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AGIO Q2 Earnings Lag, Stock Down on Missing Pediatric Study Goal
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Agios Pharmaceuticals (AGIO - Free Report) reported a loss of $1.69 per share in second-quarter 2024, wider than the Zacks Consensus Estimate of a loss of $1.58. In the year-ago quarter, the company reported a loss of $1.51.
AGIO reported revenues of $8.6 million, which missed the Zacks Consensus Estimate of $9.4 million. In the year-ago quarter, the company recorded revenues of $6.7 million.
Quarter in Detail
In the reported 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.
Pyrukynd revenues were up 5% sequentially, driven primarily by increased patient demand. Per management, a total of 128 patients are on Pyrukynd therapy, up 7% from first-quarter 2024 levels.
Research & development expenses rose 12% year over year to $77.4 million, driven by an increase in costs associated with the siRNA TMPRSS6 program in-licensed from Alnylam Pharmaceuticals (ALNY - Free Report) last year. Agios intends to develop this in-licensed Alnylam candidate as a potential disease-modifying therapy for polycythemia vera, a rare and potentially-fatal hematologic disease.
Selling, general and administrative expenses increased 17% year over year to $35.5 million. The upside was caused by the company’s commercial preparations for a potential launch of Pyrukynd in thalassemia indication.
As of Jun 30, 2024, cash, cash equivalents and marketable securities totaled $645.3 million compared with $714.3 million as of Mar 31, 2024.
Pipeline & Other Updates
In a separate press release, Agios reported top-line results from the phase III ACTIVATE-KidsT study evaluating Pyrukynd in children aged one to less than 18 years with PK deficiency who are regularly transfused. The study did not meet the prespecified statistical criterion for the primary endpoint of transfusion reduction response. Shares were down 4.1% on Aug 1 due to this miss.
Year to date, Agios’ shares have surged 99.8% compared to the industry’s 3.9% growth.
Image Source: Zacks Investment Research
However, management noted that the ACTIVATE-KidsT study results were clinically meaningful — 28.1% of patients in the mitapivat arm achieved the primary endpoint compared with 11.8% in the placebo arm. AGIO plans to present a detailed analysis of data from this study at a future medical meeting.
Agios also evaluates Pyrukynd in the late-stage ACTIVATE-Kids study in children with PK deficiency who are not regularly transfused. Topline data from this study is expected in 2025.
Apart from PK deficiency, Pyrukynd is also being developed for other hemolytic anemias, including SCD and thalassemia, in several label expansion studies.
In first-half 2024, Agios reported encouraging data from two phase III studies, ENERGIZE and ENERGIZE-T, which evaluated Pyrukynd for alpha- or beta-thalassemia patients who are non-transfusion-dependent (NTD) and transfusion-dependent (NTD), respectively. Both studies achieved their primary and key secondary endpoints. Per management, these results strengthen Pyrukynd’s potential to become the first oral therapy for NTD and TD thalassemia patients. Based on data from the two studies, the company plans to seek label expansion from the FDA for Pyrukynd across all thalassemia sub-types before 2024-end.
It plans to complete enrollment in the phase III portion of the RISE UP study investigating Pyrukynd in sickle cell disease (SCD) by 2024-end. Data readout from this portion is expected next year.
Management intends to commercially launch Pyrukynd in thalassemia and SCD indications by 2025 and 2026, respectively.
During the second quarter, Agios entered into a deal with Royalty Pharma to sell the royalty rights on potential net sales of vorasidenib, a brain cancer therapy. Per the deal, Agios will receive an upfront payment of $905 million if the FDA approves the drug. Vorasidenib was a part of its oncology business that was sold to France-based pharmaceutical company Servier in 2021.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 12.2%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings has risen from $3.69 per share to $3.90. For 2025, earnings estimates have increased from $4.50 to $4.81 in the past 60 days. Year to date, shares of HALO have surged 48.9%.
Earnings of Halozyme beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 9.40%.
