3. Cautionary Statement
Presentations 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.
312/9/15
4. 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
412/9/15
5. 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
512/9/15
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.
712/9/15
8. Edwards’ Guiding Philosophies
8
Our Credo Our Aspirations
We 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
9. Global Leadership
Over 95% of sales from products
in #1 global positions
Serving patients in more than
100 countries worldwide
9
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
10. 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
11. 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 11
12. 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
13. 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
1312/9/15
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
1512/9/15
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
1612/9/15
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 $5B in 2021
– TAVR redefines therapy options for patients
– Confident in intermediate risk approval
– Further indication expansion opportunity is significant
1712/9/15
18. 2016: Executing Our Long Term Strategy
Edwards expects continued strong performance in 2016 led by TAVR
– Continued leadership in core businesses
– Investing in pipeline to strengthen leadership
Projecting solid financial results
– Partially offset foreign exchange headwinds with disciplined U.S. spending
Implementing our strategic imperatives
– Update and expand infrastructure and production capacity
– Continue investment in quality systems
– Fuel long-term TAVR growth
– Expanding into structural heart adjacencies
1812/9/15
19. 2016: Guidance
(Excludes special items)
19
($ 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
20. 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
2012/9/15
21. Michael A. Mussallem
Chairman & CEO
Edwards’ Leadership Team
Aimee S. Weisner
General Counsel
Larry L. Wood
Transcatheter Heart Valves
Donald E. Bobo, Jr.
HVT, Corp Strategy &
Development
Dirksen J. Lehman
Public Affairs
Scott B. Ullem
Chief Financial Officer
John P. McGrath
Quality, Regulatory,
Clinical
Rich Lunsford
Healthcare Solutions
Stanton J. Rowe
Advanced Technology
& Chief Scientific Officer
Christine Z. McCauley
Human Resources
Patrick B. Verguet
EMEA, Canada and
Latin America
Huimin Wang, M.D.
Japan, Asia and Pacific
Katie M. Szyman
Critical Care
2112/9/15
23. Transcatheter Heart Valve Therapy
23
Estimated 2015 Global Sales
U.S.Europe
Japan
ROW
Transcatheter
Heart
Valve Therapy
Surgical Heart
Valve Therapy
Critical
Care
12/9/15
The Leader in a ~$2B Global Transcatheter Heart Valve Segment
24. Leadership & Innovation Strategy
Focus on expanding patient access
– Disease and therapy education and awareness
– Patient community outreach and advocacy
– Patient peer support programs
24
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
25. $0
$200
$400
$600
$800
$1,000
$1,200
$1,400
2013 2014 2015
Global THVT Sales for 2015 Expected at the High End
of Guidance Range
25
Global THVT Sales1
$M,USD
Estimate
(1) Non-GAAP, reported sales excluding impact of sales return reserves.
2015
Guidance
(Q3 Earnings Call)
$1.1B - $1.2B
(high end of 25% - 35%
underlying growth)
12/9/15
26. The Growth Rate of TAVR Has Been Strong
but Not Linear
26
Sales($M)
YoY Sales
Growth
Edwards’ Global TAVR Sales by Quarter1
$0
$50
$100
$150
$200
$250
$300
12/9/15
(1) Non-GAAP, reported sales excluding impact of sales return reserves.
2008 2009 2010 2011 2012 2013 2014 2015(E)
>1000% 111% 84% 62% 65% 31% 29% 25%
27. The Growth Rate of TAVR Has Been Strong
but Not Linear
27
Sales($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
$0
$50
$100
$150
$200
$250
$300
12/9/15
(1) Non-GAAP, reported sales excluding impact of sales return reserves.
28. The Growth Rate of TAVR Has Been Strong
but Not Linear
28
Sales($M)
YoY Sales
Growth
Edwards’ Global TAVR Sales by Quarter1
$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%
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 29
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 mortality
0.8% 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.
30
SAPIEN 3 Valve
• Next-generation sheath
• Facilitates dynamic expansion and contraction
12/9/15
31. The Edwards SAPIEN 3 Ultra Delivery System –
Innovating Valve Delivery
Redesigned shaft
Facilitates greater distal flex
No 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
3112/9/15
SAPIEN 3 Ultra Delivery System is not approved for sale.
32. The Edwards Axela Sheath – Innovating Access
32
• 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.
17.5%1
15.5%2
9.6%2
5.3%3
PARTNER I Cohort B
SAPIEN Valve
PARTNER II Cohort B
SAPIEN Valve
PARTNER II Cohort B
SAPIEN XT Valve
PARTNER II Trial
SAPIEN 3 Valve
30-DayMajor
VascularComplications
Reduction in Major Vascular Complications
in Transfemoral Patients
n = 271 n = 282 n = 491n = 177
12/9/15
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
33
Expect CE Mark Approval in Second Half of 2017
12/9/15
CENTERA is not approved for sale.
