Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — Investor Day (December 2021)
127 slides from Edwards Lifesciences's investor day presentation, Dec 8, 2021
Slide 1: 2021 Investor Conference
? — = oy A en ie | 1] 2021 Investor Conference
Slide 2: Investor Conference
2021 Investor Conference Mark Wilterding VP, IR and Treasurer
Slide 3: 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 4: 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 "adjusted sales" or “underlying growth rate” when referring to non-GAAP sales information, which excludes foreign exchange rate fluctuations, the conversion to a consignm
Slide 5: Helping Patients is Our Life's Work, and, now
Helping Patients is Our Life’s Work, and, now fife
Slide 6: Opening Remarks
Opening Remarks Michael A. Mussallem Chairman and CEO
Slide 7: Our Credo
Our Credo Through our actions, we will become trusted partners with customers, colleagues, and patients– creating a community unified in its mission to improve the quality of life around the world. Our results will benefit customers, patients, employees and shareholders. We will celebrate our succes
Slide 8: Our Aspirations
Our Aspirations Edwards is a global leader dedicated to… Transforming patient lives Delivering exceptional with breakthrough shareholder value medical technologies Excelling as a trusted partner Passionate engagement that through distinguished quality and strengthens our communities integrity Foster
Slide 9: Edwards Lifesciences at a Glance
Edwards Lifesciences at a Glance 600K+ 15,000+ Global Employees Patients Treated with Transcatheter Therapies ~2,000 80%+ 7 Engineers Charitable employee 50% + Manufacturing Facilities Around the World engagement Millennials and Generation Z Investment in R&D 95%+ 17-18% Sales from Products with Res
Slide 10: 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 11: Patient-focused innovation strategy has produced sustained underlying sales growth
Edwards’ patient-focused innovation strategy has produced sustained underlying 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 eff
Slide 12: Conference Highlights
Conference Highlights Delivering results in 2021 2022 expected to be a Long-term global Highly strategic while investing to create year of significant market opportunity is and experienced future value milestone achievements expanding leadership team 12/8/2021 10
Slide 13: 2021 Delivering Results to Drive Value
2021 Delivering Results to Drive Value Strengthening Positions Despite COVID Estimated 2021 TAVR therapy and geographic expansion Critical Care exceeding growth Sales Growth: expectations High-Teens Surgical driving adoption of premium technologies TMTT implementing bold agenda Achieving Clinical an
Slide 14: 2022 expected to be a year of significant milestone achievements
2022 expected to be a year of significant milestone achievements and investment in our future TAVR TMTT SURGICAL CRITICAL CARE Moderate AS trial enrollment PASCAL - DMR approval in the U.S. MITRIS approval in the U.S. HemoSphere with Viewfinder SAPIEN X4 trial enrollment EVOQUE TR approval in Europe
Slide 15: Global Market Opportunity by 2028
Global Market Opportunity by 2028 Currently around $10 billion TAVR $10B TMTT $5B Surgical $2B Nearly Critical Care ~$2B $20B We are just getting started 12/8/2021 13
Slide 16: 2021 Investor Conference Agenda
2021 Investor Conference Agenda 12/8/2021 14
Slide 17: Edwards' Executive Leadership Team
Edwards’ Executive Leadership Team Mike Mussallem Don Bobo, Jr. Todd Brinton, M.D. Strategy & Corporate Chairman & CEO Chief Scientific Officer Development Daveen Chopra Dirksen Lehman Jean-Luc Lemercier EMEA, Canada Surgical Structural Heart Public Affairs and Latin America Christine McCauley Joe N
Slide 18: Trademark notice
Edwards, Edwards Lifesciences, the stylized E logo, EVOQUE, HemoSphere, Life is Now, MITRIS, PASCAL, RESILIA, SAPIEN, SAPIEN X4, Viewfinder, and X4. All other trademarks are the property of their respective owners. © 2021 Edwards Lifesciences Corporation. All rights reserved.
