EX-99.7 9 d82371dex997.htm EX-99.7 EX-99.7

Exhibit 99.7

 

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HeartWere


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HeartWare® Valtech

Advancing Our Technology Leadership in Advanced Heart Failure

Investor and Analyst Conference Call and Webcast

September 1, 2015

HeartWare®

2


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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 HeartWare and

Valtech products; timing, progress and outcomes of clinical trials and regulatory approvals; research and

development activities; our ability to integrate, manage and take advantage of acquired and pipeline

technology; and the costs and benefits to be achieved from the Valtech transaction. 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 SEC. 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

SEC.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 3

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Additional Shareholder Information

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 in connection with the proposed transaction. 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 SEC on April 30, 2015. This document is available free of charge at the SEC’s website at www.sec.gov or by going to HeartWare’s Investors page on its corporate website at www.heartware.com. 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, will be set forth in a proxy statement/prospectus when it is filed with the SEC.

Additional Information and Where You Can Find It

A new holding company will file a Registration Statement on Form S-4 containing a joint proxy statement/prospectus and other documents concerning the proposed transaction with the SEC. Investors are urged to read the joint proxy statement/prospectus when it becomes available and other relevant documents filed with the SEC because they will contain important information. Security holders may obtain a free copy of the proxy statement/prospectus (when it is available) and other documents filed by HeartWare and the new holding company with the SEC on the SEC’s website at www.sec.gov. The joint proxy statement/prospectus and other documents may also be obtained for free by contacting HeartWare Investor Relations by e-mail at investors@heartware.com or by telephone at +1 (508) 739-0864.


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List of Participants

Doug Godshall President and CEO, HeartWare International

Peter McAree Senior Vice President and CFO, HeartWare International

Amir Gross Founder and CEO, Valtech Cardio

Prof. Francesco Chair of Cardiovascular Surgery, University Hospital of

Maisano, M.D. Zurich

Prof. Karl-Heinz Head of Cardiology Department, Asklepios Klinik St. Kuck, M.D., Ph.D. Georg, Hamburg, Germany


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President and CEO, HeartWare International

DOUG GODSHALL

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 6 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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9000+ ~120

Patients U.S.

Implanted Centers

Mission Globally ~175

46 Intl.

We create Countries Centers

revolutionary technology for the 2009: CE Mark

treatment of heart failure to allow 2012: FDA Approval

patients to get back to life.

HVAD® System—A Proven Track

Record

Note: Data as of June 30, 2015.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 7

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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HeartWare + Valtech: Creating the Technology Leader in

Advanced Heart Failure

Advance Our Mission: Accelerates goal of revolutionizing the treatment of

advanced heart failure patients

Leverage Competitive Differentiation: Adds uniquely comprehensive portfolio

with potential to serve patients across the spectrum of mitral and tricuspid

valve disease

Expand Our Market Opportunity: Opens access to the multi-billion-dollar-

potential mitral and tricuspid valve repair and replacement market

Accelerate Our Growth: Adds near-term revenue opportunity in existing

$250M transcatheter mitral repair market

Deepen Our Team: Combined team of ~700 with 6 first-in-man (FIM)

experiences to execute on mechanical circulatory support and mitral and

tricuspid valve pipeline

Drive Shareholder Value: Provides exceptional opportunity for significant

value creation with risk-mitigating and cash-preserving transaction structure

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 8

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Strategic Fit: A Compelling Combination

HeartWare® Valtech

Focus

Portfolio

Patients

Customer

Team

Market Opportunity

Provider of mechanical circulatory support devices serving end-stage heart failure patients

6 Technologies, 2 FIM

HVAD® commercially available

MVAD® under clinical investigation

Advanced Heart Failure

Stages IIIb and IV HF patients

BTT and DT patients

Heart Team

Cardiac surgeons and HF cardiologists

>600 employees globally

Robust sales and marketing team

Cardiac surgery R&D core competency

VAD Market >$2B

Full-support

Partial-support

Will serve multiple patient segments within the vast mitral and tricuspid valve markets

