FRAMINGHAM, Mass. and SYDNEY, April 29, 2013 /PRNewswire/ -- 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 Chief Executive Officer. "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 +1-480-629-9760.
A live webcast of the call will also be available at the Company's website (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 www.heartware.com.
HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of HeartWare, Inc.
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the commercial launch of the HeartWare® Ventricular Assist System in the U.S., continued support from international customers, progress of clinical trials and post-approval studies, regulatory status, research and development activities and commercialization strategies. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A. "Risk Factors" in HeartWare's Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A "Risk Factors" in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.
For further information:
HeartWare International, Inc.
Phone: +1 508 739 0864
- Tables to Follow-
HEARTWARE INTERNATIONAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)(unaudited)Three Months EndedMarch 31,20132012Revenue, net
$ 49,239$ 26,346Cost of revenue
30,45915,518Operating expenses:Selling, general and administrative
16,48812,716Research and development
22,14220,007Total operating expenses
38,63032,723Loss from operations
(8,171)(17,205)Other expense, net
$ (12,959)$ (18,845)Net loss per common share — basic and diluted
(1.33)Weighted average shares outstanding — basic and diluted
HEARTWARE INTERNATIONAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)
2012ASSETSCurrent assets:Cash and cash equivalents
$ 208,878$ 85,921Short-term investments, net
20,02016,887Accounts receivable, net
36,20838,443Prepaid expenses and other current assets
6,6425,925Total current assets
304,076172,401Property, plant and equipment, net
19,31119,380Other assets, net
$ 338,047$ 206,499LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable
$ 12,969$ 12,024Other accrued liabilities
17,21822,020Total current liabilities
30,18734,044Convertible senior notes, net
101,942100,315Other long-term liabilities
202,00368,211Total liabilities and stockholders' equity
$ 338,047$ 206,499
|SOURCE HeartWare International, Inc.|
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