0001193125-15-382191.txt : 201511190001193125-15-382191.hdr.sgml : 2015111920151119163238ACCESSION NUMBER:0001193125-15-382191CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:27CONFORMED PERIOD OF REPORT:20151119ITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20151119DATE AS OF CHANGE:20151119

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:HeartWare International, Inc.CENTRAL INDEX KEY:0001389072STANDARD INDUSTRIAL CLASSIFICATION:SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]IRS NUMBER:980498958STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-34256FILM NUMBER:151243994

BUSINESS ADDRESS:STREET 1:500 OLD CONNECTICUT PATHCITY:FRAMINGHAMSTATE:MAZIP:01701BUSINESS PHONE:508-739-0873

MAIL ADDRESS:STREET 1:500 OLD CONNECTICUT PATHCITY:FRAMINGHAMSTATE:MAZIP:01701

FORMER COMPANY:FORMER CONFORMED NAME:HeartWare LTDDATE OF NAME CHANGE:20070206

8-K1d78644d8k.htm8-K

8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM8-K

CURRENT REPORT

Pursuantto Section13 OR 15(d)

of the Securities Exchange Act of 1934

Date of report (date of earliest event reported): November19, 2015

HEARTWARE INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

Delaware001-3425626-3636023

(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 belowif the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

xWritten 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))

Item8.01.Other Events.

On November19, 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 HeartWares presentation was HeartWares proposed acquisition of Valtech Cardio, Ltd.(Valtech). A live webcast of HeartWares presentation was provided through HeartWares investor relations website and is available for replay at ir.heartware.com. HeartWares slide presentation used at theforum is attached hereto as Exhibit 99.1 and is hereby incorporated by reference.

As previously announced, HeartWare intends to acquire Valtech asset forth in that certain Business Combination Agreement, dated as of September1, 2015, by and among HeartWare, Valtech, HW Global, Inc., a Delaware corporation and a direct wholly owned subsidiary of HeartWare (Holdco), HWMerger 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 strategiccombination 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 BusinessCombination Agreement, the Transactions).

Additional information concerning the proposed Transactions is included in the preliminaryproxy statement/prospectus, which was filed by Holdco with the Securities and Exchange Commission on October16, 2015.

Item9.01Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1November 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 proposedTransactions. 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 proxystatement/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 securityholders may obtain free copies of the documents filed with the SEC by Holdco or HeartWare by directing a written request to HeartWares investor relations department at HeartWare International, Inc., 500 Old Connecticut Path, Framingham, MA01701, 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 theTransactions.

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 anysecurities, 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 ofsecurities shall be made except by means of a prospectus meeting the requirements of Section10 of the Securities Act.

Participants in theSolicitation

HeartWare, Valtech and their respective directors, executive officers, certain members of management and certain employees may be deemedto 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 HeartWares directors and executive officers in thetransaction 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 endedDecember31, 2014, which was filed with the SEC on March2, 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 Form8-K contains forward-looking statements within the meaning of the Section27A of the Securities Act and Section21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve certain risks anduncertainties 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 closingconditions to the consummation of the proposed Transactions; and such other risks and uncertainties pertaining to HeartWares business as detailed in its filings with the SEC on Forms 10-K and 10-Q, which are available on the SECs websiteat 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 undersignedhereunto duly authorized.

HeartWare International, Inc.

Date: November19, 2015

By:

/s/ Lawrence J. Knopf

Name:Lawrence J. Knopf

Title:Senior Vice President, General Counsel and Secretary

INDEX TO EXHIBITS

Exhibit

No.

Description

99.1November 19, 2015 HeartWare Slide Presentation for the Canaccord Genuity Medical Technologies and Diagnostics Forum.