Slide 19: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Larry L. Wood Corporate Vice President Transcatheter Aortic Valve Replacement
Slide 20: Over a decade ago, we set out to establish new frontiers in heart valve therapy
Over a decade ago, we set out to establish new frontiers in heart valve therapy Original SAPIEN System used in PARTNER Study SAPIEN 3 Ultra System TA2, 50% Alt3, 7% 22/24F 14/16F TF1, 50% TF, 93% Over 600,000 patients treated with SAPIEN platform 1. TF = Transfemoral; 2. TA = Transapical; 3. Alt = A
Slide 21: Where we are today
Where we are today 2011 2019 All-cause Death 3.4% 1% All-Stroke 5.5% 1.2% Major Vascular Complications 11% 2% Index Hospitalization 8 days 3 days At 30-days At 1-year 12/8/2021 3
Slide 22: We have made significant progress
We have made significant progress 30-day all-cause mortality 30-day disabling stroke Moderate or severe Paravalvular Leak* SAPIEN SAP valve SAPIEN XT SAPIEN 3 valve SAPIEN API valve SAPIEN XT SAPIEN 3 valve at 30 days valve valve 11.8% 5.0% 5.0% 5.1% 3.7% 0.8% 3.9% 3.8% 3.4% 3.5% 3.2% 3.2% 3.0% PART
Slide 23: We have made significant progress
We have made significant progress 30-day all-cause mortality 30-day disabling stroke Moderate or severe Paravalvular Leak* SAPIEN SAP valve SAPIEN XT SAPIEN 3 valve SAPIEN API valve SAPIEN XT SAPIEN 3 valve at 30 days valve valve 11.8% 5 0% 5.0% 5.1% 5.0% 3.7% 0.5% 0.8% 3 9% 3.9% 3.8% 3.4% 3.5% 3.2%
Slide 24: TAVR has transformed patient care for the Severe Symptomatic AS patient
TAVR has transformed patient care for the Severe Symptomatic AS patient Median Survival Years for All SAS Patients Post-TAVR era After 2008 Demonstrates Our Commitment to Our Innovation Strategy Overall survival for SAS patients doubled Create from 6.8 years to >11.5 Meaningful Pre-TAVR era Value by
Slide 25: SAPIEN 3 economically dominant compared to SAVR in low-risk patients
SAPIEN 3 economically dominant compared to SAVR in low-risk patients x SAPIEN 3 resulted in cost savings of >$2,000 per patient through the 2-year study period x Driven by reductions in LOS and substantially lower follow-up costs x SAPIEN 3 had small but significant improvement in quality-adjusted l
Slide 26: Next generation valve platforms are focused on future needs of AS patients
Next generation valve platforms are focused on future needs of AS patients Continue to raise Optimizing valve Enhanced durability Further enhance benchmark and sizing in complex for patients with future Coronary eliminate mild PV anatomy longer life expectancy access leak We are just getting started
Slide 27: We will continue to advance our portfolio
We will continue to advance our portfolio SAPIEN 3 SAPIEN 3 Ultra SAPIEN X4 Future Platform US and EU launches ALLIANCE U.S. IDE approval Evolutionary advancements expected by end of 2021 12/8/2021 9
Slide 28: Treatment of other progressive diseases focuses on early detection and intervention
The treatment of other progressive diseases focuses on early detection and intervention – cancer is an example Progression of Cancer Stage 0 Stage I Stage II Stage III Stage IV Carcinoma in situ Localized Early Locally Late Locally Metastasized – early form Advanced Advanced Early intervention preve
Slide 29: Aortic stenosis is a progressive disease but treatment waits until symptoms
Aortic stenosis is a progressive disease but the treatment paradigm is to wait until symptoms For 20 Years, We Have Been Progression of Aortic Stenosis Focused on This Mild Moderate Severe Asymptomatic Severe Symptomatic • PARTNER 1: Inoperable/ High-risk • PARTNER 2: Intermediate risk • PARTNER 3:
Slide 30: With TAVR as a treatment option, the current paradigm needs a deeper look
With TAVR as a treatment option to treat progressive AS disease, we believe the current paradigm needs a deeper look 99% 99% Freedom from Freedom from death1 stro 1 disabling stroke 80% 96% Next day Discharged Discharge2 home1 TAVR - Minimally Superior Patient TAVR-in-TAVR Invasive Therapy O Outcome
Slide 31: The first step is understanding if intervention should occur before symptoms
The first step is understanding if intervention should occur before symptoms develop Asymptomatic severe aortic stenosis Key questions Screening What percentage of patients are truly Asymptomatic Symptomatic Symp Sym mpto pto tom toma ma matic asymptomatic? Negative stress test OR O confirmation via
Slide 32: With EARLY TAVR, we are still only addressing Severe AS patients
With EARLY TAVR, we are still only addressing Severe AS patients For 20 Years, We Have Only Progression of Aortic Stenosis Been Focused on This Mild Moderate Severe Asymptomatic Severe Symptomatic • Asymptomatic patients who • PARTNER 1: Inoperable/ High-risk still have severe AS • PARTNER 2: Interm
