Impedimed Limited · ASX:IPD
Impedimed — Shareholder Meeting (November 2019)
36 slides from Impedimed's shareholder meeting presentation, Nov 11, 2019
Slide 1: Together, We Can End Cancer-Related Lymphoedema
Together, We Can End Investor Presentation Cancer-Related ASX:IPD November 2019 Lymphoedema Annual General Meeting 1
Slide 2: Disclaimer
Disclaimer • The material contained in this document is a presentation of • To the extent permitted by law, no responsibility for any loss general information about the activities of ImpediMed Limited arising in any way (including by way of negligence) from anyone (“ImpediMed”) current as at the dat
Slide 3: Forward Looking Statements
Forward Looking Statements • Certain statements in this presentation may constitute forward- • There can be no assurance that any existing or future regulatory looking statements or statements about future matters that are filings will satisfy the relevant authorities’ requirements regarding based o
Slide 4: Corporate Overview
Corporate Overview ImpediMed is a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS) ASX Listed 67 Total Staff Share Register IPD.AX US (San Diego) Institutional: 70% October 2007 Australia
Slide 5: Major Achievements Last 12 Months
Major Achievements Last 12 Months Business • Successfully Transitioned to SaaS Business Model (>440 devices sold with <0.5% churn) • $13.9 Million Fully Underwritten Non-Renounceable Entitlement Offer – 27 June 2019 • ImpediMed Becomes Business Associate Compliant with Launch of Third Generation SOZ
Slide 6: Investment Highlights
SOZO Patient Tests To-Date Investment Highlights (69,000+ on File) 20,000 Highly Disruptive Technology Proprietary Digital Health Platform 16,000 with Robust Patent Portfolio Large, Attractive, and Growing Markets 12,000 Regulatory Clearances FDA, CE Mark, and ARTG 8,000 Significant Body of Clinical
Slide 7: Transition to SaaS Business Model Complete and Revenue now Accelerating
Transition to SaaS Business Model Complete and Revenue now Accelerating Expecting 2X - 3X Revenue Growth in FY’20 SOZO Replaces Legacy Revenue Crossover Complete and Revenue Now Accelerating Total Reported Medical Reported Medical Revenue Legacy and SOZO Revenue (in A$ Millions) (in A$ Millions) $9.
Slide 8: Well on Track to Meet Guidance
Well on Track to Meet Guidance SOZO Revenue SOZO (Excluding Legacy) (Contracted Revenue Pipeline & Annual Recurring Revenue) $1.0 A$10.0 $0.8 A$7.5 AU$ Millions AU$ Millions $0.6 A$5.0 $0.4 A$2.5 $0.2 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Q3'
Slide 9: SaaS Business Model Accelerating Revenue in Lymphoedema
SaaS Business Model Accelerating Revenue in Lymphoedema Growth Drivers FY’20 • Aggressively drive National Lymphoedema Prevention Guidance Program in new key centres and build out in existing centres Midrange Low Midrange High Growth vs. (increases device and subscription sales) FY’19 • Target exist
Slide 10: ImpediMed’s Proprietary Technology Directly Measures Fluid in the Body
ImpediMed’s Proprietary Technology Directly Measures Fluid in the Body Indirect Measure of Fluid Direct Measure of Fluid Bioimpedance Spectroscopy (BIS) • Imaging Low Frequency Current passes around cells • Implantables Fluid • Weight 256 frequencies Fat High Frequency Current passes through cells •
Slide 11: SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform
SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform • L-Dex® for assessing subclinical unilateral Lymphoedema • Sensitive detection of small changes in body fluid: FPO • L-Dex for assessing subclinical • Intracellular bilateral Lymphoedema • Extracellular • Non-invasive measurem
Slide 12: Connected Digital Health Platform
