Edwards Lifesciences 2011 Investor Conference

12/9/2011

EDWARDS LIFESCIENCES
Transcatheter Heart Valves

Larry L. Wood
Corporate Vice President, Transcatheter Valve Replacement

Edwards Lifesciences 2011 Investor Conference

12/9/2011

Executive Summary
Global transcatheter heart valve opportunity continues to be strong and growing Edwards' TAVR procedures grew more than 50% in 2011 Expect to add high-risk patients to the U.S. launch in 2012 TAVR motivates untreated patients to explore therapy options Edwards extended leadership in 2011 Edwards SAPIEN launched for inoperable patients in the U.S. The PARTNER Trial Cohort A U.S. IDE data published in NEJM The PARTNER II Trial U.S. IDE approved for moderate risk Edwards will continue to aggressively invest Initiate CE Mark trials on two new valve platforms in 2012 Plan a regular cadence of advancing technology
Estimated Underlying Sales Growth of 70% - 90% in 2012
12/9/2011 3

The PARTNER Trial, Cohort B Confirms Severe, Symptomatic AS has a Dismal Natural Course
Post Mortem Study, 1968
Ross and Braunwald. Circulation, 1068. Valvular Aortic Stenosis in Adults
Average Course (Post Mortem Data)
100 80

Randomized Controlled Trial, 2010

The PARTNER Trial, Cohort B The PARTNER Trial, Cohort B
ITT PMA Control Patients* Survival

% survival

60 40 20 0

12

18

24

30

36

Months Post Randomization

With severe symptomatic AS, survival without intervention is 2-5 years

12/9/2011 *Crossover patients censored at crossover

Actual survival for patients with severe, symptomatic AS without intervention was ~25% at 3 yrs
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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Approximately a Quarter of a Million Americans Have Severe, Symptomatic AS

Moderate and Severe Aortic Stenosis(1) (AS)
~1.5 M

Severe AS(1)
~500,000
Severe AS, Symptomatic(2)

~1/3rd Severe

~250,000

~1/2 Symptomatic

12/9/2011

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005

The Majority of These Patients Do Not Receive LifeLife-saving Aortic Valve Replacement (AVR)
Moderate and Severe Aortic Stenosis(1) (AS)
~1.5 M

Severe AS(1)
~500,000
Severe AS, Symptomatic(2)

~1/3rd Severe

~250,000

~1/2 Symptomatic

Currently Untreated Indicated for surgery(3) g y TAVR SAVR

12/9/2011

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005 (3) Bonow 2006

Edwards Lifesciences 2011 Investor Conference

12/9/2011

Edwards Believes TAVR Will Motivate Untreated Patients to Explore Options

U.S. Severe, Symptomatic AS
(~250 000 Patients) ( 250,000

These untreated patients do not receive intervention for reasons which could include:
Too sick to benefit from AVR High risk or inoperable Patient refusal Not currently managed by a cardiologist Undiagnosed

Currently Untreated
Indicated for surgery(1) TAVR SAVR

With TAVR, untreated patients are more likely to be evaluated for therapy

12/9/2011

(1) Bonow 2006

The Introduction of TAVR Stimulated Procedure Growth in Europe

E.U. AVR Units (SAVR & TAVR)
TAVR SAVR

2004

2005

2006

2007

2008

2009

2010

2011(E)

2004AVR CAGR 2004-2007

3.1%
2007-2011(E) AVR CAGR2007-2011(E

6.3%
8

12/9/2011

Source: Internal Estimates

Edwards Lifesciences 2011 Investor Conference

12/9/2011

Edwards AVR Growth Has Been Lifted Even Further with TAVR
Edwards E.U. AVR Units (SAVR & TAVR)
EDWARDS

TAVR

SAVR

2004

2005

2006

2007

2008

2009

2010

2011(E)

2004AVR CAGR 2004-2007

5.6%
2007AVR CAGR2007-2011(E)

13.3%
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12/9/2011

Source: Internal Estimates

Formal Reimbursement for TAVR in Europe is Expected to Expand

Spain Greece Belgium Finland Norway Switzerland United Kingdom Italy Austria The Netherlands Sweden Denmark France Germany Spain Greece Belgium United Kingdom Italy Finland Norway Switzerland Austria The Netherlands Sweden Denmark France Germany

