thoratec news

Thoratec Reports Fiscal 2006 Results; Enrollment in HeartMate II(R) Trial More Than Doubles in Past Year, Surpassing 500 Patients; Destination Therapy Trial 75% Complete



PLEASANTON, Calif., Feb. 15 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, today reported financial results for fiscal 2006.

For the year ended December 30, 2006, Thoratec reported revenues of $214.1 million, a six percent increase over revenues of $201.7 million in fiscal 2005. Revenues for the fourth quarter of fiscal 2006 were $58.8 million, a seven percent increase over revenues of $54.8 million in the same period a year ago.

Net income on a GAAP basis in fiscal 2006 was $4.0 million, or $0.07 per diluted share, compared with net income of $13.2 million, or $0.26 per diluted share, in fiscal 2005. Non-GAAP net income, which is described later in this news release, was $20.4 million, or $0.38 per diluted share, in fiscal 2006 versus non-GAAP net income of $24.3 million, or $0.48 per diluted share, a year ago.

For the fourth quarter of fiscal 2006, net income on a GAAP basis was $3.1 million, or $0.06 per diluted share, compared with $4.5 million, or $0.08 per diluted share, in the same period a year ago. Non-GAAP net income for the fourth quarter of 2006 was $7.2 million, or $0.14 per diluted share, compared with non-GAAP net income of $8.9 million, or $0.16 per diluted share, in the same period a year ago.

The adoption of SFAS No. 123R negatively impacted GAAP earnings per share in the full year and fourth quarter of 2006 by $0.14 and $0.06 per share, respectively. Operating expenses for both periods in 2005 included $2.6 million and $2.0 million related to CEO transition expenses, respectively. In addition, operating expenses for all of fiscal 2006 include $1.1 million related to CEO transition expenses and $1.1 million in in-process research and development expenses related to our acquisition of A-VOX Systems, which occurred in the fourth quarter of 2006.

"Thoratec ended 2006 with meaningful revenue growth in both our VAD (Ventricular Assist Device) business and at our International Technidyne Corporation (ITC) division," noted Gary Burbach, president and chief executive officer of Thoratec. "In addition, we achieved some key milestones in our pivotal clinical trial for the HeartMate II, our next generation VAD," he continued.

"The quarter was highlighted by significant progress in our HeartMate II pivotal trial program. Trial enrollment has now surpassed 500 patients as we continued to experience a very active pace of enrollment, particularly in the Destination Therapy (DT) arm of the trial. We also completed the submission of our PreMarket Approval (PMA) seeking approval for bridge-to-transplantation (BTT) with the filing of the clinical summary and draft final labeling module," Burbach noted.

As of January 26, 2007, the company had enrolled 503 patients, an increase of 87 over the 416 patients enrolled three months ago, and an increase of 344 patients over the 159 patients enrolled at January 26, 2006.

The updated HeartMate II pivotal trial enrollment includes 250 patients enrolled in the BTT arm versus 220 three months ago, and 253 DT patients versus 196 three months ago. Of the DT patients, 151 are enrolled in the randomized portion of the trial, which means that enrollment is now at more than three-quarters of the 200 patient enrollment called for in the DT arm of the trial.

The increased pace of enrollment in the DT arm is a result of several factors, including the participation of new centers, continued progress with the company's Market Development group and the positive impact from the short-term gap that occurred in the fourth quarter while the company was awaiting approval for a new Continued Access Protocol for the bridge arm of the trial. Enrollment in the DT arm is expected to be completed prior to the commercial launch for BTT.

The full data set from the BTT arm of the pivotal trial will be presented at the upcoming meeting of the American College of Cardiology (ACC). The presentation by Dr. Leslie Miller of Washington Hospital Medical Center has been accepted for a late-breaking clinical trial session at 11:30 a.m., Central Standard Time, Tuesday, March 27. Thoratec will host a conference call with Dr. Miller, to discuss the data, at 11 a.m., Pacific Standard Time, Thursday, March 29.

Thoratec is also supporting a clinician-led trial that is designed to validate the data from a study in the United Kingdom regarding the recovery of the natural heart in advanced-stage chronic heart failure patients. The findings from the study were discussed in the November 2nd edition of the New England Journal of Medicine in an article authored by Dr. Emma Birks and Sir Professor Magdi Yacoub of Harefield Hospital. It indicated that 11 of 15 patients treated with a therapy combining the company's HeartMate VAD and certain drugs experienced recovery sufficient to allow the pump to be removed after an average of 320 days of support. The condition of these patients improved dramatically and the freedom from recurrence of heart failure was 89 percent four years after pump removal.

A number of leading clinicians and heart centers are participating in the U.S. trial, called HARPS, or Harefield Recovery Protocol Study. Initial patient enrollment in the trial is expected to occur in the first half of 2007.

"While we accomplished a great deal last year, 2007 will be an important one for the company as we await BTT approval for our HeartMate II," Burbach said. "We are putting the plans in place to drive a successful U.S. commercial launch of the HeartMate II, while continuing to execute on our market development initiatives, VAD product development activities and our distribution agreement with Levitronix."