Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (April 2019)
34 slides from Impedimed's investor presentation, Apr 18, 2019
Slide 1: US Investor Presentation
US Investor Presentation ASX:IPD April 2019
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: Investment Highlights
Investment Highlights Connected Digital Health Platform Technology Adoption CY by Quarter 12,000 Large, Attractive, and Growing Markets Amazon Web Services Highly Disruptive Technology 33,000+ 9,000 Patient Tests on File Proprietary Digital Health Platform Significant Body of Clinical Evidence 6,000
Slide 5: Corporate Overview
Corporate Overview • ASX listed (October 2007) • Operations in US (San Diego), Australia (Brisbane) and Europe (Greece) (74 total staff) • Market capitalization ~AU$78M (380M shares on issue) • Cash on hand AU$22.6M (31 December 2018) Share Register Breakdown Substantial Shareholders 19% Allan Gray
Slide 6: Business Model
Business Model Software as a Service (SaaS) Business Model • SOZO devices sold to hospitals and clinics Contracted Revenue Pipeline (CRP) and • SaaS monthly subscription contract per device Annual Recurring Revenue (ARR) for up to 3 years by FY Quarter (in AU$ millions) • Monthly subscription fee ba
Slide 7: Large, Attractive and Growing Markets
Large, Attractive and Growing Markets Newly Diagnosed Cancer Cases Heart Failure Patients by Classification 1.8 Million per Year 6.5 Million Class I Class IV 35% 5% All Others 45% At Risk of Limb Lymphedema Class III 55% 25% Class II 35% $2+ Billion $1+ Billion Annual Addressable Market1 Annual Addr
Slide 8: Fluid balance in the human body
• Up to 60% of the of the human body is made up of water • Fluid balance is critical to a healthy body • Small variations between intracellular and extracellular fluid can have dire consequences • Until now there has not been an easy, fast, accurate and non-invasive way for clinicians to obtain deta
Slide 9: 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 Fluid • Implantables 256 frequencies Fat • Weight High Frequency Current passes through cells M
Slide 10: SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform
SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform • L-Dex® for assessing subclinical unilateral lymphedema • Sensitive detection of small changes in body fluid: FPO • L-Dex for assessing subclinical • Intracellular bilateral lymphedema • Extracellular • Non-invasive measuremen
Slide 11: SOZO for Cancer Survivors
SOZO FOR CANCER SURVIVORS • Over 15.5 million cancer survivors in the U.S. • 1 in 3 will develop lymphedema • More than 5.5 million patients suffering from persistent cancer-related lymphedema • Lymphedema usually presents within first 36 months • Lymphedema is one of the most feared consequences of
Slide 12: Game Changing Technology
Game Changing Technology Annual Cost of Lymphedema L-Dex Reduction in Lymphedema Lymphedema is a leading post-surgical complication for many Data from theCancer PREVENTRelated Lymphedema Trial, the largest randomized cancer patients lymphedema clinical study ~$7 Billion 95% Based on ~1 million cance
Slide 13: Lymphedema is a Consequence of Cancer Treatment
Lymphedema is a 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% Penile
Slide 14: Current State of Lymphedema Detection and Treatment
Current State of Lymphedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected capacity is fluid and protein consistency, limb becomes reduced, setting causing tissue fibrosis very large and the stage for an swelling; pitting causing misshapen, and overload of the e
Slide 15: The Future of Lymphedema Detection and Treatment
The Future of Lymphedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected capacity is fluid and protein consistency, limb becomes reduced, setting causing tissue fibrosis very large and the stage for an swelling; pitting causing misshapen, and overload of the edem
Slide 16: Subclinical Detection of Lymphedema Optimizes Patient Outcomes
Subclinical Detection of Lymphedema Optimizes Patient Outcomes Resolution of Lymphedema based on Stage at the Time of Detection1 Lymphedema Total Stage when Patients Resolved Chronic Detected (N=49) (n=40) (n=9) Subclinical 25 25 0 Stage 1 17 15 2 Simple and inexpensive Stage 2 6 0 6 treatment - a r
Slide 17: 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 18: Clinical Practice Guidelines
L-Dex Already Recommended in Several Clinical Practice Guidelines eviCore Clinical Guidelines for Physical and Occupational Therapy Services 2019 BIS is a validated clinical tool for diagnosing lymphedema Clinical Practice Guidelines 2018 NAPBC follow National Lymphedema Network guidance (including
Slide 19: SOZO Delivers Compelling Healthcare Cost Savings
