Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — Investor Day (December 2024)
139 slides from Edwards Lifesciences's investor day presentation, Dec 4, 2024
Slide 1: Edwards Lifesciences 2024 Investor Conference
Edwards Lifesciences 2024 Investor Conference
Slide 2: 2024 Investor Conference
2024 Investor Conference Mark Wilterding
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. To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP historical financial measures. Management
Slide 5: Opening Remarks
Opening Remarks Bernard Zovighian Chief Executive Officer
Slide 6: Edwards is the leader in Structural Heart Innovation
Edwards is the leader in Structural Heart Solving Innovation large and complex patient needs Pioneering and leading therapeutic categories Delivering sustainable, long-term growth
Slide 7: Structural Heart Disease represents a substantial opportunity
Structural Heart Disease represents a substantial opportunity Aortic Mitral Large and growing stenosis regurgitation patient populations Tricuspid Critical regurgitation Pulmonic disease unmet patient needs with severe consequences Aortic Structural regurgitation heart failure Significant burden on
Slide 8: Edwards is uniquely positioned to lead
Edwards is uniquely positioned to lead Aortic Mitral stenosis regurgitation Differentiated and comprehensive innovation MITRIS M3* PASCAL SAPIEN INSPIRIS KONECT Tricuspid regurgitation Pulmonic Deep disease structural heart expertise PASCAL EVOQUE ALTERRA Aortic Structural regurgitation heart failur
Slide 9: Edwards: Built to innovate and transform lives
Edwards: Built to innovate and transform lives Elevating the 24 years Corporate impact Resilient global supply chain standard of care for of strong financial is integrated with millions performance since IPO our strategy of patients Committed to giving back 16,000+ employees Global charitable scale
Slide 10: Our innovation strategy
Edwards: Our innovation strategy Long-term Risk-taking Leading Pioneering commitment and agility with science breakthroughs Lifetime management 10,000+ patents ~95% Iteration 1,000+ of Edwards’ publications including Launch INNOVATION technologies are 10 category-leading publications of FDA-approved
Slide 11: Exiting 2024 in a position of strength
Exiting 2024 in a position of strength FINANCIAL INNOVATION EXPANSION Launched Continued 8-10% Company sales growth first-of-its-kind technology global adoption in tricuspid replacement with EVOQUE of SAPIEN 3 Ultra RESILIA 5-7% TAVR sales growth Strengthened our Invested Invested in Rightsized Edwa
Slide 12: Our expansion within Structural Heart results in diversified sources of growth
Our expansion within Structural Heart results in diversified sources of growth Structural Heart Failure Implantable Heart Failure Management TAVR TMTT Aortic Stenosis Mitral Tricuspid TAVR-AR Aortic Regurgitation Three major growth drivers: TAVR, Mitral and Tricuspid Surgical Additional Internal and
Slide 13: Catalysts for growth in 2025 and beyond
Catalysts for growth in 2025 and beyond Developing new therapeutic areas Structural TAVR TMTT Heart Failure Category leadership reinforced by Unique portfolio with multiple years of rapid Implantable Heart practice-changing evidence growth to address full spectrum of patients Failure Management Asym
Slide 14: Edwards is positioned for strong financial performance in 2025
Edwards is positioned for strong financial performance in 2025 $5.6B - $6.0B 8-10% SALES SALES GROWTH 5-7% 50-60% TAVR GROWTH TMTT GROWTH $2.40 - $2.50 Led by diversified sources of growth across EPS structural heart therapies, 2025 sets the stage for sustainable, long-term, profitable growth Sales
Slide 15: Edwards is projecting sustainable and profitable growth in 2026 and beyond
Edwards is projecting sustainable and profitable growth in 2026 and beyond TAVR Mid-to-high single digit growth Targeting Increasing contribution to Edwards growth, TMTT reaching $2B by 2030 ~10% total company growth Surgical Mid-single-digit growth in 2026 and beyond Annual variability based on tim
Slide 16: We proceed confidently into the future
We proceed confidently into the future Structural heart represents a significant and growing opportunity Edwards is uniquely positioned to elevate the standard of care for patients 2025 sets the stage for strong performance led by diversified sources of growth in structural heart 2026 and beyond pos
Slide 17: Long-tenured leaders with deep expertise
Long-tenured leaders with deep expertise implementing our unique innovation strategy Edwards’ Executive Leadership Team Bernard Don Todd Annette Daveen Zovighian Bobo, Jr. Brinton, M.D. Brüls Chopra Chief Executive Officer Strategy & Corporate Chief Scientific Officer EMEA, Canada, Transcatheter Mit
Slide 18: Conference Agenda
Conference Agenda Perspective on the Burden of Structural Heart Disease Todd Brinton, M.D. Transcatheter Aortic Valve Replacement (TAVR) Larry Wood Aortic Stenosis Transcatheter Aortic Valve Replacement (TAVR-AR) Aortic Regurgitation Transcatheter Mitral and Tricuspid Therapies (TMTT) Daveen Chopra
Slide 19: Perspective on the Burden of Structural Heart Disease
Perspective on the Burden of Structural Heart Disease Todd Brinton, M.D.