Slide 33: Moderate AS disease may have a similarly poor prognosis
Studies have suggested that Moderate AS disease may have a similarly poor prognosis Progression of Aortic Stenosis Mild Moderate Severe Asymptomatic Severe Symptomatic Geoff Strange et al. J Am Coll Cardiol 2019; 74:1851-1863. We believe that Moderate AS patients may benefit from early intervention
Slide 34: Understanding the true impact of Moderate AS
We are also embarking on understanding the true impact of Moderate AS Key questions Moderate, calcific AS and appropriate anatomy for transfemoral TAVR 1:1 Randomization (n = 750) How fast do people progress from moderate to severe AS? Clinical C Clin lin nic niical cal survei surveillance l TAVR Do
Slide 35: PROGRESS Trial and AS disease progression
We have an opportunity to increase our understanding of AS disease progression and timing of intervention with the PROGRESS Trial For 20 Years, We Have Only Progression of Aortic Stenosis Been Focused on This Mild Moderate Severe Asymptomatic Severe Symptomatic • Patients with moderate AS who • Asym
Slide 36: Moderate AS patient cohort is significantly larger than severe AS cohort
We believe the moderate AS patient cohort is significantly larger than the severe AS cohort In 2021, I-ENHANCED-AS1, retrospective Ratio of moderate to severe AS patients study, examined 240K+ patients Echo database ~1.3M sAS patients in U.S. Over 210K echos from Australia2 and 34% over 30K echos fr
Slide 37: We delivered on the key milestones we set out in the last year
Despite continued COVID challenges, we delivered on the key milestones we set out in the last year Low-risk Approval in Japan EARLY TAVR Enrollment Complete Moderate AS Trial FDA Expecting Approval of ALTERRA Adaptive Approved SAPIEN X4 IDE by Pre-stent FDA Approval Year End On Track for Year End Ex
Slide 38: Bringing patients off the sidelines was challenging even before COVID
Bringing patients off the sidelines was challenging even before COVID Despite progressive nature and poor prognosis of AS, the rate of people “knowing and being concerned” about AS is still very low1 2019 Survey of ~13,000 people aged ≥60 years old across 11 European Countries showed: 34% of p
Slide 39: Nationwide TV ad campaign to drive awareness of TAVR
We have launched a nationwide TV ad campaign to drive awareness of patients to TAVR therapy 12/8/2021 21
Slide 40: Fundamentals of TAVR remain strong and the opportunity is significant
The fundamentals of TAVR remain strong and the opportunity ahead is significant We expect the global TAVR Growth drivers beyond market to double and reach the plan horizon $10B by 2028 remain strong 12/8/2021 22
Slide 41: 2022 Underlying Global Sales Growth Outlook
2022 Underlying Global Sales Growth Outlook Headwinds $4.0B Tailwinds Benefits of TAVR therapy Overall healthcare spending pressures $3.7B and strong patient preference COVID recovery Low risk expansion in key regions 2022E Underlying Global TAVR Estimated Sales Growth 12-15% 12/8/2021 23
Slide 42: SAPIEN 3 Transcatheter Heart Valve System Indications
Edwards SAPIEN 3 and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Indications: The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who a
Slide 43: Contraindications
a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter
Slide 44: Investigational devices cautions
Edwards SAPIEN 3 and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System INVESTIGATIONAL DEVICES. CAUTION: The Edwards SAPIEN 3 transcatheter heart valve is an investigational device when used in asymptomatic patients. Limited by Federal (USA) law to investigational use only. These devices are n
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Slide 46: Surgical Structural Heart
Surgical Structural Heart Daveen Chopra Corporate Vice President Surgical Structural Heart
Slide 47: Surgical Structural Heart is transforming patients' lives
Surgical Structural Heart is transforming patients’ lives by solving critical unmet needs in cardiac surgery The surgical structural heart market will continue to grow mid-single digits to $2B by 2028 We closely partner with surgeons to understand and address unsolved challenges in surgery We are pi
Slide 48: The surgical structural heart market continues to grow
The surgical structural heart market continues to grow Cardiac surgery remained a high priority throughout the COVID pandemic Improved awareness and diagnosis of structural heart disease is contributing to the growth of the global structural heart market As more patients are diagnosed, referrals to
Slide 49: Edwards Surgical continues to bring leading innovation
