edwards lifesciences 2015 investor conference

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2015 Investor Conference December 9, 2015 Irvine, California

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Page 1: Edwards Lifesciences 2015 Investor Conference

2015 Investor ConferenceDecember 9, 2015Irvine, California

Page 2: Edwards Lifesciences 2015 Investor Conference

2015 Investor ConferenceDavid K. EricksonVice President, Investor Relations

Page 3: Edwards Lifesciences 2015 Investor Conference

3

Cautionary StatementPresentations and comments made today by the management of Edwards Lifesciences Corporation will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions. These may include, but are not limited to, the company’s financial goals or expectations for 2015, 2016 and beyond (including sales, gross profit, earnings per share and its key components, free cash flow, SG&A, R&D, net interest expense, tax rate, diluted shares outstanding, and other financial expectations, such as several of these measures expressed as percentages); expectations for new products (including, first-in-human feasibility, the timing and results of clinical trials and regulatory approvals, and reimbursement coverage); industry growth projections, the ability to extend leadership positions and build clinical and economic evidence, forecasted trends in patient treatment and demographics; timing and impact of competitor product introductions; strategies for the company’s new and existing products; and the impact of foreign exchange, and special items on the company’s results.

Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the Company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward looking statements are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2014.

12/9/15

Page 4: Edwards Lifesciences 2015 Investor Conference

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Use of Non-GAAP Financial Measures Unless otherwise indicated, all figures are GAAP financial measures The Company uses the term “underlying” when referring to non-GAAP sales information,

which excludes discontinued and acquired products, foreign exchange fluctuations, and the THVT sales return reserves and “excluding special items” and “adjusted net income” and “adjusted EPS” to also exclude gains and losses from special items such as significant investments, litigation, amortization and business development transactions.

A reconciliation of non-GAAP historical financial measures to the most comparable GAAP measure is available at www.edwards.com

The Company is not able to provide a reconciliation of future projections that exclude special items to expected reported results due to the unknown effect, timing and potential significance of special charges or gains, and management’s inability to forecast charges associated with future transactions and initiatives

12/9/15

Page 5: Edwards Lifesciences 2015 Investor Conference

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Clinician Disclosures Dr. Vinod Thourani and Dr. Maurice Sarano are paid to consult for Edwards Lifesciences

The opinions expressed by these clinicians are their own and do not necessarily reflect the views of Edwards Lifesciences

12/9/15

Page 6: Edwards Lifesciences 2015 Investor Conference

Opening RemarksMichael A. MussallemChairman and CEO

Page 7: Edwards Lifesciences 2015 Investor Conference

7

Driven by a Passion to Help Patients

Edwards partners with

clinicians to develop innovative

technologies in the areas of

structural heart disease and

critical care monitoring that enable

them to save and enhance lives.

12/9/15

Page 8: Edwards Lifesciences 2015 Investor Conference

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Edwards’ Guiding Philosophies

Our Credo Our AspirationsWe are dedicated to providing innovative solutions for people fighting cardiovascular disease

Trusted partner Unify stakeholders Improve patients’ quality of life

Edwards will be recognized as a company that…

Transforms patient care though innovative technology

Excels as a trusted partner and global leader through the quality of our work

Attracts and engages talented employees Strengthens our communities Creates exceptional shareholder value

12/9/15

Page 9: Edwards Lifesciences 2015 Investor Conference

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Global Leadership

Over 95% of sales from products in #1 global positions

Serving patients in more than 100 countries worldwide

U.S.

Europe

Japan

ROW

2010 2015E

Transcatheter Heart

Valve Therapy

Surgical Heart Valve

Therapy

Critical CareSurgical Heart

Valve Therapy

Critical Care

THVT

12/9/15

Page 10: Edwards Lifesciences 2015 Investor Conference

Edwards’ Strategy

10

• Breakthrough therapies with superior clinical and economic evidence

• Active product portfolio management

Focused Innovation

• Pioneering legacy of establishing standards of care

• Trusted relationships with clinicians, payors and regulators

Industry LeadershipPatient-Centric

• Fulfilling unmet needs of structural heart and critically ill patients

• Transforming care drives enduring value creation

Create Value with Therapies that Transform Patient Care

12/9/15

Page 11: Edwards Lifesciences 2015 Investor Conference

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Patient Focus Drives Value Creation

Patients are our ultimate customer Significant opportunities in addressing unmet patient needs Globally, demand is growing, as is desire for superior therapies Although under-represented, the patients’ voice is intensifying It aligns our strategy with clinicians, payors and providers Employees are inspired by patient focus

12/9/15

Page 12: Edwards Lifesciences 2015 Investor Conference

Benefits of Focused Innovation for Patients

An unmatched expertise concentrated on the structures of the heart and technologies that monitor its performance

Strengthened ability to learn and innovate faster than others with broader interests

Each innovation lays the groundwork for the next step forward Creates a healthy discipline for investment priorities Expertise to develop the evidence to support superior, highly differentiated

products

1212/9/15

R&D investments in new products drove 5-year double-digit sales CAGR

Page 13: Edwards Lifesciences 2015 Investor Conference

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Industry Leadership is a Competitive Advantage

Enduring leadership provides credibility to meet challenges and transform care Trusted relationships with key stakeholders in new therapy development Ability to help develop regulatory pathways and appropriate pricing Demonstrate value through improved quality of life and healthcare economics

12/9/15

Page 14: Edwards Lifesciences 2015 Investor Conference

2015 Review & 2016 Outlook

Page 15: Edwards Lifesciences 2015 Investor Conference

15

2015: Macro Environment Healthcare industry is consolidating and evolving rapidly Innovation environment continues to advance

− Regulatory climate in U.S. more flexible, yet quality standards are much higher− Appropriate reimbursement requires demonstrated value

Emerging markets challenging but remain attractive long-term Strengthening U.S. dollar is a significant headwind Edwards-specific sector trends

− THVT: has become the standard of care for higher risk patients

− SHVT: favorable demographics and preference for less invasive options− CC: preference for improved outcomes and noninvasive therapies− Investments in interventional structural heart solutions are on the rise

12/9/15

Page 16: Edwards Lifesciences 2015 Investor Conference

16

2015: Results are Exceeding Original Expectations

Total underlying sales growth estimated to reach 15%– Global THVT underlying sales growth estimated around 35%

Strengthened leadership positions– SAPIEN 3 reinforced leadership – Global SHVT growing as we expected driven by INTUITY Elite– Critical Care meeting our expectations driven by ESR

FX hedging protected +30% earnings growth Significant investments in our operations Encouraging progress on key R&D milestones

– Aggressively invested in mitral innovations– Bolstered pipeline of structural heart initiatives

12/9/15

Page 17: Edwards Lifesciences 2015 Investor Conference

17

Growing Confidence in TAVR Outlook

Strong evidence driving adoption, indication expansion, new applications SAPIEN 3 is the clear leader with differentiated results Indication expansion pathways becoming clearer Global TAVR opportunity could exceed $5B in 2021

– TAVR redefines therapy options for patients– Confident in intermediate risk approval– Further indication expansion opportunity is significant

12/9/15

Page 18: Edwards Lifesciences 2015 Investor Conference

18

2016: Executing Our Long Term Strategy

Edwards expects continued strong performance in 2016 led by TAVR– Continued leadership in core businesses– Investing in pipeline to strengthen leadership

Projecting solid financial results– Partially offset foreign exchange headwinds with disciplined U.S. spending

Implementing our strategic imperatives– Update and expand infrastructure and production capacity– Continue investment in quality systems– Fuel long-term TAVR growth– Expanding into structural heart adjacencies

12/9/15

Page 19: Edwards Lifesciences 2015 Investor Conference

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2016: Guidance(Excludes special items)

($ in millions, except EPS) 2016 Guidance

Total Net Sales $2,500 - $2,750

Gross Profit Margin 74% - 75%

Free Cash Flow $400- $440

EPS $2.30 - $2.40($4.60 - $4.80 pre-split)

12/9/15

Page 20: Edwards Lifesciences 2015 Investor Conference

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Conference Agenda

Transcatheter Heart Valve Therapy - Larry L. Wood– Optimizing the Treatment of Aortic Stenosis

Guest Speaker: Vinod H. Thourani, MD Surgical Heart Valve Therapy – Bernard J. Zovighian Structural Heart Growth Initiatives – Donald E. Bobo, Jr.