Slide 20: The burden of Structural Heart Disease is quite significant
The burden of Structural Heart Disease is quite significant Untreated patients enter an aggressive, downward spiral Health Status Increasing aging population drives incidence of Structural Heart Disease Hospitalization Patients’ quality of life deteriorates suddenly #1 reason for hospitalization Hos
Slide 21: Structural Heart Disease is comprised of Valvular Disease
Structural Heart Disease is comprised of Valvular Disease Stenosis Structural Heart Disease Calcification of the valve causing stiffening Stiffening Valvular Regurgitation Disease An enlarged valve annulus causes regurgitation Enlargement
Slide 22: Structural Heart Disease is also comprised of Non-Valvular Disease
Structural Heart Disease is also comprised of Non-Valvular Disease Stenosis Structural Heart Disease Impaired Filling Calcification of the valve Left ventricle stiffening causing stiffening causing impaired filling like Stiffening in HFpEF Stiffening Valvular Non-Valvular Disease Disease Regurgitati
Slide 23: One structural defect can lead to another
One structural defect can lead to another Stenosis Structural Heart Disease Impaired Filling Calcification of the valve Left ventricle stiffening causes stiffening causing impaired filling like Stiffening in HFpEF Stiffening Valvular Non-Valvular Disease Disease Regurgitation Impaired Pumping An enl
Slide 24: Without treatment, patients develop heart failure
As Structural Heart Disease progresses without treatment, patients develop heart failure How patients feel when they How physicians see experience heart failure structural heart disease CLINICAL SYMPTOMS CLINICAL SIGNS Shortness of Breath Physical Exam Fatigue Labs Swelling Imaging
Slide 25: Structural Heart Disease leads to heart failure
Guidelines are aligned Structural Heart Disease leads to heart failure How patients feel when they How physicians see experience heart failure structural heart disease CLINICAL SYMPTOMS CLINICAL SIGNS Shortness of Breath Physical Exam Fatigue Labs Swelling Imaging Heart Failure is a complex clinical
Slide 26: Structural Heart Disease is the most common cause of heart failure globally
Structural Heart Disease is the most common cause of heart failure globally How patients feel when they How physicians see experience heart failure structural heart disease CLINICAL SYMPTOMS CLINICAL SIGNS Shortness of Breath Physical Exam Fatigue Labs Swelling Imaging Heart Failure is a complex cli
Slide 27: Patients with severe Structural Heart Disease can present without symptoms
Patients with severe Structural Heart Disease can present without symptoms “My knees have been killing me. I can hardly walk on the golf course anymore. I need to get these fixed!”
Slide 28: Severe disease diagnosed during evaluation for a different problem
Patients with severe Structural Heart Disease can present without symptoms but can be diagnosed during evaluation for a different problem Evaluation by orthopedic specialist for knee surgery “My knees have been killing me. I can hardly walk on the golf course anymore. I need to get these fixed!” Car
Slide 29: Patients can present with multiple structural abnormalities
Patients with Structural Heart Disease can present with multiple structural abnormalities “My quality of life is deteriorating. I’m so fatigued and my legs are recently swollen.”
Slide 30: Patients can present with multiple structural abnormalities
Patients with Structural Heart Disease can present with multiple structural abnormalities “My quality of life is deteriorating. Hospitalized for severe fatigue and swelling I’m so fatigued and my legs are Clinical evaluation by specialist, including echocardiogram recently swollen.” Diagnosis 60%1 L
Slide 31: Our physician partners need to address the complexity of Structural Heart Disease
Our physician partners need to address the complexity of Structural Heart Disease Aortic Mitral stenosis regurgitation Best-in-class technologies, including multiple therapies for complex patients Tricuspid Pulmonic Partnership regurgitation disease for procedural training to optimize outcomes Commi
Slide 32: Patients need to be met where they are in their disease progression
Patients need to be met where they are in their disease progression Health Status Hospitalization Chronic Duration of Disease
Slide 33: Patients need to be met where they are in their disease progression
Patients need to be met where they are in their disease progression Asymptomatic diseases / early structural abnormalities Health Status “My knees have been killing me. I Hospitalization can hardly walk on the golf course anymore. I need to get these fixed!” Chronic Duration of Disease
Slide 34: Patients need to be met where they are in their disease progression
Patients need to be met where they are in their disease progression Asymptomatic diseases / early structural abnormalities Health Status “My quality of life is deteriorating, Hospitalization I’m so fatigued and my legs are recently swollen.” Multiple symptomatic structural abnormalities Chronic Dura
Slide 35: Early intervention will shift the trajectory for Structural Heart patients
Early intervention with the right solution will shift the trajectory for Structural Heart patients Health Status New outlook on life expectancy Hospitalization Decreased hospitalizations Quality of life matters most Chronic Duration of Disease
Slide 36: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Larry Wood
Slide 37: A new era of TAVR transforming patient care
