GZMO continues to crater on lowish volume; now ~1.5x cash.
>>FRAMINGHAM, Mass., Apr 17, 2002 /PRNewswire-FirstCall via COMTEX/ -- Genzyme Corp. today reported that total revenues for Genzyme Molecular Oncology (Nasdaq: GZMO chart, msgs) for the first quarter of 2002 were $2.4 million, up from $1.4 million in the first quarter of 2001. The revenue increase is the result of progress in Genzyme Molecular Oncology's two major commercial collaborations -- one with the pharmaceutical division of Kirin Brewery of Japan focused on antiangiogenesis and the other with Purdue Pharma L.P. on antigen discovery.
Total research and development and collaborator-funded research expenses were $6.4 million in the first quarter of 2002, up from $6.2 million in the first quarter of 2001. Of this total, research and development expenditures for the first quarter of 2002 were $5.3 million, compared to $5.7 million in the first quarter of 2001.
Net loss for the first quarter of 2002 was $6.0 million, or $0.36 per share, compared to a net loss of $6.3 million, or $0.39 per share for the first quarter of 2001.
"Our clinical programs are advancing very well, as we conclude some trials and advance plans to begin others," stated Gail Maderis, president, Genzyme Molecular Oncology. "We recently achieved the target enrollment for our gene therapy melanoma vaccine trial and will report data this summer from our three tumor-specific fusion trials. Our antigen discovery program also continues to generate interesting targets and we are on track to complete another product development and discovery collaboration later this year."
Genzyme Molecular Oncology ended the quarter with $32.6 million in cash and marketable securities - enough to fund its operations into 2003. It also has access to $11 million through its financing arrangement with Genzyme General and additional credit through Genzyme Corporation's revolving credit facility.
Progress in the Clinic
Genzyme Molecular Oncology made significant progress with its clinical trials during the first quarter of 2002, pursuing diverse approaches in cancer vaccines and advancing the goal of developing product candidates with the greatest likelihood of successful commercialization.
Genzyme Molecular Oncology is currently expanding the protocol in its gene therapy cancer vaccine trial for melanoma to accommodate up to eight additional patients beyond the thirty-six now enrolled. This expansion is in response to interest from investigators and eligible patients.
The trial is being conducted at six sites across the country and utilizes an in vivo approach to deliver two of the most widely expressed melanoma tumor antigens, MelanA/MART1 and gp100. The vaccine uses an adenovirus vector to deliver the antigens intradermally, or between the layers of the skin. Frank G. Haluska, M.D., Ph.D., of the Massachusetts General Hospital Cancer Center, is the lead investigator of the trial. Genzyme Molecular Oncology expects to complete patient treatment in this trial by the end of the year.
At the same time, Genzyme Molecular Oncology has completed all patient treatment in its other gene therapy melanoma trial, also being led by Dr. Haluska. Preliminary clinical data from twenty out of twenty-one patients in this trial, which used an ex vivo approach, was shared last December at the American Society of Hematology conference.
Patient treatment is also now complete in three, patient-specific cancer vaccine trials. The trials were focused on breast cancer, melanoma and renal cancer. A total of thirty-five patients were treated in the three trials. Genzyme Molecular Oncology is now working with the trials' lead investigator, David Avigan, M.D., of the Beth Israel Deaconess Medical Center, to analyze the data and announce trial results in the third quarter of the year.
Lastly, Genzyme Molecular Oncology expects to initiate three new cancer vaccine clinical trials within the next year, including two additional patient-specific vaccine trials that use an electrofusion production method, and a melanoma trial using the first group of SPHERE(TM) peptides.
Discovery Progress
Genzyme Molecular Oncology and its collaborators continue to be recognized for generating high potential targets through their powerful discovery programs. Two Genzyme Molecular Oncology cancer researchers were part of a larger group to report evidence of a gene that appears to influence the genetic predisposition of some men to prostate cancer. The group's findings were published last February in Nature Genetics. Genzyme Molecular Oncology, the only commercial party in the research study, has an exclusive option to license this invention.
Earlier this month, Genzyme Molecular Oncology signed an exclusive patent license for use of a gene believed to be implicated in metastatic colon cancer. Discovered by Genzyme Molecular Oncology's research partners at The Johns Hopkins University using the patented SAGE(TM) (serial analysis of gene expression) technology, the gene called PRL-3 has been shown to be expressed in much higher levels in colon cancer cells that have metastasized to the liver than in non-metastatic colon tumors and normal colon tissue. In licensing rights related to the gene, Genzyme Molecular Oncology will begin conducting research and drug development in collaboration with the team at The Johns Hopkins University to learn how metastasis believed to be associated with PRL-3 could be blocked.
Genzyme Molecular Oncology also strengthened its intellectual property position and antigen discovery program again earlier this year through the issuance of a patent covering its high-throughput, SPHERE(TM) platform. A separate patent was issued late last year covering a group of novel, melanoma peptides identified using SPHERE.
