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): November 19, 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 |
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of incorporation) |
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(Commission
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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
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)) |
On November 19, 2015, HeartWare International, Inc. (“HeartWare”)
presented at the Canaccord Genuity Medical Technologies and Diagnostics Forum held in New York, New York. One of the topics covered in HeartWare’s presentation was HeartWare’s proposed acquisition of Valtech Cardio, Ltd.
(“Valtech”). A live webcast of HeartWare’s presentation was provided through HeartWare’s investor relations website and is available for replay at ir.heartware.com. HeartWare’s slide presentation used at the
forum is attached hereto as Exhibit 99.1 and is hereby incorporated by reference.
As previously announced, HeartWare intends to acquire Valtech as
set forth in that certain Business Combination Agreement, dated as of September 1, 2015, by and among HeartWare, Valtech, HW Global, Inc., a Delaware corporation and a direct wholly owned subsidiary of HeartWare (“Holdco”), HW
Merger Sub, Inc., a Delaware corporation and a direct wholly owned subsidiary of Holdco (“US Merger Sub”), Valor Merger Sub Ltd., a private company incorporated under the laws of Israel and a direct wholly owned subsidiary of Holdco
(“ISR Merger Sub”) and Valor Shareholder Representative, LLC, a Delaware limited liability company, pursuant to which, subject to satisfaction or waiver of the conditions therein, HeartWare and Valtech will effect a strategic
combination of their respective businesses under Holdco wherein (a) US Merger Sub shall merge with and into HeartWare, with HeartWare surviving the merger as a wholly owned subsidiary of Holdco (the “US Merger”), and
(b) ISR Merger Sub shall merge with and into Valtech, with Valtech surviving the merger as a subsidiary of Holdco (the “ISR Merger,” together with the US Merger and the other transactions contemplated by the Business
Combination Agreement, the “Transactions”).
Additional information concerning the proposed Transactions is included in the preliminary
proxy statement/prospectus, which was filed by Holdco with the Securities and Exchange Commission on October 16, 2015.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
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| Exhibit
No. |
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Description |
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| 99.1 |
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November 19, 2015 HeartWare Slide Presentation for the Canaccord Genuity Medical Technologies and Diagnostics Forum. |
Important Information
Additional Information about the Transactions and Where to Find It
In connection with the proposed Transactions, 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.
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 from the stockholders of HeartWare and Valtech in connection with the proposed transaction. Information regarding the special interests of HeartWare’s directors and executive officers in the
transaction is included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of HeartWare is also included in the HeartWare Annual Report on Form 10-K for the year ended
December 31, 2014, which was filed with the SEC on March 2, 2015. This document is available free of charge at the SEC website (www.sec.gov) and from Investor Relations at HeartWare at the address described above.
Forward-Looking Statements
This Current Report on Form
8-K contains forward-looking statements within the meaning of the Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve certain risks and
uncertainties that could cause actual results to differ materially from those indicated in such forward-looking statements, including, but not limited to, the ability of the parties to consummate the proposed Transactions; satisfaction of closing
conditions to the consummation of the proposed Transactions; and such other risks and uncertainties pertaining to HeartWare’s business as detailed in its filings with the SEC on Forms 10-K and 10-Q, which are available on the SEC’s website
at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date thereof. HeartWare assumes no obligation to update any forward-looking statement contained in this document.
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: November 19, 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 Secretary |
INDEX TO EXHIBITS
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| Exhibit
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Description |
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| 99.1 |
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November 19, 2015 HeartWare Slide Presentation for the Canaccord Genuity Medical Technologies and Diagnostics Forum. |
Exhibit 99.1 HeartWare®
Canaccord Genuity Medical Technologies and Diagnostics Forum November 19, 2015 · New York, NY DOUG GODSHALL PRESIDENT AND CEO HEARTWARE, HVAD and the HEARTWARE logo are
registered trademarks of HeartWare. HeartWare®
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Safe Harbor Statement 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 Cardio, Ltd. 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. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe
HeartWare® 3
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Additional Shareholder Information Participants in the Solicitation HeartWare, Valtech Cardio, Ltd. (“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. 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. 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, are set forth in a preliminary proxy statement/prospectus filed with the SEC on October 16, 2015. 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) before making any voting or investment decision with respect to the transactions because they will contain important information about HeartWare, Valtech and the transactions. The proxy
statement/prospectus and other relevant materials, and any other documents filed by Holdco or HeartWare with the SEC, may be obtained free of charge on the SEC website at www.sec.gov. In addition, investors and security holders may obtain free
copies of these documents 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. 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”). HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 4
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Mission We create revolutionary technology for the treatment of heart failure to allow patients to get back to life. Note: Data as of November 2, 2015. 9,000+ Patients Implanted
Globally 47 Countries 2009: CE Mark 2012: FDA Approval ~125 U.S. Centers ~180 Intl. Centers HVAD® System—A Proven Track Record HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 5
Enabling Patients to Get Back to Life HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 6
HeartWare® Ventricular Assist System HVAD® System Miniaturized Implantable Blood Pump Features • Pericardial placement – no pump pocket • Provides up to 10 L/min of
flow • Centrifugal design, continuous flow • Hybrid magnetic / hydrodynamic impeller suspension • Optimizes flow, pump surface washing and hemocompatibility • Thin (4.2 mm), flexible driveline with fatigue-resistant cables
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions
prior to using this device. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 7
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Global HVAD® Sales Growth; 697 Units in Q3 Total Unit Sales: Int’l & U.S. 3,000 2,751 2,500 2,183 2,079 1357 2,014 2,000 1,084 1,500 1101 1,002 Int’l 1,217 928 U.S.