A new era of TAVR transforming Base opportunity With undertreatment and an aging population, the patient care symptomatic severe AS opportunity remains significant Additional growth catalysts EARLY TAVR trial evidence expands the addressable patient population in the near-term PROGRESS trial evidenc
Slide 38: TAVR growth in symptomatic severe AS has been significant, but center constraints
TAVR growth in symptomatic severe AS patients has been significant, but constraints in TAVR centers have been impacting trends US TAVR Volume and Site Growth1 140K 1700 1600 US TAVR Volume US TAVR Sites 120K 1300 100K 1200 80K ~850 900 800 60K Total TAVR 500 40K centers 400 constrained 20K ~200 100
Slide 39: Investments in evidence and technology leadership enabled TAVR growth
Our investments in evidence and technology leadership have enabled TAVR growth in Symptomatic Severe AS Technology Evolution SAPIEN SAPIEN XT SAPIEN 3 SAPIEN 3 Ultra SAPIEN 3 Ultra RESILIA Low-Risk PARTNER 3 trial 17 Years of Int-Risk High-Risk PARTNER IA trial PARTNER IIA trial PARTNER II S3i trial
Slide 40: SAPIEN is the leading TAVR platform with consistent global data
SAPIEN is the leading TAVR platform with consistent global data OPERA-TAVI OCEAN-TAVI BERN-TAVI FRANCE-TAVI 1. Hase H, Yoshijima N, Yanagisawa R, et al. Transcatheter aortic valve replacement with Evolut R versus SAPIEN 3 in Japanese patients with a small aortic annulus: The OCEAN-TAVI registry. Cat
Slide 41: SAPIEN delivered best-in-class outcomes in largest head-to-head FDA trial
SAPIEN delivered best-in-class outcomes in the largest head-to-head randomized controlled FDA trial Reardon M. One-year Outcomes of ACURATE neo2 vs Approved TAVR Devices in All-Risk Patients with Severe AS: the ACURATE IDE Trial. Presented at TCT; October 30, 2024; Washington D.C., US.
Slide 42: Edwards TAVR platform remains highly differentiated
The Edwards TAVR platform remains highly differentiated as the best-suited technology for patients with Aortic Stenosis 1 Million Patients Treated 99% alive and well 90% survival THV-in-THV indication at 1-year1 at 5-years2 1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacem
Slide 43: We continue to raise the bar with innovation
We continue to raise the bar with innovation SAPIEN 3 Ultra RESILIA now the most implanted valve in the US and Japan EU launch is underway
Slide 44: We continue to raise the bar with innovation
We continue to raise the bar with innovation SAPIEN X4* SAPIEN 3 Ultra RESILIA now the most implanted valve in the US and Japan Enrollment completed EU launch is underway *Investigational Device. Not available for commercial sale.
Slide 45: We continue to raise the bar with innovation
We continue to raise the bar with innovation SAPIEN 3 Ultra RESILIA SAPIEN X4 Future TAVR now the most implanted valve Platforms in the US and Japan Enrollment EU launch completed is underway Under development
Slide 46: EARLY TAVR evidence represents a new frontier
EARLY TAVR evidence represents a new frontier for patients and the medical community in the battle against this deadly disease The PARTNER Trial Series The EARLY TAVR Trial Symptomatic Severe AS Asymptomatic Severe AS Largest, Most Rigorous Trials First and Most Rigorous Pivotal to Study AVR Therapy
Slide 47: EARLY TAVR: First RCT studying early intervention in asymptomatic SAS
EARLY TAVR: First RCT studying the best strategy for treating asymptomatic SAS and benefits of early intervention with TAVR 1578 “asymptomatic” patients ~20% of rigorously assessed by protocolized stress test or medical history patients were symptomatic with Class I Excluded* from AVR indication ran
Slide 48: Asymptomatic patients felt extremely well with highest baseline KCCQ
Asymptomatic patients felt extremely well with the KCCQ: 93 highest KCCQ at baseline ever seen in a TAVR trial 100% NYHA I Baseline Characteristics Baseline Echo Characteristics The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures symptoms, physical and social limitations, and quality of lif
Slide 49: Early intervention superior to clinical surveillance for primary endpoint
Early intervention was found to be superior to guideline- recommended clinical surveillance for the primary endpoint Primary Endpoint Primary Endpoint Components No mortality or stroke penalty for early intervention 1. TAVR for Asymptomatic Severe Aortic Stenosis: Results of The EARLY TAVR Trial. Pr
Slide 50: Surveillance patients experienced rapid and unpredictable disease progression
Patients in clinical surveillance experienced rapid and unpredictable disease progression with significant decline in quality of life Signs & Symptoms at Time of Conversion to AVR Clinical Presentation of AVR Conversions Patients in the trial had been pre-screened by the Heart Team, had a CT, and we
Slide 51: The current patient pathway for SAS patients is complex
The current patient pathway for SAS patients is complex GC Visit Echo with Severe AS GC Visit Refer to Heart Team TAVR Significant Symptoms ~160 Days1 Patients deemed Asymptomatic GC Visit Refer to Heart Team TAVR Guidelines suggest re-evaluate in ~6-12 months Symptomatic 1. Based on claims data on
Slide 52: The current patient pathway for SAS patients is complex
The current patient pathway for SAS patients is complex GC Visit Echo with Severe AS GC Visit Refer to Heart Team TAVR Significant Symptoms Patients deemed Asymptomatic GC Visit Refer to Heart Team TAVR Guidelines suggest re-evaluate in ~6-12 months Symptomatic
Slide 53: EARLY TAVR data simplifies the patient pathway
The EARLY TAVR trial data simplifies the patient pathway for all severe AS patients without symptom assessment GC Visit Echo with Severe AS Refer to Heart Team TAVR ≤ 90 Days Patients with an echo indicating severe AS can be directly referred to the Heart Team for evaluation 1. Jneid, H, Chikwe, J.
