Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — Investor Day (December 2022)
141 slides from Edwards Lifesciences's investor day presentation, Dec 8, 2022
Slide 1: 2022 Investor Conference
2022 Investor Conference Edwards
Slide 2: Cautionary Statement
Cautionary Statement Presentations and comments made today by management of Edwards Lifesciences Corporation (the “Company”) will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
Slide 3: Use of Non-GAAP Financial Measures
Use of Non-GAAP Financial Measures Unless otherwise indicated, all figures are GAAP financial measures. The Company uses the term “underlying or organic or constant currency growth rate” when referring to non-GAAP sales information, which excludes foreign exchange rate fluctuations, the conversion t
Slide 4: Opening Remarks
Opening Remarks Michael A. Mussallem Chairman and CEO
Slide 5: Our Credo
Our Credo At Edwards Lifesciences, we are dedicated to providing innovative solutions for people fighting cardiovascular disease. We will celebrate our successes, thrive on discovery, and continually expand our boundaries. We will act boldly, decisively, and with determination on behalf of people fi
Slide 6: Edwards Lifesciences at a Glance
Edwards Lifesciences at a Glance 12/8/2022 7
Slide 7: Our Aspirations
Our Aspirations Edwards is a global leader dedicated to… Transforming patient lives with Delivering exceptional breakthrough medical technologies shareholder value Excelling as a trusted partner through Passionate engagement that distinguished quality and integrity strengthens our communities Foster
Slide 8: Patient-Focused Innovation Strategy
Patient-Focused Innovation Strategy Innovation Leadership Focus Pioneer breakthrough Lead groundbreaking Singular focus on the large technologies with standards of care through unmet needs of structural compelling evidence trusted relationships heart and critically ill patients Create Meaningful Val
Slide 9: Patient-focused innovation strategy has produced sustained sales growth
Edwards’ patient-focused innovation strategy has Produced Sustained Sales Growth Focused on Track record of Long-term opportunities where triple wins: investments have patient demand is Improved outcomes yielded high-value, very large Enhanced quality of life organic growth Cost effectiveness
Slide 10: Conference Highlights
Conference Highlights Conference Highlights Grew during 2023 expected 9-12% Opportunity to double Highly strategic challenging sales growth and the already large and experienced environment in 2022 achieving innovation global addressable leadership team while investing to milestones market create fu
Slide 11: Growing in 2022 while investing to create future value
Growing in 2022 while investing to create future value Obtained Important Regulatory Approvals SAPIEN 3 Ultra RESILIA U.S. and Japan PASCAL Precision CE Mark PASCAL U.S. DMR approval MITRIS RESILIA U.S. Achieving Clinical and R&D Milestones Continued enrollment in Moderate AS trial Initiated ALLIANC
Slide 12: COVID triggered global healthcare staffing challenges
COVID triggered global healthcare staffing challenges 12/8/2022 13
Slide 13: Prioritizing widespread initiatives to improve near-term patient access
Prioritizing widespread initiatives to improve near-term patient access 12/8/2022 14
Slide 14: 2023 expected to be a year of strong growth and investment
2023 expected to be a year of strong growth and investment in our future TAVR TMTT SAPIEN 3 Ultra RESILIA launch Present CLASP IID full cohort 1-yr data Moderate AS trial enrollment ENCIRCLE trial complete enrollment SAPIEN X4 trial enrollment 9 – 12% Receive CE Mark for EVOQUE TR Underlying sales g
Slide 15: Significant Global Market Opportunity
Significant Global Market Opportunity Currently around $10B By 2028 Beyond TAVR $10B Significant opportunity to increase with: TMTT Moderate AS indication $20B $5B ~ Global TMTT valve Surgical replacement expansion Interventional heart failure $2B innovations Critical Care ~$2B Entering a New Era of
Slide 16: 2022 Investor Conference Agenda
2022 Investor Conference Agenda 12/8/2022 17
Slide 17: Edwards' Executive Leadership Team
Edwards’ Executive Leadership Team Mike Todd Daveen Dirksen Don Bobo, Jr. Mussallem Strategy & Corporate Brinton, M.D. Chopra Lehman Development Surgical Structural Chairman & CEO Chief Scientific Officer Public Affairs Heart Jean-Luc Christine Joe Arnold Gary Sorsher Lemercier McCauley Nuzzolese Pi
Slide 18: Trademarks
Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Acumen IQ, ALLIANCE, CLASP, COMMENCE, ENCIRCLE, EVOQUE, ForeSight, Life is Now, MITRIS, MITRIS RESILIA, MOMENTIS, PASCAL, PASCAL Precision, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, SAPIEN X4, and TRISCEND are trademarks of Edwards Lifesci
Slide 19: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Larry L. Wood Corporate Vice President Transcatheter Aortic Valve Replacement
Slide 20: Immediate Challenges are Transient; TAVR Fundamentals Remain Strong
Immediate Challenges are Transient; TAVR Fundamentals Remain Strong Key Pillars of Our Strategy Increase Therapy Adoption in Growing AS Opportunity Expand Indications Deliver Strong Portfolio Innovation 12/8/2022 2
Slide 21: Global EW TAVR has delivered double-digit growth over six years
