Auxilium Pharmaceuticals Inc. Reports Operating Results (10-Q)

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Nov 08, 2010
Auxilium Pharmaceuticals Inc. (AUXL, Financial) filed Quarterly Report for the period ended 2010-09-30.

Auxilium Pharmaceuticals Inc. has a market cap of $1.03 billion; its shares were traded at around $21.57 with and P/S ratio of 6.27. AUXL is in the portfolios of Steven Cohen of SAC Capital Advisors, Columbia Wanger of Columbia Wanger Asset Management.

Highlight of Business Operations:

Net revenues for the three months ended September 30, 2010 include $4.6 million of U.S. product sales of XIAFLEX for Dupuytrens which was launched late in the first quarter of this year. Under our agreements with our specialty distributor and specialty pharmacy customers, they have the right to return XIAFLEX for any reason for up to six months after product expiration. Since XIAFLEX is new to the marketplace, we are currently assessing the flow of product through our distribution channel. Because current authoritative guidance precludes revenue recognition until a reasonable estimate of returns can be made, we are deferring the recognition of revenue, and related product costs, of XIAFLEX product shipments to our specialty distributor and specialty pharmacy customers until an estimate of returns can be made. However, we are recognizing XIAFLEX product sale revenues, and related product costs, at the time the product is shipped to physicians for administration to patients. Such revenues have been reduced for estimated discounts and allowances based on the contractual terms of sales. As of September 30, 2010, the amount of deferred XIAFLEX revenues was approximately $1.1 million. The increase in XIAFLEX international contract revenue for the third quarter of 2010 over the comparable period in 2009 is due to the $15 million European MAA milestone payment we received from Pfizer during the first quarter of 2010 which is being amortized to revenue over the estimated remaining contract life of the December 2008 development, commercialization and supply agreement with Pfizer (the Pfizer Agreement).

Cost of goods sold. Cost of goods sold was $11.6 million and $9.5 million for the three months ended September 30, 2010 and 2009, respectively. Cost of goods sold reflects the cost of product sold, royalty obligations due to the Companys licensors, and the amortization of the deferred costs associated with the Pfizer Agreement. The increase in cost of goods sold for the three months ended September 30, 2010 over the comparable period in 2009 was principally attributable to the increase in Testim units sold. Gross margin on our net revenues was 78.4% in the third quarter of 2010 compared to 77.4% in the comparable 2009 period. The increase in the gross margin rate is the result of the contribution of high margin XIAFLEX product sales and the impact of year-over-year price increases on U.S. Testim revenues, partially offset by a decline in Testim international contract revenues.

Research and development expenses. Research and development spending for the quarter ended September 30, 2010 was $14.4 million, compared to $12.8 million for the quarter ended September 30, 2009. The increase in expense results principally from the commencement of start-up activities related to the Phase III XIAFLEX clinical trials for Peyronies and costs related to development of a larger scale production process.

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $40.3 million for the quarter ended September 30, 2010 compared with $34.7 million for the year-ago quarter. 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 Dupuytrens in the U.S.

product shipments to our specialty distributor and specialty pharmacy customers until an estimate of returns can be made. However, we are recognizing XIAFLEX product sale revenues, and related product costs, at the time the product is shipped to physicians for administration to patients. Such revenues have been reduced for estimated discounts and allowances based on the contractual terms of sales. As of September 30, 2010, the amount of deferred XIAFLEX revenues was approximately $1.1 million. The increase in XIAFLEX international contract revenue for the first nine months of 2010 over the comparable period in 2009 is due to the $15 million European MAA milestone payment we received from Pfizer during the first quarter of 2010 which is being amortized to revenue over the estimated remaining contract life of the Pfizer Agreement.

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