Slide 54: Financial costs of treatment delays will drive severe AS prioritization
Financial costs of treatment delays will drive severe AS prioritization and hospital investment Non-elective Cases are Significantly More Costly1 higher rate of unplanned Elective $45,686 2X CV hospitalization with clinical surveillance Urgent +$23,983 Total cost = $69,669 Emergent +$50,399 Total co
Slide 55: EARLY TAVR data is a durable catalyst for all SAS patients
EARLY TAVR data is a durable catalyst for all SAS patients Now 2025 2026 Clinical Evidence Asymptomatic SEVERE Indication Global Guideline AS & Policy Evolution Mid-2025 1 in 5 patients were Heart Team workup all Begin Guideline Process All Severe AS symptomatic with SAS patients referred & NCD Upda
Slide 56: PROGRESS Trial evidence expected in the mid-term
We continue to advance science in disease management: The PROGRESS Trial evidence expected in the mid-term 2:1 Ratio of Moderate to Severe AS patients Trial completed enrollment earlier this year and is in follow-up Data release anticipated Enrollment completed TCT 2026 2 years ahead of schedule The
Slide 57: EARLY TAVR data is a durable catalyst for all SAS patients
EARLY TAVR data is a durable catalyst for all SAS patients Now 2025 2026 Clinical Evidence Asymptomatic SEVERE Indication Global Guideline AS & Policy Evolution Mid-2025 1 in 5 patients were Heart Team workup all Begin Guideline Process All Severe AS symptomatic with SAS patients referred & NCD Upda
Slide 58: Evidence to expand the TAVR population will provide durable catalysts
Evidence to expand the TAVR population will provide durable catalysts for growth over the horizon Now 2025 2026 2027+ SEVERE AS MODERATE AS Asymptomatic Clinical Evidence Clinical Evidence Indication Global Guideline & Policy Evolution TCT Mid-2025 2026 1 in 5 patients Heart Team were symptomatic Be
Slide 59: TAVR: Aortic Regurgitation
TAVR: Aortic Regurgitation Stenosis Regurgitation Restricted valve opening Backflow Calcified, unrepairable Healthy leaflets with leaflets Annular Dilation
Slide 60: Aortic Regurgitation is a deadly disease that goes largely untreated
Aortic Regurgitation is a deadly disease that goes largely untreated Undertreatment of Diagnosed Symptomatic Severe AR Patients1 Treatment within 1-year of diagnosis High mortality if left untreated 1-year Mortality Rate1 74% Untreated 24% Diagnosed ssAR patients treated by medical management 26% No
Slide 61: Structural valve expertise with new complementary technologies
Our structural valve expertise with new complementary technologies positions us to bring early therapies to patients J-Valve* Technology First patients enrolled in Entered agreement to acquire JenaValve; pivotal trial anticipate transaction close in mid-2025 *Investigational Device. Not available fo
Slide 62: Aortic Regurgitation represents an additional opportunity
Aortic Regurgitation represents an additional opportunity We expect this journey to be like TAVR Technology Iteration Clinical Evidence Generation SAPIEN SAPIEN XT SAPIEN 3 SAPIEN 3 Ultra SAPIEN 3 Ultra RESILIA Education and Training for Best-in-Class Patient Outcomes Through investment in innovatio
Slide 63: TAVR 2025 Sales Outlook and 2026 and Beyond
2025 Sales Outlook 2026 and Beyond 7% growth MID TO HIGH SINGLE DIGIT GROWTH Annual variability based on timing of key catalysts 5% growth • Asymptomatic SAS Guideline Update & Policy Expansion • MID-TERM Scaling AHA Target: Aortic Stenosis Initiative • Asymptomatic SAS Indication Globalization • PR
Slide 64: SAPIEN 3 Important Safety Information: 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 65: Warnings
Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatmen
Slide 66: 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 67: Potential Adverse Events
Potential Adverse Events: Potential risks associated with the overall procedure, including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; s
Slide 68: Investigational device cautions
EARLY TAVR Trial NOTE: SAPIEN 3 TAVR has not been approved by FDA for use in asymptomatic severe aortic stenosis patients. These devices are not available for marketing or commercial sale for the treatment of asymptomatic severe aortic stenosis patients. The PROGRESS Trial CAUTION: INVESTIGATIONAL D
Slide 69: Transcatheter Mitral and Tricuspid Therapies (TMTT)
Transcatheter Mitral and Tricuspid Therapies (TMTT) Daveen Chopra
Slide 70: Millions of patients are suffering from Mitral and Tricuspid valve disease
Millions of patients are suffering from Mitral and Tricuspid valve disease Debilitating symptoms leading to Poor quality of life Difficulty Painful Fatigue Difficulty Chest breathing swelling walking pain Symptoms of heart failure Medical and Surgical options are suboptimal
Slide 71: Treatment requires both Repair and Replacement transcatheter therapies
Treatment of the broad patient population requires both Repair and Replacement transcatheter therapies TRICUSPID MITRAL Accelerating Expanding Two modalities Improving TEER outcomes catalyzing treatment and increasing evidence drive additional patient Three positive RCTs referrals and treatment crea
