Exhibit 99.1
THORATEC REPORTS RECORD FIRST QUARTER SALES
RESULTS REFLECT FIRST FULL QUARTER FOR DESTINATION THERAPY APPROVAL, REIMBURSEMENT
(PLEASANTON, CA), April 27, 2004—Thoratec Corporation (NASDAQ: THOR), a world leader in products to treat cardiovascular disease, today reported results for the first quarter ended April 3, 2004.
The company said product sales for the period were a record $42.8 million, a 19 percent increase over sales of $36.1 million in the first quarter a year ago.
Taxed cash earnings, which exclude the effect of legal settlement, merger, restructuring and other costs and amortization of purchased intangible assets, were $3.2 million, or $0.06 per share, versus taxed cash earnings of $3.3 million, or $0.06 per share, in the same period a year ago.
On a GAAP basis, Thoratec reported net income in the first quarter of fiscal 2004 of $1.3 million, or $0.02 per share, versus net income of $1.4 million, or $0.03 per share, in the same period a year ago.
“Our results for the quarter reflect solid growth in both our Cardiovascular and ITC divisions,” noted D. Keith Grossman, president and chief executive officer of Thoratec.
“Sales of our heart assist devices benefited from this being the first full quarter in which we had Destination Therapy approval and the National Coverage Decision from Medicare, as sales of our HeartMate® device grew by 26 percent. We feel we are off to a very good start with this new indication for use, as 42 Destination Therapy implants took place in the quarter.
“The overall patient experience and outcomes with Destination Therapy patients to date have been very positive and the centers are reporting a decreasing number of adverse events. Many of these patients have been implanted with our HeartMate® XVE that incorporates the new inflow valve conduit and the clinician response to this product enhancement has been very favorable to date. In addition, we currently have 67 centers approved by the Centers for Medicare and Medicaid Services (CMS) for Destination Therapy reimbursement by Medicare.
“At ITC,” he continued, “revenues grew 34 percent versus the first quarter a year ago, as its offerings continued to achieve market share gains. Revenues from ITC’s alternate site testing products increased 60 percent versus a year ago, and its point-of-care coagulation testing devices also experienced strong sales growth. We also recorded sales
from theIRMA® TRUpoint product line, which we acquired last year. Even without theIRMATRUpoint revenues, ITC sales would have increased nearly 20 percent versus a year ago.”
Jeffrey Nelson, president of the company’s cardiovascular division, noted that operating expenses in the quarter reflect costs associated with the ramp up of sales and marketing programs to support Destination Therapy, such as the Heart Hope™ initiative.
“This effort, which is a collaboration between Thoratec and leading heart centers committed to advancing clinical, educational and economic outcomes of Destination Therapy, is just beginning to have an impact in the marketplace,” Nelson noted.
“Approximately 20 leading centers have signed up for the Heart Hope program and several more have indicated they will be doing so. We believe that between 25 and 30 centers may accept our invitation to commit to the program this year. We are very pleased with the response to Heart Hope to date. In fact, approximately 70 percent of the 42 Destination Therapy procedures during the quarter were done at our targeted Heart Hope centers,” he added.
Nelson noted that a key element of Heart Hope is the development of HeartMate Destination Therapy Advanced Practice Guidelines and that these were presented at the first Heart Hope Users Conference last week. The meeting was attended by some 50 clinicians, including cardiac surgeons, heart failure cardiologists and VAD coordinators.
“The response from attendees, who are thought leaders in the cardiology field, was very positive and they came away with even a higher level of enthusiasm for the Destination Therapy opportunity. They felt that these new practice guidelines were right on target with respect to the important issues facing development of the market—particularly those guidelines related to nutrition management—which are among the first of its kind for heart failure patients,” he noted.
The company also said that it has now implanted four patients in the U.S. HeartMate II clinical trial, and they are doing well. The initial two patients have now been supported by the device for nearly six and four months, respectively. Two patients have been implanted in the European trial for the device, although both passed away for reasons unrelated to the device.