Edwards Surgical continues to bring leading innovation Through Transformative Our Patient Focus Impacts Lives Globally Innovation Pioneering more resilient Redefining tissue Increasing global surgical therapies that durability standards with patient access and help patients live longer robust clinic
Slide 50: RESILIA tissue improves durability through anti-calcification properties
RESILIA tissue improves durability through its novel anti-calcification properties Clinical Need Investing in long-term, real-world evidence on durability The primary mode of failure for tissue valves is calcification Feasibility Multi-Center Multiple Clinical Study Pivotal Trial Post-Market Studies
Slide 51: Increasing global adoption of RESILIA accelerates long-term growth
Increasing global adoption of RESILIA accelerates long-term growth RESILIA Tissue Valves Aortic Mitral Bovine Tissue Valves INSPIRIS KONECT MITRIS Aortic valve Aortic valved conduit Mitral valve Porcine Our RESILIA portfolio is empowering patients to engage in Tissue Valves surgical valve choice for
Slide 52: INSPIRIS is the leading surgical aortic valve in the world
INSPIRIS is the leading surgical aortic valve in the world Designed with expandable VFit technology, enabling potential future valve-in-valve procedures More than 5 years of promising clinical data on RESILIA Driving global access to accelerate conversion to premium tissue valves 12/8/2021 7
Slide 53: KONECT is a ready-to-implant tissue conduit
KONECT is a ready-to-implant tissue conduit for complex aortic patients Only device on market that simplifies difficult, combined aortic valve and root surgeries This segment, best addressed surgically, is forecasted for double-digit growth in the US Rapidly increasing adoption of this specialized,
Slide 54: MITRIS is designed to improve durability in the mitral valve
MITRIS is designed to improve durability by withstanding higher pressures in the mitral valve Enhanced ease-of-use for implantation and valve-in-valve compatibility Leading mitral valve in Japan six months post-launch; US launch planned for 2022 Long-term growth opportunity as 60% of global mitral v
Slide 55: Opportunity to grow patient impact in emerging markets
Significant opportunity to grow and accelerate patient impact in emerging markets Adult cardiac surgery continues to grow quickly in emerging regions due to increased awareness, diagnosis, and wealth Surgery remains the predominant treatment option, and most patients receive mechanicall valves that
Slide 56: Two opportunities for innovation in surgical mitral repair
Two opportunities for innovation in a growing surgical mitral repair market Innovating Premium Surgical Repair Therapies Helping surgeons achieve excellent, consistent When performed well, surgical mitral procedural outcomes repair is the most durable treatment option and restores patients to their
Slide 57: 2022 Underlying Global Sales Growth Outlook
2022 Underlying Global Sales Growth Outlook Headwinds $950M Tailwinds Continued TAVR conversion Adoption of in developed markets $870M RESILIA products Accelerated COVID recovery mechanical-to-tissue valve conversion 2022E Underlying Global Surgical Estimated Sales Growth Mid single-digits 12/8/2021
Slide 58: In Summary
In Summary The Surgical Structural Heart market is anticipated to grow mid-single digits, including growth in surgical aortic valve replacement 2022 growth driven by the adoption of our RESILIA platform, becoming the new standard of care for surgical patients We will continue to extend patient
Slide 59: 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 60: [IPS
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Slide 61: Transcatheter Mitral and Tricuspid Therapies
Transcatheter Mitral and Tricuspid Therapies Bernard J. Zovighian Corporate Vice President Transcatheter Mitral and Tricuspid Therapies
Slide 62: TMTT has a bold vision to transform care for Mitral and Tricuspid patients
TMTT has a bold vision to transform care for the many patients with Mitral and Tricuspid valve disease… > 4M patients1 TRICUSPID MITRAL Global Transcatheter Mitral and Tricuspid Market expected to grow < 2% from ~$1B in 2021 to treated2 $5B by 2028 Poor quality of life High mortality Ineffective med
Slide 63: TMTT overcame numerous obstacles to achieve milestones in 2021
TMTT overcame numerous obstacles to achieve our ambitious milestones in 2021… Differentiated Robust Real-World / Portfolio Clinical Evidence Commercial Outcomes Initial clinical experience with Enroll CLASP IID trial by year-end Continued pivotal enrollment supporting late 2022 PASCAL DMR U.S. appro
Slide 64: PASCAL's adoption is driven by a large body of Mitral evidence
PASCAL’s adoption is driven by an increasingly large and compelling body of Mitral evidence and experience >4,500 total patients treated with PASCAL Mitral1 >3,800 >450 study patients PASCAL patients with @ 1-year follow-up3 reported data2 1. Total cumulative commercial and clinical patients treated
