Results for all periods exclude the impact of Thoratec's divestiture of its International Technidyne Corp. division, completed in November 2010.
For the quarter ended Oct. 1, 2011, Thoratec reported net income on a Generally Accepted Accounting Principles (GAAP) basis of $19.0 million, or $0.31 per diluted share, versus GAAP net income of $15.5 million, or $0.26 per diluted share, in the same period a year ago. Non-GAAP net income was $25.1 million, or $0.41 per diluted share, in the third quarter of 2011, versus non-GAAP net income of $20.8 million, or $0.32 per diluted share, in the third quarter a year ago.
For the first nine months of fiscal 2011, revenues were $313.3 million, an increase of 10% over revenues of $285.4 million in the same period a year ago. On a GAAP basis, Thoratec reported net income of $57.2 million, or $0.95 per diluted share, for the first nine months of 2011. For the first nine months of 2010, the company reported GAAP net income of $46.4 million, or $0.78 per diluted share. Non-GAAP net income in the first nine months of 2011 was $74.3 million, or $1.18 per diluted share, compared with non-GAAP net income of $61.7 million, or $0.95 per diluted share, in the first nine months of 2010.
"Thoratec had a solid third quarter, generating double-digit growth in pump unit sales year-over-year in both the U.S. and international markets," said Gary F. Burbach, president and chief executive officer of Thoratec. "We continue to benefit from increased adoption of mechanical circulatory support, as well as the market leadership position of the HeartMate II LVAS (Left Ventricular Assist System)."
"We also experienced a strong quarter with respect to new center development, as we added eight HeartMate II centers globally, including six in the U.S. and two internationally," he added. "As of the end of the third quarter, we had 280 HeartMate II centers worldwide, including 141 in the U.S. and 139 internationally, versus a total of 254 at the end of fiscal 2010."
"Our continued growth is being facilitated by our market development and clinical education programs," he continued. "In addition, the ongoing flow of data is demonstrating compelling long-term outcomes in HeartMate II patients, including data published recently in leading peer-reviewed journals."
One of the recent data publications, which appeared in the October edition of The Annals of Thoracic Surgery, compared outcomes from nearly 1,500 commercial bridge-to-transplantation (BTT) HeartMate II patients with those of nearly 500 patients who participated in the HeartMate II BTT clinical trial.
The findings included Kaplan-Meier survival of 89% at six months and 85% at one year for commercial patients. In addition, commercial patients experienced declines in most adverse events versus patients in the trial, with catastrophic events such as device replacement and stroke occurring in just 1% and 6% of patients, respectively.
"This dataset demonstrates excellent and improving outcomes for HeartMate II patients in a real-world setting among a broad range of implanting centers," Burbach noted.