MALVERN, Pa., May 9, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended March 31, 2011. For the first quarter of 2011, Auxilium reported net revenues of $58.4 million compared to net revenues of $45.5 million in the first quarter of 2010. The net loss for the first quarter of 2011 was $(11.8) million, or $(0.25) per share, compared to a net loss of $(8.6) million, or $(0.18) per share, reported for the first quarter of 2010.
"We are pleased with the steady progress we made in the first quarter of 2011. XIAFLEX showed double-digit growth compared to the fourth quarter of 2010, our European partner, Pfizer, received EMA approval for XIAPEX® for Dupuytren's contracture and we signed an agreement with Asahi Kasei Pharma for development of XIAFLEX in Japan," said Armando Anido, Chief Executive Officer and President of Auxilium. "We continue to be encouraged by the success stories that we receive from patients, physicians and payers on XIAFLEX use. Testim also continues to perform well with 9% U.S. prescription growth year over year in the first quarter."
First Quarter and Recent Operational Highlights: XIAFLEX:
Global Testim Revenues
$200 - 210 millionXIAFLEX:U.S. Revenues
50 - 60 millionEx U.S. / Def Rev
9 - 11 millionTotal XIAFLEX
$59 - 71 millionTotal Revenues
$259 -281 millionR & D Expense
$60 - 70 millionS G & A Expense
$170 - 180 millionNet Income (Loss)
$(31) - (41) millionStock Base Comp Expense
$15 - 20 millionFirst Quarter 2011 Revenue DetailsAuxilium reported the following unaudited net revenues (all amounts in millions of dollars): Quarter EndQuarter EndIncrease3/31/20113/31/2010 (Decrease)Testim U.S. Revenue
$45.5$43.94%Testim Ex – U.S. & Contract Revenue
0.60.388%Total Testim Revenue
$46.1$44.24%XIAFLEX U.S. Revenue
$8.7$0.25083%XIAFLEX Revenue Recognition Change
1.80.0n/aXIAFLEX Contract Revenue
1.81.164%Total XIAFLEX Revenue
$12.3$1.3732%Total Worldwide Revenue
$58.4$45.528%Contract Revenues represent amortization of previously received upfront and milestone payments. XIAFLEX revenue recognition change reflects the one-time recognition of previously deferred revenue upon the Company changing its revenue recognition methodology to record sales of XIAFLEX when units are sold to its distributors rather than when those distributors ship to the physician's office.
First Quarter 2011 Financial DetailsThe net loss for the first quarter of 2011 was $(11.8) million, or $(0.25) per share, compared to a net loss of $(8.6) million, or $(0.18) per share, reported for the first quarter of 2010. Net loss for the first quarter of 2011 includes total stock-based compensation expense of $4.3 million, compared to $3.8 million for the first quarter of 2010.
Gross margin on net revenues was 81% for the quarter ended March 31, 2011 compared to 79% for the comparable period in 2010. Gross margin reflects the costs of products sold, royalty obligations due to the Company's licensors, and the amortization of the deferred costs associated with the Pfizer contract. The increase in the gross margin rate is due to the contribution of high margin XIAFLEX product sales, including a contribution from the impact of the change in revenue recognition, and year-over-year price increases of Testim in the U.S., partially offset by non recurring favorable Testim product cost adjustments recorded in 2010, and increased managed care rebates.
Investments in research and development for the quarter ended March 31, 2011 were $15.8 million, compared to $8.5 million for the comparable period in 2010. The increase results principally from the activities related to the phase III XIAFLEX clinical trials for Peyronie's disease, costs incurred to address inspection comments received from European regulators concerning our manufacturing plant and the continued development of a larger scale XIAFLEX production process.
Selling, general and administrative costs for the quarter ended March 31, 2011 were $43.2 million, compared to $36.1 million in the comparable 2010 period. The increase was primarily due to the addition of the sales and reimbursement field force and infrastructure, and promotional and training activity in support of the launch of XIAFLEX for Dupuytren's in the U.S.
As of March 31, 2011, Auxilium had $130.9 million in cash, cash equivalents and short-term investments, compared to $128.2 million at December 31, 2010.
Conference CallAuxilium will hold a conference call today, May 9, 2011 at 10:00 a.m. ET, to discuss first quarter 2011 results and operational highlights. The presentation slides to be used during the call are now available on the "For Investors" section of the Company's web site under the "Presentations" tab. A question and answer session will follow the presentation. The conference call and the presentation slides will be simultaneously web cast on the "For Investors" section of the Company's web site under the "Events" tab. The conference call will be archived for future review until June 9, 2011.
Conference call details: Date:Monday, May 9, 2011Time:10:00 a.m. ETDial-in (U.S.):866-314-4483Dial-in (International):617-213-8049Web cast:http://www.auxilium.com Passcode:AUXILIUMTo access an audio replay of the call:Access number (U.S.):888-286-8010Access number (International):617-801-6888Replay Passcode #:77302853About AuxiliumAuxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer Inc. has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia and Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has two projects in clinical development. XIAFLEX is in phase III 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 also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the timing of the milestone payments from Pfizer; Pfizer's ability to commercialize XIAPEX for Dupuytren's contracture in EU and Eurasian markets; the timing or likelihood of additional launches of XIAPEX in other EU and Eurasian markets and our receipt of any applicable milestone payments from Pfizer; Asahi Kasei Pharma's ability to develop, register for approval and commercialize XIAFLEX for Dupuytren's contracture and Peyronie's disease in Japan; the timing of reporting of results from the phase III trial for XIAFLEX for the treatment of Peyronie's disease; the Company's expected financial performance in 2011; products in development for Dupuytren's contracture and Frozen Shoulder syndrome; and the potential for XIAFLEX to be used in multiple indications.
Forward-looking statements often address Auxilium's expected future financial position or business strategy and plans and objectives of management for future operations. 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 various risks and uncertainties.
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, 2010, which is 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.
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
AUXILIUM PHARMACEUTICALS, INC.
Condensed Consolidated Statement of Operations
(In thousands, except share and per share amounts)
(Unaudited)Three Months Ended March 31,20112010Net revenues
45,480Operating expenses*:Cost of goods sold
11,2529,451Research and development
15,7548,479Selling, general and administrative
43,15936,103Total operating expenses
70,16554,033Loss from operations
(11,796)(8,553)Interest Income (expense), net
(8,609)Basic and diluted net loss percommon share
(0.18)Weighted average common sharesoutstanding
47,765,28447,131,289*Includes the following amounts of stock-based compensation expense:Cost of goods sold
-Research and development
803553Selling, general and administrative
3,5283,237AUXILIUM PHARMACEUTICALS, INC.
Selected Consolidated Balance Sheet Data
(Unaudited)March 31,December 31,20112010Cash and cash equivalents
252,341243,904Total stockholders' equity
|SOURCE Auxilium Pharmaceuticals, Inc.|
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