Dendreon Reports Fourth Quarter and 2008 Year End Financial Results
March 12 2009 - 4:27PM
PR Newswire (US)
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 http://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 http://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 DATASOURCE:
Dendreon Corporation CONTACT: Jennifer Cook Williams, Investor
Relations of Dendreon Corporation, +1-206-829-1500 Web Site:
http://www.dendreon.com/
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