Reimbursement in 2011
Formal Reimbursement

Reimbursement in 2012
Hospital Budget

Temporary and/or Case by Case Reimbursement

12/9/2011

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

We Believe Edwards Maintains Leadership Even With Increased Competition

Estimated OUS TAVR Units*
Startup Strategics

Edwards

2010

2011

2012

2013

2014

2015

2016

2017

12/9/2011

*Excludes Japan

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The SAPIEN Valve Was Approved in the United States on November 2, 2011

INDICATION
Transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis
12/9/2011 12

Edwards Lifesciences 2011 Investor Conference

12/9/2011

Edwards is Planning Rigorous Post Approval Studies

Two Post Approval Studies (PAS) Planned
PAS 1:
Continued Follow-Up of Premarket Cohort
Follow all patients from The PARTNER Trial and continued access (total ~3,100) Objectives are to describe: - Valve durability at five years - Patient Quality of Life (QOL) outcomes at five years y Annual assessment for five years

PAS 2:
Newly Enrolled Study
Follow newly enrolled patients (minimum ~1,100) Objectives are to evaluate: - Learning curve at 50 + sites - Safety and effectiveness - Complications Assessment at 30 days and annually for 5 years

Edwards to collect data and report to FDA

Ultimately recorded into a national registry

12/9/2011

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Edwards Believes That a Well-Written WellNCD Should Include:

Indication
Inoperable and high risk patients Future indications as they are FDA approved IDE or other qualifying clinical study Multidisciplinary heart team Modified cath lab and operating room or hybrid OR Volume restrictions should be reasonable, as these are not a consistent predictor of quality outcomes*

Facility Requirements Training Program Data Collection

Edwards-provided comprehensive training program Credentialing responsibility retained by hospitals

All patients enrolled in a audited registry or clinical trial Coverage with Evidence Development for other indications

12/9/2011

*Khumbhani 2009, Epstein 2004, Garg 2011, Plomondon 2006

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Formalized U.S. Reimbursement is Moving Quickly

CMS Timeline
2011
Oct Nov Dec Jan Feb Mar

2012
Apr p May y Jun Jul

NCD Assessment Begins

CMS Issues Proposed NCD

CMS Issues Final NCD

30 day Public Comment Period

30 day Public Comment Period

In October 2011, new TAVR ICD Codes were aligned to the DRGs for surgical AVR, setting the payment rate.

A well-written National Coverage Determination well(NCD) would be positive for patients and physicians by insuring uniform coverage nationally

12/9/2011

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First Twelve Months of U.S. Launch Estimated at $150M - $250M

Edwards U.S. THV Cumulative Revenue
$500

Cumulative Sales (USD, $K K)

$250

Cohort A Approval

High Risk Patients

$0

Inoperable Patients
0 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct

November Launch

Months After Launch

12 months

2012 U.S. sales estimated at $200M - $260M

12/9/2011 16

Edwards Lifesciences 2011 Investor Conference

12/9/2011

Edwards is On Track for $20-$25 Million of $20Sales in the First Three Months
Guiding Principle
Site Selection

As always, our guiding principle is to ensure excellent clinical outcomes for patients
Af focus on capability and partnership secure a bilit d t hi successful heart team on day one and long term Sites demonstrate commitment to a TAVR program through an initial stocking order of 8 units Edwards robust program includes: Didactic session Case observation Simulations Proctoring Clinical specialists will support initial cases

Disciplined Training

Sites with proven volume and procedural success will become eligible for consignment

12/9/2011

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Procedures are Expected to Ramp Steadily as the Launch Progresses

Conceptual U.S. TAVR Growth by Quarter

Procedures

4Q

1Q

2Q

3Q

4Q

1Q

2Q

3Q

4Q

2011

2012

2013

12/9/2011

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Reported Sales are Impacted by Stocking and Consignment Cadence

Conceptual U.S. TAVR Growth by Quarter
Reported Sales Procedures

4Q

1Q

2Q

3Q

4Q

1Q

2Q

3Q

4Q

2011

2012

2013

Stocking orders boost sales in early launch

12/9/2011 19

Reported Sales are Impacted by Stocking and Consignment Cadence

Conceptual U.S. TAVR Growth by Quarter
Reported Sales Procedures

4Q

1Q

2Q

3Q

4Q

1Q

2Q

3Q

4Q

2011

2012

2013

Reported sales appear flat in mid-launch middue to consignment effect

12/9/2011 20

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Reported Sales are Impacted by Stocking and Consignment Cadence

