Slide 1: For personal use only
For personal use only
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 For personal use only general information about the activities of ImpediMed Limited arising in any way (including by way of negligence) from anyone (“ImpediMed”)
Slide 3: Forward Looking Statements
Forward Looking Statements For personal use only • 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’ requirem
Slide 4: Investment Highlights
SOZO Digital Platform Investment Highlights 1 Device, Multiple Applications For personal use only Lymphoedema Highly Disruptive Technology FDA, CE Mark Proprietary Digital Health Platform Heart Failure with Robust Patent Portfolio FDA, CE Mark End Stage Renal Disease** Large and Growing Markets CE M
Slide 5: ImpediMed's Proprietary Technology Directly Measures Fluid in the Body
ImpediMed’s Proprietary Technology Directly Measures Fluid in the Body Using Bioimpedance Spectroscopy (BIS), SOZO non-invasively measures, monitors and manages fluid status and tissue composition For personal use only Inferred Measures of Fluid SOZO Directly Measures Fluid Bioimpedance Spectroscopy
Slide 6: Connected Digital Health Platform
Connected Digital Health Platform Connected Digital Health Platform Key Centres For personal use only • Comprehensive patient data (HIPAA compliant) • Access to information across the care continuum • Manage large patient populations • Integrates seamlessly into hospital, clinical, and home settings
Slide 7: Connected Digital Healthcare Platform Allows Data Access and Sharing
Connected Digital Healthcare Platform Allows Data Access and Sharing For personal use only Test Patients at Any Location and Share Information Across the Entire Healthcare System Cloud Access Scalable Test patients at any location Add and move test locations and immediately review without any additi
Slide 8: Initial Focus on Three Large and Growing Markets
Initial Focus on Three Large and Growing Markets For personal use only Oncology Heart Failure Lymphoedema Fluid Overload Protein Calorie Malnutrition^ Protein Calorie Malnutrition^ Dehydration A$700+ million A$1+ billion Renal Failure Fluid Overload Protein Energy Wasting^ $2.0+ Billion A$300+ milli
Slide 9: Markets with Significant Opportunities
Markets with Significant Opportunities Oncology Heart Failure Renal Failure For personal use only Lymphoedema Fluid Overload Fluid Overload Protein Calorie Malnutrition Protein Calorie Malnutrition Dehydration Chronic disease Long-term patient management High cost of care Large unmet need 9
Slide 10: Markets Significantly Overlap
Markets Significantly Overlap • Cardiovascular disease is the leading cause of death among For personal use only people on dialysis with kidney disease • Dialysis patients experience high rates of mortality, driven largely by an exceptionally high rate of cardiovascular related mortality, which exce
Slide 11: For personal use only
For personal use only
Slide 12: Oncology: Lymphoedema and Protein Calorie Malnutrition
Lymphoedema Oncology Protein Calorie Malnutrition For personal use only Newly Diagnosed Cancer Cases • Currently 1 in 3 at risk cancer survivors will develop secondary lymphoedema 1.8 Million per Year • Lymphoedema costing the US healthcare system ~$7 billion annually • ImpediMed’s PREVENT trial sho
Slide 13: Lymphoedema is a Real and Growing Problem
Lymphoedema is a Real and Growing Problem For personal use only • 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 • Lympho
Slide 14: Lymphoedema Does Not Just Affect Breast Cancer Survivors
Lymphoedema Does Not Just Affect Breast Cancer Survivors Prevalence by Cancer and Treatment For personal use only Melanoma + Irradiation 50% SLNB + Whole Breast & Regional Lymph… 41% Gynecologic + Irradiation 34% ALND + Whole Breast Irradiation 32% Vulvar 30% Gynecologic Misc. 27% ALND for Breast Ca
Slide 15: Current State of Lymphoedema Detection and Treatment
For personal use only Current State of Lymphoedema Detection and Treatment Stages STAGE 0 - Not Visible STAGE 1 - Pitting Oedema STAGE 2 - Irreversible STAGE 3 - Elephantiasis Subclinical Clinical Clinical Clinical Detection Perometry Tape Measure Imaging (Optical Scanner) $7 Billion Annual Cost Tre
Slide 16: Demonstrated Real World Outcomes in Breast Cancer Related Lymphoedema
Demonstrated Real World Outcomes in Breast Cancer Related Lymphoedema 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) For personal use only 80 50 23 • Compelling clinical data 60 -7
Slide 17: Practice-Changing Results – PREVENT Trial Interim Results
Practice-Changing Results – PREVENT Trial Interim Results 12 Month Interim Results Publication: For personal use only 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 • Internat
Slide 18: Reimbursement is the Key to Accelerating Lymphoedema Revenues
Reimbursement is the Key to Accelerating Lymphoedema Revenues For personal use only NCCN Guidelines® Commercial Payors • Joint application by Vanderbilt, LE&RN and the American • Discussions ongoing with National and Regional payors Society of Breast Surgeons Foundation led to the following • Retain
Slide 19: Oncology - Key Takeaways and Next Steps
Oncology - Key Takeaways and Next Steps Key Takeaways Next Steps For personal use only Lymphoedema is a real and growing problem Further supporting evidence for Private Payors and NCCN • Over 15.5 Million cancer survivors in the U.S. • Level 1 evidence for Private Payors and NCCN • 1 in 3 will devel
