Transcript Surgical Heart Valves

Edwards Lifesciences 2014 Investor Conference
12/8/2014
Edwards Lifesciences
Heart Valve Therapy
Donald E. Bobo, Jr.
Corporate Vice President,
Surgical Heart Valves
12/8/14
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Executive Summary
• Surgical procedural growth enabled by long-term patient trends
– Global procedure growth driven by an aging population and increased access
– Advances in patient and technology trends expected to partially offset TAVR
expansion
• Transforming surgical valve therapy
– Distinguished Evidence: Unparalleled PERIMOUNT ~25+ year clinical studies
– Procedural Innovation: Expanded surgical options for complex and MIS cases
– New Patients: RESILIATM tissue platform for next generation valves (ZETA,
CENTERA, FORTIS))
• Edwards’ surgical valves expected to continue to extend leadership, but 2015
growth will likely be moderated by the rationalization of the Cardiac Surgery
Systems (CSS) business
12/8/14
RESILIA and ZETA are investigational and are not available for commercial sale.
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We Extended Heart Valve Leadership
in 2014
Advanced Key Milestones
2014 Global Performance
Underlying FY Growth
Estimate: 4% - 6%*
Achieved INTUITY Elite CE
Mark; expanded adoption
Technology
Advanced the RESILIA and
ZETA programs
Integrating CSS
business into HVT
Commercial
Investing to address FDA
observations in Utah facility
Expanding global under-treatment
i iti ti
initiatives
Over 30 podium presentations
delivered
 Extended Unit Leadership  Maintained Global ASPs
Evidence
Published 1-year follow up clinical
outcome data
PERIMOUNT ~30-year clinical study
presented, publication pending
12/8/14
*Based upon internal full-year global estimates.
RESILIA and ZETA are investigational and are not available for commercial sale.
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
PERIMOUNT: In a Class of its Own
Unparalleled, Long-Term Evidence Distinguished
Edwards’ Cornerstone Valve Platform
New 25-Year Study in Mitral Position
New 30-Year Study in Aortic Position
Durability study by Dr. Bourguignon*
Durability study abstract by Cleveland Clinic
12/8/14
• Focus:
Edwards Mitral
pericardial valves
• Focus:
Edwards Aortic
pericardial valves
• 400+ patients over 25 yrs
• 12K+ patients over 30 years
• Excellent long-term
durability shown
• Excellent long-term durability
shown
*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. Nov 2014; 148(5): 2004-11.
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Broadest, Most Differentiated Valve Portfolio
Today
INTUITY Elite
INTUITY Elite
Magna Ease
Magna Ease
Magna Ease
PERIMOUNT
PERIMOUNT
PERIMOUNT
PERIMOUNT Platform
PERIMOUNT Platform
PERIMOUNT Platform
Porcine
Mechanical
12/8/14
RESILIA | ZETA Valves
PERIMOUNT Platform
Yesterday
PERIMOUNT Pllatform
Value to Patiients and Hospital Syste
ems
Tomorrow
Magna Ease
Mechanical and Porcine Valves Discontinued
The EDWARDS INTUITY Elite valve system is investigational and not available for commercial sale in the U.S.
RESILIA and ZETA are investigational and are not available for commercial sale.
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Underlying Surgical Industry Growth
Outlook is Favorable
Estimated Surgical Tissue Valve Unit CAGR through ~2020
Organic
O
i
Surgical Growth
+
Additional
Additi
l
Growth Drivers
–
Likely
Lik l
Growth Range
Transcatheter
Substitution
Surgical
Innovation
Aging Global
Demographics
=
TAVR
Mech-to-Tissue
Conversion
Emerging
Markets
2% - 4%
Accessing
U d Treated
T
t d
Under
Patients
12/8/14
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Our Investments Align with
Long Term Growth Drivers
Organic Surgical Growth
Additional Growth Drivers
Mechanical
Aging Global
Demographics
+
Edwards Surgic
cal
Emerging
Markets
12/8/14
Expanded
Global Reach
Tissue
Mech-to-Tissue
Conversion
Surgical
Innovation
RESILIA | ZETA
Platform
INTUITY
System
Younger Patient
Options
Advanced Therapies
Standardized
MIS Procedures
Complex
Cases
The EDWARDS INTUITY Elite valve system is investigational and not available for commercial sale in the U.S.
RESILIA and ZETA are investigational and are not available for commercial sale.
