Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — Investor Day (December 2023)
124 slides from Edwards Lifesciences's investor day presentation, Dec 7, 2023
Slide 1: Edwards Lifesciences 2023 Investor Conference
Edwards Lifesciences 2023 Investor Conference
Slide 2: 2023 Investor Conference
2023 Investor Conference Mark Wilterding Senior Vice President Investor Relations
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: Cautionary Use of Non-GAAP Financial Measures
Cautionary Use of Non-GAAP Statement 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 fluct
Slide 5: Opening Remarks
Opening Remarks Bernard Zovighian Chief Executive Officer
Slide 6: Entering a new era of Structural Heart innovation
Entering a new era of Structural Heart innovation Sharpened Expanding Sustainable Focus on SHD Opportunity Growth Our Credo Patient-Focused Culture Unique Innovation Strategy
Slide 7: Sustainable growth achieved through key investments
Sustainable growth achieved through key investments New New Patient New SHD Technologies Indications Activation Segments
Slide 8: Edwards is uniquely positioned to transform patient care
Edwards is uniquely positioned to transform patient care Structural Heart Disease: a leading driver of cardiovascular death 33 SECONDS every 33 seconds One person in the US dies from cardiovascular disease Enabling a world where structural heart patients are diagnosed earlier, are treated routinely,
Slide 9: Expanded opportunities to increase treatment of SHD patients
Expanded opportunities to increase treatment of SHD patients Structural Heart Disease Aortic Mitral Tricuspid • New Indications • Portfolio of Technologies • Portfolio of Technologies Asymptomatic, moderate Mitral Repair (TEER) Tricuspid Repair (TEER) Mitral Replacement (TMVR) Tricuspid Replacement
Slide 10: Expanded opportunities to increase treatment of SHD patients
Expanded opportunities to increase treatment of SHD patients Structural Heart Disease Valvular Non-Valvular Aortic Mitral Tricuspid Heart Failure • New indications • Portfolio of Technologies • Portfolio of Technologies • 1 in 4 Asymptomatic, moderate Mitral Repair (TEER) Tricuspid Repair (TEER) wil
Slide 11: Technology advancements and evidence have doubled AS treatment rates
Technology advancements and evidence have doubled AS treatment rates, yet significant undertreatment remains Patients with AS have high mortality risk … aortic valve replacement rates remain low1 Many patients with AS are currently undertreated even in experienced centers2 – Eugene Braunwald, MD, 20
Slide 12: Patient activation is central to our TAVR growth strategy
Patient activation is central to our TAVR growth strategy Severe Aortic Stenosis Patients are unaware they have the disease Out-of- Patients have a cardiac echo Out-of- System indicating Severe AS System Mid-to- long term focus Near-to- mid term In- In- focus System System
Slide 13: Our leadership creates momentum within SHD: Surgical
Our leadership creates momentum within SHD Leading innovator Innovating premium technology for patients best treated with surgery Surgical
Slide 14: Our leadership creates momentum within SHD: TAVR
Our leadership creates momentum within SHD Revolutionizing AS treatment Accelerating the transformation of care for millions of AS patients still untreated TAVR
Slide 15: Our leadership creates momentum within SHD: TMTT
Our leadership creates momentum within SHD Pioneering breakthroughs Reaching inflection point with a therapy portfolio to treat millions of MR and TR patients TMTT
Slide 16: Our leadership creates momentum within SHD
Our leadership creates momentum within SHD Leading Revolutionizing Pioneering Natural innovator AS treatment breakthroughs progression Surgical TAVR TMTT Interventional HF Innovating premium Accelerating the Reaching inflection point Investing in early-stage technology for patients best transformati
Slide 17: With the common goal of transforming the patient experience
With the common goal of transforming the patient experience Healthy Trajectory Treated SHD Health Status Patients Improved Quality of Life Untreated Reduced Mortality Chronic Duration of Disease SAPIEN 3 THV EVOQUE Tricuspid PASCAL “I got my life back.” “I am able to walk long “I'm glad to be he
Slide 18: Exiting 2023 in a position of strength
Exiting 2023 in a position of strength Achieved Clinical Obtained Important Maintained Durable and R&D Milestones Regulatory Approvals Financial Profile Rapidly enrolling ALLIANCE pivotal trial for CE Mark approval for EVOQUE, world’s Expect total company sales growth of groundbreaking next-ge
