IMPEDIMED LIMITED — Investor Presentation 2017

Mar 26, 2017

Investor Presentation ASX:IPD March 2017

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Disclaimer

• 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 only for use in countries in which it has received regulatory approval. 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 may contain references to products that have not been granted regulatory approval in your country. You should consult your health professional for detailed information regarding ImpediMed’s products and their suitability for you, as well as the regulatory approval 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.

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Forward Looking Statements

• Certain statements in this presentation may constitute forward-looking statements or 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 timing of the launch of the next generation product, the ability of the new features to broaden the appeal of the product, and the ability of any new product to meet the needs of the customer base, among others. These statements are subject to risks and uncertainties that are difficult to predict and are based on 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 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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Investment Summary

Proven, Proprietary Technology, IPD’s Bioimpedance Spectroscopy (BIS)

• Provides a simple, accurate, non-invasive system for precisely measuring and monitoring tissue composition and fluid status

Next Generation Platform Technology

• SOZO™ is the world’s first connected health platform using patented BIS technology; enabling early detection and better management of chronic disease in both clinic and at-home settings

• Obtain CE Marks in Q3 CY2017 and submit for FDA 510(k) clearances in Q3 CY2017

• Approvals and / or clearances will cover all uses of SOZO™ (lymphoedema, CHF, fluid monitoring, etc.)

Commercial rollout of L-Dex[®] for early detection of lymphoedema tracking well

• Strong clinical endorsement

• 72 leading US cancer centres already adopted

• • 12 of 27 NCCN Member Institutions now using L-Dex [®]

• US Medicare reimbursement in place

• CPT® Category I code

• US$127 per patient assessment*

• First data from post-approval trial anticipated in 2017, expected to drive private payor coverage and broader uptake

• Poised for strong acceleration in sales

Rapid progress in Chronic Heart Failure (CHF)

• A significant and compelling market opportunity

• Partnering with major institutions - Harvard, Mayo Clinic, Lancaster General, Atlantic Health, and Scripps Health

• Reimbursement pathway - a reimbursement code has been established to pay providers to manage patients remotely

• On track for EU and US regulatory approval / clearance CY2017

Strong IP position

• Over 250 patents and patents pending

• Requires engagement with local Medicare Administrative Contractors if and when necessary

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Corporate Overview

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ASX listed (October 2007) Management Change July 2012 S&P/ASX 300 – added March 2015

• Operations in US (San Diego, CA and Bloomington, MN), Australia (Brisbane) and Europe (Greece) (79 staff)

Market capitalisation ~AU$266M (~375M shares on issue)

Cash on hand AU$73.2M (31 December 2016)

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SHARE REGISTER BREAKDOWN
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SHARE PRICE PERFORMANCE
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SUBSTANTIAL SHAREHOLDERS
Allan Gray	15.0%
Fidelity (FIL)	8.3%
Starfish Ventures	6.8%
Kinetic Investment Partners	5.2%
Paradice Investment Management	5.0%

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Bioimpedance Spectroscopy (BIS) Technology

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BIS Technology
Low Frequency
Fluid
Unique Spectra
Fat
Current passes around cells
High Frequency
Muscle
256 Frequencies
Bone
Current passes through cells
Impedance
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Advantages

• Simple and sophisticated method for measuring fluid and tissue composition

• Rapid, non-invasive and highly accurate

• IPD’s full frequency spectrum approach provides the most accurate information available about each of the fluid compartments of the body

• With accurate determination of each fluid compartment based on individual measurements, there is no need for the general, population-specific regression algorithms used by BIA devices

• IPD devices used worldwide to measure fluid and body composition for various disease states in clinical studies (AstraZeneca, Philips, Kaiser Permanente, University of Alabama, etc.)

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Simple and Sophisticated Tool for Chronic Disease Management

Game Changing Technology

• Uniquely simple for easy patient and clinician use:

• Reduces testing time from tens of minutes to mere seconds

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• No need for an examination room

• No gel backed electrodes

• No need for a patient to be lying down

• Does not require a highly trained clinician to administer test

• Easily integrates with patients’ electronic health records (EHR)

• Cloud based, HIPAA security compliant

• Opens up the large and fast growing at-home patient monitoring market

Additional Enhancements

• Combines all our technology/products into a single platform

• 4 channels to automate complete data collection

• Measures both sides of the whole body for a more accurate set of results

• Segmental measurements for more detailed analysis

Numerous Opportunities

• Clinicians/institutions regularly inquiring about SOZO™ for a variety of potential uses in disease states where measuring fluid is critical

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Cancer Survivors

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L-Dex[®] for the Early Detection of Lymphoedema

