| Forward Looking Statements 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: the potential size of the addressable market for Feraheme and the potential size of the broad IDA market; the potential incremental Feraheme sales potential from geographic and label expansion; our expectations regarding EU Commission approval and subsequent commercial launch of Rienso(R) in the EU, the expected timing thereof, the expected timing of Feraheme's commercial launch in Canada, and the milestone payments we expect to receive from Takeda in connection therewith; the expected timing of our sNDA filing for the broad IDA indication for Feraheme; statements regarding our 2012 financial guidance, including our expected 2012 net Feraheme product revenues, our expected 2012 operating expenses, including expected research and development and selling, general and administrative expenses, our expected cost of goods sold, and our expected 2012 year-end cash and investments balance, and any potential milestone payments we expect to receive; our expectation to operate at cash flow break even in 2012; our expectations regarding the 2012 market growth in the hematology/oncology and hospital segments and our targeted 2012 Feraheme market share in those segments; our expectation regarding the growth of Feraheme provider demand in 2012 as compared to 2011; 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., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) the risk that ferumoxytol/Rienso(R) does not receive final marketing approval in the EU from the EMA, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011. 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. 2 |