9 Technologies, 4 FIM

Cardinal & Cardioband commercial stage

4 product platforms

Heart Failure

Stages II, III and IVa HF patients

Mitral and tricuspid regurgitation patients

Heart Team

Cardiac surgeons, interventional cardiologists, and HF cardiologists

>60 employees

Significant valve and delivery experience

Over 40% with 3-year tenure

Mitral & Tricuspid Markets >$7B

Mitral surgical and transcatheter

Tricuspid surgical and transcatheter

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

9


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Mitral & Tricuspid Regurgitation: Two Disease States Requiring

Multiple Tools

1 2

Mitral Regurgitation Tricuspid Regurgitation

Complex disease Significantly

1

Multiple approaches underserved surgically required to serve entire Annuloplasty as primary

2 population solution

Portfolio of solutions Solution needed for needed for inoperable inoperable patient patient group segment

Note: Stuge 2006 JTCS, Rogers 2009 Circulation.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 10 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd. MitraClip is a registered trademark of Abbott Laboratories.


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Current Treatment Landscape: Novel Transcatheter Repair and

Replacement for Mitral and Tricuspid Valves on the Horizon

Available Today

Not Available Today

Mitral Regurgitation

Tricuspid Regurgitation

U.S. Prevalence Functional ~3.2M Degenerative ~1.0M Functional ~1.2M Degenerative ~0.4M

Low Surgical Risk Surgical Surgical Surgical Surgical

Repair Repair Repair Repair

Surgical Surgical Surgical Surgical

Replacement Replacement Replacement Replacement

Transcatheter Transcatheter Transcatheter Transcatheter

Repair* Repair Repair Repair

High Surgical Risk Transcatheter Transcatheter Transcatheter Transcatheter

Replacement Replacement Replacement Replacement

* EU Only.

Source: Nkomo 2006 Lancet, Stuge 2006 JTCS, Rogers 2009 Circulation.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

11


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Cardinal™ & V-Chordal®: Bringing Beating-Heart Adjustability to

Surgery

Cardinal V-Chordal

CE Marked, innovative, adjustable, Surgical and transcatheter chord

semi-rigid, annuloplasty ring system repair for mitral regurgitation

Dynamic mitral and tricuspid repair Chord repair performed in many

system for all user-levels surgical repairs

Allows bi-lateral adjustment on a beating Successful surgical FIM; completed

heart under echocardiography for one-year follow-up

precise sizing and optimal coaptation • Facilitates treatment of degenerative

CE study n=30, Post-Market Study n=45 mitral regurgitation

Transfemoral in combination application with Cardioband may be used

products

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 12

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Cardioband®: Commercial-Stage Product Offers Surgical-Like Repair, Less Invasively

Gold-standard annuloplasty on a catheter

Cardioband Mitral CE Mark expected by end of 2015

– 50+ patients implanted to date

European commercial launch expected following CE Mark

Cardioband designed as a safe, first-line option for high-surgical risk patients

– the Transfemoral patient, large approach untreated safe for patient population

– Real beating -time heart adjustment on a

– 6 implant sizes

Tricuspid FIM expected late 2016

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 13 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Cardioband: Potential First-Line Interventional Treatment Option

Surgical-Like Ring Implanted Transfemorally

Surgical Annuloplasty Cardioband

Based on Proven Surgical Solution

Benefits Relative to Current Interventional Therapy Options

Potentially better safety profile

– Supra-annular procedure does not interfere with leaflets or chordae

Replicates surgical standard

Does not prevent future interventions

– Preserves valve’s natural anatomy

Enables future interventions, if needed

– Potential docking station for future valve replacement

– Leaflets intact for clip

Predictable procedure and outcome

Differentiated Transcatheter Repair Solution

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

14


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CardioValve™: Starting With End in Mind – Transseptal From Day 1

Potential to be one of first transseptal mitral replacement valves

Transseptal and transapical options

Proven transseptal capabilities

Designed based on well-established valve principles

Orientation-indifferent shape

Low profile

steerability Delivery system with five degrees of

Potential synergy of Cardioband-CardioValve combination – replace When possible, if needed repair first, then


