3-transcatheter heart valves

Edwards Lifesciences 2011 Investor Conference 12/9/2011

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EDWARDS LIFESCIENCESEDWARDS LIFESCIENCES

Transcatheter Heart ValvesTranscatheter Heart ValvesTranscatheter Heart ValvesTranscatheter Heart Valves

Corporate Vice President,Corporate Vice President,Transcatheter Valve ReplacementTranscatheter Valve Replacement

Larry L. WoodLarry L. Wood

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• Global transcatheter heart valve opportunity continues to be strong and growing

– Edwards' TAVR procedures grew more than 50% in 2011

Executive SummaryExecutive Summary

– 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

312/9/2011

Estimated Underlying Sales Growth of 70% Estimated Underlying Sales Growth of 70% -- 90% in 201290% in 2012

The PARTNER Trial, Cohort B Confirms Severe, The PARTNER Trial, Cohort B Confirms Severe, Symptomatic AS has a Dismal Natural CourseSymptomatic AS has a Dismal Natural Course

Post Mortem Study, 1968Ross and Braunwald. Circulation, 1068.

Randomized Controlled Trial, 2010The PARTNER Trial, Cohort B

Valvular Aortic Stenosis in AdultsAverage Course (Post Mortem Data)

The PARTNER Trial, Cohort BITT PMA Control Patients* Survival

100

80

60

40

20

% s

urv

ival

0

4*Crossover patients censored at crossover

With severe symptomatic AS, survival without

intervention is 2-5 years

Actual survival for patients with severe, symptomatic AS without intervention was ~25% at 3 yrs

Months Post Randomization

0 6 12 18 24 30 36

12/9/2011


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

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

Severe AS(1)

~500,000

~250,000

~1/3rd Severe

~1/2 Symptomatic

Severe AS, Symptomatic(2)

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

512/9/2011

The Majority of These Patients Do Not Receive The Majority of These Patients Do Not Receive LifeLife--saving Aortic Valve Replacement (AVR)saving Aortic Valve Replacement (AVR)

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

Severe AS(1)

~500,000

Severe AS, Symptomatic(2)

~250,000

~1/3rd Severe

~1/2 Symptomatic

Currently UntreatedCurrently UntreatedIndicated for surgeryIndicated for surgery(3(3))

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

TAVR

g yg y

SAVR

612/9/2011


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Edwards Believes TAVR Will Motivate Edwards Believes TAVR Will Motivate Untreated Patients to Explore OptionsUntreated Patients to Explore Options

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

These untreated patients do not These untreated patients do not receive intervention for reasons receive intervention for reasons ( 250,000 Patients)

TAVR

Currently UntreatedCurrently UntreatedIndicated for surgeryIndicated for surgery(1)(1)

SAVR

which could include:which could include:•• Too sick to benefit from AVRToo sick to benefit from AVR•• High risk or inoperableHigh risk or inoperable•• Patient refusalPatient refusal•• Not currently managed by a cardiologistNot currently managed by a cardiologist•• UndiagnosedUndiagnosed

(1) Bonow 2006 712/9/2011

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

The Introduction of TAVR Stimulated The Introduction of TAVR Stimulated Procedure Growth in EuropeProcedure Growth in Europe

E.U. AVR Units (SAVR & TAVR)

TAVRTAVR

SAVR

2004 2005 2006 2007 2008 2009 2010 2011

8Source: Internal Estimates

AVR CAGRAVR CAGR 3.1%3.1%(E)

20042004--20072007

AVR CAGRAVR CAGR 6.3%6.3%20072007--2011(E2011(E)

12/9/2011


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Edwards’ AVR Growth Has Been Lifted Edwards’ AVR Growth Has Been Lifted Even Further with TAVREven Further with TAVR

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

TAVR

EDWARDS

TAVR

SAVR

AVR CAGRAVR CAGR 20042004--20072007

AVR CAGRAVR CAGR

2004 2005 2006 2007 2008 2009 2010 2011

20072007--2011(E)2011(E)

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(E)

5.6%5.6%13.3%13.3%

12/9/2011 Source: Internal Estimates

Formal Reimbursement for TAVR in Formal Reimbursement for TAVR in Europe is Expected to ExpandEurope is Expected to Expand

