IMPEDIMED LIMITED — Investor Presentation 2014

Oct 29, 2014

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ASX:IPD October 2014

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This presentation has been produced by ImpediMed Limited (“ImpediMed”) only and may contain forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this presentation may include statements about future financial and operating results, status of our regulatory submissions, possible or assumed future growth opportunities and risks and uncertainties that could affect ImpediMed’s product and products under development. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein. In any forward-looking statement in which ImpediMed expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. We are not under any duty to update forward-looking statements unless required by law.

This investor presentation is not an offer of the sale of securities.

ImpediMed and their respective directors, employees, associates, affiliates or agents, make no:

(a) representations or warranties, express or implied, in relation to this presentation or the accuracy, reliability or completeness of any information in it or the performance of ImpediMed; and

• (b) accept no responsibility for the accuracy or completeness of this presentation and the information contained in it.

This presentation is intended to provide background information only and does not constitute or form part of an offer of securities or a solicitation or invitation to buy or apply for securities, nor may it or any part of it form the basis of, or be relied on in any connection with any contract or commitment whatsoever. The information in this presentation does not take into account the objectives, financial situation or particular needs of any person. Nothing contained in this presentation constitutes investment, legal, tax or other advice. Potential investors should make their own decision whether to invest in ImpediMed shares based on their own enquiries. Potential investors are advised to seek appropriate independent advice. This presentation does not, and does not purport to, contain all the information prospective investors in ImpediMed would desire or require in reaching an investment decision.

To the maximum extent permitted by law, none of ImpediMed , their officers, directors, employees, associates, affiliates or agents, nor any other person accepts any liability for any loss, claim, damages, costs or expenses of whatever nature (whether or not foreseeable), including, without limitation, any liability arising from fault or negligence on the part of any of them or any other person, for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it or any errors or omissions in it.

The distribution of this presentation in jurisdictions outside Australia may be restricted by law and you should observe any such restrictions. This presentation has not been filed, lodged, registered or approved in any jurisdiction and recipients of this presentation should keep themselves informed of and comply with and observe all applicable legal and regulatory requirements. This presentation is made only to sophisticated or professional investors under the Corporations Act.

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Game changing technology platform

• Bioimpedance spectroscopy (BIS) accurately measures tissue composition and fluid status

First product, L-Dex[®] , addresses a growing medical need

• Lymphoedema affects approximately 20% - 30% of cancer survivors

• A precise and cost effective solution to detect lymphoedema at its earliest stages

• • Large addressable market;

• 900,000+ relevant cancer cases per year in the US alone

• US$350 million addressable market

Sales poised to accelerate in 2015

• CPT[®] Category I code for reimbursement effective Jan 2015 (BIS)

• All cancer code descriptor expands market opportunity

• Seven out of top ten US cancer centres already using L-Dex

• More than 21,000 patient tests in last twelve months

• Targeting key regional oncology groups over coming 12 months

Strong pipeline of BIS product opportunities

• Numerous medical and non-medical uses for our technology

• • $3 billion+ estimated addressable markets

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Reimbursement

• CPT Category I Code effective January 2015

• CPT descriptor for all cancer related lymphoedema expected to significantly expand the market opportunity – September 2014

• A leap forward in commercial strategy, allowing IPD to pursue maximum market for L-Dex at least one year earlier than expected

Key appointments

• Leading US oncologist Dr Frank Vicini appointed Chief Medical Officer - September 2014

• Brings industry expertise, important advisor on clinical development and strategy

Post approval study

• Crucial to driving market adoption

• Multiple leading international cancer centres participating

• First enrolment June 2014 – enrolment progressing well

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•

• Fluid imbalance can have significant clinical implications

• Fluid levels are incredibly predictive (actionable information)

• Excess fluid can lead to chronic swelling, lymphoedema, left ventricular complications, etc.