Slide 20: For personal use only
For personal use only
Slide 21: Heart Failure – A Significant Healthcare Issue
For personal use only Heart Failure – A Significant Healthcare Issue • Global pandemic affecting at least 26 Million people worldwide HF Patients by Classification • HF costs US healthcare system estimated $31 billion annually 6.5 Million Class I • Estimated 6.5 Million Americans live with heart fai
Slide 22: 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 For personal use only Fluid and Heart Failure Current Monitoring Methods • Assessment of fluid burden is critical to the management of Device Method Benefit Shortcomings heart failure patients • Current met
Slide 23: HF-Dex Fluid Analysis for Heart Failure
HF-Dex™ Fluid Analysis for Heart Failure SOZO Heart Failure Patient Output For personal use only • Announced a new software release that includes the HF-Dex™ heart failure assessment for the SOZO Digital Health Platform. The new software also includes an assessment for patients with end stage renal
Slide 24: Heart Failure - Key Takeaways and Next Steps
Heart Failure - Key Takeaways and Next Steps Key Takeaways Next Steps For personal use only • Global pandemic affecting at least 26 million people • First commercial sales worldwide and costing US healthcare system • Obtain real world evidence estimated $31 billion annually • To demonstrate that SOZ
Slide 25: For personal use only
For personal use only
Slide 26: Renal Failure
Renal Failure CE Mark obtained. US Regulatory strategy currently being formulated For personal use only • There are in excess of 450,000 US dialysis patients • Centers for Medicaid and Medicare Services expects >44 million dialysis treatments in 2021 • More than 85% of these treatments will be perfo
Slide 27: Renal Failure Market is Significantly Concentrated
Renal Failure Market is Significantly Concentrated The dialysis market is dominated by two companies: Fresenius and DaVita For personal use only • Concentrated market with Fresenius and DaVita caring for 85% of ESRD patients • Fresenius and DaVita both operate more than 2,500 dialysis clinics each a
Slide 28: SOZO and Dry Weight for Renal Failure
SOZO and Dry Weight for Renal Failure ImpediMed believes SOZO could provide a reliable scientific way of calculating dry weight For personal use only • Fluid is removed during dialysis to return the patient to his or her dry weight by the end of the treatment. Ideally, the goal is to target a weight
Slide 29: Renal Failure - Key Takeaways and Next Steps
Renal Failure - Key Takeaways and Next Steps Key Takeaways Next Steps For personal use only • There are in excess of 450,000 US dialysis patients Announcements regarding: • Centers for Medicaid and Medicare Services • Clinical Strategy expects >44 million dialysis treatments in 2021 • Regulatory Str
Slide 30: Corporate and Financial Overview
CORPORATE ~» _ AND FINANCIAL OVERVIEW TL ee
Slide 31: Corporate Overview
Corporate Overview ImpediMed is a medical software technology company that non-invasively measures, For personal use only monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS) ASX Listed 69 Total Staff Share Register US (San Diego) Private: 63% IPD.AX Austral
Slide 32: Financial Overview – as at September 2020
Financial Overview – as at 30 September 2020 Revenues are predominantly for Lymphoedema only, prior to private pay reimbursement and Heart or Renal Failure revenues Key Takeaways For personal use only • Strong rebound across the entire business, despite COVID-19, driven principally by: o Adding new
Slide 33: Range of Selling Models
Range of Selling Models For personal use only DIRECT CHANNEL _ DISTRIBUTION CHANNEL SOFTWARE-AS-A- HYBRID SaaS SALE RENTAL HYBRID SaaS SALE SERVICE (US Market) (US Market) (Global Clinical Trial Market) (Outside of US Market) • No capital equipment fee, • Capital equipment fee of • Capital equipment
Slide 34: Expected Milestones and Upcoming News Flow
Expected Milestones and Upcoming News Flow Oncology For personal use only • Continued strong growth in SOZO SaaS subscription-based business • The Meta-Analysis has been accepted and is currently pending publication in the coming weeks • Publication of an additional scientific paper assessing the ri
Slide 35: For personal use only
For personal use only
Slide 36: Management Team
Richard Carreon Managing Director and Chief Executive Officer • Joined July 2012 • 30+ years experience Management Team • Extensive experience in the medical device field For personal use only Deep and Broad Commercialisation Experience • and growth companies Previously Vice President at Medtronic (
Slide 37: Board of Directors
Board of Directors For personal use only 37 Scott R. Ward David Anderson Robert M. Graham Richard Carreon Judith Downes Donald A. Williams Amit R. Patel MS, BSc BSc AO, FAA, FAHMS, MBBS, MD, Managing Director and BA(Hons), DipEd, BAcy, CPA MBA, BME Non-Executive Chairman Non-Executive Director FRACP
Slide 38: Glossary
Glossary Glossary of Terms used by IPD For personal use only The total revenue recognised during a given period related to the Medical Revenue medical segment. The amount of revenue reasonably expected to be booked for the Annual Recurring Revenue (ARR) (i) next 12-month period based on existing con