Slide 19: Our sharpened focus will significantly expand the SHD opportunity
Our sharpened focus and investments will significantly expand the SHD opportunity through 2028 and beyond Interventional HF Structural Heart Opportunities New Indications 1 internal and multiple external investments SHD Indication Expansion Trials New Technologies TMVR TAVR TEER TTVR SAPIEN M3 X4 Pa
Slide 20: Entering 2024 with strong momentum
Entering 2024 with strong momentum TAVR TMTT Surgical Critical Care Moderate AS trial enrollment Launching EVOQUE transcatheter Continuing to extend Advancing the next generation of complete in Q1, 2 years early valve in Europe; planning U.S. leadership in Surgical smart, predictive sensors
Slide 21: Strategic spin-off of Critical Care creates industry-leading monitoring company
Strategic spin-off of Critical Care creates industry-leading advanced monitoring company • Starting from a position of strength as a ~$1 billion global market leader, with more than 4,000 talented employees dedicated to helping patients • Enables increased focus and flexibility to improve the qualit
Slide 22: Edwards' executive leadership team
Edwards’ executive leadership team Bernard Todd Daveen Dirksen Don Bobo, Jr. Zovighian Strategy & Corporate Brinton, M.D. Chopra Lehman Development Transcatheter Mitral Chief Executive Officer Chief Scientific Officer Public Affairs & Tricuspid Therapies Jean-Luc Dan Wayne Christine Joe Lemercier Li
Slide 23: Edwards' Board is accomplished and engaged
Edwards’ Board is accomplished and engaged Leading governance practices Highly experienced leaders Active engagement Strategy Incentive alignment Shareholder engagement Compliance and risk oversight
Slide 24: 2023 investor conference agenda
2023 investor 1 Transcatheter Aortic Valve Replacement conference agenda Larry Wood Transcatheter Mitral and Tricuspid Therapies 2 Daveen Chopra Surgical Structural Heart 3 Wayne Markovitz Critical Care 4 Katie Szyman Financial Outlook 5 Scott Ullem Closing Remarks 6 Bernard Zovighian 7 Q&A Session
Slide 25: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Larry L. Wood Corporate Vice President and Group President Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Slide 26: One million+ SAPIEN heart valves and counting
({ MILLION. \) ‘\ PATIENTS J) SS c ONE MILLION+ SAPIEN 3 > HEART VALVES AND COUNTING Vin
Slide 27: We expect the Global TAVR opportunity to exceed $10B by 2028
We expect the Global TAVR opportunity to exceed $10B by 2028 The Severe Aortic Stenosis (SAS) opportunity remains significant - we are gaining momentum in patient activation We have made significant progress in evidence generation, including within the Asymptomatic SAS and Moderate AS patient popula
Slide 28: Treatment rates of Severe AS patients have more than doubled since TAVR
Treatment rates of Severe AS patients have more than doubled since the introduction of TAVR ~160K patients >2X Severe AS patients received AVR1 patients treated & treatment rate ~70K patients Technology, evidence, and efforts in Severe AS patients received AVR1 pre-TAVR patient activation have advan
Slide 29: Severe AS is a deadly disease, yet treatment rates remain low
Severe AS is a deadly disease, yet treatment rates remain low Aortic Stenosis is one of the most common AVR treatment remains underutilized and serious heart valve diseases1 1 in 10 may die* ~13 of 100 *SSAS patients within the first 5 weeks while of all Severe AS patients awaiting treatment2 receiv
Slide 30: Undertreatment merits a deeper look into the severe AS opportunity
Undertreatment merits a deeper look into the severe AS opportunity Patients who are unaware SEVERE AS they have the disease Patients have a cardiac echo that indicates Severe AS but either: Out-of- Out-of- − Have not been formally diagnosed OR System System − Have been diagnosed but not referred ~13
Slide 31: Undertreatment of in-system SAS patients is significant
Research supports that undertreatment of in-system SAS patients specifically is significant SEVERE AS Out-of- System <50% of in-system patients are In- treated with AVR1,2 System So, why do the majority of in-system patients not receive therapy? (1) Li et al, J Am Coll Cardiol, 2022. (2) Généreux et
Slide 32: The complexity of diagnosis and referral helps explain undertreatment
The complexity of diagnosis and referral helps explain the undertreatment rate Diagnosis of Severe AS So, Referrers typically Guidelines are complex starts with Echo focus on only pressure Several key criteria to assess degree of valve constriction > Pressure (mean gradient ≥40 mm Hg) > Diameter (AV