– The Burden of Structural Heart Disease Guest Speaker: Maurice E. Sarano, MD

Critical Care – Katie M. Szyman Financial Outlook - Scott B. Ullem Closing Remarks - Michael A. Mussallem

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Page 21: Edwards Lifesciences 2015 Investor Conference

21

Michael A. MussallemChairman & CEO

Edwards’ Leadership Team

Aimee S. WeisnerGeneral Counsel

Larry L. WoodTranscatheter Heart Valves

Donald E. Bobo, Jr.HVT, Corp Strategy & Development

Dirksen J. LehmanPublic Affairs

Scott B. UllemChief Financial Officer

John P. McGrathQuality, Regulatory, Clinical

Rich LunsfordHealthcare Solutions

Stanton J. RoweAdvanced Technology& Chief Scientific Officer

Christine Z. McCauleyHuman Resources

Patrick B. VerguetEMEA, Canada and Latin America

Huimin Wang, M.D.Japan, Asia and Pacific

Katie M. SzymanCritical Care

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Page 22: Edwards Lifesciences 2015 Investor Conference

Transcatheter Heart Valve TherapyLarry L. WoodCorporate Vice President,General Manager,Transcatheter Heart Valves

Page 23: Edwards Lifesciences 2015 Investor Conference

23

Transcatheter Heart Valve Therapy

Estimated 2015 Global Sales

U.S.Europe

JapanROW

Transcatheter Heart

Valve Therapy

Surgical Heart Valve Therapy

Critical Care

12/9/15

The Leader in a ~$2B Global Transcatheter Heart Valve Segment

Page 24: Edwards Lifesciences 2015 Investor Conference

24

Leadership & Innovation Strategy

Focus on expanding patient access– Disease and therapy education and awareness– Patient community outreach and advocacy– Patient peer support programs

Patient-Centric Focus

Focused Innovation

Industry Leadership

SAPIEN 3 delivered superior clinical outcomes Actively leveraging current platforms for additional indications Next generation valve platforms under development

Edwards is well positioned to maintain global TAVR leadership– Driven by our technology, clinical evidence, and improving economics

Trusted relationships with clinicians, payers, and regulators

12/9/15

Page 25: Edwards Lifesciences 2015 Investor Conference

2013 2014 2015$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

Global THVT Sales for 2015 Expected at the High End of Guidance Range

25

Global THVT Sales1

$M, U

SD

Estimate

(1) Non-GAAP, reported sales excluding impact of sales return reserves.

2015 Guidance (Q3 Earnings Call)

$1.1B - $1.2B(high end of 25% - 35%

underlying growth)

12/9/15

Page 26: Edwards Lifesciences 2015 Investor Conference

The Growth Rate of TAVR Has Been Strong but Not Linear

26

Sale

s ($

M)

YoY Sales Growth

Edwards’ Global TAVR Sales by Quarter1

1Q08

2Q08

3Q08

4Q08

1Q09

2Q09

3Q09

4Q09

1Q10

2Q10

3Q10

4Q10

1Q11

2Q11

3Q11

4Q11

1Q12

2Q12

3Q12

4Q12

1Q13

2Q13

3Q13

4Q13

1Q14

2Q14

3Q14

4Q14

1Q15

2Q15

3Q15

$0

$50

$100

$150

$200

$250

$300

12/9/15

(1) Non-GAAP, reported sales excluding impact of sales return reserves.

2008 2009 2010 2011 2012 2013 2014 2015(E)

>1000% 111% 84% 62% 65% 31% 29% 25%

Page 27: Edwards Lifesciences 2015 Investor Conference

The Growth Rate of TAVR Has Been Strong but Not Linear

27

Sale

s ($

M)

2008 2009 2010 2011 2012 2013 2014 2015(E)

>1000% 111% 84% 62% 65% 31% 29% 25%YoY Sales Growth

Edwards’ Global TAVR Sales by Quarter1

1Q08

2Q08

3Q08

4Q08

1Q09

2Q09

3Q09

4Q09

1Q10

2Q10

3Q10

4Q10

1Q11

2Q11

3Q11

4Q11

1Q12

2Q12

3Q12

4Q12

1Q13

2Q13

3Q13

4Q13

1Q14

2Q14

3Q14

4Q14

1Q15

2Q15

3Q15

$0

$50

$100

$150

$200

$250

$300

12/9/15

(1) Non-GAAP, reported sales excluding impact of sales return reserves.

Page 28: Edwards Lifesciences 2015 Investor Conference

The Growth Rate of TAVR Has Been Strong but Not Linear

28

Sale

s ($

M)

YoY Sales Growth

Edwards’ Global TAVR Sales by Quarter1

1Q08

2Q08

3Q08

4Q08

1Q09

2Q09

3Q09

4Q09

1Q10

2Q10

3Q10

4Q10

1Q11

2Q11

3Q11

4Q11

1Q12

2Q12

3Q12

4Q12

1Q13

2Q13

3Q13

4Q13

1Q14

2Q14

3Q14

4Q14

1Q15

2Q15

3Q15

$0

$50

$100

$150

$200

$250

$300

12/9/15

(1) Non-GAAP, reported sales excluding impact of sales return reserves.

2008 2009 2010 2011 2012 2013 2014 2015(E)

>1000% 111% 84% 62% 65% 31% 29% 25%

Page 29: Edwards Lifesciences 2015 Investor Conference

29

The TAVR Opportunity Remains Attractive with Our Primary Growth Drivers Technology

– Less invasive– Alternative to surgery for high-risk aortic stenosis patents– Transfemoral access continues to increase over time

Clinical evidence– Tens of thousand of people enrolled in clinical studies– Our trials and technology prove TAVR to be a better option for many patients

Improving economics– Dramatic technology improvements addressing critical needs and improving outcomes– Decreasing length of stay and improving reimbursement

12/9/15

Page 30: Edwards Lifesciences 2015 Investor Conference

30

The Edwards SAPIEN 3 Ultra System Further Streamlines the TAVR Procedure

SAPIEN 3 Ultra Delivery System Axela Sheath

• On-balloon delivery system• 14F compatibility for all valve sizes

Expect CE Mark Approval in Q4 2016

1.6% All-cause mortality0.8% Disabling stroke

491 Patients

Partner II Trial high-risk TF SAPIEN 3 valve 30-day outcomes. SAPIEN 3 Ultra Delivery System and Axela Sheath are not approved for sale.

SAPIEN 3 Valve

• Next-generation sheath• Facilitates dynamic expansion and contraction

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Page 31: Edwards Lifesciences 2015 Investor Conference

31

The Edwards SAPIEN 3 Ultra Delivery System –Innovating Valve Delivery

Redesigned shaftFacilitates greater distal flexNo pusher required

On-balloon design Reduces steps and streamlines procedure

Ergonomic handle design Allows for single-handed control

Short, tapered atraumatic tip For improved crossability

12/9/15

SAPIEN 3 Ultra Delivery System is not approved for sale.

Page 32: Edwards Lifesciences 2015 Investor Conference

32

The Edwards Axela Sheath – Innovating Access

• Dynamic expansion and contraction

• Improved haemostasis• 14F compatibility across

all valve sizes

Innovating expandable sheath technology with the Axela sheath

(1) Généreux P. JACC 2012. (2) Pichard A. JACC 2014. (3) Kodali S. Presented at ACC 2015. . Axela Sheath is not approved for sale.

PARTNER I Cohort B SAPIEN Valve

PARTNER II Cohort B SAPIEN Valve

PARTNER II Cohort BSAPIEN XT Valve

PARTNER II TrialSAPIEN 3 Valve

17.5%115.5%2

9.6%2

5.3%330- D

ay M

ajor

Va

scul

ar C

ompl

icat

ions

Reduction in Major Vascular Complications in Transfemoral Patients

n = 271 n = 282 n = 491n = 177

12/9/15

Page 33: Edwards Lifesciences 2015 Investor Conference

33

Flex mechanism for trackability and coaxial alignment

User-controlled motorized handle

CENTERA Design Expected to be Best-in-Class Self-Expanding Platform

Enhanced delivery system articulation 100% repositionability Low 14F profile Quick device preparation Stable and predictable deployment

Expect CE Mark Approval in Second Half of 2017

12/9/15

CENTERA is not approved for sale.

