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HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
Date:11/3/2010

ghtened engineering, testing, document and related preparation costs associated with the planned bridge-to-transplant premarket approval application (PMA) submission to the FDA, together with increased expenditure on the Company's pipeline technologies.  Selling, general and administrative expenses were $7.0 million in the third quarter of 2010, with non-cash, share-based compensation charges contributing $1.8 million.  For the first nine months of 2010, total operating expenses were $40.8 million compared to $21.7 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 expected rising demand for the Company's products and the need to support clinicians in a larger number of centers.

Net loss for the third quarter of 2010 was $7.8 million, or a $0.57 loss per basic and diluted share, compared to a $5.9 million net loss, or a loss of $0.60 per basic and diluted share, in the third quarter of 2009.  For the nine months ended September 30, 2010, the Company recorded a net loss of $22.4 million, or a $1.66 loss per basic and diluted share, compared to a $19.0 million net loss, or a loss of $2.07 per basic and diluted share, in the first nine months of 2009.

"Today, nearly 700 advanced heart failure patients globally have received the HVAD® pump," added Mr. Godshall.  "Our current priorities include: preparation for the presentation of data from our U.S. bridge-to-transplant (BTT) study at the American Heart Association Scientific Sessions on November 14; compilation of preclinical, manufacturing and clinical data into a PMA submission to the FDA for BTT, which is targeted for year-end; initiation of all 50 sites in our destination therapy trial; and preparing the MVAD portfolio for Good Laboratory P
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SOURCE HeartWare International, Inc.
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