(Source: MARKETWIRE)
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended June 30, 2009. For the second quarter of 2009, Auxilium reported net revenues of $39.2 million compared to net revenues of $30.9 million in the second quarter of 2008. The net loss for the second quarter of 2009 was $(13.4) million, or $(0.32) per share, compared to a net loss of $(11.7) million, or $(0.29) per share, reported for the second quarter of 2008.
"We believe that the second quarter of 2009 was a great success for Auxilium. We received filing acceptance of our Biologics License Application ('BLA') for XIAFLEX(TM) with Priority review from the U.S. Food and Drug Administration ('FDA') and a date for an FDA advisory committee. We added significant commercial and medical expertise to support the launch of XIAFLEX, and we achieved record Testim(R) revenues," said Armando Anido, Chief Executive Officer and President of Auxilium. "I'd like to thank our employees who gave their all and contributed to our success."
Second Quarter Operational Highlights:
XIAFLEX:
-- On April 28, the Company was notified that the FDA had accepted the XIAFLEX BLA filing for Dupuytren's contracture and granted Priority review with a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2009. -- On June 18, the Company announced that an FDA Arthritis Advisory Committee had been tentatively set for September 16, 2009 to review XIAFLEX for Dupuytren's contracture. -- Key Commercial and Medical personnel have been added in anticipation of a potential launch within 60 days of approval. -- The Company's phase IIb study of XIAFLEX for Peyronie's disease continued to follow patients, and Auxilium expects to announce top-line results in the fourth quarter of 2009.
TESTIM:
-- According to IMS Health, Inc., a pharmaceutical research firm ("IMS"), a total of 150,830 prescriptions for Testim were dispensed in the second quarter of 2009, a growth of 15.7% over the second quarter of 2008. -- Total prescriptions within the gel segment of the testosterone replacement therapy market in the U.S. grew 15.6% versus the second quarter of 2008, according to IMS. -- Testim ended the month of June 2009 with a 21.9% share of total prescriptions for testosterone gels in the U.S., unchanged from the 21.9% share at the end of June 2008, according to IMS.
SUBSEQUENT EVENTS:
-- On July 31, the FDA's Arthritis Advisory Committee confirmed it will review XIAFLEX during an advisory committee hearing at the Holiday Inn in Gaithersburg, MD on September 16, 2009. The FDA has not updated its PDUFA goal date of August 28, 2009 for completion of its review of the XIAFLEX BLA. -- On August 5, the Company announced that it had secured a $30 million revolving credit line from Silicon Valley Bank. -- The Company is today announcing that it has enrolled the first patients in a long-term clinical trial for Dupuytren's contracture patients who participated in XIAFLEX's Phase III clinical trials to track recurrence and safety data over 2-5 years after initial treatment with XIAFLEX. The Company expects to continue to enroll patients into the first half of 2010.
Second Quarter 2009 Financial Details
For the quarter ended June 30, 2009, Auxilium reported net revenues of $39.2 million compared to net revenues of $30.9 million in the second quarter of 2008, an increase of 26.8%. Sales of Testim in the U.S. were $37.0 million, a 22.1% increase over the $30.3 million recognized in the second quarter of 2008. There was $1.3 million of ex-U.S. partner milestone revenue recognition and shipments of Testim in the second quarter of 2009, compared to $0.6 million in the second quarter of 2008. The Company also recognized $0.9 million in revenues in the second quarter from the amortization of upfront payments related to the out-licensing of XIAFLEX. The net loss for the second quarter of 2009 was $(13.4) million, or $(0.32) per share, compared to a net loss of $(11.7) million, or $(0.29) per share, reported for the second quarter of 2008. Net loss for the second quarter of 2009 includes total stock-based compensation expense of $4.9 million, compared to $2.8 million for the second quarter of 2008.
Gross margin on net revenues was 76.4% for the quarter ended June 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 June 30, 2009 was $13.7 million, compared to $13.4 million for 2008. Although the overall spending was comparable year over year, there was a significant reduction in clinical development costs primarily related to the completion of XIAFLEX clinical trials that were conducted in 2008, offset by increases in regulatory costs for XIAFLEX and costs at our Horsham manufacturing facility.
Selling, general and administrative expenses totaled $29.4 million for the quarter ended June 30, 2009 compared with $22.2 million for the year-ago quarter.
