AMAG Pharma (AMAG) Incurs Loss In Q1, Revenues Rise Y/Y

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) reported adjusted earnings of 99 cents per share in the first quarter of 2017 compared with earnings of 68 cents in the year-ago quarter. Adjusted earnings exclude a one-time payment of $60 million for the acquisition of exclusive U.S. rights to develop and commercialize Palatin Technologies, Inc.’s (NYSE:PTN) HSDD drug, Rekynda. A new drug application for Rekynda is expected to be filed in early 2018

However, including one-time and special items, reported loss was $1.06 per share in the first quarter of 2017 compared with loss of 22 cents in the year-ago quarter. The Zacks Consensus Estimate was of earnings of 9 cents per share.

The company’s quarterly revenues came in at $139.5 million, up approximately 27.6% from the year-ago quarter figure of $109.3 million. The upside was driven by impressive growth in net sales of Makena. However, revenues missed the Zacks Consensus Estimate.

AMAG’s share price has decreased 38.4% year to date against the Zacks classified Medical - Biomedical and Genetics industry’s gain of 5.5%.

Quarter in Detail

Makena sales came in at $86.5 million, up 33.1% year over year, primarily driven by an increase in market share to 44%. However, ex-factory sales were down sequentially due to a decline in channel inventory.

Combined sales of Feraheme and MuGard amounted to $26.1 million, up 6.5%. During the quarter, service revenues from CBR came in at $26.9 million, 38% higher than $19.5 million in the year-ago quarter.

Total adjusted costs and expenses increased almost 18% to $83.2 million. Adjusted costs and expenses exclude one-time and special items.

Key Developments

Concurrent with the press release, AMAG announced results from a phase III label extension study evaluating Feraheme intravenous (IV) infusion compared to Injectafer IV infusion in patients with iron deficiency anaemia (IDA). The study met its primary endpoint demonstrating no-inferiority of Feraheme to Injectafer.

The top-line results showed that 0.6% of the patients under trial experienced moderate-to-severe hypersensitivity reactions (including anaphylaxis) and/or moderate-to-severe hypotension when treated with Feraheme in comparison to 0.7% for Injectafer. Also, the incidence of hypophosphatemia reduced to 0.4% for Feraheme from 38.6% for Injectafer.

Based on this data, AMAG is planning to submit a supplemental new drug application (sNDA) to the FDA by mid-2017 for expanding Feraheme’s label to include adult IDA patients who are intolerable to oral iron treatment.

Subsequent to this quarter, AMAG announced closing of its exclusive licensing agreement to buy the U.S. commercial rights to Endoceutics, Inc.’s drug Intrarosa (prasterone), a FDA-approved non-estrogen product for the treatment of moderate-to-severe dyspareunia. Also, the company filed a supplemental New Drug Application (sNDA) to the FDA for the subcutaneous auto-injector form of its marketed drug Makena in the U.S. in April this year.

2017 Outlook

The company raised its total revenue guidance range from $620 million - $670 million to $625 million - $685 million to include revenues from the recently acquired Intrarosa. The company expects loss in the range of $44 million to $88 million. The company had earlier expected earnings in the range of $19 million to $60 million. The company reiterated its revenue guidance for Makena ($410 million - $440 million), Feraheme and MuGard ($100 million - $110 million) and CBR Segment ($110 million - $120 million).

Our Take

The acquisitions of Makena and CBR proved to be huge positives for the company. Meanwhile, the addition of Intrarosa and Rekynda will allow AMAG to address the key needs of women’s healthcare, with three potential new product launches over the next two years, starting with Intrarosa in 2017, followed by Makena subcutaneous auto-injector and Rekynda, if approved.

AMAG Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

AMAG Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | AMAG Pharmaceuticals, Inc. Quote

Zacks Rank & Key Picks

AMAG currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) and Nivalis Therapeutics, Inc. (NASDAQ:NVLS) . While Progenics sports a Zacks Rank #1 (Strong Buy), Nivalis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Progenics’ loss estimates narrowed by 24.4% and 28.6% for 2017 and 2018, respectively over the past 30 days. Also, it recorded a positive earnings surprise in three of the last four quarters, with the average being 8.45%.

Nivalis’ earnings estimates increased 23.5% for 2017 and 16.2% for 2018, over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 12.26%. Its share price has increased 4.1% year to date.

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