IMPEDIMED LIMITED — Investor Presentation 2017

Jul 23, 2017

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Investor Presentation ASX:IPD July 2017

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Disclaimer and Forward Looking Statements

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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.

Forward Looking Statement

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 Highlights

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• Connected device for precisely measuring and monitoring tissue composition and fluid status using bioimpedance spectroscopy (BIS) technology for early detection and management of chronic disease (e.g. fluid build up in lymphoedema (L-Dex [®] score), fluid burden for chronic heart failure patients)

• Strong momentum in US adoption of L-Dex[®] for

• lymphoedema

• 100+ Leading US cancer centres on board

• SOZO[TM] FDA 510(k) for lymphoedema submitted July 2017

• Poised for substantial acceleration of L-Dex [®] revenues

SOZO[TM] commercially launched in Australia and Europe

• CE Mark achieved June 2017

• Broad range of applications both in clinic and at-home

• Strong initial enquiry and early sales

Chronic Heart Failure (CHF) being readied for US launch

• Development complete

• Small trials at world leading heart institutions begin Q3 CY2017

• FDA 510(k) submission in Q3/Q4 CY2017

• Significant news flow Commercial – US, AU and Europe sales expansion • expected over next Clinical – various lymphoedema and CHF (internal and 3rd party) six months[[TM]]

• Regulatory – 510(k) clearances for SOZO[[TM]] in the US

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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

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• Operations in US (San Diego, CA and Bloomington, MN), Australia (Brisbane) and Europe (Greece) (76 staff)

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Share Register Breakdown
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2%
20%
78%
Institutional Private Founder/Management
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Substantial Shareholders

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• Market capitalisation ~AU$275M (~375M shares on issue)

• Cash on hand AU$54.9M (30 June 2017)

Allan Gray	15.0%
Fidelity (FIL)	9.3%
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
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• Simple and sophisticated method for measuring fluid and tissue composition

• Rapid, non-invasive

• IPD’s full frequency spectrum (256 frequencies) approach uniquely accurate and specific

• IPD BIS devices used worldwide by major players to measure fluid and body composition in their own various clinical trials (e.g. AstraZeneca, Philips, Kaiser Permanente, University of Alabama, Eiger BioPharmaceuticals)

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SOZO[TM] – ImpediMed’s State of the Art BIS Tool for Chronic Disease Management

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IPD Legacy BIS Measurement Tool (U400)

SOZO[TM] – IPD State of the Art BIS Measurement Tool

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• Ground breaking accuracy from 256 frequencies

• However:

• Cumbersome

• Requires examination room

• Requires highly trained clinician to administer

• Patient has to lie down

• Gel-backed electrodes

• Testing time: tens of minutes

• Manual data entry for Electronic Health Records

• Equivalent or superior accuracy compared with L-Dex [®] U400 and SFB7

• Highly sophisticated device that is uniquely simple for easy patient and clinician use

• Eliminates need for:

• An examination room

• Gel backed electrodes

• Patient to be lying down

• A highly trained clinician to administer test

• Reduces testing time from tens of minutes to mere seconds

• Connected device:

• Ability to track protocol compliance

• Simple expansion with add on software modules for expanded indications

• Add on features within modules for increased functionality

• Access to de-identified datasets allows for real time analyse to refine algorithms and develop other healthcare uses

• Easily integrates with patients’ Electronic Health Records (EHR)

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

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Cancer Survivors

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

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Lymphoedema is a leading post-surgical complication for many 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 build-up in the extremities

• It can become an irreversible, lifelong, debilitating condition that progressively gets worse

• 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™[1] , is designed to be used both clinically and by patients at-home

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

• SOZO™ is not yet approved, cleared or registered for sale in the United States

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US Commercialisation of L-Dex[®] Poised for Sustained Acceleration

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• 100+ major multi-disciplinary cancer centres have incorporated L-Dex[®]

• Currently using IPD’s FDA cleared U400 device

• Purpose is to integrate L-Dex[®] testing into clinical work flow practices and systems in preparation for routine use and adoption once SOZO[TM] is available

