Reflecting substantial acquisitions in fiscal year 2006, Clinical
Data, Inc. (NASDAQ: CLDA), Newton, Mass., has reported financial results
for the fiscal year ended March 31, 2006.
Total revenue for the year ended March 31, 2006 increased 22% to
$68.8 million as compared to $56.4 million in fiscal 2005. The increase
was primarily due to including the operating results of Genaissance
Pharmaceuticals, Inc. and Icoria, Inc. from the dates of their
acquisition. Genaissance was acquired in October 2005 and Icoria was
acquired in December 2005. Product revenue in our traditional business
increased 2% to $50.6 million in fiscal 2006 versus $49.8 million in
fiscal 2005.
The company reported a net loss of $50.9 million, or a net loss of
$8.54 per basic and diluted share, in fiscal 2006 versus net income of
$3.4 million, or net income of $0.77 per basic ($0.75 per diluted)
share, in fiscal 2005. The net loss in fiscal 2006, calculated in
accordance with U.S. generally accepted accounting principles, was
primarily attributable to expensing $39.7 million of in-process research
and development projects being conducted by Genaissance and Icoria at
the time of their acquisition. The balance of the loss in fiscal 2006
was due primarily to increased operating expenses due to the inclusion
of Genaissance and Icoria as Clinical Data continues to integrate these
operations. Excluding the write-off of the in-process research and
development expenses and amortization of other intangible assets
purchased in the fiscal 2006 acquisitions, the net loss on a non-GAAP
basis was $8.6 million, or a net loss of $1.44 per basic and diluted
share.
On June 13, 2006, the company announced that it entered into
definitive agreements with certain institutional and other accredited
investors with respect to the private placement of 1,039,783 shares of
newly issued common stock, and warrants to purchase 519,889 shares of
common stock, for net proceeds of approximately $17.0 million, after
transaction expenses of approximately $50,000. The net proceeds from
this financing will be used for general working capital purposes,
executing the company's previously announced Phase III clinical
trail of vilazodone for the treatment of depression, accelerating the
integration of the newly acquired operations, development of genetic
markers, and commercialization and market expansion for its genetic
tests including its proprietary test for Long QT, Clozapine-Induced
Agranulocytosis and the warfarin response tests. At June 16, 2006, cash
and cash equivalents totaled approximately $20.8 million. Drew Fromkin,
president and CEO, said, "Clinical Data made the strategic decision
to move into the exciting realm of genomics from its roots in the
classic diagnostics business. In so doing, we are seeking to capitalize
on significant new growth opportunities within several distinct market
segments of health care. Our targeted offerings meet crucial market
needs for payers, providers, and patients as well as pharmaceutical,
biotech, agricultural, academic, governmental and other constituents.
The company is clearly transforming itself to take advantage of these
strategic assets.
"The companies we acquired in fiscal 2006 are the basis for
the significant transformation of the business, and as of today, this
transformation remains an ongoing process. Not surprisingly, more work
remains to be done, but we have been working aggressively to better
align costs with revenue and leverage our strategic assets. We believe
this core financial objective is achievable through continued focus, the
building of a strong management team, fiscal discipline and hard work.
While we understand that some shareholders will take note of our recent
financial performance, shareholders can be assured that we have
identified and continue to identify the key drivers in the business that
most significantly impact profit and loss in our new businesses, and we
are actively executing a plan to optimize value.
"The companies we acquired had considerable assets but, in our
opinion, did not leverage those assets in such a way as to achieve
profitability. Upon consummation of our 2005 genomic acquisitions, we
have been moving rapidly to integrate these businesses and organize them
in a way that targets the appropriate business lines to the right
constituents. We have already taken significant costs out of the
businesses and will continue to do so in upcoming quarters. Our strategy
and goal remains to create more value for each of these constituencies
and to deliver these services in a profitable way. This reorganization
and improvement continues, and one thing that may not be readily
discernible in our financial results is the fact that we have
experienced significant improvements in a broad range of key operating
parameters. At the same time, however, it is important to set
expectations appropriately: this realignment process will take time.
"Going forward, a key objective is to optimize vilazodone, a
promising asset obtained through our acquisition of Genaissance.
Vilazodone is a dual action, SSRI/5HT1A partial agonist drug candidate
for depression with unique pharmacological properties, including an
anti-anxiety component that has recently entered into a pivotal Phase
III clinical study. We are now in the patient enrollment stage of the
Phase III study, and we are very excited about the potential for this
drug candidate. In addition, using the genomics expertise of our
Cogenics(TM) and PGxHealth(TM) divisions, we are examining certain
critical genetic biomarkers that may enable us to develop a genetic test
to better target patient populations for vilazodone. This
potential-associated genetic test capability is at the cutting edge of
an important facet of personalized medicine that is gaining the
attention of the medical community and regulators. After significant
review, management collectively determined that the vilazodone asset
warrants an environment where it can thrive and where it can be funded
in a way that optimizes the likelihood for success. Consequently, we are
moving ahead with plans to spin this asset off to shareholders through
the creation and financing of a new company called Precigen
Therapeutics, Inc. We are working to complete this effort as soon as
possible.
"Separately, we are very excited about the strong growth of
Familion(TM), our proprietary genetic test to identify inherited forms
of Long QT Syndrome and Brugada Syndrome, cardiac channelopathies that
create serious risks in families with these genetic mutations. The test,
for which we own the underlying intellectual property, is scaling, and
we are seeing growing demand for the test in North America and abroad.
We believe this and the other tests in our pipeline constitute a model
for the types of higher-margin, genetic tests in which our PGxHealth
division will specialize. We expect to continue to build a pipeline of
products that will focus on the use of genetic markers to optimize the
use of therapeutics.
"In terms of our genomics businesses, we seek to leverage the
biomarker know-how and substantial capital invested into our Genaissance
and Icoria operations. With these assets, we have identified strong
market opportunities to develop and commercialize new genetic tests,
in-license and validate additional genetic markers, and establish a
broader line of products in the vein of the recently announced warfarin
test and our test for Clozapine-Induced Agranulocytosis. These
Therapeutic Diagnostics(TM) are being developed and commercialized
through PGxHealth. We will leverage our know-how, experience and HAP
database and technology with the goal of building and expanding our
pipeline as we grow into existing and new therapeutic disease areas. It
is our belief that this new generation of tests should provide
tremendous value to payers and providers seeking to improve patient
clinical outcomes, while reducing the cost of care. By reducing costs
while simultaneously improving therapeutic efficacy and/or safety, these
products have the unique potential to achieve something the healthcare
industry has sought for a long time.
"Our Cogenics division, which combines services from the
Genaissance, Icoria, Lark and Genome Express acquisitions, addresses
another set of constituencies as one of the world's largest
independent providers of genomic, DNA and RNA services. Regulated and
unregulated genomic services are marketed to pharmaceutical, biotech,
agricultural, academic, governmental and other constituents. We continue
to consolidate operations within the Cogenics division, with particular
emphasis on better utilization of plant and related assets, while
growing our business lines to set a course toward profitability. We have
been aggressive in reducing costs, as we have stated previously, yet it
is an ongoing process. "Our traditional Vital Diagnostics(TM) IVD
and clinical chemistry business remains a strong and significant
contributor to today's revenue stream. A leader in its space, this
business (on a stand-alone basis) remains profitable, driven by
significant operations in the U.S. and Europe. Consistent with
historical performance, Vital Diagnostics continues to function as a
leading niche player in the business of bringing diagnostic products and
equipment to physician office laboratories and small hospitals and
clinic settings.
"In terms of management and personnel, we continue our search
for a permanent chief financial officer. The company is actively
interviewing candidates for the position. In addition, we are bolstering
the senior management team as necessary to realign our business and
execute our plans. The company expects to announce additions to the team
in the very near future.
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