Hmmm, delayed and still a very perfunctory balance sheet. Might be worth sniffing around in the 10-Q when it's released.
A snip concerning the commercialization of the multiple biomarker approach (emphasis mine):
>>Our current strategy is to select the two most promising
studies and move the associated assays into development as potential
"home brew" diagnostics while exploring our ability to out-license
these to partners in the diagnostics field.<<
>>FREMONT, Calif., Oct. 31 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (Nasdaq: CIPH - News) today reported financial results for the third quarter of 2002. For the quarter ended September 30, 2002, total revenue increased 90% to $10.2 million, up from revenue of $5.4 million in the third quarter of 2001. The increase in revenue was due to increased sales of ProteinChip® Systems and Arrays, increased collaboration and other service revenue, as well as increased consumable revenue from Ciphergen's BioSepra Process Division. BioSepra revenue was included for two months in the 2001 third quarter following its acquisition. Ciphergen's gross profit increased to $6.7 million for the third quarter of 2002, up from $3.5 million for the comparable period in 2001. The Company reported a net loss of $7.9 million for the third quarter of 2002, compared to a net loss of $6.9 million for the comparable period of 2001.
For the first nine months of 2002, total revenue increased 119% to $25.7 million, up from revenue of $11.8 million in the comparable period of 2001. Gross profit increased to $16.8 million in the first nine months of 2002, up from $7.8 million in the first nine months of 2001. The Company reported a net loss of $22.4 million in the first nine months of 2002, compared to a net loss of $18.7 million for the comparable period of 2001. On September 30, 2002, the Company held cash, cash equivalents and investments in securities of $51.6 million.
"We're pleased that we've broken through the $10 million revenue mark for the first time in a quarter, despite a difficult economic environment for suppliers of research tools and services," commented William Rich, President and CEO of Ciphergen. "We attribute our growth to the increasing number of important discoveries made by users of our SELDI ProteinChip technology, such as our breakthrough work in HIV with the Aaron Diamond AIDS Research Center, as highlighted this quarter by the journal Science."
Third Quarter Highlights:
-- Discovery of HIV Inhibitors and Research Proteomics
-- AIDS Research Breakthrough. It has been known for many years that a
small percentage of HIV-infected individuals do not progress to
AIDS. Numerous AIDS research groups over the last 16 years have
been attempting to identify the CD8+ Antiviral Factor (CAF) which is
believed to be responsible for this outcome. Ciphergen's
ProteinChip technology, local field scientists and Biomarker
Discovery Center scientists, working in collaboration with the Aaron
Diamond AIDS Research Center (ADARC), reported through the
prestigious journal Science that, together, they had discovered and
identified the proteins believed to be responsible for suppressing
HIV-1 replication in these long-term non-progressing patients. In
addition to validating the enabling power of Ciphergen's technology
to rapidly discover novel functionally important proteins through
disease-associated protein profiling studies, this discovery
potentially opens up new therapeutic and diagnostic strategies in
the fight against AIDS. As part of its agreement with ADARC,
Ciphergen retains therapeutic and diagnostic rights to discoveries
made under the collaboration, with royalties back to ADARC.
-- Progress with Products Targeting Research Proteomics and Core Labs.
Ciphergen's ProteinChip Interface to a Tandem Mass Spectrometer,
used to provide the definitive identification in our AIDS work,
continues to experience accelerating demand. Our SEND array
surfaces, previously described as providing significant improvements
in the detection of small organic molecules including peptides, has
been moved into formal product development.
-- Clinical Proteomics and Protein-Based Predictive Medicine
-- Clinical Trial Stratification Studies. Ciphergen's Biomarker
Discovery Centers completed their first clinical trial
stratification studies on behalf of two unnamed major pharmaceutical
companies. Ciphergen has previously conducted several collaborative
research projects in the predictive toxicology area, but these were
the first two studies to focus on the discovery of protein
biomarkers that could potentially be used to separate responders
from non-responders in a clinical trial or to identify patients who
are likely to experience adverse drug side-effects. Ciphergen
believes that these studies, one measuring drug response to an
anti-asthma agent and the other to an anti-inflammatory drug,
demonstrate important proof-of-principle of the Company's technology
to enable protein-based predictive medicine.
