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8-K
HEARTWARE INTERNATIONAL, INC. filed this Form 8-K on 01/11/2016
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8-K

 

 

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 11, 2016

 

 

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)

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:

 

x 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 January 11, 2016, HeartWare International, Inc. (“HeartWare” or the “Company”) presented at the 34th Annual J.P. Morgan Healthcare Conference held in San Francisco, California. A live webcast of HeartWare’s presentation was provided through the Company’s investor relations website and is available for replay at ir.heartware.com. HeartWare’s slide presentation used at the conference is attached hereto as Exhibit 99.1 and is hereby incorporated by reference.

As previously announced, HeartWare intends to acquire Valtech Cardio, Ltd. (“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 and amended on November 25, 2015.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

  

Description

99.1    January 11, 2016 HeartWare Slide Presentation for the 34th Annual J.P. Morgan Healthcare Conference.


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 may be further 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’s 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, as well as in HeartWare’s Definitive Proxy Statement for its 2015 Annual Meeting of Stockholders, which was filed with the SEC on April 30, 2015. These documents are available free of charge at the SEC’s 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.

 

  HeartWare International, Inc.
Date: January 11, 2016   By:  

/s/ Lawrence J. Knopf

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


INDEX TO EXHIBITS

 

Exhibit

No.

  

Description

99.1    January 11, 2016 HeartWare Slide Presentation for the 34th Annual J.P. Morgan Healthcare Conference.
EX-99.1

Slide 1

JANUARY 11, 2016 · SAN FRANCISCO 34th Annual J.P. Morgan Healthcare Conference Exhibit 99.1


Slide 2

PRESIDENT AND CEO DOUG GODSHALL


Slide 3

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 clinical evaluation of the MVAD® System; timing, progress and outcomes of clinical trials; regulatory submissions and quality compliance; investigation, 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. 


Slide 4

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 originally filed with the SEC on October 16, 2015 and amended on November 25, 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 may be further 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").


Slide 5

Focused on Progress. Committed to Making a Difference. Our goal: To meaningfully extend the lives of heart failure patients by dramatically enhancing their quality of life. “Prior to the HVAD® System, life was hard; I could not walk, I could not play with my kids, every day was a struggle.” “This device can aid in your life and help you move forward. I am so grateful for the HVAD® Pump. I have my life back.” “I am in control of my treatment with the HVAD® System. I am now working with my heart failure, rather than it working against me.” “It’s a wonderful piece of equipment. Your life does change; you get your life back. I couldn’t be more pleased with it.” Source: actual patient quotes


Slide 6

Announcing Today… Preliminary revenue for Q4 ’15 and full year 2015 HVAD® DT PMA submission timing MVAD® System CE Mark trial update Appointment of new director to HeartWare’s board


Slide 7

Unit Sales Q4 ’14 Q4 ’15 Commercial 679 720 DT2 58 0 Fourth Quarter 2015 Preliminary Revenue U.S. 16%; Int’l (3)% Note: Preliminary estimates assume negative FX impact of ~$3.4M vs. Q4 ’14. 2015 results subject to audit. FX Impact $73.2M GAAP ~$68M GAAP Revenue in Millions


Slide 8

Full-Year 2015 Preliminary Revenue Note: 2015 revenues are preliminary and unaudited. Revenue in Millions


Slide 9

HVAD® System Global Units Sold *Note: 2015 unit sales are preliminary and unaudited.


Slide 10

HEARTWARE PORTFOLIO


Slide 11

HeartWare® Ventricular Assist System 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. HVAD® System Miniaturized Implantable Blood Pump Features


Slide 12

HeartWare Achieves 10,000 HVAD® Implants Argentina Australia Austria Belarus Belgium Brazil Canada Chile Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hungary India Israel Italy Japan Kazakhstan Lebanon Luxembourg Malaysia Netherlands New Zealand Norway Poland Romania Saudi Arabia Serbia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom United States Vietnam 10,000 Thank you to the 300+ HVAD® customers around the world!


Slide 13

Pumps HVAD® Longer sintering DT indication MVAD® Next-gen, more versatile pump CircuLite® Class III, partial-assist 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: Expanding Our Leadership in VAD Innovation


Slide 14

Expedited Timeline for HVAD® System DT Indication PMA Submission U.S. Destination Therapy Market U.S. market shifting increasingly toward DT U.S. DT ~30% of global market Earlier submission for DT indication has potential to be a significant catalyst Premarket Approval Submission Positive trends observed in ENDURANCE2 data from regulatory reports and filings Intend to submit PMA application in mid-2016 Based on two-year data from ENDURANCE and minimum of six-month follow-up from ENDURANCE2 Data adjudication prior to submission ENDURANCE2 Primary endpoint: Incidence of neurologic injury at 12 months on the originally implanted device 465 patients enrolled at 50 U.S. centers Six-month follow-up complete Feb. 2016 One-year follow-up complete Aug. 2016


