For the quarter ended Sept. 30, HeartWare posted a net loss of $7.4 million, or -43¢ a share, down from a loss of $11.4 million, or -69¢ a share, for the same quarter in 2013. Excluding 1-time items, HeartWare would have posted a loss of -64¢ a share, versus 69¢ in Q3 2013.
Revenue for the quarter shot up 25% to $68.6 million, from $54.8 million in the year-ago period. U.S. sales rose to $39.1 million, up from $28.2 million last year.
"On top of our strong commercial results, we advanced our clinical initiatives, including preparing our request to commence a CE Mark study of our next-generation MVAD system, which we expect to submit for regulatory review later this year or in early 2015," CEO Doug Godshall said in a statement.
“For the HVAD system, we also completed enrollment in our Japan study during the quarter, advanced enrollment in our U.S. destination therapy study and are finalizing plans to initiate a U.S. IDE study for the thoracotomy implant technique later this year," Godshall added.
Godshall also said the company remains "focused" on addressing issues raised by FDA inspectors during a recent tour of its Miami Lakes, Fla., facility.
The FDA issued HeartWare a warning letter in June, citing various violations at the Florida plant and concerns about the company’s quality control practices.
HTWR shares closed down 11.5% at $75.02 each yesterday.