Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — 2020 Edwards Lifesciences Virtual Investor Conference
21 slides from Edwards Lifesciences's conference presentation, Dec 10, 2020
Slide 1: 2020 Investor Conference: Transcatheter Aortic Heart Valves
2020 Investor Conference Transcatheter Aortic Heart Valves
Slide 2: We entered 2020 with strong momentum on a path to exceed our goals
We entered 2020 with strong momentum on a path to exceed our goals… • PARTNER 3 results demonstrated SAPIEN 3 is the only valve superior to surgery EW Global TAVR Sales ($M) • Low-risk approval in U.S. and EU • In U.S., revised NCD drove therapy access • Strong trajectory in the first 10 weeks of 20
Slide 3: …then the pandemic hit
…then the pandemic hit • All non-emergent hospital procedures were deferred • Hospitals had to re-think medical care and EW Global TAVR Sales ($M) resources as COVID-19 patients overwhelmed the system • In many areas, hospitals reserved critical resources in anticipation of pandemic wave, deferring
Slide 4: But we did not stop…
But we did not stop… Severe Aortic Severe AS patients’ mortality Helping patients Stenosis is a deadly rates increase drastically as remains our top disease patients wait for treatment priority EW Global TAVR Sales ($M) We remain laser focused on patient care and clinical partnership Q1 Q2 Q3 Q4 Q1
Slide 5: Bicuspid precaution removed
Bicuspid precaution removed Provides further confidence for low risk, younger patients Low rates of complications that matter most to bicuspid patients1 30 Days 1 Year CEC-adjudicated Event (n=71) (n=71) All-cause mortality 0% 1.4% All stroke 2.8% 2.8% Disabling stroke 0% 0% New permanent 9.9% 11.3%
Slide 6: Edwards SAPIEN 3 TAVR Now Approved for TAVR-in-TAVR Indication
Edwards SAPIEN 3 TAVR Now Approved for TAVR-in-TAVR Indication Provides long-term treatment option for patients with AS and reflects our dedication to long-term care 12/10/2020 6
Slide 7: Expanding Options for Congenital Pulmonic Heart Disease Patients
Expanding Options for Congenital Pulmonic Heart Disease Patients • SAPIEN 3 now approved for pulmonic patients (direct valve replacement) • Alterra Adaptive Prestent and SAPIEN 3 Pulmonic System expands therapy • Alterra U.S. Approval anticipated in 2H 2021 SAPIEN 3 Valve Alterra Adaptive Prestent C
Slide 8: SAPIEN 3 Now Approved in China For High Risk Patients
SAPIEN 3 Now Approved in China For High Risk Patients • Focused on establishing strong relationships to become the trusted clinical partner • Patient outcomes remain the priority • Contributor to long-term growth 12/10/2020 8
Slide 9: The COVID-19 experience helped to inform our future
The COVID-19 experience helped to inform our future • Patients with Aortic Stenosis don’t wait well, and TAVR is an essential procedure • High-touch model remains valued • We expect hospitals to adapt to local outbreaks and prioritize structural heart procedures until the pandemic subsides • TAVR ou
Slide 10: Data from New York City and Switzerland demonstrate risks of waiting
Data from New York City and Switzerland demonstrate risks of waiting “TAVR Delays During Pandemic’s Peak Led to Hospitalizations, Deaths”, www.tctmd.com, Sept 30, 2020 12/10/2020 10
Slide 11: PARTNER Best-in-Class Outcomes
PARTNER 3 Best-in-Class Outcomes 99% Freedom from death 96% of patients 90% did not need to be and disabling stroke discharged home rehospitalized at 1 year within 2 years Low Low rates pacemaker of PVL rates PVL: Paravalvular Leak 12/10/2020 11
Slide 12: Edwards' TAVR allows hospitals to treat patients with confidence
Edwards’ TAVR allows hospitals to treat patients with confidence Low Short Patients Low complication length-of-stay discharged re-hospitalization rates home rates TAVR has become a healthcare priority and Edwards’ TAVR advantage is now stronger than ever PARTNER 3 Trial data, 2019 12/10/2020 12
Slide 13: TAVR fundamentals remain strong in developed markets around the world
TAVR fundamentals remain strong in developed markets around the world SAPIEN 3 now approved in China For High-Risk Patients Long-term opportunity • Treatment rates • Aging population • Mix of countries with remain low increasing rapidly high and low treatment penetration • Opportunity with • Mat
Slide 14: Asymptomatic and Moderate Risk Clinical Trials
Asymptomatic and Moderate Risk Clinical Trials Expected to add significant growth beyond 2024 • Beyond Severe Aortic stenosis, we believe our TAVR therapy may benefit patients with Moderate Aortic Stenosis • Currently working closely with KOLs on a pivotal trial design Anticipate FDA approval to sta
Slide 15: Our portfolio is constantly evolving
Our portfolio is constantly evolving Next-Generation SAPIEN X4 SAPIEN 3 SAPIEN 3 Ultra Clinical work expected to begin in U.S. in 2021 U.S. and EU launches evolutionary advancements Revolutionary platform SAPIEN X4 Caution: Investigational Devices. Not available for commercial sale. 12/10/2020 15
Slide 16: 2021 Global Sales Outlook
2021 Global Sales Outlook Headwinds Tailwinds $3.6B 20% Overall healthcare Therapy benefits and budget constraints $3.2B strong patient preference 15% Low risk expansion Competition in key regions 2021E TAVR Estimated Global Sales and Sales Growth 12/10/2020 16
Slide 17: Executive Summary
Executive Summary • Aortic Stenosis is a deadly disease and timely treatment is paramount • Globally, diagnosis and treatment rates of AS remain low providing opportunity for low-double digit TAVR growth long-term • We have learned from the pandemic and Edwards’ TAVR therapy fundamentals remain stro
Slide 18: CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician
CAUTION: Federal (United States) 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. Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultr
Slide 19: Precautions: Safety, effectiveness, and durability have not been established for THV-in-THV procedures
Precautions: Safety, effectiveness, and durability have not been established for THV‐in‐THV procedures. 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
Slide 20: Additional potential risks associated with the use of the valve, delivery system, and/or accessories
Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring int
Slide 21: Helping Patients is Our Life's Work
P| PP TN Re ND, ave Edwards Helping Patients is Our Life’s Work, and, now) pe?
Edwards Lifesciences — 2020 Edwards Lifesciences Virtual Investor Conference on 6ix