Agios Pharmaceuticals, Inc. AGIO posted third-quarter 2017 loss of $1.59 per share, narrower than both the Zacks Consensus Estimate of a loss of $1.74 and the year-ago loss of $1.63.
Agios’ shares have significantly outperformed the industry so far this year. The company’s shares have surged 48.6% compared with the industry’s increase of 21.2%.
In August, Agios along with partner Celgene Corp. announced that the FDA has granted an approval to its lead candidate, Idhifa (enasidenib) for treatment of patients with relapsed or refractory acute myeloid leukemia (“AML”) with an isocitrate dehydrogenase-2 (IDH2) mutation. However, apart from Idhifa, Agios lacks any sanctioned product in its portfolio. Hence, the company’s top line mainly comprises collaboration revenues and royalty revenues.
Total revenues in the third quarter amounted to $11.4 million, marginally beating the Zacks Consensus Estimate of $11 million. The top line surged 26.7% from the year-ago figure of $9 million. This swell in revenues is primarily attributable to reimbursement from Celgene for Idhifa’s commercialization efforts in the United States and royalty revenues gained from Idhifa.
Research & development expenses jumped 20.3% year over year to $72.9 million. This increase was largely driven by escalated costs associated with the ivosidenib program.
General and administrative expenses climbed 47% year over year to $17.5 million due to higher costs related to Idhifa’s launch and the potential launch of ivosidenib in 2018.
Agios has several candidates in its pipeline, including an IDH1 mutant inhibitor, ivosidenib (AG-120) and pan-IDH mutant inhibitor, AG-881.
In June, Agios presented positive data from dose escalation and expansion cohorts of the phase I study, evaluating single agent ivosidenib in mutant-positive cholangiocarcinoma at the American Society of Clinical Oncology (“ASCO”) Annual Meeting.
Agios also initiated a phase III study to evaluate ivosidenib in front-line AML patients with an IDH1 mutant-positive advanced cholangiocarcinoma. The FDA granted an orphan drug designation to ivosidenib for treatment of cholangiocarcinoma. The company said that it is on track to submit a new drug application (“NDA”) to the FDA for ivosidenib by this year-end.
Additionally, Agios is conducting phase I studies on another pipeline candidate, AG-881, for treatment of patients with advanced IDH1 or IDH2 mutant-positive solid tumors, including glioma.
Notably, the company also plans to initiate a perioperative ‘window’ study to evaluate ivosidenib and AG-881 in low grade glioma for investigating their effects on brain tumor tissue in the first half of 2018.
Zacks Rank & Other Key Picks
Agios currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the health care sector include Ligand Pharmaceuticals Inc. LGND and Exelixis, Inc. EXEL. While Ligand sports a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 6.19%. The share price of the company has surged 41.8% year to date.
Exelixis’ earnings per share estimates have moved up from 62 cents to 64 cents for 2017 over the last 60 days. The company came up with positive earnings surprises in each of the trailing four quarters with an average beat of 572.92%. The share price of the company has soared 62.5% year to date.
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