(Source: Business Wire)

Clinical Data, Inc. (NASDAQ: CLDA) today announced the Company's
operational and financial results for its second fiscal quarter ended
September 30, 2009.
Second Quarter and Recent Highlights
Completed a public offering which generated approximately $47.4
million in gross proceeds
Hosted an investor day in New York City which focused on vilazodone
and featured leading expertsin the treatment of depression,
antidepressants and related sexual dysfunction; Company on track to
submit its new drug application (NDA) for vilazodone in the first
quarter of calendar 2010
Expanded the Board of Directors to include pharmaceutical industry
leader, Scott Tarriff
Generated proceeds from the sale of certain non-core assets from the
Avalon Pharmaceuticals acquisition for $1.5 million, with an estimated
annual cost-savings of $4.0 to $5.0 million
Established a collaboration and licensing agreement for A2A
agonist ATL313, with the potential to receive up to $252.0 million in
milestones, as well as royalties related to the commercialization of
multiple myeloma and other B-cell cancer treatments
Reported a 51% increase in FAMILION genetic testing gross
revenue, as well as improved gross margins which rose from 36% to 47%,
when compared to the same period a year ago
"The majority of our resources remain focused on driving our late-stage
products toward key development milestones, several of which we
anticipate over the next few quarters," said Drew Fromkin, Clinical
Data's President and Chief Executive Officer. "We plan to submit our NDA
for vilazodone for the treatment of depression in the first quarter of
calendar 2010, and will initiate our Phase III program for Stedivaze for
cardiac stress testing, shortly. During the quarter, we again
demonstrated our ability to secure capital by selling non-core assets
and executing transactions that will reduce overall expenses. More
recently, we successfully obtained capital through the public markets,
improving our stock's liquidity and significantly expanding our
shareholder base. We believe that our ability to attract high-quality
investors in this recent financing is further evidence of the value we
are building for shareholders."
Financial Results for the Three Months
Ended September 30, 2009
Gross revenue for the three months ended September 30, 2009 increased to
$3.7 million, or 47%, from $2.5 million for the same period a year ago.
This was primarily driven by an increase in gross sales from PGxHealth's
FAMILION tests of $1.2 million, or 51%, compared to the same period
a year ago. The increase in gross revenue was partially offset by a rise
in contractual allowances of $542,000, which represents an increase from
5% to 18% of gross genetic testing revenues when compared to the second
quarter of fiscal year 2009. This increase in contractual allowances is
due to additional coverage policies, as well as the revenue mix from
third-party payors. Management also noted that weakened economic
conditions had negatively impacted revenue as well as higher than normal
contractual allowances for the period. The Company anticipates that
future revenue will continue to be driven by expanding genetic test
offerings, driving greater test adoption and increasing insurance
coverage from third-party payors.
For the three month period ended September 30, 2009, gross profit
margins increased to 47% from 36% for the same period last year. The
year-over-year improvement in gross margins was due to an increase in
revenues coupled with the realization of significant investments the
Company has made in infrastructure improvements. Gross margins are
anticipated to improve as revenues and test volumes and reimbursement
increases over time.
Research and development expenses for the three months ended September
30, 2009 increased to $8.9 million, up from $8.6 million for the same
period last year. This modest increase was attributable primarily to the
concluding activities related to the vilazodone safety trial, Phase III
clinical program and initial preparations for the NDA submission, which
is anticipated in the first quarter of calendar year 2010. Ongoing
research and development expenses are expected to increase with
continued activities focused on NDA preparations and the imminent start
of the Phase III program for Stedivaze, the Company's potential
best-in-class vasodilator for use in cardiac stress testing.
In August 2009, the Company sold certain non-core assets from the Avalon
acquisition, which is expected to result in future cost savings in
Avalon research and development activities of approximately $4.0 to $5.0
million annually.
Sales and marketing expense of $2.0 million was essentially flat when
compared to the three months ended September 30, 2008. Expense in this
area should continue at a similar rate for the next several quarters as
the Company leverages a well-established FAMILION sales and
marketing organization.
General and administrative expenses decreased to $5.3 million, down from
$5.6 million in the second quarter of last fiscal year. The decrease was
primarily driven by a reduction in stock-based compensation, however,
this was partially offset by an increase in provisions for uncollectable
accounts largely due to the current economic conditions.
Financial Results for the Six Months
Ended September 30, 2009
Gross revenue for the six months ended September 30, 2009 increased to
$7.8 million, or 65%, from $4.7 million for the six months ended
September 30, 2008. This increase was mainly driven by the increase in
gross sales of genetic tests of $2.9 million, or 67%, compared to the
same period a year ago. Revenue has risen as a result of continued
expansion of the commercial sales and marketing team in fiscal 2009, and
increased coverage policies from third-party payors, such as Blue Cross
and Blue Shield, Aetna and Humana. As of September 30, 2009, PGxHealth
was an approved Medicare provider and a Medicaid provider in certain
states. These increases were partially offset by in an increase in
contractual allowances of $762,000 from $274,000, or 6% of gross genetic
testing revenue, to $1.0 million, or 14% of gross genetic testing
revenue.