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Description of Business
12 Months Ended
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Description of Business
DESCRIPTION OF BUSINESS
AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care, including Makena® (hydroxyprogesterone caproate injection), Feraheme® (ferumoxytol) for intravenous (“IV”) use and MuGard® Mucoadhesive Oral Wound Rinse. Through services related to the preservation of umbilical cord blood stem cell and cord tissue units (the “CBR Services”) operated through Cord Blood Registry® (“CBR”), we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and which we believe have the potential to play a valuable role in the ongoing development of regenerative medicine.

We are subject to risks common to companies in the pharmaceutical industry including, but not limited to (as such risks pertain to our business) our dependence on the success of our product portfolio and maintaining commercialization of our products and services, including Makena, the CBR Services and Feraheme; intense competition, including from generic products; maintaining and defending the proprietary nature of our technology; our ability to expand our product portfolio through business development transactions; our dependence upon third-party manufacturers; our reliance on other third parties in our business, including to conduct our clinical trials and undertake our product distribution; our reliance on and the extent of reimbursement from third parties for the use of our products, including Makena’s high Medicaid reimbursement concentration; the impact of Makena’s loss of orphan drug exclusivity in February 2018; competition from compounded pharmacies; our ability to implement Makena’s next generation development programs, including regulatory approvals for such programs; our ability to differentiate Makena from compounded HPC products; perceptions related to pricing and access for Makena; the potential for cord blood stem cell and cord tissue science and its recognition in regenerative medicine; if our storage facility in Tucson, Arizona is damaged or destroyed; competition in the cord blood and tissue banking business; compliance with cord blood and tissue regulations and laws; post-approval commitments for Makena; limitations on Feraheme sales given its narrow chronic kidney disease indication and the potential impact on sales of any actual or perceived safety problems; our ability to receive regulatory approval for Feraheme in the broader iron deficiency anemia indication and Feraheme’s ability to compete in such market even if regulatory approval is received; competition from generic versions of Feraheme and iron replacement therapy products; our customer concentration, especially with regard to Feraheme; our ability to obtain approval for the sale of RekyndaTM (bremelanotide) by the FDA, our restrictions that may be imposed by the FDA; our ability to commercialize Rekynda; uncertainty regarding the market and competitors or Rekynda and IntrarosaTM (prasterone); our ability to commercialize Intrarosa, including the ability to drive awareness of dyspareunia; our ability to consummate the Intrarosa licensing transaction; uncertainties regarding federal and state legislative initiatives; potential inability to obtain raw or other materials; our potential failure to comply with federal, state or foreign healthcare fraud and abuse laws, marketing disclosure laws or other federal, state or foreign laws and regulations and potential civil or criminal penalties as a result thereof; our ability to managing our expanded product portfolio and operations; uncertainties regarding reporting and payment obligations under government pricing programs and our level of indebtedness; our ability to repay our indebtedness, including upon a change of our variable rate indebtedness; restrictions on our business related to our indebtedness; our access to sufficient capital; the availability of net operating loss carryforwards and other tax assets; employee retention; our ability to be profitable in the future; the potential fluctuation of our operating results; potential differences between actual future results and the estimates or assumptions used by us in preparation of our consolidated financial statements; the volatility of our stock price; current or potential litigation, including securities and product liability suits; provisions in our charter, by-laws and certain contracts that discourage an acquisition of our Company; the impact of disruptions to our information technology systems and the impact of market overhang on our stock price.

Throughout this Annual Report on Form 10-K, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.”