SpainSpain

GreeceGreece

BelgiumBelgium

SpainSpain

GreeceGreece

BelgiumBelgium

FinlandFinland

NorwayNorway

SwitzerlandSwitzerland

United KingdomUnited Kingdom

ItalyItaly

AustriaAustria

The NetherlandsThe Netherlands

SwedenSweden

United KingdomUnited Kingdom

ItalyItaly

FinlandFinland

NorwayNorway

SwitzerlandSwitzerland

AustriaAustria

The NetherlandsThe Netherlands

SwedenSweden

DenmarkDenmark

FranceFrance

GermanyGermany

DenmarkDenmark

FranceFrance

GermanyGermany

Reimbursement in 2012

Formal Reimbursement Temporary and/or Case by Case Reimbursement Hospital Budget

Reimbursement in 2011

1012/9/2011


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We Believe Edwards Maintains Leadership We Believe Edwards Maintains Leadership Even With Increased CompetitionEven With Increased Competition

Estimated OUS TAVR Units*

Startup

Edwards

Strategics

2010 2011 2012 2013 2014 2015 2016 2017

1112/9/2011 *Excludes Japan

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

INDICATION

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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


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Edwards is Planning Rigorous Post Edwards is Planning Rigorous Post Approval StudiesApproval Studies

Two Post Approval Studies (PAS) Planned

PAS 1: PAS 2:Continued Follow-Up of

Premarket Cohort

PAS 2:Newly Enrolled Study

• 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

• 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 annuallyy

• Annual assessment for five years

Edwards to collect data and Edwards to collect data and report to FDAreport to FDA

Ultimately recorded into a Ultimately recorded into a national registrynational registry

Assessment at 30 days and annually for 5 years

1312/9/2011

Edwards Believes That a WellEdwards Believes That a Well--Written Written NCD Should Include:NCD Should Include:

IndicationIndication• Inoperable and high risk patients • Future indications as they are FDA approved• IDE or other qualifying clinical study

FacilityFacilityRequirementsRequirements

• 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*

Training Training ProgramProgram

• Edwards-provided comprehensive training program• Credentialing responsibility retained by hospitals

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

Data Data CollectionCollection

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

1412/9/2011


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2011 2012

Oct Nov Dec Jan Feb Mar Apr May Jun Jul

Formalized U.S. Reimbursement is Formalized U.S. Reimbursement is Moving QuicklyMoving Quickly

CMS Timeline

p y

30 day Public Comment Period

NCD Assessment Begins

CMS Issues Proposed NCD

CMS IssuesFinal NCD

30 day Public Comment Period

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

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A wellA well--written National Coverage Determination written National Coverage Determination (NCD) would be positive for patients and physicians (NCD) would be positive for patients and physicians

by insuring uniform coverage nationallyby insuring uniform coverage nationally

12/9/2011

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

Edwards U.S. THV Cumulative Revenue$500

K)

High Risk Patients

Cohort A Approval

$250

Cum

ulat

ive

Sal

es (

US

D, $

K

16

Inoperable Patients

Months After Launch$0

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

November Launch

12 months

12/9/2011

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


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Edwards is On Track for $20Edwards is On Track for $20--$25 Million of $25 Million of Sales in the First Three MonthsSales in the First Three Months

As always, our guiding principle is to ensure excellent clinical outcomes for patients

SiteSite A f bilit d t hi

Guiding Guiding PrinciplePrinciple

Site Site SelectionSelection

• A focus on capability and partnership secure a successful heart team on day one and long term

• Sites demonstrate commitment to a TAVR program through an initial stocking order of 8 units

Disciplined Disciplined TrainingTraining

Edwards’ robust program includes:• Didactic session• Case observation• Simulations • ProctoringProctoring• Clinical specialists will support initial cases

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

1712/9/2011

Procedures are Expected to Ramp Procedures are Expected to Ramp Steadily as the Launch ProgressesSteadily as the Launch Progresses

Conceptual U.S. TAVR Growth by Quarter

Procedures

4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

2011 2012 2013

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2011 2012 2013

12/9/2011


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Reported Sales are Impacted by Reported Sales are Impacted by Stocking and Consignment CadenceStocking and Consignment Cadence


Procedures

ReportedSales

4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

2011 2012 2013

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Stocking orders boost sales Stocking orders boost sales in early launchin early launch

2011 2012 2013

12/9/2011



Procedures

ReportedSales

4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

2011 2012 2013

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Reported sales appear flat in midReported sales appear flat in mid--launch launch due to consignment effectdue to consignment effect

2011 2012 2013

12/9/2011


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Procedures

ReportedSales

4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

2011 2012 2013

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2011 2012 2013

12/9/2011

Reported sales approximate procedure Reported sales approximate procedure growth in midgrowth in mid--20132013

