- As of April 30, 2010, over 1,100 physicians have attested to completing the required training through XIAFLEX Xperience™ and are eligible to use XIAFLEX for the treatment of Dupuytren's contracture.
- As of April 30, 2010, three of the ten Medicare Administrative Contractors ("MAC") that manage claims processing across the fifteen MAC jurisdictions in the U.S. have issued final guidelines on covering XIAFLEX. Additionally, two large commercial insurers, Aetna and HealthNet, have issued guidelines on covering XIAFLEX.
- On February 2, 2010, the Company received approval for XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord from the U.S. Food and Drug Administration ("FDA").
- In January 2010, the Company and its European commercialization partner, Pfizer Inc., announced the European Union's scientific/technical review procedure for the Marketing Authorization Application for XIAFLEX for the treatment of Dupuytren's contracture commenced. As a result of accomplishing this milestone, the Company received a $15 million milestone payment from Pfizer.
- Worldwide revenues for Testim were $44.2 million, up 30.9% over the first quarter of 2009.
- According to IMS Health, Inc., a pharmaceutical market research firm ("IMS"), over 158,000 total prescriptions for Testim were dispensed in the first quarter of 2010, a growth of 14.8% over the first quarter of 2009.
- Total prescriptions within the gel segment of the testosterone replacement therapy market in the U.S. increased 10.3% versus the first quarter of 2009, according to IMS.
- Testim ended the month of March with a 22.4% share of total prescriptions for testosterone gels in the U.S., up from 21.6% at the end of March 2009, according to IMS.
Conference call details: Date: Monday, May 3, 2010 Time: 10:00 a.m. ET Dial-in (U.S.): 866-770-7051 Dial-in (International): 617-213-8064 Web cast: http://www.auxilium.com Passcode: AUXILIUM To access an audio replay of the call: Access number (U.S.): 888-286-8010 Access number (International): 617-801-6888 Replay Passcode #: 56511282About Auxilium Auxilium 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 topical testosterone gel, for the treatment of hypogonadism. Auxilium has four projects in clinical development. 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 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 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. 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, 2009, 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.
AUXILIUM PHARMACEUTICALS, INC.
Condensed Consolidated Statement of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
March 31,
----------------------
2010 2009
---------- ----------
Net revenues $ 45,480 $ 34,674
---------- ----------
Operating expenses:
Cost of goods sold 9,451 7,877
Research and development* 8,479 13,534
Selling, general and administrative* 36,103 26,403
---------- ----------
Total operating expenses 54,033 47,814
---------- ----------
Loss from operations (8,553) (13,140)
Interest income (expense), net (56) 220
---------- ----------
Loss before income taxes (8,609) (12,920)
Income tax expense - 314
---------- ----------
Net loss $ (8,609) $ (13,234)
========== ==========
Basic and diluted net loss per common share $ (0.18) $ (0.31)
========== ==========
Weighted average common shares outstanding 47,131,289 42,320,072
========== ==========
*includes the following amounts of stock-based
compensation expense:
Research and development $ 553 $ 1,132
Selling, general and administrative 3,237 3,398
AUXILIUM PHARMACEUTICALS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
March 31, December 31,
2010 2009
-------------- --------------
Cash and cash equivalents $ 175,805 $ 181,977
Total assets 266,411 260,564
Total stockholders' equity 117,100 120,519
Contact Information: For More Information, Contact: James E. Fickenscher CFO Auxilium Pharmaceuticals, Inc. (484) 321-5900 William Q. Sargent Jr. VP IR Auxilium Pharmaceuticals, Inc. (484) 321-5900