| Copyright © 2014 AMAG Pharmaceuticals, Inc. All Rights Reserved. Forward Looking Statements 1 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to: statements regarding (i) our strategic plan; (ii) our 2014 financial outlook, including projected sales, cost of goods sold, operating expenses and cash and investments balance; (iii) plans to drive revenue growth of Feraheme in the current indication and possible plans to seek to enhance Feraheme’s label and expand into new markets; (iv) commercial opportunities for Feraheme in the current indication; (v) the possibility and next steps for label expansion, including assumptions regarding the patient study and its return on investment; (vi) the expected timing and magnitude of milestone payments; (vii) expectations regarding the demand for MuGard and our s trategies to increase MuGard’s commercial success; (viii) our business development goals and opportunities, including our expectations that more than 50% of our revenues will be attributable to new products by 2018; (ix) the impact of business development transactions on EBITDA; (x) our ability to optimize after-tax cash flows with business development transactions; and (xi) our statement that AMAG is well positioned for success in 2014 and beyond are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: (1) uncertainties regarding the likelihood and timing of potential approval of AMAG’s supplemental New Drug Application (sNDA) for Feraheme in the U.S. in the broader iron deficiency anemia (IDA) indication, (2) the possibility that following the FDA’s review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, the FDA will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme, (3) uncertainties regarding our and Takeda Pharmaceutical’s ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, including as a result of limitations, restrictions or warnings in Feraheme’s/Rienso’s current or future label that put Feraheme/Rienso at a competitive disadvantage, (4) uncertainties regarding Takeda’s ability to obtain regulatory approval for Feraheme in Canada, and Rienso in the EU, in the broader IDA patient population, (5) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales, or the company’s ability to market the product both in the U.S. and outside of the U.S., including the EU, (6) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (7) uncertainties relating to our patents and proprietary rights both in the U.S. and outside the U.S., (8) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s recently published draft bioequivalence recommendation for ferumoxytol, (9) uncertainties regarding our ability to compete in the oral mucositis market in the U.S. and (10) other risks identified in our filings with the U.S. Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such s tatements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. |
