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Dendreon Reports Fourth Quarter and 2008 Year End Financial Results

Posted on: Thursday, 12 March 2009, 15:27 CDT

SEATTLE, March 12 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the year and quarter ended December 31, 2008. Revenues for the year ended December 31, 2008 were $111,000 compared to $743,000 for the year ended December 31, 2007. Revenues for the fourth quarter of 2008 were $28,000, compared to $28,000 for the same period in 2007.

The net loss for the year ended December 31, 2008 was $71.6 million, or $0.79 per share, compared to $99.3 million, or $1.20 per share for the year ended December 31, 2007. Net loss in the fourth quarter of 2008 was $8.8 million or $0.09 per share, compared to a net loss of $27.0 million, or $0.32 per share, for the same period in 2007. Dendreon's total operating expenses for the year ended December 31, 2008 were $70.6 million compared to $102.4 million in 2007.

As of December 31, 2008, Dendreon had approximately $108.5 million in cash, cash equivalents, and short-term and long-term investments compared to $120.6 million as of December 31, 2007.

Recent Highlights:

• Completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with androgen-independent prostate cancer. While Dendreon remains blinded to the data, the independent data monitoring committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC observed no safety concerns and recommended that the study continue to its final analysis, which is expected to be completed by the end of April 2009
• Filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to evaluate D-3263, the Company's lead small molecule candidate which targets TRPM8 (a transmembrane cation channel protein), in a Phase 1 dose escalation study in cancer. The application was cleared by the FDA in January 2009.

"This is an exciting time for Dendreon as we await the completion of the final analysis of our IMPACT trial, expected by the end of April. The 20 percent reduction in the risk of death that we saw in the PROVENGE arm at our interim analysis is encouraging to us," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon Corporation. "Our mission is to bring PROVENGE to the many prostate cancer patients seeking treatment alternatives that offer a meaningful survival benefit coupled with a more tolerable safety profile than current options, ultimately translating the success of PROVENGE into a platform of products that could benefit patients with many different types of cancer."

Dendreon expects to have final results from the IMPACT trial in April. The Company expects to host a conference call after the data from the IMPACT trial are known.

About Dendreon

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.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further 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 CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Three months ended Year ended December 31, December 31, 2008 2007 2008 2007 (unaudited) Revenue $28 $28 $111 $743 Operating expenses: Research and development 10,755 21,743 50,086 76,523 General and administrative 4,783 5,382 20,503 25,839 Total operating expenses 15,538 27,125 70,589 102,362 Loss from operations (15,510) (27,097) (70,478) (101,619) Interest income 712 1,717 3,619 6,461 Interest expense (1,161) (1,571) (5,156) (4,106) Gain from valuation of warrant liability 7,122 - 371 - Net loss ($8,837) ($26,951) ($71,644) ($99,264) Basic and diluted net loss per share ($0.09) ($0.32) ($0.79) ($1.20) Shares used in computation of basic and diluted net loss per share 95,109 83,051 90,357 82,531 December 31, December 31, 2008 2007 Balance Sheet Data: Cash and cash equivalents $59,523 $75,721 Short-term investments 45,638 27,115 Long-term investments 3,386 17,739 Total assets 147,204 161,662 Warrant liability 14,190 - Convertible senior subordinated Notes 85,250 85,250 Total stockholders' equity 27,006 40,377

SOURCE Dendreon Corporation

Source: PR Newswire

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