Slide 33: Not all Severe AS patients present with high pressure
But, not all Severe AS patients present with high pressure Types of Severe AS1 High Pressure Low Pressure Mean gradient ≥ 40 mmHg Mean gradient 20 to 39 mmHg Less complex, classical diagnosis More complex, intensive diagnosis Treatment Rate Treatment Rate 33% 33% 67% 67% AVR No AVR (1) Li et al, J A
Slide 34: High pressure SAS patients benefit significantly from therapy
High pressure SAS patients benefit significantly from the therapy, regardless of heart function Subtypes of High Pressure Severe AS1 High Pressure - Normal Heart Function High Pressure 97% Mean gradient ≥ 40 mmHg AVR survival benefit 85% Normal Heart Poor Heart Function Function High Pressure - Poor
Slide 35: More undertreatment in low pressure severe AS group
There is significantly more undertreatment in the low pressure severe AS group, and all patients benefit from treatment Subtypes of Low Pressure Severe AS1 Low Pressure - Poor Heart Function Low Pressure Mean gradient 20 to 39 mmHg 89% AVR survival benefit Poor Heart Normal Heart 66% Function Functi
Slide 36: Education is key in improving treatment rates for high pressure AS
For patients with high pressure classical diagnosis of severe AS, we In- believe education is key in improving treatment rates System We are raising urgency to seek care by educating on risks of deadly disease and benefits of therapy Patients Referrers
Slide 37: Reducing complexity and streamlining referral for unclear diagnosis
For severe AS patients with an unclear diagnosis, reducing complexity In- and streamlining referral is crucial System Automate guideline-directed We have several workstreams based on AI-driven diagnosis technology to streamline in-system diagnosis Solutions to identify SAS patients, leveraging echo
Slide 38: Symptom assessment is a critical step before referral
Beyond echo criteria, symptom assessment is currently a critical In- step before referral – there is an opportunity to streamline this System Symptom assessment adds further complexity to referral Understand the impact of Delays in referral are often due to TAVR on patients who are referrers1: asymp
Slide 39: AHA Target: Aortic Stenosis will establish quality metrics
The AHA Target: Aortic Stenosis will establish quality In- metrics to drive urgency between diagnosis and referral System Currently, diagnosis to treatment of SAS patients can take an average of 180 days1 Target: Aortic Stenosis Treatment of patients with Class I AVR indication within 90 days of ech
Slide 40: Multifaceted strategy to unlock the in-system opportunity
In summary, we have a multifaceted strategy to unlock the in- In- system opportunity in the near-to-mid term System AI-based technologies to Patient / Referrer help identify education patients who warrant evaluation for AVR Near-to- mid term focus Quality metrics Evidence on In- on time from asympto
Slide 41: We are also focusing on the out-of-system opportunity
Out-of- System We are also focusing on the out-of-system opportunity Patients who are unaware they have the disease Multiple efforts ongoing to bring patients into the system Out-of- Alternative detection technology System − Multiple companies also innovating to detect patients Mid-to- long term f
Slide 42: Strategies address only the SAS patient opportunity
Strategies and initiatives just discussed address only the SAS patient opportunity SEVERE AS Out-of- System In- System
Slide 43: Treatment of Moderate AS patients enhances the continuum of care
The treatment of Moderate AS patients has the potential to enhance the patient continuum of care 2:1 Ratio of Moderate Pace of enrollment has to Severe AS exceeded expectations patients MODERATE AS We now anticipate enrollment to complete 2 years ahead of schedule Expect to complete enrollment Under
Slide 44: Our technology is best positioned to serve patients with AS
Our technology is best positioned to serve patients with Aortic Stenosis today and in the future Consistent A comprehensive Making future outcomes that approach to a durable options possible matter, starting with therapy that offers the index procedure proven long-term patient outcomes
Slide 45: Consistent outcomes that matter
Our technology is best positioned to serve patients with Aortic Stenosis today and in the future 1% Consistent death or disabling stroke outcomes that at 1 year1 matter, starting with the index procedure (1) Mack et al, NEJM, 2019
