Senseonics Holdings, Inc. · NASDAQ:SENS
Senseonics — Investor Presentation (September 2019)
27 slides from Senseonics's investor presentation, September 2019
Slide 1: Live Life with Confidence and Ease
LIVE LIFE WITH CONFIDENCE AND EASE September 2019
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements that are based on management’s current expectations and projections about future events, including statements regarding the growth of the market for the Company’s products, the Company’s targets for payer coverage decis
Slide 3: Senseonics: A Global Leader in Innovation
SENSEONICS A GLOBAL LEADER IN INNOVATION 1 Disruptive, Highly-Innovative Technology in a Fast-Growing CGM Market with a Significant Unmet Need 2 Clinically Proven CGM System Providing Enhanced Patient Experience and Clinical Outcomes 3 Access to Key Global Markets with Increasing Coverage and Succes
Slide 4: High Growth Market
HIGH GROWTH MARKET CGM Fastest Growing Diabetes Technology Segment Globally* ~ 34% CAGR 6 $5.7 5 $4.8 Revenue in Billions ($) 4 $3.9 $2B+ $2.8 U.S. Market 3 by Dec. 31, 2019E 2 $1.8 1 0 *Estimates for top 4 CGM companies (Dexcom, 2017 2018 2019E 2020E 2021E Abbott, Medtronic and Senseonics), based
Slide 5: Significant Unmet Need
SIGNIFICANT UNMET NEED Top Reasons Why Patients Take a Break CGM1 Patients Have to Switch Out Their Sensor Frequently 36 SENSORS X A YEAR 59% Abbott 31% Libre Medtronic 32% 35% 44% 10% 24% Dexcom 39% 36% 25% 19% Break from Having Sensor Falls Off Get a Break from Get a Break from Something Before Ex
Slide 6: Eversense CGM – First and Only Long-Term CGM
EVERSENSE CGM – FIRST AND ONLY LONG-TERM CGM Eversense Addresses Unmet Needs ü Long-term: sensor lasts EVERSENSE CLOUD up to 180 days(1) ü Only needs to be switched 2-4x a year vs. 36x a year ü Fully implantable sensor ü On-body vibration alerts ü Accuracy ü Flexibility: removable SENSOR SMART EVERS
Slide 7: Senseonics Milestones
SENSEONICS MILESTONES 2016 2017 50%2018 YOY 2018 2018 2019 2019 CE mark US PRECISE II and FDA announced FDA expanded Senseonics FDA FDA announced received for PRECISION studies approval for Eversense® CGM announces announced approval for the Eversense® demonstrate safety Eversense® certification to
Slide 8: Evidence Build and Clinical Practice Guidelines
EVIDENCE BUILD AND CLINICAL PRACTICE GUIDELINES 8
Slide 9: Eversense Adoption Strategy
Differentiation EVERSENSE Drive Demand from HCPs and ADOPTION Patients STRATEGY Clinical Demonstration 9
Slide 10: Eversense Patient Feedback
Dianne M. EVERSENSE PATIENT FEEDBACK South Carolina Feature Rating Reinsertion How do you rate performance of the product features and Do you plan to get inserted with a new sensor use in certain areas? at the end of your current sensor wear period? 5 = extremely satisfied, 1 = extremely dissatisfie
Slide 11: Patient Testimonial - Robert
PATIENT TESTIMONIAL - ROBERT 11
Slide 12: Physician Testimonial – Dr. David Ahn
PHYSICIAN TESTIMONIAL – DR. DAVID AHN 12
Slide 13: Drive Demand – Changing Reimbursement for Diabetes
DRIVE DEMAND – CHANGING REIMBURSEMENT FOR DIABETES Current Aspirational BRIDGE PROGRAM STRATEGY PATIENT ACCESS TO 1 EVERSENSE FOR $99 By Dec 31, 76 MILLION LIVES TARGET 100 MILLION LIVES 2019 APPEAL MANAGEMENT Coverage 2 - Single case negotiations - Drive coverage policy DME PHARMACY CPT 3 PAYER UTI
Slide 14: Drive Demand – Positive US Launch and Strong Momentum
DRIVE DEMAND – POSITIVE US LAUNCH AND STRONG MOMENTUM Target 100 million covered lives by year end 2019 Covered Lives (Millions) Referring US Health Care Prescribers Prescriptions Written 550 4.5K +27% 76 >2x >4x 400 66 2K 230 60 1.1K Dec. 31, 2018 March 31, 2019 June 30, 2019 Dec. 31, 2018 March 31
Slide 15: Drive Demand – Bridge Program Impact and Key Indicators