Review of The PARTNER Trial PMA Review of The PARTNER Trial PMA TimingTiming

2010 2011 2012

The PARTNER Trial, Cohort B

1 Year Follow-Up Complete Q2Q2PMA Approved PMA Approved

November 2 2011!November 2 2011!1 Year Follow-Up Complete Q2Q2

FDA Submission Q4Q4

FDA Panel Q3Q3

PMAPMA ApprovalApproval Q4

The PARTNER Trial, Cohort A

1 Year Follow-Up Complete Q4Q4

November 2, 2011!November 2, 2011!1 year from submission 1 year from submission

to approval to approval (FDA average is ~550 days)(FDA average is ~550 days)

Assuming 1 year from submission to approval 1 Year Follow Up Complete Q4Q4

FDA Submission Q2Q2

FDA Panel* Q1Q1

PMAPMA Approval*Approval* Q2

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

pp(FDA average is ~550 days)

2212/9/2011


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The PARTNER II Trial is ApprovedThe PARTNER II Trial is Approved

Symptomatic Severe Aortic StenosisSymptomatic Severe Aortic StenosisSymptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis

ASSESSMENT: OperabilityASSESSMENT: Operability

TransapicalTransapicalTransapicalTransapical

ASSESSMENT: Access

ASSESSMENT: Access

Transfemoral Transfemoral Transfemoral Transfemoral

ASSESSMENT: Transfemoral

Access


Access

Total ~ 2,600 patients

2 Parallel Trials: Individually Powered

InoperableInoperable n>600n~2,000 OperableSTS > 4

OperableSTS > 4

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TTAVRAVRTransTrans

femoral

TTAVRAVRTransTrans

femoralAVRAVRAVRAVR

Primary Endpoint: All Cause Primary Endpoint: All Cause Mortality and Mortality and Major StrokeMajor Stroke


TTAVRAVRTransTransapicalapical


AVRAVRAVRAVR

1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization

VSVS

TTAVR AVR SAPIEN XTSAPIEN XT


Nested Nested RegistryRegistryNested Nested

RegistryRegistry

TTAVR AVR SAPIENSAPIENTTAVR AVR

SAPIENSAPIEN

Primary Endpoint: All Cause Mortality and Primary Endpoint: All Cause Mortality and Major StrokeMajor Stroke


1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization

VS

2 year follow-up 1 year follow-up

The PARTNER II Trial, Cohort B Enrollment The PARTNER II Trial, Cohort B Enrollment Continues, Expected Completion January 2012Continues, Expected Completion January 2012




Access


Access

n>600The PARTNER II Trial, Cohort B

Enrollment completion expected

InoperableInoperable



Nested Nested RegistryRegistryNested Nested

RegistryRegistry

TTAVR AVR SAPIENSAPIENTTAVR AVR

SAPIENSAPIEN



1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization

VS

1 year follow-up

expected January 2012


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The PARTNER II Trial, Cohort A was Approved for The PARTNER II Trial, Cohort A was Approved for Moderate Risk Patients on November 7, 2011Moderate Risk Patients on November 7, 2011



TransapicalTransapicalTransapicalTransapical

ASSESSMENT: Access

ASSESSMENT: Access

Transfemoral Transfemoral Transfemoral Transfemoral

n~2,000

• Includes severe, symptomatic moderate risk patients

• 1:1 randomization against surgery

• 2 year follow-up

The PARTNER II Trial, Cohort A:Trial Design

OperableSTS > 4

OperableSTS > 4

TTAVRAVRTransTrans

femoral

TTAVRAVRTransTrans

femoralAVRAVRAVRAVR





AVRAVRAVRAVR

1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization

VSVS

2 year follow-up

PARTNER II Cohort A Targets an PARTNER II Cohort A Targets an Expanded IndicationExpanded Indication

ts*

STS Risk Score for Isolated SAVRs in the U.S.30%

The PARTNER II Trial, Cohort A~40% of Total

The PARTNER

Trial<10% of Total

All

Iso

late

d S

AV

R P

atie

nt

5%

10%

15%

20%

25%

STS Score

% o

f A

12/9/2011 STS National Adult Cardiac Database, 2005 Harvest. Isolated SAVR.