-- Prostate Cancer Progress Reported. The July 1st issue of the
prestigious journal Cancer Research published a paper authored by
Ciphergen's Biomarker Discovery Center collaborators at the Virginia
Prostate Center. Protein profiles of serum from 167 prostate cancer
patients, 77 patients with benign prostate hyperplasia, and 82
age-matched unaffected healthy men were used to train and develop a
pattern recognition based assay that used a 9 protein biomarker
pattern that correctly classified 96% of the samples. We are
currently analyzing data from an expanded prostate cancer study as
part of this program which involves over 900 patient samples.
-- Other Studies Underway. Ciphergen's Biomarker Discovery Centers, in
collaboration with notable institutions such as Johns Hopkins,
Virginia Prostate Center, MD Anderson and Rigs Hospital
(Copenhagen), continue to discover new disease-associated protein
biomarkers and develop multi-protein assays designed to address a
variety of clinical questions in cancer, cardiovascular,
neurological and infectious diseases. We continue to patent
biomarkers and patterns of biomarkers discovered as part of these
studies as well as associated assays. We expect several of these
clinical proteomics studies to be completed and submitted for
publication in leading journals in the remainder of 2002 and early
2003. Our current strategy is to select the two most promising
studies and move the associated assays into development as potential
"home brew" diagnostics while exploring our ability to out-license
these to partners in the diagnostics field.
-- ProteinChip AutoBiomarker System Introduction. In mid-October,
Ciphergen announced the release of our new ProteinChip AutoBiomarker
System consisting of fully automated ProteinChip Array handling, an
array Autoloader, new Ciphergen Express(TM) database and Biomarker
Patterns(TM) software, and high throughput biomarker expression
profiling kits. This system targets those clinical proteomics users
who wish to engage in large-scale, high-throughput
disease-associated protein discovery, validation studies and assays.
-- Expanding Process Proteomics
-- Collaborative Services. To complement our existing Process
Proteomics collaborative services laboratory in France, Ciphergen
has nearly completed outfitting a similar facility in Boston, with a
mission of providing process and assay development services for
biopharmaceutical customers in North America.
-- Progress with Innovative Sorbents. At a recent industry meeting, we
announced the launch of a new line of high productivity
chromatography products: HyperZ(TM) sorbents. This line of
sorbents employs expanded bed adsorption that enables
biopharmaceutical manufacturers to simplify and consolidate their
purification steps. For certain applications, HyperZ sorbents can
lead to significant reductions in production cost and improvements
in product yield at production-scale.
-- Other Corporate Events
-- Key accounts penetration. Ciphergen continues to increase its
presence at targeted key accounts through the promotion of "benchtop
proteomics." The AIDS results at ADARC further validate this novel
proteomics strategy of putting powerful protein tools directly in
the hands of biologists and clinicians "at their benchtop." Our
installed base of ProteinChip Systems is now over 300 and growing.
Ciphergen has sold ProteinChip Systems to 15 of the top
15 pharmaceutical companies, with multiple ProteinChip Systems
installed at Pfizer and Novartis, both of which are also engaged in
collaboration discovery projects with our Biomarker Discovery
Centers.
Ciphergen's ProteinChip Systems are now owned by 13 of the top
40 NCI Comprehensive Cancer Centers in the US, with 6 systems at MD
Anderson Cancer Center.
-- Increasing Number and Quality of Key Publications. In addition to
the important publications already highlighted in this press
release, Ciphergen's technology now has over 120 citations, which
can now be easily searched and accessed through our recently
re-launched website (www.ciphergen.com).
-- Increased Presence in Japan. Effective September 1, Ciphergen
increased its ownership of Ciphergen Biosystems KK in Japan from 30%
to 70%. This involved an additional investment of approximately
$3.1 million through the purchase of stock and repayment of working
capital debt. Ciphergen Biosystems KK will shortly announce the
opening of a Biomarker Discovery Center in Yokohama to serve its
customers in Japan. In addition, Ciphergen Biosystems KK will also
begin to distribute the process chromatography sorbents of
Ciphergen's BioSepra Process Division in Japan.
