HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $32.7 million for the fourth quarter ended December 31, 2012, a 42% increase compared to $23.1 million in revenue for the same period of 2011. For the fiscal year 2012, the Company generated revenue of $110.9 million, a 34% increase compared to revenue of $82.8 million in the fiscal year 2011.
"Our results for the fourth quarter reflect positive initial trends in the commercial launch of the HeartWare® Ventricular Assist System in the U.S., following approval from the Food and Drug Administration (FDA) on November 20, 2012, and continued strong support from our international customers," explained Doug Godshall , President and Chief Executive Officer. "Today, more than 3,000 advanced heart failure patients globally have received the HeartWare® System."
During the fourth quarter of 2012, revenue from international markets increased approximately 31% to $19.3 million, from $14.7 million in the fourth quarter of 2011. U.S. revenue, which reflects FDA approval late in the year, was $13.4 million in the fourth quarter of 2012, an increase of 60% from $8.4 million in the fourth quarter of 2011. Currency fluctuations decreased revenue by 1 percent in the fourth quarter compared to the same period in 2011.
For the year ended December 31, 2012, revenue increased approximately 34% to $110.9 million, compared to $82.8 million in 2011, supported by 53% commercial revenue growth internationally. Currency fluctuations decreased revenue by 6 percent compared to the same period in 2011.
"With 345 HVAD® pumps sold during the fourth quarter, the largest number in any quarter to date, the total number of pumps sold in 2012 was 1,217, compared to 932 pumps sold in 2011," added Mr. Godshall. "Our team has been working diligently to expedite the training of additional hospitals in the U.S., and since FDA approval 18 new U.S. sites have been trained, with 2 more in training this week."
Total operating expenses for the fourth quarter of 2012 were $35.4 million, as compared to $30.8 million in the same period of 2011.
Research and development expense was $22.2 million for the fourth quarter of 2012, as compared to $17.9 million in the same period of 2011. Increased development costs are a result of continuing clinical trial costs and research and development costs related to advancing HeartWare's pipeline technologies, including the MVAD® platform and a fully implantable system, as well as other early research initiatives.