Slide 72: Edwards is the only company with a portfolio of transcatheter therapies
Edwards is the only company transforming care with a portfolio of transcatheter therapies PASCAL EVOQUE SAPIEN M31 PASCAL Mitral Tricuspid Mitral Tricuspid2 1 SAPIEN M3 is an investigational Device. Not available for commercial sale 2 United States: PASCAL TR is an investigational Device. Limited by
Slide 73: TMTT is committed to delivering across 3 strategic pillars
To enable each new therapy, TMTT is committed to delivering across 3 strategic pillars Real-World Innovation Evidence Outcomes Continuous Robust and Comprehensive innovation across expanding support for our portfolio of clinical data to excellent patient transcatheter empower outcomes Repair and phy
Slide 74: TMTT is pioneering Tricuspid transcatheter therapy
TMTT is pioneering Tricuspid transcatheter therapy Replacement and Repair EVOQUE and PASCAL TR innovations meet diverse population needs are creating a new standard of care
Slide 75: EVOQUE is a revolutionary procedure for Tricuspid regurgitation
EVOQUE is a revolutionary procedure for Tricuspid regurgitation Elimination ~60min of TR device time New larger valve significantly expands Predictable patient applicability and repeatable procedure Now approved in US and EU
Slide 76: TRISCEND II pivotal trial demonstrates practice changing outcomes
FDA-approved TRISCEND II pivotal trial demonstrates practice changing patient outcomes of EVOQUE valve 400 patients, with 1-year follow-up Dramatic Quality of Life Reduced mortality and improvements from TR elimination heart failure hospitalization EVOQUE superior to Medical Management
Slide 77: Strong and growing physician demand for EVOQUE
Strong and growing physician demand for EVOQUE Achieving excellent Real-World Outcomes Scaling commercial capabilities to meet growing interest Expecting US NCD1 end of Q1 '25 German new tech funding in place 1National Coverage Determination
Slide 78: Therapies activating the large untreated Tricuspid patient population
Edwards Transcatheter therapies activating the large untreated Tricuspid patient population EVOQUE PASCAL TR Leading Tricuspid treatment CLASP IITR trial 1 yr follow-up transformation complete in late 2025
Slide 79: TMTT is extending Mitral transcatheter therapy
TMTT is extending Mitral transcatheter therapy PASCAL MR achieves excellent SAPIEN M3 addresses patients results in a broader range of patients beyond TEER
Slide 80: PASCAL system innovation will continue to drive physician preference
PASCAL system innovation will continue to drive physician preference Next Gen '26 PASCAL Procedural Enhanced ease-of-use PASCAL PASCAL Ace Precision Innovations and outcomes Continuing a cadence of robust and rapid innovation
Slide 81: Growing body of evidence supports expanded PASCAL applicability
Broad and growing body of evidence supports expanded PASCAL patient applicability Predictable and durable Mitral regurgitation reduction Effective with simple and complex anatomies, Functional and Degenerative Enrolling
Slide 82: Differentiated PASCAL features improve TEER effectiveness
Differentiated PASCAL features improve TEER effectiveness and increase adoption Enabling Innovation Exceptional Heart Team Support Atraumatic Grasping Elongation Physician Training | Pre-case planning Intraprocedural support
Slide 83: SAPIEN M3 is the first transcatheter Mitral replacement therapy
SAPIEN M3 system is the first transcatheter Mitral replacement therapy Extends therapy beyond TEER 29-Fr transfemoral system Leverages SAPIEN 3 technology US approval EU approval 1H 2026 mid-2025
Slide 84: SAPIEN M3 will provide a new option for patients underserved by TEER
SAPIEN M3 will provide a new option for patients underserved by TEER therapy Enrollment Complete 300 TEER Suboptimal patients 100 Mitral Annular Calcification (MAC) patients Presentation Expected at TCT 2025
Slide 85: Complementary Mitral transcatheter therapies reach broader populations
Edwards complementary Mitral transcatheter therapies reach broader patient populations PASCAL MR SAPIEN M3 Excellent results Expanding treatable in more patients patient population
Slide 86: 2025 sales outlook
2025 sales outlook 60% growth LOW END HIGH END 50% growth • Time required to advance • Contemporary Mitral Repair Tricuspid therapy awareness evidence strengthens therapy and adoption confidence • Training exceptional case • Strong Real-World Outcomes support personnel for novel accelerate referral
Slide 87: Portfolio driving multiple years of rapid growth
Portfolio of life-changing therapies driving multiple years of rapid growth PASCAL TR SAPIEN M3 EVOQUE $2B Sales by 2030 PASCAL MR Increasing contribution to Edwards growth
Slide 88: PASCAL Precision Indications and Contraindications
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 primary abnormality of the mitral
Slide 89: PASCAL Potential Adverse Events
