HeartWare International Reports Fourth Quarter 2012 Revenue Of $32.7 Million; Full Year 2012 Revenue Of $110.9 Million

HeartWare International Reports Fourth Quarter 2012 Revenue Of $32.7 Million;
                   Full Year 2012 Revenue Of $110.9 Million

- Fourth Quarter 2012 U.S. Revenue of $13.4 Million; 60% Increase from Fourth
Quarter 2011; Reflects FDA Approval and First Month of Commercialization in
U.S. -

- Globally more than 3,000 advanced heart failure patients have received the
HeartWare® System -

- Conference call today at 8:30 a.m. U.S. E.T. -

PR Newswire

FRAMINGHAM, Mass. and SYDNEY, Feb. 27, 2013

FRAMINGHAM, Mass. and SYDNEY, Feb. 27, 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 $32.7 million for the fourth quarter ended December 31, 2012, a 42%
increase compared to $23.1 million in revenue for the same period of 2011. 
For the fiscal year 2012, the Company generated revenue of $110.9 million, a
34% increase compared to revenue of $82.8 million in the fiscal year 2011. 

"Our results for the fourth 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) on November 20,
2012, and continued strong support from our international customers,"
explained Doug Godshall, President and Chief Executive Officer.  "Today, more
than 3,000 advanced heart failure patients globally have received the
HeartWare^® System."

During the fourth quarter of 2012, revenue from international markets
increased approximately 31% to $19.3 million, from $14.7 million in the fourth
quarter of 2011.  U.S. revenue, which reflects FDA approval late in the year,
was $13.4 million in the fourth quarter of 2012, an increase of 60% from $8.4
million in the fourth quarter of 2011.  Currency fluctuations decreased
revenue by 1 percent in the fourth quarter compared to the same period in
2011.

For the year ended December 31, 2012, revenue increased approximately 34% to
$110.9 million, compared to $82.8 million in 2011, supported by 53% commercial
revenue growth internationally.  Currency fluctuations decreased revenue by 6
percent compared to the same period in 2011. 

"With 345 HVAD^® pumps sold during the fourth quarter, the largest number in
any quarter to date, the total number of pumps sold in 2012 was 1,217,
compared to 932 pumps sold in 2011," added Mr. Godshall. "Our team has been
working diligently to expedite the training of additional hospitals in the
U.S., and since FDA approval 18 new U.S. sites have been trained, with 2 more
in training this week."

Total operating expenses for the fourth quarter of 2012 were $35.4 million, as
compared to $30.8 million in the same period of 2011. 

Research and development expense was $22.2 million for the fourth quarter of
2012, as compared to $17.9 million in the same period of 2011.  Increased
development costs are a result of continuing 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 $13.3 million in the fourth
quarter of 2012, compared to $12.9 million in the fourth quarter of 2011.  The
increase in selling, general and administrative expenses is related to
continued growth supporting commercial activity outside of the U.S.,
preparation for and rollout of the commercial launch in the U.S., and an
overall increase in corporate infrastructure to support the Company's rapid
growth. 

Net loss for the fourth quarter of 2012 was $21.1 million, or a $1.46 loss per
basic and diluted share, compared to a $21.6 million net loss, or a loss of
$1.53 per basic and diluted share, in the fourth quarter of 2011.  For the
fiscal year ended December 31, 2012, the Company recorded a net loss of $87.7
million, or a $6.15 loss per basic and diluted share, compared to a $55.1
million net loss, or a loss of $3.94 per basic and diluted share, in fiscal
2011.

At December 31, 2012, the Company had $102.8 million of cash, cash equivalents
and investments.

HeartWare will host a conference call on Wednesday, February 27, 2013 at 8:30
a.m., U.S. Eastern Standard Time to discuss the Company's financial results,
highlights from the fourth quarter and business outlook.  The call may be
accessed by dialing 1-888-846-5003 five minutes prior to the scheduled start
time and referencing "HeartWare."  For callers outside the U.S., please dial
+1-480-629-9856.

A live webcast of the call will also be available at the Company's website
(www.heartware.com) by selecting "HeartWare Fourth Quarter 2012 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 28 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.

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 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 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, Current Reports on Form 8-K, or other filings
with the Securities and Exchange Commission.

For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
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 Ended          Year Ended

                         December 31,                December 31,
                         2012          2011          2012          2011
Revenue, net             $    32,662   $    23,060   $    110,922  $    82,764
Cost of revenue          16,606        9,540         51,023        32,932
Gross profit             16,056        13,520        59,899        49,832
Operating expenses:
Selling, general and     13,257        12,924        53,945        42,314
administrative
Research and             22,157        17,865        83,548        50,149
development
Total operating          35,414        30,789        137,493       92,463
expenses
Loss from operations     (19,358)      (17,269)      (77,594)      (42,631)
Other expense, net       (1,747)       (4,295)       (10,124)      (12,424)
Loss before income       (21,105)      (21,564)      (87,718)      (55,055)
taxes
Provision for income     —             —             —             —
taxes
Net loss                 $   (21,105)  $   (21,564)  $   (87,718)  $  
                                                                   (55,055)
Net loss per common      $             $             $             $      
share - basic and        (1.46)        (1.53)        (6.15)        (3.94)
diluted
Weighted average shares
outstanding - basic and  14,451        14,063        14,252        13,959
diluted

HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

(unaudited)
                                   December 31,           December 31,

                                   2012                   2011
ASSETS
Current assets:
Cash and cash equivalents          $             85,921   $             71,257
Short-term investments, net        16,887                 91,925
Accounts receivable, net           25,225                 14,953
Inventories, net                   38,443                 32,005
Prepaid expenses and other current 5,925                  4,507
assets
Total current assets               172,401                214,647
Property, plant and equipment, net 19,380                 18,325
Other assets, net                  14,718                 7,760
Total assets                       $          206,499     $          240,732
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable                   $              12,024  $              5,025
Other accrued liabilities          22,020                 12,436
Total current liabilities          34,044                 17,461
Convertible senior notes, net      100,315                94,277
Other long-term liabilities        3,929                  2,210
Stockholders' equity               68,211                 126,784
Total liabilities and              $          206,499     $          240,732
stockholders' equity

 

SOURCE HeartWare International, Inc.

Website: http://www.heartware.com