34. Significant Progress on Pulmonic Indication Expected
in 2016
34
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
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 Stent
Other Congenital Valve
UNLOAD trial
IVC
While smaller opportunities, these applications are
meaningful to patients and leverage existing platforms
3512/9/15
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
36
(1) Isolated SAVR for severe symptomatic AS
12/9/15
37. With an Intermediate Risk Indication We Will Expand
Patient Access
37
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 up
1-year follow up
vs.
data analysis of PII A SAPIEN XT arm
PII: PARTNER II
12/9/15
38. 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
%ofAllIsolatedSAVRPatients
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
39. Additional Risk Factors and Considerations Not Captured
in STS Risk Score Become More Important With Patient Age
39
RiskFactors
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
12/9/15
40. Heart team assessment critical in estimating patient
risk
40
Patient #1 Patient #2 Patient # 3
Age 82 year old male
Severe AS & NYHA IV Heart
Failure symptoms
73 Year old male
Severe 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
41. However, as Risk Scores Come Down, Age Has Stayed
Relatively Constant
Inoperable
PARTNER IB
High Risk
PARTNER IA
High Risk
PII S3HR
Intermediate Risk
PII S3i
Avg STS 11.2% 11.8% 8.6% 5.3%
Avg Age 83.1 years 83.6 years 82.6 years 81.9 years
N 179 348 583 1,076
0
20
40
60
80
100
0%
3%
6%
9%
12%
15%
Average Age Average STSSTSScore
Age(Years)
Baseline Patient Characteristics in Pivotal Trials
This suggests age and comorbidities not captured in the risk score are
important factors in therapy decision making
4112/9/15
42. TAVR Age Distribution Has Stayed Very Consistent
Despite Indication Expansion and Procedural Growth
0%
1%
2%
3%
4%
5%
6%
7%
40 45 50 55 60 65 70 75 80 85 90 95 100
2012
2013
2014
%ofTAVRProcedures
TAVR Distribution by Age Over Time
2012 2013 2014
Sales ($M) $227 $395 $620
Growth >100% 73% 57%
Indication Inop High Risk High Risk
Advanced age is clearly playing a role in the heart team assessment of risk
SOURCE: Edwards’ implant patient registry
4212/9/15
43. -
2,000
4,000
6,000
8,000
10,000
12,000
14,000
50 55 60 65 70 75 80 85 90 95 100
SAVR
Historically, Our Understanding of Aortic Stenosis Was
Based on Surgical Experience
43
Age
Patients
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
44. -
2,000
4,000
6,000
8,000
10,000
12,000
14,000
50 55 60 65 70 75 80 85 90 95 100
SAVR
TAVR
TAVR Experience Has Changed Our Understanding of
Aortic Stenosis
44
Age
Patients
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
45. -
2,000
4,000
6,000
8,000
10,000
12,000
14,000
50 55 60 65 70 75 80 85 90 95 100
SAVR
TAVR
Untreated (estimated)
Age Plays a Significant Role in the Diagnosis and
Treatment of Aortic Stenosis
45
Age
Patients
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
46. 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
Intermediate
Risk
Low Risk
12/9/15
Asymptomatic
47. High Risk Patients Have Gained Access Through Our
PARTNER Trials
47
Severe Symptomatic AS
High Risk
Intermediate
Risk
Low Risk
Today
PARTNER IB
Inoperable
patients
SAPIEN valve
Clinical Evidence
PARTNER IA
High risk patients
SAPIEN valve
PARTNER IIB
High risk patients
SAPIEN XT valve
PARTNER II S3
High risk patients
SAPIEN 3 valve
12/9/15
48. Partner II Results Expected to Enable Intermediate Risk
Patient Access
48
Severe Symptomatic AS
Late 2016 in
U.S.
PARTNER II S3i
Intermediate risk patients
SAPIEN 3 valve
High Risk
Intermediate
Risk
Low Risk
PARTNER II XT
Intermediate risk patients
SAPIEN XT valve
Clinical Evidence
12/9/15
49. In 2016, Edwards Plans to Initiate a Trial to Study
Patients With a Lower Risk Indication
49
Severe Symptomatic AS
Low Risk
Trial
High Risk
Intermediate
Risk
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 Trial
Early Trial Design Variables
Favorable results would allow heart teams to determine appropriate therapy
12/9/15
50. 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
51. (1) Age at time of clinical presentation
(2) Wood, P. Aortic stenosis. Amer J Cardiol. 1:553, 1958.
