HeartWare’s Increased Losses Signal Investment As Revenue Ramps

In short

Earlier this week we announced HeartWare international Inc.’s acquisition of competitor World Heart. It seems the company is in aggressive investment mode as its second quarter figures confirm a significant sales ramp accompanied by an even more significant cost hike  as it strives to occupy the Ventricular Assist space.

The company has announced revenue of $29.1 million for the second quarter ended June 30, 2012, representing a 42 percent increase from $20.4 million in revenue for the same period of 2011. However the company recorded a net loss more than double prior year as it invested in R&D and commercialisation activity.

Background

Revenue from international markets increased to $24.9 million in the second quarter of 2012, from $14.1 million in the second quarter of 2011, a 76 percent increase.  Changes in foreign currency rates unfavourably impacted revenue by approximately $1.9 million in the second quarter of 2012, compared to the second quarter of 2011.

Total operating expenses for the second quarter of 2012 were $34.2 million, as compared to $20.2 million in the same period of 2011. Underlying this number, R&D costs virtually doubled to $20 million, primarily attributable to continuing clinical trial costs and research and development costs related to advancing HeartWare’s pipeline technologies.

In addition, selling, general and administrative expenses increased from $9.9 million to $14.2 million as a result of a higher volume of OUS commercial activity and an enhanced corporate infrastructure to support overall growth and anticipated commercialization in the U.S.

So, net loss for the second quarter of 2012 was $22.8 million, compared to a $10.1 million net loss in the second quarter of 2011.

Company comments

“During the second quarter, we generated global sales for the HeartWare® Ventricular Assist System of 318 units, up from 226 units in the second quarter of 2011.  International markets accounted for 276 units sold and approximately 86 percent of our 2012 second quarter revenue, reflecting strong support of our 100 customer sites in 26 countries,” stated Doug Godshall, President and Chief Executive Officer.  “Following the positive recommendation of the Circulatory System Devices Advisory Committee in April, we have been focused on working with the FDA as it finalizes its review of our Premarket Approval (PMA) application for U.S. commercialization of the HeartWare Ventricular Assist System as a bridge to heart transplantation.

“In May, we announced the early completion of enrollment in our 450-patient ENDURANCE Destination Therapy study, resulting in an expected gap in U.S. clinical enrollment in the second quarter.  As we proceed through the two-year patient follow-up period for the trial, we have requested a Continued Access Protocol allocation for destination therapy from the FDA,” added Mr. Godshall.  “Our second quarter results also reflect increased investment in our technology pipeline, particularly our MVAD®System for which human clinical testing is expected this year, as well as ramping of personnel in anticipation of expanded commercialization.”

Source: Heartware International, Inc., PR Newswire