1,000 597 925 1394 596 500 978 1,012 1,099 232 432 122 332 292 0 110 165 ‘09 ‘10 ‘11 ‘12 ‘13 ‘14 YTD ‘14 YTD ‘15 Data as of September 30, 2015 HEARTWARE, HVAD and the HEARTWARE logo are registered
trademarks of HeartWare. Safe HeartWare® 8
Recent Milestones • Announced agreement to acquire Valtech Cardio • Commenced MVAD® System CE Mark international trial • Completed enrollment in ENDURANCE2 DT trial
• Submitted MVAD IDE to FDA • Valtech’s Cardioband® awarded CE Mark approval • Continued ramping enrollment in HVAD® LATERAL; thoracotomy study ~60% enrolled • Approaching 3 years of HVAD commercialization in U.S.
• Longest-supported HVAD patient reached 8 years on support HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 9
PIPELINE TECHNOLOGY HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare®
MCS Portfolio and Pipeline: Maintaining and Enhancing Competitiveness Pumps HVAD® • Longer sintering • DT indication MVAD® • Next-gen, more versatile pump
CircuLite® • Class III, partialassist device Longhorn® • Eliminates outflow graft Electronics Lavare • HVAD pulsatility algorithm HVAD Controller Upgrade • Improved patient management Pal™• Versatile, simple and
smart controller TET • Eliminates driveline Tools MVAD Gimbal • Angle and depth adjustment Thoracotomy Tools • HVAD and MVAD Remote Monitoring • Connected patient care HEARTWARE, HVAD and the HEARTWARE logo are registered
trademarks of HeartWare. Safe HeartWare® 11
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The MVAD® System Has Breakthrough Potential • Small size enables less invasive implant and improved anatomical fit • Advanced impeller technology for advanced
hemocompatibility • Lighter and thoughtfully designed peripherals to enhance patient quality of life MVAD® Pump PalTM Patient Peripherals Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators
Only. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 12
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qPulse™ Cycle Customizable speed adjustments (3 settings) • Designed to promote aortic valve opening, enable ventricular washing and reduce bleeding complications Pressure (mmHG)
0 20 40 60 80 100 120 20k 18k 16k 14k 12k 10k 8k Speed (RPM) Speed Aortic Left Ventricular Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators Only. CAUTION: Investigational Device. Limited by Federal
(or United States) law to investigational use. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 13
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MVAD® Advantage™ CE Mark Trial • Multi-center, prospective, non-randomized, single-arm trial • 70 patients at 11 sites in Australia, Austria, France, Germany &
the UK • Primary Endpoint: Survival at 6 months • Implantation via thoracotomy or sternotomy • First patient enrolled July 2015 mVAD AdvantageTM Trial Exclusively for Clinical Investigation. Investigational device to be used by
Qualified Investigators Only. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 14
MVAD® Pump in situ SUPINE MOBILE Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators Only. CAUTION: Investigational Device. Limited by
Federal (or United States) law to investigational use. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 15
MVAD® System Commentary • Controller assembly fix complete, software patch progressing toward submission efficiently • Investigation continues with no anticipated design
modifications • Narrowing our focus to specific areas within our manufacturing process, which we may elect to further tighten up • Working with investigators to review status and develop restart plan • Finalizing decision tree for
return to the clinic HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 16
BUSINESS COMBINATION HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare®
HeartWare + Valtech: Creating the Technology Leader in Heart Failure MVAD® System will lead a transformation of MCS portfolio and VAD market, picking up where HVAD® leaves off
Synergies with disease, customer, referral channel and delivery system will create compounding benefits over next decade Adjustable repair of MR and TR expected to emerge as firstline option, whether surgical or interventional Nearer-term commercial
opportunity in established surgical and interventional mitral repair market with >$450M in sales Sophisticated CardioValve™ design and delivery system to enable HeartWare leadership in mitral replacement Combined pipeline creates unique
opportunity for differentiated value creation HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 18
