UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
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
HEARTWARE INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-34256 |
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26-3636023 |
(State or other jurisdiction
of incorporation) |
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(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)
Registrants telephone number, including area code:
508.739.0950
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)) |
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 Companys presentation to the investment community today at the 33rd Annual J.P. Morgan Healthcare Conference. HeartWares 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 Companys
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 managements final review as well as audit by the Companys 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. |
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Description |
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99.1 |
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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. |
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Date: January 13, 2015 |
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By: |
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/s/ Lawrence J. Knopf |
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Name: |
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Lawrence J. Knopf |
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Title: |
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Senior Vice President, General Counsel and |
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Secretary |
INDEX TO EXHIBITS
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Exhibit
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Description |
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99.1 |
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Press Release issued by HeartWare International, Inc. dated January 13, 2015. |
Exhibit 99.1
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
Companys presentation to the investment community today at the 33rd Annual J.P. Morgan Healthcare Conference. HeartWares 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 Companys
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 managements final review as well as audit by the Companys
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 Companys 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 managements 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 HeartWares 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:
ctaylor@heartware.com
Phone: +1 508 739 0864
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