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Strategic Rationale: A New Portfolio of Technologies to Expand Our Treatment Footprint in Advanced Heart Failure

Create the Leading • Valtech portfolio enables a move upstream in Advanced Heart Failure heart failure care paradigm Company • VADs provide option for end-stage patients

Strengthen Ability to • Surgical and interventional heart failure portfolio Serve Heart Team meets the needs of hospital heart failure Customer treatment teams

HeartWare field team possesses substantial Leverage Commercial technical knowledge in treatment of heart failure

Extensive MCS and valve center relationships

Reach

Outreach to cardiologists more compelling with combined portfolio

Accelerate Expansion • Valtech product suite advances HeartWare’s customer reach to support interventional

Into Interventional cardiologists

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 16 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Founder and CEO, Valtech Cardio, Ltd.

AMIR GROSS

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 17 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Valtech’s Chosen Path: HeartWare Team, Culture and Deal Structure Provide Platform for Next Stage

Early HeartWare investment enabled creation of a strong partnership

Appreciation for HeartWare’s achievements with VADs and its proven commercial execution

Strong alignment of entrepreneurial cultures and shared vision; belief in HeartWare team and VAD business ? Participation in future value creation and remaining a separate business unit is attractive to our team

Stock transaction further aligns interests and allows for participation in long-term success

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 18


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Valtech: Valve Expertise Has Yielded Best-in-Class Repair and Replacement Portfolio for Mitral and Tricuspid Valves

Products

• Leveraging proven surgical solutions

– Annuloplasty

– Chord repair

– Valve replacement

• Near-term revenue generation

– Multiple commercial-stage products over next few years

• Serving multiple large, untapped markets

– Portfolio potentially serving – and expanding – current mitral and tricuspid markets

Team

• Experienced

– 62 deep; broad functional experience

– Exceptional R&D; significant valve and transcatheter delivery experience

• Proven execution

– Since 2010: 4 FIM (>120 patients treated), 1 CE Mark (1 more imminent)

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 19 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Product Pipeline: Four Platforms Comprising Nine Technologies,

Including Two Commercial-Stage Assets

Platform Product Valve / Approach Status

Mitral /

CE Mark (2011)

Adjustable surgical Surgical Surgical

annuloplasty repair Tricuspid / Repair for

Preclinical Mitral and

Surgical

Tricuspid

Mitral /

Surgical and First-in-Man (2010)

Surgical

transcatheter valve

chordae repair Mitral /

Preclinical

Transfemoral

Mitral / Transcatheter

Pending CE Mark Repair for

Transfemoral Mitral and

Adjustable Mitral /

transcatheter valve First-in-Man (2011) Tricuspid

repair Transatrial

Tricuspid /

Preclinical

Transfemoral

Mitral / Transcatheter

Preclinical

Transcatheter valve Transfemoral Mitral

replacement Mitral / Replacement

Preclinical

Transapical

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 20

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Valtech Portfolio: Comprehensive Set of Interventional and

Surgical Solutions

Mitral Regurgitation

Tricuspid Regurgitation

U.S. Prevalence

Functional Degenerative Functional Degenerative

~3.2M ~1.0M ~1.2M ~0.4M

Low Surgical

Risk

Cardinal Surgical Repair Cardinal V-Chordal Surgical Repair Cardinal Surgical Repair Cardinal Surgical Repair

Surgical Surgical Surgical Surgical

Replacement Replacement Replacement Replacement

Cardioband Transcatheter Repair

Cardioband V-Chordal Transcatheter Repair

Cardioband Transcatheter Repair

Cardioband Transcatheter Repair

High Surgical Risk

Cardiovalve Transcatheter Replacement

Cardiovalve Transcatheter Replacement

Transcatheter Repair

Transcatheter Repair

Source: Nkomo 2006 Lancet, Stuge 2006 JTCS, Rogers 2009 Circulation.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

