FRAMINGHAM, Mass., Nov. 7, 2013 /PRNewswire/ -- 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 $54.8 million for the third quarter ended September 30, 2013, a 140% increase compared to $22.9 million in revenue for the same period of 2012.
"During the third quarter, 549 HeartWare® Ventricular Assist Systems were sold globally, an increase from 256 units in the third quarter of 2012 and more than our previous high quarterly total of 523 units in the second quarter of 2013," said Doug Godshall, President and Chief Executive Officer. "Our results for the third quarter reflect continued positive trends in the commercial launch of the HeartWare® System in the U.S., following approval from Food and Drug Administration (FDA) late last year, as well as continued strong support from our international customers."
During the third quarter of 2013, U.S. revenue, which reflects the company's third full quarter of U.S. commercialization, was $28.2 million, a significant increase from $3.6 million in the third quarter of 2012. Revenue from international markets, generated through the sale of 287 units, was $26.6 million, an increase of approximately 38% from $19.3 million in the third quarter of 2012.
"Our strong commercial growth was complemented by advances made in clinical development, as we received full protocol approval from FDA for a supplemental patient cohort to our destination therapy trial and commenced enrollment last month," added Mr. Godshall. "We also remain on track for initiation of first-in-human testing of our next generation MVAD® pump, with Pal™ controller, early next year."
For the nine months ended September 30, 2013, revenue increased approximately 98% to $154.9 million, compared to $78.3 million in the first nine months of 2012.
Currency fluctuations benefitted revenue growth by 5.7% and 1.7%, respectively, in the three and nine months ended September 30, 2013 compared to the same periods in 2012.
Total operating expenses for the third quarter of 2013 were $45.8 million, as compared to $35.2 million in the third quarter of 2012.
Research and development expense was $25.9 million for the third quarter of 2013, as compared to $21.4 million in the same period of 2012. Development costs are primarily attributable to clinical trials and research and development related to advancing HeartWare's existing products and pipeline technologies.
Selling, general and administrative expenses were $19.8 million in the third quarter of 2013, compared to $13.8 million in the third quarter of 2012. The increase in selling, general and administrative expenses reflects expansion of sales and marketing activities, particularly in the U.S., an overall increase in corporate infrastructure to support the company's significant growth, and the effect of the 2.3% excise tax on the U.S. sales of medical devices which became effective January 1, 2013.
Net loss for the third quarter of 2013 was $11.4 million, or a $0.69 loss per basic and diluted share, compared to a $25.0 million net loss, or a loss of $1.75 per basic and diluted share, in the third quarter of 2012. For the nine months ended September 30, 2013, the company recorded a net loss of $37.3 million, or a $2.34 loss per basic and diluted share, compared to a $66.6 million net loss, or a loss of $4.70 per basic and diluted share, in the first nine months of 2012.
At September 30, 2013, the company had $225.0 million of cash, cash equivalents and investments, reflecting a modest net cash increase from June 30, 2013, when the company had $222.4 million of cash, cash equivalents and investments.
During the third quarter of 2013, the company generated positive cash flows from operations, a historic first-time milestone for the company.
HeartWare will host a conference call on Thursday, November 7, 2013 at 8:00 a.m., U.S. Eastern Standard Time to discuss the company's financial results, highlights from the third quarter and business outlook. The call may be accessed by dialing 1-877-941-8418 five minutes prior to the scheduled start time and referencing "HeartWare." Callers outside the U.S. should dial +1-480-629-9809.
A live webcast of the call will also be available in the Investor section of the company's website (http://ir.heartware.com/). 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 36 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.
HEARTWARE, HVAD, MVAD, PAL 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 EndedSeptember 30,Nine Months EndedSeptember 30,2013201220132012Revenue, net
78,261Cost of revenue
35,27111,93797,70043,843Operating expenses:Selling, general and administrative
19,84413,76853,54840,687Research and development
25,93021,37972,20161,392Total operating expenses
45,77435,147125,749102,079Loss from operations
(10,503)(23,210)(28,049)(58,236)Other expense, net
(24,986)$ (37,263)$ (66,613)Net loss per common share — basic and diluted
(4.70)Weighted average shares outstanding — basic and diluted
16,43914,27415,89514,185HEARTWARE INTERNATIONAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)
2012ASSETSCurrent assets:Cash and cash equivalents
35,87516,887Accounts receivable, net
37,88338,443Prepaid expenses and other current assets
11,5115,925Total current assets
303,480172,401Property, plant and equipment, net
16,31219,380Other assets, net
206,499LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable
2,024Other accrued liabilities
25,69422,020Total current liabilities
34,97434,044Convertible senior notes, net
105,345100,315Other long-term liabilities
191,94568,211Total liabilities and stockholders' equity
|SOURCE HeartWare International, Inc.|
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