Slide 15

Strong Market Appeal of HVAD® System HVAD® has been the most-implanted LVAD internationally for the past 3+ years Size advantage continues to resonate strongly Balancing R&D spend to further extend the HVAD System’s competitive position: Improved surgical tools New electronic capabilities Leveraging algorithms (Lavare) Evaluating additional enhancements Physicians initiating additional post-approval studies


Slide 16

HVAD® System: Expanding Indications & Geographies LATERAL - 75% patients enrolled - Enrollment completion expected in Q1 ‘16 Japan - BTT filing expected in ‘16 Canada - HVAD BTT commercial approval in April 2015 Lavare Cycle - Available internationally - Pending FDA approval


Slide 17

Lighter and thoughtfully designed peripherals to enhance patient quality of life Palä Patient Peripherals MVAD® Pump 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. The MVAD® System Has Breakthrough Potential Small size enables less invasive implant and improved anatomical fit Advanced impeller technology for reduced sheer MVAD® Impeller


Slide 18

qPulse™ Cycle 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. Customizable speed adjustments (3 settings) Designed to promote aortic valve opening, enable ventricular washing and reduce bleeding complications


Slide 19

MVAD® System Clinical Update Completed controller fix and software enhancements Pump thrombus events observed in late December – appear different in nature than earlier events Absence of stroke, right heart failure and driveline infection to date very promising Observations: MVAD is proving efficient and powerful and result is some patients having sustained suction, which appear to lead to thrombus Significant speed change of qPulse™ appears to increase the rate of suction Patients with qPulse off did not experience significant suction and had no thrombus events Next steps reviewed with Investigators: Turn off qPulse on all patients, monitor to confirm suction reduction Improve suction alarm to identify events sooner Goal of submitting to competent authorities requesting restart Additional activities in parallel: Evaluating other algorithms that could reduce pump sensitivity Assessing more moderate pulsatility modes Incorporating external pump designer to aid evaluation


Slide 20

VALTECH


Slide 21

Late-Stage Surgical Therapy Interventional (Transcatheter) Therapy Adjustable, semi-rigid, surgical tricuspid valve annuloplasty ring system Cardinal™ Tricuspid d Cardinal™ Mitral CE Marked, adjustable, semi-rigid, surgical mitral valve annuloplasty ring system Cardioband® Mitral CE Marked transcatheter, transfemoral- transseptal mitral valve reconstruction system Cardioband® Tricuspid Transcatheter, transfemoral- transseptal tricuspid valve reconstruction system Cardiovalve™ Mitral Transcatheter, transfemoral- transseptal and transapical mitral valve replacement V-Chordal® Mitral Surgical and transcatheter mitral chordae repair system Valtech: Setting the Standards for Industry in Treating Mitral and Tricuspid Regurgitation


Slide 22

Cardioband®: Commercial-Stage Product Offers Surgical-Like Repair, Less Invasively Gold-standard annuloplasty on a catheter Cardioband Mitral CE Mark approved in September 2015 60+ patients implanted Limited commercial launch to date Cardioband designed as a safe, first-line option for high-surgical-risk patients Transfemoral approach safe for large untreated patient population Real-time adjustment on a beating heart 6 implant sizes Tricuspid FIM expected in 2016


Slide 23

Adjustable Repair Expected to Emerge as First-Line Option, Whether Surgical or Interventional Cardioband is a novel transcatheter mitral repair device replicating the surgical standard CE Mark data establish Cardioband as an effective, durable and minimally invasive repair option Surgical experience suggests that a “good” repair is better than replacement Durability of replacement stented valves uncertain, repair will be the cardiologist’s first choice, when possible 87% MR ≤ 2+ Reverse Remodeling at 2 Years CTSN Trial Surgical Repair vs. Replacement in Ischemic MR Cardioband® MR Reduction Cardioband CE Mark Study 83% MR ≤ 2+ 89% MR ≤ 2+ 89% MR ≤ 2+ Source: Taramasso 2016 Nature DOI:10.1038/nrcardio.2015.206, Goldstein 2015 NEJM DOI: 10.1056/NEJMoa1512913.