21


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Chair of Cardiovascular Surgery, University Hospital of Zurich

PROF. FRANCESCO MAISANO, M.D.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 22 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Heart Failure Patient Journey: Early Intervention Enhances

Outcomes

Future Heart Failure Care Paradigm

NYHA EARLY MID LATE Treatment

Stage Setting

Stage I

Outpatient

Clinic

Stage II

Stage III

Cardinal

Medical LVAD Inpatient /

Cardioband

Management HTx Hospitalization

CardioValve

Stage IV

Inotrope Use

Time From Diagnosis

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 23

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Mitral & Tricuspid Regurgitation: Multiple Etiologies Require

Tailored Treatment Options

Market Etiologies Treatment Approaches

Surgical annuloplasty

1 repair gold standard

Mitral • Surgeons prefer to repair

~60% of cases

Regurgitation ®

Functional MitraClip principal

– Ventricle problem, current option for high-

1 75% of population surgical-risk patients

2 • Degenerative

– Native structural • Increasing focus to treat

2

problem, 25% of • When treated, ~90%

Tricuspid population repaired via surgical

Regurgitation annuloplasty

No options for high-

surgical-risk patients

Note: Stuge 2006 JTCS, Rogers 2009 Circulation.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 24

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd. MitraClip is a registered trademark of Abbott Laboratories.


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Cardinal: Coaptation Optimization Through Off-Pump Adjustment Offers Improved Clinical Outcomes

Utilization of Cardinal Off-Pump Improved Coaptation With Adjustment

Adjustability Off-Pump-Only Adjusted Patients, CE and Post-Market Study, n=74 CE and Post-Market Study, n=34

100% 12

On-

90% Not Pump Adjusted Only 10

80% (mm) +32% Patients 70% On & Off Pump 8 of 60% Length

50% Adjusted 6

Adjusted Off- Off- 10.2 40% Pump

Pump 4 7.7

Percentage 30% Only in ~75%

20% of cases

Coaptation 2

10%

0% 0

If Adjusted When Pre- Post- Adjusted Adjustment Adjustment

Note: Maisano 2013 Eur J Cardiothoracic Surgery.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 25 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Cardioband: Adjustability on a Beating Heart Delivered

Transfemorally

Baseline Cardioband Pre-Adjustment

Real-time / beating

heart adjustability

Reduction of septo-

lateral (A-P) diameter

Final Size Cardioband Post-Adjustment • Significant MR grade

reduction post-

adjustment

Proven surgical concept

leveraged for

interventional system

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 26

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Head of Cardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany

PROF. KARL-HEINZ KUCK, M.D., PH.D.


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Structural Heart Market: High Unmet Need in Mitral and Tricuspid

Regurgitation

Structural Heart Disease

Primary Disease Available Currently

Estimated U.S. Prevalence Cause Treatments Treated

Surgical

Aortic Age-related

replacement ~80,000

Other Aortic Stenosis calcification

TAVR

~1M Stenosis

1.0M • Surgical repair &

Left heart

Mitral replacement

failure / ~60,000

Tricuspid Regurgitation • Transcatheter

degenerative ®

Regurgitation repair: MitraClip

1.6M

Mitral Tricuspid • Surgical repair

Right and left

and ~8,000

Regurgitation Regurgitation heart failure

replacement

4.2M

Other • Surgical atrial

Varies by and ventricular Varies by

indication septal defect indication

repair

U.S. mitral and tricuspid opportunities in total estimated to be ~6x the

aortic stenosis market

Note: Tricuspid prevalence numbers estimate population of moderate-severe tricuspid regurgitation patients only.

Source: AHA Heart Disease & Stroke Statistics 2015 Circulation, Nkomo 2006 Lancet, Stuge 2006 JTCS,

U.S. Census Data.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 28

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd. MitraClip is a registered trademark of Abbott Laboratories.


