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AMAG (AMAG) Q1 Earnings Beat Estimates, Keeps 2016 View

AMAG Pharmaceuticals, Inc. AMAG reported earnings of 94 cents per share in the first quarter of 2016, surpassing the Zacks Consensus Estimate of 89 cents. Earnings were, however, lower than the year-ago quarter tally of $1.17.

The company’s quarterly revenues came in at $109.3 million, up 22.1% from the year-ago period. Reported revenues, however, missed the Zacks Consensus Estimate of $123 million.

Quarter in Detail

Makena sales came in at $65 million, up 17.1% year over year. The increase was primarily driven by a 16% jump in volume as more at-risk pregnant women were treated with the drug.

Combined sales of Feraheme and MuGard sales amounted to $24.5 million, up 11.9%.

During the quarter, service revenues from Cord Blood Registry came in at $19.5 million.

Research and development (R&D) expenses shot up 103.6% to $14.2 million. Selling, general and administrative (SG&A) expenses rose 96.7% to $63.2 million.

In the quarter, the company received approval for a single-dose, preservative-free formulation of Makena in the U.S. The product was made commercially available in April.

2016 Outlook

AMAG has reiterated its financial guidance for 2016. The company continues to expect total revenue in the range of $520 million to $570 million.

AMAG also reaffirmed its expectations of Makena sales in the range of $310–$340 million, combined Feraheme and MuGard sales of $95–$105 million and CBR revenues in the $115–$125 million band.

Pipeline Update

AMAG is evaluating Feraheme in a head-to-head phase III study on adult patients with iron deficiency anemia, who have failed or cannot tolerate oral iron treatment. The company expects to present data from the study in late 2017.

AMAG, in partnership with Antares Pharma Inc. ATRS, is developing an auto-injector for the subcutaneous administration of Makena. A range of activities such as CMC work and pilot pharmacokinetic studies are currently underway. The company expects to file a supplemental New Drug Application in the U.S. in the second quarter of 2017, with a response anticipated within the six month of submission.

Our Take

AMAG’s first-quarter 2015 results were mixed, with the company beating on the bottom line but missing top-line expectations. Nevertheless, we expect investors to focus on the company’s efforts on expanding its maternal health portfolio.

AMAG currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP and OncoMed Pharmaceuticals, Inc. OMED, both sporting a Zacks Rank #1 (Strong Buy).

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