Cell Genesys Reports Fourth Quarter and 2001 Results
Ends Year With $259 Million in Cash
FOSTER CITY, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) reported a net loss for the quarter ended December 31, 2001 of $2.2 million or $0.06 per share, and a net loss for the year then ended of $29.5 million, or $0.85 per share. This compares with net income of $38.9 million and net income of $168.2 million in the same quarter and full year of 2000, respectively. The company's net loss for 2001 includes a one-time charge of $18 million relating to the acquisition of Calydon, Inc. The company's income during 2000 can be attributed to the sale of a portion of the company's holdings in its former subsidiary, Abgenix, Inc. Cell Genesys ended 2001 with approximately $259 million in cash, cash equivalents and short-term investments.
Revenues for the fourth quarter and year ended December 31, 2001 were $13.7 million and $28.3 million, respectively, compared with $9.5 million and $24.2 million in the comparable periods of 2000. Revenues for 2001 were derived from the company's GVAX® collaboration as well as certain technology licensing agreements.
Research and development costs were $16.6 million and $50.8 million in the fourth quarter and year ended December 31, 2001, respectively, compared with $8.9 million and $30.5 million for the comparable periods of 2000. The increase can be attributed primarily to the company's expanding clinical trials for both its GVAX® cancer vaccines and oncolytic virus therapies.
``2001 was a year of tremendous progress for Cell Genesys -- a year in which we more fully defined our cancer therapeutic product focus, reported encouraging progress in multiple clinical programs and completed the acquisition of Calydon which added a third product platform and near-term product opportunity in the cancer area,'' stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. ``Moreover, our strong financial position has enabled us to expand our product development infrastructure and manufacturing capabilities to ensure that we are well positioned to initiate multiple Phase III clinical trials, the first of which is expected to begin late this year.''
Fourth Quarter 2001 and Other Recent Highlights:
-- Reported updated clinical results from a multicenter Phase I/II GVAX(R)
lung cancer vaccine trial which demonstrated a complete tumor response
rate of 12 percent and a median response duration of at least 11 months
in 26 patients with advanced non small-cell lung cancer who have failed
chemotherapy and/or radiation therapy. These data were presented at
the International Conference on Gene Therapy of Cancer.
-- Reported further results of a Phase I/II clinical trial of CG7870, an
oncolytic virus engineered to target and destroy prostate cancer cells.
The updated findings demonstrated stabilization of PSA
(prostate-specific antigen) levels in six of 23 patients (26 percent)
for a median duration of four months after just a single intravenous
injection in patients with advanced hormone refractory prostate cancer.
These data were also reported at the International Conference on Gene
Therapy of Cancer.
-- Initiated a Phase II clinical trial of GVAX(R) vaccine in patients with
pancreatic cancer who have undergone surgical resection of their tumor.
This trial was prompted by compelling results from an initial Phase I
pilot study of GVAX(R) pancreatic cancer vaccine which demonstrated
antitumor immunity and prolonged, ongoing disease-free survival for an
average of four years in a three of eight patients receiving higher
therapeutic dose levels.
-- Initiated a multicenter Phase II clinical trial of GVAX(R) cancer
vaccine for acute myelogenous leukemia (AML), the most common form of
adult leukemia, which will be evaluated in combination with bone marrow
stem cell transplantation in approximately 50 patients. This
announcement followed a data presentation at the American Society of
Hematology (ASH) Meeting from an earlier Phase I trial in leukemia
demonstrating clinical safety and the induction of antitumor immunity
following GVAX(R) vaccination.
-- Announced that the company and its collaborator, the pharmaceutical
division of Japan Tobacco (JT), agreed to modify an ongoing
collaboration for GVAX(R) cancer vaccines. The two companies, which
previously had a 50/50 worldwide cost and profit sharing arrangement
for GVAX(R) prostate and lung cancer vaccines, will now have a royalty
arrangement on sales of GVAX(R) lung cancer vaccines, and Cell Genesys
now has full commercial rights for GVAX(R) prostate cancer vaccine.