0%

5%

0 1 2 3 4 5 6 7 8 9 10 >10


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2009 2010 2011 2012 2013 2014 2015 2016 2017

Estimated U.S. Approval for SAPIEN Estimated U.S. Approval for SAPIEN and SAPIEN XTand SAPIEN XT

PARTNER PARTNER Cohort BCohort B FDA FDA R iR i

Approved

Average FDA Average FDA Review Review 22

EW AssumedEW AssumedFDA FDA ReviewReview11

PARTNER PARTNER IIIISAPIEN XTSAPIEN XT

Cohort B: NovaFlex+ Only

SAPIENSAPIEN

PARTNER Cohort APARTNER Cohort ASAPIENSAPIEN

Enroll Enroll PatientsPatients

Review Review (367 days)(367 days)

Average FDA Average FDA Review Review 22

EW AssumedEW AssumedFDA FDA ReviewReview11

Cohort A:22 YY FilFil

EW AssumedEW AssumedFDAFDA ReviewReview11

1 Yr 1 Yr Follow UpFollow Up& File PMA& File PMA

E llE ll

pp

1 Edwards assumes a 12 month or 365 day review/approval time2 FDA review/approval time averaging over 550 days over past two years

27

NovaFlex+ & Ascendra+

2 2 Yr Yr Follow UpFollow Up

File File PMAPMA Average FDA Average FDA

Review Review 22

FDA FDA ReviewReview11Enroll Enroll PatientsPatients

12/9/2011

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

Procedure enhancements

Edwards Has a MultiEdwards Has a Multi--Faceted Faceted Approach to Address StrokeApproach to Address Stroke

– 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 E th PROTAVI t i l ill t d th f t k• In Europe, the PROTAVI trial will study the causes of stroke 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

2812/9/2011


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In the U.S., the SAPIEN Platform is Commercial In the U.S., the SAPIEN Platform is Commercial While the SAPIEN XT Platform is in IDE TrialWhile the SAPIEN XT Platform is in IDE Trial

Commercial Device*Commercial Device* IDE Trial EnrollingIDE Trial Enrolling

SAPIEN XT THV*SAPIEN THV

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Provides predictable and precise valve deploymentProvides predictable and precise valve deployment

Lower profile, improved delivery and valve designLower 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.

The OUS Offering Features The OUS Offering Features SAPIEN XT, Available in Four SizesSAPIEN XT, Available in Four Sizes

OUS Commercial OfferingOUS Commercial Offering

SAPIEN XT THV*

TransapicalTransapical and and TransaorticTransaortic** ApproachApproach

Transfemoral ApproachTransfemoral Approach

NovaFlex+with eSheath

Sizes Available

16 17 18 19 20 21 22 23 24 25 26 27

20mm*

30

Ascendra+*

Annulus Size (mm)

23mm26mm

29mm*

Sizes Available

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.

Japan EU


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Building on a Solid Foundation …Building on a Solid Foundation …

O U S C i l

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.

12/9/2011

U.S. Offering

SAPIEN THV

Commercial Device*

OUS Offering

SAPIEN XT THV

IDE Trial Enrolling

SAPIEN XT THV

O.U.S. Commercial Offering

…Expect CE Mark Trials on Two New Valve …Expect CE Mark Trials on Two New Valve Platforms in 2012Platforms in 2012

Balloon Expandable Self Expanding

O U S C i l

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.

12/9/2011

U.S. Offering

SAPIEN THV

Commercial Device*

OUS Offering

SAPIEN XT THV

IDE Trial Enrolling

SAPIEN XT THV

O.U.S. Commercial Offering


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Edwards SAPIEN 3 ValveEdwards SAPIEN 3 ValveUltra Low Profile Balloon Expandable Platform

SAPIEN 3 Advances BestSAPIEN 3 Advances Best--inin--Class Class DesignDesign

Ultra Low-Profile Balloon Expandable Platform

•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

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•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.

Edwards CENTERA ValveEdwards CENTERA Valve

CENTERA is Edwards’ First CENTERA is Edwards’ First SelfSelf-- Expanding Transcatheter ValveExpanding Transcatheter Valve

Ultra Low Profile Self Expanding Platform

•Motorized delivery system for stable deployment and single operator use

•Repositionable

•Delivered through a 14 Fr eSheath

•Discrete valve that anchors in the annulus

Ultra Low-Profile Self Expanding Platform

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•Treated bovine pericardial tissue leaflets

•Transfemoral and subclavian approach

12/9/2011

FirstFirst--inin--Man Experience CompletedMan Experience Completed

The Edwards CENTERA Valve System is not available for commercial sale in the U.S.


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• Edwards v. CoreValve appeal decision expected in mid 2012

U.S. THV Litigation Provides 2012 U.S. THV Litigation Provides 2012 Potential UpsidePotential Upside

– 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

• Sales outlook of $560-$630 million– Includes $200-$260 million of U.S. sales

• Expected OUS product launches

2012 Outlook2012 Outlook

p p– 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

3612/9/2011


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3-transcatheter heart valves

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