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Cardioband: Safe and Effective MR Reduction; Durable, Surgical-Like Results

Cardioband MR Reduction

Core Lab; Dr. Paul Grayburn, Baylor University

Efficacy

88% MR 2+ 80% MR 2+ 86% MR 2+ 94% MR 2+ • Durable result, 94% at Discharge at 1 Month at 6 Months at 12 Months

100% patients have MR 2+ at

12 months

2+

80% • Favorable LV remodeling

0-1+ 0-1+ • 20% average reduction in

0-1+ 0-1+

Patients septo-lateral (A-P) 60% of diameter

40% Safety

3-4+ No

procedural mortality

2+ 2+ 2+ 2+

Percentage 20% • No long-term anticoagulation

3-4+ 3-4+

3-4+ 3-4+ requirement 0% Baseline Discharge 1 Month 6 Months 1 Year n=45 n=43 n=35 n=22 n=17

Note: Nickenig PCR 2015 Presentation.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 29 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Transcatheter Valve Therapies: Complementary Role of Repair and Replacement

Mitral valve is not just a valve, it is a complex apparatus integrated in the left ventricle

Durability, safety and disruption of adjacent cardiac structures are important concerns

Safety, including avoidance of permanent implant-related complications, will drive transcatheter repair as first-line therapy

Transcatheter replacement may be an option for patients with more advanced disease who have severe anatomical and functional abnormalities and are not eligible for repair

Source: Maisano 2015 European Heart Journal.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 30 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Senior Vice President and CFO, HeartWare International

PETER MCAREE

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 31 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Investment Highlights: Transaction Designed to Deliver Significant Long-Term Value

Combined portfolio provides leadership position in two of

Uniquely Attractive the highest-growth areas in heart failure

Heart Failure

Event-rich company with steady cadence of product

Growth Platform launches in multiple heart failure markets

Appreciably scales and accelerates long-term revenue growth potential

Differentiated

Addition of high-gross-margin products provide margin

Value Creation expansion opportunity over time

Substantially accretive to cash EPS beyond 5 years

Risk-Mitigating • Deal structure designed to align focus on value creation Structure • Contingent structure provides attractive risk/reward

Structure preserves cash to fund operations of the combined business

Capital Efficient

Sufficient cash resources to comfortably fund development

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 32 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Deal Structure: Milestone-Based Transaction Aligned With Value

Creation, Preserves Cash to Operate Combined Company

Valtech WW Revenue and Transaction Terms

2015-2025

? Closing

? Milestone

? Earn-out

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Event and ? Close, 4.4M ? Cardioband ? Warrants ? $375M stock or

shares Tricuspid FIM exercisable at cash at $450M LTM

Payments or CardioValve $75M LTM net net Valtech

? Cardioband FIM, 700K Valtech product product sales

CE Mark, shares sales

800K shares

Portfolio Mitral and Tricuspid Surgical Comprehensive Portfolio of

Breadth and Transcatheter Repair Market Transcatheter Replacement and

Repair Products

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 33

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Revenue Growth: Valtech Offers Multiple Opportunities for

Accelerated Growth

Illustrative Revenue Potential

$900

Weighted-Average

$800M Revenue, $M (Range)

$800 Market Products

2020 2025

M) $700

$ Transcatheter

( $600 Replacement Up to $30 Up to $575

$500

Revenue CAGR

$400 42% Transcatheter

$300 & Surgical $75-$170 $325-$725

Valtech Repair

$200

$140M

Total $75-$200 $325-$1,300

$100

$0

2020 2025

Note: Graph depicts weighted average of HeartWare management’s projection.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 34

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


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Transaction Summary

Transaction Terms

Acquisition of Valtech on debt-free basis for 4.4M shares of HeartWare Common Stock at closing

Clinical and revenue milestone payments:

– 800,000 shares upon Cardioband CE Mark

– 700,000 shares upon FIM Cardioband Tricuspid or FIM CardioValve

– 850,000 warrants issued at closing; vesting upon achievement of $75M in LTM net sales from Valtech products

10-year term and strike price equal to 10-day VWAP at signing ($83.73)

– $375M in stock or cash (at HeartWare’s election) upon achievement of $450M in LTM net sales from Valtech products

Earn-out period of 10 years from closing

Transaction Structure

Merger structured as a tax-free reorganization in the U.S.

