- Dendreon to Hold Conference Call Today, March 13, 2008 at 11:00 AM ET -
SEATTLE, March 13 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the year and quarter ended December 31, 2007. Revenues for the year ended December 31, 2007 were $743,000 compared to $273,000 for the year ended December 31, 2006. Revenues for the fourth quarter of 2007 were $28,000, compared to $86,000 for the same period in 2006.
The net loss for the year ended December 31, 2007 was $99.3 million, or $1.20 per share, compared to $91.6 million, or $1.27 per share for the year ended December 31, 2006. Net loss in the fourth quarter of 2007 was $27.0 million or $0.32 per share, compared to a net loss of $21.5 million, or $0.28 per share, for the same period in 2006. Dendreon's total operating expenses for the year ended December 31, 2007 were $102.4 million compared to $97.6 million in 2006. Net cash used in operating activities in 2007 was $82.6 million compared to $80.8 million in 2006.
As of December 31, 2007, Dendreon had approximately $120.6 million in
cash, cash equivalents, and short-term and long-term investments compared
to $121.3 million as of December 31, 2006.
-- The FDA agreed to amend the IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) Special Protocol Assessment (SPA),
accelerating the expected timeline for final results from the study by
approximately one year while maintaining comparable power to the
previous SPA. In addition, the FDA reconfirmed that either a positive
interim or final analysis of survival would support licensure and
enable Dendreon to amend the company's biologics license application
for PROVENGE(R) (sipuleucel-T).
-- Completed the target enrollment of 500 patients in the IMPACT study of
PROVENGE for advanced prostate cancer
-- Promoted Dr. Mark Frohlich to senior vice president of clinical
affairs and chief medical officer
-- Cancer Immunology, Immunotherapy publication on CD54 as surrogate
marker of antigen presenting cell activation
-- Data correlating the cumulative potency of PROVENGE to overall
survival presented at American Society of Clinical Oncology's
-- Received European patent covering PROVENGE and Active Cellular
Immunotherapy (ACI) platform technology
"The most significant event in 2007 was the FDA advisory panel that voted in support of the substantial evidence of efficacy of PROVENGE for men with advanced prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We have begun 2008 by accelerating the final data analysis of the pivotal IMPACT study by approximately one year and we look forward to completing the interim analysis of this study in the second half of this year. We are committed to bringing what could be this first of its kind therapy to prostate cancer patients as soon as possible, as well as advancing other product candidates in our pipeline."
Conference Call Information
Dendreon will host a conference call today at 8:00 a.m. PT, 11:00 a.m. ET. To access the live call, dial 1-877-548-7901 (domestic) or +1-719-325-4844 (international). The call will also be audio webcast and will be available from the Company's website at http://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 5074038. The replay will be available from 7:30 pm ET on Thursday, March 13 until 11:59 pm ET on Saturday, March 15. In addition the webcast will be archived for on-demand listening for 30 days at http://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 that harness the immune system to fight cancer. 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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Year ended
December 31, December 31,
2007 2006 2007 2006
Revenue $28 $86 $743 $273
Research and development 21,743 17,092 76,523 74,088
General and administrative 5,382 6,907 25,839 23,541
Total operating expenses 27,125 23,999 102,362 97,629
Loss from operations (27,097) (23,913) (101,619) (97,356)
Interest income 1,717 1,410 6,461 6,050
Interest expense (1,571) 1,017 (4,106) (336)
Net loss $(26,951) $(21,486) $(99,264) $(91,642)
Basic and diluted net loss per
share $(0.32) $(0.28) $(1.20) $(1.27)
Shares used in computation of
basic and diluted net loss per
share 83,051 75,720 82,531 72,366
December 31, December 31,
Balance Sheet Data:
Cash and cash equivalents $75,721 $60,964
Short-term investments 27,115 45,492
Long-term investments 17,739 14,827
Total assets 161,662 163,643
Convertible senior subordinated notes 85,250 --
Total stockholders' equity 40,377 125,717
|SOURCE Dendreon Corporation|
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