Despite challenges, global EW TAVR has delivered double-digit growth over the past six years $1,000 Global Edwards TAVR Sales (in $M) $900 $800 $700 $600 $500 Unpredictable Regional $400 COVID-19 Impact $300 Hospital Staffing $200 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 22: Administrative requirements before TAVR and staffing shortages
Administrative requirements before TAVR are higher than other service lines, and staffing shortages impact TAVR patients Multi- Screening involves Disciplinary multidisciplinary expertise Heart Team Cardiac morphology Aortic valve and Coronary Treatment plan evaluated vasculature evaluated assessmen
Slide 23: Over the years, we have improved TAVR efficiencies
Over the years, we have improved TAVR efficiencies Multi- Screening involves Disciplinary multidisciplinary expertise Heart Team Cardiac morphology Aortic valve and Coronary Treatment plan evaluated vasculature evaluated assessment determined Cardiac Shared Decision Echo CT Scan Catheterization Maki
Slide 24: Supporting Hospitals as Trusted Partners
We Remain Focused on Supporting Hospitals as Trusted Partners Valve Clinic Coordinator Education Programs Provider Education Programs VCCs are typically trained >2X Number of >800 nurses who support patients from referral through post- TAVR procedure follow-up 300+ fellows expected VCCs educated to
Slide 25: Long-Term Growth Drivers
We Continue to Deliver On Our Long-Term Growth Drivers Powered by Powered by Tissue Tissue ALTERRA SAPIEN 3 Ultra SAPIEN X4 EARLY TAVR PROGRESS RESILIA System Trial Trial Pulmonic Adaptive Approved in the ALLIANCE Trial Enrollment complete; Enrolling for Prestent launched U.S. and JPN enrollment sta
Slide 26: Immediate Challenges are Transient; TAVR Fundamentals Remain Strong
Immediate Challenges are Transient; TAVR Fundamentals Remain Strong Key Pillars of Our Strategy Increase Therapy Adoption in Growing AS Opportunity Expand Indications Deliver Strong Portfolio Innovation 12/8/2022 8
Slide 27: Severe aortic stenosis is a disease of the elderly
Severe aortic stenosis is a disease of the elderly: Prevalence increasing with age Clinical research papers reaffirm higher Severe Aortic Stenosis prevalence in the elderly 10% Prevalence of Severe AS by Age1 7.9% 8% 6% 4% 2.3% 2% 0.8% 0% 60-64 65-69 70-74 75-79 80-84 85-89 90+ (1) EW estimate; draw
Slide 28: Aging population increases the burden of severe AS
Rapidly growing aging population increases the burden of severe AS By 2030, we expect to see significant growth in the 65+ population U.S. Population 50+ Projections1 ~10,000 160M 140M People turn 65 120M years every day2 ~30% 100M 56M growth in 65+ 73M 80M 40M pop. 60M 35M All Baby 40M Boomers 20M
Slide 29: AVR treatment utilization remains low
While the AVR treatment growth has accelerated since the advent of TAVR, treatment utilization remains low Growth in AVR Treatment2 U.S. Population 50+ Projections1 160M “ … currently ~1.3 to 1.6 million Americans 1.5M would merit consideration for AVR…” 140M Owens DS et al., BMJ Heart 2021 120M ~30
Slide 30: Undertreatment is exacerbated in elderly patients
Undertreatment is exacerbated in elderly patients, who also have longer time to treatment Patients Diagnosed with SAS and Time from Diagnosis to AVR Treated with AVR1 Treatment2 (days) 300k 200 250k 200k Time (days) 150k 100 100k 50k 0k 0 55-69yrs 70-80yrs 80+ 55-69yrs 70-80yrs 80+ AVR SAS Dx (1) Da
Slide 31: Patients in their 80s have favorable TAVR outcomes
Patients in their 80s have as favorable TAVR outcomes with Edwards TAVR as patients in their 70s Freedom From Freedom From Freedom From All-cause Death Stroke at Death or Stroke at 30 Days 30 Days at 30 Days 80 – 89 yrs 97.9% 98.1% 96.3% n = 59,470 70 – 79 yrs n = 56,025 98.6% 98.5% 97.2% Data from
Slide 32: After TAVR, QoL in 80+ patients improves
After TAVR, QoL in 80+ year old patients improves as much as QoL of patients in their 70s Change in KCCQ NYHA Class at 1 Year (Baseline to 1 Year) Patients in Patients in their 70s their 80s 7.30% 6.90% 92.7% 93.1% Overall Physical Symptom Social QoL Limitation Frequency Limitation NYHA I/II NYHA II
Slide 33: Elderly patients are living longer
Elderly patients are living longer Expected Years of Life (U.S.)1 10.9 75 Years 12.4 12.4 7.9 80 years 9.3 9.3 1980 2019 (1) https://www.cdc.gov/nchs/products/life_tables.htm for 1980 and 2019 Life Tables; As presented by Dr. Elmariah in 2022 TCT Symposium: Treatment of Aortic Stenosis by age in the
Slide 34: This is What 80 Looks Like
This is What 80 Looks Like… If Indiana Jones were diagnosed with Severe AS, he would deserve a TAVR! © 2022 Harrison Ford by Gage Skidmore is licensed under CC BY 4.0 12/8/2022 16
Slide 35: Improve therapy penetration in 80+ cohort
Our immediate focus: Improve therapy penetration in 80+ cohort by engaging patients and referrers through our global digital and media strategy 12/8/2022 17
Slide 36: Engage clinical community through scientific education
Our immediate focus: Engage with the clinical community through scientific education to address undertreatment head-on 2022 TCT Symposium Moderated by David A. Wood; Faculty: Evelio Rodriguez, Megan Coylewright, Sammy Elmariah Dr. Sammy Elmariah, 2022 TCT Symposium: Treatment of Aortic Dr. Megan Coy
Slide 37: Quality-of-care initiative led by AHA
Edwards is supporting a quality-of-care initiative led by AHA The American Heart Association and Edwards have a shared goal of lowering cardiovascular mortality, specifically by “establishing and advancing a new standard of care in structural heart disease” 2 HCPs 80 Hospital Systems Professional ed
