Thoratec Laboratories Reports 48 Percent Increase in Second Quarter Sales; Continued Profitable Operations.Business Editors, Health/Medical Writers PLEASANTON, Calif.--(BW HealthWire)--July 25, 2000 Thoratec Laboratories Corporation (Nasdaq:THOR), a medical device company, today reported results for the second quarter and first six months of fiscal 2000. For the three months ended July 1, 2000, the company reported sales of $7.3 million, a 48 percent increase over sales of $4.9 million in the second quarter of fiscal 1999. Thoratec reported net income of $354,000, $0.02 per diluted share, versus a loss of $53,000, or $0.00 per share, in the same period a year ago. For the first six months of 2000, the company reported sales of $14.9 million, a 45 percent increase over sales of $10.3 million in the first half of 1999. The company reported net income of $1.0 million, or $0.04 per diluted share, compared with a loss of $389,000, or $0.02 per share, in the first six months of fiscal 1999. "In nine of the last 10 quarters and for the fourth consecutive quarter, the company has reported year over year sales growth of 40 percent or greater as we continue to increase the market and market share for the Thoratec(R) VAD (Value Added Dealer) Same as VAR. (Ventricular Assist Device ventricular assist device: see under heart, artificial. ) System," noted D. Keith Grossman, president and chief executive officer of Thoratec. "Not only did we grow sales with existing customers, but we added eight new centers ending the quarter with 148 centers versus 111 a year ago," he added. Grossman noted that the company ended the quarter with $18.2 million in cash and short-term investments versus $2.0 million at the end of 1999. "Our significantly improved financial condition reflects the generation of positive cash flow from operations Cash flow from operations A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses during the first half of this year and the impact of our equity offering which was completed during the quarter," he said. The quarter was marked by several key accomplishments across the company's active clinical trial programs. These included the resumption of the U.S. trial for the TLC-II in which the company has now accumulated approximately three-fourths of the patient days required by the clinical protocol. The company plans to file a PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy supplement with clinical data for the device later this year. "We also realized important milestones with our graft clinical trial efforts," Grossman said. "In mid-May, we announced 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. approval for an 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 (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu. ) for the company's Aria aria (är`ēə), elaborate and often lengthy solo song with instrumental accompaniment. In the 16th cent. it was a melody improvised over a strophic bass line, and a distinction was made between instrumental, vocal, and dance arias. (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. ) to begin our AlternativE Graft Investigational Study (AEGIS/U.S.) and just last week received approval to expand the Phase I study from two to six centers. Today we announced in a separate release the first U.S. patient enrolled in this study." The Aria is initially targeted for 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. The company launched a clinical program for the device in Canada --AEGIS/Canada-- late last year and currently has eight patients enrolled in that program. In addition, the company filed a Premarket Notification 510(k) with the FDA for its Vectra(TM) 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) seeking clearance to market the device in the U.S. The Vectra 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 hemodialysis /he·mo·di·al·y·sis/ (-di-al´i-sis) removal of certain elements from the blood by virtue of the difference in rates of their diffusion through a semipermeable membrane while being circulated outside the body; the process . The company believes the data in this filing demonstrates the viability of the device in meeting key metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. , including enabling early access for dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. , achieving equivalent or better patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. rates and improving time required for the graft to stop bleeding after dialysis, as compared to currently approved devices. Thoratec Laboratories Corporation is engaged in the research, development, manufacture and marketing of medical devices for circulatory circulatory /cir·cu·la·to·ry/ (ser´ku-lah-tor?e) 1. pertaining to circulation, particularly that of the blood. 2. containing blood. cir·cu·la·to·ry n. 1. support and vascular graft applications, all of which incorporate its proprietary biomaterial biomaterial /bio·ma·te·ri·al/ (bi?o-mah-ter´e-al) a synthetic dressing with selective barrier properties, used in the treatment of burns; it consists of a liquid solvent (polyethylene glycol-400) and a powdered polymer. , Thoralon(R). For additional information about Thoratec, visit the company's Web site at http://www.thoratec.com. To participate in the Company's second quarter 2000 earnings results conference call, the dial-in number is 719/457-2629. You can also access the call through the vcall website, www.vcall.com or through Thoratec's web site. The portions of this news release that relate to future plans, events or performance, are 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. . Investors are cautioned that all such statements involve risks and uncertainties, including risks related to announcements by the company's competitors, government regulatory approval processes and market acceptance of new products. These factors, and others, are discussed more fully in 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 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
Condensed Consolidated Balance Sheet
(Unaudited)
(numbers in thousands, except per share data)
Fiscal Period Ended
June December
2000 1999
ASSETS
Current Assets:
Cash and cash equivalents $5,938 $1,697
Short-term investments available-for-sale 12,254 276
Receivables - net 5,501 5,453
Inventories 7,839 6,612
Prepaid expenses and other 247 425
------- -------
Total current assets 31,779 14,463
Equipment and leasehold improvements - net 9,204 9,561
Other assets 1,053 1,036
======= =======
TOTAL ASSETS $42,036 $25,060
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Accounts payable $1,173 $1,703
Accrued compensation 1,494 1,466
Deferred distributor revenue 285 285
Other 588 476
------- -------
Total current liabilities 3,540 3,930
Long-term deferred distributor revenue 712 854
Total liabilities 4,252 4,784
------- -------
Shareholders' Equity 37,784 20,276
------- -------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $42,036 $25,060
======= =======
THORATEC LABORATORIES CORPORATION
Condensed Consolidated Statements of Operations
(Unaudited)
(numbers in thousands, except per share data)
Three Months Ended Six Months Ended
June June June June
2000 1999 2000 1999
Product sales - net $7,261 $4,892 $14,867 $10,267
Cost of product sales 2,561 1,661 5,493 4,009
------- ------- ------- -------
Gross profit 4,700 3,231 9,374 6,258
Operating expenses:
Research and
development 1,873 1,278 3,478 2,431
Selling, general, and
administrative 2,666 2,206 5,430 4,581
------- ------- ------- -------
Total operating
expenses 4,539 3,484 8,908 7,012
------- ------- ------- -------
Other operating income 71 71 474 143
------- ------- ------- -------
Operating income (loss) 232 (182) 940 (611)
Interest and
other income - net 134 130 137 229
------- ------- ------- -------
Income (loss)
before taxes 366 (52) 1,077 (382)
Income tax expense 12 1 74 7
Net income (loss) $354 $(53) $1,003 $(389)
======= ======= ======== =======
Earnings (loss)
per share:
Basic $0.02 $(0.00) $0.05 $(0.02)
Diluted $0.02 $(0.00) $0.04 $(0.02)
Shares used to compute
earnings (loss) per share:
Basic 21,978 20,437 21,258 20,432
Diluted 23,474 20,437 22,779 20,432
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