MALVERN, Pa., Feb. 10, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced financial results for the fourth quarter and the year ended December 31, 2010. The Company also highlighted important commercial, regulatory and clinical development progress during the year 2010 and provided financial and operational guidance for 2011.
For the quarter ended December 31, 2010, Auxilium reported record net revenues of $61.8 million compared to net revenues of $48.0 million in the fourth quarter of 2009, an increase of 29%. For the full year 2010, net revenues totaled $211.4 million compared to net revenues of $164.0 million for the full year 2009, an increase of 29%.
For the quarter ended December 31, 2010, Auxilium reported a net loss of $(16.4) million compared to a net loss of $(11.9) million in the fourth quarter of 2009. For the full year 2010, Auxilium's net loss was $(51.2) million, compared to a net loss of $(53.5) million for the full year 2009.
"In 2010, we believe that Auxilium made good progress toward our vision of becoming a rapidly growing, profitable and sustainable biopharmaceutical company. We achieved record revenues for Testim®, launched XIAFLEX® in the U.S. for Dupuytren's contracture, initiated XIAFLEX global phase III clinical trials for Peyronie's disease and Pfizer, our EU partner, received a positive CHMP opinion for Xiapex® for Dupuytren's contracture," said Armando Anido, Chief Executive Officer and President of Auxilium. "As we look forward to 2011 and beyond, we expect Testim revenues to continue to grow and believe that the potential global market for XIAFLEX represents a blockbuster opportunity, which could provide sustainable long-term growth and profitability for the Company."
2010 and Recent Highlights: XIAFLEX:
2011 Financial Guidance and Strategic PrioritiesFor 2011, Auxilium anticipates that:
Auxilium will focus on the following strategic priorities in 2011:
Fourth Quarter 2010 Revenue DetailsAuxilium reported the following unaudited net revenues (all amounts in millions of dollars) for the quarter ended December 31, 2010: Quarter EndQuarter EndIncrease12/31/201012/31/2009 (Decrease)Testim U.S. Revenue
$52.1$42.223%Testim Ex – U.S. & Contract Revenue
1.34.9(74%)Total Testim Revenue
$53.4$47.113%XIAFLEX U.S. Revenue
$7.3-n/aXIAFLEX Contract Revenue
1.10.922%Total XIAFLEX Revenue
$8.4$0.9845%Total Worldwide Revenue
$61.8$48.029%Contract Revenues represent amortization of previously received upfront and milestone payments.
Fourth Quarter 2010 Financial Detail The net loss for the fourth quarter of 2010 was $(16.4) million, or $(0.34) per share, compared to a net loss of $(11.9) million, or $(0.25) per share, reported for the fourth quarter of 2009. Net loss for the fourth quarter of 2010 includes total stock-based compensation expense of $6.0 million, compared to $4.4 million for the fourth quarter of 2009.
Gross margin on net revenues was 72% for the quarter ended December 31, 2010 compared to 78% for the comparable period in 2009. Gross margin reflects the costs of products sold, royalty obligations due to the Company's licensors, the amortization of the deferred costs associated with the Pfizer contract and period costs related to production. The reduction in the gross margin rate is due to a $3.9 million provision for XIAFLEX inventory that may expire in 2011 prior to expected future sales to customers, and lower amortization in 2010 of deferred milestone payments, partially offset by the contribution of high margin XIAFLEX product sales and the impact of year-over-year price increases on U.S. Testim revenues.
Research and development spending for the quarter ended December 31, 2010 was $14.0 million, compared to $11.4 million for 2009. The increase in expense results principally from the commencement of start-up activities related to the phase III XIAFLEX clinical trials for Peyronie's disease and costs related to development of a larger scale XIAFLEX production process.
Selling, general and administrative costs for the quarter ended December 31, 2010 were $47.0 million, compared to $38.7 million in the comparable 2009 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., and higher non-cash stock-based compensation expense.
As of December 31, 2010, Auxilium had $128.2 million in cash, cash equivalents and short-term investments, compared to $142.4 million at September 30, 2010.
2010 Revenue DetailsAuxilium reported the following unaudited net revenues (all amounts in millions of dollars) for the full year 2010: Year EndYear EndIncrease12/31/201012/31/2009 (Decrease)Testim U.S. Revenue
$190.0$152.025%Testim Ex – U.S. & Contract Revenue
3.08.5(64%)Total Testim Revenue
$193.0$160.520%XIAFLEX U.S. Revenue
$14.1-n/aXIAFLEX Contract Revenue
4.33.622%Total XIAFLEX Revenue
$18.4$3.6417%Total Worldwide Revenue
$211.4$164.029%Contract Revenues represent amortization of previously received upfront and milestone payments.
Full Year 2010 Financial Detail Auxilium reported a net loss of $(51.2) million, or $(1.08) per share, for the full year 2010, compared to a net loss of $(53.5) million, or $(1.22) per share, for the full year 2009. Net loss for 2010 includes total stock-based compensation expense of $18.0 million, compared to $17.9 million for the full year 2009.
Gross margin on net revenues was 76% for the full year 2010, compared to 77 % for the full year 2009.
Research and development costs for the full year 2010 were $48.0 million compared with $51.4 million for the full year 2009.
Selling, general and administrative expenses totaled $164.7 million for the year ended December 31, 2010, compared with $129.2 million for the year-ago period.
Conference CallAuxilium will hold a conference call today, February 10, 2011 at 10:00 a.m. ET, to discuss fourth quarter and full year 2010 results, as well as the financial and operational guidance it has provided for 2011. 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 May 10, 2011.Conference call details:Date:
Thursday, February 10, 2011Time:
10:00 a.m. ETDial-in (U.S.):
AUXILIUMTo access an audio replay of the call:Access number (U.S.):
888-286-8010Access number (International):
617-801-6888Replay Passcode #:
49964872About 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. 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 1995
In addition to historical facts or statements of current condition, 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
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:
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, 2009 and in Auxilium's Quarterly Report on Form 10-Q for the period ended September 30, 2010 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.
AUXILIUM PHARMACEUTICALS, INC.Condensed Consolidated Statement of Operations(In thousands, except share and per share amounts)(Unaudited)Three Months Ended December 31,Twelve Months Ended December 31,2010200920102009Net revenues
48,027$ 211,429$ 164,039Operating expenses*:Cost of goods sold
17,16510,41649,72537,077Research and development
13,95411,37548,00551,398Selling, general and administrative
47,00838,711164,675129,181Total operating expenses
78,12760,502262,405217,656Loss from operations
(16,297)(12,475)(50,976)(53,617)Interest income (expense), net
(99)(38)(255)160Loss before income taxes
(16,396)(12,513)(51,231)(53,457)Provision for income taxes
(53,457)Basic and diluted net loss percommon share
(1.22)Weighted average common sharesoutstanding
47,666,40647,001,77947,426,84943,650,775*includes the following amountsof stock-based compensation expense:Cost of goods sold
-Research and development
1,2831,0272,6985,048Selling, general and administrative
4,6203,33615,10912,852AUXILIUM PHARMACEUTICALS, INC.Selected Consolidated Balance Sheet Data(In thousands)(Unaudited)December 31,December 31,20102009Cash and cash equivalents
$ 128,207 $ 181,977 Total assets243,904 260,564 Total stockholders' equity 94,443 20,519 CONTACT: James E. FickenscherChief Financial Officer, Auxilium Pharmaceuticals, Inc.+email@example.com William Q. Sargent Jr.Vice-President, Investor Relations and Corporate Communicationsfirstname.lastname@example.org i Bella A. Peyronie's Disease J Sex Med 2007;4:1527–1538
|SOURCE Auxilium Pharmaceuticals, Inc.|
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