edwards lifesciences 2015 investor conference
TRANSCRIPT
2015 Investor ConferenceDecember 9, 2015Irvine, California
2015 Investor ConferenceDavid K. EricksonVice President, Investor Relations
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.
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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
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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
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Opening RemarksMichael A. MussallemChairman and CEO
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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.
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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
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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
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Edwards’ Strategy
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• 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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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
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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
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R&D investments in new products drove 5-year double-digit sales CAGR
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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
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2015 Review & 2016 Outlook
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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
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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
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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 $5B in 2021
– TAVR redefines therapy options for patients– Confident in intermediate risk approval– Further indication expansion opportunity is significant
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2016: Executing Our Long Term Strategy
Edwards expects continued strong performance in 2016 led by TAVR– Continued leadership in core businesses– Investing in pipeline to strengthen leadership
Projecting solid financial results– Partially offset foreign exchange headwinds with disciplined U.S. spending
Implementing our strategic imperatives– Update and expand infrastructure and production capacity– Continue investment in quality systems– Fuel long-term TAVR growth– Expanding into structural heart adjacencies
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2016: Guidance(Excludes special items)
($ 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)
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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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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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Transcatheter Heart Valve TherapyLarry L. WoodCorporate Vice President,General Manager,Transcatheter Heart Valves
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Transcatheter Heart Valve Therapy
Estimated 2015 Global Sales
U.S.Europe
JapanROW
Transcatheter Heart
Valve Therapy
Surgical Heart Valve Therapy
Critical Care
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The Leader in a ~$2B Global Transcatheter Heart Valve Segment
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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
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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
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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 - $1.2B(high end of 25% - 35%
underlying growth)
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The Growth Rate of TAVR Has Been Strong but Not Linear
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Sale
s ($
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
$300
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(1) Non-GAAP, reported sales excluding impact of sales return reserves.
2008 2009 2010 2011 2012 2013 2014 2015(E)
>1000% 111% 84% 62% 65% 31% 29% 25%
The Growth Rate of TAVR Has Been Strong but Not Linear
27
Sale
s ($
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
$300
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(1) Non-GAAP, reported sales excluding impact of sales return reserves.
The Growth Rate of TAVR Has Been Strong but Not Linear
28
Sale
s ($
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
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(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%
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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
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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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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
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SAPIEN 3 Ultra Delivery System is not approved for sale.
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
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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
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CENTERA is not approved for sale.
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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
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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
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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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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
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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
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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
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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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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
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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
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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
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-
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.
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-
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.
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-
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.
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There are Many Patients Who May Benefit From TAVR
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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
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Asymptomatic
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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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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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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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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
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(1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005; Brown 2008 (n=622)
Asymptomatic
(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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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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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
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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
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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%
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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
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Q&A
BREAK
Surgical Heart Valve TherapyBernard J. Zovighian Vice President and General Manager, Surgical Heart Valves
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
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Leadership & Innovation Strategy Improve therapy options for younger patients and enable earlier interventions Facilitate minimally invasive procedures and streamline complex surgeries
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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
62
Surgical AVR Expected to Continue to be the Gold Standard for Younger Patients and Complex Procedures
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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.
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
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
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.
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.
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.
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.
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.
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.
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.
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
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
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
Structural Heart Growth InitiativesDonald E. Bobo, Jr.Corporate Vice President,Heart Valve Therapy, Corporate Strategy & Development
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
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
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
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
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
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
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.
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
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.
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
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.
87
FORMA Animation
12/9/15
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
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.
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
Q&A
91
Critical CareKatie M. SzymanCorporate Vice President,Critical Care
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.
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
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
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
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)
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
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
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
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
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
Financial OutlookScott B. UllemChief Financial Officer
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
105
2016 Financial Outlook
12/9/15
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 $400 - 440 million
Diluted shares outstanding 216 - 220 million
107
2016 Sales Guidance by Business($ 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 $2,500 - 2,750 7 - 11%
2016 Guidance
108
2016 Sales Growth Drivers($ in millions at current rates)
12/9/15
$2,300 - 2,500
2015 FX Sales Growth 2016
~$200 ~$(55)
$2,500 - 2,750
109
Expect Continued Strong Sales Growth in 2016($ in billions and underlying growth rates)
12/9/15
2012 2013 2014 2015E 2016E
$1.90 $2.05 $2.32 $2.30 – 2.50
$2.50 – 2.75
Underlying CAGR: 13%
11%
11%13% ~15%
7-11%
110
Transcatheter Heart Valve Therapy Sales($ in millions and underlying growth rates)
12/9/15
2012 2013 2014 2015E 2016E
$552 $708
$944 $1,100 – 1,200
$1,200 – 1,400
Underlying CAGR: 31%
29%
30%
29%
High End25-35%
10-18%
111
Surgical Heart Valve Therapy Sales($ 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 $780 - 820
Underlying CAGR: 4%
5%
4% 5% 1-3% 3-6%
112
Critical Care Sales($ 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 $510 - 550
Underlying CAGR: 3%
1% 6% 2 - 4%
1%6%
2-4%2-4%
113
Gross Profit Margin
12/9/15
($ 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
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%
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
)
116
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
117
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
118
$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
119
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
120
$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
$4.80
New Presentation for Earnings Per Share(pre-stock split; split effective 12/14/15)
12/9/15
Non-GAAP EPS (historical convention: excludes special items)
Adjusted EPS (new convention: excludes special items and amortization expense)
121
Free Cash Flow Excluding Special ItemsOperating Cash Flow minus Capital Expenditures ($ in millions)
12/9/15
$253
$306
$445 High End$375 - 425
$400 - 440
2012 2013 2014 2015E 2016E
122
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
123
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
124
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
125
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
Closing RemarksMichael A. MussallemChairman and CEO
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
128
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
129
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
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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
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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
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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
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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
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Every Heartbeat Matters63%
Other Health7%
Community23%
Product and Other Corp. Dona-tions7%
2015 Total Giving Est. = $6.6 Million
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
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Q&A
Patient VideoDavid