HeartWare International, Inc. (HTWR)

[cjgaddy]

4-30-15: HTWR Q1/Fins q/e3-31-15 Revs=$70mm

HeartWare International Reports $70.0mm In Q1/2015 Revenue
• 713 HeartWare® Systems sold worldwide in Q1/2015
• U.S. revenue increased 25% over Q1/2014 to $42.2mm
• Intl. revenue of $27.8mm; reflects unfavorable currency trends
• Next-gen. MVAD® System targeted for 1st clinical use in Q2 2015
• Conference call today at 8:00amET
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=2042157

FRAMINGHAM, April 30, 2015: HeartWare Intl. (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 $70.0mm for Q1 ended March 31, 2015, a 5% increase compared to $66.5mm in revenue for the same period of 2014. Currency fluctuations negatively impacted total revenue growth by approx. $5mm, or nearly 8%, in the Q1/15, as compared to the same period in 2014.

"Continued U.S. commercial expansion drove the second-largest unit sales quarter for HeartWare, although year-over-year U.S. growth was offset by a decrease in intl. unit sales when compared to the exceptionally strong intl. sales we achieved in Q1/14," said Doug Godshall, President and CEO. "We continue to see enthusiastic support of the HeartWare® System around the world, with the addition of 6 intl. and 5 U.S. customers during Q1, which increases our global customer base to more than 280 hospitals."

During Q1/15, 713 HeartWare® Ventricular Assist Systems were sold globally, which represents a 7% increase from 665 units sold in Q1/2014. During the quarter, U.S. revenue, generated through the sale of 381 units, was $42.2mm, a 25% increase from $33.8mm in Q1/2014. Revenue from international markets was $27.8mm, a decrease of 15% from $32.7mm in Q1/2014, while intl. unit sales decreased 6% to 332 units in Q1/15. Intl. unit sales decreased primarily in distributor territories, which have a greater tendency to fluctuate on a quarterly basis.

"During the quarter, we continued to advance our clinical trials for the HVAD System, with enrollment in the supplemental destination therapy study nearing completion; follow-up concluded for our Japan clinical trial; and commencement of HVAD LATERAL, a trial designed to evaluate a less-invasive thoracotomy implant technique," noted Mr. Godshall. "Regarding our pipeline, we recently completed training with investigators and are eager to commence first implants in the CE Mark study for our next-generation MVAD System later this quarter, and we plan to submit our Investigational Device Exemption protocol to FDA for review in the coming weeks."
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GM% improved to 68.5% in Q1/2015, compared to 65.5% in Q1/2014, reflecting lower cost of goods and efficiencies associated with increased mfg.
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Net loss for Q1/2015 was $14.5mm, or $.85 per basic & diluted share, compared to a net loss of $19.4mm, or $1.15 for Q1/2014.
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At 3-31-15, HeartWare had ~ $174mm of cash, cash equivalents and investments, compared to $180mm at 12-31-14. . .