Cardiovascular Diagnostics Reports Third Quarter Results.RALEIGH, N.C.--(BW HealthWire)--Oct. 27, 1998--Cardiovascular Diagnostics, 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 NM: CVDI CVDI Certificado de Validación de Datos de Importadores (Argentina) CVDI Crime Victims with Disabilities Initiative (California) ) ("CVDI") today announced financial results for the three and nine months ended September 30, 1998. Highlights of the 1998 third quarter include: -- The signing of a global distribution agreement with Bayer/Chiron Diagnostics for certain CVDI diagnostic coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or tests-- The purchase by Chiron of $6 million of CVDI common stock at $10 per share -- The initiation of field trials with the theranostic test developed with Eli Lilly as an indicator for sepsis therapy -- The initiation of field trials with the theranostic test developed with Knoll AG ("Knoll") for use in stroke therapy Revenues for the 1998 third quarter were $2,202,000, an increase of 31% over revenues of $1,677,000 for the third quarter of 1997. Revenues for the 1998 third quarter were positively impacted by the shipment of the remaining Thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. Assessment System (TAS TAS abbr. 1. telephone answering system 2. true airspeed ) analyzers to Knoll related to their $2.1 million order placed earlier in the year. The increased revenues, combined with a 14% decrease in operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , led to an operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. for the 1998 third quarter of $1,002,000, a 42% improvement from the operating loss in the third quarter of 1997. The net loss for the 1998 third quarter was $945,000, or a loss of $0.14 per basic share, compared with a net loss of $1,449,000, or a loss of $0.22 per basic share, for the 1997 third quarter. Revenues for the nine months ended September 30, 1998 were $6,797,000, an increase of 19% compared with revenues of $5,720,000 for the same period last year. Year-to-date operating expenses decreased 10% to $4,944,000, compared with $5,486,000 for the same period last year. This resulted in an improved nine-month operating loss of $2,834,000, compared with the nine-month 1997 operating loss of $4,199,000. For the nine months ended September 30, 1998, CVDI reported a net loss of $2,469,000, or a loss of $0.36 per basic share, compared with a net loss of $2,874,000, or a loss of $0.43 per share, for the same period in 1997. Commenting on the quarter, John Funkhouser, President and Chief Executive Officer, said, "We continue to make strong progress in the development of our theranostic tests and remain committed to forming additional collaborations with pharmaceutical companies. Also, we are planning to implement a strategy to attempt to diversify our scientific base through the formation of joint ventures and/or acquisitions of promising new technologies. We expect these new developments to expand on our current base of business and provide additional synergies throughout the organization." An important highlight of the quarter was the August 28th signing of a global distribution agreement for certain CVDI diagnostic coagulation tests with Chiron Diagnostics ("Chiron"), which is in the process of being sold to the Bayer Group. This combination will make Bayer the world's No. 4 diagnostic company, offering further potential market opportunities for CVDI. Bayer is fully supportive of Chiron's partnership with CVDI, and Bayer's strength in the physician office and self-test markets could expand use of CVDI's products outside the hospital. As part of the August 28th agreement, Chiron purchased $6 million of CVDI common stock at $10 per share. CVDI's products are complementary to Chiron's blood gas technology, and each company believes the agreement will help to further expand their market share in point-of-care settings. Chiron will begin marketing CVDI's tests beginning in January 1999. In addition to the Chiron announcement, CVDI continued to pursue its strategy of developing rapid diagnostic specialty tests for new therapeutics. The test currently being developed in conjunction with Eli Lilly will be used to evaluate the effect of a new therapeutic anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). ("TA") that completed Phase II trials. The Phase II trials involved laboratory testing of samples collected from patients with or at risk of developing sepsis. The diagnostic test is now in clinical field trials at major centers in the United States and Canada and the data collected will be used to optimize and finalize the test format. An additional test, the Low Range Fibrinogen Fibrinogen The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion ("LRF LRF luteinizing hormone releasing factor. ") test, is currently being developed with Knoll and will be used to monitor the fibrinogen levels of patients receiving Knoll's new drug Ancrod(R) for the treatment of ischemic stroke. This diagnostic recently entered field trials in Europe. This is the second test card CVDI has developed