Potential Adverse Events: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the PASCAL Precision system: death; abnormal lab values; allergic reaction to anesthetic, contrast, heparin, Nitinol; anemia or decreased hemoglobin (may require transfusion);
Slide 90: EVOQUE Indications and Warnings
Edwards EVOQUE Tricuspid Valve Replacement System Indications: The EVOQUE tricuspid valve replacement system is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite being treated optimally with medical therapy for whom tricuspid valve rep
Slide 91: EVOQUE Precautions
Precautions: Prior to use, the patient’s eligibility depends on the anatomic conditions based on CT scan. It is advised that a multi-disciplinary heart team be of the opinion that EVOQUE valve implantation is preferable to alternative percutaneous device solutions, including minimally-invasive open
Slide 92: EVOQUE Potential Adverse Events
Potential Adverse Events: Potential adverse events related to standard cardiac catheterization, use of anesthesia, the EVOQUE valve, and the implantation procedure include: death; abnormal lab values; allergic reaction to anesthesia, contrast media, anti-coagulation medication, or device materials;
Slide 93: PASCAL and SAPIEN M3 investigational cautions
PASCAL Device CAUTION – Investigational device. Limited by Federal (United States) law to investigational use. This device is not available for marketing or commercial sale for the treatment of functional mitral regurgitation (FMR) or tricuspid regurgitation (TR) in the United States. SAPIEN M3 Mitr
Slide 94: Surgical
Surgical Wayne Markowitz
Slide 95: Surgical is delivering consistent, solid growth through leading innovation
Surgical is delivering consistent, solid growth through leading innovation supported by clinical evidence Key Catalysts to Extending our Surgical Leadership Accelerating RESILIA Adoption Increasing Procedural Mix Expanding RESILIA Access with Robust Clinical Evidence Beyond Severe AS in Emerging Mar
Slide 96: Premium RESILIA innovations are highly differentiated
Our premium RESILIA innovations are highly differentiated with extended durability Cumulative Global Surgical RESILIA Cases Surgical RESILIA Portfolio 1000 1M+ 1M 800 800k Cumulative Cases 600k 600 400k 400 370k+ 200k 200 INSPIRIS KONECT MITRIS Aortic Valve Aortic Valved Conduit Mitral Valve 0 2017
Slide 97: INSPIRIS is the leading surgical aortic valve in the world
INSPIRIS is the leading surgical aortic valve in the world The only SAVR valve INSPIRIS aortic Adoption increased with VFit technology valve is the in 2024; significant for potential future primary driver of growth opportunities TAVR valve-in-valve global revenue across the globe and now available i
Slide 98: RESILIA tissue exceptional outcomes in COMMENCE trial at 7 years
Aortic Stenosis (AS) RESILIA tissue has shown Bicuspid exceptional clinical outcomes in Aortic Valve the COMMENCE trial at 7 years Long-term, 10-year follow-up will be presented in 2026 Aortic Regurgitation (AR)
Slide 99: Surgery is the primary treatment for bicuspid aortic valve patients
Surgery is the primary treatment option for bicuspid aortic valve patients Bicuspid aortic valve Bicuspid aortic valve cases represent ~25% of SAVR cases in the US today Patients are younger with a mean age of 61 years old Normal aortic valve SAVR is well-suited for bicuspid aortic valve patients, r
Slide 100: AR is an undertreated and rapidly growing SAVR opportunity
AR is an undertreated and rapidly growing SAVR opportunity US SAVR Volume by Etiology >70% of diagnosed AR patients Aortic remain undertreated after 1 year1 Regurgitation (AR) AR growing at >75% of patients required concomitant >2x the rate surgery due to comorbidities Aortic Stenosis of AS (AS) 1 i
Slide 101: KONECT pre-assembled valve conduit addresses complex Bentall procedures
Our differentiated KONECT pre-assembled valve conduit is addressing the needs of complex Bentall procedures KONECT delivered Bentall procedures Upcoming significant growth are the fastest launches planned in 2024 and has growing SAVR in over 30 become a flagship segment in the countries around RESIL
Slide 102: MITRIS valve adoption is expanding
MITRIS valve adoption is expanding, fueled by upcoming global launches Designed for greater Increased adoption Received regulatory ease-of-use with in Europe due to approval in China; RESILIA tissue for established RESILIA launch planned in mitral patients foundation early 2025 Patient enrollment to
Slide 103: Emerging markets are a strong catalyst for Surgical growth
Emerging markets are a strong catalyst for Surgical growth today and into the future Surgical revenue growing at twice the rate of developed regions Represent ~50% of total global procedures Over 20 RESILIA launches planned for 2025
Slide 104: Asia Pacific is Surgical's fastest growing geography
Asia Pacific is Surgical’s fastest growing geography, with unique patient etiologies for cardiac surgery to address Surgical procedural CAGR of ~10% through 2030 Many patients with rheumatic disease, which is best treated surgically Higher rates of hypertension represent a key opportunity for KONECT