Connected Digital Health Platform Key Centers Connected Digital Health Platform Cloud • Comprehensive patient data (Business Associate Agreement compliant) • Access to information across the care continuum • Manage large patient populations • Integrates seamlessly into hospital, clinical, and home H
Slide 13: Large, Attractive and Growing Markets
Large, Attractive and Growing Markets FDA Clearance and CE Mark for Both Indications Newly Diagnosed Cancer Cases Heart Failure Patients by Classification 1.8 Million per Year 6.5 Million Class IV Class I 5% 35% All Others 45% At Risk of Limb Lymphoedema Class III 55% 25% Class II 35% $2+ Billion $1
Slide 14: SOZO for Cancer Survivors
SOZO FOR CANCER SURVIVORS
Slide 15: Lymphoedema is A Real and Growing Problem
Lymphoedema is A Real and Growing Problem • Over 15.5 Million cancer survivors in the U.S. • 1 in 3 will develop Lymphoedema • More than 5.5 Million U.S. patients suffering from persistent cancer-related Lymphoedema • Lymphoedema usually presents within first 36 months • Lymphoedema is one of the mo
Slide 16: Lymphoedema is a Common Consequence of Cancer Treatment
Lymphoedema is a Common Consequence of Cancer Treatment Prevalence by Cancer and Treatment Melanoma + Irradiation 50% SLNB + Whole Breast & Regional Lymph Node Irradiation 41% Gynecologic + Irradiation 34% ALND + Whole Breast Irradiation 32% Vulvar 30% Gynecologic Misc. 27% ALND for Breast Cancer 22
Slide 17: Current State of Lymphoedema Detection and Treatment
Current State of Lymphoedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected limb capacity is fluid and protein consistency, becomes very reduced, setting causing swelling; tissue fibrosis large and the stage for an pitting oedema causing misshapen, and overload
Slide 18: The Future of Lymphoedema Detection and Treatment
The Future of Lymphoedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected limb capacity is fluid and protein consistency, becomes very reduced, setting causing swelling; tissue fibrosis large and the stage for an pitting oedema causing misshapen, and overload of
Slide 19: Demonstrated Real World Outcomes
Demonstrated Real World Outcomes Nashville Breast Center, TN, USA Macquarie University, NSW, AUS Breast Care Specialists, NY, USA (n=596, F/U 17 months) (n=188, F/U 8 months) (n=206, F/U 25.9 months) 80 50 30 • Compelling clinical data 60 -75% 38 23 • Medically meaningful results 40 25 -83% 15 • Eff
Slide 20: Practice-Changing Results - PREVENT Trial Interim Results
Practice-Changing Results - PREVENT Trial Interim Results 12 Month Interim Results Publication: Primary • Does early detection and intervention with BIS reduce need for BCRL treatment with Annals of Surgical Oncology Aim CDP vs. circumference measurements May 3, 2019 • International, Multi-Instituti
Slide 21: Reimbursement Strategy
Reimbursement Strategy NCCN Guidelines® Commercial Payors • Requesting inclusion of formalised testing protocol and • Discussions ongoing with National and Regional BIS technology for Lymphoedema prevention payors. The meetings have been productive and we • Joint application remain optimistic • Vand
Slide 22: Sales Tools
Sales Tools Introducing LPP Program-Building Patient Education Marketing 22
Slide 23: Land and Expand Strategy
Land and Expand Strategy The growing patient WIDESPREAD database is driving ADOPTION revenue growth NEW SOFTWARE APPLICATIONS EXPAND NEW SOFTWARE APPLICATIONS EXPAND EXPAND DISEASE STATES PROTOCOL ADOPTION • New software applications Heart Failure Bone Density 200 MILLION+ Renal Failure DATA POINTS
Slide 24: Expansion of Accounts Accelerates Annual Recurring Revenue
Expansion of Accounts Accelerates Annual Recurring Revenue TARGETED CUSTOMER LAND INITIAL SALE: LAND • 1 – 2 units per account CONVERT EXISTING AND ADD • $5,000 per device fee NEW CUSTOMERS • Up to $1,500 per month Unilateral license fee for 36 months EXPAND PROGRAM WITH LYMPHOEDEMA PREVENTION PROGR