Slide 38: Combination of activities impacts immediate challenges and adoption
We believe that a combination of all of these activities will have a meaningful impact on immediate challenges and therapy adoption Hospital Patients HCPs Systems 12/8/2022 20
Slide 39: Immediate Challenges are Transient; TAVR Fundamentals Remain Strong
Immediate Challenges are Transient; TAVR Fundamentals Remain Strong Key Pillars of Our Strategy Increase Therapy Adoption in Growing AS Opportunity Expand Indications Deliver Strong Portfolio Innovation 12/8/2022 21
Slide 40: Build evidence to expand leadership within severe AS
Long term, we continue to build evidence to further expand our leadership within the severe AS opportunity Severe AS Opportunity in U.S. • Significant number of Patients with Severe severe AS patients are Asymptomatic AS perceived asymptomatic • Symptoms are unnoticed, ignored, or associated with ge
Slide 41: With EARLY TAVR, still only addressing severe AS
With EARLY TAVR, we are still only addressing severe AS patients Severe AS Opportunity in U.S. • EARLY TAVR trial will help us understand if intervention should occur Patients with Severe AS before symptoms develop • Enrollment completed in 2021 • Currently, in follow-up (2-year primary endpoint) 20
Slide 42: Moderate AS adds new frontier for growth
While the severe AS opportunity is significant, moderate AS adds new frontier for growth Moderate-to-Severe AS Opportunity in U.S. • The PROGRESS Patients with Moderate AS 2:1 Ratio of Trial will help us understand the true Moderate to impact of Moderate Severe AS AS and the optimal patients1 time o
Slide 43: PROGRESS Trial Design
PROGRESS Trial Design Moderate, calcific AS and appropriate anatomy for transfemoral TAVR 1:1 Randomization (n = 750) Clinical surveillance TAVR (SAPIEN 3/ SAPIEN 3 Ultra System) Potential delayed-AVR1 Primary endpoint Death, stroke and unplanned CV2 rehospitalization at 2 years Follow-up Annually t
Slide 44: Moderate AS patients have similarly poor prognoses
Contemporary data shows moderate AS patients have similarly poor prognoses as severe AS patients Fully adjusted all-cause mortality according to AS stage3 Moderate, calcific AS and appropriate anatomy for transfemoral TAVR 1:1 Randomization (n = 750) Clinical surveillance TAVR (SAPIEN 3/ SAPIEN 3 Ul
Slide 45: Immediate Challenges are Transient; TAVR Fundamentals Remain Strong
Immediate Challenges are Transient; TAVR Fundamentals Remain Strong Key Pillars of Our Strategy Increase Therapy Adoption in Growing AS Opportunity Expand Indications Deliver Strong Portfolio Innovation 12/8/2022 27
Slide 46: Future portfolio elevates TAVR and lifetime management
Our future portfolio further elevates TAVR and the benchmark of lifetime management Powered by Future Powered by Tissue Platforms Tissue SAPIEN SAPIEN XT SAPIEN 3 SAPIEN 3 Ultra SAPIEN 3 Ultra SAPIEN X4 RESILIA 2011 2014 2015 2019 2022 Future SAPIEN Valves shown above are part of the Edwards SAPIEN
Slide 47: Launch of SAPIEN 3 Ultra RESILIA system
The first step in further elevating the TAVR therapy is the launch of SAPIEN 3 Ultra RESILIA system Advanced calcium- The only THV with blocking technology dry tissue storage RESILIA Tissue: Same as INSPIRIS RESILIA surgical valve Enhanced PVL skirt for all valve sizes (including 29mm) 12/8/2022 29
Slide 48: Next Generation Technology: SAPIEN X4
Our Next Generation Technology: SAPIEN X4 Transcatheter Heart Valve System Novel Frame and Advanced Delivery System Leaflet Design to Enable Technology Offers Adjustable Sizing Commissural Alignment Frame Design to Facilitate Future Coronary Access Advanced PET Outer Skirt Technology Powered by Tiss
Slide 49: Immediate Challenges are Transient; TAVR Fundamentals Remain Strong
Immediate Challenges are Transient; TAVR Fundamentals Remain Strong Key Pillars of Our Strategy Increase Therapy Adoption in Growing AS Opportunity Expand Indications Deliver Strong Portfolio Innovation 12/8/2022 31
Slide 50: Global TAVR opportunity will double by 2028
We remain confident in our view that the global TAVR opportunity will double by 2028 2028 $10B 2021 ~$5B The fundamentals of TAVR remain strong and the opportunity ahead is significant 12/8/2022 32
Slide 51: Growth drivers beyond the plan horizon remain strong
And growth drivers beyond the plan horizon remain strong 2028 $10B 2021 ~$5B Continued Therapy Development Beyond Global Indication 2028 Expansion Moderate AS Indication The fundamentals of TAVR remain strong and the opportunity ahead is significant 12/8/2022 33
Slide 52: 2023 Underlying Global Sales Growth Outlook
2023 Underlying Global Sales Growth Outlook Headwinds $4.0B Ongoing healthcare staffing recovery $3.6B COVID uncertainties Tailwinds Increasing therapy adoption in a rapidly growing elderly population Potential patient backlog 2023E Underlying Global TAVR Estimated Sales Growth 9 – 12% 12/8/2022 34
Slide 53: Edwards SAPIEN 3 Transcatheter Heart Valve System indications
Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Indications: The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart d
Slide 54: Precautions
Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low
Slide 55: SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Indications: The Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as mea
Slide 56: Potential Adverse Events
