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| AMAG > SEC Filings for AMAG > Form 8-K on 7-Jan-2013 | All Recent SEC Filings |
7-Jan-2013
Results of Operations and Financial Condition, Regulation FD Disclosure
The following information and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
On January 6, 2013, AMAG Pharmaceuticals, Inc., or the Company, issued a press release providing a business update, including preliminary fourth quarter 2012 financial results and its outlook for 2013. A copy of the Company's press release is furnished herewith as Exhibit 99.1.
The following information and Exhibit 99.2 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
The Company will present further details on the matters noted above at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on January 9, 2013, which will be accessible by a live audio webcast through the Company's website at www.amagpharma.com on January 9, 2013 at 8:30 a.m. Pacific Time (11:30 a.m. Eastern Time). A copy of the Company's presentation slides is furnished herewith as Exhibit 99.2.
(d) Exhibits.
The Company hereby furnishes the following exhibits:
99.1 Press release dated January 6, 2013.
99.2 Copy of Company's presentation slides dated January 2013.
Forward-looking Statement
This report 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 the Company's presentation at the annual J.P. Morgan Healthcare Conference, 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 the Company's
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 E.U.,
(2) uncertainties regarding the Company's ability to
successfully and timely complete clinical development programs and obtain
regulatory approval for Feraheme/Rienso in the broader IDA indication both in
the US and outside of the U.S., including the E.U., (3) the possibility that
significant safety or drug interaction problems could arise with respect to
Feraheme/Rienso, (4) uncertainties regarding the manufacture of Feraheme/Rienso,
(5) uncertainties relating to the Company's patents and proprietary rights, both
in the U.S. and outside of the U.S., (6) the risk of an Abbreviated New Drug
Application (ANDA) filing following the FDA's recently published draft
bioequivalence recommendation for ferumoxytol, and (7) other risks identified in
the Company's Securities and Exchange Commission ("SEC") filings, including the
Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012
and subsequent filings with the SEC. The Company cautions you not to place undue
reliance on any forward-looking statements, which speak only as of the date they
are made.
The Company disclaims 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.
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