Thoratec Laboratories Reports Record Fourth Quarter; Revenues Increase 43 Percent.Business Editors PLEASANTON, Calif.--(BW HealthWire)--Jan. 24, 2000 Thoratec Laboratories Corporation (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 : THOR), a medical device company, today reported unaudited results for the fourth quarter and all of fiscal 1999. For the quarter ended January 1, 2000, Thoratec reported total revenues of $7.3 million, a 43 percent increase over revenues of $5.1 million in the fourth quarter of 1998. Thoratec reported a loss of $498,000, or $0.02 per diluted share, in the fourth quarter of 1999 versus a loss of $458,000, or $0.02 per diluted share, in the fourth quarter of 1998. &uot;Thoratec's VAD (Value Added Dealer) Same as VAR. (Ventricular Assist Device ventricular assist device: see under heart, artificial. ) system had a very strong quarter. Revenues from VAD sales increased by more than 40 percent versus both last quarter and the fourth quarter of 1998. We saw growth not only domestically but also internationally, where sales more than doubled over last quarter,&uot; said D. Keith Grossman, president and chief executive officer. &uot;Demand remained very strong as we added 36 new centers during the year bringing the total to 130.&uot; Grossman said the company is also on track to submit documentation for the validation of a new component for its TLC-II(TM) Portable VAD Driver. He said the company plans to complete testing and data analysis by the end of February and, based on satisfactory results, resume shipping to Europe and submit an amendment to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the IDE in the U.S. &uot;Thoratec also realized several key milestones with its graft devices during the quarter,&uot; noted Grossman. &uot;With our Aria(TM) CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there (Coronary Artery Bypass Graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. ) device, we have now implanted four patients in the AEGIS/Canada (AlternativE Graft Investigational Study) clinical trial for the device. The perfusion scan perfusion scan Perfusion scintigraphy Cardiology A radionuclide technique for assessing myocardial or pulmonary blood flow, measured by IV injection of 99mTc microaggregated albumin, or thallium, TC-MIBI. See Myocardial infarction. Cf Ventilation scan. for the first patient was completed at two months with normal results. We also filed our Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) with the Food and Drug Administration for the Aria CABG AEGIS/U.S. trial,&uot; he continued. &uot;We received informal notice from the FDA that there would be additional questions to answer on this filing and we intend to respond as rapidly as possible to those questions.&uot; The Aria graft, which incorporates the company's proprietary biomaterial Thoralon(TM), will be tested in patients undergoing coronary artery bypass surgery Coronary artery bypass surgery, also coronary artery bypass graft surgery, and colloquially heart bypass or bypass surgery is a surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. with few or no suitable native vessels. It is estimated that up to 20 percent of the more than 750,000 CABG procedures done per year worldwide involve patients having few or no suitable native vessels. The AEGIS/Canada and AEGIS/U.S. studies are designed to compare the patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. of the Aria graft to poor quality autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. veins at one year after implant. Donald Middlebrook, Thoratec's vice president for regulatory affairs and quality assurance, said, &uot;It is not unusual for the FDA to respond to an IDE with questions and they typically concern animal data, clinical protocol and the like. While we do not fully know the nature of these questions, we hope we will be able to address them quickly and that it will not greatly impact the timing of our U.S. clinical program.&uot; Key elements of the proposed AEGIS/U.S. protocol include less than 150 patients enrolled, one year follow up and randomizing against poor quality saphenous veins as the control group. We hope we will be able to pool data from this trial with our Canadian program, potentially reducing the number of patients and time required to complete both trials,&uot; he continued. Also during the quarter, Thoratec announced the first commercial European implant of its Vectra VAG VAG Vagina Vag Vaginal VAG Freiburger Verkehrs Ag (German transportation company) VAG Versicherungsaufsichtsgesetz (German: supervision of insurance companies act) VAG Vancouver Art Gallery (Vascular Access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing Graft), which took place at Albert Schweitzer Hospital The Medical Research Unit of the Albert Schweitzer Hospital was established in order to study major causes of disease burden in the local population. Since its foundation 25 years ago, it has become a leading African research centre, specialising in pathophysiology and treatment of in Dordrecht in the Netherlands. The device, which incorporates Thoralon, is designed to provide access to the blood stream in renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, patients undergoing hemodialysis. The patient was a 71-year-old man with polycystic polycystic /poly·cys·tic/ (-sis´tik) containing many cysts. pol·y·cys·tic adj. Having or containing many cysts. polycystic containing many cysts. renal disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg who had been undergoing hemodialysis through a jugular jugular /jug·u·lar/ (jug´u-lar) 1. cervical. 2. pertaining to a jugular vein. 3. a jugular vein. jug·u·lar adj. dialysis catheter that was performing poorly. The implant represents the first step preceding a European rollout scheduled to begin in the next several weeks for Thoratec's distribution program for the device with Guidant Corporation (NYSE/PCX:GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ). The Guidant agreement covers worldwide marketing and distribution rights to the device, except in Japan. &uot;In addition, we continued to make excellent progress with our U.S. clinical trials for the device,&uot; Grossman noted. &uot;We have now enrolled all 140 patients and will have six-month data for at least 91 of them next month. Based on our analysis of the data, we could submit our results to the FDA via a 510(k) to gain FDA clearance to begin marketing as early as the middle of this year.&uot; For all of 1999, the company reported revenues of $23.2 million, a 37 percent increase over revenues of $17.0 million in 1998. Thoratec reported a loss of $1.8 million, or $0.09 per diluted share, versus a loss of $2.3 million, or $0.11 per diluted share, in 1998. Thoratec Laboratories Corporation is engaged in the research, development, manufacture and marketing of medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon. For additional information about Thoratec, visit the company's Web site at http://www.thoratec.com. The portions of this news release that relate to future plans, events or performance, are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including the results of clinical trials, announcements by the company's competitors, risks related to the government regulatory approval process, rapidly changing technology, an intensely competitive market and market acceptance of new products. These factors, and others, are discussed more fully in the company's 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. for the fiscal year ended January 2, 1999, and the company's other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
Thoratec Laboratories Corporation
Highlights of Financial Information (Unaudited)
(numbers in thousands, except per share data)
Consolidated Operations
Fourth Quarter Ended Fiscal Year Ended
Jan. 1, Jan. 2, Jan. 1, Jan. 2,
2000 1999 2000 1999
Product sales and
rental income $7,165 $4,990 $22,508 $16,320
Interest and other income 163 137 692 660
Total revenue 7,328 5,127 23,200 16,980
Costs of products sold 3,406 2,046 9,739 6,504
Research and development 1,910 1,404 5,793 5,096
Selling, general and
administrative 2,510 2,135 9,457 7,701
Total costs and expenses 7,826 5,585 24,989 19,301
Net loss $(498) $(458) $(1,789) $(2,321)
Basic and diluted
loss per share $(.02) $(0.02) $(0.09) $(0.11)
Shares used to compute
basic and diluted
loss per share 20,465 20,396 20,446 20,340
Consolidated Balance Sheet Items
Jan. 1, Jan. 2,
2000 1999
Cash, Cash Equivalents
and Short-term investments
available for sale $1,973 $4,745
Current Assets 14,463 14,582
Total Assets 25,060 25,208
Current Liabilities 3,930 3,331
Long-term deferred
distributor revenue 854 0
Shareholders' equity 20,276 21,877
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion