Dendreon Reports Second Quarter 2009 Financial Results
August 11 2009 - 6:00AM
PR Newswire (US)
-- 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. Recent Events --
Reported final analysis of the IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) Phase 3 trial for PROVENGE (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 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 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 http://www.dendreon.com/. 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/. 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
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 Six months ended June 30, June
30, ------------------ ---------------- 2009 2008 2009 2008 ----
---- ---- ---- (unaudited) Revenue $25 $26 $55 $57 Operating
expenses: Research and development 13,321 13,193 25,119 26,671
General and administrative 7,608 5,420 12,825 11,095 ----- -----
------ ------ Total operating expenses 20,929 18,613 37,944 37,766
------ ------ ------ ------ Loss from operations (20,904) (18,587)
(37,889) (37,709) Interest income 196 951 529 2,088 Interest
expense (213) (1,246) (1,324) (2,777) Gain (loss) from valuation of
warrant liability (105,796) 2,368 (103,417) 2,368 -------- -----
-------- ----- Net loss $(126,717) $(16,514) $(142,101) $(36,030)
========= ======== ========= ======== Basic and diluted net loss
per share $(1.20) $(0.18) $(1.41) $(0.41) ====== ====== ======
====== Shares used in computation of basic and diluted net loss
------- ------ ------- ------ per share 105,880 91,217 100,851
87,265 ======= ====== ======= ====== June 30, December 31, 2009
2008 ---- ---- Balance Sheet Data: Cash and cash equivalents
$266,122 $59,523 Short-term investments 21,334 45,638 Long-term
investments - 3,386 Prepaid antigen costs 18,975 - Total assets
352,703 147,204 Warrant liability 117,607 14,190 Convertible senior
subordinated notes 52,535 85,250 Total stockholders' equity 160,746
27,006 DATASOURCE: Dendreon Corporation CONTACT: Jennifer Cook
Williams, Investor Relations of Dendreon Corporation,
+1-206-829-1500; or Katherine Stueland of WeissComm Partners,
+1-415-946-1082, for Dendreon Corporation Web Site:
http://www.dendreon.com/
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