Page 34: Edwards Lifesciences 2015 Investor Conference

34

Significant Progress on Pulmonic Indication Expected in 2016

SAPIEN XT SAPIEN 3

• PMA approval anticipated early next year• Clinical trial ramping• 10 sites / 50 patients• Expect enrollment to be completed in 2016

Commercial Clinical

IDE ApprovedPMA Status

12/9/15

Page 35: Edwards Lifesciences 2015 Investor Conference

35

MITRAL

PULMONIC

TRICUSPID

HEART FAILURE

Edwards is Pursuing Both New Valve Platforms and Indication Expansion Utilizing Current Platforms

CENTERA

SAPIEN XT

Edwards’ Platforms Additional Applications

SAPIEN 3 Next Gen

Next Gen

RVOT: Right ventricular outflow tract IVC: Interior vena cava

Mitral Annular Calcification

RVOT StentOther Congenital Valve

UNLOAD trial

IVC

While smaller opportunities, these applications are meaningful to patients and leverage existing platforms

12/9/15

Page 36: Edwards Lifesciences 2015 Investor Conference

36

An Increasing Body of Evidence is Changing the Treatment of Aortic Stenosis

PARTNER IB Inoperable patients

SAPIEN valve

2011 2012 2013 2014 2015 2016

PARTNER IA High risk patients

SAPIEN valve

PARTNER IIB High risk patients

SAPIEN XT valve

PARTNER II S3 High risk patients

SAPIEN 3 valve

PARTNER II S3i Intermediate risk

patients

SAPIEN 3 valve

TAVR

SAVR1

Currently Untreated

Currently Untreated

SAVR1

TAVR TAVR

SAVR1

Currently Untreated

(1) Isolated SAVR for severe symptomatic AS

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Page 37: Edwards Lifesciences 2015 Investor Conference

37

With an Intermediate Risk Indication We Will Expand Patient Access

PARTNER II

1:1 Randomization

TAVR

XT IR Cohort

We expect to present PARTNER II follow up data at ACC 2016 and anticipate approval late 2016

S3 IR Cohort

SAVR TAVR

n=2000 n=1000

2-year follow up1-year follow up

vs.data analysis of PII A SAPIEN XT arm

PII: PARTNER II

12/9/15

Page 38: Edwards Lifesciences 2015 Investor Conference

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

The PARTNER Trial<15% of Total

The Use of Surgical Risk Scores to Define TAVR Eligibility is Inadequate

38

STS Score

% o

f All

Isol

ated

SAV

R P

atie

nts

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

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

0%

5%

10%

15%

20%

25%

30%

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

12/9/15

Page 39: Edwards Lifesciences 2015 Investor Conference

39

Additional Risk Factors and Considerations Not Captured in STS Risk Score Become More Important With Patient Age

Ris

k Fa

ctor

s

Risks do not increase STS

Severe Symptomatic AS

NYHA IV

STS12 12 • Frailty• Hostile chest• Reoperations• Radiation

90 Year Old Patient 90 Year Old Patient

Heart team assessment is the most critical part of defining a patient’s risk

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Page 40: Edwards Lifesciences 2015 Investor Conference

40

Heart team assessment critical in estimating patient risk

Patient #1 Patient #2 Patient # 3

Age 82 year old maleSevere AS & NYHA IV Heart

Failure symptoms

73 Year old maleSevere AS & NYHA III Heart

failure symptoms

79 year old female with severe AS & NYHA class III

STS score 3.5 2.5 2.4

Patient History • Hypertension• No CAD• No PVD

• Hyperlipidemia• Hypertension• AAA

• CAD• LBBB• Anemia

Heart Team Assessment

Determined intermediate risk by the Heart Team due to limited ambulation and poor rehab potential secondary to osteoarthritis

Determined intermediate risk by the Heart Team due to history of prior sternotomy with prolonged ventilation and sternal wound infection

Determined intermediate risk by the Heart Team due to frailty and poor rehab potential

Page 41: Edwards Lifesciences 2015 Investor Conference

41

However, as Risk Scores Come Down, Age Has Stayed Relatively Constant

InoperablePARTNER IB

High RiskPARTNER IA

High RiskPII S3HR

Intermediate RiskPII S3i

Avg STS 11.2% 11.8% 8.6% 5.3%

Avg Age 83.1 years 83.6 years 82.6 years 81.9 yearsN 179 348 583 1,076

InoperablePARNTER IB

High RiskPARTNER IA

High RiskPARTNER II S3

Intermediate RiskPARTNER II S32

0%

3%

6%

9%

12%

15%

0

20

40

60

80

100

Average Age Average STSST

S Sc

ore

Age

(Yea

rs)

Baseline Patient Characteristics in Pivotal Trials

This suggests age and comorbidities not captured in the risk score are important factors in therapy decision making

12/9/15

Page 42: Edwards Lifesciences 2015 Investor Conference

42

TAVR Age Distribution Has Stayed Very Consistent Despite Indication Expansion and Procedural Growth

40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 94 97 100

0%

1%

2%

3%

4%

5%

6%

7%201220132014

% o

f TAV

R P

roce

dure

s

TAVR Distribution by Age Over Time

2012 2013 2014Sales ($M) $227 $395 $620Growth >100% 73% 57%Indication Inop High Risk High Risk

Advanced age is clearly playing a role in the heart team assessment of riskSOURCE: Edwards’ implant patient registry

12/9/15

Page 43: Edwards Lifesciences 2015 Investor Conference

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

SAVR

Historically, Our Understanding of Aortic Stenosis Was Based on Surgical Experience

43

Age

Patie

nts

2015 Severe Symptomatic AS Patients in the U.S.1

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Brown 2008, Thourani 2015, internal estimates.

12/9/15

Page 44: Edwards Lifesciences 2015 Investor Conference

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

SAVR

TAVR

TAVR Experience Has Changed Our Understanding of Aortic Stenosis

44

Age

Patie

nts

2015 Severe Symptomatic AS Patients in the U.S.1

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Brown 2008, Thourani 2015, internal estimates.

12/9/15

Page 45: Edwards Lifesciences 2015 Investor Conference

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000 SAVR

TAVR

Untreated (estimated)

Age Plays a Significant Role in the Diagnosis and Treatment of Aortic Stenosis

45

Age

Patie

nts

2015 Severe Symptomatic AS Patients in the U.S.1 Observations

For Severe, Symptomatic AS Patients

• Advanced age is a barrier not only to treatment but diagnosis

‒ A safe interventional procedure has the potential to reduce these barriers

• Historically, patient treatment rates decreased with age

‒ Opportunity for TAVR to lift treatment rates in older age groups

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Brown 2008, Thourani 2015, internal estimates.

12/9/15

Page 46: Edwards Lifesciences 2015 Investor Conference

There are Many Patients Who May Benefit From TAVR

46

Moderate and Severe Aortic Stenosis(1) (AS)~1.6 M

Severe AS(1)

~580,000

Severe AS, Symptomatic(2)

~290,000

~1/2 Symptomatic

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005; Brown 2008 (n=622)

~260,000~1/2 Asymptomatic

Severe AS, Asymptomatic(2)

~290,000

2015 Total U.S. Population

High Risk

IntermediateRisk

Low Risk

12/9/15

Asymptomatic

Page 47: Edwards Lifesciences 2015 Investor Conference

47

High Risk Patients Have Gained Access Through Our PARTNER TrialsSevere Symptomatic AS

High Risk

IntermediateRisk

Low Risk

Today PARTNER IB

Inoperable patients

SAPIEN valve

Clinical EvidencePARTNER IA

High risk patients

SAPIEN valve

PARTNER IIB

High risk patients

SAPIEN XT valve

PARTNER II S3

High risk patients

SAPIEN 3 valve

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Page 48: Edwards Lifesciences 2015 Investor Conference

48

Partner II Results Expected to Enable Intermediate Risk Patient AccessSevere Symptomatic AS

Late 2016 in U.S.

