FRAMINGHAM, Mass., Oct. 29, 2015 /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 total revenue of $65.2
million for the quarter ended September 30, 2015, compared to $68.6 million for the third quarter of 2014.
Currency fluctuations impacted revenue growth by
approximately $4.9 million, or seven
percentage points, during the three months ended September 30, 2015, as compared to the same
period in 2014. Third quarter global revenue increased 2.2%
on a constant-currency basis, compared to the same period in
2014.
"Our financial performance during the third quarter demonstrated
the underlying strength of our business but was impacted by
anticipated headwinds, including clinical trial activity and
foreign currency fluctuation," said Doug
Godshall, President and Chief Executive Officer. "The
HVAD® System drove strong, double-digit international
unit sales growth for the second quarter in a row, signifying
continued physician confidence in HVAD as the leading ventricular
assist therapy for end-stage heart failure.
"In early August, we successfully completed enrollment in the
465-patient ENDURANCE2 destination therapy study of our HVAD
System. As a result, we sold 15 units for the destination
therapy study in the third quarter of 2015, compared to 62 units
sold for this study in the third quarter of 2014. Exclusive
of ENDURANCE2 trial units, U.S. unit sales increased by
approximately 4% over the third quarter of 2014," added Mr.
Godshall. "We plan to complete the one-year patient follow-up
for ENDURANCE2 next summer and prepare a Pre-Market Approval (PMA)
application for submission late next year, seeking a destination
therapy indication."
During the third quarter, a total of 697 HeartWare HVAD Systems
were sold globally, which represented a 3.3% increase from 675
units sold during the same period in 2014. U.S. revenue,
generated through the sale of 327 units during the third quarter of
2015, was $35.6 million, or an 8.9%
decrease from the third quarter of 2014, due to the completion of
ENDURANCE2 enrollment during the quarter. International
revenue, generated through the sale of 370 units during the third
quarter of 2015, was $29.6 million,
compared to $29.5 million during the
third quarter of 2014. On a constant-currency basis,
international sales improved approximately 17% on 18% unit sales
growth.
"Since pausing enrollment in the MVAD® System CE Mark
trial during the third quarter, we have made substantial progress
toward resolving the manufacturing process issue with the MVAD
System's controller and expect to resume production next month,"
said Mr. Godshall. "We are also reviewing reported adverse events,
which are typical of those seen in other clinical trials for
ventricular assist devices, and we are confident that we will
resolve the issues in order to resume the MVAD CE Mark clinical
trial. The MVAD System represents an important advancement in
next-generation technology, and clinicians around the world remain
eager to gain access to this innovative, novel device.
"In September, we also announced our plan to acquire Valtech
Cardio – a strategic acquisition that will deepen our leadership in
the heart failure market. Valtech's differentiated mitral and
tricuspid valve repair and replacement platforms augment our
mechanical circulatory support business and will establish
HeartWare as a dynamic player in two of the potentially largest
categories in heart failure device therapies. Valtech's
flagship product, Cardioband® Mitral Reconstruction
System, which received CE Mark approval for mitral valve repair
during the third quarter, is well-positioned to be a leading
technology in the mitral repair market and represents one of
several new technologies that comprise the Valtech portfolio.
We are excited by the opportunity that the Valtech acquisition
represents and look forward to continuing to introduce Valtech to
investors and completing the transaction."
For the nine months ended September 30,
2015, total revenue increased by approximately $3.5 million to $208.8
million, compared to $205.2
million for the same period in 2014. This increase was
primarily attributable to growth from new sites and increased
utilization of the HVAD System in the U.S. during the first half of
2015, offset by international revenue declines driven by currency
fluctuation. Currency headwinds negatively impacted total
year-to-date revenues by approximately $16
million, or 7.8%, compared to the same nine-month period in
2014, reflecting a stronger U.S. dollar. Total revenue
increased by 9.5% on a constant-currency basis compared to the
first nine months of 2014. For the nine months ended
September 30, 2015, HVAD System unit
sales grew 12.7% in the U.S., excluding destination therapy
clinical trial units, and 8.2% internationally, compared to the
same period in 2014.