DRIVE DEMAND – BRIDGE PROGRAM 85% Lead Increase from IMPACT AND KEY INDICATORS March 1 - June 30, 2019 Mix of Patients Switching to Eversense 102% Prescription Increase from March 1- June 30, 2019 31% Self-Monitoring of Blood Glucose (SMBG) U.S. 35% Dexcom 310% New Patient EVERSENSE Shipment Increas
Slide 16: Drive Demand – Adding Covered Lives
DRIVE DEMAND – ADDING COVERED LIVES • Private Insurance – working with national and local plans to be added to covered CGM policies • VA Patients – now approved at Veteran’s hospitals across the country and training healthcare providers • Medicare – meeting with CMS to determine coverage model 16
Slide 17: Real-World Experience: First US Commercial Users
REAL–WORLD EXPERIENCE FIRST U.S. COMMERCIAL USERS* GLUCOMETRIC DATA ON THE FIRST 205 PATIENTS WHO COMPLETED 83.6% Percent wear of transmitter 90 DAYS SENSOR HOME USE; ~1/3 CGM NAÏVE, ~63% T1D (median) based on 90-day analysis [Recommended time – 70%]1 11.2% MARD (27,708 paired points) based on 90-da
Slide 18: Real-World Experience: European Commercial Users
REAL–WORLD EXPERIENCE EUROPEAN COMMERCIAL USERS OVER MULTIPLE USE* Eversense is safe over multiple cycles of use in the real world, home-use setting. EU Post Market Clinical 0.96% 0.66% 0 Follow up Registry • 3,023 Eversense Users • 5,417 Sensor Insertions • 534 Clinics in 14 European Of users had a
Slide 19: Clinical Demonstration: Sensor Accuracy
CLINICAL DEMONSTRATION SENSOR ACCURACY Data presented at the 79th annual American Diabetes Association Scientific Sessions1 CGM Sensor Accuracy Within 15 mg/dL for <100 mg/dL and 15% for ≥100 mg/dL 87% 81% 83% 79% Medtronic Guardian Abbott Libre Dexcom G6 Eversense Eversense 3 1 Beck, R. CGM Accurac
Slide 20: Commercial Presence in Key Global Markets
COMMERCIAL PRESENCE IN KEY GLOBAL MARKETS Select EMEA markets Nordics market 2016 for 2017 for Eversense ® CGM Eversense ® XL CGM (90-Day System) (180-Day System) 20
Slide 21: Commercial Presence in Key Global Markets
COMMERCIAL PRESENCE IN KEY GLOBAL MARKETS Select EMEA, Asia Pac, LATAM markets Nordics market Market Roche Distribution Agreement Extension in 17 Additional Markets in Asia Pacific and Latin America. Expansions 21
Slide 22: Successful European Commercialization
SUCCESSFUL EUROPEAN COMMERCIALIZATION Dexcom / Medtronic 6% 7 % 10% 6 6 +1 +2 Libre 40% NEW PATIENTS 2017 2018 2017 2018 (GERMANY) (Feb 2019) New Patients Sensor Insertions SMBG > 900 > 1,100 Most important features for European users : 50% Eversense Clinics Trained Providers (As of May 31, 2019) (A
Slide 23: Product Strategy
PRODUCT STRATEGY • Extend wear • Reduce/nearly eliminate calibrations • Improve on-body footprint • Pediatric indication • Enhance partnerships and integrate as iCGM with AP, CSII, Pens • Decision support • Type 2 strategy 23
Slide 24: 180 Day Clinical Trial: The PROMISE Study
180 DAY CLINICAL TRIAL: THE PROMISE STUDY Objective Study Design Effectiveness Demonstrate long-term Safety Up to 180 Subjects T1 / T2 ≥ 1 Accuracy against YSI in hyper / and Accuracy up to 180 days year hypoglycemia visits / subjects Visits: over 180 days >55,000 CGM-YSI ~50 percent enrolled iCGM ü
Slide 25: Promising Pipeline with Potential Enhancements
PROMISING PIPELINE WITH POTENTIAL ENHANCEMENTS 1 2 3 365-DAY AUTONOMOUS ON-DEMAND: TYPE 1: SENSOR LIFE: SENSING TYPE 2 GEMINI 1x/week calibration Battery integration FGM FGM + CGM additional analytes long-term wear w/ no flash when desired transmitter CGM for peace of mind Same sensor technology. Ex
Slide 26: Automated Insulin Delivery: Beta Bionics
PRESENTED AT THE AUTOMATED 79TH ANNUAL AMERICAN INSULIN DELIVERY DIABETES ASSOCIATION SCIENTIFIC SESSIONS 68% Time in Range % time 70-180 mg/dL BETA BIONICS PROGRAM 0.8% Gen3 iLet™ Bionic Time in Hypoglycemia Pancreas System % time <55 mg/dL with Eversense +1.4 hours/day Increased time in range with
Slide 27: Senseonics
Senseonics.
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