PARTNER II S3i Intermediate risk patients

SAPIEN 3 valve

High Risk

IntermediateRisk

Low Risk

PARTNER II XT Intermediate risk patients

SAPIEN XT valve

Clinical Evidence

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Page 49: Edwards Lifesciences 2015 Investor Conference

49

In 2016, Edwards Plans to Initiate a Trial to Study Patients With a Lower Risk Indication

Severe Symptomatic AS

Low Risk Trial

High Risk

IntermediateRisk

Low Risk

Low risk: STS 0 to 4/5

Randomized 1:1 to surgery

TAVR for tissue valve candidate

Expect to start trial 2016

Low Risk TrialEarly Trial Design Variables

Favorable results would allow heart teams to determine appropriate therapy

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Page 50: Edwards Lifesciences 2015 Investor Conference

We Also Believe that the Severe Aortic Stenosis Asymptomatic Patients May Benefit from Therapy

50

Moderate and Severe Aortic Stenosis(1) (AS)~1.6 M

Severe AS(1)

~580,000

Severe AS, Symptomatic(2)

~290,000

~1/2 Symptomatic

~260,000~1/2 Asymptomatic

Severe AS, Asymptomatic(2)

~290,000

2015 Total U.S. Population

~290,000

12/9/15

(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005; Brown 2008 (n=622)

Asymptomatic

Page 51: Edwards Lifesciences 2015 Investor Conference

(1) Age at time of clinical presentation(2) Wood, P. Aortic stenosis. Amer J Cardiol. 1:553, 1958.

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

Valvular Aortic Stenosis in AdultsAverage Course (Post Mortem Data)

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

The Previous Belief of Waiting to Treat Patients Until Symptoms Develop Based on the Braunwald Curve Deserves Further Study

51

Average age of subjects was 48 years1

Small sample size ~64 patients2

Predates widespread use of echo Bicuspid valves included Rheumatic patients included Natural course of AS assembled from

clinical and post mortem studies from before 19553

(3) A few analyses after 1955 that were supported by hemodynamic information were also included

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Page 52: Edwards Lifesciences 2015 Investor Conference

52

Asymptomatic Severe Aortic Stenosis May Not Be as Benign as Previously Thought

Heart Failure HospitalizationAll-Cause Mortality

In the conservative group, AVR was performed in 41% of patients during follow-up

Presented at TCT 2015: T. Taniguchi et al. Evaluation of Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis. JACC. 2015; 21881.

• Japan multicenter registry• 1,808 asymptomatic patients• Two groups of initial AVR and conservative strategy

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Page 53: Edwards Lifesciences 2015 Investor Conference

53

We Expect Global TAVR Opportunity to Exceed $5B in 2021Key Modeling Assumptions

We gain approvals for intermediate risk and low risk indications– Low risk approval modeled late in the plan period– Asymptomatic patients not included

Positive outcomes and expanded indications encourage untreated patients to seek therapy

Reimbursement continues to evolve with indication approvals; modest price erosion

12/9/15

Page 54: Edwards Lifesciences 2015 Investor Conference

54

2016 Milestones

Expected U.S. approvals– SAPIEN 3 & XT intermediate risk indication – SAPIEN XT pulmonic indication

Expected U.S. trials– IDE approval low risk trial – Initiate pulmonic SAPIEN 3 trial

Expected OUS approvals– SAPIEN 3 Ultra

Japan approval– SAPIEN 3

12/9/15

Page 55: Edwards Lifesciences 2015 Investor Conference

55

Tailwinds

Excellent outcomes

Improving diagnosis and referrals

Improving TAVR economics

Headwinds

Increasing global competition

Competitive clinical trials

Overall healthcare spending pressures

Underlying Global Sales Growth Outlook

2016 Outlook

2016E

Underlying Global THVT Estimated Sales Growth

10%-18%

12/9/15

Page 56: Edwards Lifesciences 2015 Investor Conference

56

Executive Summary

Expect the TAVR opportunity to exceed $5B by 2021 Continue to build robust clinical evidence to expand patient access

– Anticipate late 2016 U.S. approval of intermediate risk indication– Important progress towards pulmonic commercialization in 2016– Low risk trial to begin in 2016

Investing to be the technology leader – Launch of SAPIEN 3 Ultra System expected in late 2016– CENTERA expected to be best in class– Next generation platforms under development

12/9/15

Page 57: Edwards Lifesciences 2015 Investor Conference

Q&A

Page 58: Edwards Lifesciences 2015 Investor Conference

BREAK

Page 59: Edwards Lifesciences 2015 Investor Conference

Surgical Heart Valve TherapyBernard J. Zovighian Vice President and General Manager, Surgical Heart Valves

Page 60: Edwards Lifesciences 2015 Investor Conference

60

Surgical Heart Valve Therapy

Transcatheter Heart

Valve Therapy

Surgical Heart Valve Therapy

Critical Care

Repair

Re-placement

Estimated 2015 Global Sales

The Leader in a ~$1.8B Global Surgical Heart Valve Segment*

Cannula

* Replacement and Repair

12/9/15

Page 61: Edwards Lifesciences 2015 Investor Conference

61

Leadership & Innovation Strategy Improve therapy options for younger patients and enable earlier interventions Facilitate minimally invasive procedures and streamline complex surgeries

12/9/15

Transform surgical therapies through unparalleled innovation and rapid launch cadence

Differentiate surgical offerings with superior clinical and health economic evidence

Build upon our long-standing partnership with surgeons to transform surgical care Expand the surgical segment and extend our leadership

Patient-Centric Focus

Focused Innovation

Industry Leadership

Page 62: Edwards Lifesciences 2015 Investor Conference

62

Surgical AVR Expected to Continue to be the Gold Standard for Younger Patients and Complex Procedures

12/9/15

We Expect to Continue to Innovate for Patients Uniquely Suited for Aortic Surgery … As TAVR indications broaden, more patients

may receive therapy Isolated aortic surgeries expected to be

impacted by TAVR over time Edwards’ surgical pipeline expected to

benefit younger and complex patients

1 Thourani. Ann Thorac Surg 2015 and internal estimates.

50 53 56 59 62 65 68 71 74 77 80 83 86 89 92 95 98

SAVR TAVR

Untreated (estimated) Series4

Patie

nts

Patient Age

2015 Severe Symptomatic AS Patients in the U.S.

Page 63: Edwards Lifesciences 2015 Investor Conference

63

…And We Will Innovate Beyond Aortics Expanding Treatment Options in Other Valve Positions

12/9/15

Degenerative Mitral Regurgitation (DMR) Established treatment practice but opportunity to improve

therapy High procedural success Generally, younger patients

Pulmonic Arm of INSPIRIS Clinical Trial (COMMENCE) Pediatric congenital patient population At higher risk for structural valve deterioration,

addressing a largely unmet need

Mitral

Tricuspid

Pulmonic

Page 64: Edwards Lifesciences 2015 Investor Conference

64

1 Double-blinded survey of 255 U.S. Surgeons, Q4 2014, 80% of U.S. cardiac surgeons implanting multiple valve brands2 Bourguignon T. et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMONT Valve in Aortic Position. Ann Thorac Surg, 2015 Mar; 99(3): 831-73 Bourguignon T. et al. Very Late Outcomes for Mitral Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: 25-year Follow-up of 450 Implantations. J Thorac Cardiovasc Surg. 2014 Nov; 148(5): 2004-11

More Long-Term Clinical Publications than Any Other Surgical Valve

Latest Studies Demonstrate Outstanding Long-Term Durability

30 Year Follow-Up

Aortic position2

12,000+ patients

25 Year Follow-Up

Mitral position3

400+ patients

The most documented surgical tissue valve~700 Clinical Publications

Surgeons Trust Edwards ValvesMore than Any Other Valve Brand

Edwards Other

Other Valve

Brands

80%WOULD CHOOSE AN EDWARDS TISSUE VALVE FOR THEMSELVES OR A CLOSE FAMILY MEMBER1

Differentiated, Long-Term Evidence and Highly Trusted Brand

12/9/15

Page 65: Edwards Lifesciences 2015 Investor Conference

65

Near-Term Options Targeting Better Outcomes for Patients

12/9/15

HarpoonMedical

Strategy

Investment in less invasive DMR therapy

Large pool of under treated patients who benefit from MR improvement

Patient and Hospital Benefit Goals

INSPIRIS Innovate our core valve portfolio

Designed to improve future TAVR valve-in-valveAortic Expected 2017 Launches in EU and U.S .