The company also announced that it received home discharge approval for patients in the U.S. HeartMate II trial, and approval to resume its clinical trial for the device in the United Kingdom. In addition, the company has filed a submission with the FDA to expand the current Phase I U.S. trial from four to ten centers and seven to 15 patients.
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“The home discharge approval is significant, because we believe this will facilitate the pace of enrollment in the trial as recovery at home is a plus for both the patient and hospital, and we are hopeful that the FDA will approve our request for an expanded trial within the next three weeks. We are also delighted to be underway again in the United Kingdom and would anticipate that we might have our first patient enrolled there by later this quarter,” Nelson said.
The HeartMate II is the company’s next generation design heart assist device intended for long-term cardiac support for patients who are in end-stage heart failure. It is an implantable LVAS (left ventricular assist system) powered by a rotary pump. It weighs approximately 12 ounces, making it significantly smaller than currently approved devices. The initial U.S. safety and efficacy trial involves seven patients at four centers and the device is being evaluated initially for bridge-to-transplantation. The company hopes to use the data from this initial trial for approval of an expanded trial that will also study use of the device for Destination Therapy.
The company also reiterated its financial guidance for fiscal 2004, including revenues of $190-$200 million, cash earnings of $30-$35 million, or $0.53-$0.61 per share, or taxed cash earnings of $0.32-$0.38 per share.
Thoratec will hold a conference call to discuss its financial results and operating activities to all interested parties at 1:30 p.m. Pacific Daylight Time (4:30 p.m. Eastern Daylight Time), today, hosted by D. Keith Grossman, president and chief executive officer, and Wayne Boylston, senior vice president and chief financial officer.
The teleconference can be accessed by calling (719) 457-2649. Please dial in ten to 15 minutes prior to the beginning of the call. The web cast will also be available via the Internet at http://www.thoratec.com. A replay of the conference call will be available through Tuesday, May 4, via http://www.thoratec.com, or by telephone at (719) 457-0820, passcode 450744.
Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec VAD and HeartMate LVAS with more than 8,000 devices implanted in patients suffering from heart failure. Thoratec’s product line also includes theVectra® vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood 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.
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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 risks related to the results of clinical trials, the ability to improve financial performance, regulatory approval processes, healthcare reimbursement and coverage policies and acquisition activities. These factors, and others, are discussed more fully under the heading, “Risk Factors,” in Thoratec’s 10-K for the fiscal year ended January 3, 2004, and 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. Thoratec 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.
| | |
Investor Contact Information: | | Media Contact Information: |
Wayne Boylston | | Susan Benton |
Chief Financial Officer | | FischerHealth, Inc. |
Thoratec Corporation | | (310) 577-7870 |
(925) 847-8600 | | sbenton@fischerhealth.com |
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THORATEC CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
| | | | | | | | |
| | March | | December |
| | 2004
| | 2003
|
ASSETS | | | | | | | | |
Current Assets: | | | | | | | | |
Cash and cash equivalents | | $ | 48,022 | | | $ | 62,020 | |
Short-term available-for-sale investments | | | 45,828 | | | | 41,179 | |
Receivables, net | | | 28,851 | | | | 27,969 | |