Addressing Under
Treatment
Global Undertreatment
Programs & Initiatives
Commercial
Innovation
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Better Options for Valve Patients
Organic Surgical Growth
Additional Growth Drivers
Mechanical
Mechanical
Aging
Global
A i
Gl b l
Demographics
+
Edwards Surgical
Emerging
Markets
Expanded
Global Reach
Tissue
Mech-to-Tissue
Conversion
Surgical
Innovation
RESILIA || ZETA
ZETA
RESILIA
Platform
Platform
INTUITY
System
Younger Patient
Options
Advanced Therapies
Standardized
MIS Procedures
Complex
Cases
Addressing Under
Treatment
Global Undertreatment
Programs & Initiatives
Commercial
Innovation
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Transforming the Patient Experience
PERIMOUNT RESILIA | ZETA Platform Design Goals
Optimized for
Valve-in-Valve
Resilient Tissue
Technology
12/8/14
• Improved Valve Performance
Patient
Surgeon
• Ease of Use (Pre-mounted)
• Pediatric Sizes / Indication
Valve-in-V
Valve
Resilient Tiissue
(formerly GLX)
• Avoid Future Surgeries
Patient
Surgeon
Hospital
RESILIA and ZETA are investigational and are not available for commercial sale.
• Better Outcomes
• Continuum of Patient Care
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Vision is to Provide a
Continuum of Care
TODAY
Mechanical Valve
Limited Options
PERIMOUNT Platform
(Lifestyle Impact)
Higher Risk Re-Op/ViV
~70 Yrs Old
PERIMOUNT RESILIA | ZETA Platform Design Goals
TOMORROW
Enhanced Durability
<60 Yrs Old
12/8/14
Patient
Age
Optimized for ViV
~70 Yrs Old
Patient
Age
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RESILIA and ZETA are investigational and are not available for commercial sale.
Expanding the Tissue Valve Segment
Isolated sAVR Global Industry
Patient Age Distribution Trends
Mechanical sAVR
Tissue sAVR
Est. HVT 2014
Procedural Mix
Expand to younger
patients
RESILIA
TAVR
Expand to sAVR
patients
+
SAPIEN Platform
NonAortics
Concomitant
Aortic
Procedures
Isolated
Aortic
Tissue
TAVRcannibalization
Cannibalization
TAVR
ofof
sAVR
sAVR patients
Patientsover
overtime
Time
<55
12/8/14
30
35
40
45
50
55‐65
65 ‐ 75
75 ‐ 85
55 Isolated AVR Patient Age Groups
60 65 70 75 80 85
RESILIA and ZETA are investigational and are not available for commercial sale.
>85
90
95 100
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Innovating Advanced Therapies
Organic Surgical Growth
Additional Growth Drivers
Mechanical
Aging
Global
A i
Gl b l
Demographics
+
Tissue
Edwards Surgical
Emerging
Markets
Mech-to-Tissue
Conversion
Surgical
Innovation
RESILIA | ZETA
Platform
INTUITY
System
Younger Patient
Options
Expanded
Global Reach
Addressing Under
Treatment
Global Undertreatment
Programs & Initiatives
Commercial
Innovation
AdvancedTherapies
Therapies
Advanced
Standardized
Simplified
MIS
MIS
Procedures
Procedures
Complex
Complex
Cases
Cases
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Therapy Development: Elevating the Value
Proposition
Surgical Valves
Procedural Tools
+
PERIMOUNT
Magna Ease
INTUITY Elite
New Therapy Goals
+
Simplified
Integrated
Procedural
Evidence
Standardized
Differentiated
Clinical Data and
Compelling Health
Economics
+
+
Procedural
Training
Standardized,
Procedural-Based
Training
The EDWARDS INTUITY Elite valve system and Auto-knotting System are investigational and are not available for commercial sale in the U.S.
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
CSS Integrated into HVT to Enhance
Edwards’ Surgical Value Proposition
• Full integration of CSS business into Surgical Heart
Valve business initiated Q4 2014
• Near-term integration focus:
− Expanding procedural support for surgeons
− Aligning MIS teams with Edwards’ surgical valve portfolio
− Driving higher-value therapy platforms
• Anticipate 2015 CSS sales decline of $10-$20M due to
elimination of product codes
• Surgical heart valve sales unlikely to be affected by the
CSS integration
12/8/14
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Vision is to Drive a New Standard of
Care for Surgical Valve Therapy
Patient
Benefits
Hospital System
Benefits
Reduced Trauma / Pain,
Minimal Scarring
Expanded Patient
Access
New Therapy Goals
Predictable
Outcomes
Simplified
Simplified
Procedure
Integrated
p/
Less Time On Pump
Faster Procedure
Standardized
Shorter
Recovery Time
12/8/14
The EDWARDS INTUITY Elite valve system is investigational and not available for commercial sale in the U.S.