Post Mortem Study 1968
Ross and Braunwald. Circulation, 1068.
Valvular Aortic Stenosis in Adults
Average 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
12/9/15
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.
52
• Japan multicenter registry
• 1,808 asymptomatic patients
• Two groups of initial AVR and conservative strategy
12/9/15
53. We Expect Global TAVR Opportunity to Exceed $5B
in 2021
Key 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 53
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
55
2016 Outlook
2016E
Underlying Global THVT
Estimated Sales Growth
10%-18%
12/9/15
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
5612/9/15
60. Surgical Heart Valve Therapy
Transcatheter
Heart
Valve Therapy
Surgical Heart
Valve Therapy
Critical
Care
Repair
Replacement
Estimated 2015 Global Sales
The Leader in a ~$1.8B Global Surgical Heart Valve Segment*
* Replacement and Repair
6012/9/15
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 61
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
12/9/15 62
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 55 60 65 70 75 80 85 90 95 100
SAVR
TAVR
Untreated (estimated)
Patients
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 63
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 brands
2 Bourguignon T. et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMONT Valve in Aortic Position. Ann Thorac Surg, 2015 Mar; 99(3): 831-7
3 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
30Year Follow-Up
Aortic position2
12,000+ patients
25Year Follow-Up
Mitral position3
400+ patients
The most documented surgical tissue valve
~700 Clinical Publications
Surgeons Trust Edwards Valves
More 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 64
65. Near-Term Options Targeting Better Outcomes for
Patients
12/9/15 65
Harpoon
Medical
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-valve
Aortic 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 66
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
Innovations
ProvenPERIMOUNT
Technology
Bovine pericardium &
ThermaFix process
Trileaflet matched for
thickness & elasticity
Woven sealing cloth Balloon-expandable frame
Trusted Platform | Rapid Deployment | Smaller Incisions
EU Unit Sales
INTUITY 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 67
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 68
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
50 55 60 65 70 75 80 85 90 95 100
SAVR
Patients
TAVR Impact Over Time
Typically Mechanical Typically Tissue SAVR TAVR
Designed for
future expansion
1 Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–45
INSPIRIS not approved for sale.
69. The VFit Feature is Designed to Be Expandable
to Preserve Effective Orifice Area (EOA)
69
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.
INSPIRISConventional
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 70
Patient Vision
Create better options
for younger patients
Pre-Clinical Studies
Multiple 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 71
RESILIA™
Resilient Tissue Technology
Market Leading Conduit Market Leading Valve
Magna Ease®
PERIMOUNT® Platform
VASCUTEK® Graft
Proven Aortic Root Graft
Today
Tomorrow
Younger patients
~50% of target population are <60 years of age
Limited options
Mainly 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 72
2%
Recently Executed Agreement
with Harpoon Medical
Beating-Heart DMR Repair
Major advancement to our surgical portfolio
Goal is to Facilitate Earlier Therapy
Faster 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, 2011
2. Delahaye et al., Natural History of Severe Mitral Regurgitation, Euro Heart Journal, 1991
• Structurally abnormal valve
• 60-70% of mitral procedures
today1
73. 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
GrowthDrivers
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 74
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 76
77. Investments Are Focused and Should Result in
Transforming Patient Options
12/9/15 77
2016 Estimated Total R&D 16% of Sales
Structural
Heart
Initiatives
R&D
Programs
Allocation of 2016 R&D
Clinical
Trials
79. Mitral Regurgitation is a Large Unmet Need, but it is
Complex and Will Require Multiple Therapies
79
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
80
FMR is large1
Prevalent
FMR increases HF
morbidity and mortality2
40%
20%
Any MR
No MR
% 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 81
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 82
CardiAQ-Edwards valve is not available for sale.
83. Degenerative Mitral Regurgitation
Surgical treatment is highly effective but selectively used
83
1. Singh et al., Prevalence and Clinical Determinants of MR… (Framingham), Am J Cardiology 1999
2. Delahaye, J.P. et al., Natural history of severe mitral regurgitation, Euro Heart Journal, 1991 2. Bach, D. et al.
21%
67%
1-Yr
8-Yr
DMR is widespread
Prevalent
DMR results in significant
mortality over time
Mortality in untreated
Severe DMR patients
Deadly
Surgical invasiveness
limits 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, 2009
4. 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 84
*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
85
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
1.6M
Patients suffer from
Moderate-to-Severe TR1
10%
21%
36%
Mild
Moderate
Severe
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 86
FORMA is not available for sale.