Conceptual U.S. TAVR Growth by Quarter
Reported Sales Procedures

4Q

1Q

2Q

3Q

4Q

1Q

2Q

3Q

4Q

2011

2012

2013

Reported sales approximate procedure growth in mid-2013 mid12/9/2011 21

Review of The PARTNER Trial PMA Timing

2010 The PARTNER Trial, Cohort B
1 Year Follow-Up Complete FDA Submission FDA Panel Q2 Q4 Q3

2011

2012
PMA Approved November 2, 2011! 2
1 year from submission to approval (FDA average is ~550 days)

PMA Approval

Q4

The PARTNER Trial, Cohort A

1 Year Follow-Up Complete Follow Up FDA Submission FDA Panel* Q4 Q2 Q1

Assuming 1 year from pp submission to approval (FDA average is ~550 days)

PMA Approval*

Q2

12/9/2011

*FDA panel has not been scheduled for The PARTNER Trial, Cohort A. Panel and PMA approval timing are Edwards estimates.

22

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

The PARTNER II Trial is Approved

Symptomatic Severe Aortic Stenosis
ASSESSMENT: Operability

Total ~ 2,600 patients

n~2,000

Operable
STS > 4

2 Parallel Trials: Individually Powered

Inoperable
ASSESSMENT: Transfemoral Access

n>600

ASSESSMENT: Access Transfemoral Transapical

1:1 Randomization

1:1 Randomization

1:1 Randomization

Nested Registry

TAVR Trans femoral

AVR
VS

TAVR Trans apical

AVR
VS

TAVR SAPIEN
VS

TAVR SAPIEN XT

Primary Endpoint: All Cause Mortality and Major Stroke

Primary Endpoint: All Cause Mortality and Major Stroke

2 year follow-up

1 year follow-up

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The PARTNER II Trial, Cohort B Enrollment Continues, Expected Completion January 2012
Symptomatic Severe Aortic Stenosis
ASSESSMENT: Operability

The PARTNER II Trial, Cohort B

Inoperable
ASSESSMENT: Transfemoral Access

n>600

Enrollment completion expected January 2012

1:1 Randomization

Nested Registry

TAVR SAPIEN
VS

TAVR SAPIEN XT

Primary Endpoint: All Cause Mortality and Major Stroke

1 year follow-up

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

The PARTNER II Trial, Cohort A was Approved for Moderate Risk Patients on November 7, 2011
Symptomatic Severe Aortic Stenosis
ASSESSMENT: Operability

n~2,000

Operable
STS > 4

The PARTNER II Trial, Cohort A: Trial Design Includes severe, symptomatic moderate risk patients
Transapical

ASSESSMENT: Access Transfemoral

1:1 randomization against surgery 2 year follow-up

1:1 Randomization

1:1 Randomization

TAVR Trans femoral

AVR
VS

TAVR Trans apical

AVR
VS

Primary Endpoint: All Cause Mortality and Major Stroke

2 year follow-up

PARTNER II Cohort A Targets an Expanded Indication

STS Risk Score for Isolated SAVRs in the U.S.
% of All Isolated SAVR Patient A ts*
30% 25% 20% 15% The PARTNER II Trial, Cohort A 10% 5% 0%
0 1 2 3 4 5 6 7 8 9 10 >10 ~40% of Total

The PARTNER Trial

<10% of Total

STS Score

12/9/2011

STS National Adult Cardiac Database, 2005 Harvest. Isolated SAVR.

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Estimated U.S. Approval for SAPIEN and SAPIEN XT

2009
PARTNER Cohort B SAPIEN PARTNER Cohort A SAPIEN

2010

2011
FDA Review R i (367 days)

2012
Approved pp

2013

2014

2015

2016

2017

EW Assumed FDA Review1

Average FDA Review 2

Cohort B:

PARTNER II SAPIEN XT

NovaFlex+ Only

Enroll Patients

1 Yr Follow Up & File PMA

EW Assumed FDA Review1

Average FDA Review 2

Cohort A:
NovaFlex+ & Ascendra+

Enroll E ll Patients

2Y Yr Follow Up

File Fil PMA

EW Assumed FDA Review1

Average FDA Review 2

12/9/2011

1 Edwards 2 FDA

assumes a 12 month or 365 day review/approval time review/approval time averaging over 550 days over past two years

