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1 ImpediMed Limited Entitlement Offer and Placement Investor Conference Call - 29 April 2010 April 2010

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Page 1: ImpediMed Limited - Amazon S3s3-us-west-2.amazonaws.com/brr-streamguys/files/IPD/IPD...ImpediMed Limited is an ASX listed company with a market capitalisation of circa A$82 million

1

ImpediMed Limited

Entitlement Offer and Placement

Investor Conference Call - 29 April 2010

April 2010

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2

Greg Brown – Chief Executive Officer

Donald Myll – Chief Financial Officer

Today’s Presenters

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Disclaimer

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 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;

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

(c) make no recommendation as to whether you should participate in the proposed ImpediMed capital raising.

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 participate in the capital raising based on their own enquiries. Potential investors are advised to seek appropriate independent advice, if necessary, to determine the suitability of this investment. 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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Executive Summary

� ImpediMed Limited is an ASX listed company with a market capitalisation of circa A$82 million

� Designs, develops and sells medical devices to aid in the clinical assessment of lymphoedema

� Targeting to build its business on five key pillars

1. First to market - addressing a large underserved medical need in lymphoedema

2. IP protection – key patents and trademarks in lymphoedema

3. Strong regulatory position - first FDA cleared device with a lymphoedema assessment claim

4. Strong reimbursement position - technology specific category 3 CPT code for lymphoedema

5. Clinical validation – ten years of peer review on clinical performance, plus recent health economics

� ImpediMed is raising capital via a placement and a non-renounceable rights issue

� Proceeds from the fundraising will be used primarily to expand the US sale and reimbursement teams and for marketing programs to maximise ImpediMed’s commercialisation opportunity in the US

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Capital Structure

Capital Structure as at 30 March 2010 – ASX: IPD 12 Month Share Price Performance

Share Price A$0.75

Listed shares on issue (million) 108.8

Unlisted shares (million)1, 2 0.4

Listed options (million) 12.5

Unlisted options (million)1 4.6

Undiluted market cap (million) A$81.6

Fully diluted market cap (million)3 A$94.7

Cash (million)4 A$6.7

Enterprise value (million)3 A$88.0

1Source: ImpediMed Annual Report 2009

2Performance shares

3Includes performance shares, listed options and unlisted options

4As at 31 December 2009

$0.40

$0.45

$0.50

$0.55

$0.60

$0.65

$0.70

$0.75

$0.80

$0.85

$0.90

30/03/200 30/05/200 30/07/200 30/09/200 30/11/200 30/01/201

Sh

are

pri

ce A

$

-

50,000

100,000

150,000

200,000

250,000

300,000

Vo

lum

e

Volume Close Price

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Targeting Multiple Fluid Status Markets

Fluid Status Market

Lymphoedema market - Arms

� Arms – mainly breast cancer

� Highest awareness

� Estimate - US$150m+ annually

Lymphoedema market - Legs

� Legs – pelvic cancer

� 80% of market, 65-70% unilateral

� Estimate -US$400m+ annually

Oedema market

� Venous insufficiency

� High prevalence in elderly

Dialysis market

� Licensed by Fresenius

� Fluid status monitoring

Technology platform

Today & Near Term

Future

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Lymphoedema – Current Diagnosis is Often Too Late

� Presently diagnosed when patients can already have irreversible changes

� Successful treatment and potential prevention can occur with early detection (compression sleeve)

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L-DexTM U400’s Initial Target Market is Breast Cancer Survivors

� US breast cancer incidence:

� Currently c.250,000 cases/year

� Forecast to grow to c.420,000 cases/year within the next 20 years

� US breast cancer survivors:

� c.2.5 million people

Lymphoedema association with breast cancer survivors

� After mastectomy: 24 - 49%

� After lumpectomy: 4 – 28%

� After sentinel lymph node biopsy and radiation

therapy: 4 - 17%

� Estimated average incidence overall

approximately 20%

Longer survival of breast cancer patients is estimated to cause an increased prevalence of lymphoedema