EX-99.12d78644dex991.htmEX-99.1

EX-99.1

Exhibit 99.1 HeartWare

Canaccord Genuity Medical Technologies and Diagnostics Forum November19, 2015 New York, NY DOUG GODSHALL PRESIDENT AND CEO HEARTWARE, HVAD and the HEARTWARE logo areregistered trademarks of HeartWare. HeartWare

Safe Harbor Statement Forward-Looking Statements This announcement contains forward-looking statements that are based on managements beliefs, assumptions and expectations and oninformation 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 ourexpectations 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 shouldnot 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 inforward-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 withoutlimitation those described in Part I, Item1A. 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,Item1A. 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. SafeHeartWare 3

Additional Shareholder Information Participants in the Solicitation HeartWare, Valtech Cardio, Ltd. (Valtech) and their respective directors, executive officers, certainmembers 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 officersis set forth in HeartWares proxy statement for its 2015 Annual Meeting of Shareholders, which was filed with the Securities and Exchange Commission (the SEC) on April30, 2015. Additional information regarding the persons whomay, 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 theinterests of HeartWare stockholders or Valtech shareholders generally, are set forth in a preliminary proxy statement/prospectus filed with the SEC on October16, 2015. Additional Information and Where To Find It In connection with the proposedtransactions, 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 andother 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 readthese 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 proxystatement/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 freecopies of these documents by directing a written request to HeartWares investor relations department at HeartWare International, Inc., 500 Old Connecticut Path, Framingham, MA 01701, Attention: Investor Relations. This communication shall notconstitute 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 unlawfulprior 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 Section10 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

Mission We create revolutionary technology for the treatment of heart failure to allow patients to get back to life. Note: Data as of November2, 2015. 9,000+ Patients ImplantedGlobally 47 Countries 2009: CE Mark 2012: FDA Approval ~125 U.S. Centers ~180 Intl. Centers HVAD SystemA 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 offlow 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 cablesCAUTION: 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 Instructionsprior to using this device. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare 7

Global HVAD Sales Growth; 697 Units in Q3 Total Unit Sales: Intl& U.S. 3,000 2,751 2,500 2,183 2,079 1357 2,014 2,000 1,084 1,500 1101 1,002 Intl 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 September30, 2015 HEARTWARE, HVAD and the HEARTWARE logo are registeredtrademarks 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 Valtechs 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 pumpCircuLite Class III, partialassist device Longhorn Eliminates outflow graft Electronics Lavare HVAD pulsatility algorithm HVAD Controller Upgrade Improved patient management Pal Versatile, simple andsmart 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 registeredtrademarks of HeartWare. Safe HeartWare 11

The MVAD System Has Breakthrough Potential Small size enables less invasive implant and improved anatomical fit Advanced impeller technology for advancedhemocompatibility 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 InvestigatorsOnly. 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

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

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 byQualified 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 byFederal (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 designmodifications 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 forreturn 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 offSynergies 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 commercialopportunity 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 uniqueopportunity for differentiated value creation HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare 18

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 CardinalMitral 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

Our Mitral and Tricuspid Market Investment Thesis Consistent With Valtechs Portfolio Approach Repairs Value Understood From Surgery Surgical mitral repair longunderstood 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 marketneeds 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 cardiologists firstchoice, 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 deliverynecessary 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; annuloplastyis preferred surgical approach HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare 20

Replacement Will Eventually Have Strong Place in the Market; Repair Represents Much Stronger Near- and Mid-Term Opportunity as Valve Technology Matures Repair Transapical ReplacementTransseptal 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 earlierdisease 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 areregistered trademarks of HeartWare. Safe HeartWare 21

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

Video and Slide Replay Available For more information and to view the Analyst& Investor Meeting video webcast replay, please visit HeartWare.com HeartWare HeartWareInternational Analyst and Investor Meeting Thursday, November05, 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 Mostpatients 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 differentstages of CHF disease state makes total sense Valtech HeatrWare 70 HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare. Safe HeartWare 23

Priorities for the Months Ahead Advance discussions with shareholders regarding proposed Valtech acquisition; facilitate diligence process Complete MVAD review andimplement 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 HEARTWARElogo 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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