Current Report Filing (8-k)
09 September 2015 - 11:17PM
Edgar (US Regulatory)
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): September 9, 2015
HEARTWARE INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Delaware |
|
001-34256 |
|
26-3636023 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(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:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
On September 9, 2015, HeartWare International, Inc. (Nasdaq: HTWR) (the Company or HeartWare) presented at the 2015 Wells Fargo
Healthcare Conference held at the Hyatt Regency in Boston, Massachusetts as previously announced. A live webcast of HeartWares presentation was provided through the Companys website and is available for replay at ir.heartware.com
for approximately 90 days. The Company provided updates on topics including: (i) its proposed acquisition of Valtech Cardio, Ltd. (Valtech) as detailed in the Companys Current Report on Form 8-K filed with the Securities and
Exchange Commission (the SEC) on September 1, 2015 and incorporated by reference herein; (ii) its plans to implement voluntary corrective actions as part of HeartWares ongoing Warning Letter remediation efforts and quality system
enhancements, for which HeartWare anticipates recording a third quarter charge of approximately $7.0 million to $9.0 million; and (iii) the progress of HeartWares MVAD® System CE Mark
international clinical trial, including a voluntary pause of trial enrollment to address assembly issues identified in the controller manufacturing process, which have not been seen in study devices and do not impact pump performance.
Forward-Looking Statements
This Current Report on Form
8-K contains forward-looking statements that are based on managements beliefs, assumptions and expectations and on information currently available to management. Generally, you can identify forward-looking statements by terms such as
may, will, should, could, would, expects, plans, anticipates, believes, estimates, projects, predicts,
potential and similar expressions intended to identify forward-looking statements, which generally are not historical in nature. All statements that address operating performance or events or developments that we expect or anticipate
will occur in the future are forward-looking statements, including without limitation, our expectations regarding (a) the proposed acquisition of Valtech; (b) Warning Letter remediation efforts and related costs; and (c) enrollment in and outcomes
of ongoing clinical trials. The forward-looking statements reflect managements current view about future events and are subject to risks, uncertainties and assumptions. Accordingly, 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 (the SEC). 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 SEC. HeartWare may update risk factors from time to time in Part II, Item 1A, Risk Factors in its Quarterly Reports on Form
10-Q, Current Reports on Form 8-K or other filings with the SEC.
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.
|
|
|
|
|
|
|
HeartWare International, Inc. |
|
|
|
Date: September 9, 2015 |
|
By: |
|
/s/ Lawrence J. Knopf |
|
|
|
|
Name: Lawrence J. Knopf |
|
|
|
|
Title: Senior Vice President, General Counsel and Secretary |
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From Apr 2024 to May 2024
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From May 2023 to May 2024