Breast cancer incidence in the US

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True Innovation - Current Detection Methods are Sub-Optimal

Detection MethodDirect or indirect

measurement, volume or ECW

FDA clearance for lymphoedemaassessment

Reproducibility/Accuracy

Tape measureVolumetric calculation of

limb by measuring diameter at prescribed

intervals

NoNon-standardised and

subjective measurement

Water displacement

Volumetric calculation of limb using ‘Archimedes’

principalNo

Non-standardised and subjective measurement

PerometerVolumetric calculation 80% of limb using an

infrared scanNo

Standardised and objective measurement for volume

only

BISDirect measure of relevant

compartment - the extracellular fluid

differences between limbs

Yes

Standardised and objective measurement specific for lymphoedema changes

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Key Milestones & Events

Industry Events

ImpediMedEvents

2008

April 2008

FDA application for L-DexTM U400

November 2009

CPT code filing with AMA

October 2008

FDA clearance for L-Dex U400

June 2009

45 L-Dex devices in

US

March 2010

Category III CPT code approved

December 2009

70 L-DexTM devices in US

2009 2010

June 2008

NIH funded 5 year study early detection /treatment Cancer

publication

July 2009

First US state bill for all lymphoedema

October 2009

Journal of lymphoedemapaper proposes BIS as gold

standard

November 2009

MedCAC meeting for diagnosis & treatment of

lymphoedema

February 2010

Swedish 10 year study

April 2009

JCO health economic cost of BCRL

October 2008

FDA clearance for L-DexTM U400

June 2009

45 L-DexTM devices

in US

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15+ L-DexTM Agreements

10 – 15 L-DexTM Agreements

5 – 10 L-DexTM Agreements

1 – 5 L-DexTM Agreements

Current Device Placements in the US – Limited by Reimbursement

No L-DexTM Agreements

� There are currently 121 users of the L-DexTM device with 71 L-DexTM Agreements in place

� Targeted key opinion leaders, placements also reflective of current regional sales presence

� Effective reimbursement critical to drive new placements & pull through consumable revenues

Key:

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Business Model – Reimbursement Critical to Drive Model

� Target list price per test USD 45

� Clinician enrols 8 patients per month

� Quarterly testing over the first three years

� Builds to annual test volume of 1,152 tests

Illustrative Device Economics

Per Test(USD)

Per Annum(USD)

Reimbursement¹ $100 $115,200

Consumables $45 $51,840

Net Clinic/Surgeon $55 $63,360

Assumptions (based on primary target surgeon)

� Device placed in clinicians office free of charge, revenue from consumables per test

� Approximately 5,000 surgeons operating on the breast in the US and 4,000 radiologists

� Top 2,000 US surgeons treat approximately up to 60% of all BrCx patients – likely ASBS members

¹Reimbursement amount is what is targeted - indicative only

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Roadmap for Effective US Reimbursement – Three Critical Components

� CPT codes� I,III or Miscellaneous

Coding� National & local� Medicare & private payers

Coverage� Clinician fee schedule

Payment

All three components are critical for effective reimbursement

A product that can deliver the following key characteristics is well positioned to build unique coding, coverage and payment support:

� True innovation – targeting an unmet need

� High economic value

� Clinician & patient acceptance & demand

� First to market

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Coding – Category III CPT Code

� Not technology specific – “miscellaneous lymphoedema study”

� Documentation required from clinician regarding procedure

� Not possible to have coverage statement specific to application

� Hence manual review process by payer – often a long process

Previous Position – Miscellaneous CPT Code

� BIS technology specific code – 100 frequencies or greater, ECW

� Code states both arms and legs - limbs

� With coverage statement – often reduced documentation needed

� Reimbursement subject to payer’s policy – payment / no. of tests

� Payment directly negotiated with US payers – health economics

New Position - Category III CPT Code

Key outcomes:

1. Technology specific

2. Limbs

3. Category

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Payment & Coverage – Delivered Through US Healthcare Payers