Slide 46: A comprehensive approach to a durable therapy
Our technology is best positioned to serve patients with Aortic Stenosis today and in the future 90% A comprehensive approach to a durable survival at 5 years1 therapy that offers proven long-term patient outcomes (1) Mack et al, NEJM, 2023
Slide 47: Making future options possible: THV-in-THV
Our technology is best positioned to serve patients with Aortic Stenosis today and in the future THV-in-THV indication and design to facilitate Making future options possible future interventions1 (1) Tarantini et al, Circ Cardiovasc Interv, 2020
Slide 48: SAPIEN 3 Ultra RESILIA elevates the TAVR performance benchmark
SAPIEN 3 Ultra RESILIA further elevates the TAVR therapy performance benchmark S3UR adoption is accelerating Majority of EW volume today >95% of EW volume Early 2024 Approval expected
Slide 49: Progress on SAPIEN X4
Beyond SAPIEN 3 Ultra RESILIA, we are making meaningful progress on SAPIEN X4 SAPIEN X4 Advanced delivery system technology offers commissural alignment Novel frame and leaflet design to enable adjustable sizing RESILIA tissue Advanced PET outer skirt technology Powered by Tissue The ALLIANCE Trial
Slide 50: Multiple drivers to support sustainable growth across the horizon
We have multiple drivers to support sustainable growth across the horizon SHORT TERM MID TERM LONG TERM Activation of in-system Continued activation of Activation of out-of- Patient SAS patients in-system SAS patients system SAS patients Activation EARLY TAVR trial EARLY TAVR PROGRESS trial Moderate
Slide 51: 2024 Sales Outlook: TAVR
2024 Sales Outlook 8% - 10% Constant Currency Growth Headwinds $4.3B Overall pressure on healthcare spending Competitive product launches $4.0B Tailwinds Improving healthcare system capacity Technology and new evidence 2024E The fundamentals of TAVR remain strong and the opportunity ahead is signifi
Slide 52: Transcatheter Mitral and Tricuspid Therapies
Transcatheter Mitral and Tricuspid Therapies Daveen Chopra Corporate Vice President Transcatheter Mitral and Tricuspid Therapies
Slide 53: Millions suffering from Tricuspid and Mitral Regurgitation
Millions of patients globally are suffering from Tricuspid and Mitral Regurgitation with limited treatment options Difficulty Breathing Fatigue Edwards' Transcatheter Repair and Chest Replacement therapies are transforming Pain patient care Difficulty Walking Painful Swelling
Slide 54: Transcatheter Tricuspid solutions at the beginning of a revolution
Transcatheter Tricuspid Repair and Replacement solutions are at the beginning of a revolution of patient care Increased innovation & Complementary evidence support Transcatheter expanded therapy Tricuspid is options access no longer the available ‘forgotten’ valve
Slide 55: Transcatheter Mitral adoption increases with expanding evidence
Transcatheter Mitral adoption increases with expanding Repair evidence and market access, along with the emergence of Replacement Replacement extends options Increasing to more patient access Repair is patients to Repair expanding therapy
Slide 56: Portfolio strategy fuels Mitral and Tricuspid market opportunity
The Edwards portfolio strategy fuels a substantial Mitral and Tricuspid market opportunity
Slide 57: Portfolio strategy fuels Mitral and Tricuspid market opportunity
The Edwards portfolio strategy fuels a substantial Mitral and Tricuspid market opportunity Innovation
Slide 58: Portfolio strategy fuels Mitral and Tricuspid market opportunity
The Edwards portfolio strategy fuels a substantial Mitral and Tricuspid market opportunity Innovation Evidence
Slide 59: Portfolio strategy fuels Mitral and Tricuspid market opportunity
The Edwards portfolio strategy fuels a substantial Mitral and Tricuspid market opportunity Real-World Innovation Evidence Outcomes PASCAL EVOQUE PASCAL PASCAL EVOQUE Cardioband
Slide 60: The PASCAL Repair System is accurate, versatile, and atraumatic
The PASCAL Repair System is accurate, versatile, and atraumatic
Slide 61: PASCAL is demonstrating robust clinical outcomes
PASCAL is demonstrating robust clinical outcomes in those patients suitable for Repair Pivotal Trials Full enrollment expected in 2024
Slide 62: PASCAL is demonstrating robust clinical outcomes
PASCAL is demonstrating robust clinical outcomes in those patients suitable for Repair Pivotal Trials Post market studies ~2000 clinical study patients treated with PASCAL
Slide 63: Rapid, differentiated PASCAL therapy innovation
