Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization
2009年11月12日 - 6:00AM
PRニュース・ワイアー (英語)
-- Conference Call to be Hosted Today at 4:30 p.m. EST -- SEATTLE,
Nov. 11 /PRNewswire-FirstCall/ -- Dendreon Corporation (NASDAQ:
DNDN) today reported results for the quarter ended September 30,
2009. Revenue for the third quarter of 2009 was $25,000 compared to
$26,000 for the quarter ended September 30, 2008. Revenue for the
nine months ended September 30, 2009 was $80,000 compared to
$83,000 for the nine months ended September 30, 2008. Dendreon's
total operating expenses for the third quarter of 2009 were $25.8
million compared to $17.3 million in 2008. Dendreon's total
operating expenses for the nine months ended September 30, 2009
were $63.7 million compared to $55.1 million for the same period in
2008. The net loss for the quarter ended September 30, 2009 was
$45.6 million, or $0.40 per share, compared to a net loss of $26.8
million, or $0.29 per share, for the quarter ended September 30,
2008. The net loss for the quarter ended September 30, 2009
includes a non-cash charge associated with the revaluation of
warrants of $19.4 million or $0.17 per share, compared to a
non-cash charge of $9.1 million or $0.10 per share, for the quarter
ended September 30, 2008. The net loss for the nine months ended
September 30, 2009 was $187.7 million, or $1.79 per share, compared
to $62.8 million, or $0.71 per share for the nine months ended
September 30, 2008. The net loss for the nine months ended
September 30, 2009 includes a non-cash charge associated with the
revaluation of warrants of $122.8 million or $1.17 per share,
compared to a non-cash charge of $6.8 million or $0.08 per share,
for the quarter ended September 30, 2008. Cash, cash equivalents
and short-term and long-term investments at September 30, 2009
totaled $259.6 million compared to $108.5 million at December 31,
2008. Recent Highlights: -- Submitted amendment to Biologics
License Application (BLA) for PROVENGE® (sipuleucel-T) to the U.S.
Food and Drug Administration (FDA). -- Elected Ian Clark and Pedro
Granadillo to Board of Directors. Beginning Jan. 1, Mr. Clark will
be chief executive officer and head of North American commercial
operations at Genentech, a wholly-owned member of the Roche Group.
Mr. Granadillo was most recently senior vice president of global
manufacturing and human resources at Eli Lilly & Company.
"Submitting our BLA amendment is a milestone achievement for the
organization," stated Mitchell H. Gold, M.D., president and chief
executive officer of Dendreon Corporation. "We look forward to
working with the FDA to make PROVENGE available as quickly as
possible to the many men who currently have few appealing treatment
options." Conference Call Information Dendreon will host a
conference call today at 1:30 p.m. PT, 4:30 p.m. ET. To access the
live call, dial 1-888-516-2435 (domestic) or +1-719-457-2626
(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 5275498. The replay will be available from 6:30 pm ET on
Wednesday, November 11, until 11:59 pm ET on Friday, November 13.
In addition, the webcast will be archived for on-demand listening
for 30 days at http://www.dendreon.com/. About PROVENGE PROVENGE is
Dendreon's investigational product candidate for men with advanced
prostate cancer and may represent the first in a new class of
active cellular immunotherapies (ACIs) specifically designed to
engage the patient's own immune system against cancer. PROVENGE and
other ACIs are uniquely designed to use live human cells to engage
the patient's own immune system with the goal of eliciting a
specific long-lasting response against cancer. PROVENGE is being
studied in several ongoing clinical trials, including OpenACT, an
open label trial enrolling men with metastatic castrate-resistant
prostate cancer, ProACT (PROstate cancer Active Cellular
immunoTherapy), and NeoACT (NEOadjuvant Active Cellular
immunotherapy). For more information regarding these studies, visit
http://www.clinicaltrials.gov/. 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 ACI 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/. 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; risks and uncertainties
surrounding the presentation of data to the FDA and approval of
biologics 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; the risk that the FDA may interpret data
differently than we do, and the FDA's actions with respect to our
BLA and whether the FDA determines to convene an advisory committee
to review the BLA; progress on the commercialization efforts for
PROVENGE, including the expansion of Dendreon's manufacturing
capacity and other necessary infrastructure; success in the hiring
of additional personnel to support business growth and expansion;
the outcome of any pre-approval inspection of Dendreon's expanded
manufacturing facility; our dependence on the efforts of third
parties; our reliance on intellectual property protection; and
requisite receipt of FDA licensure for marketing of PROVENGE and
the risk that additional capital could be needed in the future to
fund additional required clinical trials or 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 http://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. DENDREON
CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands,
except per share amounts) Three months ended Nine months ended
September 30, September 30, ------------------ -----------------
2009 2008 2009 2008 ---- ---- ---- ---- (unaudited) Revenue $25 $26
$80 $83 Operating expenses: Research and development 16,494 12,660
41,613 39,331 General and administrative 9,301 4,625 22,126 15,720
----- ----- ------ ------ Total operating expenses 25,795 17,285
63,739 55,051 ------ ------ ------ ------ Loss from operations
(25,770) (17,259) (63,659) (54,968) Interest income 196 819 725
2,907 Interest expense (606) (1,218) (1,930) (3,995) Loss from
valuation of warrant liability (19,371) (9,119) (122,788) (6,751)
------- ------ -------- ------ Net loss $(45,551) $(26,777)
$(187,652) $(62,807) ======== ======== ========= ======== Basic and
diluted net loss per share $(0.40) $(0.29) $(1.79) $(0.71) ======
====== ====== ====== Shares used in computation of basic and
diluted net ------- ------ ------- ------ loss per share 113,447
91,723 105,096 88,762 ======= ====== ======= ====== September 30,
December 31, 2009 2008 ---- ---- Balance Sheet Data: Cash and cash
equivalents $172,485 $59,523 Short-term investments 71,059 45,638
Long-term investments 16,061 3,386 Prepaid antigen costs 18,975 -
Total assets 354,604 147,204 Warrant liability 136,978 14,190
Convertible senior subordinated notes 52,535 85,250 Total
stockholders' equity 118,937 27,006 DATASOURCE: Dendreon
Corporation CONTACT: Katherine Stueland, Vice President, Corporate
Communications and Investor Relations of Dendreon Corporation,
+1-206-829-1522, Web Site: http://www.dendreon.com/
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