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Agios (AGIO) Q1 Loss Lower than Expected, Pipeline in Focus

Agios Pharmaceuticals, Inc. AGIO reported a first-quarter 2016 loss of 61 cents per share, much narrower than the Zacks Consensus Estimate of a loss of 69 cents but wider than the year-ago loss of 13 cents.

Agios does not have any approved product in its portfolio. The company recognizes revenues in the form of collaboration revenues and milestone payments. Its total collaboration revenue in the first quarter of 2016 was $31.3 million, above the Zacks Consensus Estimate of $22.3 million. Revenues were however down 8.5% from the year-ago period.

In the first quarter of 2016, the company received and recognized as revenues $25 million related to a substantive clinical development milestone for the AG-221 program.

Research & development expenses increased 35.7% year over year to $44 million. The increase was largely due to higher investments in pipeline development. General and administrative expenses shot up 55.8% year over year to $10.8 million due to an increased headcount and other professional expenses to support the company’s expanding operations.

Focus on Pipeline

The company currently has several candidates in its pipeline, which includes IDH2 mutant inhibitor – AG-221, IDH1 mutant inhibitor – AG-120 and pan-IDH mutant inhibitor – AG-881.

In Mar 2016, Celgene Corporation CELG initiated a phase I/II frontline combination study on AG-221 or AG-120 in combination with Celgene’s Vidaza in newly diagnosed acute myeloid leukemia (AML) patients who are not eligible for intensive chemotherapy.

Meanwhile, enrollment in the phase II expansion cohort for the phase I/II study on AG-221 in patients with refractory/relapsed (R/R) AML was completed this month. On the other hand, enrollment in the expansion cohort for the phase I study on AG-120 in patients with R/R AML is expected to be completed in the second half of 2016. In Apr 2016, the company received an orphan drug status in the EU for AG-221 for the treatment of AML.

The company intends to initiate a phase III study on AG-120 for the treatment of patients with AML, who have an IDH1 mutation, in the second half of 2016. Also, Agios is planning to start a randomized phase II study on AG-120 in IDH1 mutant positive cholangiocarcinoma in the second half of 2016. In addition, the company plans to initiate an expansion arm in high-risk myelodysplastic syndrome patients on AG-221 this year.

The company plans to continue enrolling in the following studies – a phase III (IDHENTIFY) study on AG-221 versus standard of care chemotherapy in R/R AML patients, a phase Ib frontline combination study on AG-221 or AG-120 with standard-of-care intensive chemotherapy in AML patients and in expansion phase of the ongoing phase I study on AG-120 in patients with advanced IDH1 mutant positive solid tumors. Apart from these, enrollment is also ongoing in a phase I dose-escalation and expansion study on AG-881 in IDH mutant positive solid tumors and hematologic malignancies.

We note that Agios has a collaboration agreement with Celgene for AG-221, AG-120 and AG-881.

Apart from these, Agios’ pipeline includes AG-348, which is currently in a phase II study (DRIVE PK) in adult transfusion-independent patients with pyruvate kinase (PK) deficiency. The company plans to present DRIVE PK study data and the first data from the phase I healthy volunteer study on AG-519, another PK deficiency candidate at EHA next month.

We are encouraged by the company’s progress with its pipeline. Investor focus should remain on updates pertaining to pipeline development.

Agios is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP and Retrophin, Inc. RTRX, each sporting a Zacks Rank #1 (Strong Buy).

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