Rapid, differentiated PASCAL therapy innovation is driving Repair adoption Future Generations: Procedural Ease-of-use & PASCAL PASCAL Ace PASCAL Precision Innovations enhanced outcomes
Slide 64: PASCAL Precision continues to expand to more sites
PASCAL Precision continues to expand to more sites in more geographies Expanding US field Increasing EU accounts Initiating Japan Launch team and sites and PASCAL adoption
Slide 65: Edwards pioneers transcatheter Tricuspid Replacement with EVOQUE
Edwards pioneers transcatheter Tricuspid Replacement therapy with EVOQUE
Slide 66: EVOQUE: ~1000 patients treated
Applicable to a broad patient population Multiple valve sizes One Sub-30 Fr Delivery System Predictable and repeatable procedure Average device time of ~60 mins ~1000 patients treated
Slide 67: EVOQUE virtually eliminated TR and improved quality of life
In robust clinical trials, EVOQUE virtually eliminated TR and substantially improved quality of life for patients First 150-patient cohort, with 6-month follow-up EVOQUE met safety endpoint TR REDUCTION KCCQ ~94% TO MILD OR LESS +22 POINTS 90-patient cohort, with 2-year follow-up EVOQUE is durable T
Slide 68: EVOQUE creates Transcatheter Tricuspid Replacement in 2024
EVOQUE creates Transcatheter Tricuspid Replacement in 2024 in both the EU and US Near term EVOQUE milestones CE Mark Oct 2023
Slide 69: EVOQUE creates Transcatheter Tricuspid Replacement in 2024
EVOQUE creates Transcatheter Tricuspid Replacement in 2024 in both the EU and US Near term EVOQUE milestones US approval CE Mark Oct 2023 anticipated in mid-2024 TRISCEND II full cohort presentation expected 56mm valve launch in ’25 at TCT '24 extends therapy to more patients
Slide 70: EVOQUE next generation
EVOQUE creates Transcatheter Tricuspid Replacement in 2024 in both the EU and US NEXT GEN Improved adoptability
Slide 71: The SAPIEN M3 System extends treatment to additional Mitral patients
The SAPIEN M3 System will extend treatment to additional Mitral regurgitation patients
Slide 72: SAPIEN M3: first-to-market transfemoral replacement
On track to be the First-to-market Sub 30-Fr system Transfemoral Replacement solution Leverages SAPIEN 3 technology • 6000+ patients treated with SAPIEN platform in mitral position • >500 patients treated with SAPIEN M3 Versatile for treating a broader patient population
Slide 73: Completion of ENCIRCLE enrollment sets stage for approvals
Completion of ENCIRCLE enrollment sets the stage for commercial approvals of SAPIEN M3 Completed EU approval by the end of 2025 Enrollment US approval of 300 patients to follow in the Primary Cohort
Slide 74: Edwards primed for growth with Repair and Replacement portfolio
Edwards is primed for growth and leadership with a comprehensive portfolio of Repair and Replacement therapies for Mitral and Tricuspid patients TRICUSPID MITRAL PASCAL and PASCAL accelerates, EVOQUE drive SAPIEN M3 leadership establishes leadership PASCAL EVOQUE SAPIEN M3 Continued Growth Launch &
Slide 75: 2024 Sales Outlook: TMTT
2024 Sales Outlook Headwinds $320M Overall healthcare spending pressure Pace of EVOQUE therapy development $280M Tailwinds Contemporary Mitral Repair evidence increases therapy confidence Strong real-world evidence accelerates referral pathways for Tricuspid patients 2024E Edwards’ TMTT therapies ar
Slide 76: Surgical Structural Heart
Surgical Structural Heart Wayne Markowitz General Manager and Senior Vice President Surgical Structural Heart
Slide 77: Edwards Surgical growth outpaced the market in 2023
Edwards Surgical growth This will continue with our outpaced the market in 2023 best-in-class innovation strategy Our RESILIA innovations are driving The global cardiac surgery market is growth in established and emerging expected to exceed $2 billion by markets 2028 Our differentiated product portf
Slide 78: Above-market growth balanced across therapies and regions
Our above-market growth in 2023 was balanced across multiple therapies and regions RESILIA Aortic Gains Strong INSPIRIS and KONECT adoption, setting the new standard of care globally Increasing Mitral Sales Global MITRIS revenue more than doubled, driven largely by successful US launch Growth Around
Slide 79: SAVR has evolved and is growing
SAVR has evolved and is growing in patients best treated surgically US SAVR Procedures by Patient Age 65 80 yrs old yrs old Younger Patients Treated Before In line with latest ACC/AHA Guidelines Mean Age: Today 71 years old Mean Age: 66 years old Older SAVR Patients Shifted Away Growth in non-TAVR S
Slide 80: SAVR has evolved and is growing
