HeartWare International, Inc. (HTWR)

[cjgaddy]

4-29-13: HTWR Q1/2013 Financials; Revs=$49.2mm, Up 87%; Cash=$228.9mm

HeartWare International Reports $49.2 Million In First Quarter 2013 Revenue; 87% Increase From First Quarter Of 2012
• U.S. Revenues of $26.2 million, from $6.4 million in First Quarter of 2012
• Reflecting First Complete Quarter of Commercialization in U.S.
• Conference call today at 5:00 p.m. U.S. E.T.
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1812562

FRAMINGHAM & SYDNEY, April 29, 2013: 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 $49.2 million for the first quarter ended March 31, 2013, an 87% increase compared to $26.4 million in revenue for the same period of 2012.

"Our results for the first 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) in November 2012, and continued strong support from our international customers," explained Doug Godshall, President and CEO. "During the first quarter of 2013, 482 HVAD® pumps were sold globally, an increase from 298 units in the first quarter of 2012 and more than our previous high quarterly total of 345 units in the fourth quarter of 2012."

During the first quarter of 2013, U.S. revenue, which reflects the Company's first full quarter of U.S. commercialization, was $26.2 million, an increase of approximately 300% from $6.4 million in the first quarter of 2012. Revenue from international markets, generated through the sale of 244 units, was $23.1 million, an increase of approximately 16% from $19.9 million in the first quarter of 2012. Currency fluctuations decreased revenue by approximately 25 basis points in the first quarter compared to the same period in 2012.

"It has been quite gratifying to see such strong interest from new hospital centers thus far in our commercial launch," added Mr. Godshall. "Our team has been working diligently to expedite the training of additional hospitals in the U.S., and in the five months since FDA approval, 27 new U.S. sites have been trained. In total, HeartWare now has more than 190 customers around the world."

Total operating expenses for the first quarter of 2013 were $38.6 million, as compared to $32.7 million in the first quarter of 2012.

Research and development expense was $22.1 million for the first quarter of 2013, as compared to $20.0 million in the same period of 2012. Development costs are primarily attributable to 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.

Selling, general and administrative expenses were $16.5 million in the first quarter of 2013, compared to $12.7 million in the first quarter of 2012. The increase in selling, general and administrative expenses reflects expansion of sales and marketing activities, particularly in the United States, an overall increase in corporate infrastructure to support the Company's rapid growth, and implementation of the 2.3% excise tax on the U.S. sales of certain medical devices which became effective January 1, 2013.

Net loss for the first quarter of 2013 was $13.0 million, or a $0.87 loss per basic and diluted share, compared to a $18.9 million net loss, or a loss of $1.33 per basic and diluted share, in the first quarter of 2012.

At March 31, 2013, the Company had $228.9 million of cash, cash equivalents and investments.

HeartWare will host a conference call on Monday, April 29, 2013 at 5:00 p.m., U.S. Eastern Daylight Time to discuss the Company's financial results, highlights from the first quarter and business outlook. The call may be accessed by dialing 1-877-941-4774 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial [phone].

A live webcast of the call will also be available at the Company's website ( http://www.heartware.com ) by selecting "HeartWare First Quarter 2013 Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.

ABOUT HEARTWARE INTERNATIONAL
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 30 international countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at http://www.heartware.com .