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IMPEDIMED LIMITED Investor Presentation 2021

Oct 20, 2021

65135_rns_2021-10-20_8569d92e-a02e-484d-b199-d8e015f74247.pdf

Investor Presentation

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INVESTOR PRESENTATION

OCTOBER 2021

SOZO[®] Digital Health Platform

Technology Transformation Adoption Affirmation Growth

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Disclaimer

Forward Looking Statements

  • The material contained in this document is a presentation of general information about the activities of ImpediMed Limited (“ImpediMed”) current as at the date of this presentation. The information is provided in a summary form, does not purport to be complete and should not be relied upon as advice for investment purposes. This presentation does not take into account the investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.

  • SOZO[®] is intended for use in countries in which it has received or only regulatory approval

  • clearance. Inclusion of products and information does not imply any official medical advice, recommendation or warranty. The information provided is not a substitute for the advice of an appropriate health professional. This website can be accessed from countries around the world and contain references to that have not been may products granted regulatory approval

  • or clearance in You should consult health for detailed your country. your professional

  • information regarding ImpediMed’s products and their suitability for you, as well as the regulatory approval or clearance status of such products in your country.

  • To the extent permitted by law, no responsibility for any loss arising in any way (including by way of negligence) from anyone acting or refraining to act as a result of this presentation or its contents is accepted by ImpediMed or any of its officers, employees or agents.

  • The information in this presentation is subject to change and unless required by law, ImpediMed assumes no obligation to update this presentation or its contents for any matter arising or coming to ImpediMed’s notice after the date of this presentation.

  • Certain statements in this constitute statements or presentation may forward-looking

  • statements about future matters that are based on management’s current expectations and beliefs. The forward-looking statements in this release include statements regarding the next generation product, the ability of the new features to broaden the appeal of the product, and the ability of new product to meet the needs of the customer base, among others. These statements are to risks and uncertainties that are difficult to and are based on subject predict

  • assumptions as to future events that may not prove accurate. Actual results may differ materially from what is expressed in this presentation.

There can be no assurance that any existing or future regulatory filings will satisfy the relevant authorities’ requirements regarding SOZO nor can there be any assurance that SOZO will be approved or cleared for all applications by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding ImpediMed’s ability to commercialise SOZO, including its estimates of potential revenues, costs, profitability and financial performance could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; its ability to maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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Our Transformation

Medical Device

Connected Di ital Health Platform g

U400 BIS Device

Cancer Population[^]

U400

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  • ~20 Minute Test

  • Trained Nurse/Therapist

  • Standalone Device

  • Gel Backed Electrodes

  • Manual Data Download

  • Single Application

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SOZO Platform

SOZO[®]

Cancer Population[^]

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  • Less than 30 Second Test

  • Medical Assistant

  • Connected Device

  • Cloud-based SaaS* Pricing Model

  • On Device, Online or via EHR**

  • Multiple Applications

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  • SaaS = Software-as-a-Service

  • ** EHR = Electronic Health Records

  • ^ The bubbles depicting Cancer Population sizes is for illustrative purposes only and not reflective of actual market sizes. 1. Bone analysis and FDA clearance is in development.

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ImpediMed’s Technology

.

Using Bioimpedance Spectroscopy (BIS), SOZO non-invasively measures, monitors and manages fluid status and tissue composition

Inferred Measures of Fluid

SOZO Directly Measures Fluid

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Imaging
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Implantables

Weight

Volume

Observation

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Bioimpedance Spectroscopy (BIS)
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Low Frequency
Current passes
around cells
Fluid
256 frequencies
Fat
High Frequency
Current passes
through cells
Muscle
Bone
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Comprehensive Data

SOZO[®] measures and tracks critical patient data

  • L-Dex[®] lymphoedema index

  • Total body water

  • Extracellular fluid

  • Intracellular fluid

  • Skeletal muscle mass

  • Fat mass

  • Fat-free mass

  • HF-Dex[TM] heart failure index

  • Protein and minerals

  • Basal metabolic rate

  • Phase angle

  • Body mass index

  • Segmental analysis

  • Hy-Dex[®] hydration analysis[1]

  • Hy-Dex[®] hydration analysis is only intended for use with healthy individuals.