Gross margin percentage declined to 49.4% during the third
quarter of 2015, from 65.7% during the second quarter of 2015 and
66.5% in the third quarter of 2014. This was attributable to
a charge of $8.5 million primarily
related to a previously announced voluntary corrective action
related to certain older batteries. Foreign exchange rates
and geographic mix of revenue sources were other factors
contributing to the decline.
Total operating expenses for the third quarter of 2015 were
$57.9 million, compared to
$46.4 million for the third quarter
of 2014 and $56.2 million for the
second quarter of 2015. Total operating expenses for the
third quarter of 2015 included Valtech acquisition transaction
costs of $3.6 million and a
$6.0 million net change associated
with accounting for the estimated fair value of the contingent
consideration recorded in connection with the CircuLite
acquisition, which was completed in 2013.
Research and development (R&D) expense was $30.4 million for the third quarter of 2015,
compared to $29.5 million for the
same period in 2014. This increase in R&D expense was
primarily attributable to increased clinical and regulatory
expenses and quality system improvements.
Selling, general and administrative (SG&A) expenses were
$25.2 million for the third quarter
of 2015, compared to $20.6 million
for the third quarter of 2014. The increase in SG&A
expenses was primarily attributable to Valtech acquisition
transaction costs, as well as additional headcount-related
expenses.
Net loss for the third quarter of 2015 was $29.9 million, or a loss of $1.73 per basic and diluted share, compared to a
net loss of $7.4 million, or
$0.43 per basic and diluted share,
for the third quarter of 2014. Non-GAAP net loss for the
third quarter of 2015 was $23.5
million, or a loss of $1.36
per basic and diluted share, compared to a non-GAAP net loss of
$10.8 million, or a loss of
$0.64 per basic and diluted share,
for the third quarter of 2014.
For the nine months ended September 30,
2015, the company recorded a net loss of $71.9 million, or a loss of $4.16 per basic and diluted share, compared to a
net loss of $18.5 million, or a loss
of $1.09 per basic and diluted share,
for the nine months ended September
30, 2014. Non-GAAP net loss for the nine months ended
September 30, 2015 was $40.8 million, or a loss of $2.36 per basic and diluted share, compared to a
non-GAAP net loss of $27.6 million,
or a loss of $1.63 per basic and
diluted share, for the nine months ended September 30, 2014.
Items impacting comparability of operating results for the
three- and nine-month periods ended September 30, 2015 to the same periods in 2014
include purchase accounting amortization, restructuring charges,
contingent consideration adjustments, loss on extinguishment of
long-term debt and transaction-related expenses, as described later
in this news release under "Use of Non-GAAP Financial Measures" and
"Reconciliation of GAAP to Non-GAAP Net Loss per Common Share."
At September 30, 2015, HeartWare
had approximately $249 million of
cash, cash equivalents and investments. This compares to
approximately $252 million of cash,
cash equivalents and investments as of June
30, 2015, which included approximately $76 million in net proceeds from a convertible
note exchange and issuance executed during the second quarter of
2015.
Conference Call and Webcast Information
HeartWare will host a conference call on Thursday, October 29, 2015 at 8:00 a.m., U.S. Eastern Time to discuss its
financial results, highlights from the third quarter and the
company's business outlook. The call may be accessed by
dialing 1-877-407-0789 five minutes prior to the scheduled start
time and referencing "HeartWare." Callers outside the U.S.
should dial +1-201-689-8562.
A live webcast of the call will also be available in the
Investors section of the company's website
(http://ir.heartware.com/). A replay of the conference call
will be available through the above link immediately following
completion of the call.
About HeartWare International
HeartWare International develops and manufactures miniaturized
implantable heart pumps, or ventricular assist devices, to treat
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 47 countries. The device is also currently the subject
of a U.S. clinical trial for destination therapy. For
additional information, please visit 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, SYNERGY, CIRCULITE and HeartWare
logos are trademarks of HeartWare, Inc. or its affiliates. VALTECH,
CARDIOBAND, CARDINAL, CARDIOVALVE, V-CHORDAL and Valtech logos are
trademarks of Valtech Cardio, Ltd.
