Senseonics Holdings, Inc. · NASDAQ:SENS
Senseonics — Investor Presentation (July 2019)
21 slides from Senseonics's investor presentation, Jul 16, 2019
Slide 1: Forward-Looking Statements
1 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements that are based on management’s current expectations and projections about future events. Statements made in this presentation speak only as of the date of this presentation and should not be relied upon as of any subs
Slide 2: Today's Presenters
2 Today’s Presenters Timothy T. Goodnow President and Chief Executive Officer Previously held positions at TheraSense, Verax Biomedical, Dade Behring and Baxter Healthcare Holds a PhD and BS in Chemistry from the University of Miami Mike Gill Vice President and General Manager, US Previously held po
Slide 3: Investment Highlights
3 Investment Highlights A Global CGM System Leader Robust Product Strategy and Deep Pipeline to Support Long-Term Growth 4 Large Fast Growing Continuous Glucose Monitoring (“CGM”) Market with Significant Unmet Need 1 Clinically Proven CGM System Providing Enhanced Patient Experience and Clinical Out
Slide 4: Senseonics past: years to develop the technology and gain approval
4 Senseonics past: Almost 20 years to develop the technology, 4 years of pivotal studies to gain US and Outside US (“OUS”) approval 50% YOY Founded Patented first fluorescent optical sensor First successful human safety trial for the sensor 1 to 6-month sensor feasibility established EU PRECISE pivo
Slide 5: Senseonics present
5 Senseonics present: June 2018: FDA announced approval for Eversense® CGM (90-day system) Made Eversense available in the United States, as it already was in some European markets November 2018: FDA expanded Eversense® CGM certification to include nurse practitioners (NP) and physician assistants (
Slide 6: Successful recent initiatives and near term milestones
6 Successful recent initiatives and near term Milestones FDA and Product Development Payer Coverage Commercial Ramp Recent Success Expected Near Term Milestones From initiation of Bridge Access Program in February 17, 2019 to June 30, 2019: Weekly shipments have quadrupled Weekly scripts have double
Slide 7: High Growth Market
7 HIGH GROWTH MARKET CGM Fastest Growing Diabetes Technology Segment Globally* ~ 34% CAGR *Estimates for top 4 CGM companies (Dexcom, Abbott, Medtronic and Senseonics), based upon available publicly stated guidance, historic performance, and external CGM market models $2B+ U.S. Market by Dec. 31, 20
Slide 8: Significant unmet need
8 Significant unmet need (1) Type 1 Diabetes (T1D) Exchange Registry (2016). 36 sENSORS X A YEAR Reasons for discontinuation 27% of Patients Discontinue CGM Use within 1 Year(1) Patients Have to Switch Out Their Sensor Frequently 71% 61% 41% 28% CGM Not Working Properly / Accurately Enough Problems
Slide 9: Eversense CGM – First and only long-term CGM
9 (1) Labeled up to 90 days (US) or 180 days (Europe) SENSOR + Fully implanted + Small size + Up to 180 days(1) SMART TRANSMITTER + On-body vibe alerts + Removable/ rechargeable + Gentle adhesive EVERSENSE APP + Real-time readings every 5 mins + No extra receiver + Trends, threshold and predictive a
Slide 10: Access to key global markets
10 Access to Key global markets 2018 for Eversense® CGM (90-Day System) 2017 for Eversense® XL CGM (180-Day System) 2016 for Eversense® CGM (90-Day System)
Slide 11: Positive US launch and strong momentum
11 POSITIVE Us launch and Strong momentum Referring US Health Care Prescribers Covered Lives (Millions) Prescriptions Written +27% >2x >4x Target 100 million covered lives by year end 2019 with goal of 250 million covered lives by year end 2020 230 550 Dec.31, 2018 Through Jun. 30, 2019 60 66 76 Dec
Slide 12: Real-World Data on First U.S. Patients
12 Real-World Data on First U.S. patients* n=205 90-Day Analysis Mean Sensor Glucose mg/dL 161.8 (33.3) Mean SD mg/dL 57.4 (14.8) Mean CV 0.35 (0.06) Mean GMI% 7.18 (0.8) % Time spent <54 mg/dL 1.2 (1.7) % Time spent 54-70 mg/dL 2.9 (2.5) % Time spent 70-180 mg/dL 62.3 (19.0) % Time spent 180-250 mg
Slide 13: Changing reimbursement for diabetes
13 CHANGING REIMBURSEMENT FOR DIABETES 76 MILLION LIVES By Dec 31, 2019 TARGET 100 MILLION LIVES Coverage Coding DME CPT PHARMACY Payment INITIAL INSERTION 0446T REMOVAL 0447T REMOVAL & INSERTION 0448T HCP PATIENT PATIENT SENSOR A9276 TRANSMITTER A9277 BRIDGE PROGRAM STRATEGY 1 2 3 4 PATIENT ACCESS
Slide 14: Bridge program impact and key indicators
14 Bridge program Impact and Key indicators 85% Lead Increase from March 1, 2019 to June 30, 2019 102% Prescription Increase from March 1, 2019 to June 30, 2019 310% New Patient Shipment Increase from March 1, 2019 to June 30, 2019 550 HCP’s Prescribed as of June 30, 2019 Mix of Patients Switching t
Slide 15: Successful European commercialization
15 Successful European COMMERCIALIZATION > 900 > 1,100 Eversense Clinics (As of May 31, 2019) Trained Providers (As of May 31, 2019) +167% New Patients +266% Sensor Insertions Select EMEA, Asia Pac, LATAM markets Nordics market Most important features for European users: Long sensor life Predictive
Slide 16: 180-Day Clinical Trial: The Promise study
16 180 Day Clinical Trial: The Promise study Objective Demonstrate long-term Safety and Accuracy up to 180 days ~50 percent enrolled iCGM analysis after all subjects complete 90 & 180 days Study Design Up to 180 Subjects T1 / T2 > 1 year Visits: Screening Insertion Days 1, 7, 14, 22 Days 60, 90, 120
Slide 17: Product strategy
17 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 Product strategy This image cannot currently be displayed.
Slide 18: Automated Insulin Delivery: Beta Bionics program
18 AUTOMATED INSULIN DELIVERY Beta bionics program Gen3 iLet™ Bionic Pancreas System with Eversense
Slide 19: Promising Pipeline with Potential Enhancements
19 Promising Pipeline with POTENTIAL Enhancements Same sensor technology. Expanded opportunities. 1 2 3 365-DAY SENSOR LIFE: AUTONOMOUS SENSING ON-DEMAND: TYPE 2 TYPE 1: GEMINI 1x/week calibration additional analytes Battery integration FGM long-term wear w/ no transmitter FGM + CGM flash when desir
Slide 20: Preliminary Q2 2019 Financials
20 Preliminary Q2 2019 Financials Three Months Ended June 30, 2019 (estimated range)* Three Months Ended March 31, 2019 (unaudited) ($ in millions) Low High Actual Revenue US Revenue $1.0 $1.1 $0.8 OUS Revenue $3.4 $3.6 $2.6 Total Revenue $4.4 $4.7 $3.4 Cash Balance Approximately $65 $103.7 *These f
Slide 21: Preliminary Q2 2019 Financials
PRELIMINARY Q2 2019 FINANCIALS Three Months Ended June 30, 2019 | Three Months Ended March 31, 2019 (Sin miions) Revenue US Revenue $1.0 sit $08 OUS Revenue $34 $36 $26 Total Revenue $44 $47 $34 Cash Balance Approximately $65 $103.7
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