SPHERE is a key component of Genzyme Molecular Oncology's discovery platform, allowing it to rapidly identify optimized antigen fragments. Candidates identified using SPHERE have been demonstrated by in vitro studies to be more effective than the natural epitope in stimulating an immune response.
Progress In Antiangiogenesis
Genzyme Molecular Oncology's program in antiangiogenesis is moving forward at a swift pace. Progress includes cloning and characterizing the 46 novel tumor endothelial markers (TEMs) identified using SAGE and conducting validation work around the smaller group of TEMs involved in the antibody collaboration with Kirin. Researchers at Genzyme Molecular Oncology have now confirmed that some of these TEMs are indeed located on the cell surface, making them very promising antibody targets.
The collaboration that Genzyme Molecular Oncology formed with the pharmaceutical division of Kirin Brewery of Japan is focused on the development and commercialization of fully human antibodies for use as therapeutic agents in antiangiogenesis and vascular targeted cancer drug delivery.
About Genzyme Molecular Oncology
Genzyme Molecular Oncology is positioned where the power and promise of genomics and biotechnology meet. It is utilizing its powerful proprietary functional genomics and antigen discovery technology platforms to develop novel cancer products focused on cancer vaccines and angiogenesis inhibitors and to generate partnering revenue. It is shaping these new therapies through the integration of its genomics, gene and cell therapy, small-molecule drug discovery, and protein therapeutic capabilities. Genzyme Molecular Oncology is a division of Genzyme Corporation.
This press release contains forward-looking statements, including statements regarding: the advancement of Genzyme Molecular Oncology's product pipeline, the timing of completion of patient treatment in its ongoing gene therapy melanoma vaccine clinical trial, the timing of the announcement of data from its three patient-specific cancer vaccine trials, the initiation of three new cancer vaccine trials, and collaboration goals for Genzyme Molecular Oncology's antigen discovery program. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: expenses incurred by Genzyme Molecular Oncology to fund its preclinical and clinical development activities and amounts of partnering income received; the results of Genzyme Molecular Oncology's ongoing clinical trials; the timing and content of decisions made by the FDA and other regulatory authorities; the ability to enroll patients in clinical trials; the ability to successfully analyze clinical trial data; the ability to identify new business opportunities and execute definitive agreements with academic and commercial partners; and the factors contained under the caption "Factors Affecting Future Operating Results" in Exhibit 99.2 to Genzyme Corporation's 2001 Annual Report on Form 10-K. Genzyme Molecular Oncology Division common stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme Molecular Oncology Division common stock are subject to all of the risks and uncertainties described in those reports. We caution investors not to place undue reliance on the forward- looking statements contained in this document. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements, except as may be required by law.
Genzyme(R) is a registered trademark, and SAGE(TM) and SPHERE(TM) are trademarks of Genzyme Corporation. All rights reserved.
Conference Call Information
There will be a conference call today at 1:00 p.m. ET to discuss Genzyme Molecular Oncology's first quarter financial results. If you would like to participate in the call, please dial 913-981-5517. A replay of this call will be available from 4:00 p.m. ET through midnight on April 24 by dialing 719- 457-0820. Please reference reservation number 436909. This call will also be webcast live over the internet at www.genzyme.com/ir/events.htm
Upcoming Events
Genzyme Corporation will report second-quarter 2002 financial results on July 17. If you would like to participate in any of these calls, please dial 913-981-5517 at 11:00 a.m. for Genzyme General, at 1:00 p.m. for Genzyme Molecular Oncology, and 3:00 p.m. for Genzyme Biosurgery. There is no passcode necessary. Please refer to www.genzyme.com one week prior to the financial reporting date for any updates to this information. This call will also be webcast live over the internet at www.genzyme.com
Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.
Media Contact Investor Contact
Maria Foley Catherine Forte
617-591-5690 617-591-5881
GENZYME MOLECULAR ONCOLOGY (A Division of Genzyme Corporation)
Combined Statements of Operations
(Unaudited, amounts in thousands, Three Months Ended
except per share amounts) March 31,
2002 2001
Total revenues $2,422 $1,412
Operating costs and expenses:
Cost of revenues 1,254 544
Selling, general and administrative 2,069 1,891
Research and development 5,298 5,661
Total operating costs and expenses 8,621 8,096
Operating loss (6,199) (6,684)
Other income (expenses):
Interest income 188 423
Interest expense (20) (13)
Total other income (expenses) 168 410
Division net loss $(6,031) $(6,274)
Net loss per share of Molecular
Oncology Stock - basic and diluted $(0.36) $(0.39)
Weighted average shares outstanding 16,763 15,907
Condensed Combined Balance Sheets March 31, December 31,
(Amounts in thousands) 2002 2001
(Unaudited)
Cash and all marketable securities $32,564 $41,135
Other current assets 663 1,165
Equipment, net 88 119
Total assets $33,315 $42,419
Current liabilities $11,148 $13,493
Noncurrent liabilities 1,473 2,113
Division equity 20,694 26,813
Total liabilities and division equity $33,315 $42,419<<
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Cheers, Tuck |
