Clinical Data Issues Results for Fiscal 2007 and Announces Key Corporate Developments.NEWTON, Mass. -- Clinical Data, Inc.: * Increases Yearly Revenue by 69% * Completes Its First 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 Trial for Vilazodone * Sells US-Focused IVD (Interactive VideoDisc) See interactive video. Business * Increases Authorized Share Capital 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 reported consolidated financial results for the Company's fiscal year ended March 31, 2007. The Company also announced the completion of its initial pivotal Phase III study of the anti-depressant drug candidate Vilazodone, the sale of the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. segment of its Vital Diagnostics division known as Clinical Data Sales & Service, Inc. ("CDSS CDSS California Department of Social Services CDSS Clinical Decision Support Systems CDSS Country Dance and Song Society CDSS Canadian Down Syndrome Society CDSS Community Day Secondary Schools (Malawi) "), and the filing of an amendment to its certificate of incorporation certificate of incorporation n. some states issue a certificate to prove a corporation's existence upon the filing of Articles of Incorporation. In most states the Articles are sufficient proof. increasing the Company's share authorization. Revenue for the fiscal year ended March 31, 2007 increased 69% to $63.7 million compared to $37.8 million for fiscal 2006. The year-over-year increase was primarily attributed to the inclusion of a full year of operations from PGxHealth[TM] and Cogenics[TM], an increase in volume of instruments sold, and a sales mix sales mix See product mix. more heavily weighted to higher-priced products. The loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the for fiscal 2007 was $27.9 million, compared to $50.4 million in fiscal 2006, which represents an improvement of 44.6% year-over-year. Included in the net loss from continuing operations for fiscal 2007 were non-cash charges totaling approximately $17.4 million relating to depreciation and amortization, impairment of intangible assets and stock based compensation, as well as $7.0 million of expenses associated with the development of Vilazodone, including $5.0 million related to completion of clinical work related to the pivotal Phase III trial and $1.6 million of additional non-cash expense related to the issuance of stock to Merck KGaA in exchange for Vilazodone manufacturing rights. The Company generated net cash flow of $6.7 million during fiscal 2007, compared to $3.1 million in fiscal 2006, and had cash and cash equivalents of $13.9 million at March 31, 2007. The increased net cash flow in fiscal 2007 was primarily due to net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $20.6 million from the issuance of common stock and warrants related to private placements. The Company also absorbed cash charges of $3.3 million related to severance and restructuring associated with acquisitions. Net cash flow in fiscal 2006 includes net proceeds of approximately $11.9 million from the issuance of common stock and warrants in a private placement completed by the Company in November 2005. During fiscal 2007, the Company sold its Australia-based Vital Diagnostics Pty Ltd. (VDPL)1 business, and on June 18, 2007, the Company divested its CDSS business unit headquartered in Smithfield, RI. The Company received proceeds of $1.5 million from the sale of VDPL, and $7.0 million from the sale of CDSS. At the close of business on June 18, 2007, the Company had approximately $17.0 million of cash and cash equivalents. The increase in cash since March 31, 2007, is primarily related to the receipt of a litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. settlement by its Vital Scientific subsidiary, and to proceeds received from the sale of CDSS. Approximately $3.3 million of the proceeds were used to retire a line of credit. The Company reported a loss in fiscal 2007 from continuing operations applicable to common shareholders of $2.962, compared to a loss applicable to common shareholders of $8.46 in fiscal 20063. 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 execute on its objective of securing a leadership position in clinical pharmacogenomics. We believe this represents the most promising innovation in the advancement of healthcare delivery and cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. , and is central to the mission of our Company. "Our team is extremely proud of our results. We have managed our cash resources and businesses beyond our expectations and have achieved many key milestones that reinforce the foundation for our strategic businesses. "In May, our PGxHealth division completed its first pivotal Phase III study of Vilazodone for depression. Vilazodone is a unique compound that combines selective serotonin reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. inhibition with partial agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. activity at the 5HT1A receptor, thus combining a common first and second line therapy strategy in one drug. We then hope to develop a Vilazodone biomarker assay that will help predict patient response in the targeted population, resulting in response rates for Vilazodone beyond those typically seen with drugs in this class. "We are preparing to unblind Un`blind´ v. t. 1. To free from blindness; to give or restore sight to; to open the eyes of. the top line efficacy data and review it and the related biomarker data from the study later this summer. We will then analyze the entire dataset to determine the results of the trial and next steps for development. Should this clinical study and our biomarker identification show promising results, we plan to embark on our second Phase III pivotal trial and aim to submit a new drug application for Vilazodone as early as late 2009. If successful, this could substantially alter the clinical and economic value proposition for therapeutics in this class. We are pleased to have been able to advance Vilazodone with no additional