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
8812/9/15
* 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 89
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 90
93. Transcatheter
Heart
Valve Therapy
Surgical Heart
Valve Therapy
Critical
Care
Critical Care
93
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
94
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 95
ClearSight
Finger Cuff
Swan-Ganz
Pulmonary
Artery Catheter
FloTrac
Sensor
TruWave
Transducers
Core Hemodynamic Products Enhanced Surgical Recovery Products
EV1000
Clinical
Platform
96. We are Strengthening Our Core
96
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 97
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 98
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
$0
$50
$100
$150
$200
'10 '11 '12 '13 '14 '15E '16E
$millions
Strong Underlying Sales Growth of FloTrac
and ClearSight Disposables
99. ClearSight Noninvasive Sensor Expands Benefits
of ESR to a Broader Patient Population
99
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
100
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 Outlook
101
2016 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
12/9/15 102
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
12/9/15 119
120. $2.75
$3.23
$3.50
$2.81
$3.29
$3.55
2012 2013 2014 2015E 2016E
2012 2013 2014 2015 2016
$4.43
to
$4.53
$4.48
to
$4.58
$4.54
to
$4.74
$4.60
to
$4.80
New Presentation for Earnings Per Share
(pre-stock split; split effective 12/14/15)
12012/9/15
Non-GAAP EPS (historical convention: excludes special items)
Adjusted EPS (new convention: excludes special items and amortization expense)
121. Free Cash Flow Excluding Special Items
Operating Cash Flow minus Capital Expenditures ($ in millions)
12112/9/15
$253
$306
$445 High End
$375 - 425
$400 - 440
2012 2013 2014 2015E 2016E
122. Longer-Term Financial Expectations
12212/9/15
Our long-term strategic plan projects organic underlying sales growth at
a meaningfully higher rate than industry average
Annual growth rates may fluctuate significantly
Gross Profit Margin
Modest 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 future
Significant 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 rate
Expect moderate upward pressure on effective tax rate resulting from
U.S. growth in TAVR
Shares Outstanding
Offset all dilution from incentive compensation; potential net reduction
over time
Sales
Research & Development
Selling, General &
Administrative Expense
123. Capital Allocation Priorities
12312/9/15
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
12/9/15 124
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
12/9/15 125
127. Edwards’ Strategy
12/9/15 127
• 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
12/9/15 128
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
12/9/15 129
130. 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
130
131. 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
12/9/15 131
132. 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
12/9/15 132
133. 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
12/9/15 133
134. 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
12/9/15 134
Every Heartbeat
Matters
63%
Other Health
7%
Community
23%
Product and Other Corp. Donations
7%
2015 Total Giving Est. = $6.6 Million
135. 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
We Will Continue to Drive Growth by Innovating in Surgical AVR and Extending our Focus Beyond Aortics
We Will Continue to Drive Growth by Innovating in Surgical AVR and Extending our Focus Beyond Aortics
THV all amortization of TVT patents (through 2017)
2013 Total Amortization 9.8M: THV (5.2), Cardiovations (1.8), Embrella (.9), Embolx (.7), BMEYE (.2), Other (1)
2014 Total Amortization 8.4M: THV (4.2), Cardiovations (.8), Embrella (.9), Embolx (.7), BMEYE (.8), Other (1)
2015 Total Amortization 7.3M: THV (4), Cardiovations (.7), Embrella (.7), Embolx (.7), BMEYE (1), Other (.2)
Note: For CardiAQ, intangibles consist entirely of IPR&D, which is not amortized. Once the technology is developed and ready for commercialization, it is then classified as developed technology and amortization begins. Therefore, there will be no amortization related to CardiAQ in 2015.
You are correct – the CardiAQ amortization will commence upon regulatory approval.
$69 million of the IPR+D was ascribed to Europe (per the valuation study) and $121 million was ascribed to the US.
Amortization will be recorded proportionate with total projected revenues over the expected useful life of the technology – estimated at 9 years in our valuation model.
Assuming CE mark approval in 2018 and FDA approval in 2020, our amortization on a SL method would be as follows (the SL method is a much quicker calculation for me than matching it with revenue projections and I was hoping this is sufficient for your immediate needs – the revenue matching approach would result in a shift of the amortization to the back years):
2018 $8 million
2019 $8 million
2020-2026 $21 million
2027 $14 million
2028 $14 million
Edwards is executing a differentiated business strategy to:
Transform therapies to extend and improve patient lives
Generate attractive investment returns for investors
R&D e.g., transcatheter mitral valve replacement/repair as well as devices to address congestive heart failure