SOUTH SAN FRANCISCO, Calif., March 1 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today reported financial results for the
fourth quarter and full year ended December 31, 2006.
For the fourth quarter of 2006, the company reported a net loss of
$30.3 million, or $0.54 per fully diluted share, compared with net income
of $19.1 million, or $0.33 per fully diluted share, for the same period in
2005. The increase in net loss in the current quarter is attributed
primarily to the absence of gains from sales of marketable securities
compared to the fourth quarter of 2005, at which time the company had a
gain of $48.8 million from the sale of 3.0 million shares of common stock
of Abgenix, its former subsidiary.
For the year ended December 31, 2006, the company had a net loss of
$82.9 million, or $1.67 per share, compared with $64.9 million, or $1.43
per share in 2005. The increase in net loss in 2006 is primarily due to an
income tax provision recorded in 2006 relating to the realized gain from
the sale of 3.0 million shares of Abgenix common stock in 2006.
The company's research and development costs were $24.6 million and
$96.3 million in the fourth quarter and year ended December 31, 2006,
respectively, compared with $21.0 million and $92.4 million for the
comparable periods of 2005. R&D expenses for the full year of 2006 are
higher primarily due to the expansion of Phase 3 clinical trials of the
company's lead product development program, GVAX immunotherapy for prostate
cancer, to Europe and included $4.6 million in non-cash stock-based
compensation expense recorded under Statement of Financial Accounting
Standards No. 123 revised 2004 (FAS 123R). General and administrative
expenses were $4.4 million and $18.1 million in the fourth quarter and
year-ended December 31, 2006, respectively, compared with $5.0 million and
$16.3 million for the comparable periods of 2005. G&A expenses for the full
year of 2006 are higher primarily due to recording $1.3 million in 2006 of
non-cash stock-based compensation expenses related to adoption of FAS 123R.
Cell Genesys ended 2006 with approximately $154.1 million in cash, cash
equivalents and short-term investments.
"We are pleased with our product development progress during 2006,
particularly that of our lead program, GVAX immunotherapy for prostate
cancer, which is now being evaluated in two Phase 3 clinical trials in the
U.S., Canada and Europe. During 2006, we reported encouraging additional
clinical data for this product, both in Phase 2 single agent and Phase 1
combination immunotherapy trials," stated Stephen A. Sherwin, M.D.,
chairman and chief executive officer of Cell Genesys. "We are pleased to
continue to have the financial resources we need to move our clinical
programs forward in pursuit of our goal of bringing novel biological
therapies to patients with cancer."
Recent Highlights:
-- Reported at the American Society of Clinical Oncology (ASCO)
Gastrointestinal Cancer Symposium in January 2007, follow-up data from
a Phase 2 clinical trial of GVAX immunotherapy for pancreatic
cancer in 60 patients with operable pancreatic cancer who received the
immunotherapy after surgical resection of their tumor and adjuvant
radiation and chemotherapy. The updated results showed a median
survival of 26.8 months. This compares favorably with published,
historical data from multiple single-arm and randomized studies in
patients undergoing pancreatic cancer surgery and adjuvant therapy for
whom the median survival has been reported to be in the range of 17 to
22 months, including the most recently reported results for gemcitabine
chemotherapy.
-- Entered into a new Committed Equity Financing Facility, with
Kingsbridge Capital Limited in February 2007, pursuant to which
Kingsbridge committed to purchase, subject to certain conditions, up to
$75 million of our common stock. The company had previously raised
$35.0 million in a similar transaction with Kingsbridge.
-- Reported at the ASCO Prostate Cancer Symposium last week, encouraging
follow-up data on the first twelve patients with advanced prostate
cancer treated on a Phase 1 clinical trial of Cell Genesys' GVAX
immunotherapy for prostate cancer, administered in combination with
Medarex's fully human anti-CTLA-4 antibody, ipilimumab (MDX-010). The
twelve patients who have completed treatment to date include six
patients who received the combination therapy at doses currently being
evaluated in both GVAX and ipilimumab Phase 3 clinical trials.
Antitumor activity has been observed in five of these six patients
including prostate-specific antigen (PSA) declines of greater than 50%
that were maintained in four of these patients for at least six months
with the longest response ongoing at more than 12 months. Moreover,
clinical evidence of antitumor activity has been observed in three of
these five PSA responders, including improvement of multiple lesions on
bone scan, resolution of abdominal lymph node disease by CT scan, and
improvement in pain due to bone metastases, respectively. Two
additional patients have had stable disease on bone scan for at least
three months.
