2009-10-28 12:15:13 -

MALVERN, PA -- (Marketwire) -- 10/28/09 -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2009. For the third quarter of 2009, Auxilium reported net revenues of $42.1 million compared to net revenues of $32.6 million in the third quarter of 2008.
The net loss for the third quarter of 2009 was $(14.9) million, or $(0.35) per share, compared to a net loss of $(10.1) million, or $(0.24) per share, reported for the third quarter of 2008.



"I'm extremely proud of our accomplishments in the third quarter. We received a unanimous vote for approval of XIAFLEX(TM) for Dupuytren's contracture from the U.S. Food and Drug Administration's Arthritis Advisory Committee and announced publication of XIAFLEX's pivotal Dupuytren's contracture trial in the prestigious New England Journal of Medicine.
Additionally, we achieved record Testim® revenues, completed an equity offering of $115.7 million and received what we believe is a positive response to our Citizen's Petition," said Armando Anido, Chief Executive Officer and President of Auxilium. "The Auxilium team has provided excellent results this quarter, and I'd like to congratulate all of our employees, each of whom contributed to our success."



Third Quarter Operational Highlights:



XIAFLEX:

--  On September 16th, the U.S. Food and Drug Administration's (FDA)
    Arthritis Advisory Committee voted 12-0 to unanimously recommend approval
    of XIAFLEX (collagenase clostridium histolyticum) for Dupuytren's
    contracture.
--  In its September 3rd edition, The New England Journal of Medicine
    published data from the pivotal CORD I phase III clinical trial of XIAFLEX,
    which is the largest, prospective, double blind, placebo controlled
    clinical trial ever conducted in the field of Dupuytren's contracture.
--  Key commercial and medical personnel have been added in anticipation
    of a potential launch approximately 60 days after approval.
    

TESTIM:

--  An FDA response to the Company's Citizen's Petition was received in
    August 2009. The FDA agreed with some of the statements made in the
    Citizen's Petition regarding the testing required for generic versions of
    Testim and disagreed with other statements. Although not commenting upon
    any filing in particular, the FDA did state that "the practical effect of
    this determination is that any application for a testosterone gel product
    that has different penetration enhancers than the reference listed drug
    cannot be submitted as an abbreviated new drug application (ANDA) and,
    instead, will have to be submitted as a NDA under section 505(b) of the
    Act."
--  According to IMS Health, Inc., a pharmaceutical research firm (IMS), a
    total of 161,000 prescriptions for Testim were dispensed in the third
    quarter of 2009, a growth of 17.3% over the third quarter of 2008.
--  Total prescriptions within the gel segment of the testosterone
    replacement therapy market in the U.S. grew 16.8% versus the third quarter
    of 2008, according to IMS.
--  Testim ended the month of September 2009 with a 22.3% share of total
    prescriptions for testosterone gels in the U.S., up slightly from the 22.2%
    share at the end of September 2008, according to IMS.
    

COMPANY HIGHLIGHTS:



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OTHER EVENTS:



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Third Quarter 2009 Financial Details


For the quarter ended September 30, 2009, Auxilium reported net revenues of $42.1 million compared to net revenues of $32.6 million in the third quarter of 2008, an increase of 29.3%. Sales of Testim in the U.S. were $40.2 million, a 25.1% increase over the $32.1 million recognized in the third quarter of 2008. There was $1.1 million of ex-U.S. partner milestone revenue recognition and shipments of Testim in the third quarter of 2009, compared to $0.5 million in the third quarter of 2008. The Company also recognized $0.9 million in revenues in the third quarter of 2009 from the amortization of upfront payments related to the out-licensing of XIAFLEX.
The net loss for the third quarter of 2009 was $(14.9) million, or $(0.35) per share, compared to a net loss of $(10.1) million, or $(0.24) per share, reported for the third quarter of 2008. Net loss for the third quarter of 2009 includes total stock-based compensation expense of $4.1 million, compared to $3.2 million for the third quarter of 2008.



Gross margin on net revenues was 77.4% for the quarter ended September 30, 2009 compared to 76.0% for the comparable period in 2008. Gross margin reflects the cost of product sold and royalty obligations due to the Company's licensor on the sales of Testim, and the amortization of deferred costs associated with the XIAFLEX out-licensing. The increase in the gross margin rate is the result of the impact of year-over-year price increases on U.S. Testim revenues and the increase in amortization of upfront and milestone payments, partially offset by higher coupon usage in 2009.



Research and development spending for the quarter ended September 30, 2009 was $12.8 million, compared to $13.3 million for 2008. This reduction in overall spending was the result of a reduction in clinical development costs primarily related to the completion of XIAFLEX clinical trials that were conducted in 2008, partially offset by increases in regulatory costs for XIAFLEX and costs at our Horsham manufacturing facility.



Selling, general and administrative expenses totaled $34.7 million for the quarter ended September 30, 2009 compared with $21.9 million for the year-ago quarter. The increase was primarily due to investments in preparing for the potential U.S. launch of XIAFLEX and increases in stock-based compensation costs.



As of September 30, 2009, Auxilium had $192.3 million in cash and cash equivalents compared to $80.4 million on June 30, 2009.



Conference Call


Auxilium will hold a conference call today, October 28, 2009 at 10:00 a.m.
EDT, to discuss third quarter 2009 financial results and operational highlights. The conference call will be simultaneously web cast on Auxilium's web site and archived for future review until November 28, 2009.



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About Auxilium


Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has five projects in clinical development. XIAFLEX(TM) (collagenase clostridium histolyticum), formerly referred to as AA4500, has completed phase III clinical trials for the treatment of Dupuytren's contracture, and the biologics license application is under review at the FDA for the treatment of Dupuytren's contracture. XIAFLEX is in phase IIb of development for the treatment of Peyronie's disease and is in phase II of development for treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) and its fentanyl pain product using its transmucosal delivery system are in phase I of development. The Company is currently seeking a partner to further develop these transmucosal film product candidates. Auxilium has rights to additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit www.auxilium.com : .



SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995


In addition to historical facts, this release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding:



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Forward-looking statements often address Auxilium's expected future financial position or business strategy and plans and objectives of management for future operations, and often contain the words "believe,"
"may," "could," "will," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "expect," and "potentially," and similar expressions.
Forward-looking statements provide Auxilium's current expectations or forecasts of future events. Auxilium's performance and financial results could differ materially from those reflected in these forward-looking statements due to:



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A more detailed list and description of the risks and uncertainties that Auxilium faces may be found under the heading "Risk Factors" in Auxilium's Annual Report on Form 10-K for the year ended December 31, 2008 and in Auxilium's Quarterly Report on Form 10-Q for the period ended June 30, 2009, which are on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of the forward-looking statements contained in this release may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Auxilium undertakes no obligation to update publicly any forward-looking statement.



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CONTACT:
James E. Fickenscher
Chief Financial Officer
Auxilium Pharmaceuticals, Inc.
+1-484-321-5900
Email Contact :
or
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
+1-484-321-5900
Email Contact :