HeartWare International Reports Fourth Quarter Revenues of $12.2 Million; Full Year 2009 Revenues of $24.2 Million

FRAMINGHAM, Mass. and SYDNEY, Feb. 22 /PRNewswire-FirstCall/ -- 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 $12.2 million for the fourth quarter ended December 31, 2009.  This compares to $7.5 million in revenues for the third quarter ended September 30, 2009.  For the 2009 fiscal year, the Company reported $24.2 million in revenues, compared with $332,000 in 2008.

"Since our first international commercial sale in March 2009, we have continued to receive positive physician feedback -- both in approved international markets, where physician acceptance continues to build, and also in the U.S., where the pace of enrollment in our clinical study accelerated toward year end," explained HeartWare President and Chief Executive Officer Doug Godshall.  "Today we have 20 sites implanting the HeartWare HVAD pumps internationally and, importantly, our U.S. bridge-to-transplant trial recently completed enrollment, paving the way for a submission to the FDA for pre-market approval in the second half of this year."

Total operating expenses for the fourth quarter of 2009 were $9.8 million, as compared to $6.8 million in the prior year period.  For the 2009 year, total operating expenses were $31.5 million compared to $29.6 million in 2008.  The increases reflect expansion of commercialization activities in Europe following the receipt of CE Marking in January 2009, non-recurring costs associated with the terminated Thoratec merger, additional expenditure on the Company's technology pipeline and the expansion of the Company's U.S. clinical trial.

Net loss for the fourth quarter of 2009 was $1.9 million, or a $0.17 loss per basic and diluted share, compared to a $3.9 million net loss, or a loss of $0.44 per basic and diluted share, in the fourth quarter of 2008.  For the 2009 year, net loss was $20.9 million, or a loss of $2.15 per basic and diluted share, compared to a $23.8 million net loss, or a loss of $3.00 per basic and diluted share, in 2008.

"To capitalize on strong growth prospects for the HVAD pump, we are investing in additional marketing and customer support infrastructure in international markets and domestically, as well as other key areas such as reimbursement and patient outcome management," added Mr. Godshall.  "Importantly, we are also now in a position to strongly advance the development of a broad array of technologies in our pipeline portfolio given the completion of a $62 million public offering earlier this month."

At December 31, 2009, the Company's balance sheet reflected $50.8 million in cash and cash equivalents, which does not include the proceeds from the February 2010 public offering.  This compares to approximately $20.8 million in cash and cash equivalents at December 31, 2008.  

The Company will host a conference call on Tuesday, February 23, 2010 at 8:00 a.m. U.S. Eastern time (being 12:00 a.m. Australian Eastern Daylight Time between February 23 and 24, 2010) to discuss its fourth quarter and full year 2009 results.  The call may be accessed by dialing 1-877-407-9039 five minutes prior to the scheduled start time and referencing "HeartWare."  For callers outside the United States, dial +1-201-689-8470. Doug Godshall, Chief Executive Officer, President and Executive Director, and David McIntyre, Chief Financial Officer and Chief Operating Officer, will host the conference call.

A live web cast of the call will also be available at the Company's website (www.heartware.com) by selecting "Q4 2009 HeartWare International Earnings 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 and Class 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 a United States clinical trial for a bridge-to-transplant indication. For additional information, please visit the company's website at www.heartware.com.

HeartWare International, Inc. is a member of the Russell 2000(R) and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.

Forward-Looking Statements

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 progress of clinical trials. 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 "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, or other current reports, as filed with the Securities and Exchange Commission.  

    
    
                                - 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,
                                 ------------       ----------------------
                               2009        2008        2009        2008
                               ----        ----        ----        ----
    Revenues, net           $12,219        $244     $24,172        $332
    Cost of revenues          6,809          78      13,211          78
                              -----         ---      ------         ---
    Gross profit              5,410         166      10,961         254
    
    Operating expenses:
    Selling, general and 
     administrative expenses  4,723       2,988      16,444      10,981
    Research and
     development expenses     5,073       3,842      15,067      18,644
                              -----       -----      ------      ------
    Total operating
     expenses                 9,796       6,830      31,511      29,625
    
    Loss from operations     (4,386)     (6,664)    (20,550)    (29,371)
    
    Other income (expense)    2,475       2,738        (359)      5,607
                              -----       -----        ----       -----
    
    Net loss                $(1,911)    $(3,926)   $(20,909)   $(23,764)
                            =======     =======    ========    ========
    
    Net loss per common
     share - basic and
     diluted                 $(0.17)     $(0.44)     $(2.15)     $(3.00)
                             ======      ======      ======      ======
    
    Weighted average
     shares outstanding -
     basic and diluted   11,369,289   8,866,702   9,713,925   7,929,054
                         ==========   =========   =========   =========
    
    

    
    
    
                          HEARTWARE INTERNATIONAL, INC.
                     CONDENSED CONSOLIDATED BALANCE SHEETS
                                 (in thousands)
                                   (unaudited)
    
                                                  December 31,  December 31,
                                                     2009          2008
                                                   ---------     ---------
    ASSETS
    Current assets:
      Cash and cash equivalents                      $50,835       $20,804
      Accounts receivable                             11,385           244
      Inventories, net                                 8,871         3,508
      Prepaid expenses and other current assets        1,663         1,062
                                                       -----         -----
        Total current assets                          72,754        25,618
    Property, plant and equipment, net                 3,719         3,609
    Other intangible assets, net                       1,192           823
    Restricted cash                                      288           288
                                                         ---           ---
        Total assets                                 $77,953       $30,338
                                                     =======       =======
    
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
      Accounts payable                                $3,122          $699
      Accrued expenses and other current liabilities   3,848         2,883
                                                       -----         -----
        Total current liabilities                      6,970         3,582
    Commitments and contingencies
    Stockholders' equity                              70,983        26,756
                                                      ------        ------
        Total liabilities and stockholders' equity   $77,953       $30,338
                                                     =======       =======
    
    

SOURCE HeartWare International, Inc.