Clinical Data Reports Strong Fourth Quarter and Fiscal Year 2008 Results

Business Wire,  June 16, 2008  

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NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ:CLDA), a leader in the development of predictive tests and targeted therapeutics from its growing portfolio of proprietary genetic biomarkers, today announced strong revenue growth and continued achievement of its corporate objectives for the fourth quarter and fiscal year ended March 31, 2008.

Total revenue for the fourth quarter rose 25% to $7.8 million from $6.3 million for the same period a year ago, while full fiscal 2008 revenue increased 20% to $29.4 million compared with $24.4 million in fiscal 2007, in each case excluding the impact associated with the planned wind-down of certain grant revenue from the acquisition of Icoria, Inc. Total fiscal 2008 revenue was $34.0 million including the Icoria grant revenue.

"2008 was a transformative and foundational year for Clinical Data," said Drew Fromkin, Clinical Data's President and CEO. "We successfully completed the divestiture of our legacy diagnostics businesses, and with the acquisition of Epidauros Biotechnologie AG, continued to enhance our proprietary, biomarker driven and genomic services businesses. We have integrated and organized these acquisitions into two core business units: PGxHealth([R]), which brings together our experience and capabilities in the identification and clinical validation of biomarkers, to develop and commercialize genetic and pharmacogenetic tests and targeted therapeutics, and Cogenics([R]), a global provider of value-based genomic services and solutions to the healthcare and lifesciences industries.

"By successfully completing, in fiscal 2008, the first of two Phase III clinical trials for vilazodone, a dual serotonergic antidepressant, Clinical Data has demonstrated its ability to independently advance a novel drug candidate through late stage clinical development and concurrently identify proprietary biomarkers of response. This trial demonstrated both statistical and clinical significance on primary and secondary endpoints of efficacy in major depressive disorder, and we quickly progressed to the initiation of a safety trial and second Phase III registration trial. We also expanded our FAMILION([R]) family of genetic tests for life threatening cardiac conditions by introducing a test for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) in October and, since the end of the fiscal year, a test for Hypertrophic Cardiomyopathy (HCM) to expand our offerings and revenue in this well-established and rapidly growing sales channel."

Fourth Quarter Highlights

Predictive Genetic Tests: Significant Growth in Sales and Payer Coverage

* PGxHealth completed the second full quarter with its new sales force in place. As a result, revenue from PGxHealth's FAMILION and PGxPredict[R] tests increased sequentially by 15% from the prior quarter and by 80% from the same period a year ago.

* PGxHealth announced that its flagship FAMILION LQTS (Long QT Syndrome) test met the criteria for establishing the diagnosis of LQTS, in certain patients, from the Blue Cross and Blue Shield Association Technology Evaluation Center, which the Company believes will lead to even more expansive payer coverage for this important test.

* PGxHealth has applied to be an approved laboratory provider in all 50 state Medicaid programs and has received approval in 30 states. In the remaining states, we continue to pursue Medicaid acceptance through pending claims and contract negotiations.

* PGxHealth's FAMILION LQTS test achieved significant growth in positive reimbursement policies from private and public insurers covering 140 million lives.

Vilazodone Clinical Development: Key Milestones Achieved

In March, Clinical Data initiated the second of two Phase III trials of vilazodone, the Company's novel drug candidate for the treatment of depression. This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of vilazodone. It will also further evaluate genetic biomarkers of response to vilazodone identified during the first Phase III trial, which are intended to lead to the development of a pharmacogenetic test that would help to identify those patients most likely to respond to vilazodone. Prior to the launch of the second Phase III trial, the Company also initiated a long-term safety trial in December 2007 and recently completed enrollment of that trial.

Genomic Services: Ongoing Leadership of the Market

During the fourth quarter, Cogenics installed new-to-market technologies, completed leading-edge research and announced several collaborations that strengthen its suite of value-based service offerings for academic, industrial and biotech customers. Some highlights include:

* Increased revenue for the quarter of 19% to $6.2 million compared to $5.3 million, for same period last year after excluding the impact associated with the wind-down of Icoria's grant revenue.

* Completion of a semi-exclusive marketing agreement with Affymetrix, Inc. for a new drug metabolism service using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET).