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Agios (AGIO) Q1 Loss Narrower than Expected, Indhifa in Focus
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Agios Pharmaceuticals, Inc. (AGIO - Free Report) posted first-quarter 2017 loss of $1.56 per share, narrower than the Zacks Consensus Estimate of a loss of $1.79 but wider than the year-ago loss of 61 cents.
Agios’s shares have underperformed the Zacks classified Medical-Products industry so far this year. The company’s shares gained 13.3% compared with the industry’s increase of 14.4%.
Agios does not have any approved product in its portfolio yet. In fact, the company’s top line mainly comprises collaboration revenues and milestone payments.
Total collaboration revenue in the first quarter amounted to $10.5 million, which beat the Zacks Consensus Estimate of $10 million. However, revenues were significantly lower than $31.3 million generated in the year-ago period. The decrease in revenues is mainly attributable to recognition of a $25 million milestone payment from Celgene Corporation in the year-ago quarter for initiation of a phase III IDENTIFY study with Indhifa/enasidenib.
Research & development expenses were up almost 42.5 % year over year to $62.7 million. The increase was largely driven by higher investments associated with the advancement of the company's lead investigational medicines into late-stage studies.
General and administrative expenses increased 37% year over year to $14.8 million due to a higher headcount and other professional costs to support the expansion of operations.
Pipeline Updates
Agios and Celgene submitted a new drug application (NDA) for Indhifa in the U.S. for IDH2m positive relapsed/refractory (R/R) acute myeloid leukemia (AML) in the fourth quarter of 2016. The NDA was based on data from an ongoing phase I/II trial in patients with R/R AML and other advanced hematologic malignancies. In Mar 2017, the FDA accepted the NDA and granted priority review to Indhifa with a Prescription Drug User Fee Act (PDUFA) action date of Aug 30, 2017.
Agios has several other candidates in its pipeline, including an IDH1 mutant inhibitor ivosidenib (AG-120) and pan-IDH mutant inhibitor AG-881.
Enrollment in the expansion cohort for the phase I study on ivosidenib in 125 patients with R/R AML has been completed. Meanwhile, Agios initiated a phase III study to evaluate ivosidenib in front-line AML patients with an IDH1 mutation advanced cholangiocarcinoma. In Apr 2017, the FDA granted orphan drug designation to ivosidenib for the treatment of cholangiocarcinoma. The company plans to submit a NDA to the FDA for ivosidenib by the end of 2017.
Aditionally, Agios expects to complete the dose-escalation stage of the ongoing phase I study of AG-881 in IDHm positive glioma in the first half of 2017.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Galena Biopharma, Inc. and Aeglea Biotherapeutics, Inc. . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 53.83%.
Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 30 days. The company’s shares gained 54.7% so far this year.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
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Agios (AGIO) Q1 Loss Narrower than Expected, Indhifa in Focus
Agios Pharmaceuticals, Inc. (AGIO - Free Report) posted first-quarter 2017 loss of $1.56 per share, narrower than the Zacks Consensus Estimate of a loss of $1.79 but wider than the year-ago loss of 61 cents.
Agios’s shares have underperformed the Zacks classified Medical-Products industry so far this year. The company’s shares gained 13.3% compared with the industry’s increase of 14.4%.
Agios does not have any approved product in its portfolio yet. In fact, the company’s top line mainly comprises collaboration revenues and milestone payments.
Total collaboration revenue in the first quarter amounted to $10.5 million, which beat the Zacks Consensus Estimate of $10 million. However, revenues were significantly lower than $31.3 million generated in the year-ago period. The decrease in revenues is mainly attributable to recognition of a $25 million milestone payment from Celgene Corporation in the year-ago quarter for initiation of a phase III IDENTIFY study with Indhifa/enasidenib.
Research & development expenses were up almost 42.5 % year over year to $62.7 million. The increase was largely driven by higher investments associated with the advancement of the company's lead investigational medicines into late-stage studies.
General and administrative expenses increased 37% year over year to $14.8 million due to a higher headcount and other professional costs to support the expansion of operations.
Pipeline Updates
Agios and Celgene submitted a new drug application (NDA) for Indhifa in the U.S. for IDH2m positive relapsed/refractory (R/R) acute myeloid leukemia (AML) in the fourth quarter of 2016. The NDA was based on data from an ongoing phase I/II trial in patients with R/R AML and other advanced hematologic malignancies. In Mar 2017, the FDA accepted the NDA and granted priority review to Indhifa with a Prescription Drug User Fee Act (PDUFA) action date of Aug 30, 2017.
Agios has several other candidates in its pipeline, including an IDH1 mutant inhibitor ivosidenib (AG-120) and pan-IDH mutant inhibitor AG-881.
Enrollment in the expansion cohort for the phase I study on ivosidenib in 125 patients with R/R AML has been completed. Meanwhile, Agios initiated a phase III study to evaluate ivosidenib in front-line AML patients with an IDH1 mutation advanced cholangiocarcinoma. In Apr 2017, the FDA granted orphan drug designation to ivosidenib for the treatment of cholangiocarcinoma. The company plans to submit a NDA to the FDA for ivosidenib by the end of 2017.
Aditionally, Agios expects to complete the dose-escalation stage of the ongoing phase I study of AG-881 in IDHm positive glioma in the first half of 2017.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Agios Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Galena Biopharma, Inc. and Aeglea Biotherapeutics, Inc. . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 53.83%.
Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 30 days. The company’s shares gained 54.7% so far this year.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>