EDWARDS INTUITY

Facilitate MIS and concomitant treatment

Fewer complications, faster recovery, reduced LOS1 2016 Expected U.S. Launch

Aortic Valved Conduit (AVC)

Pre-assembled tissue valve conduit solution Expected 2017 Launches in EU and U.S.

Offer better options for younger patients

1 SOURCE: CADENCE-MIS trial, EACTS 2015; Al-Sarraf N., Int J Surg., 2011; Phan K, Ann Thorac Surg., 2014 INTUITY not approved in the U.S. INSPIRIS, AVC and Harpoon not approved for sale.

Page 66: Edwards Lifesciences 2015 Investor Conference

66

EDWARDS INTUITY Continues to Gain Broader Adoption in Europe

12/9/15

Strong EDWARDS INTUITY Elite Momentum in Europe EDWARDS INTUITY Elite Facilitates MIS AVR

2013 2014 2015E

~60% of EDWARDS INTUITY EU cases are MIS Driving ~75% of EU HVT sales growth in 2015 2X-3X price premium over Magna Ease

New

In

nova

tions

Pr

oven

PER

IMO

UN

T Te

chno

logy

Bovine pericardium & ThermaFix process

Trileaflet matched for thickness & elasticity

Woven sealing cloth Balloon-expandable frame

Trusted Platform | Rapid Deployment | Smaller Incisions

EU Unit SalesINTUITY not approved in the U.S.

Page 67: Edwards Lifesciences 2015 Investor Conference

67

Disciplined U.S. Launch Planned for EDWARDS INTUITY Elite

Robust Clinical Training Program

Methodical Account Targeting

Solid Clinical Evidence

Focused Health Economics Program

12/9/15

Value Proposition

Facilitate Minimally Invasive Surgery

Streamline Concomitant Procedures

U.S. Launch Preparation Leveraging EU Experience

INTUITY not approved in the U.S.

Page 68: Edwards Lifesciences 2015 Investor Conference

68

INSPIRIS Should Extend Our Leadership in Surgical Valves

12/9/15

Tissue option for younger patients

Improved TAVR valve-in-valve option

INSPIRIS Platform Attributes

• RESILIA tissue has demonstrated reduced calcification and improved hemodynamics in rigorous preclinical studies1

• VFit technology could improve hemodynamics following future TAVR valve-in-valve procedure

INSPIRIS(formerly ZETA)

Patient Needs

Expanding the Tissue Valve Segment to More and Younger Patients

Age

SAVR

Patie

nts

TAVR Impact Over Time

Typically Mechanical Typically Tissue SAVR TAVR

Designed for future expansion

1 Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–45INSPIRIS not approved for sale.

Page 69: Edwards Lifesciences 2015 Investor Conference

69

The VFit Feature is Designed to Be Expandable to Preserve Effective Orifice Area (EOA)

Larger is Better1

Better survival of Valve-in-Valve TAVR patients in

larger-size surgical valves

1Dvir D, et al. JAMA, Transcatheter Aortic Valve Implantation in Failed Bioprosthetic Surgical Valves, 2014;312(2):162-170.

INSP

IRIS

Con

vent

iona

l

INSPIRIS TAVR Valve

Conventional TAVR Valve

Initial Surgical Valve EOA preserved after TAVR Valve-in-Valve

Significant Surgical Valve expansion

12/9/15

INSPIRIS not approved for sale.

Page 70: Edwards Lifesciences 2015 Investor Conference

70

Our Confidence in the RESILIA Tissue Platform is Built Upon Rigorous Research and Differentiated Pre-Clinical Evidence

12/9/15

Patient Vision Create better options for younger patients

Pre-Clinical StudiesMultiple studies on RESILIA vs. conventional valves

Clinical Studies In patients since 2011

20172004 2008 2011+

INSPIRIS Anticipated Launches in the EU and US in 2017

Building Clinical ConfidenceNew Tissue Platform

800+ Patients• EU Study (2011+)

Excellent Outcomes

• COMMENCE Trial (2013+)Aortic, Mitral and Pulmonic Arms

• Pulmonic Arm offers potential solution for younger patients

THERAPY EXPANSION

• Compelling alternative to mechanical valves

SHARE GAIN

• Offering a better tissue valve technology option

Superior Anti-Calcification1

Final Calcium Content at the End of 8 Months

p=0.002

1 Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–45. *p=0.002; †p=0.03 versus PERIMOUNT; ‡p<0.01 versus week 1 INSPIRIS not approved for sale.

Page 71: Edwards Lifesciences 2015 Investor Conference

71

Transforming Options for Patients Needing an Aortic Valve and a Replacement Aortic Conduit

12/9/15

RESILIA™Resilient Tissue Technology

Market Leading Conduit Market Leading Valve

Magna Ease®

PERIMOUNT® Platform

VASCUTEK® GraftProven Aortic Root Graft

Today

Tomorrow

Younger patients ~50% of target population are <60 years of age

Limited optionsMainly mechanical valves

First pericardial tissue conduit Unique ready-to-implant design Simplifies a complex procedure

AVC is not approved for sale.

Page 72: Edwards Lifesciences 2015 Investor Conference

72

There is a Large Unmet Need in Degenerative Mitral Regurgitation (DMR) Patients

12/9/15

2%

Recently Executed Agreement with Harpoon Medical

Beating-Heart DMR RepairMajor advancement to our surgical portfolio

Goal is to Facilitate Earlier TherapyFaster recovery, shorter hospital stay, less morbidity

Large opportunity as treated patient population expands

Treated each year surgically

1.6M Est. U.S. population with moderate-to-severe DMR

50%survival at 5 yrs2

33% survival at 8 yrs2

Marked decline in survival after symptoms if left untreated

DMR

1. Marchena et al., Respective Prevalence of the Different Carpentier Classes of Mitral Regurgitation, J Cadr Surg, 20112. Delahaye et al., Natural History of Severe Mitral Regurgitation, Euro Heart Journal, 1991

• Structurally abnormal valve

• 60-70% of mitral procedures today1

Page 73: Edwards Lifesciences 2015 Investor Conference

Tailwinds

• INTUITY Elite mid-year U.S. launch and increased EU penetration

• Premium product share gain

Headwinds

• Broader TAVR cannibalization

• Overall healthcare spending pressures

Underlying Global Sales Growth Outlook

73

Gro

wth

Driv

ers

2016 Estimated Underlying Sales Growth

Industry SHVT

3%-6%

2016 Outlook

1%-2%

12/9/15

Page 74: Edwards Lifesciences 2015 Investor Conference

74

Executive Summary

We expect surgical AVR to remain the gold standard for younger and complex patients supported by our focused innovation strategy

We are accelerating our investment beyond aortics to further transform the patient experience and extend leadership

Surgical Heart Valve Therapy continues to offer a compelling growth opportunity for Edwards

12/9/15

Page 75: Edwards Lifesciences 2015 Investor Conference

Structural Heart Growth InitiativesDonald E. Bobo, Jr.Corporate Vice President,Heart Valve Therapy, Corporate Strategy & Development

Page 76: Edwards Lifesciences 2015 Investor Conference

76

Executive Summary

Structural Heart Initiatives are focused on significant unmet patient needs, including: – Mitral and Tricuspid valves – Heart Failure interventions

Likely technical challenges and clinical timelines will require patience and sustained investment to reach commercialization

We are investing aggressively to lead in these transformational therapies

12/9/15

Page 77: Edwards Lifesciences 2015 Investor Conference

77

Investments Are Focused and Should Result in Transforming Patient Options

12/9/15

2016 Estimated Total R&D 16% of Sales

Structural Heart Initiatives

R&D Programs

Allocation of 2016 R&D

Clinical Trials

Page 78: Edwards Lifesciences 2015 Investor Conference

78

Structural Heart Investments Include Multiple Programs

CardiAQ-Edwards Mitral Replacement

FORMA Tricuspid Repair

HF Programs LV Restoration

CardioKinetix LV Reduction

Harpoon Degenerative Mitral Repair

FMR Program Functional Mitral Repair

Selected Programs Description

Adj

acen

t Val

ves

Hea

rt F

ailu

re

12/9/15

Page 79: Edwards Lifesciences 2015 Investor Conference

79

Mitral Regurgitation is a Large Unmet Need, but it is Complex and Will Require Multiple Therapies

Functional Mitral Regurgitation (FMR)

Degenerative Mitral Regurgitation (DMR)

• Etiologies:- Ischemic cardiomyopathy- Any cause of dilation to the LV- Dilated LA

• Loss of leaflet coaptation due to:- Annular enlargement- Papillary muscle displacement

causing leaflet tethering / tenting

• Etiologies:- Advanced Barlow’s Disease- Fibroelastic deficiency

• Leaflet prolapse due to:- Leaflet deformities or lesions- Ruptured / elongated chordae- Papillary muscle rupture

12/9/15

Page 80: Edwards Lifesciences 2015 Investor Conference

80

Functional Mitral Regurgitation

1) Internal Estimates 2) Baskett, R et al. Mitral Insufficiency... Can J Cardiol .Vol. 23 No. 10 August 2007.