Use of Non-GAAP Financial Measures
HeartWare management supplements its GAAP financial reporting
with certain non-GAAP financial measures for financial and
operational decision making. For example, we use "non-GAAP
adjusted net loss" and "non-GAAP adjusted net loss per common
share" to refer to GAAP loss per share excluding certain
adjustments such as amortization of intangible assets, impairment
charges, purchase accounting and acquisition-related transaction
costs, and restructuring and severance costs. These are non-GAAP
financial measures under Section 101 of Regulation G under the
Securities Exchange Act of 1934, as amended. Management believes
that providing this additional information enhances investors'
understanding of the financial performance of the company's
operations and increases comparability of its current financial
statements to prior periods. Non-GAAP measures should not be
considered a substitute for measures of financial performance in
accordance with GAAP, and they should be reviewed in comparison
with their most directly comparable GAAP financial results.
Reconciliations of HeartWare's GAAP to non-GAAP financial measures
are provided at the end of this news release under "Reconciliation
of GAAP to Non-GAAP Net Loss per Common Share."
Participants in the Solicitation
HeartWare, Valtech and their respective directors, executive
officers, certain members of management and certain employees may
be deemed to be participants in the solicitation of proxies in
connection with the proposed acquisition of Valtech Cardio, Ltd. A
description of the interests in HeartWare of its directors and
executive officers is set forth in HeartWare's proxy statement for
its 2015 Annual Meeting of Shareholders, which was filed with the
Securities and Exchange Commission (the "SEC") on April 30, 2015. This document is available free
of charge at the SEC's website at www.sec.gov or by going to
HeartWare's Investors page on its corporate website at
www.heartware.com. Additional information regarding the
persons who may, under the rules of the SEC, be deemed participants
in the solicitation of proxies in connection with the proposed
transaction, and a description of their direct and indirect
interests in the proposed transaction, which may differ from the
interests of HeartWare stockholders or Valtech shareholders
generally, will be set forth in a proxy statement/prospectus when
it is filed with the SEC.
Additional Information and Where To Find It
In connection with the proposed Transactions, HW Global, Inc.
("Holdco"), has filed a Registration Statement on Form S-4 that
contains a preliminary proxy statement/prospectus, which is not yet
final and will be amended. Holdco intends to file a final
prospectus and other relevant materials and HeartWare intends to
file a definitive proxy statement and other relevant materials with
the SEC in connection with the proposed Transactions. Investors and
security holders of HeartWare and Valtech are urged to read these
materials when they become available because they will contain
important information about HeartWare, Valtech and the
Transactions. The proxy statement/prospectus and other relevant
materials (when they become available), and any other documents
filed by Holdco or HeartWare with the SEC, may be obtained free of
charge at the SEC website at www.sec.gov. In addition, investors
and security holders may obtain free copies of the documents filed
with the SEC by Holdco or HeartWare by directing a written request
to HeartWare's investor relations department at HeartWare
International, Inc., 500 Old Connecticut Path, Framingham, MA 01701, Attention: Investor
Relations. Investors and security holders are urged to read the
proxy statement/prospectus and the other relevant materials when
they become available before making any voting or investment
decision with respect to the Transactions.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended (the "Securities Act").
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: commercialization of the HeartWare HVAD System and
introduction of the MVAD System; timing, progress and outcomes of
clinical trials; regulatory and quality compliance; research and
development activities; consummation of our proposed acquisition of
Valtech and our ability to take advantage of acquired and pipeline
technology. 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, except as may be required by federal securities laws
and the rules and regulations of the Securities and Exchange
Commission. 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.
