.8% from second-quarter 2024 levels.
Research & development expenses declined 11.4% year over year to $72.5 million. The decrease was primarily due to a $17.5 million upfront payment recorded last year associated with the license agreement with Alnylam Pharmaceuticals (ALNY - Free Report) , .
Agios in-licensed TMPRSS6 siRNA from Alnylam in August 2023. It is in preclinical studies as a potential treatment for polycythemia vera, a rare and potentially fatal hematologic disease.
Selling, general and administrative expenses increased 49.2% year over year to $38.5 million. The upside was due to the company’s commercial preparations for a potential launch of Pyrukynd in thalassemia indication.
As of Sept. 30, 2024, cash, cash equivalents and marketable securities totaled $1.7 billion compared with $645.3 million as of Jun 30, 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.
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 are regularly transfused, respectively.
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.
In October 2024, AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD. Top-line data from the same is expected in late 2025.
Besides Pyrukynd, Agios is developing a novel PK activator, tebapivat, for the treatment of myelodysplastic syndromes (MDS), a rare type of blood cancer.
The FDA granted orphan drug designation to tebapivat for treating MDS in September 2024.
During the third quarter, Agios initiated patient enrollment in the phase IIb study on tebapivat for treating lower-risk myelodysplastic syndromes (LR-MDS).
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for Elevation Oncology’s 2024 loss per share have narrowed from 86 cents to 82 cents. Loss per share estimates for 2025 have narrowed from 90 cents to 86 cents during the same time. Year to date, shares of ELEV have increased 6.9%.
ELEV’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 12.05%.
In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 19.5%.
FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.
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AGIO's Q3 Earnings Miss Mark, Revenues In Line, Stock Down
Agios Pharmaceuticals, Inc. (AGIO - Free Report) reported earnings of $16.22 per share for the third quarter of 2024, which missed the Zacks Consensus Estimate of $16.69. In the year-ago quarter, the company had reported a loss of $1.64 per share.
The abovementioned earnings included a gain on the sale of contingent payments and a milestone payment from a gain on the sale of the oncology business. Excluding these items, the company incurred a loss of 15 cents per share.
Earnings grew significantly year over year owing to a $1.1 billion payment from Servier and Royalty Pharma, following the FDA approval for vorasidenib for the treatment of IDH-mutant diffuse glioma.
In August 2024, the FDA approved vorasidenib for a brain tumor called IDH-mutant diffuse glioma. Per the terms of the sale executed between Agios and Servier, the latter was to pay a milestone payment of $200 million to Agios for this approval. In May 2024, Agios entered into a deal with Royalty Pharma to sell its royalty rights on potential net sales of vorasidenib in exchange for an upfront payment of $905 million.
In the third quarter, AGIO reported revenues of $9 million, which came in line with the Zacks Consensus Estimate. In the year-ago quarter, the company had recorded revenues of $7.4 million.
Shares of Agios were down 4% on Oct. 31 following the announcement of the results.
The stock is up 99.5% in the year-to-date period compared with the industry’s rise of 14.3%.
Image Source: Zacks Investment Research
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on AGIO's Q3 Earnings
In the reported 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 4% sequentially, driven primarily by increased patient demand. Per management, a total of 127 patients are on Pyrukynd therapy, down 0.8% from second-quarter 2024 levels.
Research & development expenses declined 11.4% year over year to $72.5 million. The decrease was primarily due to a $17.5 million upfront payment recorded last year associated with the license agreement with Alnylam Pharmaceuticals (ALNY - Free Report) , .
Agios in-licensed TMPRSS6 siRNA from Alnylam in August 2023. It is in preclinical studies as a potential treatment for polycythemia vera, a rare and potentially fatal hematologic disease.
Selling, general and administrative expenses increased 49.2% year over year to $38.5 million. The upside was due to the company’s commercial preparations for a potential launch of Pyrukynd in thalassemia indication.
As of Sept. 30, 2024, cash, cash equivalents and marketable securities totaled $1.7 billion compared with $645.3 million as of Jun 30, 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.
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 are regularly transfused, respectively.
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.
In October 2024, AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD. Top-line data from the same is expected in late 2025.
Besides Pyrukynd, Agios is developing a novel PK activator, tebapivat, for the treatment of myelodysplastic syndromes (MDS), a rare type of blood cancer.
The FDA granted orphan drug designation to tebapivat for treating MDS in September 2024.
During the third quarter, Agios initiated patient enrollment in the phase IIb study on tebapivat for treating lower-risk myelodysplastic syndromes (LR-MDS).
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote
AGIO's Zacks Rank
Agios currently carries a Zacks Rank #2 (Buy).
Other Key Picks Among Biotech Stocks
Some other top-ranked stocks from this space are Elevation Oncology, Inc. (ELEV - Free Report) and Amicus Therapeutics, Inc. (FOLD - Free Report) , each 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 Elevation Oncology’s 2024 loss per share have narrowed from 86 cents to 82 cents. Loss per share estimates for 2025 have narrowed from 90 cents to 86 cents during the same time. Year to date, shares of ELEV have increased 6.9%.
ELEV’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 12.05%.
In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 19.5%.
FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.