Primary opportunity of Transcatheter Mitral Replacement

FMR is large1

Prevalent

FMR increases HF morbidity and mortality2

Any MR

No MR

40%

20%

% Mortality or HF Hospitalization at 2 Years

Deadly

Limited treatment options for FMR1

<1%FMR patients currently

receive surgery

Underserved

900KUS and EU patients1

12/9/15

Page 81: Edwards Lifesciences 2015 Investor Conference

81

Combined CardiAQ-Edwards Platform Can Drive Leadership Focus on building clinical experience in TMVR

– Early clinical experience drove key learnings– Edwards accounts for half of all TMVR cases at >35 cases– TMVR clinical experience still early at just ~80 cases globally

CardiAQ platform complements the FORTIS program– One valve, multiple delivery systems– Unique anchoring mechanism– Designed to promote physiologic flow

Early patient experience is encouraging We have an integrated, dedicated team from both companies

12/9/15

Page 82: Edwards Lifesciences 2015 Investor Conference

82

CardiAQ-Edwards Progress and Milestones

Planned clinical timelines:– CE Mark trial to begin mid-2016– U.S. EFS enrollment to start soon

Near-term product additions:– Lower valve profile– Additional valve sizes– Delivery system improvements– Edwards tissue

12/9/15

CardiAQ-Edwards valve is not available for sale.

Page 83: Edwards Lifesciences 2015 Investor Conference

83

Degenerative Mitral Regurgitation

Surgical treatment is highly effective but selectively used1. Singh et al., Prevalence and Clinical Determinants of MR… (Framingham), Am J Cardiology 19992. Delahaye, J.P. et al., Natural history of severe mitral regurgitation, Euro Heart Journal, 1991 2. Bach, D. et al.

1-Yr

8-Yr

21%

67%

DMR is widespread

Prevalent

DMR results in significant mortality over time

Mortality in untreated Severe DMR patients

Deadly

Surgical invasivenesslimits DMR treatment

2%Treated surgically

despite strong evidence4

Underserved

1.6MUS patients

45-85 years old1

2

3

12/9/15

3. Failure to Guideline Adherence for Intervention in Patients with Severe MR, JACC, 20094. Braungerger et al., Very Long Term Results (20+ years) of Valve Repair…, Circulation, 2001

Page 84: Edwards Lifesciences 2015 Investor Conference

84

Transcatheter Harpoon Therapy an Alternative to Surgical Mitral Chordal Repair Transcatheter approach to chordal repair

– Beating heart repair based on an existing surgical technique

– May enable earlier intervention– Potential for improved morbidity and outcomes

Investment and option to acquire Harpoon Medical – Upfront investment to fund CE Mark study– Exclusive option to acquire

Expect to begin CE Mark enrollment early 2016

12/9/15

*Delahaye, J.P. et al., Natural History of Severe Mitral Regurgitation, Euro Heart Journal, 1991. Harpoon is not available for sale.

Page 85: Edwards Lifesciences 2015 Investor Conference

85

Tricuspid Regurgitation

Today’s TR treatment is limited to patients undergoing surgical mitral repair

Large Prevalence Pool of TR Patients

Prevalent

TR Significantly Increases Mortality

1-yr Mortality in TR Patients2

Deadly

Limited treatment options for TR

0.5%Moderate-to-Severe TR

patients receive surgery1

Underserved

1.6MPatients suffer from

Moderate-to-Severe TR1

Mild

Moderate

Severe

10%

21%

36%

1. Stuge and Liddicoat. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardio Surg 2006;132:1258-1261 2. Nath et al. Impact of Tricuspid Regurgitation on Long-Term Survival. JACC 2004;43:405–9

12/9/15

Page 86: Edwards Lifesciences 2015 Investor Conference

86

The FORMA Repair System is a Novel Therapeutic Approach for Tricuspid Regurgitation (TR) Implantable spacer that reduces regurgitant tricuspid

flow Early human clinical experience is promising

– 12/13 implants successful– No deaths or major complications– Improvement of TR, edema and functional status

observed– Strong clinical interest

Clinical Timelines:– CE Mark trial and U.S. EFS to begin in 2016

Device safety and functional improvement will likely determine the size of the opportunity

12/9/15

FORMA is not available for sale.

Page 87: Edwards Lifesciences 2015 Investor Conference

87

FORMA Animation

12/9/15

Page 88: Edwards Lifesciences 2015 Investor Conference

88

We are Focusing on NYHA Class III Heart Failure Patients Which is a Large Underserved Population

Interventional HF is a promising adjacency, but will take time

III• Drugs insufficient

• ~3 HF hospitalizations per year on average

• Marked physical limitation

I• Drugs sufficient

• No physical limitation

II• Drugs sufficient

• Slight physical limitation

IV• Requires LVAD or

transplant

• Severe physical limitation

• Dyspnea at rest

1.4M*

U.S. Patients Underserved NYHA IV = End StageNYHA I = Asymptomatic

Served well by medical management

Interventional devices unlikely to help

12/9/15

* IMPROVE-HF Registry, Nursing Home Survey 2004, NHANES 2009-12, CVRG 2015

Page 89: Edwards Lifesciences 2015 Investor Conference

89

CardioKinetix Shows Promise in Treating Left Ventricular (LV) Dysfunction in Heart Failure CardioKinetix could be a meaningful HF therapy

– Targets large underserved population with promising approach Strategic investment in CardioKinetix

– Exclusive option to acquire– Dependent upon achievement of certain milestones and

regulatory approvals Clinical Progress:

– PARACHUTE IV U.S. pivotal trial 50% enrolled– CE Mark as of 2011 and reimbursement status in Germany

12/9/15

CardioKinetix• LV Reduction• Improves efficiency

CardioKinetix is not available for sale.

Page 90: Edwards Lifesciences 2015 Investor Conference

90

Executive Summary

Structural Heart Initiatives are focused on significant unmet patient needs, including: – Mitral and Tricuspid valves – Heart Failure interventions

Likely technical challenges and clinical timelines will require patience and sustained investment to reach commercialization

We are investing aggressively to transform these interventions transformational therapies

12/9/15

Page 91: Edwards Lifesciences 2015 Investor Conference

Q&A

91

Page 92: Edwards Lifesciences 2015 Investor Conference

Critical CareKatie M. SzymanCorporate Vice President,Critical Care

Page 93: Edwards Lifesciences 2015 Investor Conference

93

Transcatheter Heart

Valve Therapy

Surgical Heart Valve Therapy

Critical Care

Critical Care

Core Product

Disposables

Capital

FloTrac and ClearSight

Disposables (ESR Products)

Vascular

2015 Revenue Breakdown

The Leader in the $750M Global Hemodynamic Monitoring Industry*

12/9/15

* Includes pulmonary artery catheters and pressure monitoring products.