Potential Adverse Events: Potential risks associated with the anesthesia, interventional procedure, and imaging include but are not limited to death; stroke/transient ischemic attack; respiratory insufficiency or respiratory failure; cardiovascular or vascular injury, such as perforation or damage (
Slide 57: Helping Patients is Our Life's Work
Helping Patients is Our Life’s Work, and, now) fife”
Slide 58: Transcatheter Mitral and Tricuspid Therapies
Transcatheter Mitral and Tricuspid Therapies Bernard J. Zovighian Corporate Vice President Transcatheter Mitral and Tricuspid Therapies
Slide 59: Mitral / Tricuspid disease is common, complex, and undertreated
Mitral / Tricuspid disease is common, complex, and undertreated Transcatheter therapies can revolutionize patient care 4 Million+ U.S. patients with ≥ moderate-to-severe Mitral / Tricuspid Disease TRICUSPID MITRAL 30 – 45% ~20% MORTALITY MORTALITY of moderate or severe of ≥ moderate-to-severe TR at
Slide 60: Bold vision enabled by three key value drivers
Our bold vision to transform patient care is enabled by three key value drivers Transforming care INNOVATION A portfolio of transcatheter therapies CLINICAL EVIDENCE Starting with 5 simultaneous pivotal trials REAL-WORLD OUTCOMES Deep partnerships supporting for patients in need optimal patient outc
Slide 61: Paradigm shift in treatment of mitral disease
Advancements in transcatheter therapies are driving a paradigm shift in the treatment of mitral disease More options to reach more patients Growing TEER confidence Slow TEER adoption, as compared to TAVR Historical Today Tomorrow Modality TEER (1-device) TEER (2-devices) TEER + TMVR + more Innovatio
Slide 62: PASCAL Precision system delivers new Mitral treatment options
PASCAL Precision system delivers new Mitral treatment options Committed to ongoing innovation to further elevate TEER Atraumatic Versatile Implant Accurate, Clasp & Closure Configuration Intuitive Control Early commercial experience with PASCAL Precision system suggests: Faster procedures PMA Approv
Slide 63: Mitral TEER positive randomized clinical data
TMTT is advancing Mitral TEER therapy with positive randomized clinical data on patients with degenerative disease N = ~180 patients EVEREST II RCT, 2010 * At Discharge At 6 Months 13% 12% 16% 14% 27% 31% 87% 84% ≤ Mild MR ≤ Mild MR 87% 89% 84% 71% 53% 53% > Moderate MR (≥ 3+) ≤ Mild MR Moderate MR
Slide 64: U.S. launch of PASCAL Precision system
The U.S. launch of PASCAL Precision system focuses on achieving exceptional patient outcomes with TMTT’s high-touch model High-Touch Model Expanding U.S. Launch Comprehensive Patient Physician Screening Training Support Scale Organization Expand highly-trained Dedicated 100% Case Broaden TMTT field
Slide 65: Transfemoral Mitral Valve Replacement to complement TEER
Anticipate safe and effective Transfemoral Mitral Valve Replacement to complement TEER, expand mitral treatment options Transcatheter mitral replacement Not all transcatheter And not all transfemoral offers distinct potential advantages systems are equal… systems are equal… Access Site Transfemoral
Slide 66: Leading Mitral Replacement with 2 transfemoral systems
Edwards is committed to leading Mitral Replacement, currently advancing 2 transfemoral, <30 Fr systems SAPIEN M3 Device • Leverages proven SAPIEN 3 platform • Recapturable, Patients with Symptomatic, ≥3+ MR deemed unsuitable for repositionable dock commercial treatment options Main Cohort Failed TEE
Slide 67: Near-term milestones extend therapy to more Mitral patients
Near-term milestones extend transcatheter therapy to more Mitral patients in 2023 and beyond • Advance next-generation INNOVATION PASCAL and EVOQUE Eos systems • Present CLASP IID trial full cohort 1-year data CLINICAL EVIDENCE • Complete enrollment of ENCIRCLE trial Main Cohort around end of 2023 R
Slide 68: Tricuspid Regurgitation is a significant patient need
Growing experience reinforces that Tricuspid Regurgitation is a significant patient need, addressable with transcatheter therapies Tricuspid emerges as the ‘unforgettable’ valve Transcatheter therapy fueling momentum in tricuspid 5 Global randomized trials1 Transcatheter Medical ‘Forgotten’ valve; T
Slide 69: PASCAL Precision system treats TR patients with confidence
PASCAL Precision system enables clinicians to treat TR patients with confidence Versatility of PASCAL Precision system enables tailored therapy in tricuspid anatomy Positive outcomes in real-world study of 177 patients with 6-months follow-up 1 Preserve Integrity of Thin Leaflets Spacer bridges 99%
Slide 70: Early EVOQUE device outcomes
Early EVOQUE device outcomes are setting the standard for Transcatheter Tricuspid Replacement Excellent survival and symptom Substantial improvement at 1-year 1 TR reduction 1 p < 0.001 90% 100 21.7 80 28.6 Survival at 1-year 21.1 98% Patients (%) 91% 60 ≤ Mild TR at 1-year Discharged Home 40 44.7 6
Slide 71: TRISCEND II trial continues enrolling well
TRISCEND II trial continues enrolling well, putting the EVOQUE system on track for a U.S. approval around the end of 2024 EVOQUE system builds on 60+ years of Edwards innovation in tissue technology and valve design Patients with Symptomatic, ≥ Severe TR 4 Valve Sizes Randomization EVOQUE TTVR + Opt
Slide 72: Extend transcatheter therapy to more Tricuspid patients
