Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — 2021 Edwards Lifesciences Investor Conference
16 slides from Edwards Lifesciences's conference presentation, Dec 8, 2021
Slide 1: Transcatheter Mitral and Tricuspid Therapies
Transcatheter Mitral and Tricuspid Therapies Bernard J. Zovighian Corporate Vice President Transcatheter Mitral and Tricuspid Therapies
Slide 2: TMTT has a bold vision to transform care for patients with Mitral and Tricuspid valve disease
TMTT has a bold vision to transform care for the many patients with Mitral and Tricuspid valve disease… > 4M patients1 TRICUSPID MITRAL Global Transcatheter Mitral and Tricuspid Market expected to grow < 2% from ~$1B in 2021 to treated2 $5B by 2028 Poor High Ineffective quality of life mortality med
Slide 3: TMTT overcame numerous obstacles to achieve ambitious milestones in 2021
TMTT overcame numerous obstacles to achieve our ambitious milestones in 2021… Differentiated Robust Real-World / Portfolio Clinical Evidence Commercial Outcomes Initial clinical experience with Enroll CLASP IID trial by year-end Continued pivotal enrollment supporting late 2022 PASCAL DMR U.S. appro
Slide 4: PASCAL's adoption is driven by a large body of Mitral evidence and experience
PASCAL’s adoption is driven by an increasingly large and compelling body of Mitral evidence and experience >4,500 total patients treated with PASCAL Mitral1 >3,800 >450 study patients PASCAL patients with @ 1-year follow-up3 reported data2 1. Total cumulative commercial and clinical patients treated
Slide 5: TMTT is delivering a rapid cadence of innovation in TEER
TMTT is delivering a rapid cadence of innovation in transcatheter edge-to-edge repair (TEER) PASCAL is designed to …and the new PASCAL Precision System address meaningful patient needs… extends this differentiated performance Versatile implant to safely navigate even challenging anatomies Atraumatic
Slide 6: TMTT expects FDA approval of PASCAL Precision for DMR in late 2022
TMTT expects FDA approval of PASCAL Precision for DMR in late 2022 Controlled launch planned in the U.S. with a dedicated field team deploying our high-touch clinical support model Support Comprehensive 100% patient screening physician training case support Caution: Investigational Devices. Limited
Slide 7: Transfemoral replacement is expected to significantly expand the Mitral opportunity
Transfemoral replacement is expected to significantly expand the Mitral opportunity in the mid-term Addressing patients’ needs with product design Two-platform strategy positions TMTT for leadership Eliminating residual MR offers significant SAPIEN M3 patient benefits ▪ On-track to be the first comm
Slide 8: TMTT is well positioned to achieve critical Mitral milestones in 2022
TMTT is well positioned to achieve critical Mitral milestones in 2022, setting up a strong 2023 Differentiated Robust Favorable real-world / Portfolio Clinical Evidence commercial outcomes Initial clinical experience with novel FDA submission with CLASP IID: PASCAL Precision DMR approval in US: next
Slide 9: Early tricuspid clinical evidence is promising
Early tricuspid clinical evidence is promising, and demonstrates the diversity of patients’ needs… Pivotal Trials >1,500 total patients treated with TMTT’s Tricuspid Portfolio1 EVOQUE PASCAL ~500 >150 study patients patients with @ 1-year follow-up3 Cardioband reported data2 1. Total cumulative comm
Slide 10: Tricuspid portfolio is designed to treat with safety, efficacy, and ease-of-use
…which TMTT’s Tricuspid portfolio is designed to treat, with safety, efficacy, and ease-of use Tricuspid Repair: Tricuspid Replacement: PASCAL Precision System EVOQUE Compliant Atraumatic implant design clasp control Wide Thin leaflet gaps leaflets Dense Imaging chordae challenges Versatile Intuitiv
Slide 11: Excitement is building for EVOQUE, with 6-month late breaking trial data
Excitement is building for EVOQUE, which kicked off TCT 2021 with a live case, and presented 6-month late breaking trial data 96% 94% Survival Freedom from Heart Failure Hospitalization At 6-month follow-up 12/8/2021 11
Slide 12: Tricuspid clinical needs drive significant milestones in 2022
TMTT’s understanding of Tricuspid clinical needs drives an ability to achieve significant milestones in 2022 Differentiated Robust Favorable real-world / Portfolio Clinical Evidence commercial outcomes Initial clinical experience with novel Continued enrollment of TRISCEND II EVOQUE approval in Euro
Slide 13: 2022 Global Sales Outlook
2022 Global Sales Outlook Headwinds $170M Tailwinds European Mitral market The new European regulatory system $140M returns more quickly to higher growth High quality evidence COVID recovery across the TMTT portfolio 2022E Global TMTT Estimated Sales 12/8/2021 13
Slide 14: Committed to delivering on our vision in 2022
TMTT is committed to continue delivering on our vision in 2022, with significant sales growth and major product approvals… PASCAL Precision DMR approval in U.S.: Late 2022 PASCAL Precision approval in EU: Late 2022 EVOQUE approval in EU: Late 2022 >6,000 patients treated in 2022 Revenue of $140-$170
Slide 15: Important Safety Information
IMPORTANT SAFETY INFORMATION SAPIEN M3 Transcatheter Heart Valve System INVESTIGATIONAL DEVICES. CAUTION: The SAPIEN M3 System consists of investigational devices, limited by Federal (United States) law to investigational use. These devices are not available for marketing or commercial sale. See ins
Slide 16: | PE TN
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