Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — 2021 Edwards Lifesciences Investor Conference
27 slides from Edwards Lifesciences's conference presentation, Dec 8, 2021
Slide 1: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Larry L. Wood Corporate Vice President Transcatheter Aortic Valve Replacement
Slide 2: 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 3: 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 4: 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 valve SAPIEN XT SAPIEN 3 valve SAPIEN 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% PARTNER 1B¹
Slide 5: 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 valve SAPIEN XT SAPIEN 3 valve SAPIEN valve SAPIEN XT SAPIEN 3 valve at 30 days valve valve 11.8% 5.0% 5.1% 5.0% 3.7% 0.5% 0.8% 3.9% 3.8% 3.4% 3.5% 3.2% 3.2% 3.0% PARTNER
Slide 6: 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 7: SAPIEN 3 economically dominant compared to SAVR in low-risk patients
SAPIEN 3 economically dominant compared to SAVR in low-risk patients • SAPIEN 3 resulted in cost savings of >$2,000 per patient through the 2-year study period • Driven by reductions in LOS and substantially lower follow-up costs • SAPIEN 3 had small but significant improvement in quality-adjusted l
Slide 8: 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 9: 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 10: The 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 11: Aortic stenosis is a progressive disease but the treatment paradigm is to wait 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 12: With TAVR as a treatment option, we believe 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 disabling stroke1 80% 96% Next day Discharged Discharge2 home1 TAVR - Minimally Superior Patient TAVR-in-TAVR Invasive Therapy Outcomes and Be
Slide 13: The first step is understanding if intervention should occur before symptoms develop
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 asymptomatic? Negative stress test OR confirmation via med history* Positive stress test Ran
Slide 14: 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 15: Studies have suggested that 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 16: We are also embarking on 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 surveillance TAVR Do all patients progress at the (SAPI
Slide 17: We have an opportunity to increase our understanding of AS disease progression with the PROGRESS Trial
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 18: We believe the moderate AS patient cohort is significantly larger than the 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 19: Despite continued COVID challenges, we delivered on the key milestones
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 20: 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 21: We have launched a nationwide TV ad campaign to drive awareness of TAVR therapy
We have launched a nationwide TV ad campaign to drive awareness of patients to TAVR therapy 12/8/2021 21
Slide 22: The fundamentals of TAVR remain strong and the opportunity ahead 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 23: 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 24: Edwards SAPIEN and Edwards SAPIEN Ultra Transcatheter Heart Valve System
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 25: Contraindications and safety information
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 26: Edwards Lifesciences • One Edwards Way, Irvine CA 92614 USA • edwards.com
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
Slide 27: | PE TN
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Edwards Lifesciences — 2021 Edwards Lifesciences Investor Conference on 6ix