TMTT continues to extend transcatheter therapy to more patients with Tricuspid valve disease in 2023 and beyond • Advance next-gen PASCAL and Cardioband systems INNOVATION • Expand EVOQUE platform with larger valve size • Complete enrollment of TRISCEND II trial CLINICAL in first-half of 2023 EVIDEN
Slide 73: 2023 Global Sales Outlook
2023 Global Sales Outlook Headwinds $200M Evolving EU regulatory environment Hospital staffing recovery and COVID uncertainty Tailwinds $160M Robust evidence across the TMTT portfolio, driving accelerated therapy adoption Stronger recovery of Mitral market growth 2023E 12/8/2022 16
Slide 74: Near-term milestones advance TMTT's vision
Near-term milestones advance TMTT’s vision of transforming Mitral and Tricuspid patient care REAL-WORLD INNOVATION CLINICAL EVIDENCE OUTCOMES Advance next-generation of Present CLASP IID trial full Execute patient focused launch PASCAL & Cardioband systems cohort data: 2023 of PASCAL Precision
Slide 75: Important Safety Information: PASCAL Precision
Important Safety Information: Edwards PASCAL Precision Transcatheter Valve Repair System Indications: The PASCAL Precision Transcatheter Valve Repair System (the PASCAL Precision system) is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR > 3+) due to pri
Slide 76: Caution: Federal law restricts this device
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consu
Slide 77: Helping Patients is Our Life's Work
Helping Patients is Our Life’s Work, and, now) fife”
Slide 78: Surgical Structural Heart
Surgical Structural Heart Daveen Chopra Corporate Vice President Surgical Structural Heart
Slide 79: Surgical Structural Heart growing by solving unmet needs
Edwards Surgical Structural Heart is growing by identifying and solving for increasing critical unmet needs in cardiac surgery • The surgical structural heart market is expected to grow by mid-single digits to over $2B by 2028 • As structural heart disease therapy expands, many patients are best tre
Slide 80: Surgical structural heart market is growing
The surgical structural heart market is growing due to several dynamics around the world Macro Trends Increased Growth in • Aging global population Diagnosis Surgery • Growing access and wealth in emerging markets Greater More Heart • New structural heart Awareness Team Referrals innovations 12/8/20
Slide 81: Long history of partnering with cardiac surgeons
We have a long history of partnering with cardiac surgeons to drive leading surgical therapies Introduced Pioneered Mitral Led Bovine Launched the Developed the Only Expanded RESILIA the First Successful & Tricuspid Pericardial Valve RESILIA Tissue Pre-Assembled Tissue Tissue to the Artificial Valve
Slide 82: Vision to transform lives through surgical innovations
Our vision is to transform patients’ lives through surgical structural heart innovations that address their unmet needs Extended Durability & Solutions for Complex Global Access to Lifetime Management & Concomitant Cases Best-in-Class Innovations 12/8/2022 5
Slide 83: RESILIA tissue technology meets need for extended durability
Our innovative RESILIA tissue technology is meeting patients’ needs for extended valve durability Clinical Need The primary mode of long-term failure for tissue valves is calcification RESILIA tissue’s novel capping technology effectively stops specific calcification formation pathways to significan
Slide 84: Robust evidence proves value of RESILIA tissue technology
Our robust evidence is proving the clear value proposition of RESILIA tissue technology for patients “ Having a fully functional valve Zero cases of structural valve deterioration (SVD) in pre-market studies of 822 patients at 5-year follow-up for the first time in my life has felt amazing. I can’t
Slide 85: Two new RESILIA clinical evidence milestones in 2023
In 2023, we will achieve two new meaningful RESILIA tissue technology clinical evidence milestones Foundational Clinical Evidence on MITRIS valve Global Post-Market Study RESILIA Tissue Technology of 500 Patients, 10-Year Follow-Up Pivotal 7-Year Data to Be Patient Enrollment to Presented in Mid-202
Slide 86: INSPIRIS valve improves durability and lifetime management
INSPIRIS valve improves durability and lifetime management for surgical aortic valve replacement (SAVR) patients • The leading SAVR valve in the world, continuing to outpace surgical market growth • Features RESILIA tissue technology for extended durability and VFit expandability for TAVR valve-in-v
Slide 87: INSPIRIS VFit expands for valve-in-valve
With the VFit feature, INSPIRIS valve expands for larger TAVR valve-in-valve, leading to better clinical outcomes Without VFit With VFit Expanded VFit Feature 20mm SAPIEN 3 Platform in a 26mm SAPIEN 3 Platform in a 21mm Traditional Valve 21mm INSPIRIS Valve 12/8/2022 10
Slide 88: KONECT valved conduit
KONECT valved conduit streamlines difficult, complex aortic procedures for both surgeons and patients • The leading tissue valved conduit for cases where the aortic valve, root and ascending aorta are replaced • RESILIA tissue technology with a pre-assembled design increases surgeon confidence over
Slide 89: Patients needing mitral valve replacement seek better options
Patients in need of mitral valve replacement (MVR) are seeking better options ~200,000 MVR Mechanical valves Porcine valves cases worldwide used in most used in most US annually cases globally MVR cases Growing in the Lifelong anticoagulation Patients are looking for mid-single digits for patients m
Slide 90: MITRIS valve designed for better surgical MVR outcomes
MITRIS valve is designed to deliver better outcomes for surgical MVR patients around the world • Our newest premium valve, the MITRIS valve is specifically designed for the mitral position and its higher pressures • Features RESILIA tissue technology for extended durability with key ease of use and
Slide 91: Mitral regurgitation under-treated but growing
Mitral regurgitation (MR) is largely under-treated but growing; surgical repair indicated for low-risk degenerative MR patients <3% of patients with MR As overall treatment increases, a significant portion of patients receive treatment in the US will continue to be treated surgically US Surgical Mit
Slide 92: Innovating to improve surgical mitral repair outcomes
Consistent, optimal results can be challenging to achieve with mitral repair; we are innovating to improve surgical outcomes When performed well, surgical Mitral Adjustable Repair System Program repair can restore patients to their normal life expectancy Enables beating-heart adjustability of implan
Slide 93: 2023 Underlying Global Sales Growth Outlook
2023 Underlying Global Sales Growth Outlook Headwinds $970M Additional TAVR conversion in developed markets Overall healthcare spending pressure Tailwinds $870M Adoption of our premium RESILIA innovations Accelerated mechanical-to-tissue valve conversion 2023E Underlying Global Surgical Structural H
Slide 94: In Summary
In Summary The surgical market is growing, especially in patients who require complex and concomitant procedures Edwards Surgical is outpacing market growth with our premium RESILIA tissue aortic and mitral innovations There continue to be many unmet needs within surgery and significant growth oppor
Slide 95: Important Safety Information: RESILIA Tissue Devices
Important Safety Information: RESILIA Tissue Devices Indications: INSPIRIS RESILIA Aortic Valve - For use in replacement of native or prosthetic aortic heart valves. KONECT RESILIA Aortic Valved Conduit - For use in replacement of native or prosthetic aortic heart valves and the associated repair or
Slide 96: Helping Patients is Our Life's Work
Helping Patients is Our Life’s Work, and, now) fife”
Slide 97: Critical Care
Critical Care Katie Szyman Corporate Vice President Critical Care
Slide 98: Our vision is to improve the quality of care
Drive Smart Recovery with leading predictive technology Reach more patients with compelling clinical evidence Our vision is to improve the quality of care for millions of Increase awareness to drive patients adoption of innovative solutions 12/8/2022 2
Slide 99: Evolving our portfolio toward Smart Monitoring
Evolving our portfolio toward Smart Monitoring Hemodynamic Monitoring Market1 Core Monitoring is highly penetrated and is a large portion of the overall LEGEND hemodynamic segment Core Monitoring ~$1.2B ~$1.8B Smart Monitoring Smart Monitoring represents an under penetrated growth opportunity with g
Slide 100: Smartify Strategy
Smart Recovery begins with technology SENSORS Smartify Strategy Connects patient Acumen IQ Acumen IQ Swan-Ganz IQ and monitor sensor cuff catheter (2018) (2022) (Future) 94 ALGORITHMS Enables smarter patient care Acumen HPI Acumen AFM (2018) (2022) SMART MONITORING PLATFORM HemoSphere builds the fou
Slide 101: Algorithms advance predictive and prescriptive technologies
Algorithms advance predictive and prescriptive technologies Prescriptive Acumen Assisted Fluid Management Predictive Clinical Value Acumen Hypotension Prediction Indicator Descriptive Monitoring platform & sensors Algorithm Progression 12/8/2022 5
Slide 102: Success with HemoSphere conversion and expansion
Continued success with HemoSphere conversion and expansion HemoSphere Platform Conversions surpassing 50% of installed base 2018 2023 2028 HemoSphere with Viewfinder Remote app Expansion + Supports portfolio of sensors Conversion (Every ~7-9 years) 94 Acumen IQ 94 Acumen IQ HPI HPI sensor & HPI cuff
Slide 103: HemoSphere Smart Recovery product introductions drive growth
HemoSphere Smart Recovery product introductions drive growth 2022 Product Introductions Accelerating Acumen IQ Conversion Smart Recovery Sales MultiTech Monitoring (Acumen IQ and Swan-Ganz) IQ HPI software Smart Trends IQ HemoSphere Assisted Fluid Management with Viewfinder Remote app Version 7 Toda
Slide 104: Growing clinical evidence proves value of Smart Recovery
Growing clinical evidence proves value of Smart Recovery Proved ability to reduce hypotension Ongoing studies advance hemodynamic learnings Mean Minutes of Hypotension Multi-center Prospective Registry 28 mins Observe patient hypotension using Acumen HPI 12 mins Multi-center Open Randomized Trial Ev
Slide 105: Edwards HPI shown to reduce ICU stay
Edwards HPI shown to reduce ICU stay in cardiac patients Key Results Real world data Analysis before and after implementation of Acumen HPI guided hemodynamic management Mean ICU length 34% reduction in Decrease in post- ~1400 of stay decrease total initial op renal failure in cardiac patients of ~7
Slide 106: Increase awareness through multiple avenues
Increase awareness through multiple avenues to drive adoption Public Awareness Recognizing hypotension as top harm1 Real World Evidence Key groups demonstrating prevalence of hypotension H yp o t e n s io n Aw a ren es s Hypotension Quality Measure Setting a standard for improved quality of care 1.
Slide 107: 2023 Underlying Global Sales Growth Outlook
2023 Underlying Global Sales Growth Outlook Headwinds $940M Recession impacts capital budgets Semiconductor supply chain risk Tailwinds $840M Accelerated adoption of IQ technologies Impact of real-world data on adoption 2023E Underlying Global Critical Care Estimated Sales Growth Mid Single-Digits 1
Slide 108: Executive Summary
Executive Summary We are leading Smart Recovery with AI Enabled Technology We are reaching more patients with clinical Evidence We are gaining Adoption to get patients home to their families faster The Best Is Yet To Come
Slide 109: Caution: Federal law restricts these devices
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information. Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Acumen AFM, Acumen HPI, Acumen IQ, AFM, ClearSight, FloTrac, ForeSight, HPI, HemoSphere
Slide 110: Helping Patients is Our Life's Work
Helping Patients is Our Life’s Work, and, now) fife”
Slide 111: Financial Outlook
Financial Outlook Scott Ullem Chief Financial Officer
Slide 112: Return to double-digit constant currency sales growth in 2023
Edwards expects a return to double-digit constant currency sales growth in 2023, lifted by TAVR 9 – 12% Low end of $5.35 – 5.55 billion 18% 1% 15% 16% 10% 19% 13% 17% 2014 2015 2016 2017 2018 2019 2020 2021 2022E 2023E 12/8/2022 2
Slide 113: Edwards expects durable organic growth
Edwards expects to generate durable organic growth Sales Growth Profitability Capital Allocation Constant currency sales growth Continued healthy gross profit Strategic balance sheet in the low double-digits and operating margins management and capital (significant FX impact in 2023) deployment Long
Slide 114: Edwards Financial Objectives
Edwards Financial Objectives Strong Organic Sales Growth Addressing large and growing Global sales growth fueled by Sustained leadership position patient populations successful long-term R&D supported by strong evidence- investments to drive breakthrough based value to patients, clinicians therapies
Slide 115: 2022 sales and growth impacted by TAVR and FX
2022 sales and growth impacted by TAVR and FX ($ in millions except earnings per share) 2021 Investor Conference October Guidance Guidance (Unchanged) Sales $5,500 - 6,000 Low-end of (Constant Currency Growth) (Low double-digit) $5,350 - 5,550 ~($120) ~($270) FX Impact on Sales ~2pp downside to sale
Slide 116: Expecting 9–12% total company sales growth
Expecting 9 – 12% total company sales growth (Constant currency growth, $ in billions) Assumes gradual recovery of hospital staffing and improving procedure volumes Growth across all major regions At current rates, negative FX impact expected to be approximately $100 million, or 1.5%, compared to 20
Slide 117: Expecting 9–12% sales growth in TAVR
Expecting fewer staffing disruptions, enabling 9 – 12% sales growth in TAVR (Constant currency growth, $ in billions) 2023 LONG - TERM Strong growth across all major regions Growing patient population including the U.S. Investing in mitigating staffing disruptions Launch of SAPIEN 3 Ultra RESILIA in
Slide 118: TMTT sustains strong momentum
TMTT sustains strong momentum ($ in millions) Remain focused on excellent patient outcomes PASCAL launch in the U.S. and continued expansion in Europe drives growth Expect EVOQUE TR Europe approval in late 2023 with reimbursement in 2024 Complete enrollment in ENCIRCLE for SAPIEN M3, and advance ong
Slide 119: Surgical Structural Heart continues to grow
Surgical Structural Heart continues to grow (Constant currency growth, $ in millions) Increased adoption of premium technologies drives growth Continue generating meaningful RESILIA clinical evidence Continue launch of MITRIS RESILIA valve in the U.S. Mid Mid single-digit single-digit 2023 Expectati
Slide 120: Critical Care accelerates shift to Smart Recovery
Critical Care accelerates shift to Smart Recovery (Constant currency growth, $ in millions) Drive Smart Recovery with leading predictive technology Generate compelling clinical evidence Increase awareness to drive adoption Mid Mid single-digit single-digit 2023 Expectations $725 $835 $820 – 900 $840
Slide 121: Edwards Financial Objectives: Healthy Profitability
Edwards Financial Objectives Healthy Profitability Generating strong Funding growing field Investing aggressively in Maintaining efficient gross profit organization and innovation for profitable tax structure strengthening global organic growth supply chain 12/8/2022 11
Slide 122: 2023 gross profit margin unfavorably impacted by FX
2023 gross profit margin unfavorably impacted by FX Gross Profit Margin Between 76 - 78% Product mix FX impact Operational efficiencies Wage and materials inflation 12/8/2022 12
Slide 123: 2023 Operating Expenses
2023 Operating Expenses OPEX SG&A: 29 - 30%; R&D: 17 - 18% Investments in clinical trials and Leveraging Scale product development FX: translation of OUS expenses Therapy adoption initiatives 12/8/2022 13
Slide 124: Negative FX impact outweighs profit growth from operations