external funding, thereby preserving significant value for our shareholders. "PGxHealth also saw strong revenue growth in its FAMILION([R]) test for Long QT and other cardiac channelopathies, with revenues of $3.3 million in this last fiscal year. The Company has formed two relationships in Europe for the distribution of its FAMILION test. Also this year, PGxHealth launched PGxPredict[TM] tests for Warfarin, Clozapine-Induced Agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. , and Rituximab. Our April 2007 hiring of James P. Shaffer, an experienced sales and marketing executive, represents a major step in building the sales and marketing engine to support growth in our line of pharmacogenetic tests. "Our Cogenics division has in recent months announced the addition of new technologies and services from Roche Diagnostics, Epigenomics AG, Agilent Technologies, Inc., Algynomics and Luminex. Meanwhile, partnerships between Cogenics 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. and Spacelabs Healthcare Clinical Trial Services have set the stage for our Long QT pharmacogenomics services to be introduced into clinical trials. We expect that our tests will provide a valuable tool for clinical studies, especially in light of the FDA's mandating of thorough QT testing for all new drugs in development. "As Cogenics continues to pursue strategic relationships and new technologies in this dynamic sector, we expect to enlarge our global footprint. "Clinical Data plans to use the proceeds of our sale of CDSS in support of our pharmacogenomics businesses. We are pleased to have been able to monetize CDSS, thereby reducing our debt burden and eliminating the cash burn associated with it." Separately, Clinical Data announced that it has amended its Certificate of Incorporation increasing its authorized shares Authorized shares Number of shares authorized for issuance by a firm's corporate charter. of common stock from 14,000,000 to 60,000,000. Evan Ballantyne, Senior Vice President and CFO See Chief Financial Officer. of Clinical Data, remarked, "Clinical Data's disciplined cash management has allowed the Company to reduce its cash burn despite continued investments in its strategic businesses and Vilazodone's first pivotal Phase III clinical trial Noun 1. phase III clinical trial - 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 . We are now able to devote an increasing portion of our resources to investments in platforms, information systems, genetic markers, and opportunities for our pharmacogenetic testing and services franchises. "The number of authorized but unissued shares available under Clinical Data's charter had diminished, and with it our flexibility to pursue acquisitions, consider future stock splits, and other activities necessary to advance our long-term goals Long-term goals Financial goals expected to be accomplished in five years or longer. . The increase to our authorized share capital will allow us greater flexibility as we accelerate the growth of Clinical Data." Clinical Data noted that its independent auditors issued an unqualified opinion Unqualified opinion An independent auditor's opinion that a company's financial statements comply with accepted accounting procedures. Antithesis of qualified opinion. unqualified opinion See clean opinion. on the Company's 2007 consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge that included a material uncertainty related to the Company's ability to continue as a going concern for a reasonable period of time. As discussed in Note 1 to the Company's consolidated financial statements in its Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission, the Company continues to undertake steps to improve liquidity. [TABLE OMITTED] [TABLE OMITTED] 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 development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and pharmacogenomics 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 Vital Diagnostics Pty Ltd. is currently owned by VDPL's general manager, Adrian Tennyenhuis, and New River Management IV, LP. New River Management IV, LP is an affiliate of, and is funded and controlled by, Third Security, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , which is controlled by Randal J. Kirk New River Pharmaceuticals was acquired in a deal worth approximately $2.6 billion, making Randal J. Kirk, New River Pharmaceutical's founder, chairman and chief executive officer approximately $1.46 billion. , the chairman of Clinical Data's board of directors. 2 based on 9.5 million weighted average shares outstanding 3 based on 6.0 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 and its subsidiaries that is intended to be covered by the safe harbor for "forward-looking statements" 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 raise cash or produce cash from operations sufficient to fund our current level of activities, including clinical trials; the effects of regulatory decisions and approvals (or failure to obtain approvals) on our drug candidates and other existing products; our ability to successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; our ability to continue to attract new customers and obtain new and expanded business opportunities from existing customers; continued growth in demand in the U.S. and abroad for products and services such as those we offer, and the effect of intensifying competition among a rising number of companies offering products and services similar to those we offer; 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 we will be able to finance our operations through sales of securities and/or cash generated from continuing operations; 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 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 (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 Annual Report on Form 10-K for the year ended March 31, 2007, 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 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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