Slide 65: Rapid cadence of innovation in TEER
TMTT is delivering a rapid cadence of innovation in transcatheter edge-to-edge repair (TEER) PASCAL is designed to …and the new PASCAL Precision System address meaningful patient needs… extends this differentiated performance Versatile implant to safely navigate even challenging anatomies Atraumatic
Slide 66: FDA approval of PASCAL Precision for DMR expected in late 2022
TMTT expects FDA approval of PASCAL Precision for DMR in late 2022 Controlled launch planned in the U.S. with a dedicated field team deploying our high-touch clinical support model Support Comprehensive 100% patient screening physician training case support Caution: Investigational Devices. Limited
Slide 67: Transfemoral replacement expected to expand the Mitral opportunity
Transfemoral replacement is expected to significantly expand the Mitral opportunity in the mid-term Addressing patients’ needs with product design Two-platform strategy positions TMTT for leadership Eliminating residual MR offers significant SAPIEN M3 patient benefits On-track to be the first comm
Slide 68: Critical Mitral milestones in 2022
TMTT is well positioned to achieve critical Mitral milestones in 2022, setting up a strong 2023 Differentiated Robust Favorable real-world / Portfolio Clinical Evidence commercial outcomes Initial clinical experience with novel FDA submission with CLASP IID: PASCAL Precision DMR approval in US: next
Slide 69: Early tricuspid clinical evidence is promising
Early tricuspid clinical evidence is promising, and demonstrates the diversity of patients’ needs… Pivotal Trials >1,500 total patients treated with TMTT’s Tricuspid Portfolio1 EVOQUE PASCAL ~500 >150 study patients patients with @ 1-year follow-up3 Cardioband reported data2 1. Total cumulative comm
Slide 70: Tricuspid portfolio designed for safety, efficacy and ease of use
…which TMTT’s Tricuspid portfolio is designed to treat, with safety, efficacy, and ease-of use Tricuspid Repair: Tricuspid Replacement: PASCAL Precision System EVOQUE Compliant Atraumatic implant design clasp control Wide Thin leaflet gaps leaflets Dense Imaging chordae challenges Versatile Intuitiv
Slide 71: EVOQUE presented 6-month late breaking trial data at TCT 2021
Excitement is building for EVOQUE, which kicked off TCT 2021 with a live case, and presented 6-month late breaking trial data 96% 94% Survival Freedom from Heart Failure Hospitalization At 6-month follow-up 12/8/2021 11
Slide 72: Significant Tricuspid milestones in 2022
TMTT’s understanding of Tricuspid clinical needs drives an ability to achieve significant milestones in 2022 Differentiated Robust Favorable real-world / Portfolio Clinical Evidence commercial outcomes Initial clinical experience with novel Continued enrollment of TRISCEND II EVOQUE approval in Euro
Slide 73: 2022 Global Sales Outlook
2022 Global Sales Outlook Headwinds $170M Tailwinds European Mitral market The new European regulatory system $140M returns more quickly to higher growth High quality evidence COVID recovery across the TMTT portfolio 2022E Global TMTT Estimated Sales 12/8/2021 13
Slide 74: TMTT committed to delivering on our vision in 2022
TMTT is committed to continue delivering on our vision in 2022, with significant sales growth and major product approvals… PASCAL Precision DMR approval in U.S.: Late 2022 PASCAL Precision approval in EU: Late 2022 EVOQUE approval in EU: Late 2022 >6,000 patients treated in 2022 Revenue of $140-$170
Slide 75: Important Safety Information
IMPORTANT SAFETY INFORMATION SAPIEN M3 Transcatheter Heart Valve System INVESTIGATIONAL DEVICES. CAUTION: The SAPIEN M3 System consists of investigational devices, limited by Federal (United States) law to investigational use. These devices are not available for marketing or commercial sale. See ins
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Slide 77: Critical Care
Critical Care Katie M. Szyman Corporate Vice President, Critical Care
Slide 78: Our vision is to improve the quality of care for millions
Our vision is to improve the quality of care for millions Leading Smart Recovery with AI enabled technologies Reaching more patients with compelling clinical evidence Improving patient care with adoption of innovative solutions
Slide 79: We continue to shift mix towards Smart Recovery
We continue to shift mix towards Smart Recovery TODAY TOMORROW Smart Monitoring Smart Monitoring Growth Potential Growth Potential Capital and Software Capital and Software Core Monitoring Core Monitoring Share of Revenue Share of Revenue Smart Monitoring Faster Recovery Smart Recovery 12/8/2021 3
Slide 80: Shift to Smart Recovery accelerates long-term growth