SAVR has evolved and is growing in patients best treated surgically US SAVR Procedures by Etiology & Type Younger Patients Treated In line with latest ACC/AHA Guidelines Aortic Regurgitation and Mixed Disease Other Etiologies Moderate AS Growth in non-TAVR Segments Asymptomatic SAS Other etiologies
Slide 81: SAVR has evolved and is growing
SAVR has evolved and is growing in patients best treated surgically US SAVR Procedures by Patient Age 50 65 Tissue Valves Mechanical Valves Younger Patients Treated yrs old yrs old In line with latest ACC/AHA Guidelines Growth in non-TAVR Segments ~30% Increase in tissue valve use in 50-65 year olds
Slide 82: RESILIA Aortic portfolio suited for SAVR patients
Our RESILIA Aortic portfolio is ideally suited for the SAVR patients of today and tomorrow INSPIRIS RESILIA Aortic Valve The leading SAVR valve in the world, featuring RESILIA tissue technology with extended durability Unique VFit expandability enables larger TAVR valve-in-valve use for improved
Slide 83: MITRIS RESILIA Mitral Valve gaining adoption
Our MITRIS RESILIA Mitral Valve is gaining significant adoption around the world Greater ease-of-use features and RESILIA tissue with enhanced durability for mitral patients Significant conversion opportunity for MITRIS RESILIA in mitral valves European CE Mark approval received in October; la
Slide 84: Slide 84
Slide 85: Strong cadence of clinical evidence to drive RESILIA adoption
We are continuing our strong cadence of meaningful clinical evidence to drive RESILIA adoption 2023 2024 Beyond 10-year data release from RESILIA pivotal trial 7-year results Largest, core lab adjudicated published in JTCVS surgical MVR study European study of INSPIRIS in younger patients KONECT 5-y
Slide 86: COMMENCE trial 7-year data
Latest COMMENCE trial 7-year data demonstrates excellent outcomes of RESILIA tissue in patients Outperformed previous-generation surgical tissue valves 99.3% Published in the Journal of Thoracic and Cardiovascular Surgery in freedom from structural valve September 2023 deterioration (SVD) at 7 y
Slide 87: Surgical Structural Heart's future is bright
Surgical Structural Heart’s future is bright with many patients to treat globally Significant Surgical Differentiated Rich Innovation Opportunity RESILIA Portfolio Pipeline In both developed and Ideally suited for surgical Addressing unmet needs emerging markets patients of today and tomorrow across
Slide 88: 2024 Sales Outlook: Surgical
2024 Sales Outlook Mid-Single Digit Constant Currency Growth Headwinds $1.1B Healthcare spending pressures Competitor pricing tactics $1.0B Tailwinds Global RESILIA Aortic adoption Accelerated MITRIS RESILIA penetration 2024E Many patients to be treated with our differentiated RESILIA portfolio back
Slide 89: Critical Care
Critical Care Katie Szyman Corporate Vice President Critical Care
Slide 90: Driving growth through Smart Recovery and Smart Expansion
Driving growth through Smart Recovery and Smart Expansion Shifting our patients from classic to smart monitoring technology Driving Smart Recovery drives adoption with clinical evidence Leveraging our leadership to drive Smart Expansion and growth Getting Patients Home to their Families Faster
Slide 91: Large opportunities for Smart Recovery and Smart Expansion
Large opportunities for Smart Recovery and Smart Expansion Smart Recovery Smart Expansion Smart Faster Smart Continuous Clinical Smart Monitoring Recovery Recovery Non-Invasive Monitoring Need Expansion Current Patient Settings Potential Expansion Opportunities Starting in 2024 OR ICU Outpatient Sur
Slide 92: Shifting to Smart Monitoring Technology
Shifting to Smart Monitoring Technology Gold standard Continuous, less invasive, predictive and prescriptive FloTrac ClearSight ForeSight HemoSphere Swan-Ganz TruWave Acumen IQ Acumen IQ Oximetry All-in-One Platform Catheters Sensors Sensors Finger Cuffs Sensors Acumen Software Enabled1 Capital Clas
Slide 93: Continuing the shift toward Smart Monitoring
Continuing the shift toward Smart Monitoring Critical Care Disposables Portfolio Double Digit Growth TODAY 5-Year CAGR Smart Monitoring Under penetrated opportunity with greater clinical value Smart Tomorrow Growth Potential Monitoring Single Digit Growth Classic Tomorrow Monitoring 5-Year CAGR Clas
Slide 94: Driving Adoption with Clinical Evidence
Driving Adoption with Clinical Evidence Proven Ability to Reduce Hypotension 75+ Studies Showing Importance of Smart Recovery1 Mean Minutes of Intraoperative Hypotension3 28 mins 25% of surgical patients experienced complications leading to longer hospital stays, readmission and even death2 12 mins
