Dendreon Reports Second Quarter 2009 Financial Results
-- Company expanding manufacturing capacity in New Jersey and completed leases establishing manufacturing sites in Atlanta, GA & Orange County, Calif.
Conference Call to be Hosted Today at 11:30 a.m. EDT --
SEATTLE, Aug. 11 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended June 30, 2009. Revenue for the second quarter of 2009 was $25,000 compared to $26,000 for the quarter ended June 30, 2008. Revenue for the six months ended June 30, 2009 was $55,000 compared to $57,000 for the six months ended June 30, 2008.
Dendreon's total operating expenses for the second quarter of 2009 were $20.9 million compared to $18.6 million in 2008. Dendreon's total operating expenses for the six months ended June 30, 2009 were $37.9 million compared to $37.8 million for the same period in 2008. The net loss for the quarter ended June 30, 2009 was $126.7 million, or $1.20 per share, compared to a net loss of $16.5 million, or $0.18 per share, for the quarter ended June 30, 2008. The net loss for the quarter ended June 30, 2009 includes a non-cash charge of $105.8 million or $1.00 per share, compared to a non-cash gain of $2.4 million or $0.03 per share, for the quarter ended June 30, 2008 associated with the revaluation of warrants. The net loss for the six months ended June 30, 2009 was $142.1 million, or $1.41 per share, compared to $36.0 million, or $0.41 per share for the six months ended June 30, 2008. The net loss for the six months ended June 30, 2009 includes a non-cash charge of $103.4 million or $1.03 per share associated with the revaluation of warrants, compared to a non-cash gain of $2.4 million or $0.03 per share, for the six months ended June 30, 2008.
Cash, cash equivalents and short-term and long-term investments at June 30, 2009 totaled $287.5 million which includes approximately $221 million in net proceeds from the May 2009 stock offering. This compares with $108.5 million at December 31, 2008.
Reported final analysis of the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) Phase 3 trial for PROVENGE(R) (sipuleucel-T) which demonstrated a statistically significant increase in overall survival in patients with advanced prostate cancer. Data were presented at the American Urological Association (AUA) Annual Meeting in April. Based on these data, the Company intends to amend its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), for PROVENGE in the fourth quarter of this year.
Results from an integrated analysis of two Phase 3 studies of PROVENGE, D9901 and D9902A, were published in August 15, 2009 edition of Cancer. The data demonstrates a survival advantage for patients randomized to PROVENGE versus those randomized to placebo.
Completed a stock offering with net proceeds totaling approximately $221 million. Approximately 12 million shares were issued to the public at a price of $19.20 per share.
Initiated construction of the remaining 75 percent capacity of its lead manufacturing facility in Morris Plains, N.J. The Company expects to substantially complete construction by April 2010. The Company intends to launch PROVENGE into the marketplace from the portion of the facility that is currently completed and has been performing clinical manufacturing.
Executed lease agreements for additional manufacturing facilities in Atlanta, Ga. and Orange County, Calif. The Company expects additional capacity from these facilities to be available to ship commercial product in the second half of 2011.
"The company achieved a major milestone with the positive results from our Phase 3 IMPACT trial for PROVENGE. We are actively building out the infrastructure necessary to supply PROVENGE to the many patients with advanced prostate cancer who have few appealing treatment options," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Our top priority remains working through the regulatory process with the FDA, and we remain on track for filing the amendment to our BLA in the fourth quarter of this year."
Conference Call Information
Dendreon will host a conference call today at 8:30 a.m. PT, 11:30 a.m. ET. To access the live call, dial 1-877-548-7903 (domestic) or +1 719-325-4873 (international). The call will also be audio webcast and will be available from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 or +1-719-457-0820 for international callers; the conference ID number is 3674422. The replay will be available from 2:30 pm ET on Tuesday, August 11 until 11:59 pm ET on Thursday, August 13. In addition, the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington, and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.
This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE and requisite receipt of FDA licensure for marketing and the risk that additional capital could be needed in the future for the potential commercialization of PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.