Shift to Smart Recovery accelerates long-term growth HEMODYNAMIC MONITORING MARKET 2021 2028 Pressure Monitoring is highly penetrated and is a large portion of the overall Core Core Monitoring ~$1.1B Monitoring ~$1.8B hemodynamic segment Hemodynamic Hemodynamic Segment Breakdown1 Segment Smart Break
Slide 81: Building blocks for Smart Recovery acceleration
Building blocks for Smart Recovery acceleration Technology Evidence Adoption Deploying the Right Generating Compelling Creating Solutions that Technologies Clinical Evidence Drive Adoption 12/8/2021 5
Slide 82: Smart Recovery Begins with Technology
Smart Recovery Begins WITH TECHNOLOGY SENSORS Connects patient and monitor ALGORITHMS 94 Enables smarter patient care SMART MONITORING PLATFORM HemoSphere builds the foundation 12/8/2021 6
Slide 83: HemoSphere platform builds foundation for growth
HemoSphere platform builds foundation for growth Two HemoSphere Offerings Phased rollout to replace legacy platforms 2018 2021 2028 Cardiac Swan-Ganz 94 Acumen IQ HPI Sensor & HPI Cardiac Smart Recovery Vigilance II Replacement ForeSight SIGHT FORE Non-Cardiac Non-Cardiac Smart Recovery 94 Acumen IQ
Slide 84: Smartify to improve patient care
“Smartify” to improve patient care Legacy… …Today and Beyond SENSORS SMART SENSORS Machine Data Learning Analytics FLOTRAC CLEARSIGHT SWAN-GANZ SENSOR CUFF CATHETER 2018 2021 “Smartify” DESCRIPTIVE ALGORITHM SMART ALGORITHM Clinical Connectivity CO BP SV Insights 94 92 HPI AFM Future Algorithms 2018
Slide 85: Connectivity solution enables remote patient care
Connectivity solution enables remote patient care Viewfinder Remote App HemoSphere FDA clearance received 2021 9:41 Track on Hospital phone EMR Multiple patients Insights anywhere The Viewfinder Remote App enables remote patient supervision and earlier intervention 12/8/2021 9
Slide 86: Smart Recovery Advances with Evidence
Smart Recovery Advances WITH EVIDENCE Hypotension Prediction Index (HPI) Data On Label Acumen IQ mix increasing Mean Minutes of Hypotension Acumen IQ Sensor FloTrac Classic 28 mins 12 mins 58% Decrease in IOH Edwards MPOG Study1 2021 Future HPI software proven to reduce hypotension 1. Edwards MPOG S
Slide 87: Hypotension can be prevented
Hypotension can be prevented Top 5 Global Causes of Death1 (percent of total) Hypotension is associated with increased risk of postoperative mortality2 17% of surgical patients 10% 88% experience hypotension3 8% 5% 4% Intraoperative hypotension seems to be a threat to patient safety that is hiding i
Slide 88: New study evaluating HPI's impact on outcomes
New study evaluating HPI’s impact on outcomes HPI SMART BP Timeline U.S. Adaptive multi-center RCT First Patient 50% Enrollment Anticipated Enrolled Complete Study Completion Q4 2021 Q4 2022 Q4 2023 Objectives Generate clinical outcomes linking HPI software to clinical benefit for intraoperative a
Slide 89: Smart Recovery Expands with Adoption
Smart Recovery Expands WITH ADOPTION Hypotension Quality Measure Real World Evidence Intraoperative Hypotension (IOH) Leverage data registries to demonstrate quality measure approved by CMS IOH association with increased risk Measure endorsed by ASA with Quality improvement projects using initial ta
Slide 90: 2022 Underlying Global Sales Growth Outlook
2022 Underlying Global Sales Growth Outlook Headwinds $900M Tailwinds Long conversion Rebound in hospital cycles $820M capital budgets Discontinuing Impact of clinical non-strategic products evidence on adoption 2022E Underlying Global Critical Care Estimated Sales Growth Mid single-digits 12/8/2021
Slide 91: Executive Summary
Executive Summary Leading Smart Recovery with AI enabled technologies Reaching more patients with compelling clinical evidence Improving patient care with adoption of innovative solutions 12/8/2021 15
Slide 92: Caution: Federal law restricts these devices
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. For professional use. For a listing of indications, contraindic
Slide 93: Ewa
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Slide 94: Financial Outlook
Financial Outlook Scott Ullem Chief Financial Officer
Slide 95: Edwards has delivered strong financial performance
Edwards has delivered strong financial performance Sales Growth Profitability Capital Allocation Strong sales growth Healthy gross profit and Balance sheet management and exceeding medtech sector operating margins disciplined capital deployment Long-Term Shareholder Returns 12/8/2021 2
Slide 96: Edwards Financial Objectives: Strong Sales Growth
Edwards Financial Objectives STRONG SALES GROWTH EXCEEDING MEDTECH SECTOR Sales growth fueled by successful long-term investments in R&D and advancements of focused breakthrough therapies Sustained leadership position supported Sales Growth by strong evidence-based value to patients and clinicians a