Under the new arrangement, JT will pay Cell Genesys an undisclosed
royalty on GVAX(R) lung cancer vaccine sales in Japan, Taiwan and
Korea, and Cell Genesys will pay JT the same royalty on such sales in
North America and the rest of the world.
-- Completed a $60 million asset-backed debt financing in connection with
the construction of the company's manufacturing facility in Hayward,
CA, which is scheduled for completion prior to the initiation of Phase
III trials later this year, and appointed Michael W. Ramsay to the new
position of vice president, manufacturing operations.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. For additional information, please visit the company's website at www.cellgenesys.com.
Cell Genesys will host its quarterly conference call to discuss events that occurred during the fourth quarter and to provide financial guidance for 2002 at 11:30 a.m. EST on Tuesday, January 29, 2002. Investors may listen to the webcast of the conference call live on Cell Genesys' web site. A replay of the webcast will be available for two weeks following the call. Alternatively, investors may listen to a replay of the call by dialing 800-633-8284 from locations in the U.S. and 858-812-6440 from outside the U.S. The call-in replay will be available for 48 hours following the call. Please refer to reservation number 20169073.
Statements made herein about the company and its subsidiaries, other than statements of historical fact, including statements about the application of the company's financial assets, progress reports and plans for clinical trials, the company's progress and results and timing of clinical trials and preclinical programs, progress and capabilities of manufacturing facility sites 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 research and development programs, clinical trials, 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 dated April 2, 2001 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: Jennifer Cook Williams
Associate Director
Corporate Communications
650-425-4542
SELECTED FINANCIAL INFORMATION
(unaudited)
STATEMENTS OF OPERATIONS
(in thousands except Three months ended Twelve months ended
per share data) December 31, December 31,
2001 2000 2001 2000
Revenue under collaborative
agreements $13,672 $9,513 $28,317 $24,209
Operating expenses:
Research and development 16,631 8,851 50,752 30,474
General and administrative 3,548 1,894 11,850 6,984
Charge for purchased in-
process technology -- -- 18,042 --
Total operating expenses 20,179 10,745 80,644 37,458
Gain on sale of stock of Abgenix -- 49,423 -- 239,660
Interest and other income 4,655 3,734 18,378 13,558
Interest expense (278) (68) (500) (386)
Net income (loss) before
minority interest, income
taxes and cumulative effect
of change in accounting (2,130) 51,857 (34,449) 239,583
Income (loss) attributed to
minority interest 197 -- 264 --
Income (loss) before income
tax and cumulative effect of
change in accounting (1,933) 51,857 (34,185) 239,583
Benefit (provision) for income
tax 525 (12,212) 5,512 (64,203)
Income (loss) before
cumulative effect
of change in accounting (1,408) 39,645 (28,673) 175,380
Cumulative effect of change in
accounting principle, net of tax -- -- -- (6,460)
Income (loss) before deemed
dividend (1,408) 39,645 (28,673) 168,920
Deemed dividend to preferred
shareholders (785) (756) (785) (756)
Net income (loss) attributed
to common shareholders $(2,193) $38,889 $(29,458) $168,164
Basic income (loss) per
common share $(0.06) $1.14 $(0.85) $4.99
Diluted income (loss) per
common share $(0.06) $1.05 $(0.85) $4.55
Weighted average shares of
common stock outstanding
- basic 35,549 34,124 34,746 33,716
Weighted average shares of
common stock outstanding
- diluted 35,549 37,090 34,746 36,952
CONDENSED BALANCE SHEETS
(in thousands)
12/31/01 12/31/00
Cash, cash equivalents and
short-term investments $258,649 $259,647
Investment in Abgenix common stock 301,217 528,858
Other current assets 10,603 482
Property and equipment, net 43,217 4,439
Other assets 1,624 290
Total assets $615,310 $793,716
Current liabilities $149,690 $239,002
Long-term obligations 60,000 1,350
Minority interest in equity of subsidiary 96 --
Series B preferred stock 17,970 17,185
Stockholders' equity 387,554 536,179
Total liabilities and stockholders' equity $615,310 $793,716
SOURCE: Cell Genesys, Inc. |