-- ISO 9001 Status. Ciphergen was audited for the international
quality standard ISO 9001:2000 during the third quarter and has
received formal certification of ISO for the design, manufacture and
distribution of ProteinChip Systems and Arrays. These quality
standards are an important step in Ciphergen's evolution from
providing tools and services solely to researchers and
biopharmaceutical manufacturers to also providing tools and services
for other markets such as diagnostics.
About Ciphergen
Ciphergen develops, manufactures and markets a family of ProteinChip® Systems and services for clinical, research and process proteomics applications, as well as a broad range of bioseparations media for protein purification through its BioSepra Process Division. ProteinChip Systems and Biomarker Discovery Center® collaborative services enable protein discovery, profiling, characterization and assay development to provide researchers with predictive analysis capabilities and a better understanding of biological functions at the protein level. ProteinChip Systems are enabling tools in the emerging field of protein-based biology research, known as proteomics. Proteomics provides a direct approach to understanding the role of proteins in the biology of disease, monitoring disease progression and evaluating the therapeutic effects and adverse side-effects of drugs. Ciphergen believes proteomics will be a major focus of biological research by enhancing the understanding of gene function and the molecular basis of disease.
Safe Harbor Statement
Note Regarding Forward-Looking Statements: This press release contains forward-looking statements, including statements about the potential therapeutic and diagnostic applications of discoveries made in the field of AIDS using our technology, the ability of researchers to use protein biomarkers and patterns of biomarkers for clinical trial stratification or for the diagnosis of various cancers and other diseases or for other predictive medicine applications, the anticipated completion of clinical proteomics studies and the submission of the results of these studies for publication in leading scientific journals, our strategy of attempting to develop specific diagnostic assays and our plans to enter into licensing arrangements with diagnostics companies, increased customer acceptance of our existing and recently introduced products, and the expansion of our business activities in Japan. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the ability of Ciphergen and ADARC to overcome the significant technological and scientific challenges involved with an AIDS therapeutic or diagnostic and the risk that once useful therapies and targets are identified that we and our partners may not be able to develop them into viable therapies or diagnostics that can achieve FDA approval and commercial success, the ability of Ciphergen and its customer base to use ProteinChip Systems to discover biomarkers and biomarker patterns that have utility in predictive diagnostics, clinical trial stratification and drug discovery, the risk that the Company's products including the ProteinChip Interface, HyperZ sorbents and the AutoBiomarker System will not achieve or maintain market acceptance, the risk that our assays can not be developed into diagnostics or successfully licensed to diagnostic companies, the risk that Ciphergen is unsuccessful in attracting Biomarker Discovery Center business or selling BioSepra products in Japan, and the risk that proteomics does not continue to emerge as a major focus of biological research and drug discovery. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2001 and its Form 10-Q for the quarter ended June 30, 2002, for further information regarding these and the other risks of the Company's business.
NOTE: Ciphergen, ProteinChip and Biomarker Discovery Center are registered trademarks of Ciphergen Biosystems, Inc.
Ciphergen Biosystems, Inc.
Summary Financial Information
(Unaudited)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2002 2001 2002
Revenue $5,404 $10,241 $11,750 $25,708
Cost of revenue 1,950 3,532 3,977 8,882
Gross profit 3,454 6,709 7,773 16,826
Operating expenses:
Research and development 3,264 6,071 8,899 14,692
Sales and marketing 3,420 4,714 9,840 14,642
General and administrative 3,275 3,973 9,722 10,277
Amortization of intangible assets 214 207 366 621
Write-off of acquired in-process
technology 1,000 -- 1,000 --
Total operating expenses 11,173 14,965 29,827 40,232
Loss from operations (7,719) (8,256) (22,054) (23,406)
Interest and other income, net 803 391 3,340 1,190
Income attributable to minority
interest -- (90) -- (90)
Loss before income taxes (6,916) (7,955) (18,714) (22,306)
Income tax provision (benefit) -- (48) -- 61
Net loss $(6,916) $(7,907) $(18,714) $(22,367)
Net loss per share, basic and
diluted $(0.26) $(0.29) $(0.71) $(0.83)
Shares used in computing net loss
per share 26,593 27,027 26,450 26,906
December 31, September 30,
2001 2002
Cash, cash equivalents and investments
in securities $77,124 $51,567
Total assets 106,816 90,748
Stockholders' equity 93,229 73,553<<
Cheers, Tuck |