Inventories | | | 36,830 | | | | 36,417 | |
Other current assets | | | 13,193 | | | | 12,796 | |
| | | | | | | | |
Total Current Assets | | | 172,724 | | | | 180,381 | |
Property, plant and equipment, net | | | 28,948 | | | | 28,492 | |
Goodwill | | | 95,116 | | | | 96,065 | |
Purchased intangible assets | | | 161,934 | | | | 164,865 | |
Other assets | | | 6,965 | | | | 6,328 | |
| | | | | | | | |
TOTAL ASSETS | | $ | 465,687 | | | $ | 476,131 | |
| | | | | | | | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
Current Liabilities: | | | | | | | | |
Accounts payable | | $ | 6,698 | | | $ | 6,952 | |
Accrued expenses | | | 11,477 | | | | 15,820 | |
| | | | | | | | |
Total Current Liabilities | | | 18,175 | | | | 22,772 | |
Long-term deferred tax liability and other | | | 65,600 | | | | 67,123 | |
| | | | | | | | |
Total Liabilities | | | 83,775 | | | | 89,895 | |
Shareholders’ Equity | | | 381,912 | | | | 386,236 | |
| | | | | | | | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | | $ | 465,687 | | | $ | 476,131 | |
| | | | | | | | |
THORATEC CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
| | | | | | | | |
| | Fiscal Quarter Ended
|
| | March | | March |
| | 2004
| | 2003
|
Product sales | | $ | 42,792 | | | $ | 36,062 | |
Cost of product sales | | | 17,721 | | | | 14,891 | |
| | | | | | | | |
Gross profit | | | 25,071 | | | | 21,171 | |
| | | | | | | | |
Operating expenses: | | | | | | | | |
Selling, general and administrative | | | 13,013 | | | | 10,060 | |
Research and development | | | 7,338 | | | | 6,260 | |
Amortization of purchased intangible assets | | | 2,931 | | | | 3,096 | |
Legal settlement, merger, restructuring and other costs | | | 133 | | | | (57 | ) |
| | | | | | | | |
Total operating expenses | | | 23,415 | | | | 19,359 | |
| | | | | | | | |
Income from operations | | | 1,656 | | | | 1,812 | |
Interest and other income — net | | | 465 | | | | 512 | |
| | | | | | | | |
Income before taxes | | | 2,121 | | | | 2,324 | |
Income tax expense | | | 827 | | | | 906 | |
| | | | | | | | |
Net income | | $ | 1,294 | | | $ | 1,418 | |
| | | | | | | | |
Net income per share: | | | | | | | | |
Basic | | $ | 0.02 | | | $ | 0.03 | |
| | | | | | | | |
Diluted | | $ | 0.02 | | | $ | 0.03 | |
| | | | | | | | |
Shares used to compute net income per share: | | | | | | | | |
Basic | | | 56,106 | | | | 55,057 | |
Diluted | | | 57,458 | | | | 55,534 | |
Reconciliation of Taxed Cash Earnings to GAAP Income Before Taxes
This press release discloses “taxed cash earnings” which is not a financial measure prepared in accordance with United States Generally Accepted Accounting Principles (“GAAP”). Management believes that taxed cash earnings can be a useful measure for investors to evaluate our financial performance by providing the results of our company’s primary business operations, excluding the effects of charges associated with legal settlement, merger, restructuring and other activities. However, this measure should be considered in addition to, and not as a substitute, or a superior measure to, income before taxes or other measures of financial performance prepared in accordance with GAAP. Taxed cash earnings reconciles to GAAP income before taxes, as follows:
| | | | | | | | |
| | Fiscal Quarter Ended
|
| | March | | March |
| | 2004
| | 2003
|
Income before taxes as reported under GAAP | | $ | 2,121 | | | $ | 2,324 | |
Adjustments to reconcile GAAP income before taxes with taxed cash earnings: | | | | | | | | |
Amortization of purchased intangible assets | | | 2,931 | | | | 3,096 | |
Legal settlement, merger, restructuring and other costs | | | 133 | | | | (57 | ) |
| | | | | | | | |
Cash earnings before taxes | | | 5,185 | | | | 5,363 | |
Income tax at 39% | | | 2,022 | | | | 2,092 | |
| | | | | | | | |
Taxed cash earnings | | $ | 3,163 | | | $ | 3,271 | |
| | | | | | | | |
Taxed cash earnings per share: | | | | | | | | |
Basic | | $ | 0.06 | | | $ | 0.06 | |
| | | | | | | | |
Diluted | | $ | 0.06 | | | $ | 0.06 | |
| | | | | | | | |