Slide 95: Successful Capital Conversion and Smart Expansion
Successful Capital Conversion and Smart Expansion 7th Generation HemoSphere Platform Conversions Surpassing 50% of Installed Base 2018 2023 2028 Smart Expansion Conversion (Every ~7-9 years) Next Gen coming 2025 Legend All-in-One, AI-Enabled, Connected Platform % Capital conversion Capital expansion
Slide 96: Smart Expansion with Continuous Non-Invasive Blood Pressure
Smart Expansion with Continuous Non-Invasive Blood Pressure Clinical Studies Results Accuracy Proven accuracy of continuous non-invasive blood pressure Piloting in 2024 technology2 VitaWave Finger Cuff Continuous finger-cuff based blood pressure monitoring is superior to intermittent cuff3,4,5 Stand
Slide 97: Smart Expansion with HemoSphere Vita
Smart Expansion with HemoSphere Vita Piloting in 2024 Beat-to-beat insights for elevated care Actionable blood pressure trends for informed, proactive interventions. VitaWave “…there is still a Finger Cuff critical need for a continuous non- invasive blood pressure monitor ForeSight that will, beat-
Slide 98: Expanding Long-term Market Opportunity
Expanding Long-term Market Opportunity Classic Monitoring Smart Monitoring 2028 Today ~$1.2B Smart ~$1.8B Smart Additional Hemodynamic Recovery Hemodynamic Expansion New Patient Strategy Segment Strategy Segment Breakdown¹ Breakdown¹ Segments Strong growth above general patient monitoring market r
Slide 99: 2024 Sales Outlook: Critical Care
2024 Sales Outlook Mid-Single Digit Constant Currency Growth Headwinds $1.0B Hospital Budget Constraints Supply Chain Risks $900M Tailwinds Accelerated shift to Smart Recovery Successful pilots for Smart Expansion 2024E We are ready. The best is yet to come.
Slide 100: Financial Outlook
Financial Outlook Scott Ullem Chief Financial Officer
Slide 101: Approach to Financial Value Creation
Approach to Financial Value Creation Strong Strong Organic Healthy Strategic Organic SalesSales Growth Growth Profitability CapitalDeployment Capital Allocation Constant currency long-term Exceptional gross profit margin Conservative balance sheet with sales growth goal of 10%+ supported by value-ad
Slide 102: 2023 expectations in line with prior guidance
2023 expectations in line with prior guidance 2022 Investor October Current Conference Guidance Guidance Outlook Total Company Sales Growth (Constant Currency) 9 - 12% 10 - 13% 10 - 13% Gross Profit Margin 76 - 78% 76 - 78% 76 - 78% Earnings Per Share $2.45 - $2.60 $2.47 - $2.53 $2.47 - $2.53
Slide 103: Future Financial Goals
Future Financial Goals 2025 and Beyond 2024 Guidance (Excluding Critical Care) Total Company and TAVR Sales Growth 8 - 10% 10% + (Constant Currency) Margin expansion Operating Margin 29 - 30% over time $2.70 - $2.80 Double-digit growth Earnings Per Share (9 - 11% growth) (subject to tax law changes)
Slide 104: Edwards Financial Objectives
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Edwards Financial Objectives Strong Organic Sales Growth Addressing large and Growth fueled by successful long- Sustained leadership position growing patient populations term R&D investments to drive supported by strong evidence-based breakthrough therap
Slide 105: 2024 Sales Outlook by Product Group
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION 2024 Sales Outlook by Product Group TAVR Continued global launch of SAPIEN 3 Ultra RESILIA 8% - 10% growth Focused patient activation initiatives TMTT EVOQUE transcatheter tricuspid valve launch in Europe and U.S. $280 - $320 million PASCAL global expans
Slide 106: Edwards Financial Objectives: Healthy Profitability
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION 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 ch
Slide 107: Profitability fueled by high value products and disciplined spending
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Profitability fueled by high value products, efficient supply chain, strategic R&D, and disciplined spending High value technologies yield strong gross profit margins Proven model for gaining efficiencies as volumes increase, partially offset by new
Slide 108: 2023 investments set to fuel 2024 earnings
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION 2023 investments set to fuel 2024 earnings $0.24 - 0.30 $2.70 - 2.80 $0.05 - 0.07 $0.13 - 0.15 $2.47 - 2.53 $(0.07 - 0.09) $2.48 $0.07 - 0.09 $(0.19 - 0.21) 2022 Operating Performance FX Interest/Shares/Tax 2023 Operating Performance FX Other 2024 Actual