• SOZO[TM] FDA 510(k) for lymphoedema submitted July 2017

• Poised for sustained acceleration in L-Dex[®] revenues following SOZO[TM] FDA clearance (expected 4Q CY2017)

• Immediate SOZO[TM] device sales

• Widespread monitoring of cancer patients (reimbursed at US$127 per patient assessment*)

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

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Introduction of Private Payors will Further Drive Acceleration

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Two main drivers of Private Payors are:

1 Global Clinical Trial Data

• IPD’s own 1,100 patient post approval trial

  • Nearly fully enrolled (5 top 50 cancer centres and 3 NCCN institutions are participants in trial)

  • 1st data expected 2H CY2017

• Various independent trials being conducted worldwide

  • E.g. recently reported 6-year, 596-patient trial in Tennessee showing only 3% lymphoedema rates with L-Dex[®] (vs. 7%-36% expected without L-Dex[®] )

• 2 Published Industry Guidelines

• NAPBC accreditation requires survivorship care plan

• Lymphoedema introduced into NCCN guidelines in July 2015

• L-Dex[®] recommended in American Physical Therapy Association Guidelines in July 2017

IPD is building a compelling case for Private Payors to initiate coverage in CY2018

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Chronic Heart Failure

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CHF Overview

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CHF is a chronic, progressive and debilitating condition

Among the most expensive diseases for the US health care system

6.5m+

patients

US$31bn+ hospitalisation costs alone

US government funding Reducing hospital bonuses and assessing stay and readmission penalties for physicians is a major focus and hospitals that over/under perform

Assessing/monitoring fluid status is critical to the management of CHF patients

• A change of fluid status may signal the need to increase/decrease medication levels

• Correct medication levels significantly reduce hospital stays and readmissions

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Role of SOZO™ in Optimising Outcomes for CHF Patient Management

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

• Current monitoring methods have major shortcomings:

• Weight Scale Inaccurate and rudimentary (although low cost – ~US$150 per month) • Implantables Invasive and expensive – ~US$25,000 (although accurate/precise)

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SOZO [TM] is uniquely positioned to replace current
monitoring methods
Precision/accuracy of
...at the cost of a scale
implantables...
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Heart Failure Program Making Rapid Progress Towards Commercialisation in EU and US

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SOZO[TM] Regulatory Preparations

• CE Mark achieved in June 2017

• Submitting for FDA 510(k) clearance for CHF in Q3/Q4 CY2017

Clinical Data for Marketing Purposes

• Working with world leading institutions on CHF trials

• IRB (Ethics) approvals in place for pilot trials

• Sites trained

• Sites open for enrolment

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 – EU and US

• Initial EU commercial launch to commence Q3/A4 CY 2017

• Initial US launch to commence late CY2017 (subject to regulatory clearance / approval)

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CHF Business Model

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Expected CHF Business Model

Initial focus on Class III CHF patients

Preliminary Estimate of Initial US Addressable Market

• Estimated at 25% of US 6.5 million CHF patients

• Monitor and manage the disease progression for Class III patients

Estimated initial patient population

~1.6 million

SOZO[TM] CHF usage model

• Baseline reading to be performed in a clinical setting

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

Preliminary estimated addressable per annum US market based on US$60 per >US$1.0 billion[1] patient per month over 12 months

SOZO[TM] CHF Revenue Model

• Initial device purchase plus a per patient per month subscription model

• Well established and growing in CHF market

• Excludes revenue from initial device sales

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SOZO[TM] Approved and Launched in Australia and Europe

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• Australia

• Strong initial enquiry, both existing and new customers

  • Large Institutional Clients

  • Physiotherapists

  • Distributors

    • Cancer focused

    • Medical

• Initial units shipped

  • To select practices and institutions

  • Installation and training underway

• New business model introduced

  • Multi-year licensing contracts (standard software and updates)

  • Upgrade pathway for new indications and uses

• Europe

• Targeted launch

  • Initial units shipped

  • Partnered with master distributor exclusively focused on breast cancer space

  • Targeting high volume cancer centres in select markets

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Expected News Flow

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L-Dex[®] adoption and revenue growth

