HeartWare International, Inc. (HTWR)

[cjgaddy]

5-1-14: HTWR’s Q1 Financials – revs=$66.5MM, 665 HVAD’s worldwide, now over 5,000 HVAD implants…

5-1-14: HeartWare Reports $66.5mm In Q1/’14 Revenue; 35% Increase From Q1/’13
- Record 665 HeartWare Ventricular Assist Systems sold worldwide in Q1; exceeds previous quarterly high of 549 units
- U.S. revenue of $33.8 million, 29% growth from first quarter 2013
- International revenue of $32.7 million, 42% growth from first quarter 2013
- Conference call today at 8:00 a.m. U.S. EDT

http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1924745
FRAMINGHAM, Mass, May 1, 2014: HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $66.5 million for the first quarter ended March 31, 2014, a 35% increase compared to $49.2 million in revenue for the same period of 2013.

During the first quarter, 665 HeartWare® Ventricular Assist Systems were sold globally, a 38% increase from 482 units in the first quarter of 2013. U.S. revenue during the first quarter of 2014 was $33.8 million, a 29% increase from $26.2 million in the first quarter of 2013. Revenue from international markets, generated through the sale of 352 units, was $32.7 million, an increase of 42% from $23.1 million in the first quarter of 2013.

"Reflecting expanded global adoption, our team generated sales of more than 300 units in both the U.S. as well as international markets, for the first time in our history," said Doug Godshall, President and CEO. "We continue to see enthusiastic support of the HeartWare® System around the world, with the addition of 12 international and 5 U.S. customers during the first quarter, increasing our global customer base to nearly 250 hospitals."

"During the quarter, we continued to make investments in clinical trials related to the ongoing HVAD® destination therapy study, recently initiated Japan trial and upcoming MVAD® CE Mark studies," noted Mr. Godshall. "Additionally, enrollment in our supplemental destination therapy study in the U.S. continues to gain momentum, with 48 sites receiving Institutional Review Board approval and more than 80 patients currently enrolled."

Currency fluctuations benefitted revenue growth by approximately 2% in the first quarter in 2014, as compared to the same period in 2013.

Gross margin percentage improved to 65.5% in the first quarter of 2014 compared to 61.9% in the first quarter of 2013, reflecting efficiencies associated with increased manufacturing throughput. Total operating expenses for the first quarter of 2014 were $60.0 million, as compared to $38.6 million in the first quarter of 2013.

Research and development expense was $32.6 million for the first quarter of 2014, as compared to $22.1 million in the same period of 2013. Increased development costs are primarily attributable to the addition of a full quarter of expenses from CircuLite, which was acquired by HeartWare in December 2013, as well as preparations for human clinical testing for MVAD and associated peripherals and increasing clinical activity.

Selling, general and administrative expenses were $24.2 million in the first quarter of 2014, compared to $16.5 million in the first quarter of 2013. The increase in selling, general and administrative expenses reflects a full quarter of CircuLite expenses, the expansion of sales and marketing activities, increased employee expenses and other administrative expenses.

Net loss for the first quarter of 2014 was $19.4 million, or a $1.15 loss per basic and diluted share, compared to a $13.0 million net loss, or a loss of $0.87 per basic and diluted share, in the first quarter of 2013. Net loss decreased on a sequential quarter basis, from a net loss in the fourth quarter of 2013 of $22.0 million. The first quarter results included CircuLite's operations, as well as approximately $7.5 million of acquisition and restructuring related costs as set forth in this release under "Reconciliation of GAAP to Non-GAAP Net Loss per Common Share."

Non-GAAP net loss per share for the first quarter of 2014 was $0.70 per basic and diluted share, compared to a loss of $0.87 per basic and diluted share in the first quarter of 2013. See "Use of Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Net Loss per Common Share."

At March 31, 2014, HeartWare had $181 million of cash, cash equivalents and investments.