(Source: Business Wire)
Clinical Data, Inc. (NASDAQ: CLDA) today announced operational and financial results for the first fiscal quarter ended June 30, 2009. During the quarter, the Company reported positive results from a confirmatory Phase III trial of its lead drug candidate, vilazodone, for the treatment of depression. The positive results from the second Phase III trial of vilazodone will contribute to a comprehensive new drug application (NDA) anticipated to be submitted to the U.S. Food and Drug Administration (FDA) by year end. The Company also reported that gross revenue for Clinical Data's PGxHealth FAMILION® genetic testing business grew $1.7 million or 81% to $3.7 million compared to the same period a year ago.
First Quarter and Recent Highlights
Reported that vilazodone, a novel dual-mechanism of action drug candidate being developed for the treatment of major depressive disorder (MDD) achieved the primary endpoint with strong statistical significance in the second of two Phase III trials. Data from the two Phase III trials indicate that vilazodone may have a substantial effect against the symptoms of depression, while having a positively differentiated side effect profile compared with current depression medications. Notably, in both registration trials, vilazodone's impact on sexual function was comparable to placebo, as measured by validated scales.
Sold the Cogenics division to Beckman Coulter for initial proceeds of $13.1 million, excluding $2.2 million in cash retained prior to the sale and $2.5 million held in escrow.
Completed the acquisition of Avalon Pharmaceuticals, Inc.
Initiated Phase I clinical studies to demonstrate safety of Stedivaze, a highly selective adenosine A2A agonist in development as a vasodilator for use in myocardial perfusion imaging, in patients with chronic obstructive pulmonary disease (COPD) and asthma. Stedivaze's increased selectivity may permit safe use in patients with COPD and asthma compared to other adenosine agonists currently available, which carry warnings or are contra-indicated in these patient populations.
Reported that FAMILION genetic testing revenues increased sequentially by 15% from the prior quarter and by 81% from the same period a year ago
Gross profit margins increased 27 percentage points to 55% for fiscal Q1 2010 compared to 28% for the same period a year ago
Announced a newly enhanced FAMILION Long QT Syndrome (LQTS) Test that will double number of genes analyzed. This follows the 3-gene expansion of the FAMILION Hypertrophic Cardiomyopathy (HCM) Test released earlier this year.
Achieved significant growth in positive reimbursement from private and public insurers, with coverage for 230 million lives up from 130 million from the same period a year ago
"During the first quarter, Clinical Data achieved critical business objectives in both the clinical and operational aspects of our business, highlighted by the positive results from the second Phase III trial of vilazodone, a major achievement for this Company. The results from our Phase III trials and the long term exposure study data will support our NDA submission, which we anticipate by the end of the year," commented Drew Fromkin, Clinical Data's President and Chief Executive Officer. "We have also launched clinical studies of Stedivaze to establish its safe use in patients with obstructive lung diseases, where we believe the selectivity of Stedivaze may be advantageous over currently approved agents, and our Phase III program is expected to begin in the coming months. In addition, we believe the consistent revenue growth and gross margin improvement that we report again this quarter further validates the investments we have made in refining our operations, adding new genetic tests and gaining broader insurance coverage to support our cardiac testing franchise."
Financial Results for the Three Months Ended June 30, 2009
Revenue for the three months ended June 30, 2009 increased $1.7 million, or 81%, to $3.7 million from $2.0 million for the same period a year ago. This increase was primarily driven by the increase in net sales of PGxHealth's FAMILION tests of $1.5 million from the same period a year ago.
For the three month period ended June 30, 2009, gross profit margins increased 27 percentage points from 28% for fiscal Q1 2009 to 55% for fiscal Q1 2010. The year-over-year improvement in gross margins was due to an increase in revenues coupled with the realization of infrastructure improvements associated with prior period investments in lab technologies including a laboratory information management system (LIMS); these investments have driven improvements in lab and operational efficiencies. We expect to see continued gross margin improvement as revenues and test volumes increase in future periods.