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Covering the Spectrum of Heart Failure Heart Failure Continuum Today Cardioband Mitral HVAD Tomorrow Cardinal Mitral and Tricuspid Cardioband Mitral and Tricuspid MVAD HVAD Future Cardinal
Mitral and Tricuspid Cardioband Mitral and Tricuspid Cardiovalve CircuLite MVAD HVAD Longhorn HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 19
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Our Mitral and Tricuspid Market Investment Thesis Consistent With Valtech’s Portfolio Approach Repair’s Value Understood From Surgery • Surgical mitral repair long
understood to be the preferred approach • Annuloplasty the most frequently performed surgical mitral repair Mitral Anatomy Complex • Multiple tools required to serve the spectrum of MR patients • A leading player in the mitral market
needs repair and replacement Physicians Will Prefer to Repair First • Transcatheter mitral valve replacement (TMVR) will be much more challenging than TAVR • Repair will be a safer treatment and therefore the cardiologist’s first
choice, when possible Transseptal Required to Meet TMVR Potential • The majority of inoperable mitral and tricuspid regurgitation patients are sick heart failure patients; left ventricular trauma a watch-out • Transseptal delivery
necessary to achieve large market opportunity Tricuspid Next Horizon • Tricuspid regurgitation is drastically undertreated today, and there is a growing body of evidence supporting intervention • Tricuspid is a repair story; annuloplasty
is preferred surgical approach HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 20
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Replacement Will Eventually Have Strong Place in the Market; Repair Represents Much Stronger Near- and Mid-Term Opportunity as Valve Technology Matures Repair Transapical Replacement
Transseptal Replacement Phase I: Repair + Early TA Replacement Phase II: Repair + Mature TA and Early TS Replacement Phase III: Repair + Mature TS Replacement Repair • Repair safer, available first and more proven • Broader use in earlier
disease stages and lower-risk patients • Mature repair market • Younger FMR patients • Growth in DMR Segment Replacement • Early transapical replacement outcomes varied • Mostly reserved for high-risk severe FMR patients
• Mature transapical, early transseptal replacement • Mature transseptal replacement valves • Older FMR patients • Select DMR etiologies Note: Transapical (TA), Transseptal (TS). HEARTWARE, HVAD and the HEARTWARE logo are
registered trademarks of HeartWare. Safe HeartWare® 21
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Combined Portfolio Provides Leadership Position in Two of the Highest-Growth Areas in Heart Failure 2015 VAD 2030 Class IV Class III $2.2B $800M $600M Valve Mitral Tricuspid $7.5B +18%
CAGR Source: HTWR estimates. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 22
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Video and Slide Replay Available… For more information and to view the Analyst & Investor Meeting video webcast replay, please visit HeartWare.com HeartWare® HeartWare
International Analyst and Investor Meeting Thursday, November 05, 2015, 9:00 am EST Webcast Slide Search Slides Speakers Downloads FMR / FTR Summary Advanced CHF is a growing problem with significant mortality and repeat hospitalization Most
patients with CHF have FMR and in very advanced stages FTR GDMT and resynchronization therapy work Surgery is seldom used Transcatheter therapy and MCS are major opportunities A Vertically integrated device company capable of managing different
stages of CHF disease state makes total sense Valtech HeatrWare® 70 HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 23
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Priorities for the Months Ahead… • Advance discussions with shareholders regarding proposed Valtech acquisition; facilitate diligence process • Complete MVAD® review and
implement any appropriate actions identified • Resume enrollment in CE Mark clinical trial of MVAD System • Pursue initiation of MVAD System clinical trials in U.S. and Canada • Complete Warning Letter remediation process •
Complete follow-up for ENDURANCE2 DT trial • Secure approval in U.S. for Lavare Cycle • Complete enrollment in HVAD® LATERAL thoracotomy IDE study • Advance CircuLite® System toward clinic HEARTWARE, HVAD and the HEARTWARE
logo are registered trademarks of HeartWare. Safe HeartWare® 24
Thank You HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare® 25
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