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AGIO Q2 Earnings Lag, Stock Down on Missing Pediatric Study Goal
Agios Pharmaceuticals (AGIO - Free Report) reported a loss of $1.69 per share in second-quarter 2024, wider than the Zacks Consensus Estimate of a loss of $1.58. In the year-ago quarter, the company reported a loss of $1.51.
AGIO reported revenues of $8.6 million, which missed the Zacks Consensus Estimate of $9.4 million. In the year-ago quarter, the company recorded revenues of $6.7 million.
Quarter in Detail
In the reported 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.
Pyrukynd revenues were up 5% sequentially, driven primarily by increased patient demand. Per management, a total of 128 patients are on Pyrukynd therapy, up 7% from first-quarter 2024 levels.
Research & development expenses rose 12% year over year to $77.4 million, driven by an increase in costs associated with the siRNA TMPRSS6 program in-licensed from Alnylam Pharmaceuticals (ALNY - Free Report) last year. Agios intends to develop this in-licensed Alnylam candidate as a potential disease-modifying therapy for polycythemia vera, a rare and potentially-fatal hematologic disease.
Selling, general and administrative expenses increased 17% year over year to $35.5 million. The upside was caused by the company’s commercial preparations for a potential launch of Pyrukynd in thalassemia indication.
As of Jun 30, 2024, cash, cash equivalents and marketable securities totaled $645.3 million compared with $714.3 million as of Mar 31, 2024.
Pipeline & Other Updates
In a separate press release, Agios reported top-line results from the phase III ACTIVATE-KidsT study evaluating Pyrukynd in children aged one to less than 18 years with PK deficiency who are regularly transfused. The study did not meet the prespecified statistical criterion for the primary endpoint of transfusion reduction response. Shares were down 4.1% on Aug 1 due to this miss.
Year to date, Agios’ shares have surged 99.8% compared to the industry’s 3.9% growth.
However, management noted that the ACTIVATE-KidsT study results were clinically meaningful — 28.1% of patients in the mitapivat arm achieved the primary endpoint compared with 11.8% in the placebo arm. AGIO plans to present a detailed analysis of data from this study at a future medical meeting.
Agios also evaluates Pyrukynd in the late-stage ACTIVATE-Kids study in children with PK deficiency who are not regularly transfused. Topline data from this study is expected in 2025.
Apart from PK deficiency, Pyrukynd is also being developed for other hemolytic anemias, including SCD and thalassemia, in several label expansion studies.
In first-half 2024, Agios reported encouraging data from two phase III studies, ENERGIZE and ENERGIZE-T, which evaluated Pyrukynd for alpha- or beta-thalassemia patients who are non-transfusion-dependent (NTD) and transfusion-dependent (NTD), respectively. Both studies achieved their primary and key secondary endpoints. Per management, these results strengthen Pyrukynd’s potential to become the first oral therapy for NTD and TD thalassemia patients. Based on data from the two studies, the company plans to seek label expansion from the FDA for Pyrukynd across all thalassemia sub-types before 2024-end.
It plans to complete enrollment in the phase III portion of the RISE UP study investigating Pyrukynd in sickle cell disease (SCD) by 2024-end. Data readout from this portion is expected next year.
Management intends to commercially launch Pyrukynd in thalassemia and SCD indications by 2025 and 2026, respectively.
During the second quarter, Agios entered into a deal with Royalty Pharma to sell the royalty rights on potential net sales of vorasidenib, a brain cancer therapy. Per the deal, Agios will receive an upfront payment of $905 million if the FDA approves the drug. Vorasidenib was a part of its oncology business that was sold to France-based pharmaceutical company Servier in 2021.
Agios Pharmaceuticals, Inc. Price
Agios Pharmaceuticals, Inc. price | Agios Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Immatics (IMTX - Free Report) and Halozyme Therapeutics (HALO - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 12.2%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings has risen from $3.69 per share to $3.90. For 2025, earnings estimates have increased from $4.50 to $4.81 in the past 60 days. Year to date, shares of HALO have surged 48.9%.
Earnings of Halozyme beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 9.40%.