• Excess fluid is also indicative of heart failure stage and severity

• • Fluid imbalances in dialysis patents can cause adverse events and contributes to higher mortality/morbidity rates

• Accurate fluid and body composition measurements are key components of a patient’s clinical diagnosis and treatment Optimising fluid levels in cancer and dialysis patients is likely to have profound impact on reducing hospitalisation rates and mortality

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•

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• Current measurements tools are rudimentary and unreliable, or prohibitively expensive, complicated and invasive

• High-tech tools include CT scan, MRI, X-Ray absorptiometry, isotope dilution (lymphoscintigraphy) and perometry

• Low-tech tools include tape measure, “pinching” with calipers, and water displacement

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Imaging*

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Tape Measure*

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Water Displacement

Perometry

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Calipers

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• Images courtesy of Macquarie University

• Measurements using bioimpedance at a single frequency can be used to estimate body composition (limited capabilities)

• However, multiple frequencies are required to obtain complete information of tissue composition and fluid burden

• ImpediMed’s patented technology utilises 256 frequencies effectively creating a spectrum of bioimpedance

• Using a spectrum of data obtained by BIS allows a direct and detailed measure of tissue composition (muscle, fluid, fat)

Low Frequency

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Current cannot pass through cells

High Frequency

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Current able to pass through cells

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• Informative – 256 frequency spectra provides detailed measurements of muscle, fluid, and fat • Simple to Use – easy placement of electrodes

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Fast – 5-10 mins to measure

Non-invasive – no dyes or radiation

Safe – no safety concerns reported after thousands of measurements Accurate – precise algorithms analyse information and produce accurate and immediate results

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•

US addressable market $350+ million per year (assumes $30 per reading)

• Lymphoedema affects ~1 in 3 cancer survivors • 900,000+ relevant new cancer cases per year

• Lymphoedema is a progressive swelling that can occur following cancer treatment due to lymph nodes being removed, damaged or irradiated • Lymphoedema can become a chronic, debilitating, life-long condition • Current measurements and treatments are reactive rather than proactive and actionable

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• Clinical practice is moving towards early detection and early intervention

• Current techniques used to assess lymphoedema cannot detect it before it is visibly apparent

• L-Dex is able to detect minute changes in extracellular fluid (i.e. 35 mls versus other technologies 200 mls - 300 mls) L-Dex detects lymphoedema up to 200 days prior to current techniques

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• “BIS is a significant leap in technology. It is able to detect lymphedema at the earliest possible stage of

• development (stage 0) where treatment is the most

• effective, and can potentially stabilize or even reverse the early stage lymphedema.”

This patient has subclinical lymphoedema identified by L-Dex allowing early treatment

• Dr. Stanley Rockson, Stanford University Medical Center, 2013

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Annual US Relevant Cancer Incidences[1 ]

939,000

Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)	Patient Testing Protocols (assuming $30 per reading)
Per Patient	Year 1	Year 2	Year 3	Year 4	Year 5	Total
Readings	5	1 - 4	1 - 4	1 - 2	0 - 2	8 - 17
Revenue	$150	$30 - $120	$30 - $120	$30 - $60	$0 - $60	$240 - $510

Addressable Per Annum US Lymphoedema Market

Total $225M - $480M

Rest of World Market[2] is more than 5 times the US Market

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1. Estimated cases in 2013, NCI Cancer Statistics, http://seer.cancer.gov/csr/1975_2010/results_merged/sect_01_overview.pdf 2. New Cases 2012, International Agency for Research on Cancer http://globocan.iarc.fr/ia/World/atlas.html

Focusing on top US oncology practices and institutions (deliberate and disciplined approach)

• Increased opportunity for US market based on securing descriptor for all cancers

• Initial Objectives – lay foundation for long-term sustainable growth and expansion of technology

• Previous strategy focused on breast cancer related lymphoedema

• Updated Targeted Launch Strategy

• Focus the bulk of the sales and marketing resources to building foundations for wide scale adoption in broader oncology market

