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HeartWare International Reports Fourth Quarter 2010 Revenues of $20.9 Million; 71% Increase From $12.2 Million In Fourth Quarter 2009
Date:2/24/2011

rth quarter of 2010, primarily attributable to costs associated with the Company's Pre-Market Approval (PMA) application, which was submitted to the FDA for a bridge-to-transplant indication in late December 2010, together with increased expenditure on HeartWare's pipeline technologies.  Selling, general and administrative expenses were $7.4 million in the fourth quarter of 2010.  For the full fiscal year of 2010, total operating expenses were $59.8 million compared to $31.5 million for the same period of 2009.  The increases described above also reflect ongoing expansion of commercialization activities in Europe and other countries outside the U.S., additional investment in HeartWare's technology pipeline and increased recruitment for key positions to meet rising demand for the Company's products and the need to support clinicians in a larger number of centers.

Net loss for the fourth quarter of 2010 was $7.0 million, or a $0.51 loss per basic and diluted share, compared to a $1.9 million net loss, or a loss of $0.17 per basic and diluted share, in the fourth quarter of 2009.  For the full fiscal year 2010, the Company recorded a net loss of $29.4 million, or a $2.17 loss per basic and diluted share, compared to a $20.9 million net loss, or a loss of $2.15 per basic and diluted share, in 2009.

"Today, nearly 900 advanced heart failure patients globally have received the HVAD® pump," added Mr. Godshall.  "Our current priorities include: working to obtain FDA approval for our PMA submission for BTT; initiation of all 50 sites in our destination therapy trial; expanding our international footprint and preparing our next generation, miniaturized MVAD® pump for Good Laboratory Practice (GLP) animal studies, which are expected to commence this quarter."

At December 31, 2010, the Company's balance sheet showed $217.5 million in cash, cash equivalents and investments.  This compares to approximately $50.8 millio
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SOURCE HeartWare International, Inc.
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