Clinical Data Announces Results for Fiscal Third Quarter 2007 Led by Revenue Growth and Continued Cash Management.Quarterly Revenue Up 19.9% Over Prior Year and 14.6% Sequentially Over Prior Quarter Strong Top-Line Performance Driven By Compelling Demand for Services Modest Burn Rate Despite Strategic Investments Reflects Aggressive Cash Management NEWTON, Mass. -- 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 ) today announced consolidated revenues and earnings for the Company's fiscal third quarter ended December 31, 2006, highlighted by significant revenue growth over the previous quarter and the comparable period last year, as well as continued management of cash burn despite investments in strategic initiatives. Revenue for the three-month period increased 19.9% to $22.0 million compared to $18.4 million for the same period a year ago. Sequentially, third quarter revenue increased 14.6% over the prior quarter's revenue of $19.2 million. For the nine-month period ended December 31, 2006, revenue increased 53.8% to $64.3 million as compared to $41.8 million for the same period last year. The Company reported a third-quarter net loss applicable to common stockholders of $6.3 million, or a loss of $0.65 per basic and diluted common share1, compared with a Q3 2006 net loss of $42.8 million, or a loss of $6.25 per basic and diluted common share2. Sequentially, the Company's net loss moderated by $1.8 million, or 22.5%, compared with the net loss of $8.1 million in the prior quarter. Included in the net loss for the quarter was approximately $1.3 million of research and development expense related to the issuance of stock to Merck KGaA This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. in exchange for vilazodone manufacturing rights. Excluding the $1.3 million impact related to equity-based expense, the quarter-over-quarter net loss improved by $3.2 million or 38.3%. For the nine-month period ended December 31, 2006, the Company reported a net loss of $20.6 million, or a loss of $2.21 per basic and diluted common basic share3, as compared with a net loss of $42.0 million, or $8.07 per basic and diluted common share, for the same period last year4. During the last four quarters, the Company's operational cash burn decreased from $8.7 million in fiscal Q4 2006 to $4.6 million in fiscal Q1 2007, to $2.2 million in Q2 2007, and increased slightly in fiscal Q3 2007 to $2.6 million. This modest increase in cash burn was primarily associated with legal and severance costs related to the Genaissance, Icoria and Genome Express acquisitions. In the near term, the Company expects modest increases in its operational cash burn associated with the development of biomarkers for vilazodone, in development for the treatment of depression, and the continued vilazodone 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 trials. Drew Fromkin, 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, "Clinical Data continues to make strong progress in key operational areas. During the third quarter, Clinical Data built important distribution channels in Europe and elsewhere by entering into separate agreements with Lab21, Diagene GmbH, VWR International VWR International is a global leader in the distribution of research laboratory products, with over 1,200,000 items to more than 250,000 customers in North America and Europe. The U.S. division is headquartered in West Chester, Pennsylvania. , and Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. Transnational Corp. These partnerships and collaborations follow the landmark agreement achieved in the prior quarter with one of the nation's largest pharmaceutical benefit managers, CVS's PharmaCare, and support Clinical Data's commitment to introduce its Therapeutic Diagnostics([TM])into clinical care, with the goal of significantly reducing the cost of care while improving patient outcomes." Fromkin continued, "Even as we have begun to grow revenues in our genomics businesses and continue to move our first Phase III trial for vilazodone toward completion, our management team has successfully preserved Clinical Data's cash resources. As we move into the final quarter of our fiscal year, we remain focused on revenue growth and committed to investment in our strategic businesses. We recently launched new PGxPredict(TM) tests related to Warfarin, Clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. safety, and Rituximab, and we are creating marketing relationships that will lead the way in this new and rapidly growing area." Evan Ballantyne, Senior Vice President and CFO See Chief Financial Officer. of Clinical Data, said, "Our continued focus on cash and cash management has allowed the Company to self-fund the first vilazodone Phase III pivotal study without a partner. This independence will substantially enhance shareholder value should this clinical study establish vilazodone's efficacy and the Company prove able to develop a companion test." About Clinical Data, Inc. Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its PGxHealth division focuses on genetic test and 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. development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and 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. services to both research and regulated environments. Its Vital Diagnostics division offers in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists, and health plans worldwide. 1 based on 9.70 million weighted average shares outstanding 2 based on 6.84 million weighted average shares outstanding 3 based on 9.33 million weighted average shares outstanding 4 based on 5.21 million weighted average shares outstanding 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 about Clinical Data that is intended to be covered by the safe harbor for "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. " provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements 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. These statements include, but are not limited to statements regarding: our ability to successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many 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 and whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration and equivalent foreign 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; whether vilazodone will be successfully marketed if approved, and whether the company will be able to successfully develop and market a companion biomarker for vilazodone; whether our PGxPredict tests will gain wide acceptance in the market; the extent to which 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. (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; our ability to achieve the expected synergies and operating efficiencies from all of our acquisitions; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended December 31, 2006, and our Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed with the 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, and we do not undertake any obligation to revise and disseminate dis·sem·i·nate v. dis·sem·i·nat·ed, dis·sem·i·nat·ing, dis·sem·i·nates v.tr. 1. To scatter widely, as in sowing seed. 2. forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. Internet Website: www.clda.com |
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