Negative FX impact forecasted to outweigh profit growth from operations (Adjusted earnings per share) $0.25 - 0.30 $2.45 - 2.60 $2.40 - 2.50 $0.08 - 0.10 $0.04 - 0.08 $0.17 - 0.22 $(0.02 - 0.03) $(0.27 - 0.31) $2.22 2021 Operating FX Interest/Shares/Tax 2022 October Operating FX Interest/Shares/Tax
Slide 125: Robust Cash Flow and Strategic Capital Deployment
Edwards Financial Objectives Robust Cash Flow and Strategic Capital Deployment Supports global Strategic acquisitions to support Returning capital to capacity expansion and supplement R&D initiatives shareholders through opportunistic share repurchases 12/8/2022 15
Slide 126: Cash Flow and Capital Deployment
Cash Flow and Capital Deployment 2023 Expectations Continued growth results in significant cash flows that fund future internal and external opportunities Diluted shares outstanding estimated between 610 and 615 million Adjusted Free Cash Flow ($ in billions) $1.4 YTD Q3 $1.0 – 1.4 $0.7 $0.8 2020 20
Slide 127: Share Buyback Activity
Share Buyback Activity Share Repurchases ($ millions) Shares Outstanding (millions) 750 700 ~1,700 650 625 513 263 2019 2020 2021 2022E 600 2012 2014 2016 2018 2020 2022E 12/8/2022 17
Slide 128: Investing Capital for the Future
Investing Capital for the Future CAPEX ($ in millions) Where are we investing? Other Research Capacity Infrastructure Manufacturing $326 Investment Resiliency ~$300 ~$265 2021 2022E 2023E 12/8/2022 18
Slide 129: Active Portfolio Management
Active Portfolio Management FOCUSED ADDITIONS Closed Transactions Since 2017 Structural heart Smaller tuck-ins Acquisitions & 11 Options to Aquire Early-stage, pre-revenue start-ups Strategic fit Minority Investments 23 EXITS IP investments to protect R&D 16 innovations Non-strategic products Low gr
Slide 130: 2023 Guidance Summary
2023 Guidance Summary ($ in millions except earnings per share) Sales $5,600 - 6,000 Operating Margin ~30% Underlying growth 9 - 12% Tax rate 13 - 17% FX Impact on Sales ~($100) Earnings Per Share $2.45 - 2.60 At current rates (1.5pp downside to growth) Gross Profit Margin 76 - 78% Diluted Shares 61
Slide 131: Longer-Term Outlook
Longer-Term Outlook Constant Currency Sales Growth Operating Efficiency Earnings Organic sales growth in the low Gross Profit Margin Tax Rate double-digits Mix and efficiencies expected to Neutral to upward pressure benefit longer-term margin SG&A Earnings Per Share Global Market Opportunity Discipl
Slide 132: Edwards expects durable organic growth
Edwards expects to generate durable organic growth Sales Growth Profitability Capital Allocation Constant currency sales growth Continued healthy gross profit Strategic balance sheet in the low double-digits and operating margins management and capital (significant FX impact in 2023) deployment Long
Slide 133: Trademarks
Edwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, EVOQUE, Life is Now, MITRIS, MITRIS RESILIA, PASCAL, RESILIA, SAPIEN, SAPIEN M3, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective
Slide 134: Closing Remarks
Closing Remarks Michael A. Mussallem Chairman and CEO
Slide 135: Patient-Focused Innovation Strategy
Patient-Focused Innovation Strategy Innovation Leadership Focus Pioneer breakthrough Lead groundbreaking Singular focus on the large technologies with standards of care through unmet needs of structural compelling evidence trusted relationships heart and critically ill patients Create Meaningful Val
Slide 136: 2023 expected to be a year of strong growth and investment
2023 expected to be a year of strong growth and investment in our future TAVR TMTT SAPIEN 3 Ultra RESILIA launch Present CLASP IID full cohort 1-yr data Moderate AS trial enrollment ENCIRCLE trial complete enrollment SAPIEN X4 trial enrollment 9 – 12% Receive CE Mark for EVOQUE TR Underlying sales g
Slide 137: Edwards' Board is accomplished and engaged
Edwards’ Board is accomplished and engaged Leading governance practices Highly experienced leaders Oversees compensation program based on performance: Financial performance Key operating drivers Shareholder value creation 12/8/2022 4
Slide 138: Sustainability is integrated into our culture and strategy
Sustainability is integrated into our culture and strategy 12/8/2022 5
Slide 139: Edwards is Committed to Giving Back
Edwards is Committed to Giving Back Foundation supporting nearly 50 countries in 2022 Every Heartbeat Strengthening Matters Our Communities Improve the lives of 2.5M Aspire for 100% employee additional underserved involvement in charitable structural heart and critical activity; focused on care pati
Slide 140: Edwards is poised for long-term value creation
Edwards is poised for long-term value creation Large Credibility Patient- Innovative Sustainable Populations and Trust Focused R&D organic long-term sales growth of patients with with clinicians, Culture 7 produces unmet needs regulators, payors motivates and guides breakthrough and patients our glo
Slide 141: Trademarks
Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Acumen IQ, CLASP, COMMENCE, ENCIRCLE, EVOQUE, ForeSight, Life is Now, MITRIS, MOMENTIS, RESILIA, SAPIEN, SAPIEN X4, SAPIEN 3, SAPIEN 3 Ultra, TRISCEND are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademark