re: + vcr and medicare + stolwyk Hi Stolwyk,
I don't think you should make unsubstantiated statements in regards to Thoratec, such as.........
"Thoratek can barely exist now"
That statement is clearly incorrect as the enclosed Thoratec press release clearly shows.
Also, how do you know that?................
"They'll blow Thoratek away also on costs"
Do you know how much Thoratec charges for a device? For that matter, do you know how much Ventracor will be charging for a device?
Seaking_______________asking
Thoratec Reports 17 Percent Increase in Revenues
Third Consecutive Quarter of Double-Digit Revenue Growth
PLEASANTON, Calif., July 22 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that product revenues in the second quarter of 2003 increased by 17 percent over those in the second quarter of last year.
Product sales for the quarter ended June 28, 2003 were $36.2 million versus $31.0 million in the second quarter of 2002.
Cash earnings, which the company defines as net income before taxes and excluding merger, restructuring and other expenses, and amortization of purchased intangible assets, were $4.7 million, or $0.08 per share, versus cash earnings of $2.7 million, or $0.05 per share, in the same period a year ago. Further information is provided in a table below to reconcile cash earnings as disclosed in this press release to reported GAAP net income before taxes.
On an as reported basis, Thoratec reported net income of $1.0 million, or $0.02 per share, compared with a loss of $556,000, or $0.01 per share, in the same period a year ago.
"This is the third consecutive quarter in which the company experienced double-digit top line growth versus the comparable quarter. We experienced solid increases across all product lines, led by our ventricular assist device (VAD) business," noted D. Keith Grossman, president and chief executive officer of Thoratec.
"Cardiovascular division revenues increased 19 percent over the same quarter a year ago, aided by a particularly strong quarter from our HeartMate(R) LVAS (left ventricular assist systems) that experienced a 21 percent increase in revenues. At the same time, revenues at our International Technidyne Corporation (ITC) division grew by 12 percent over the comparable quarter," he continued.
"The impact of our growth is also reflected in the strength of our balance sheet, as we ended the quarter with nearly $90 million in cash and investments, an increase of more than $13 million -- or 18 percent-since the end of fiscal 2002."
For the first six months of 2003, Thoratec reported revenues of $72.2 million, a 19 percent increase over revenues of $60.7 million in the first six months of fiscal 2002. VAD related revenues year to date are 21 percent higher than the first six months of last year.
Cash earnings for the first half of 2003 were $10.1 million, or $0.18 per share, versus cash earnings of $3.2 million, or $0.06 per share, in the same period last year. Reported net income was $2.4 million, or $0.04 per share, versus a loss of $2.3 million, or $0.04 per share, in the first six months of fiscal 2002.
As announced on July 18, Thoratec's ITC subsidiary has entered into an asset purchase agreement to acquire the IRMA (Immediate Response Mobile Analysis) point-of-care (POC) diagnostic system intermittent blood gas monitoring performance product line from Diametrics Medical, Inc. (OTC BB: DMED). ITC will pay approximately $5 million and assume certain trade payables related to the assets. The acquisition is subject to a number of conditions, including approval from Diametrics shareholders, and is expected to close later this year.
The company said the transaction is expected to be neutral to Thoratec's previous financial guidance for 2003 and neutral or slightly accretive to cash earnings in 2004. The IRMA business is currently generating approximately $5- $10 million of annual revenues.
As was announced on July 14, the Centers for Medicare & Medicaid Services (CMS) extended for 30 days the due date for its decision regarding coverage for LVADs (left ventricular assist devices) for Destination Therapy to allow additional time for agency clearance.
The company said that according to CMS the extension was a result of CMS' standard review process. Thoratec noted that delays of this type are not unusual for decisions regarding major procedures and that the due dates for several other recent coverage decisions had also been extended.
Thoratec said its discussions with CMS continue to be positive and productive. The company believes that CMS will post its decision within 30 days and it remains optimistic that CMS will issue a National Coverage Decision for LVADs for Destination Therapy.
"A significant highlight of the quarter was the FDA granting conditional approval of the company's IDE (Investigational Device Exemption) to initiate a feasibility clinical trial in the U.S. for its HeartMate II," Grossman said. "This was a major clinical milestone for Thoratec as the HeartMate II is a next generation design for the treatment of heart failure patients. Including this study, we will have six distinct ongoing or pending clinical trials or filings for regulatory approval in our very active product pipeline."
The HeartMate II safety and early efficacy trial will begin with seven patients at four centers and will be evaluated initially for use as a bridge to heart transplantation. The company is currently identifying prospective centers and enrollment could begin once the centers have the appropriate internal approvals -- a process that is expected to be completed during the current quarter. The company plans to utilize 30-day data from the seven patients to seek approval for an expanded study -- something it hopes can occur by the end of 2003 or early in 2004. In addition, the company is currently responding to some routine questions from regulatory authorities in the United Kingdom and hopes to initiate a separate trial for the HeartMate II there early in the fourth quarter.
"The HeartMate II incorporates enhanced control software and other improvements based on our early clinical experience in Europe. It represents a simple and elegant design and the fact that it is equivalent in size to a D- cell battery makes it suitable for a wider range of patients, including small adults and children," said Jeffrey Nelson, president of the company's cardiovascular division.
Nelson said that the company's European and U.S. clinical trials for the Thoratec IVAD(TM) (Implantable Ventricular Assist Device) continue to go well and that the company hopes to receive CE Mark certification, enabling sales of the device in Europe, soon.
Thirteen patients have been enrolled in the European trial, while 16 have been implanted in the U.S. study. The company hopes to file a PMA (PreMarket Approval) Supplement seeking FDA approval later this year. The IVAD is an implantable version of the highly successful Thoratec(TM) VAD System and its smaller size, design and construction enable internal placement resulting in greater comfort, mobility and patient satisfaction. Weighing less than a pound, it is the smallest implantable pulsatile VAD device.
"We have now accumulated more than 2,100 days in cumulative patient support with no serious device malfunctions or unanticipated adverse events. Patients have ranged in age from 16 to 71 years of age with one patient supported for approximately eight months," Nelson noted.
Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec(R) VAD and HeartMate LVAS implanted in more than 5,800 patients suffering from heart failure. Thoratec's product line also includes the Vectra(R) vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood coagulation testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com or http://www.itcmed.com .
VCR
ventracor limited