Slide 97: Delivering strong 2021 performance despite COVID impact
Delivering strong 2021 performance despite COVID impact ($ in millions except earnings per share) 2020 Investor Conference October Guidance (Unchanged) Sales $4,900 - 5,300 $5,200 - 5,400 FX Impact on Sales ~$35 ~$70 (~1% upside to sales) (~1.5% upside to sales) Adjusted Gross Profit Margin 76-77% 7
Slide 98: 2021 Sales Guidance – Product Group
2021 Sales Guidance – Product Group ($ in millions) 2020 Investor Conference October Guidance (Unchanged) Transcatheter Aortic Valve $3,200 - 3,600 $3,400 - 3,600 Replacement Transcatheter Mitral & ~$80 $80 - 100 Tricuspid Therapies Surgical Structural Heart $800 - 900 $875 - 925 Critical Care $725
Slide 99: Low double-digit sales growth expected in 2022
Low double-digit sales growth expected in 2022 Gradual COVID recovery and assumes no significant impact from new variants Growth across all major regions FX impact expected to be approximately $120 million or 2% downside to reported sales at current rates Expect high variability in year-over
Slide 100: TAVR sustains double-digit sales growth in 2022
TAVR sustains double-digit sales growth in 2022 Double-digit growth across all major regions Anticipated stable ASP and share position Q2 expiration of ~$40M annual royalty revenue Around 12 - 15% 20% $3.7 - 4.0 2022 $2.7 $2.9 $3.4 - 3.6 Expectations 2019 2020 2021E 2022E $ in billions; underl
Slide 101: TMTT continues strong momentum
TMTT continues strong momentum Remain focused on excellent patient outcomes PASCAL expansion in Europe drives growth PASCAL in the U.S. and EVOQUE TR in Europe approved late 2022 with negligible impact on 2022 sales Build enrollment in ENCIRCLE, TRISCEND II, and MISCEND trials $140 - 170 202
Slide 102: Surgical Structural Heart brings leading innovations
Surgical Structural Heart brings leading innovations Increased adoption of RESILIA products drives growth MITRIS U.S. launch Ongoing mechanical to tissue valve conversion Mid single-digits Mid-teens 2022 $842 $875 - 925 $870 - 950 $762 Expectations 2019 2020 2021E 2022E $ in millions; underlyi
Slide 103: Critical Care shifting focus to Smart Recovery
Critical Care shifting focus to Smart Recovery Accelerated adoption of Smart Recovery and the expansion of HPI technology Launch Viewfinder connectivity solution Advance Smart BP enrollment Mid single-digits Low double-digits 2022 $740 $725 $800 - 850 $820 - 900 Expectations 2019 2020 2021E 20
Slide 104: Edwards has delivered strong financial performance
Edwards has delivered strong financial performance Sales Growth Profitability Capital Allocation Strong sales growth Healthy gross profit and Balance sheet management and exceeding medtech sector operating margins disciplined capital deployment Long-Term Shareholder Returns 12/8/2021 11
Slide 105: Edwards Financial Objectives: Healthy Profitability
Edwards Financial Objectives HEALTHY PROFITABILITY Generating strong gross profit Funding growing field organization and strengthening global supply chain Profitability Investing aggressively in innovation for profitable organic growth Maintaining efficient tax structure 12/8/2021 12
Slide 106: 2022 Gross Profit margin favorably impacted by FX
2022 Gross Profit margin favorably impacted by FX GROSS PROFIT MARGIN Between 78 - 79% + - FX impact Investments in manufacturing capacity Operational efficiencies Expiration of TAVR royalty Product mix 12/8/2021 13
Slide 107: 2022 Operating Expenses
2022 Operating Expenses OPEX SG&A: 28 - 30%; R&D: 17 - 18% + - FX impact TMTT U.S. launch Leveraging scale Investments in clinical trials and product development Nominal impact from inflation Normalization of pre-COVID activities 12/8/2021 14
Slide 108: Expanding Operating Margin in 2022
Expanding Operating Margin in 2022 Gross Profit Margin Selling General and Research & Adjusted Gross Profit Administrative Development margin forecast 78 - 79%, Continuing to support Targeted investments lifted primarily by foreign high-touch model for to continue profitable exchange TAVR and ongoin
Slide 109: Operating performance drives Adjusted EPS growth
Operating performance drives Adjusted EPS growth $2.50 - 2.65 $0.01 - 0.03 $0.29 - 0.36 $(0.02 - 0.04) High-end of $0.41 - 0.43 $0.00 - 0.01 $2.07 - 2.27 $(0.02 - 0.03) $1.86 2020 Operating FX Tax/Shares 2021 October Operating FX Tax/Shares 2022 Actual Performance Impact Impact Guidance Performance
Slide 110: Edwards has delivered strong financial performance
Edwards has delivered strong financial performance Sales Growth Profitability Capital Allocation Strong sales growth Healthy gross profit and Balance sheet management and exceeding medtech sector operating margins disciplined capital deployment Long-Term Shareholder Returns 12/8/2021 17
