AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its technology for the development and commercialization of a therapeutic iron compound to treat anemia, and imaging agents to aid in the diagnosis of cancer and cardiovascular disease. The Company has one product candidate, Feraheme (ferumoxytol injection), and two approved products, Feridex I.V. and GastroMARK. Feraheme is being developed for use as an intravenous (IV) iron replacement therapeutic agent for the treatment of iron deficiency anemia (IDA) and as a diagnostic agent for vascular enhanced magnetic resonance imaging (MRI) to assess peripheral arterial disease (PAD). Feridex I.V., the Company’s liver contrast agent, is approved and has been sold in the United States, Europe and other countries. In November 2008, ceased manufacturing Feridex I.V. GastroMARK, its oral contrast agent used for delineating the bowel in MRI, is approved and marketed in the United States, Europe, and other countries.

AMAG Pharmaceuticals Announces First Quarter 2017 Financial Results and Provides Corporate Update
First quarter 2017 GAAP revenue increased 28%

Company announced positive Feraheme Phase 3 data

Conference call scheduled for 8:00 a.m. ET today

WALTHAM, Mass., May 02, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the quarter ended March 31, 2017. Total GAAP revenue for the first quarter of 2017 increased to $139.5 million, approximately 28% higher than the same period last year. This increase was primarily driven by growth in net sales of Makena® (hydroxyprogesterone caproate injection). The company reported an operating loss of $40.0 million in the first quarter of 2017, compared with operating income of $7.4 million in the same period last year. The operating loss in the first quarter of 2017 was primarily due to a one-time payment of $60 million to Palatin Technologies, Inc. related to the bremelanotide licensing transaction. Non-GAAP adjusted EBITDA increased approximately 21% to $57.6 million in first quarter of 2017, as compared to the corresponding period in 2016.1

"Today we are reaffirming our 2017 annual revenue guidance on our existing commercial portfolio of Makena, Feraheme and CBR based on the strong underlying fundamentals of those products," stated William Heiden, AMAG's president and chief executive officer. "While our commercial team drove higher physician-level Makena demand (distributor shipments to end users) in the first quarter of 2017 compared to the fourth quarter of 2016, first quarter 2017 ex-factory sales of Makena (shipments to distributors) decreased compared to the fourth quarter of 2016. The difference between demand and ex-factory sales was primarily due to a decline in channel inventory, as well as one-time items impacting net price in the first quarter of 2017."

The company today also separately announced positive Phase 3 clinical data evaluating the safety of Feraheme® (ferumoxytol) compared to Injectafer® (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA). The study achieved all primary and secondary safety and efficacy endpoints and will be the basis for a supplemental new drug application (sNDA) filing planned in mid-2017 to broaden the Feraheme label beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.

"We made strong progress against key 2017 goals with today's announcement of a successful Phase 3 study for Feraheme, the April filing of an sNDA for the Makena subcutaneous auto-injector, and the closing of two transactions that expand our product portfolio and position AMAG well for sustainable long-term growth,” added Mr. Heiden.  “Our license agreements for IntrarosaTM and bremelanotide represent significant opportunities to address unmet medical needs in women’s health, and combined with Makena and our CBR offerings, demonstrate AMAG’s growing commitment to women's healthcare."

First Quarter 2017 and Recent Business Highlights:

Generated strong revenues, including 33% growth in Makena sales and 7% growth in Feraheme sales over the first quarter of 2016
Increased Makena market share2 by 2% to 44% over the fourth quarter of 2016
Ended the quarter with $558.4 million of cash and investments
Filed an sNDA with the U.S. Food and Drug Administration (FDA) in April 2017 for the Makena subcutaneous auto-injector, with an anticipated six month review timeline
Announced positive Phase 3 clinical data evaluating the safety of Feraheme compared to Injectafer in adults with IDA (see separate press release dated May 2, 2017)
Closed two licensing transactions in the women's health space for rights to Intrarosa and bremelanotide
Initiated the hiring of a new ~150-person women's health commercial team to support the anticipated mid-2017 launch of Intrarosa
Advanced ongoing clinical work with our partner Palatin for the submission of a new drug application for bremelanotide in early 2018

Copyright  2017