Clinical Data, Inc. (NASDAQ: CLDA) today announced the Company’s
operational and financial results for its third fiscal quarter ended
December 31, 2009, confirming its plans to submit a new drug application
(NDA) for vilazodone for the treatment of depression this quarter.
“We have completed all of the clinical studies and related requirements
to submit our NDA for vilazodone to the FDA this quarter”
Third Quarter and Recent Highlights
-
Completed a public offering which generated approximately $47.4
million in gross proceeds
-
Initiated the first Phase III trial of Stedivaze, a potential
best-in-class coronary vasodilator for cardiac stress testing
-
Increased FAMILION® genetic testing gross revenue by
25% and improved gross margins from 35% to 53%, over the same period a
year ago
-
Launched the sixth FAMILION test used to diagnose or confirm
familial heart disease and established a Scientific Advisory Board for
cardiovascular genetics
“We have completed all of the clinical studies and related requirements
to submit our NDA for vilazodone to the FDA this quarter,” said Drew
Fromkin, Clinical Data’s President and Chief Executive Officer. “We are
also advancing Stedivaze, our potential best-in-class coronary
vasodilator, by enrolling patients in our first Phase III trial, and
planning for the second Phase III study that we expect to begin later
this year. Our preclinical programs are also moving forward, and we
anticipate filing an investigational new drug application for at least
one of these compounds in the next 12 to 18 months. We strengthened our
financial resources in support of these programs and broadened our
investor base through our successful public offering completed in
November. We will also continue to pursue collaborative opportunities to
advance our growing pipeline and supplement our financial resources.”
Financial Results for the Three Months
Ended December 31, 2009
Gross revenue for the three months ended December 31, 2009 increased to
$3.7 million, or 22%, up from $3.0 million when compared to the same
period a year ago. This was primarily driven by an increase in gross
sales from PGxHealth’s FAMILION tests of $719,000, or 25%,
compared to the same period a year ago. The increase in gross revenue
was partially offset by a rise in contractual allowances of $323,000,
which represents an increase from 8% to 15% of gross genetic testing
revenues, when compared to the third quarter of fiscal year 2009. This
increase in contractual allowances is due to greater overall coverage
policies, as well as the revenue mix of third-party payors and
challenging macroeconomic conditions. The Company anticipates that
future revenue will continue to be driven by expanding genetic test
offerings, greater test adoption and increasing insurance coverage from
third-party payors.
For the three-month period ended December 31, 2009, gross profit margins
increased to 53%, up from 35% for the same period last year. The
year-over-year improvement in gross margins was due to the increase in
revenues, coupled with the realization of benefits from the significant
investments the Company has made in infrastructure improvements. Gross
margins are anticipated to continue to improve as revenues increase over
time.
During the quarter, the Company expanded its genetic test offerings with
the launch of its sixth genetic test, the FAMILION DCM Test for
Dilated Cardiomyopathy (DCM). DCM is an inherited heart disease which is
the leading cause of heart transplants and a possible cause of sudden
cardiac death. The launch marked the third significant genetic test
launched by PGxHealth, a division of Clinical Data, Inc., within the
past 18 months.
Research and development expenses for the three months ended December
31, 2009 were $9.7 million, down from $15.1 million for the same period
last year. This decrease was primarily attributable to the completion of
the vilazodone safety trial and Phase III clinical program. These
reductions were partially offset by costs incurred with advancing
Stedivaze into the clinic, progressing preclinical programs, and
commercial scale-up activities and preparations for the NDA submission
for vilazodone. Ongoing research and development expenses are expected
to increase due to the Stedivaze Phase III clinical trials and
preparations for the commercialization of vilazodone.
During the quarter, the Company initiated a Phase III trial of Stedivaze
(apadenoson) to evaluate its safety and efficacy for use as a
pharmacologic stress agent in myocardial perfusion imaging (MPI), a
method for evaluating blood flow to the heart. The Phase III ASPECT
Trial (Apadenoson Single Photo Emission Computed
Tomography) will also compare the tolerability of Stedivaze to
adenosine, a standard pharmacologic stress agent used in MPI scans.
Sales and marketing expenses of $1.9 million were essentially flat when
compared to the three months ended December 31, 2008. Expense in this
area should continue at a comparable rate for the next several quarters
as the Company continues to leverage its well-established FAMILION
sales and marketing organization.
General and administrative expenses were $4.4 million, down from $5.0
million in the third quarter of last fiscal year. The decrease was
primarily driven by a reduction in stock-based compensation, partially
offset by an increase in the provision for uncollectable accounts
largely due to the current economic conditions.
Financial Results for the Nine Months
Ended December 31, 2009