| 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 commercial objective and the opportunity to increase share of the current chronic kidney disease (CKD) intravenous (IV) iron market; (ii) expansion opportunities, including plans for our potential label expansion for the broader iron deficiency anemia (IDA) indication for Feraheme and the related call audience; (iii) expectations regarding regulatory matters, including timing; (iv) opportunities for growth in the U.S. IV iron market, including potential future call points; (v) plans to pursue additional managed care acceptances and other strategies for MuGard; (vi) market share opportunity for MuGard, including our belief that the market for MuGard is growing; (vii) plans to pursue our business development objectives, including the impact of completed transactions on revenues; (viii) our business development targeting strategy; (ix) expectations that by 2018 we will have a diversified portfolio, an exit period with potential for significant cash generation and additional products contributing to more than 50% of our revenues; (x) our 2014 financial outlook, including projected revenues, cost of goods sold, operating expenses and cash and investments balance; (xi) our 2014 goals, including plans to maximize Feraheme opportunities, drive MuGard sales, execute on business development transactions and continue to operate the business with financial discipline; and (xii) 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. Statements about AMAG’s past financial results for the quarter and six months ended June 30, 2014, do not, and are not meant to, predict future results. AMAG can provide no assurance that such results and performance will continue. Such risks and uncertainties include, among others: (1) the likelihood and timing of potential approval of Feraheme in the U.S. in the broader IDA indication in light of the complete response letter we received from the FDA informing us that our supplemental new drug application (sNDA) for the broader indication could not be approved in its present form and stating that we had not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed broader indication, (2) the possibility that following FDA review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, and/or in light of the label changes requested by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and confirmed by the Committee for Medicinal Products for Human Use (CHMP), the FDA (or other regulators) 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 indication for Feraheme for IDA in adult patients with CKD and the additional costs and expenses that will or may be incurred in connection with such activities,(3) whether our proposed label changes will be acceptable to the FDA or other regulatory authorities and what impact such changes, or such additional changes as the FDA, CHMP or other regulators may require, will have on sales of Feraheme/Rienso, (4) our and Takeda Pharmaceutical’s ability to successfully compete in the IV iron replacement market both in the U.S. and outside the U.S., including the EU, as a result of limitations, restrictions or warnings in Feraheme’s/Rienso’s current or future label, including the changes recommended by PRAC and confirmed by CHMP that Rienso be administered to patients by infusion over at least 15-minutes (replacing injection) and that it be contraindicated for patients with any known history of drug allergy, (5) our ability to execute on our long-term strategic plan or to realize the expected results from our long-term strategic plan, (6) Takeda’s ability to obtain regulatory approval for Feraheme in Canada, and Rienso in the EU, in the broader IDA patient population, (7) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales, or our ability to market the product both in the U.S. and outside of the U.S., including the EU, (8) the relationship between Takeda and AMAG and the impact on commercialization efforts for Feraheme/Rienso in the EU and Canada, (9) the likelihood and timing of milestone payments, if any, in connection with AMAG’s licensing arrangement with Takeda, (10) the manufacture of Feraheme/Rienso or MuGard, (11) our patents and proprietary rights both in the U.S. and outside the U.S., (12) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s recently published draft bioequivalence recommendation for ferumoxytol, (13) the possibility that AMAG will disseminate future Dear Healthcare Provider letters in the U.S. (or, working Takeda, in Europe or other markets, (14) uncertainties regarding our ability to compete in the oral mucositis market in the U.S. and (15) 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 March 31, 2014 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. |