Cell Genesys is focused on the development and commercialization of
novel biological therapies for patients with cancer. The company is
currently pursuing two clinical stage product platforms -- GVAX(TM) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a
Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell
Genesys continues to hold an equity interest in its former subsidiary,
Ceregene, Inc., which is developing gene therapies for neurodegenerative
disorders. Cell Genesys is headquartered in South San Francisco, CA and has
its principal manufacturing operation in Hayward, CA. For additional
information, please visit the company's website at http://www.cellgenesys.com.
Cell Genesys will host its quarterly and year-end conference call to
discuss events that occurred during the fourth quarter 2006 and to provide
financial guidance for 2007 at 2:00 p.m. PST on Thursday, March 1, 2007.
Investors may listen to the webcast of the conference call live on Cell
Genesys' website. Alternatively, investors may listen to a replay of the
call by dialing 800-475-6701 from locations in the U.S. and 320-365-3844
from outside the U.S. The call-in replay will be available for at least 72
hours following the call. Please refer to reservation number 863676.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress, results
and timing of clinical trials and preclinical programs and the nature of
product pipelines are forward-looking statements and are subject to a
number of uncertainties that could cause actual results to differ
materially from the statements made, including risks associated with the
success of clinical trials and research and development programs, the
regulatory approval process for clinical trials, competitive technologies
and products, patents, continuation of corporate partnerships and the need
for additional financings. For information about these and other risks
which may affect Cell Genesys, please see the company's Annual Report on
Form 10-K for the year ended December 31, 2006 filed on March 1, 2007 as
well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed
from time to time with the Securities and Exchange Commission. The company
assumes no obligation to update the forward-looking information in this
press release.
Contact: Ina Cu
Investor Relations
650-266-3200
SELECTED CONSOLIDATED FINANCIAL INFORMATION
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(unaudited, in thousands except per share data)
Three months ended Twelve months ended
December 31, December 31,
2006 2005 2006 2005
Revenue $90 $85 $1,364 $4,584
Operating expenses:
Research and
development 24,633 21,030 96,346 92,405
General and
administrative 4,435 4,986 18,123 16,342
Restructuring charges (25) 753 (82) 2,350
Total operating
expenses 29,043 26,769 114,387 111,097
Loss from operations (28,953) (26,684) (113,023) (106,513)
Other income (expense):
Gain on sale of
Abgenix, Inc.
common stock -- 48,830 62,677 55,123
Interest and
other income 2,088 748 7,495 3,058
Interest expense (2,607) (2,635) (10,465) (10,679)
Income (loss) before
income taxes (29,472) 20,259 (53,316) (59,011)
Income tax provision (778) (1,203) (29,613) (5,928)
Net income (loss) (30,250) 19,056 (82,929) (64,939)
Dividend in kind to
preferred
stockholders -- -- -- (4)
Net income (loss)
attributed to common
stockholders $(30,250) $19,056 $(82,929) $(64,943)
Basic net income
(loss) per
common share $(0.54) $0.42 $(1.67) $(1.43)
Diluted net income
(loss) per
common share $(0.54) $0.33 $(1.67) $(1.43)
Weighted average
shares of common
stock outstanding
-basic 55,522 45,547 49,728 45,434
Weighted average
shares of common
stock outstanding
- diluted 55,522 61,616 49,728 45,434
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
December 31, December 31,
2006 2005
(unaudited) Note 1
Cash, cash equivalents and short-term
investments, including restricted cash $154,074 $129,139
Investment in Abgenix, Inc. common stock -- 63,824
Prepaid expenses and other current assets 3,481 2,563
Property and equipment, net 129,643 142,225
Noncurrent deferred tax assets -- 24,430
Unamortized debt issuance costs and other assets 3,969 4,794
Total assets $291,167 $366,975
Other current liabilities $15,904 $12,343
Accrued income taxes 35,410 32,612
Deferred income tax liabilities -- 24,430
Other liabilities 2,851 2,174
Non-current portion of capital lease obligation 48,475 49,919
Convertible senior notes 145,000 145,000
Stockholders' equity 43,527 100,497
Total liabilities and stockholders' equity $291,167 $366,975
Note 1. Derived from audited financial statements.
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
+1-650-266-3200
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