Page 94: Edwards Lifesciences 2015 Investor Conference

94

Leadership & Innovation Strategy Critical Care products benefit millions of patients per year Enhanced Surgical Recovery is an underpenetrated opportunity focused

on reducing complications and length of stay

Patient-Centric Focus

Focused Innovation

Industry Leadership

Our ClearSight noninvasive platform expands benefits of Enhanced Surgical Recovery to a broader patient population

We continue to innovate with a new monitor platform and semi-closed loop system in development

Critical Care is the global leader with the broadest portfolio of hemodynamic monitoring solutions

12/9/15

Page 95: Edwards Lifesciences 2015 Investor Conference

95

Edwards’ Unmatched Portfolio of Market Leading Hemodynamic Products is a Competitive Advantage

12/9/15

ClearSightFinger Cuff

Swan-Ganz Pulmonary

Artery CatheterFloTrac Sensor

TruWave Transducers

Core Hemodynamic Products Enhanced Surgical Recovery Products

EV1000 Clinical Platform

Page 96: Edwards Lifesciences 2015 Investor Conference

96

We are Strengthening Our Core

Gold standard core products deliver industry-leading financial performance

We are refreshing our core product lines

We are expanding and leveraging our sales channel across the entire portfolio

We continue to broaden our presence in China

Core Product

Disposables

Capital

FloTrac and ClearSight

Disposables (ESR Products)

Vascular

12/9/15

Page 97: Edwards Lifesciences 2015 Investor Conference

97

Enhanced Surgical Recovery is Focused on Reducing Complications and Length of Stay

12/9/15

25% of surgical patients will experience complications leading to longer hospital stays, readmission, and even death(1)

(1) Ghaferi et al. Variation in Hospital Mortality Associated with Inpatient Surgery. New Engl J Med 2009(2) Thacker et al. Perioperative Fluid Utilization Variability and Association With Outcomes. AnnSurg 2015, in press

(2)

Page 98: Edwards Lifesciences 2015 Investor Conference

98

Enhanced Surgical Recovery is an Underpenetrated Global Opportunity

12/9/15

Size of ESR Opportunity

Unpenetrated$550M

Penetrated$150M

Large Opportunity Exists to Reduce Complications

from Surgery

Edwards 80%

Leading Minimally-Invasive and Noninvasive Hemodynamic

Technologies

2015E

Other

'10 '11 '12 '13 '14 '15E '16E$0

$50

$100

$150

$200

$ m

illion

s 5 Year CAGR: 14%

Strong Underlying Sales Growth of FloTrac and ClearSight Disposables

Page 99: Edwards Lifesciences 2015 Investor Conference

99

ClearSight Noninvasive Sensor Expands Benefits of ESR to a Broader Patient Population

Pneumatic Cuff

Infrared Sensor

ClearSight Algorithm

ClearSight represents a combination of technologies developed over 30 years

Offers 6 parameters and intuitive graphical user interface

ClearSight technology launched on the EV1000 Clinical Platform EU and U.S. in 2014 Japan in 2015

12/9/15

Page 100: Edwards Lifesciences 2015 Investor Conference

100

GPS-like guided fluid delivery to maintain proper patient fluid balance

Innovating to Drive Future ESR Growth

Next generation hemodynamic monitor

Integrated semi-closed loop system for standardized management of patient fluid levels

Wireless connectivity platform for data integration and clinical analytics

Sleek and progressive design and improved graphic interface

Scalable platform that allows for proactive clinical decision support

Interoperability between Edwards hemodynamic monitoring and CareFusion infusion pumps

Accelerate penetration of ESR program and utilization of FloTrac and ClearSight sensors

12/9/15

Page 101: Edwards Lifesciences 2015 Investor Conference

101

Tailwinds

Enhanced Surgical Recovery program drives noninvasive and minimally invasive growth

Increased utilization in emerging markets

Headwinds

Uncertainty associated with buyer consolidation

Healthcare expenditure containment in Japan

Underlying Global Sales Growth Outlook2016 Outlook

2016E

Underlying Global Critical Care Estimated Sales Growth

2% - 4%

12/9/15

Page 102: Edwards Lifesciences 2015 Investor Conference

102

Executive Summary

Our Critical Care portfolio of solutions is expected to lead the global industry that is estimated to grow 2-4%– We are investing in strengthening our core hemodynamic product portfolio and best in

class sales channel and education programs– We continue to drive our Enhanced Surgical Recovery programs to become the standard

of care with our proven ability to improve patient outcomes and hospital metrics– We are accelerating innovation with a new monitor and semi-closed loop system in

development Critical Care products benefit millions of patients per year

12/9/15

Page 103: Edwards Lifesciences 2015 Investor Conference

Financial OutlookScott B. UllemChief Financial Officer

Page 104: Edwards Lifesciences 2015 Investor Conference

104

Reaffirming October 2015 Guidance($ in millions, except per share)

12/9/15

Fiscal Year 2015 Guidance2014 Investor

ConferenceOct

Guidance

Total Net Sales $2,300 - 2,500 $2,300 - 2,500

Gross Profit Margin ~75% Q4 ~75%

Non-GAAP EPS $3.90 - 4.10 $4.43 - 4.53Adjusted EPS (excluding amortization) $3.95 - 4.15 $4.48 - 4.58

Free Cash Flow $375 - 425High End

$375 - 425

Pre-stock split effective 12/14/15

Excludes special items

Page 105: Edwards Lifesciences 2015 Investor Conference

105

2016 Financial Outlook

12/9/15

Page 106: Edwards Lifesciences 2015 Investor Conference

106

2016 Guidance(Split-adjusted; non-GAAP basis)

12/9/15

Reported Sales $2,500 - 2,750 million

Underlying sales growth 7 - 11%

Gross profit margin 74 - 75%

SG&A % of Sales 32 - 33%

R&D % of Sales ~16%

Interest expense ~$11 million

Tax rate (assuming R&D tax credit renewal) 22 - 23%

Adjusted EPS (excluding amortization) $2.30 - 2.40

Free cash flow $400 - 440 million

Diluted shares outstanding 216 - 220 million

Page 107: Edwards Lifesciences 2015 Investor Conference

107

2016 Sales Guidance by Business($ in millions, except per share)

12/9/15

SalesUnderlying

Growth

Transcatheter Heart Valve Therapy $1,200 - 1,400 10 - 18%

Surgical Heart Valve Therapy $780 - 820 3 - 6%

Critical Care $510 - 550 2 - 4%

Total Sales $2,500 - 2,750 7 - 11%

2016 Guidance

Page 108: Edwards Lifesciences 2015 Investor Conference

108

2016 Sales Growth Drivers($ in millions at current rates)

12/9/15

$2,300 - 2,500

2015 FX Sales Growth 2016

~$200 ~$(55)

$2,500 - 2,750

Page 109: Edwards Lifesciences 2015 Investor Conference

109

Expect Continued Strong Sales Growth in 2016($ in billions and underlying growth rates)

12/9/15

2012 2013 2014 2015E 2016E

$1.90 $2.05 $2.32 $2.30 – 2.50

$2.50 – 2.75

Underlying CAGR: 13%

11%

11%13% ~15%

7-11%

Page 110: Edwards Lifesciences 2015 Investor Conference

110

Transcatheter Heart Valve Therapy Sales($ in millions and underlying growth rates)

12/9/15

2012 2013 2014 2015E 2016E

$552 $708

$944 $1,100 – 1,200

$1,200 – 1,400

Underlying CAGR: 31%

29%

30%

29%

High End25-35%

10-18%

Page 111: Edwards Lifesciences 2015 Investor Conference

111

Surgical Heart Valve Therapy Sales($ in millions and underlying growth rates)

12/9/15

Includes the impact of discontinued non-strategic products

2012 2013 2014 2015E 2016E

$788 $801 $826 Lower End$780 - 820 $780 - 820

Underlying CAGR: 4%

5%

4% 5% 1-3% 3-6%

Page 112: Edwards Lifesciences 2015 Investor Conference

112

Critical Care Sales($ in millions and underlying growth rates)

12/9/15

Includes the impact of discontinued non-strategic products

2012 2013 2014 2015E 2016E

$560$537

$553Lower End$520 - 570 $510 - 550

Underlying CAGR: 3%

1% 6% 2 - 4%

1%6%

2-4%2-4%

Page 113: Edwards Lifesciences 2015 Investor Conference

113

Gross Profit Margin

12/9/15

($ in

mill

ions

)

