Navigation Links
HeartWare International Reports Fourth Quarter 2010 Revenues of $20.9 Million; 71% Increase From $12.2 Million In Fourth Quarter 2009

FRAMINGHAM, Mass. and SYDNEY, Feb. 24, 2011 /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 revenues of $20.9 million for the fourth quarter ended December 31, 2010.  This compares to $12.2 million in revenues for the fourth quarter of 2009, and revenues of $13.8 million in the third quarter of 2010.  For the 2010 fiscal year, the Company generated revenues of $55.2 million, compared with $24.2 million in 2009.

"Our results for 2010 reflect increasing demand throughout the year, particularly in the fourth quarter during which we saw the largest number of units sold – 236 pumps worldwide – of the HeartWare® Ventricular Assist System in any quarter to date," explained Doug Godshall, President and Chief Executive Officer.  "The international markets accounted for approximately 69 percent of our revenues for the quarter, as we have increased the number of implanting sites to 47 hospitals, from only 16 at the start of 2010.

"In the U.S., the rate of implant procedures remained variable, as hospital sites went through the re-initiation process to participate in the second allotment of 54 patients granted by the Food and Drug Administration (FDA) in September under the Continued Access Protocol (CAP) for our bridge-to-transplant clinical study," Mr. Godshall added.  "In our 450-patient destination therapy study, we now have 30 of the planned 50 U.S. sites approved for implantation, and 78 patients have been randomized and enrolled in the study to date."

Total operating expenses for the fourth quarter of 2010 were $18.9 million, compared to $9.8 million in the prior year period.  Research and development expense was $11.5 million for the fourth quarter of 2010, primarily attributable to costs associated with the Company's Pre-Market Approval (PMA) application, which was submitted to the FDA for a bridge-to-transplant indication in late December 2010, together with increased expenditure on HeartWare's pipeline technologies.  Selling, general and administrative expenses were $7.4 million in the fourth quarter of 2010.  For the full fiscal year of 2010, total operating expenses were $59.8 million compared to $31.5 million for the same period of 2009.  The increases described above also reflect ongoing expansion of commercialization activities in Europe and other countries outside the U.S., additional investment in HeartWare's technology pipeline and increased recruitment for key positions to meet rising demand for the Company's products and the need to support clinicians in a larger number of centers.

Net loss for the fourth quarter of 2010 was $7.0 million, or a $0.51 loss per basic and diluted share, compared to a $1.9 million net loss, or a loss of $0.17 per basic and diluted share, in the fourth quarter of 2009.  For the full fiscal year 2010, the Company recorded a net loss of $29.4 million, or a $2.17 loss per basic and diluted share, compared to a $20.9 million net loss, or a loss of $2.15 per basic and diluted share, in 2009.

"Today, nearly 900 advanced heart failure patients globally have received the HVAD® pump," added Mr. Godshall.  "Our current priorities include: working to obtain FDA approval for our PMA submission for BTT; initiation of all 50 sites in our destination therapy trial; expanding our international footprint and preparing our next generation, miniaturized MVAD® pump for Good Laboratory Practice (GLP) animal studies, which are expected to commence this quarter."

At December 31, 2010, the Company's balance sheet showed $217.5 million in cash, cash equivalents and investments.  This compares to approximately $50.8 million in cash and cash equivalents at December 31, 2009, and reflects incorporation of proceeds from the Company's common stock and convertible notes public offerings in 2010.

HeartWare will host a conference call on Thursday, February 24, 2011 at 8:00 a.m. U.S. Eastern Standard Time (being midnight Australian Eastern Daylight Time, between February 24 and February 25, 2011) to discuss the Company's financial results, highlights from the quarter and full year, and business outlook.  The call may be accessed by dialing 1-877-941-2322 five minutes prior to the scheduled start time and referencing "HeartWare."  For callers outside the United States, dial +1-480-629-9715.  Doug Godshall, President and Chief Executive Officer and David McIntyre, Chief Financial Officer and Chief Operating Officer, will host the conference call.

A live webcast of the call will also be available at the Company's website ( by selecting "HeartWare Fourth Quarter 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 InternationalHeartWare 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-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  HeartWare has received CE Marking for the HeartWare System in the European Union.  The device is currently the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy.  For additional information, please visit

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.