for use by Knoll to monitor its new highly potent drugs. The first diagnostic test, the Ecarin Clotting Time Ecarin clotting time (ECT) is a laboratory test used to monitor anticoagulation during treatment with hirudin, an anticoagulant medication which was originally isolated from leech saliva. ("ECT ECT electroconvulsive therapy. ECT abbr. electroconvulsive therapy ECT Electroconvulsive therapy sometimes is used to treat depression or mania when pharmaceutical treatment fails. ") test, was developed to monitor the effect of Knoll's thrombin inhibitor Thrombin inhibitor Thrombin inhibitors are one type of anticoagulant medication, used to help prevent formation of harmful blood clots in the body by blocking the activity of thrombin. Mentioned in: Anticoagulant and Antiplatelet Drugs PEG Hirudin hirudin /hi·ru·din/ (hi-rldbomacd´in) the active principle of the buccal secretion of leeches; it prevents coagulation by acting as an antithrombin. hir·u·din n. . The ECT test completed all phases of development this year and the Company filed a 510(k) with the U.S. Food and Drug Administration. Knoll will be using these test cards and analyzers in their Phase III trials. Commenting on these and other developments, Mr. Funkhouser said, "We are pleased these tests are proceeding into more advanced stages of development. Although more work must be done to commercialize these products, we are encouraged that our technology platform has shown flexibility during these development stages. Further, other drug targets have been identified and, in some cases, initial feasibility studies have been completed to evaluate the potential of developing theranostic tests. Some of these results have been presented to potential pharmaceutical partners in order to initiate collaboration discussions." As CVDI makes further progress in establishing itself in the emerging field of theranostics, or the rapid near-patient testing in which the diagnostic results influence treatment decisions, CVDI has submitted for shareholder approval a proposal to change the Company's corporate name to PharmaNetics and its NASDAQ ticker symbol Ticker Symbol An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors to PHAR. Shareholders are expected to vote on the proposed name change at a special meeting scheduled for December 2, 1998. Cardiovascular Diagnostics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot blood clot n. A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network. formation and dissolution. The Company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of powerful new drug compounds, some of which have narrow therapeutic ranges, as well as for monitoring routine anticoagulants Anticoagulants Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms. Mentioned in: Embolism, Heart Valve Replacement . The Company's therapeutic diagnostics are used in the treatment of angina, myocardial infarction myocardial infarction: see under infarction. (heart attack), stroke, deep venous thrombosis deep venous thrombosis n. Abbr. DVT A condition in which one or more thrombi form in a deep vein, especially in the leg or pelvis, resulting in an increased risk of pulmonary embolism. , and pulmonary and arterial emboli emboli /em·bo·li/ (em´bo-li) plural of embolus. Emboli Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel. . This press release contains forward-looking statements regarding future events and the future performance of Cardiovascular Diagnostics that involve risks and uncertainties, such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause actual results to materially differ from those in the forward-looking statements is contained in the Company's SEC filings, including 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. , Form 10-Q and Form 8-K reports. -0-
Cardiovascular Diagnostics Inc.
Selected Financial Summary
Consolidated Income (Loss) Statements
Three Months Ended Nine Months Ended
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
1998 1997 1998 1997
Net Revenue $2,201,908 $ 1,677,003 $ 6,797,440 $ 5,720,155
Cost of Goods Sold 1,539,655 1,483,662 4,688,078 4,433,757
Gross Profit 662,253 193,341 2,109,362 1,286,398
Operating Expenses 1,664,739 1,926,233 4,943,723 5,485,773
Operating Loss (1,002,486) (1,732,892) (2,834,361) (4,199,375)
Other Income 72,021 298,321 432,579 1,368,186
Net Loss Before
Taxes (930,465) (1,434,571) (2,401,782) (2,831,189)
Provision for
Income Taxes (14,750) (14,273) (67,250) (42,819)
Net Loss ($945,215) ($1,448,844) ($2,469,032) ($2,874,008)
Basic and Diluted
Loss Per Common
Share ($ 0.14) ($ 0.22) ($ 0.36) ($ 0.43)
Weighted Average
Common Shares
Outstanding 7,010,706 6,733,452 6,859,330 6,725,959
Consolidated Balance Sheets
September 30, December 31,
1998 1997
Cash and investments $ 9,071,378 $ 5,884,522
Other Current Assets 4,754,529 5,102,572
Total Assets 20,296,208 17,684,503
Current Liabilities 1,536,331 2,140,620
Total Liabilities 3,393,413 4,491,795
Total Shareholders' Equity 16,902,795 13,192,708
Total Liabilities and
Shareholders' Equity $20,296,208 $17,684,503
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