74% 75%74%

~76%74 - 75%

65%

70%

75%

80%

85%

$1.0

$1.5

$2.0

2012 2013 2014 2015E 2016E

GP $ GP Margin

Adjusted to exclude impact of THV product exchanges

Page 114: Edwards Lifesciences 2015 Investor Conference

114

2016 Gross Profit Margin

12/9/15

Adjusted to exclude impact of THV product exchanges

~74%

~76%

0.3%

1.5% (1.5)%

(2.0)%

2014 2015E Operations /Mix

FX - HedgeContracts

FX Impacton OUSSales

Amortizationof

Intangibles

2016E

74% - 75%

Page 115: Edwards Lifesciences 2015 Investor Conference

115

Research & Development

12/9/15

15%16%

15%High End 15 - 16%

~16%

10%

12%

14%

16%

18%

20%

22%

$0

$250

$500

2012 2013 2014 2015E 2016E

R&D Percentage of Sales

($ in

mill

ions

)

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37%

36%

37%

~34%

32 - 33%

30%

32%

34%

36%

38%

40%

42%

$300

$500

$700

$900

2012 2013 2014 2015E 2016E

SG&A Percentage of Sales

Selling, General & Administrative Expenses

12/9/15

($ in

mill

ions

)

Adjusted to exclude special items

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2012 2013 2014 2015E 2016E

-200

-150

-100

-50

0

50

100

$12$22

$8

~$70

~$30

$(42) $(44) $(22) $(170) $(55)

Cash Flow Hedge Negative FX Impact on Sales

Annual Impact of Strengthening U.S. $($ in millions; at current rates)

12/9/15

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$12$22

$8

~$70

~$30

$(42) $(44)$(22)

$(170)

$(55)

1.24 1.23 1.21

1.04

0.95

1.05

1.15

1.25

-200

-150

-100

-50

0

50

100

2012 2013 2014 2015E 2016E

Cash Flow Hedge Negative FX Impact on Sales Inverse of USD Index (DXY)

Annual Impact of Strengthening U.S. $($ in millions; at current rates)

12/9/15

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Changing to Cash EPS Reporting

Historical amortization expense has been < $10 million per year in 2013-2015 However, to be consistent with sector peers and improve comparability, Edwards’

adjusted Earnings Per Share will exclude amortization expense beginning in 2016 This does not signify a change in acquisition philosophy

– Continued focus on smaller transactions of early-stage technologies and intellectual property

– Continued strategic approach toward fit and valuation

12/9/15

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$2.75

$3.23 $3.50

$2.81

$3.29 $3.55

2012 2013 2014 2015E 2016E2012 2013 2014 2015 2016

$4.43to

$4.53

$4.48to

$4.58

$4.54to

$4.74

$4.60to

$4.80

New Presentation for Earnings Per Share(pre-stock split; split effective 12/14/15)

12/9/15

Non-GAAP EPS (historical convention: excludes special items)

Adjusted EPS (new convention: excludes special items and amortization expense)

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Free Cash Flow Excluding Special ItemsOperating Cash Flow minus Capital Expenditures ($ in millions)

12/9/15

$253

$306

$445 High End$375 - 425

$400 - 440

2012 2013 2014 2015E 2016E

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Longer-Term Financial Expectations

12/9/15

Our long-term strategic plan projects organic underlying sales growth at a meaningfully higher rate than industry averageAnnual growth rates may fluctuate significantly

Gross Profit MarginModest margin expansion due to improving mix, partially offset by continuing investments in operations and new products

Consistent with current ratio of sales for the foreseeable futureSignificant investments in clinical trials to expand TAVR risk indications and develop new technologies

Disciplined focus on leveraging our scale and controlling growth in SG&A

Expect low-30% ratio of sales

Operating Profit Improvement as a percentage of sales

Tax rateExpect moderate upward pressure on effective tax rate resulting from U.S. growth in TAVR

Shares OutstandingOffset all dilution from incentive compensation; potential net reduction over time

Sales

Research & Development

Selling, General & Administrative Expense

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Capital Allocation Priorities

12/9/15

Fund strategic external investments:– Selective acquisitions, likely smaller in size– Minority investments and options– Intellectual property

Disciplined capital expenditures to support growth Share repurchase is the preferred method for returning capital to investors Management is committed to disciplined use of cash

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Pay for Performance Compensation Program

Long-term performance awards aligned with shareholder value creation Annual incentive compensation based on:

– Financial Performance Underlying sales growth (50%), net income (30%), free cash flow (20%)

– Key Operating Drivers Rigorous milestones towards strategic priorities

Active management and oversight by Board of Directors Compensation Committee and independent outside advisors

12/9/15

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Edwards is an Attractive Investment

Durable leadership positions in focused, growing areas Strong organic topline growth Disciplined SG&A expense control Successful long-term track record Shareholder-friendly governance profile Pay-for-performance philosophy Robust free cash flow Commitment to returning capital to shareholders

12/9/15

Page 126: Edwards Lifesciences 2015 Investor Conference

Closing RemarksMichael A. MussallemChairman and CEO

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127

Edwards’ Strategy

12/9/15

• Breakthrough therapies with superior clinical and economic evidence

• Active product portfolio management

Focused Innovation

• Pioneering legacy of establishing standards of care

• Trusted relationships with clinicians, payors and regulators

Industry LeadershipPatient-Centric

• Fulfilling unmet needs of structural heart and critically ill patients

• Transforming care drives enduring value creation

Create Value with Therapies that Transform Patient Care

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THVT Executive Summary

Expect the TAVR opportunity to exceed $5B by 2021 Continue to build robust clinical evidence to expand patient access

– Anticipate late 2016 U.S. approval of intermediate risk indication– Important progress towards pulmonic commercialization in 2016– Low risk trial to begin in 2016

Investing to be the technology leader – Launch of SAPIEN 3 ULTRA System expected in late 2016– CENTERA expected to be best in class– Next generation platforms under development

12/9/15

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SHVT Executive Summary

We expect surgical AVR to remain the gold standard for younger and complex patients supported by our focused innovation strategy

We are accelerating our investment beyond aortics to further transform the patient experience and extend leadership

Surgical Heart Valve Therapy continues to offer a compelling growth opportunity for Edwards

12/9/15

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CC Executive Summary

Our Critical Care portfolio of solutions is expected to lead the global industry that is estimated to grow 2-4%– We are investing in strengthening our core hemodynamic product portfolio and best in

class sales channel and education programs– We continue to drive our Enhanced Surgical Recovery programs to become the standard

of care with our proven ability to improve patient outcomes and hospital metrics– We are accelerating innovation with a new monitor and semi-closed loop system in

development Critical Care products benefit millions of patients per year

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Growth Initiatives Executive Summary

Structural Heart Initiatives are focused on significant unmet patient needs, including: – Mitral and Tricuspid valves – Heart Failure interventions

Likely technical challenges and clinical timelines will require patience and sustained investment to reach commercialization

We are investing aggressively to lead in these transformational therapies

12/9/15

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Edwards is Committed to Good Corporate Citizenship It begins with our Credo

– Strive to earn and maintain trust of our stakeholders, partners and communities

– Forms the framework for our Aspirations– We report on our sustainability efforts as

they relate to our 5 Aspirations Transforming Patient Care Through

Innovative Technology Excel as Trusted Partner and Global

Leader Through the Quality of our Work Attracts and Engages Talented Employees Strengthens our Communities Creates Exceptional Shareholder Value

 

12/9/15

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Edwards and its Board are Committed to Good Corporate Governance A strong and independent board Regularly review governance practices Routinely engage with stockholders for their input on governance matters Compensation programs that place higher emphasis on performance-based awards

– Annual incentive compensation based on: Financial performance Key Operating Drivers

– Long-term performance awards aligned with shareholder value creation

12/9/15

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Edwards Lifesciences Foundation

Every Heartbeat Matters initiative to impact global burden of valve disease among underserved

On-track to educate, screen or treat one million underserved people by 2020

12/9/15

Every Heartbeat Matters63%

Other Health7%

Community23%

Product and Other Corp. Dona-tions7%

2015 Total Giving Est. = $6.6 Million

Page 135: Edwards Lifesciences 2015 Investor Conference

Edwards is Poised for Long-Term Success

Patient-centric culture Leading edge research and development Industry leading competitive positions Trusted relationships with clinicians, regulators and payors globally Strong geographic diversification Nimble, adaptive business model Focused strategy to deliver patient benefit and shareholder value

13512/9/15

Page 136: Edwards Lifesciences 2015 Investor Conference

Q&A

Page 137: Edwards Lifesciences 2015 Investor Conference

Patient VideoDavid

Page 138: Edwards Lifesciences 2015 Investor Conference