Lymphoedema is a leading post-surgical complication for many breast cancer patients and greatly impacts quality of life Simple and accurate measurement of fluid in limbs allows early detection and intervention

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• Cancer treatment can damage the lymphatic system and result in fluid buildup in the extremities

• It can become an irreversible, life-long, debilitating condition that progressively gets worse

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• L-Dex[®] detects the onset of lymphoedema very early, ~35 ml of fluid build up versus 200 ml+ for other approaches

• L-Dex [®] , via SOZO™, is designed to be used both clinically and by patients athome

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• If detected early, the progression of lymphoedema can be prevented, and often reversed

SOZO™ is not yet approved, cleared or registered for sale

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Commercialisation
of L-Dex [®]
Accelerating
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Successful Targeted Launch to Major US Cancer Centres

• 72 multi-disciplinary cancer centres utilising L-Dex [®] in their high risk breast cancer programs

• Integrating L-Dex [®] into clinical work flow practices and systems

Clear Drivers for Accelerating Growth

• Reimbursement increase effective 1 January 2017

• Expecting to double customer base in top tier cancer centres during CY2017

• Continuing to add NCCN alliance cancer centres

• Clinical data generated globally to drive awareness and uptake

• Clinical data will drive private payors to begin to cover

• Commence at-home patient monitoring

• Expand to all cancer related lymphoedema patients in top tier cancer centres

• Apply to NCCN for inclusion of our technology (BIS) in cancer guidelines

Introduction of SOZO™ Expected to be Strong Driver of Acceleration of Sales (testing takes seconds vs tens of minute)

• Subscription revenue model

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Lymphoedema Post Approval Trial to Drive Private Payors

Post Approval Trial Data Drives Private Payors Enabling Broad Adoption by Cancer Centres

IPD’s Post Approval Trial is Nearing Full Enrolment

• 1,100 patient trial with 3 years follow-up

• ~875 patients enrolled to date

• Full enrolment expected later CY2017

• First data expected 2H CY2017

Top-Tier Centres are Participating in the Trial

• Columbia now the fifth top-50 cancer centre

• Three NCCN institutions participating in trial

Two Major Centres Conducting At-Home Patient Trials with SOZO™

• Vanderbilt, 50 patients followed for 12 months begins Q2 2017

• Macquarie, 30 patients followed for 12 months begins Q2 2017

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Patient Enrolment

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Chronic Heart Failure

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Chronic Heart Failure Large and Compelling Opportunity

Chronic Heart Failure (CHF)

• Is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen

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CHF is Among the Most Expensive Diseases for Medicare

  - Estimated 5.7 million people in the US suffer from heart failure

  - 870,000 newly diagnosed cases per year

• The heart tries to make up for this by:

• Enlarging - When your heart chamber enlarges, it stretches more and can contract more strongly, so it pumps more blood. With an enlarged heart, your body starts to retain fluid, your lungs get congested with fluid and your heart begins to beat irregularly.

• Developing More Muscle Mass - The increase in muscle mass occurs because the contracting cells of the heart get bigger. This lets the heart pump more strongly, at least initially.

• Pumping Faster - This helps to increase the heart's output.

• Heart failure costs the US an estimated US$31 billion each year

• By 2030 these costs are expected to increase to US$70 billion

• 80% of these costs are spent on hospitalisation

• Length of stay and readmissions have become major issues

“If this (BIS) technology has the ability to measure alterations in fluid levels accurately over time, it has the potential to significantly improve the delivery of care for heart failure patients.”

-Dr. Roy Small

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Strong Economic Drivers (Incentives and Penalties) for Improved CHF Patient Management

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Chronic Care Quality Measures

• Key Centers for Medicare and Medicaid Services (CMS) chronic care quality measurement programs includes Physician Quality Reporting System (PQRS): Provides incentives (0.5-2% bonus) to physicians and group practices.

• Chronic care measures include:

• Diabetes

• Heart failure

• Coronary artery disease

• Stroke management

• COPD and asthma management

Hospital Readmission Reduction Plan (HRRP)

• Relative measures - hospitals need to outperform against their peers

• HRRP penalises hospitals with relatively higher readmission rates for Medicare patients

• Penalties are a reduction in payment of up to 3% for every Medicare patient for 12 months

• Readmission is to any hospital for any reason (“all causes”) within 30 days

• Current focus on:

• Heart attack

• Heart failure

• COPD

• Hip or knee replacements

44% of eligible providers earned an incentive in 2014, totalling $224 million

86% of the 9.5 million Medicare Readmissions resulted in penalties in 2014, totalling $420 million

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Current Heart Failure Monitoring Methods Inaccurate or Invasive and Expensive

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• Assessment of fluid burden is critical to the management of CHF patients

• Current practice is to monitor CHF patients daily for fluid burden in both in-clinic and at-home