New U.S. holding company

Timing

Subject to regulatory and shareholder approvals

Hart-Scott-Rodino approval expected Fall 2015

Shareholder vote and closing expected prior to year-end

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

35


LOGO

 

President and CEO, HeartWare International

DOUG GODSHALL

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 36 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


LOGO

 

HeartWare Core Business: Momentum Returning to VAD Market

Transaction timing supported by recent milestones MVAD® System CE Mark clinical trial now enrolling Enrollment completed in HVAD® System U.S. destination therapy study ENDURANCE2 Strong Q2 results driven by record unit sales in U.S. and international markets Increased clinical trial activity stimulating interest within VAD referral community HeartWare balance sheet recalibrated with convertible note financing and extension of maturity


LOGO

 

A New HeartWare: Extending Treatment Across the Advanced Heart Failure Continuum

Combined Company Offering

Heart Failure Treatment Paradigm

Class I Class II Class III Class IV

Early Stage Mid Stage Late Stage End Stage

Portfolio Focus

Valtech

HeartWare

Medical Surgical Transcatheter

Tx/CRT Valve Tx Valve Repair

Treatment Options

Transcatheter Valve Replace

Mechanical Circulatory Support

Heart Transplant

Functional mitral and tricuspid regurgitation patients suffer from advanced heart failure

Patients may receive multiple valve interventions over the course of their disease

VAD patients often receive concomitant mitral or tricuspid valve procedures

VADs remain the treatment option for progressed patients

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

38


LOGO

Synergistic Patient Population: Combined Portfolio Offers Solutions for Broader Advanced Heart Failure Population

Heart Failure

HFrEF HFpEF Right Heart Primary Valve Disease

MCS Valve MCS MCS Valve Valve

(mitral) (tricuspid) (mitral & tricuspid)

hVAD®

mVAD®

CircuLite®

longHORNTM

Cardinal

Cardioband

Cardiovalve

CircuLite®

hVAD®

mVAD®

Cardinal

Cardioband

Cardinal

V-Chordal

Cardioband

Cardiovalve

Note: Heart Failure Reduced Ejection Fraction (HFrEF), Heart Failure Preserved Ejection Fraction (HFpEF).

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

HeartWare®

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High-Impact Clinical Cadence: Comprehensive Portfolio Delivers Inflection Points for Many Years

2015

Cardinal Mitral

Cardinal Tricuspid

Cardioband Mitral

Valve Cardioband Tricuspid

V-Chordal

CardioValve Transseptal

CardioValve Transapical

MVAD

CircuLite Surgical

MCS CircuLite Endovascular

Fully-Implantable System

Longhorn

FIM to CE Mark Today

Initiate U.S. Study

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.

40


LOGO

 

Integration Plan and Opportunities: Valtech to Operate as a Strategic Business Unit, Enabling Seamless Integration

Valtech to operate as a separate, strategic business unit located and operating in Israel

– delivering Seamless integration on valve product allows strong pipeline Valtech team to remain focused on – business Integration officer to oversee successful transition into a HeartWare

– Cardinal Recruit 20 and -25 field Cardioband team members in 2016 to support commercialization of

HeartWare core team remains focused on advancing MCS business

Anticipate complementary market development, clinical and back-office capabilities between MCS and Valve businesses

– Leverage heart team customer base

– Use experienced clinical team to execute clinical development strategy

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 41 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.


LOGO

 

HeartWare + Valtech: Creating the Technology Leader in Advanced Heart Failure

MVAD® System leading a transformation of MCS portfolio and VAD market 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 first-line option, whether surgical or interventional Nearer-term commercial opportunity in established interventional mitral repair market with >$250M 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, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates. 42 VALTECH, CARDIOBAND, CARDINAL, CARDIOVALVE and V-CHORDAL and Valtech logos are trademarks of Valtech Cardio, Ltd.