Forward-Looking StatementsThis 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 timing and progress of, and presentation of data related to, clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities. 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, the possibility the FDA does not accept our PMA application or approve the marketing of the HeartWare® Ventricular Assist System in the U.S., and those described in "Item 1A. Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission.  We may update our risk factors from time to time in "Part II, Item 1A "Risk Factors" in our Quarterly Reports on Form 10-Q, Form 8-K, or other current reports, as filed with the Securities and Exchange Commission.For further information:Christopher TaylorHeartWare International, Inc.Email: ctaylor@heartwareinc.comPhone: +1 508 739 0864- Tables to Follow-HEARTWARE INTERNATIONAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share data)(unaudited)Three Months Ended December 31, Year Ended December 31, 2010200920102009Revenues, net$   20,887$
24,172Cost of revenues8,4656,80924,44113,211Gross profit12,4225,41030,72310,961Operating expenses:Selling, general and administrative7,4044,72326,64216,444Research and development11,5285,07333,10815,067Total operating expenses18,9329,79659,75031,511Loss from operations(6,510)(4,386)(29,027)(20,550)Other income (expense), net(516)2,475(370)(359)Net loss$
(1,911)$  (29,397)$  (20,909)Net loss per common share - basic and diluted$
(2.15)Weighted average shares outstanding - basic and diluted13,873,54711,369,28913,569,8769,713,925HEARTWARE INTERNATIONAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited)December 31, 2010December 31, 2009ASSETSCurrent assets:Cash and cash equivalents $
50,835Short-term investments, net21,330—Accounts receivable, net19,05311,385Inventories, net15,0778,871Prepaid expenses and other current assets2,4061,663Total current assets250,01472,754Property, plant and equipment, net7,4843,719Other intangible assets, net1,5961,192Long-term investments, net4,006—Deferred financing costs, net2,939—Restricted cash1,538288Total assets$
77,953LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable$
3,122Accrued expenses and other current liabilities7,0013,848Total current liabilities10,8916,970Convertible senior notes, net88,922—Stockholders' equity167,76470,983Total liabilities and stockholders' equity$

SOURCE HeartWare International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
2. HeartWare to Present at the 29th Annual J.P. Morgan Healthcare Conference
3. HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
4. HeartWare International, Inc. Announces Completion of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
5. HeartWare International, Inc. Announces Pricing of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
6. HeartWare International, Inc. Announces Concurrent Public Offerings of Convertible Senior Notes and Common Stock
7. HeartWare to Present at the Canaccord Genuity Cardio/Diabetes & Obesity Conference
8. HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial, ADVANCE
9. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
10. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
11. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
Post Your Comments:
(Date:5/26/2016)... 26, 2016 A key trend ... the emergence of new treatments. Cardax, a development stage ... treatment. The therapy is expected to fulfil large unmet ... is conducting studies to develop new treatments for osteoarthritis. ... genes involved in osteoarthritis are being investigated, and early ...
(Date:5/25/2016)... PUNE, India , May 25, 2016 ... "Medical Animation Market by Type (3D, 2D, 4D), by ... Patient Education), by End User (Medical Device Manufacturers, Hospitals/ ... report studies the global Medical Animation Market for the ... expected to reach USD 301.3 Million by 2021 from ...
(Date:5/25/2016)... NEW YORK , May 25, 2016 ... Device Market Size, Share, Development, Growth and Demand Forecast ... Insulin Syringe, Insulin Pump and Others)" published by P&S ... valued at $9,998.3 million in 2015, and it is ... 2016-2022. Based on type, the insulin pump segment is ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... With a ... medical and food industries. Aside from its GMP accreditation, Validation Center is also ... successfully certified products, services and staff. , Validation Center is ISO17025 accredited and ...
(Date:5/26/2016)... ... ... There are many ways to cook a hot dog, but new research ... their dogs straight off the grill. Of the 90 percent of Americans who say ... a hot dog, far outpacing other cooking methods such as steaming (12 percent), microwaving ...
(Date:5/26/2016)... California (PRWEB) , ... May 26, 2016 , ... ... associated with discovery of thousands of defective respirators, according to court documents and ... the case of William and Becky Tyler v. American Optical Corporation, Case No. ...
(Date:5/26/2016)... ... May 26, 2016 , ... Georgia State University College of ... programs. , Answering to the increasing demand for curricular specializations, the Certificate in ... environmental and land use law. ,  , “The demand for lawyers with specific ...
(Date:5/26/2016)... ... ... On Memorial Day, Hope For Heroes and USA Medical Card ... the country. The nonprofit Hope For Heroes partnered with the leading provider of ... disabled military veterans, as well as police, firemen, and EMS professionals across the country, ...
Breaking Medicine News(10 mins):