Contact:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.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
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
Revenue,
net
|
$ 65,166
|
|
$ 68,608
|
|
$ 208,756
|
|
$ 205,211
|
Cost of
revenue
|
32,990
|
|
22,977
|
|
80,258
|
|
68,846
|
Gross
profit
|
32,176
|
|
45,631
|
|
128,498
|
|
136,365
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
25,171
|
|
20,584
|
|
69,347
|
|
65,765
|
Research and
development
|
30,386
|
|
29,477
|
|
93,355
|
|
88,981
|
Change in fair value
of contingent consideration
|
2,360
|
|
(3,620)
|
|
6,700
|
|
(14,180)
|
Total operating
expenses
|
57,917
|
|
46,441
|
|
169,402
|
|
140,566
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(25,741)
|
|
(810)
|
|
(40,904)
|
|
(4,201)
|
|
|
|
|
|
|
|
|
Other expense,
net
|
(3,914)
|
|
(6,472)
|
|
(30,142)
|
|
(13,586)
|
Loss before
taxes
|
(29,655)
|
|
(7,282)
|
|
(71,046)
|
|
(17,787)
|
Income tax (benefit)
expense
|
272
|
|
88
|
|
809
|
|
663
|
Net loss
|
$ (29,927)
|
|
$ (7,370)
|
|
$ (71,855)
|
|
$ (18,450)
|
|
|
|
|
|
|
|
|
Net loss per common
share – basic and diluted
|
$ (1.73)
|
|
$ (0.43)
|
|
$ (4.16)
|
|
$ (1.09)
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding – basic and diluted
|
17,303
|
|
17,007
|
|
17,256
|
|
16,977
|
|
|
|
|
|
|
|
|
|
|
HEARTWARE
INTERNATIONAL, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
September
30,
2015
|
|
December 31,
2014
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
184,882
|
|
$
102,946
|
Short-term
investments
|
63,391
|
|
75,535
|
Accounts receivable,
net
|
34,968
|
|
38,041
|
Inventories
|
47,245
|
|
54,046
|
Prepaid expenses and
other current assets
|
6,744
|
|
5,975
|
Total current
assets
|
337,230
|
|
276,543
|
Property, plant and
equipment, net
|
15,711
|
|
19,036
|
Other assets,
net
|
135,525
|
|
128,234
|
Total
assets
|
$
488,466
|
|
$
423,813
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
12,731
|
|
$
13,322
|
Other accrued
liabilities
|
47,463
|
|
36,589
|
Total current
liabilities
|
60,194
|
|
49,911
|
Convertible senior
notes, net
|
188,790
|
|
114,803
|
Other long-term
liabilities
|
55,120
|
|
50,565
|
Stockholders'
equity
|
184,362
|
|
208,534
|
Total liabilities and
stockholders' equity
|
$
488,466
|
|
$
423,813
|
|
|
Reconciliation to
Constant Currency Revenue Growth (unaudited) (see
explanation below)
|
(dollars in
thousands)
|
|
|
|
Three Months Ended
September 30,
|
Reported $
chg
|
Reported %
chg
|
FX
impact
|
Constant Currency
$ chg
|
Constant Currency
% chg
|
|
|
2015
|
2014
|
|
|
|
|
|
Total U.S.
Revenue
|
35,578
|
39,068
|
(3,490)
|
-8.9%
|
-
|
(3,490)
|
-8.9%
|
Total Int'l
Revenue
|
29,588
|
29,540
|
48
|
0.2%
|
4,936
|
4,984
|
16.9%
|
Total
Revenue
|
65,166
|
68,608
|
(3,442)
|
-5.0%
|
4,936
|
1,494
|
2.2%
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
Reported $
chg
|
Reported %
chg
|
FX
impact
|
Constant Currency
$ chg
|
Constant Currency
% chg
|
|
|
2015
|
2014
|
|
|
|
|
|
Total U.S.
Revenue
|
120,689
|
109,801
|
10,888
|
9.9%
|
-
|
10,888
|
9.9%
|
Total Int'l
Revenue
|
88,068
|
95,410
|
(7,343)
|
-7.7%
|
16,013
|
8,671
|
9.1%
|
Total
Revenue
|
208,756
|
205,211
|
3,545
|
1.7%
|
16,013
|
19,558
|
9.5%
|
|
Constant currency
changes in the tables above take into consideration the foreign
exchange rates in effect during the three- and nine-month periods
ended September 30, 2015 and 2014.
