Dendreon second-quarter revenue increases to $2.8 million

Aug 4 2010

Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended June 30, 2010. Revenue for the quarter ended June 30, 2010 was $2.8 million compared to $25,000 for the quarter ended June 30, 2009. Revenue for the six months ended June 30, 2010 was $2.8 million compared to $55,000 for the six months ended June 30, 2009.  Over the first three months of launch, the company has seen revenue from sales of PROVENGE® (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC) grow from $340 thousand in May to $2.45 million in June and $5.2 million in July.  

"We have established a strong foundation for the launch of PROVENGE, based on the month-over-month revenue growth and positive coverage guidelines published by local Medicare carriers and private payers," said Hans Bishop, executive vice president and chief operating officer.  "Demand for PROVENGE is strong, as we have already received prescriptions for more than 500 patients during the first three months.  In addition, we are on track with the expansion of all of our manufacturing facilities in order to provide PROVENGE to more patients in 2011."

Dendreon's total operating expenses for the second quarter of 2010 were $68.4 million compared to $20.9 million in 2009. Dendreon's total operating expenses for the six months ended June 30, 2010 were $126.1 million compared to $37.9 million for the same period in 2009. The net loss for the quarter ended June 30, 2010 was $142.6 million, or $1.04 per share which includes a $0.55 charge associated with the revaluation of warrants, compared to $126.7 million, or $1.20 per share for the quarter ended June 30, 2009, which included a $1.00 charge for warrant revaluation. The net loss for the six months ended June 30, 2010 was $268.3 million, or $2.00 per share which includes a charge associated with the revaluation of warrants of $1.06, compared to $142.1 million, or $1.41 per share for the six months ended June 30, 2009, which included a $1.02 charge for warrant revaluation.

As of June 30, 2010, Dendreon had $492.4 million in cash, cash equivalents, and short-term and long-term investments compared to $606.4 million as of December 31, 2009.

Recent Highlights:

• U.S. Food and Drug Administration (FDA) approved PROVENGE.  Dendreon immediately launched PROVENGE to approximately 50 sites throughout the country.  
• Dendreon is on track to provide PROVENGE to approximately 2,000 patients over the first 12 months of launch and to date has already received prescriptions for more than 500 patients.
• On May 12, 2010, the National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines™) for Prostate Cancer added PROVENGE to the list of treatment options for patients with mCRPC as a Category 1 indication. 
• Nine local Medicare Administrative Contractors (MACs) have formally published coverage guidelines, and an additional 3 MACs have provided customers with written confirmation of coverage and an additional 2 MACs have provided customers with verbal confirmation of coverage.  As for private payers, Dendreon has secured national and local coverage with major plans, including Aetna, Emblem Health, Humana, Kaiser and several Blues plans.
• On June 30, 2010, Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Analysis (NCA). NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.
• On July 28, 2010, Dendreon submitted a response to CMS asking the agency to reconsider whether a NCA is necessary, based upon the overwhelming clinical evidence showing a significant improvement in overall survival in this patient population, which is the gold standard of all endpoints in oncology clinical trials.  
• Dendreon is on track to make PROVENGE more broadly available in 2011 with the expansion and anticipated licensure of its New Jersey facility in early 2011 and its facilities in Atlanta, Georgia and Orange County, California in mid-2011.
• The pivotal Phase III IMPACT data were published in the New England Journal of Medicine and were presented at the European Association of Urology annual meeting in Barcelona, Spain.  

"The FDA approval of PROVENGE and our rapid launch represents the beginning of an entirely new era in medicine," said Mitchell H. Gold, M.D., president and chief executive officer. "We are committed to continuing our expansion in the United States in order to serve the many patients with advanced prostate cancer who until now had few appealing treatment options.  In addition, we are investing in our pipeline and establishing the infrastructure required for global growth."