• Current monitoring methods have major shortcomings

  • Weight Scale - inaccurate, unable to distinguish fluid increase from fat or muscle weight gain

  • Implantables - invasive and expensive $25k+

• Compelling clinical evidence and support for the role of BIS in monitoring fluid burden in CHF patients

	Device	Method	Measurement	Brought on by	Shortcomings
Weight Scale		Weight gain	2 kilograms gained in 2 days	Fluid burden	Inaccurate and rudimentary
Implantables		Intrathoracic Impedance	Resistance	Fluid burden	Invasive Suitable for only small sub-set of patients
		PA Waveforms	Cardiac Filling Pressure	Fluid burden	Invasive and very expensive

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Role of our BIS (SOZO™) in Optimising Outcomes for CHF Patients

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• Class III/IV HF patients account for the majority of the annual HF readmission

• Reducing readmissions has a profound impact on the cost of care

• Our BIS technology (SOZO™) targeted to be used as a highly effective and low cost early warning system to optimise patient care and significantly reduce hospital readmissions

• Objective is to have the precision/accuracy of implantable, but delivered at the cost of a scale

“BIS can detect and follow the changes in lung impedance in patients and is sensitive to extracellular volume. Since most patients with acute HF suffer not only from pulmonary edema but also from edema in the limbs, a combination of different segmental BIS measurements offers the best option to manage the course of disease.” - Weyer 2014

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CHF Trial Focus
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Heart Failure Hospitalisation
CardioMEMS™ OptiVol™
Weight Scales
Implantable Implantable
pulmonary artery cardiac lead for
pressure monitor Medtronic
defibrillators
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Heart Failure Program Making Rapid Progress Towards Commercialisation in EU and US

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SOZO[TM] Regulatory Preparations

• Passed quality, safety and accuracy testing for notified bodies

• Cybersecurity assessment and testing underway

• Submitting for SOZO[TM] FDA 510(k) clearance and obtaining CE Mark by Q3 CY2017

Clinical Data for Marketing Purposes

• A number of smaller short trials getting underway with leading CHF institutions beginning in Q2 CY2017

• Scripps Health, up to 30 patients followed for 30 days

• The Mayo Clinic, Lancaster General, and Atlantic Health, 30 patients followed for 30 days

• European trial, 30 patients followed for 30 days

• Larger Clinical Trial planned for 2H CY2017

• Randomised Trial ~400 patients followed for 90 days

Favourable Reimbursement and Guidelines Regime

• Reimbursement code established to pay providers to remotely manage patients

• Current guidelines in place for daily monitoring of class III patients for fluid burden in US

Commercialisation – US and EU

• Targeting US and EU commercial launch CY2017 (subject to regulatory clearance / approval)

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CHF Business Model

Anticipated CHF Business Model

• Initial focus on Class III CHF patients

• Estimated at 25% of US 5.7 million CHF patients

• Monitor and manage the disease progression for Class III patients

• Initially establish SOZO[TM] CHF program in key clinics

• Baseline reading to be performed in a clinical setting

• Daily monitoring to continue in either a clinical or remote setting

• Revenue Model - Initial device purchase plus a per patient per month subscription model

• Well established and growing in CHF market

• Philips

• Medtronic

• Abbott (formally St. Jude Medical)

Preliminary Estimate of US Addressable Market	Preliminary Estimate of US Addressable Market
Estimated Initial Patient Population	~ 1.4 Million
Preliminary Estimated Addressable Per Annum US Market • Based on $60 per patient per month over 12 months	> US$1.0 Billion*

• *Excludes revenue from initial device sales

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Expected News Flow

Next 12 Months

L-Dex[®] adoption and revenue growth

• CE Mark and FDA clearance for SOZO™

• First data from post-approval trial

• Private payors to begin coverage of L-Dex [®] enabling broad adoption

• Double customer base across top tier cancer centres

• Expand L-Dex [®] business into patients’ homes

SOZO™ CHF coming to market 2H CY2017

• CE Mark and FDA clearance for SOZO™

• Completion and reporting of various smaller trials (Scripps and Mayo/ Lancaster/Atlantic Health)

• Full enrolment and completion of larger scale marketing trial

• CHF commercial launch in US and EU

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Appendix

Management Team Has Deep and Broad Commercialisation Experience

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Richard Carreon

Managing Director and Chief Executive Officer

• Joined July 2012

• 30+ years experience

• Extensive experience in the medical device field and growth companies

• Previously Vice President at Medtronic (10 years)

Frank Vicini, MD Chief Medical Officer

• Joined September 2014

• 25+ years as radiation oncologist

• Completed his fellowship at Harvard Medical School, has authored over 200 peer reviewed publications, and participated in 6 NIH clinical trials and the MammoSite Registry trial

