Clinical Data Announces Results for Fiscal Third Quarter Ended December 31, 2005; Performance Reflects Recent Acquisitions of Genaissance, Icoria, and Electa Lab Including One-time $40.1 Million Non-Cash Charge.NEWTON, Mass. -- Quarterly Revenue up 38% over Prior Year Quarter Clinical Data, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CLDA CLDA California Lyme Disease Association ), a worldwide leader in commercializing pharmacogenomic services and products to guide drug utilization, today announced consolidated revenues and earnings for the third quarter ended December 31, 2005. Revenues for the three-month period were $19.9 million compared to $14.4 million for the same period a year ago, an increase of 38.6%. The Company reported a net loss of $42.7 million and a net loss applicable to common stockholders of $42.8 million, or ($6.25) per basic common share, based on 6.84 million weighted average shares outstanding compared with net income of $1.0 million, or $0.23 per common share, for the third quarter last year based on 4.39 million average shares outstanding. Revenues for the nine-month period ended December 31, 2005 were $45.6 million as compared to $43.7 million for the same period last year, an increase of 4.2%. The Company reported a net loss of $41.9 million, or a net loss applicable to common stockholders of $42.0 million, or ($8.05) per common basic share, based on 5.21 million weighted average shares outstanding as compared with net income of $3.2 million, or $0.73 per basic common share, for the same period last year based on 4.39 million weighted average shares outstanding. Israel M. Stein, M.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Clinical Data, said, "The quarter ending December 31, 2005 represents a key period in the strategic repositioning repositioning Laparoscopic surgery The changing of a Pt's position during a procedure to improve access or visualization of the operative field, which may be linked to complications, as it changes anatomic planes of operation. Cf Laparoscopic surgery. of the Company with our series of acquisitions during the period of industry-leading companies in molecular services. Revenues for the quarter were up sharply from the comparable period a year ago on a larger asset base, while profitability was impacted primarily by one-time, non-cash charges Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. associated with these strategic acquisitions. Specifically, we recognized $40.1 million in aggregate purchased in-process R&D expense primarily related to the development of an efficacy biomarker biomarker /bio·mark·er/ (bi´o-mahr?ker) 1. a biological molecule used as a marker for a substance or process of interest. 2. tumor marker. bi·o·mark·er n. 1. for our anti-depressant vilazodone and a safety biomarker for the antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. , two of the leading products in development acquired from Genaissance." Dr Stein continued, "In aggressively pursuing a return to profitability of Genaissance and Icoria, we eliminated annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. expenses of over $9 million resulting in a positive trend in the underlying operational performance of both companies. We also continue to invest heavily in the development of vilazodone. We have made substantial progress in moving vilazodone clinical trials forward with the first of our two anticipated pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA studies where we have already screened our first patients for the first study. We have had a very encouraging quarter and we believe the strategic repositioning we have undertaken is providing tangible benefits." About Clinical Data, Inc. Clinical Data, Inc. is a worldwide leader in providing molecular services and clinical diagnostics to improve patient care. Clinical Data's molecular services division is among the largest independent providers of pharmacogenomics Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. and metabolomics services globally and consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. The division is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic therapeutics by finding genetic markers genetic marker n. A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene. to guide drug development and utilization. These services are marketed to the pharmaceutical, biotech, clinical, academic, government and agricultural marketplaces. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l., which are each focused on the small volume clinical diagnostics market worldwide. Vital Diagnostics' instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has also achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . SAFE HARBOR Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and OF 1995 This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, whether vilazodone will advance further in the clinical trials process; whether future clinical trials will warrant continued product development; whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration or equivalent regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , and for which indications; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; whether vilazodone will be successfully marketed; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to republish re·pub·lish tr.v. re·pub·lished, re·pub·lish·ing, re·pub·lish·es 1. To publish again. 2. Law To revive (a libel or a canceled will). revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q. Internet Website: www.clda.com
Clinical Data, Inc. and subsidiaries
(unaudited)
CONSOLIDATED STATEMENT OF OPERATIONS DATA
(in thousands, except for per share data)
For the For the
Three Months Ended Nine Months Ended
12/31/05 12/31/04 12/31/05 12/31/04
------------------- -------------------
Revenues $19,901 $14,343 $45,562 $43,660
(Loss) Income from operations $(42,109) $1,738 $(40,801) $5,215
Net (Loss) Income applicable to
common shareholders $(42,769) $1,016 $(41,986) $3,197
Basic net (loss) income per
share $(6.25)(a) $0.23 $(8.05)(a) $0.73
Diluted net (loss) income per
share $(6.25)(a) $0.23 $(8.05)(a) $0.71
Basic Weighted Average
Common Shares Outstanding 6,843 4,392 5,214 4,387
Diluted Weighted Average
Common Shares Outstanding 6,843 4,509 5,214 4,502
(a) The earnings per share reflect a preferred stock dividend of
$52 for the three and nine months of fiscal year 2006.
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