Slide 105: 2025 Sales Outlook
2025 Sales Outlook Mid-single digit growth LOW END HIGH END • Healthcare resource demand • Global RESILIA portfolio adoption • Slower adoption of premium • Expanding procedural mix beyond technologies AS 2025E Surgical is projecting mid-single digit growth in 2025
Slide 106: Surgical projecting mid-single-digit growth in 2026 and beyond
Surgical is projecting mid-single-digit growth in 2026 and beyond Accelerating adoption of our RESILIA portfolio with unparalleled clinical evidence Expanding surgical procedural mix beyond severe AS in areas such as bicuspid aortic valve, AR and Bentall procedures Expanding access to our best-in-cl
Slide 107: 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 108: Implantable Heart Failure Management (IHFM)
Implantable Heart Failure Management (IHFM) Diane Gomez-Thinnes
Slide 109: Significant patient opportunity
Significant patient opportunity Heart failure is a major burden and progressive disease 1.2M+ Severe Patients3 75% $40B+ 5-yr mortality1 cost of care2 Active heart failure management improves outcomes and quality of life4 1. US only; Bozkurt B., JCF 2024; 2. Heidenreich P., Circ HF 2013; 3. US TAM i
Slide 110: The Cordella Sensor and Heart Failure System
The Cordella Sensor and Heart Failure System transforming HF patient management Goal is to drive adoption through… Advancing a roadmap of innovation IHFM Building compelling evidence Empowering patients and HCPs
Slide 111: Innovation enabling broad adoption
Enabling broad adoption Innovation Hardware | Software | Data Sciences Cath Lab Home Clinic Procedure & calibration Engaging two-way communication Scalable workflow and insights simplification drives patient behavior that enable action
Slide 112: Unlocking a new era of HF management
Unlocking a new era of HF management Evidence EXPANDING Randomized Trial Cohorts CONFIRMING 49% reduction in rate of HFH and all-cause mortality1 n = 456 NYHA II Expand indications and influence guidelines n = 1,150 HFH or death at 24 mos 3 RCTs Pulmonary Artery Pressure (PAP) PAS and patient-self m
Slide 113: What to expect in 2025
Driving toward a new standard of care for heart failure management What to expect in 2025 NCD in Q1 PRO2 Clinical Progress Commercialization Coverage for most patients in US Evidence for the future New Capabilities Setting the foundation for long-term growth
Slide 114: Important Risk Information: Cordella Pulmonary Artery Sensor
Important Risk Information Cordella Pulmonary Artery Sensor Intended Use: The Cordella Pulmonary Artery Sensor is designed to measure and send pulmonary artery pressure (PAP) data for patients with Class III heart failure who are receiving medical treatment and have been stable for 30 days. Who shou
Slide 115: Financial Update
Financial Update Scott Ullem
Slide 116: Financial strategy designed to create significant value
Financial strategy designed to create significant value Projecting 2025 sales growth of 8-10% Strong organic Targeting ~10% average annual sales growth in 2026 and beyond sales growth driven by broad portfolio of structural heart therapies with annual variability based on timing of key catalysts Gro
Slide 117: Edwards financial objectives
SALES GROWTH Edwards financial objectives Strong organic Addressing large and growing sales growth patient populations Growth fueled by successful long-term Healthy and R&D investments expanding margins to pioneer breakthrough therapies Sustained leadership position supported by strong Strategic cap
Slide 118: Sales profile
SALES GROWTH Sales profile 2019-2024E performance 2024E regional mix Top 3 fastest growth (billions) rate therapies ROW $5.4 EVOQUE Japan 10% $5.0 5% PASCAL $4.5 $4.3 SAPIEN 3 25% ULTRA RESILIA Europe 60% $3.6 $3.5 US 2019 2020 2021 2022 2023 2024E Sales from continuing operations
Slide 119: Sales outlook by product group
SALES GROWTH Sales outlook by product group TAVR TMTT Surgical Structural Heart Failure & TAVR-AR 2025 2026 and beyond 2025 2026 and beyond 2025 2026 and beyond 2025 2026 and beyond 5%–7% Mid-to-high single $500–$530 Reaching $2 billion Mid-single Mid-single Minimal Increasing growth digit CAGR mill
Slide 120: Edwards financial objectives: profitability
PROFITABILITY Edwards financial objectives Strong organic Generating sales growth strong gross profit while strengthening global supply chain Healthy and Expanding expanding margins field organization to support therapy adoption Investing strategically Strategic capital in innovation for profitable
Slide 121: Profitability fueled by premium technologies and efficient supply chain
PROFITABILITY Profitability fueled by premium technologies, efficient supply chain, strategic R&D and disciplined spending GROSS PROFIT MARGIN OPERATING MARGIN 78-79% 27-28% of 2025E sales of 2025E sales Impactful and differentiated technologies support strong Planning for 50 to 100 bps of constant
Slide 122: Active R&D portfolio management will continue to fuel growth
PROFITABILITY Active R&D portfolio management will continue to fuel growth Generating R&D priorities scientific evidence to expand opportunities 40% Investments in valvular and non-valvular solutions ~$1.1B Actively managing our portfolio to 2024E Continuing New product prioritize and fund best idea
Slide 123: 2024E to 2025E adjusted EPS bridge
PROFITABILITY 2024E to 2025E adjusted EPS bridge ~$0.35 Double-digit growth ~$0.10 $2.40 - $2.50 ~$(0.15) $2.37 - $2.41 ~$(0.15) ~$(0.10) 2024E Continuing Core Business Acquisition Interest/Shares Tax FX 2025E 2026+ Operations Operations + Operating Burn Guidance Rightsizing
Slide 124: Edwards financial objectives: capital allocation
CAPITAL ALLOCATION Edwards financial objectives Strong organic Supports sales growth global capacity expansion Strategic acquisitions Healthy and to support and supplement expanding margins R&D initiatives Returning capital to shareholders through Strategic capital opportunistic share deployment rep
Slide 125: Strong and flexible balance sheet enables capital allocation strategy
CAPITAL ALLOCATION Edwards’ strong and flexible balance sheet enables capital allocation strategy Invest to support growth Capital expenditures to support innovative R&D, production including production capacity capacity and IT systems External investments Focus on structural heart including acquisi
Slide 126: Track record of opportunistic share repurchases
CAPITAL ALLOCATION Track record of opportunistic share repurchases Share repurchases Shares outstanding $ millions millions $1,727 700 $1,159 650 $875 $625 $513 600 550 2020 2021 2022 2023 2024 YTD 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024E
Slide 127: Investing capital for the future
CAPITAL ALLOCATION Investing capital for the future Capital spending Where are we investing? $ millions Includes Critical Care through September 3, 2024 Manufacturing $253 ~$250 ~$250 resiliency Infrastructure investment Research capacity Other 2023 2024E 2025E
Slide 128: 2025 financial guidance
Supplemental 2025 financial guidance $5,600–$6,000 8–10% ~($100) SALES (2pp downside to growth) TOTAL SALES GROWTH FX IMPACT ON SALES At current rates 78–79% 27–28% $4,100–$4,400 $500–$530 GROSS OPERATING 5–7% SALES GROWTH 50–60% SALES GROWTH PROFIT MARGIN MARGIN TAVR TMTT 15–18% $2.40–$2.50 TAX RAT
Slide 129: Financial strategy designed to create significant value
Financial strategy designed to create significant value Projecting 2025 sales growth of 8-10% Strong organic Targeting ~10% average annual sales growth in 2026 and beyond sales growth driven by broad portfolio of structural heart therapies with annual variability based on timing of key catalysts Gro
Slide 130: Adjusted supplemental historical financials
Adjusted supplemental historical financials In millions Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Continuing Operations Net Sales $1,221.3 $1,278.9 $1,243.4 $1,266.4 $1,329.9 $1,369.4 $1,354.4 Gross Profit $992.3 $1,031.1 $992.8 $1,015.4 $1,043.0 $1,093.9 $1,091.5 Operating Income $335
Slide 131: Closing Remarks
Closing Remarks Bernard Zovighian
Slide 132: Edwards is the leader in Structural Heart Innovation
Edwards is the leader in Structural Heart Innovation Solving large and complex patient needs Pioneering and leading therapeutic categories Delivering sustainable, long-term growth
Slide 133: The Edwards board is accomplished and engaged
The Edwards board is accomplished and engaged Leading governance practices Highly qualified with broad expertise Active engagement
Slide 134: Edwards is committed to underserved patients and our communities
Edwards is committed to underserved patients and our communities Every Heartbeat Matters Improve the lives of $185 million donated since inception in 2004 2.5 million underserved structural heart patients by the end of 2025 countries 44 supported by the foundation in 2024 Strengthening Communities w
Slide 135: We proceed confidently into the future
We proceed confidently into the future Significant and growing opportunities Uniquely positioned to elevate the standard of care for patients Setting the stage in 2025 Positioning Edwards for sustainable growth and shareholder value creation
Slide 136: Non-GAAP Financial Information
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 for items (both charges and gains)
Slide 137: Non-GAAP Financial Information
Non-GAAP Financial Information The items described below are adjustments to the GAAP financial results in the reconciliations that follow: Certain Litigation Expenses, net - The Company incurred certain litigation expenses of $8.9 million and $6.5 million in the first quarter of 2024 and 2023, respe
Slide 138: Unaudited Reconciliation of GAAP to Non-GAAP Financial Information
Unaudited Reconciliation of GAAP to Non-GAAP Financial Information (in millions, except per share and percentage data) RECONCILIATION OF GAAP TO ADJUSTED OPERATING INCOME FROM CONTINUING OPERATIONS Three Months Ended 2024 2023 March 31 June 30 September 30 March 31 June 30 September 30 December 31 G
Slide 139: Ewa
Ewa Re yD a Ve Edwards