• Continue to devote resources to service core breast cancer related lymphoedema market – existing and new user base

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• Concentrate initial sales and support efforts on optimising uptake and processes at select large leading oncology sites

• Targeting six major oncology groups over coming 12 months

• Establish best practice at each of the six sites for:

• Practice integration and patient flow

• • Electronic Medical Record (EMR) integration of L-Dex results

• Data collection (publications and podium presentations)

• Reimbursement support

• Expand to other target practices once initial data is reviewed and critical lessons learned applied

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Clinical

• Standardising testing protocol

• • Practice integration

• Patient education

• Expand practice guidelines to National Comprehensive Cancer Network (NCCN)

Marketing

• Expand to all cancer related lymphoedema

• Expand patient advocacy groups – key markets

• • Direct to patient – in partnership with key practices

Reimbursement expansion

• Post approval study

• Accelerate and expand publication strategy

• Enlist KOLs to educate Medicare Carrier Advisory Committees (CACs) and private payers

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• Key position statements on early detection of lymphoedema - recommendations for BIS

• Australasian Lymphology Association (ALA), Aus

• National Lymphedema Network (NLN), US

• • National Accreditation Program for Breast Centers (NAPBC), US

Formally published guidelines

• Kaiser Permanente (the largest vertically integrated health care delivery system in the US)

• Magee-Womens Hospital of the University of Pittsburgh Medical Center (top 25 Cancer Centre)

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United States

• 2 randomised controlled trials (n ~100 each site) being conducted at large teaching hospitals

• Both investigating whether early intervention, identified with BIS, halts the progression of lymphoedema

• Comparison between L-Dex and tape measure or water displacement

Europe

• United Kingdom

• Large National Health Service (NHS) study (n > 1,000) to demonstrate the equivalence of BIS with perometry

• Small subset randomised controlled trial demonstrating efficacy of early intervention with compression sleeve

• France

• Leading European oncology centre trial (n>600) conducting multi-centre randomised trial to study detection and treatment of lymphoedema related to breast cancer

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• To help drive adoption ImpediMed is also sponsoring an international study

• Study commenced in June 2014 with Vanderbilt already recruiting patients. All trial sites expected to be live by year end

• Large (n=1,100), multi-centre, randomised controlled study to prove that use of BIS to enable early treatment reduces progression of lymphoedema

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• Straightforward study design and low cost

• 5 year prospective trial

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• Total cost approximately US$3 million

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• Interim results expected in 2017 • Drives adoption of private payers

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• BIS is a platform technology for precise measurement of:

• Fluid Levels – e.g. fluid burden; fluid change; hydration; oedema

• Tissue Composition – e.g. fat mass; lean body mass

• Fluid Levels and Tissue Composition are incredible predictors of health • Fluid Levels- e.g. lymphoedema; dialysis; heart failure; hydration

• • Tissue Composition – e.g. obesity; nutrition; muscle wasting; wound care; geriatric health

ImpediMed's regulatory approvals (FDA, TGA and CE Mark) cover a number of these potential applications;

• Both in the clinical and at-home settings

• Increasing engagement by physicians around various potential applications of our technology

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• CMS announces new Medicare payment rates November 2014

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• CPT codes and new Medicare payment rates implemented January 2015

• Accelerating revenue in the US on the back of the CPT I code

  • Medicare reimbursement expected January 2015

• Building private payer adoption

  • Increasing profile in cancer survivorship guidelines

  • • Incorporated into NCCN guidelines

  • Results of third party trials published

  • Post-approval trial continues in leading cancer centres

• Expand into new geographies

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• Create new and leverage existing partnerships

• Expand into other markets

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Thank You

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Appendix

Corporate Overview

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• ASX listed (October 2007)

• Operations in US (San Diego) and Aus (Brisbane)