27

Edwards Has a Multi-Faceted MultiApproach to Address Stroke

Opportunities to reduce stroke
Lower profile delivery systems and device enhancements Patient selection Procedure enhancements

The PARTNER II Trial evaluates stroke

Protocolized anti-coagulation and anti-platelet regimen Specific pre- and post-operative neurological assessments Standardized Rankin questionnaire

I Europe, the PROTAVI trial will study the causes of stroke In E th t i l ill t d th f t k and evaluate Embrella
Evaluate where and when neurological events occur Data could be used to support a U.S. 510(k) clearance Planned initiation Q1 2012
12/9/2011 28

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

In the U.S., the SAPIEN Platform is Commercial While the SAPIEN XT Platform is in IDE Trial
Commercial Device* IDE Trial Enrolling

SAPIEN THV

SAPIEN XT THV*

Provides predictable and precise valve deployment

Lower profile, improved delivery and valve design

12/9/2011

* The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S.

29

The OUS Offering Features SAPIEN XT, Available in Four Sizes

OUS Commercial Offering
SAPIEN XT THV*
Transfemoral Approach

NovaFlex+ with eSheath

Transapical and Transaortic* Approach

Sizes Available
20mm*
Annulus Size (mm)

23mm

26mm

29mm*

16

17

18

19

20

21

22

23

24

25

26

27

Japan

EU

Ascendra+*

12/9/2011

* The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S.

30

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

Building on a Solid Foundation

Commercial Device*

IDE Trial Enrolling

O.U.S. Commercial OUS C i l Offering SAPIEN XT THV

SAPIEN THV

SAPIEN XT THV

U.S. Offering
12/9/2011

OUS Offering
31

* The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S.

Expect CE Mark Trials on Two New Valve Platforms in 2012

Balloon Expandable
Commercial Device* IDE Trial Enrolling

Self Expanding
O.U.S. Commercial OUS C i l Offering SAPIEN XT THV

SAPIEN THV

SAPIEN XT THV

U.S. Offering
12/9/2011

OUS Offering
32

* The Edwards SAPIEN XT valve, the Edwards SAPIEN valve with the Ascendra delivery system, the Edwards SAPIEN 3 valve and the Edwards CENTERA valve are investigational devices and are not available for commercial sale in the U.S.

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

SAPIEN 3 Advances Best-in-Class Best-inDesign

Edwards SAPIEN 3 Valve
Ultra Low Profile Balloon Expandable Platform Low-Profile
Designed to further reduce PV leaks Lower profile valve delivered through a
14 Fr eSheath

Discrete valve that anchors in the

annulus

Treated bovine pericardial tissue

leaflets

Dramatically reduced profile for the

transapical approach

12/9/2011

The Edwards SAPIEN 3 System is not available for commercial sale in the U.S.

33

CENTERA is Edwards First SelfSelf- Expanding Transcatheter Valve

Edwards CENTERA Valve
Ultra Low Profile Self Expanding Platform Low-Profile
Motorized delivery system for stable
deployment and single operator use

Repositionable Delivered through a 14 Fr eSheath Discrete valve that anchors in the

annulus

Treated bovine pericardial tissue

leaflets

Transfemoral and subclavian approach

First-inFirst-in-Man Experience Completed

12/9/2011 The Edwards CENTERA Valve System is not available for commercial sale in the U.S. 34

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

U.S. THV Litigation Provides 2012 Potential Upside

Edwards v. CoreValve appeal decision expected in mid 2012
Federal jury found that Edwards U.S. Andersen transcatheter heart valve patent is valid and Medtronic CoreValve LLC willfully infringes it Both sides appealed Substantial potential damages, future royalties or injunction $74M assessed on 4/1/2010 $

New THV lawsuits in California initiated in 2011 by both Edwards and Medtronic
12/9/2011 35

2012 Outlook
Sales outlook of $560-$630 million
Includes $200-$260 million of U.S. sales

Expected OUS p p product launches

Ascendra+ for SAPIEN XT with a TAo indication mid-2012 NovaFlex+ for 29mm SAPIEN XT mid-2012

PARTNER Cohort A
Expect FDA panel meeting in Q1 2012 Expect approval mid-2012

Japan clinical filing 1H 2012 PARTNER II

Complete enrollment in Cohort B January 2012

Begin CE Mark trial in 2012

SAPIEN 3 CENTERA
12/9/2011 36

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Edwards Lifesciences 2011 Investor Conference

12/9/2011

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