p
Reduced Hospital
Resources
Reduced
LOS
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
INTUITY Platform
2014 Commercial Highlights
~1,600
Global Clinical Implants to Date
g
• Significant
investments in clinical evidence
 INTUITY Elite launched in
Europe
• Strong procedural success of ~98%
 Increased adoption
• Significant cross-clamp time reduction
 ~120% unit growth YOY
 ~50% of INTUITY cases were MIS
• Excellent valve performance
 Enhanced procedural value
 2x-3x Magna Ease ASP
 2015 Germany
y reimbursement
improved
U.S. Launch Outlook
• TRANSFORM clinical enrollment complete
 Contributed solid sales growth
• PMA submission 2015
 ~50% of EU growth enabled by
INTUITY Elite launch
12/8/14
• U.S. anticipated approval in 2016
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The EDWARDS INTUITY Elite valve system is not available for commercial sale in the U.S.
Address the Undertreatment Opportunity
Organic Surgical Growth
Additional Growth Drivers
Mechanical
Aging
A
i
Global
Gl b l
Demographics
+
Edwards Surgical
Emerging
Markets
Expanded
Global Reach
Tissue
Mech-to-Tissue
Conversion
Surgical
Innovation
Addressing Under
Treatment
RESILIA | ZETA
Platform
INTUITY
System
Global
Global Undertreatment
Undertreatment
Programs
Programs &
& Initiatives
Initiatives
Younger Patient
Options
Advanced Therapies
Standardized
MIS Procedures
Complex
Cases
Commercial
Innovation
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Regionally-Specific Patient Access
Programs Initiated Across the Globe
Focus is Reaching Undertreated Patients
Pericardial Tissue
Penetration Programs
Patient Awareness and
Physician Access
Project LIFE
Initiative
12/8/14
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Edwards Expects to Grow Faster Than
the Industry
Edwards Surgical Growth Drivers
• Aging Populations
• Innovative Therapies
• Younger Patient Options
• Complex Patients
Edwards’ Innovative Therapies
NonAortics
Concomitant
Aortic
Procedures
NonAortics
Isolated
Aortic
Concomitant
Aortic
Procedures
Today
12/8/14
Edwards’ Conventional Products
Isolated
Aortic
Tomorrow
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Edwards Experience in Germany Drives
Confidence in Our Surgical Growth Outlook
Industry-Level
PreTAVR
Surgical Growth (CAGR)
4%
PostTAVR
~2X
20
PreTAVR
PostTAVR
5%
2001-2007
Thousands
Thousands
Total Isolated Aortic
Procedures in Germany
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Edwards
Surgical Growth (CAGR)
2007-2014
2001-2007
30
0%
20
6%
2007-2014
Edwards Isolated Aortic
Procedures in Germany
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14
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TAVR
15
~3X
10
8
10
4
12/8/14
TAVR Source: Internal estimates
SAVR Source: Funkat et al. “Cardiac Surgery in Germany during 2013.” Thoracic Cardiovasc Surg. 2014
'13
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2007
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'05
'04
'03
2001
'14…
Isolated Surgical AVR
0
'02
'14…
2014E
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'10
2
'09
'08
2007
'07
'06
'05
'04
'03
'01
2001
'02
Isolated Surgical AVR
'01
5
0
TAVR
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2014E
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Key 2015 Surgical Milestones
• FDA PMA submission
INTUITY Elite
• Expanded OUS INTUITY Elite launch
• COMMENCE trial enrollment complete
• FDA PMA regulatory submission
RESILIA | ZETA
• CE Mark regulatory submission
• Completing all integration activities
• Complete
p
remediation p
plan in Utah
HVT + CSS
• Expanded patient access initiatives
Patient Access
Programs
12/8/14
The EDWARDS INTUITY Elite valve system is investigational and not available for commercial sale in the U.S.
RESILIA and ZETA and auto-knotting are investigational and are not available for commercial sale.
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Edwards Lifesciences 2014 Investor Conference
12/8/2014
Underlying Global Sales Growth Outlook
2015 Estimated
y g Sales Growth
Underlying
2015 Outlook
Tailwinds
• EDWARDS INTUITY Elite adoption in EU
3% -5%
• Expanding pericardial adoption in China
(~2%)
Gro
owth Drivers
2% - 4%
• Under-treatment programs increase
1% - 3%
patient access
Headwinds
S
• Hospital economic pressures in U
U.S.
• Undisciplined competitor pricing
• Increased TAVR penetration
Industry
12/8/14
HVT
CSS
Total
Surgical
Total
Surgical
Sales
Sales
The EDWARDS INTUITY Elite valve system is investigational and not available for commercial sale in the U.S.
RESILIA and ZETA and auto-knotting are investigational and are not available for commercial sale.
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