Slide 24

Expanding Cardioband® Commercial Footprint: Setting the Stage for a Strong Launch FRANCE Paris – Hôpital Bichat-Claude Bernard GERMANY Bad Nauheim – Kerckhoff-Klinik Berlin – Vivantes Klinikum Am Urban Bonn – Universitätsklinikum Bonn Frankfurt – CardioVasculäres Centrum Frankfurt Hamburg – Asklepios Klinik St. Georg Hamburg – HGH Universitäres Herz- und Gefäßzentrum Hamburg GmbH Hamburg – Universitätsklinikum Hamburg-Eppendorf (UKE) Köln – Universität zu Köln Mainz – Universitätsmedizin der Johannes Gutenberg Universität Mainz München – Ludwig Maximilians Universität (LMU) Klinikum Rostock – Universitätsmedizin Rostock ISRAEL Haifa – Rambam Health Care Campus Petah Tikva – Rabin Medical Center ITALY Catania – Ospedale Ferrarotto Milan – Ospedale San Raffaele (OSR) Rome – Policlinico Tor Vergata NETHERLANDS Nieuwegein – St. Antonius Ziekenhuis SWITZERLAND Zurich – UniversitätsSpital Zürich Cardioband® Center Locations in Europe & Israel


Slide 25

Valtech: Consistent, Meaningful Milestone Cadence 2019 2016 2017 2018 Cardiovalve CE Mark Cardioband TR PMA Cardioband® Launch Cardioband IDE Cardinal™ Launch EU Cardioband TR FIM Cardiovalve™ FIM Cardioband TR IDE Cardinal IDE Cardioband PMA Cardioband TR CE Mark Cardinal PMA Cardiovalve IDE


Slide 26

Longhorn® CircuLite® Cardiovalve™ Cardinal Mitral and Tricuspid Cardioband Mitral and Tricuspid MVAD HVAD Cardioband® Mitral HVAD® Cardinal™ Mitral and Tricuspid Cardioband Mitral and Tricuspid MVAD® HVAD Heart Failure Continuum Today Tomorrow Future HeartWare + Valtech: Covering the Heart Failure Continuum


Slide 27

HeartWare + Valtech: Addressing Two of the Highest-Growth Areas in Heart Failure Valve VAD +7% CAGR +18% CAGR 2015 2030 Mitral Tricuspid Class IV Class III $2.2B $7.5B $600M $800M Source: HTWR estimates.


Slide 28

HeartWare + Valtech: Creating the Technology Leader in Heart Failure Synergies with disease, customer, referral channel and delivery system will create compounding benefits over next decade HVAD® early DT brings growth forward and MVAD® promise remains substantial Adjustable repair of MR and TR expected to emerge as first-line option, whether surgical or interventional Nearer-term commercial opportunity in established surgical and interventional mitral repair market Sophisticated Cardiovalve™ design and delivery system to advance HeartWare leadership in mitral replacement Combined pipeline creates unique opportunity for differentiated value creation


Slide 29

Renowned Panel of Intl. VAD and Valve Specialists HeartWare’s Analyst & Investor Day Meeting video and slide webcast replay is available at: www.HeartWare.com. Prof. Karl-Heinz Kuck, M.D. Ph.D. Asklepios Klinik St. Georg Paul Jansz, M.D. St. Vincent’s Hospital, Sydney Paul Grayburn, M.D. Baylor Univ. Medical Center Steven Boyce, M.D. MedStar Washington Hospital Michael Mack, M.D. Baylor Health Care System Prof. Francesco Maisano, M.D. University Hospital of Zurich


Slide 30

Expected Timeline for Valtech Vote Important Dates Ahead for HeartWare-Valtech Merger Record Date: January 15th Mail Date: January 19th Vote Date: February 19th


Slide 31

HeartWare BOD Welcomes Dr. Stephen Oesterle Venture Partner, New Enterprise Associates Former SVP for Medicine and Technology, Medtronic; served on Exec. Committee Strategic Advisor, EQT & Temasek Holdings Former Assoc. Prof. of Medicine, Harvard Medical School Former Director of Invasive Cardiology Services, Mass. General Hospital Directed interventional cardiology programs at Good Samaritan Hospital, Georgetown University & Stanford University Stephen N. Oesterle, M.D. Timothy Barberich Seth Harrison, M.D.Robert Stockman Cynthia FeldmannRay Larkin, Jr.Robert Thomas Doug GodshallStephen Oesterle, M.D.Denis Wade, M.D. HeartWare Expands Board of Directors:


Slide 32

Clarifying Priorities While Expanding Footprint Complete Warning Letter remediation activities Submit DT mid ‘16 and enhance supporting HVAD® accessories Restart current MVAD® trial or implement design enhancements followed by new study Close on Valtech, launch Cardioband® and commence IDE trial


Slide 33

Announced Today… Preliminary revenue for Q4 ‘15 of approximately $68 million Preliminary 2015 fiscal year revenue of approximately $277 million HVAD® DT PMA submission expected mid-2016; ahead of plan MVAD® System CE Mark trial update Expanded HeartWare Board of Directors with appointment of Stephen Oesterle, M.D.


Slide 34

Enabling Patients to Get Back to Life


Slide 35