• FDA clearance for SOZO™ for lymphoedema – catalyst for significant acceleration in US sales

• First data from Vanderbilt PREVENT trial

• Private payors to begin coverage of L-Dex[®] - catalyst for broad adoption in US

• Continue building customer base across top tier cancer centres

• Expansion into selective markets in Europe and other territories

SOZO™ for heart failure

• Initial adoption of SOZO[TM] in EU and AU

• File FDA 510(k) application for SOZO™ for fluid monitoring of heart failure patients

• Commercial launch of heart failure in US following FDA clearance

• Completion and reporting of pilot trials

• Initiation of larger multi-centre marketing trial

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Appendix

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Management Team

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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)

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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

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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

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David Adams

SVP Ventures, Licensing & Corporate Development

• On Board November 2013 to August 2016

• Joined August 2016

• Background as medical device investment & business development executive

• 25+ years experience in tax, financial planning, and business development

• Previously Vice President, Integrations and Divestitures at Medtronic

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Catherine Kingsford SVP Medical Affairs

• Joined January 2007

• 20+ years global clinical experience with medical devices

• Previously worked as a cardiac scientist at several world-class medical institutions including St. Andrew's War Memorial Hospital, The Prince Charles Hospital, and Royal Brompton Hospital

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Dennis Schlaht

SVP Quality, R&D and Technology

• 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 Gary Goetzke FTSE, MBBS, BEdSt, Juris Doctorate D.Univ (Hon), FAICD Non-Executive Director Non-Executive Chairman • Joined August 2016

• 15+ years in senior management positions with medical device companies

• On Board since 2005

• Appointed NonExecutive Chairman in Nov 2011

• Currently the Principle and Chief Executive Officer of Compass Medical Advisors, LLC

• Leading medical practitioner in breast cancer screening/diagnosis

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

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Scott R. Ward MS, BSc Non-Executive Director

• Joined July 2013

• Venture capitalist with 30+ years experience in healthcare industry

• Previously Senior Vice President and President of the Cardiovascular business of Medtronic

• Chairman of the Board of CregannaTactx Medical Devices and Cardiovascular Systems, Inc.

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Richard Carreon Managing Director and Chief Executive Officer

• See previous slide

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Judith Downes Non-Executive Director

• Joined April 2017

• 20+ years of accounting and senior management expertise with large ASX listed companies

• Previously a CFO at Alumina Limited and CFO/COO of Institutional Division, ANZ Banking Group Limited

• Currently Board Chairman of Bank Australia Limited and Honorary Fellow of the University of Melbourne’s Faculty of business and Economics

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Donald A. Williams BAcy, CPA Non-Executive Director

Amit R. Patel MBA, BME Non-Executive Director

• Joined March 2017

• Joined March 2017

• 35+ years in • 8+ years in senior leadership roles management serving the life positions science, biotech, and • Currently the board of medical device Vios Medical and industries Pillsbury United

• • Currently the Audit Communities Committee Chair of • Currently the CEO Akari Therapeutics, and Co-Founder of Alphatec Holdings, Vios Medical Marina Biotech, and Proove Biosciences, and the Compensation Committee for Marina Biotech

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World Renowned Medical Advisory Board from Leading US CHF Institutions

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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

Laura Mauri, MD, MSc

J. Thomas Heywood, MD

Andrew Accardi, MD

• Director, Heart Failure • Chairman of Emergency • Chief Scientific Advisor, Recovery and Research Medicine, Scripps Harvard Clinical Research Program, Scripps Health Memorial Hospital Institute; Recognised Encinitas 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, Professor Piotr Ponikowski, PhD MD, PhD • Professor of Innovative • Head of Cardiology Clinical Trials at U Medical Department, Medical Center Gottingen, University Wroclaw Poland Germany

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Financials YTD

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For the Twelve Months Ended 30 June 2017 (Unaudited and Preliminary)

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Oncology Revenue (000’s)

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Cash Balance (000’s)

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Market Cap (millions)

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