|
|
|
Reconciliation of
GAAP to Non-GAAP Net Loss per Common Share (unaudited) (see
explanation of adjustments below) (in thousands, except per share
data)
|
|
|
|
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
GAAP net
loss
|
|
$ (29,927)
|
|
$ (7,370)
|
|
$ (71,855)
|
|
$ (18,450)
|
GAAP net loss per
common share – basic and diluted
|
|
$ (1.73)
|
|
$ (0.43)
|
|
$ (4.16)
|
|
$ (1.09)
|
|
|
|
|
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
Amortization
of purchased intangible assets and goodwill
|
(a)
|
|
|
|
|
|
|
|
-Selling,
general and administrative
|
|
84
|
|
84
|
|
252
|
|
252
|
-Research
and development
|
|
327
|
|
247
|
|
981
|
|
721
|
Acquisition-related transaction costs
|
(b)
|
3,641
|
|
—
|
|
3,941
|
|
—
|
Contingent
consideration adjustments
|
(c)
|
2,360
|
|
(3,620)
|
|
6,700
|
|
(14,180)
|
Loss on
extinguishment of long-term debt
|
(d)
|
—
|
|
—
|
|
16,588
|
|
—
|
Restructuring
costs
|
(e)
|
|
|
|
|
|
|
|
-Selling,
general and administrative
|
|
13
|
|
(79)
|
|
436
|
|
2,985
|
-Research
and development
|
|
—
|
|
(66)
|
|
2,213
|
|
1,032
|
Total
adjustments
|
|
6,425
|
|
(3,434)
|
|
31,111
|
|
(9,190)
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjusted net
loss
|
|
$ (23,502)
|
|
$ (10,804)
|
|
$ (40,744)
|
|
$ (27,640)
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjusted net
loss per common share – basic and diluted
|
|
$ (1.36)
|
|
$ (0.64)
|
|
$ (2.36)
|
|
$ (1.63)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing non-GAAP adjusted net loss per common share – basic and
diluted
|
|
17,303
|
|
17,007
|
|
17,256
|
|
16,977
|
|
|
(a)
|
Represents
amortization of purchased intangible assets related to CircuLite
and WorldHeart during the three and nine months ended September 30,
2015 and 2014.
|
(b)
|
Represents
transaction costs associated with the possible business combination
with Valtech.
|
(c)
|
Represents the change
in fair value of contingent consideration associated with the
acquisition of CircuLite in December 2013.
|
(d)
|
Represents the loss
on extinguishment of 3.5% convertible notes.
|
(e)
|
Represents certain
restructuring costs incurred during the three and nine months ended
September 30, 2015 and 2014 as follows (in thousands):
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
|
|
|
|
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
Lease exit charge for
HeartWare's
former Massachusetts
corporate offices
|
$ —
|
|
$ (98)
|
|
$ (28)
|
|
$ 373
|
|
|
|
|
|
|
|
|
Charges related to
CircuLite acquisition:
|
|
|
|
|
|
|
|
Lease exit
charge for former
N.J.
corporate
offices
|
13
|
|
19
|
|
464
|
|
1,709
|
Lease exit
charge for
Aachen,
Germany office
|
—
|
|
—
|
|
139
|
|
—
|
Contract
termination costs
|
—
|
|
—
|
|
340
|
|
688
|
Employee
severance
|
—
|
|
(66)
|
|
598
|
|
618
|
Abandoned
fixed assets
|
—
|
|
—
|
|
1,137
|
|
629
|
Total
|
13
|
|
(47)
|
|
2,677
|
|
3,644
|
|
|
|
|
|
|
|
|
Total restructuring
costs
|
$ 13
|
|
$ (145)
|
|
$ 2,649
|
|
$ 4,017
|
|
The terms "non-GAAP
adjusted net loss" and "non-GAAP adjusted net loss per common
share" refer to GAAP net (loss)/income and GAAP net (loss)/income
per common share excluding certain adjustments such as amortization
of purchased intangible assets, impairment charges, purchase
accounting and acquisition-related transaction costs, and
restructuring and severance costs as follows:
|
|
1)
|
We exclude
amortization of purchased intangible assets and periodic impairment
charges related to long-lived assets from this measure because such
charges do not represent what our management believes are the costs
of developing, producing, supporting and selling our products and
the costs to support our internal operating structure.
|
2)
|
We exclude purchase
accounting adjustments and acquisition-related costs from this
measure because they occur as a result of specific events and are
not reflective of our internal investments and the ongoing costs to
support our operating structure. Purchase accounting
adjustments include contingent consideration fair market value
adjustments.
|
3)
|
We exclude
restructuring and severance costs from this measure because they
tend to occur as a result of specific events such as acquisitions,
divestitures, repositioning our business or other unusual events
that could make comparisons of long-range trends difficult and are
not reflective of our internal investments and the costs to support
our operating structure.
|
|
|
|
|
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SOURCE HeartWare International, Inc.