SOZO Delivers Compelling Healthcare Cost Savings Complicated Lymphedema Costs the Healthcare System ~$120k per patient over 2 years Implementing a prospective model of care for cancer patients has the potential to: • Reduce lymphedema rates by as much as 95% • Reduce the healthcare costs associated
Slide 20: Overview of the PREVENT Randomized Controlled Trial
Overview of the PREVENT Randomized Controlled Trial 12 Month Interim Results Publication: • International, Multi-Institutional Randomized Controlled Trial Annals of Surgical Oncology • Planned enrollment 1,100 patients, 10 medical centers across the United May 3, 2019 States and Australia • Randomiz
Slide 21: Commercialization and Reimbursement Strategy
Commercialization and Reimbursement Strategy Communications Plan Underway Customer Strategy • American Society of Breast Surgeons (ASBrS) • Establish lymphedema prevention • Principal Investigator press interviews programs in the top 500 cancer centers • Podium presentation at key scientific session
Slide 22: SOZO for Heart Failure
SOZO CA NCEFOR HEART R S UR VIVOFAILURE RS • Global pandemic affecting at least 26 million people worldwide • Estimated 6.5 million Americans live with heart failure • 1 in 5 over the age of 40 will develop heart failure • Most common cause of hospitalization of people 65 years and older • About hal
Slide 23: Current Heart Failure Monitoring Methods are Inadequate
Current Heart Failure Monitoring Methods are Inadequate • Current practice is to monitor HF patients daily for fluid burden both in-clinic and at-home • Substantial opportunity to improve on existing monitoring methods Device Method Benefit Shortcomings Inaccurate and Weight Scale Rapid Weight Gain
Slide 24: BIS Offers the Best Option for Managing Heart Failure Patients
BIS Offers the Best Option for Managing Heart Failure Patients 5 papers, including 3 from Aachen University / BIS differentiates between healthy and Philips Technologie GmbH Innovative Technologies unhealthy patients • 242 patients Findings: • Peripheral edema detected with a sensitivity of 100% and
Slide 25: SOZO Non-invasively Monitors Signs of Heart Failure as well as CardioMEMS at a Fraction of the Cost
SOZO Non-invasively Monitors Signs of Heart Failure as well as CardioMEMS at a Fraction of the Cost Case Study • Advanced heart failure patient with implanted CardioMEMS device ™ • Changes made in diuretic medication to keep fluid balance stable ™ • SOZO fluid measurements taken daily Conclusion r =
Slide 26: Early Detection of Fluid Build-up Critical to Reducing Heart Failure Readmissions
Early Detection of Fluid Build-up Critical to Reducing Heart Failure Readmissions Progression to Heart Failure Hospitalization • After a single heart failure hospitalization • Nearly 25% of patients are readmitted in 30 days1 ImpediMed Focus • Nearly 50% of patients are readmitted in 6 months1 • Med
Slide 27: US Heart Failure Business Model
US Heart Failure Business Model Initial Focus on Class III HF Patients • Estimated at 25% of US 6.5 million HF patients • Monitor and manage the disease progression for Class III patients Preliminary Estimate of Initial US Addressable Market SOZO HF Usage Model Estimated initial patient population ~
Slide 28: Heart Failure Action Plan
Heart Failure Action Plan SOZO Regulatory Milestones • CE Mark achieved June 2017 • FDA 510(k) clearance for fluid monitoring of patients living with HF achieved December 2017 Clinical Data for Widespread Adoption • Working with world leading institutions on HF trials • First data presented at 23rd
Slide 29: Connected Digital Health Platform
Connected Digital Health Platform Key Centers Cloud Connected Digital Health Platform • Comprehensive patient data • Access to information across the care continuum • Manage large patient populations • Integrates seamlessly into hospital, clinical, and home settings Home Based Hospital • Growing dat
Slide 30: Opportunities for Growth
Opportunities for Growth Traditional FDA Submissions Lymphedema Heart Failure Real World Evidence for FDA Submissions Malnutrition Bone Density Dehydration Renal Failure R&D Clinical FDA Submission FDA Cleared Commercial • Large markets where detailed fluid and tissue analysis are critical to improv
Slide 31: Expected Milestones and Upcoming News Flow
Expected Milestones and Upcoming News Flow • Continued strong growth in SOZO SaaS subscription based business • PREVENT Trial interim results presented at American Society of Breast Surgeons (May 3, 2019) • PREVENT national educational seminars • PREVENT Trial — additional publications • NCCN Guidel
Slide 32: Appendix
Annual General October 2018 Meeting Appendix 32
Slide 33: 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 34: 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 Non-Executive Director BAcy, CPA MBA, BME Non-Executive Director Non-Executive Director FRACP, FACP, F