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Connected Digital Health Platform

Test patients at any location and allows data access and sharing across the entire healthcare system

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Cloud

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Access Test patients at any location and immediately review results online

Trends Track trends in patient data for actionable results

Scalable

Add and move test locations without any additional software setup

Secure

Control who accesses the SOZO network and establish unique security settings

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SOZO[®] Digital Health Platform

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1 Device, Multiple Applications
Lymphoedema
FDA Clearance, CE Mark
Heart Failure
FDA Clearance, CE Mark
End Stage Renal Disease
CE Mark
Protein Calorie Malnutrition
FDA Clearance, CE Mark
Body Composition
FDA Clearance, CE Mark
^
Bone Density
^^
Venus Insufficiency
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  • Refer to Appendix for a Glossary of terms used

  • ** kidneyfund.org: Kidney failure is the last and most severe stage of chronic kidney disease and is also referred to as End-Stage Renal Disease (ESRD) ^ Algorithm has been developed and preliminary discussions have been held with FDA

^^ Proof of concept studies undertaken; no regulatory applications submitted to date

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Platform Technology, Transforming Care: Initial Focus on Three Large Addressable Markets

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Oncology
Heart Failure
Lymphoedema
Fluid Overload
Protein Calorie Malnutrition^
Protein Calorie Malnutrition^
Dehydration
A$700+ million
A$1+ billion
Renal Failure
Fluid Overload
$2.0+ Billion Protein Energy Wasting^
A$300+ million
Annual Addressable Market
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^In Renal Failure, the terms Protein Calorie Malnutrition (PCM) and Protein Energy Wasting are often used interchangeably. ImpediMed most commonly refers to this disease state as PCM

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Markets Significantly Overlap

  • Cardiovascular disease is the leading cause of death among people on dialysis with kidney disease

  • Dialysis patients experience high rates of mortality, driven largely by an exceptionally high rate of cardiovascular related mortality

  • Common for people with chronic kidney disease or end stage renal failure to develop heart disease

  • Heart failure leads to a 11.4x greater risk for end stage renal failure

  • Protein calorie malnutrition or protein energy wasting is common in patients with chronic kidney disease and is one of the strongest predictors of patient mortality

  • Cardiovascular disease is the predominant cause of death in breast cancer patients aged over 50

  • The risk of death from heart disease in cancer patients is 2.24x that of the general population

Heart Oncology Failure Renal Failure

  • Protein calorie malnutrition is the most common

  • secondary diagnosis in cancer patients affecting more than 50% of patients with certain cancers

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Strong Adoption, Validated Technology

770+ SOZO Devices in Core Business

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375+ SOZO Devices in Clinical Business 2 international drug studies involving 375+ sites in 28 countries evaluating fluid volumes (heart failure & renal failure patients)

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Q4 FY 2021 SOZO[®] Revenue and Patient Tests

$10m+ Annual Revenue Run Rate $2.3m SOZO Revenue +109% YOY ✓ RECORD QUARTER

37,000+ Patient Tests +109% YOY ✓ RECORD QUARTER

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SOZO Revenue Patient Tests To-Date
(Excluding Legacy) (261,000+ on File)
$2,300,000 38,000
30,400
$1,725,000
22,800
$1,150,000
15,200
$575,000
7,600
COVID-19 COVID-19
$- '-
Patient Tests
SaaS^ Device and Contract Fees
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^The values shown are for SaaS Revenue are across all lines of business, including the Core Business and Clinical Business.

All figures are stated in Australian dollars (AUD) unless otherwise notated.

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Oncology

  • 1.8m newly diagnosed cancer cases per year in the US

  • 1 in 3 at risk cancer survivors will develop secondary lymphoedema

  • Lymphoedema costs the US healthcare system ~$7 bn p.a.

