| 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: improving Feraheme gross margins; our efforts to drive growth in the CKD segment; our plans for the third quarter AMAG launch of MuGard and MuGard commercial integration; the potential expansion of Feraheme’s labeled indication and our expectations regarding the FDA’s review of our sNDA for Feraheme; planning for the potential label expansion; expectations regarding our 2013 results, including our expected 2013 revenues and operating expenses; opportunities in the IV iron market; Feraheme market demand; competition; business development plans; expectations as to year-end cash; preparations for 2014 and positioning for success in 2013 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: (1) uncertainties regarding our and Takeda's ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (2) uncertainties regarding our ability to compete in the oral mucositis market in the U.S., (3) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the U.S. and outside of the US, including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, and in turn affect sales, regulatory approval or our ability to market the product both in the U.S. and outside of the U.S., including the EU, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to our patents and proprietary rights, both in the U.S. and outside of the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s draft bioequivalence recommendation for ferumoxytol, (8) the risk that we may not realize the anticipated benefits of our licensing arrangement for and continued integration of MuGard and (9) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended June 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 statements 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. Copyright © 2013 AMAG Pharmaceuticals. All Rights Reserved. |