Slide 111: Edwards Financial Objectives: Disciplined Capital Deployment
Edwards Financial Objectives ROBUST CASH FLOW AND DISCIPLINED CAPITAL DEPLOYMENT Supports global capacity expansion Strategic acquisitions to support and Capital Allocation supplement R&D initiatives Returning capital to shareholders through opportunistic share repurchases 12/8/2021 18
Slide 112: Cash Flow and Capital Deployment
Cash Flow and Capital Deployment Continued growth results in significant cash flows that fund future internal and external opportunities EPS model expects diluted shares outstanding between 630 and 635 million Includes ~$200M of accelerated tax payments starting in 2022 due to change in tax tr
Slide 113: Investing Capital for the Future
Investing Capital for the Future Other Research Capacity Manufacturing $407 Resiliency Infrastructure ~$350 Investment $254 2019 2020 2021E CAPEX ($ in millions) Where are we investing? 12/8/2021 20
Slide 114: Acquisitions & Divestitures
Acquisitions & Divestitures FOCUS CLOSED TRANSACTIONS SINCE 2016 • Structural heart • Smaller tuck-ins • Early-stage, pre-revenue companies Acquisitions & Options to Aquire 7 • Strategic fit Minority Investments 23 EXIT IP Purchases & Other 17 • Non-strategic products • Low growth potential 12/8/202
Slide 115: 2022 Guidance Summary
2022 Guidance Summary ($ and shares in millions except earnings per share) Expansion to Sales $5,500 - 6,000 Operating Margin* 31 - 34% Underlying growth Low double-digits Tax rate* 11 - 15% (~3pp ETB benefit) FX Impact on Sales ~($120) Earnings Per Share* $2.50 - 2.65 (2% downside to sales) Gross P
Slide 116: Global Market Opportunity
Global Market Opportunity TAVR SURGICAL Greater awareness By 2028 By 2028 RESILIA adoption Today Today Indication and geographic Mitral opportunity $5B expansion $10B $2B Emerging markets $1.5B New technologies Nearly $20B TMTT CRITICAL CARE Today Differentiated portfolio By 2028 Shi
Slide 117: Longer-Term Guidance
Longer-Term Guidance SALES GROWTH OPERATING EFFICIENCY EARNINGS Underlying Sales Growth Gross Profit Margin Tax Rate Innovation expected to drive organic Mix and efficiencies expected to Upward pressure growth that exceeds medtech sector benefit longer-term margin SG&A Earnings Per Share Globa
Slide 118: Edwards' plan generates strong financial performance
Edwards' plan generates strong financial performance Sales Growth Profitability Capital Allocation Strong sales growth Healthy gross profit and Balance sheet management and exceeding medtech sector operating margins disciplined capital deployment Long-Term Shareholder Returns 12/8/2021 25
Slide 119: Trademark notice
Edwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, HPI, Life is Now, MISCEND, MITRIS, PASCAL, RESILIA, TRISCEND, and Viewfinder. All other trademarks are the property of their respective owners. © 2021 Edwards Lifesciences Corporation. All rights reserved.
Slide 120: Closing Remarks
Closing Remarks Michael A. Mussallem Chairman and CEO
Slide 121: 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 122: 2022 expected to be a year of significant milestone achievements
2022 expected to be a year of significant milestone achievements and investment in our future TAVR TMTT SURGICAL CRITICAL CARE Moderate AS trial enrollment PASCAL - DMR approval in the U.S. MITRIS approval in the U.S. HemoSphere with Viewfinder SAPIEN X4 trial enrollment EVOQUE TR approval in Europe
Slide 123: 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 12/8/2021 4
Slide 124: Sustainability is integrated into our culture and strategy
Sustainability is integrated into our culture and strategy 12/8/2021 5
Slide 125: Edwards is committed to giving back
Edwards is committed to giving back Foundation supporting 250+ global charities in 2021 Every Heartbeat Matters Improve the lives of 2.5M additional underserved structural heart and critical care patients by the end of 2025 Strengthening Our Communities Meet basic community needs where we live and w
Slide 126: Edwards is poised for long-term value creation
Edwards is poised for long-term value creation Large Populations Patient-Focused Culture Sustainable of patients with unmet needs motivates and guides our global team organic long-term sales growth Credibility and Trust Innovative R&D with clinicians, regulators, produces breakthrough therapies payo
Slide 127: Trademark notice
Edwards, Edwards Lifesciences, the stylized E logo, EVOQUE, HemoSphere, Life is Now, MITRIS, PASCAL, RESILIA, SAPIEN, SAPIEN X4, Viewfinder, and X4. All other trademarks are the property of their respective owners. © 2021 Edwards Lifesciences Corporation. All rights reserved.