Morten Vigeland Chief Financial Officer

• Joined April 2011

• 15+ years in financial management in the medical technology industry

• Experience in med-tech start-ups and emerging growth companies

Dennis Schlaht SVP Quality, R&D and Technology

Ann Holder Catherine Kingsford SVP General SVP Medical Affairs Management and Operations • Joined January 2007

David Adams

SVP Ventures, Licensing & Corporate Development

• Development and Operations • Joined January 2007 • 20+ years global •

• • On Board November • Joined July 2015 clinical experience with • 2013 to August 2016 • 20+ years experience medical devices

• • Joined August 2016 • Extensive experience • Previously worked as a • Background as medical in the medical device cardiac scientist at device investment & field with focus on the several world-class • business development cardiovascular space medical institutions executive • Previously at including St. Andrew's

• • 25+ years experience Medtronic with several War Memorial Hospital, in tax, financial years in the Cardiac The Prince Charles planning, and business and Vascular Group Hospital, and Royal development more recently at the Brompton Hospital

• • Previously Vice corporate level focused President, Integrations on building new and Divestitures at solutions Medtronic for disease management

Joined October 2007 30+ years in engineering development and product marketing Previously Vice President of Marketing and Product Development at XiTRON’s Test and Measurement Business

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Board of Directors

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Cherrell Hirst AO FTSE, MBBS, BEdSt, D.Univ (Hon), FAICD Non-Executive Chairman

Gary Goetzke Juris Doctorate Non-Executive Director

Scott R. Ward MS, BSc Non-Executive Director

• Joined August 2016

  • Joined July 2013

• On Board since 2005

• • 15+ years in senior • Venture capitalist with

• • Appointed Nonmanagement positions 30+ years experience in Executive Chairman in with medical device healthcare industry Nov 2011 companies •

• companies • Previously Senior Vice

• • Currently the Principle President and President and Chief Executive of the Cardiovascular Officer of Compass business of Medtronic Medical Advisors, LLC • Chairman of the Board

• Leading medical practitioner in breast cancer screening/diagnosis

• Chairman of the Board of Creganna-Tactx Medical Devices and Cardiovascular Systems, Inc.

• Currently Chairman of Tissue Therapies Ltd and Non-Executive Director of Medibank Private Ltd

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Richard Carreon Managing Director and Chief Executive Officer

• See previous slide

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Donald A. Williams BAcy, CPA Non-Executive Director

• Joined March 2017

• 35+ years in leadership roles serving the life science, biotech, and medical device industries

• Currently the Audit Committee Chair of Akari Therapeutics, Alphatec Holdings, Marina Biotech, and Proove Biosciences, and the Compensation Committee for Marina Biotech

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Amit R. Patel MBA, BME Non-Executive Director

• Joined March 2017

• • 8+ years in senior management positions

• • Currently the board of Vios Medical and Pillsbury United Communities

• Currently the CEO and Co-Founder of Vios Medical

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World

Renowned Medical

Advisory Board from Leading US CHF Institutions

US Advisory Board Members and Clinical Research Team

Paul Friedman, MD - Vice Chair, Department of Cardiovascular Medicine, Medical Director, Remote Monitoring, Mayo Clinic

Roy Small, MD FACC, FSCAI - Medical Director of Clinical Research, Lancaster General Hospital

J. Thomas Heywood, MD - Director, Heart Failure Recovery and Research Program, Scripps Health

Andrew Accardi, MD - Chairman of Emergency Medicine, Scripps Memorial Hospital Encinitas

Laura Mauri, MD, MSc - Chief Scientific Advisor, Harvard Clinical Research Institute; Recognised leader in the use of statistical methods in clinical

European Advisory Board Members

Professor Gerasimos Filippatos, MD, FESC, FACC - Head of the Heart Failure Unit at Athens University Hospital Attikon, Greece. Current President of European Society of Cardiology - Heart Failure (ESC-HF)

Marco Metra, MD - Professor of Cardiology at University of Brescia, Italy

Professor Stefan Anker, MD, PhD - Professor of Innovative Clinical Trials at U Medical Center Gottingen, Germany

Professor Piotr Ponikowski, MD, PhD - Head of Cardiology Department, Medical University Wroclaw Poland

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Financials YTD

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CASH BALANCE (000’s)
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MARKET CAP (millions)
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$2,000 $74,000 $400
$1,500 $55,500 $300
$1,000 $37,000 $200
$500 $18,500 $100
$‐ $‐ $0
FY12 FY13 FY14 FY15 FY16 FY17 FY12 FY13 FY14 FY15 FY16 FY17 FY12 FY13 FY14 FY15 FY16 FY17
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