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Form 8-K HeartWare International, For: Jan 13

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January 13, 2015 11:00 AM EST

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM�8-K

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CURRENT REPORT

Pursuant to Section�13 OR 15(d) of the

Securities Exchange Act of 1934

Date of report (date of earliest event reported): January�13, 2015

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HEARTWARE INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

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Delaware � 001-34256 � 26-3636023

(State or other jurisdiction

of incorporation)

 �

(Commission

File Number)

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(I.R.S. Employer

Identification No.)

500 Old Connecticut Path

Framingham, MA 01701

(Address of principal executive offices)

Registrant�s telephone number, including area code:

508.739.0950

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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� Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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� Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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� Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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� Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Item�2.02 Results of Operations and Financial Condition.

On January�13, 2015, HeartWare International, Inc. (NASDAQ: HTWR) announced that it expects revenues for the fourth quarter of 2014 will be approximately $73 million, bringing expected full-year 2014 revenues to approximately $278 million.

These preliminary results are being provided in conjunction with the Company�s presentation to the investment community today at the 33rd Annual J.P. Morgan Healthcare Conference. HeartWare�s presentation commences at 8:00 a.m. Pacific Standard Time (11:00 a.m. EST). The conference is being held January�12-15 at the Westin St. Francis Hotel in San Francisco.

A live webcast of the Company�s presentation at the conference will be available via a link provided at www.heartware.com. A replay of the webcast will be available for 90 days at the site after the presentation.

The financial estimates presented are preliminary and remain subject to management�s final review as well as audit by the Company�s independent registered accounting firm. The Company intends to report complete fourth quarter and full-year 2014 financial results in late February. Details regarding the timing of the release of those results, as well as details of a conference call and publically available webcast, will be announced in a subsequent news release.

The information in this Item�2.02 to Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed �filed� for purposes of Section�18 of the Securities Exchange Act of 1934 (the �Exchange Act�) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

A copy of the release issued by HeartWare is furnished with this report as Exhibit 99.1.

Item�7.01 Regulation�FD Disclosure

A copy of the release issued by HeartWare is furnished with this report as Exhibit 99.1.

The information in this Item�7.01 to Current Report on Form 8-K and Exhibit�99.1 attached hereto shall not be deemed �filed� for purposes of Section�18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

Item�9.01 Financial Statements and Exhibits

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Exhibit

No.

 ��

Description

99.1 �� Press Release issued by HeartWare International, Inc. dated January�13, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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� � HeartWare International, Inc.
Date: January�13, 2015 � � By: �

/s/ Lawrence J. Knopf

� � � Name: � Lawrence J. Knopf
� � � Title: � Senior Vice President, General Counsel and
� � � � Secretary

INDEX TO EXHIBITS

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Exhibit

No.

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Description

99.1 �� Press Release issued by HeartWare International, Inc. dated January�13, 2015.

Exhibit 99.1

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LOGO

HEARTWARE INTERNATIONAL ANNOUNCES PRELIMINARY

FOURTH QUARTER 2014 REVENUES

Fourth Quarter 2014 Revenues Approximately $73 Million; up 38% from Q4 in 2013

2014 Preliminary Revenues Approximately $278 Million; 34% increase from 2013

Framingham, Mass., January�13, 2015 � 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 that it expects revenues for the fourth quarter of 2014 will be approximately $73 million, bringing expected full-year 2014 revenues to approximately $278 million.

�Our full-year revenue growth of 34% for 2014 above 2013 reflects the strong market penetration we have experienced to date for the HeartWare� Ventricular Assist System in both the U.S. and international markets,� said Doug Godshall, President and Chief Executive Officer. �Fourth quarter 2014 unit sales increased by approximately 9 percent sequentially compared to the third quarter of 2014, a key driver of our strong revenue performance.�

�Looking ahead, we are focused on complementing our continued commercial growth with clinical progress, including the conclusion of enrollment in the second cohort of our destination therapy trial and ramping of enrollment in a U.S. thoracotomy implant study which commenced yesterday. In international markets, the six-month follow-up period concludes next month for our clinical trial in Japan, a future growth market, and I am pleased to report that submissions of our CE Marking Trial Application to regulatory authorities are underway requesting approval to commence a trial to evaluate our next-generation MVAD� System,� Godshall added.

These preliminary results are being provided in conjunction with the Company�s presentation to the investment community today at the 33rd Annual J.P. Morgan Healthcare Conference. HeartWare�s presentation commences at 8:00 a.m. Pacific Standard Time (11:00 a.m. EST). The conference is being held January�12-15 at the Westin St. Francis Hotel in San Francisco.

A live webcast of the Company�s presentation at the conference will be available via a link provided at www.heartware.com. A replay of the webcast will be available for 90 days at the site after the presentation.

The financial estimates presented above are preliminary and remain subject to management�s final review as well as audit by the Company�s independent registered accounting firm. The Company intends to report complete fourth quarter and full-year 2014 financial results in late February. Details regarding the timing of the release of those results, as well as details of a conference call and publicly-available webcast, will be announced in a subsequent news release.

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 40 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, SYNERGY, CIRCULITE 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 our preliminary revenue forecast, commercialization of the HeartWare� Ventricular Assist System, progress of clinical trials, regulatory status, 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, 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.

For further information:

Christopher Taylor

HeartWare International, Inc.

Email: [email protected]

Phone: +1 508 739 0864

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