Slide 25: SOZO for Heart Failure
CA NCER S URVIVOR S SOZO for Heart Failure
Slide 26: Heart Failure is a Significant Healthcare Issue and Current Monitoring Methods are Inadequate
Heart Failure is a Significant Healthcare Issue and Current Monitoring Methods are Inadequate Impact of Heart Failure Current Monitoring Methods • Global pandemic affecting at least 26 Million people worldwide Device Method Benefit Shortcomings • Estimated 6.5 Million Americans live with heart failu
Slide 27: Compelling Heart Failure Data
Compelling Heart Failure Data Independent Research Current Research Research Research • Conducted with IPD’s SFB7 BIS Device • Conducted with IPDs SOZO BIS Digital Health Platform • 5 papers, including 3 from Aachen University / Philips • Approximately 300 enrolled in 5 studies Research Technologies
Slide 28: Discrimination Between Healthy Controls and Decompensated HF Patients
Discrimination Between Healthy Controls and Decompensated HF Patients Preliminary Findings • SOZO Impedance ratios demonstrate a SOZO Impedance Ratio patient’s extracellular fluid level • These Impedance Ratios may allow: • Clinicians to determine fluid overload with a single test (wet versus dry pa
Slide 29: SOZO Able To Track Medically Meaningful Fluid Shifts
SOZO Able To Track Medically Meaningful Fluid Shifts Key Takeaways Patient Re-admitted • SOZO was able to track small fluid shifts • SOZO was able to track effectiveness of dosing • Patient discharged from hospital in severe fluid overload (2 Apr) • Admitted to Skilled Nursing Facility (8 Apr to 2 M
Slide 30: SOZO Outputs Correlate to Patient Symptoms
SOZO Outputs Correlate to Patient Symptoms Key Takeaways Patient Grossly Symptomatic • Patient’s symptoms correlated to SOZO outputs (19 Mar - 12 Apr and 22 Apr - 10 May) • When SOZO readings were in the green the patient was not symptomatic • SOZO was able to track small fluid shifts and the impact
Slide 31: SOZO Able To Better Identify Cause of Symptoms
SOZO Able To Better Identify Cause of Symptoms Key Takeaways Patient Stable • SOZO was able to track fluid retention brought on by Prednisone (a steroid known to cause fluid retention) • SOZO was able to track dosing changes • Not all symptoms due to HF. Shortness of breath noted on 22 Feb due to br
Slide 32: Heart Failure - Key Takeaways and Next Steps
Heart Failure - Key Takeaways and Next Steps Key Takeaways Next Steps • SOZO has the potential to: • Gain FDA Clearance to remove implantable cardiac device contradictions (expected Dec • Become a valuable triage and prognosis 2019) tool for managing HF patients • Advance to final phase of study • A
Slide 33: Expected Milestones and Upcoming News Flow
Expected Milestones and Upcoming News Flow • Continued strong growth in SOZO SaaS subscription-based business • PREVENT Trial 2-year data published • PREVENT Trial — additional publications • Meta-analysis published • NCCN Guidelines® — The addition of a formal testing protocol and inclusion of BIS
Slide 34: Appendix
Annual General October 2018 Meeting Appendix
Slide 35: Management Team
Management Team Deep and Broad Commercialization Experience Richard Carreon Frank Vicini, MD Morten Vigeland Catherine Kingsford Managing Director and Chief Medical Officer Chief Financial Officer SVP Medical Affairs Chief Executive Officer • Joined September 2014 • Joined April 2011 • Joined Januar
Slide 36: Board of Directors
Board of Directors Scott R. Ward Gary Goetzke Robert M. Graham Richard Carreon Judith Downes Donald A. Williams Amit R. Patel MS, BSc Juris Doctorate AO, FAA, FAHMS, MBBS, MD, Managing Director and BA(Hons), DipEd, BAcy, CPA MBA, BME Non-Executive Director Non-Executive Director FRACP, FACP, FAHA Ch