30 - 85% at risk of 55% at risk of Protein Calorie Lymphoedema Malnutrition (PCM)

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$1.4 Billion Annual Addressable Market[1]

Stage 2 - Irreversible

Stage 1 – Pitting Edema

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Stage 3 - Elephantiasis
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  • ImpediMed’s PREVENT trial showed 92% of patients with early detection of cancer-related lymphoedema using L-Dex and intervention did not progress to chronic lymphoedema

  • Protein Calorie Malnutrition is the most common secondary diagnosis in cancer patients, affecting more than 50% of patients with certain cancers

  • ImpediMed is the first and only company with an FDA Clearance for Protein Calorie Malnutrition

1 Assumes: 17 lymphoedema tests as per Lymphoedema Prevention Program protocol and 7 PCM checks at $50

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PREVENT Trial Successful, Statistically Significant

Key to a significant acceleration of near-term results

Consistent Reduction in Lymphoedema Progression Study after Study

  • PREVENT Trial met primary end point and reached statistical significance

  • Results demonstrate that BIS screening should be a standard approach for prospective breast cancer-related lymphoedema (BCRL) surveillance

  • In patients with early detection using L-Dex, intervention resulted in a 7.9% rate of chronic lymphoedema compared to a 19.2% rate of chronic lymphoedema in patients with early detection using tape measure (p=0.016)

  • This level I evidence is key to reimbursement and establishing L-Dex as standard of care

About PREVENT:

  • PREVENT results published on medRxiv.org in October 2021

  • Peer-review publication expected in coming months

  • Largest randomised trial for detection of subclinical lymphoedema

  • 1,200 patients followed for up to 3 Years

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  • 10 US and International centres across 13 sites, including Vanderbilt University, Mayo Clinic and MD Anderson

PREVENT Trial: Ridner SH, et al. A Randomized Clinical Trial of Bioimpedance Spectroscopy or Tape Measurement Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. medRxiv.org 2021; https://www.medrxiv.org/content/10.1101/2021.10.12.21264773v1. Breast Care Specialists: Kaufman DI, et al. Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema. Breast Can Res Treat. 2017;DOI 10.1007/s10549-017-4451-x. Macquarie University: Koelmeyer LA, et al. Early surveillance is associated with less incidence and severity of breast cancer-related lymphedema compared with a traditional referral model of care. Cancer 2018;DOI: 10.1002/cncr.31873. Nashville Breast Center: Whitworth PW and Cooper A. Reducing chronic breast cancer-related lymphedema utilizing a program of prospective surveillance with bioimpedance spectroscopy. Breast J. 2017;1-4. Texas Breast Specialists: Laidley A and Anglin B. The impact of L-Dex measurements in assessing breast cancer-related lymphedema as part of routine clinical practice. Frontiers in Oncology 2016;6(192). University of Kansas: Kilgore L, at al. Reducing breast cancer-related lymphedema (BCRL) through prospective surveillance monitoring using bioimpedance spectroscopy (BIS) and patient direction self-interventions. Ann Surg Oncol 2018;http://doi.org/10.1245/s10434-018-6601-8. UPMC: Soran A, et al. The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study. Lymph Res Bio. 2014;12(4):289-94.

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Growth Drivers: Reimbursement & NCCN Guidelines[®]

Reimbursement

NCCN[®]

  • PREVENT randomised control trial the key to reimbursement and accelerating growth

  • PREVENT delivers clear path to reimbursement

  • NCCN Submission upon PREVENT publication

  • Current NCCN submission covering the Meta-Analysis and Radiation Paper data is being evaluated

  • IPD Case Assistance Program:

  • Current Guidelines

  • Won 298 cases of 307 with commercial payors

  • Lymphoedema is a potential side effect after surgery

  • Equates to 97% of all cases won to date with target payors

  • Early detection is key for optimal management

  • 1,300+ active cases

  • Consider pre-treatment baseline measurements

  • Standard Medicare rate:

    • Majority of clinicians still using tape measure to comply
  • $146 per SOZO[®] test

  • Facilities are receiving increased payments through recently obtained Medicare Advantage:

  • $174 - $222 per SOZO[®] test

  • Payor advisory board to convene in the coming weeks to chart path forward

  • Meta-Analysis and the Radiation Paper data show volumetric measurements, such as tape measure, aren’t as effective as ImpediMed’s BIS L-Dex[®] measurements

  • PREVENT removes any sense of ambiguity regarding the comparison of BIS to a tape measure. Statistically and clinically significant evidence that BIS makes an important contribution in preventing lymphoedema

  • BIS L-Dex being specified in NCCN Guidelines would significantly accelerate adoption

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Heart Failure

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HF Patients by Classification
6.5 Million
Class I
Class IV
35%
5%
Class III
25%
Class II
35%
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  • Affecting at least 26 million people worldwide

  • Costs US healthcare system estimated $31 billion annually

  • Estimated 6.5 million Americans live with heart failure

  • 1 in 5 people over the age of 40 will develop heart failure

  • Most common cause of hospitalisation of people 65 years and older

  • About half of people who develop heart failure die within five years

  • After a single heart failure hospitalisation:

  • Above 20% of patients are readmitted within 30 days

  • o Nearly 50% are readmitted in six months

$700+ Million

Annual Addressable Market[1]

1 Assumes: Hospital and follow-up testing at $30 per test with home testing for class III and IV patients for 30 days at $15 per day

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HF-Dex™Fluid Analysis for Heart Failure

SOZO[®] Heart Failure Patient Output

  • Assessment of fluid burden is critical to the management of Heart Failure patients

  • Current methods of determining fluid levels are either inaccurate or invasive and expensive

  • SOZO gives clinicians an objective measure of fluid volume

  • Ongoing detection of fluid build up is critical to reducing hospital readmissions

  • HF Patients with HF-Dex over 51% at time of discharge are 4.25x more likely to be readmitted[1]

  • SOZO technology adopted by AstraZeneca to measure fluid outcomes in heart failure patients with chronic kidney disease

  • Recent Advocate Aurora Health contract sets the stage for demonstrating reimbursement and establishing the commercial model

1 Daleiden-Burns A, Accardi AJ, and Heywood JT, Bioimpedance spectroscopy measurement of ongoing fluid overload post-discharge from hospitalization for decompensated heart failure. Journal of the American College of Cardiology 2021. 77(18_Supplement_1):798.

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Renal Failure

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CE Mark obtained, US Regulatory strategy currently being formulated

  • There are in excess of 450,000 US dialysis patients receiving treatment three times a week for about four hours

  • Unhealthy kidneys are no longer properly removing wastes and extra fluid from the body

  • Centers for Medicaid and Medicare Services expects >44 million dialysis treatments in 2021 accounting for 1% of the Medicare population but 7% of the Medicare budget

Renal Failure Fluid Overload Protein Energy Wasting

  • More than 85% of these treatments will be performed in dialysis centres

  • Protein calorie malnutrition or protein energy wasting, is common in patients with chronic kidney disease and is one of the strongest predictors of patient mortality

  • SOZO[® ] technology adopted by AstraZeneca to measure fluid outcomes in heart failure patients with chronic kidney disease

$300+ Million Annual Addressable Market[1]

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1 ESRD and PCM testing at $2.50 per test

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Renal Failure Market: Attractive Market Dynamics

  • Very attractive concentrated market

  • Two companies caring for 85% of ESRD patients

  • Both operate more than 2,500 dialysis clinics each and together treat in excess of 400,000 ESRD patients

  • ImpediMed received FDA Breakthrough Designation for SOZO[®] for a proposed indication in a renal patient population

  • Currently finalising clinical and regulatory strategies

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SOZO[®] and Dry Weight for Renal Failure

  • ImpediMed believes SOZO can provide a reliable scientific way of calculating dry weight

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Breakthrough Designation

  • ImpediMed received FDA Breakthrough Device Designation for Renal Application

  • To be granted breakthrough designation, you must demonstrate the following:

  • The device provides a more effective treatment or diagnosis of a lifethreatening disease or condition

  • In addition, you must also demonstrate one or more of the following criteria:

  • Represent breakthrough technology

No approved or cleared alternative exists

  • Offer significant advantages over existing approved or cleared alternatives

    • Device availability is in the best interest of patients
  • ImpediMed demonstrated that SOZO meets all 5 of the criteria

Current Practice

  • Current practice in dialysis clinics rely on scales to determine the amount of fluid to remove

  • Scales cannot account for changes in body composition, with muscle loss being prevalent in end-stage renal disease patients

  • The potential for SOZO to address this deficiency was paramount in meeting the criteria for Breakthrough Designation

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Key Highlights and Takeaways

  • Transformation to Connected Digital Health Platform complete

  • $10m annual revenue run rate with strong growth despite COVID-19 headwinds

  • Multiple applications addressing significant health care needs

  • Inflection point, with 3 focus areas set to accelerate adoption:

  • PREVENT driving Lymphoedema and Oncology adoption 2. Heart Failure commercialisation underway 3. Renal Failure accelerated with breakthrough designation

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Contact Details

Investor Relations Mike Bassett [email protected] +61 407 431 432 www.impedimed.com