Slide 109: 2024 Implications of Critical Care Spin-off
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION 2024 Implications of Critical Care Spin-off No core financial impact in 2024; separation expected at the start of 2025 One-time charges associated with typical spin-off transactions More financial information to be filed with Form 10 in mid-2024
Slide 110: Robust Cash Flow and Strategic Capital Deployment
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Edwards Financial Objectives Robust Cash Flow and Strategic Capital Deployment Supports global Strategic acquisitions to Returning capital to capacity expansion support and supplement shareholders through R&D initiatives opportunistic share repurchases
Slide 111: Cash Flow and Capital Deployment
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Cash Flow and Capital Deployment 2024 Expectations Continued growth results in significant cash flows that fund future internal and external opportunities Strong free cash flow conversion supporting healthy balance sheet Diluted shares outstanding estima
Slide 112: Track Record of Opportunistic Share Repurchases
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Track Record of Opportunistic Share Repurchases Share Repurchases ($ millions) Shares Outstanding (millions) 750 700 650 1,727 600 625 513 431 263 550 2019 2020 2021 2022 YTD Q3 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023E
Slide 113: Investing Capital for the Future
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION Investing Capital for the Future Capital Spending ($ millions) Where are we Investing? Other Research Capacity Infrastructure ~$300 Investment $245 ~$240 Manufacturing Resiliency 2022 2023E 2024E
Slide 114: Active Portfolio Management
SALES GROWTH PROFITABILITY CAPITAL ALLOCATION FOCUSED ADDITIONS Active Portfolio Management TAVR / TMTT / Surgical Closed Transactions in Last 5 Years New SHD segments Acquisitions and Early-stage, pre-revenue start-ups 13 options to aquire Minority investments 28 EXITS Non-strategic products IP inv
Slide 115: 2024 Guidance Summary
2024 Guidance Summary Sales $6,300 - 6,600 Operating Margin 29% - 30% Constant Currency 8 - 10% Tax Rate 14 - 17% Growth FX Impact on Sales ~($50) Earnings Per Share $2.70 - 2.80 At current rates (1.0pp downside to growth) Gross Profit Margin 76 - 78% Diluted Shares 600 – 610 SG&A % of Sales 29 - 30
Slide 116: Longer-Term Outlook
Longer-Term Outlook Strong Sales Healthy Operating Efficiency Strategic Earnings Organic Sales Growth Profitability Capital Allocation Gross Profit Margin Tax Rate Constant currency Upward pressure, Mix and efficiencies expected to sales growth of 10%+ benefit margin, partially offset by new subject
Slide 117: Closing Remarks
Closing Remarks Bernard Zovighian Chief Executive Officer
Slide 118: Entering a new era of Structural Heart innovation
Entering a new era of Structural Heart innovation Sharpened Expanding Sustainable Focus on SHD Opportunity Growth Our Credo Patient-Focused Culture Unique Innovation Strategy
Slide 119: Our leadership creates momentum within SHD
Our leadership creates momentum within SHD Leading Revolutionizing Pioneering Natural innovator AS treatment breakthroughs progression Surgical TAVR TMTT Interventional HF Innovating premium Accelerating the Reaching inflection point Investing in early-stage technology for patients best transformati
Slide 120: Clear strategy for sustainable growth
Clear strategy for sustainable growth 2024 2025-2026 Long-term Building Faster Expanding momentum growth opportunities Key milestones Achievement of new Continued healthy and strong financial indications and launch momentum driven by performance of new technologies new indications, new following spi
Slide 121: One million+ SAPIEN heart valves and counting
GLOBALLY, i ONE MILLION+ SAPIEN : HEART VALVES AND COUNTING 49
Slide 122: Non-GAAP Financial Information
EDWARDS LIFESCIENCES CORPORATION Non-GAAP Financial Information To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP historical financial measures. Management makes adjustments to the GAAP measures f
Slide 123: Reconciliation of GAAP to Non-GAAP Financial Information
EDWARDS LIFESCIENCES CORPORATION Reconciliation of GAAP to Non-GAAP Financial Information Adjusted Free Cash Flow * Year Ended Nine Months Ended December 31, September 30, (in millions) 2022 2023 Net cash provided by operating activities $1,218.2 $759.2 Capital expenditures (244.6) (164.7) Intellect
Slide 124: Helping Patients is Our Life's Work
Helping Patients is Our Life’s Work, and, now) pe?