Auxilium has been advised that, in connection with the note hedge and warrant transactions, the hedge counterparties or their affiliates have entered into, or expect to enter into, various derivative transactions with respect to Auxilium's common stock and may, from time to time, enter into or unwind various derivatives and/or purchase or sell Auxilium's common stock or other securities of Auxilium in secondary market transactions (and are likely to do so during any observation period relating to a conversion of Convertible Notes). These activities may have increased, or could increase (or reduce the size of any decrease in), the price of Auxilium's common stock, and could also cause or avoid an increase or a decrease in the price of Auxilium's common stock at any time prior to the maturity date.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any of the Convertible Notes in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus, including the prospectus supplement, forming a part of the effective registration statement.
Auxilium is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism and XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord in the U.S. GlaxoSmithKline co- promotes Testim with Auxilium in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer Inc. has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia through
April 24, 2013
; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in
; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in
and Mexico. The sBLA for XIAFLEX for the treatment of Peyronie's disease was submitted to the FDA on
November 6, 2012
and has been accepted for standard review with a PDUFA date of
September 6, 2013
. Additionally, collagenase clostridium histolyticum ("CCH") is in phase IIa of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for CCH.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including statements made with respect to Auxilium's strategy, progress and timing of development programs and related trials, the efficacy of its product candidates, the commercial benefits available to it as a result of its agreements with third parties, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Although forward-looking statements are based on Auxilium's current plans or assessments that are believed to be reasonable as of the date of this press release, they inherently involve certain risks and uncertainties. These forward-looking statements are subject to a number of risks and uncertainties, including those discussed under ''Risk Factors'' in Auxilium's Annual Report on Form 10-K for the year ended
December 31, 2011
, each of Auxilium's Quarterly Reports on Form 10-Q for the three months ended
September 30, 2012
June 30, 2012
March 31, 2012
and Auxilium's Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on
January 23, 2013
. While Auxilium may elect to update the forward-looking statements made in this news release in the future, Auxilium specifically disclaims any obligation to do so. Our SEC filings may be accessed electronically by means of the SEC's home page on the Internet at
. There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc. +1-484-321-5900