• Transformed Board & Management in 2013

• 37 FTE staff

• Market capitalisation ~$107M (~239M shares on Issue)

• Cash on hand $9.5M (30 September 2014)

• Revenue FY14 – $3.5M

Share Register Breakdown

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33%
4%
63%
Founder / Management Institutional Private
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Share Price Performance – CY2014

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Substantial Shareholders

Allan Gray	19.9%
Starfish Ventures	10.2%
Founder & Management	4.1%
Top 20	56.9%

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Financials

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	FY2014 $000	FY2013 $000	% Change
Lymphedema Revenue	1,594	1,188	34% ↑
Body Composition Revenue	891	728	22% ↑
Test & Measurement Revenue	1,036	817	27% ↑
Total Group Revenue	3,521	2,733	29% ↑
Operating Expenses	9,967	10,751	7% ↓
Operating Loss	7,935	8,464	6% ↓

Cash Balance at 30 September 2014: $9.5 million

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Lymphedema Revenue
(in thousands)
$1,600
$1,200
$800
$400
$0
FY12 FY13 FY14
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Management Team Has Deep and Broad Commercialisation Experience

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Rick Carreon	•Joined July 2012
President and Chief	•30+ years experience
Executive Officer	•Extensive experience in the medical device field and growth companies
	•Previously Vice President at Medtronic (10 years)
Frank Vicini, MD	•Joined September 2014
Chief Medical Officer	•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
	Registrytrial
Morten Vigeland	•Joined April 2011
Chief Financial Officer	•15+ years in financial management in the medical technology industry
	•Experience in med-tech start-ups and emerging growth companies
Catherine Kingsford	•Joined January 2007
VP Regulatory, Clinical	•20+ years global clinical experience with medical devices
Affairs, and Intellectual Property	•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
Dennis Schlaht	•Joined October 2007
VP Product Development,	•30+ years in engineering development and product marketing
Quality and Marketing	•Previously Vice President of Marketing and Product development at XiTRON’s Test and
	Measurement Business
Mike Schreiber	•Joined July 2013
VP Global	•20+ years in medical device arena
Commercialisation	•Entrepreneurial business leader
	•Previous founder of VendorClear
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Board of Directors

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Cherrell Hirst AO	•On Board since 2005
FTSE, MBBS, BEdSt, D.Univ	•Appointed Non-Executive Chairman in Nov 2011
(Hon), FAICD Non-Executive Chairman	•Leading medical practitioner in breast cancer screening/diagnosis •Currently a Director of Tissue Therapies Ltd and Medibank Private Ltd.
James Hazel	•On Board since 2006
BEc, SF Fin, FAICD	•Expertise in investment banking (previously Chief General Manager of Adelaide Bank)
Non-Executive Director	•Experienced in ASX listed companies and corporate governance
	•Currently a Director of Bendigo & Adelaide Bank Limited, Ingenia Communities Group and
	Centrex Metals Ltd.
Michael Panaccio	•On Board since 2005
PhD, MA, BSc (Hons), FAICD	•Investment principal and founder of Starfish Ventures (12+ years)
Non-Executive Director	•Experienced at capital raising, ASX listed companies, med/tech, M&A, corporate
	governance
	•Previously Director of numerous technology businesses in Australia and the US
	•Currently a Director of MuriGen, NeuProtect, Ofidium, dorsaVi and Protagonist
Scott R. Ward	•On Board since July 2013
MS, BSc	•Venture capitalist with 30+ years experience in healthcare industry
Non-Executive Director	•Previously Senior Vice President and President of the Cardiovascular business of
	Medtronic
	•Chairman of the Board of Creganna-Tactx Medical Devices, and Surmodics, Inc.
David Adams	•On Board since November 2013
BS, JD	•Background as medical device investment & business development executive
Non-Executive Director	•25+ years experience in tax, financial planning, and business development
	•Previously Vice President, Integrations and Divestitures at Medtronic
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