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Corgentech Announces Fourth Quarter and Year-End 2004 Financial Results
Management Will Host Conference Call at 4:30 p.m. EST
SOUTH SAN FRANCISCO, Calif., Feb 03, 2005 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc. (Nasdaq: CGTK) today reported financial results for the fourth quarter and year ended December 31, 2004.
"We look forward to releasing top-line results from our PREVENT IV, Phase 3 trial in coronary artery bypass graft (CABG) failure by the end of the first quarter of 2005. With positive data from that clinical trial, we will meet with the FDA to discuss whether we can file for product approval on the basis of this trial," said John P. McLaughlin, Corgentech's president and chief executive officer. "In December 2004, we announced that our PREVENT III, Phase 3 trial investigating the use of edifoligide (E2F Decoy) to prevent the failure of peripheral bypass grafts (in the leg), failed to meet its primary and secondary endpoints. Since that time, Corgentech has continued to analyze the data set. Secondary patency in treated grafts was improved over the 12- month study period in a statistically significant manner (p value = 0.016 per the pre-specified analysis). Secondary patency, a measure defined by and commonly used by the vascular surgical community to evaluate peripheral grafts, assesses the ability to preserve flow through the graft allowing the use of additional procedures over time. The study steering committee had pre- specified secondary patency as an important analysis, although it was not included as an endpoint in the study protocol. More grafts treated with edifoligide (E2F Decoy) were in place and functioning at the end of the 12- month study period than those treated with placebo. The relative risk reduction was 19.5 percent. These data suggest that edifoligide (E2F Decoy) had biological activity in this Phase 3 trial."
"During the quarter, we also made steady progress with our other clinical development programs and, in January, we filed an investigational new drug application (IND) to begin the Phase 1/2 clinical trial for our next product candidate, NF-kappaB Decoy (NF-kB Decoy). This is the first of two Phase 1/2 trials for the treatment of eczema that afflicts about 15 million people in the United States alone," continued McLaughlin.
Fourth Quarter and Year End 2004 Financial Results
Revenue in the fourth quarter of 2004 was $8.7 million, compared to $8.7 million in the fourth quarter of 2003. Revenue was derived from the reimbursement of development costs and from the amortization of the initial non-refundable, up-front license payment of $25.0 million received from Bristol-Myers Squibb in connection with our collaboration signed in October 2003 to jointly develop and commercialize edifoligide (E2F Decoy).
Total operating expenses were $21.2 million in the fourth quarter of 2004, compared to $13.2 million in the fourth quarter of 2003. The increase in operating expenses was due to increased expenses related to the continued expansion of preclinical development of next generation transcription factor decoys for inflammatory diseases and cancer, the manufacturing of edifoligide (E2F Decoy) material and related costs for regulatory submissions, and pre- marketing costs associated with edifoligide (E2F Decoy).
For the fourth quarter of 2004, the net loss attributable to common stockholders was $12.0 million, or $0.44 per share, versus a net loss of $37.9 million, or $16.58 per share, in the fourth quarter of 2003. The net loss attributable to common stockholders in the fourth quarter of 2003 included a one-time preferred stock deemed dividend charge of $14.4 million.
For the year ended December 31, 2004, the company had revenue of $36.4 million and a net loss attributable to common stockholders of $39.8 million, or $1.63 per share, compared to revenue of $8.7 million and a net loss attributable to common stockholders of $77.6 million, or $37.90 per share for 2003.
As of December 31, 2004, cash, cash equivalents and short-term investments were $115.2 million, compared to $130.7 million at September 30, 2004 and $54.6 million at December 31, 2003.
The company will provide financial guidance for 2005 after the release of top-line results from its Phase 3 clinical trial for prevention of bypass graft failure in coronary artery bypass surgery, which it expects to report toward the end of the first quarter.
Conference Call Details
Corgentech will conduct a webcast conference call with the investment community at 4:30 p.m. EST, today, February 3, 2005 to discuss the fourth quarter 2004 results, and to review the company's progress and outlook. The call will be available via live audio broadcast over the Internet on the Corgentech website at www.corgentech.com from the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by calling (800) 642-1687 [international dial: (706) 645-9291] and giving the following pass code: 3654405. The webcast will be available until the company's next quarterly financial results conference call.
About Corgentech
Corgentech is a biopharmaceutical company engaged in the discovery, development and commercialization of a new class of therapeutics called transcription factor decoys, or TF decoys. We are creating a pipeline of novel therapeutics based on our proprietary TF decoy technology, focused initially on the treatment of cardiovascular disease, inflammatory disease, and cancer. For more information on the company and its technology, visit www.corgentech.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Act of 1995. These include without limitation statements related to our clinical trials, product candidates, and operations. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon our current expectations. Forward-looking statements involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of our clinical trials, intellectual property matters, difficulties or delays in obtaining regulatory approval, manufacturing our lead product candidate, competition from other pharmaceutical or biotechnology companies, our ability to obtain additional financing to support our operations and other risks detailed in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2003 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Corgentech undertakes no obligation to revise or update any forward-looking statements as a result of new information, future events or otherwise after the date hereof.
Corgentech Inc.
Statements of Operations
(In thousands, except share and per share amounts)
Three months ended Year ended
December 31, December 31,
2004 2003 2004 2003
(unaudited) (unaudited) (unaudited) (Note)
Contract revenue $8,731 $8,678 $36,382 $8,678
Operating expenses:
Research and development 16,166 10,382 62,997 46,004
General and administrative 5,081 2,783 15,013 6,067
Total operating expenses 21,247 13,165 78,010 52,071
Loss from operations (12,516) (4,487) (41,628) (43,393)
Interest and other income, net 543 (18,968) 1,780 (19,774)
Net loss (11,973) (23,455) (39,848) (63,167)
Preferred stock deemed
dividend -- (14,407) -- (14,407)
Net loss attributable to
common stockholders $(11,973) $(37,862) $(39,848) $(77,574)
Basic and diluted net loss
per common share $(0.44) $(16.58) $(1.63) $(37.90)
Shares used to compute basic
and diluted net loss per
common share 27,490,072 2,283,835 24,499,022 2,046,944
Corgentech Inc.
Condensed Balance Sheets
(In thousands)
December 31, December 31,
2004 2003
(unaudited) (Note)
Assets
Cash, cash equivalents and short-term
investments $115,178 $54,590
Other current assets 11,137 9,715
Total current assets 126,315 64,305
Property and equipment, net 3,492 2,278
Other assets, non-current 1,741 2,740
Total assets $131,548 $69,323
Liabilities, convertible preferred stock
and stockholders' equity (deficit)
Current liabilities $17,898 $17,289
Long term obligations 8,516 16,520
Convertible preferred stock -- 114,332
Total stockholders' equity (deficit) 105,134 (78,818)
Total liabilities, convertible preferred
stock and stockholders' equity $131,548 $69,323
(Note): Derived from audited financial statements at that date and period.
SOURCE Corgentech Inc.
Jennifer Cook Williams, Senior Director, Investor Relations of Corgentech Inc., +1-650-624-9600, or [email protected]
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