US Health insurers by covered lives (2007)

Aetna

5%

Wellpoint

12%

Cigna

3%CMS

15%Kaiser

3%

BCBS

33%

Humana

3%

United

6%

Uninsured

16% others

4%

Approximately 800 plus payers of US Healthcare, multiple delivery systems

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Coverage Strategy - Targeting Major Payers (max. coverage quickly)

Greater than 30 million covered lives

Greater than 18 million covered lives

Greater than 14 million covered lives

HCSC only - greater than 12 million covered lives

Greater than 9 million covered lives

Greater than 45 million covered lives

Five key private payers responsible for 83 million covered lives – 30% of US population

CMS covers 45 million lives – 15% of US population

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Estimated Health Economics of L-DexTM Aids Coverage & Payment

Govt. financed healthcare in US (CMS) is mandated by law to be budget neutral with new technology

� 2 yr estimate of economic burden of breast cancer related lymphoedema (BCRL)

� “Matched cohort analysis showed that the BCRL group had significantly higher medical costs (US$14,877 to US$23,167)”

Covered Lives 20,000,000 BCRL Cost (Shih 2009) US$9,500

Estimated BrCa cases < 65 yrs 7,929 L-Dex® Reimbursement US$518

Incidence Rate of BCRL 22% Annual L-Dex® Cost (x4) US$2,072

BCRL cases 1,744 Cost OTS Sleeve/Gauntlet US$80

Current estimate for a payer (20 million lives) - cost related to BrCa lymphoedema: US$16,570,863

Estimated break-even cost using L-Dex for new diagnosed BrCa patients only: US$16,570,863

Model estimates payment at $518 per test for payer to break even US$0

Company is targeting a payment of approximately $100 per test

Annual payer of 20 million covered lives, estimated L-Dex break-even analysis is $518

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External Factors Supporting Coverage - Legislative Support

No state laws in place requiring third-party payers to offer or provide coverage for lymphoedema treatment incidental to breast cancer

State laws in place requiring third-party payers to offer or provide coverage for lymphoedematreatment incidental to breast cancer (Mastectomy)

State laws in place requiring specified third-party payers to offer payment for the treatment of all forms of lymphoedema

State by State Coverage for Third-Party Payers to Offer or Provide Lymphoedema Treatment (Mastectomy only)

� 1999: Federal

� Women’s Health Rights Act - Mastectomy

� 1999 – 2009: State

� Numerous state laws have been put in place requiring specified third-party payers to offer or provide coverage for lymphoedema treatment - Mastectomy

� 2009: North Carolina

� Mandatory coverage for every health benefit plan to provide coverage for the diagnosis, evaluation and treatment of all lymphoedema

� Present activity

� Working to update WHRA act for all lymphoedema

� Lymphoedema Diagnosis and Treatment Cost Saving Act of 2010 before Congress

Key:

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15+ L-DexTM Agreements

10 – 15 L-DexTM Agreements

5 – 10 L-DexTM Agreements

1 – 5 L-DexTM Agreements

How IPD Builds Coverage on its Code to Drive Placements & Sales

No L-DexTM Agreements

Placements estimated to increase as the business model develops through effective reimbursement

� Expand direct managed care resources – reimbursement is a critical requirement to drive sales

� Expand sales team and support teams

� Registry – expand program for legs and arms and apply for Medicare reimbursement

� Working with Avon for a sponsored program for screening underserved populations

Key:

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Targeting Broader Lymphoedema Patient Registry

Medicare Evidence Development and

Coverage Advisory Committee (MEDCAC)

� MEDCAC panel meeting – “clinical evidence for the diagnosis and treatment of secondary lymphoedema” (September 2009)

� Key suggestions: need for a standardised metric & patient registry (arms/legs)

� Possibility to have Medicare reimburse testing for registry

Approaching Key US Surgeons to aid administration

� Targeting key clinicians to coordinate clinician participation into a registry

� IPD currently beginning discussions with key clinician groups

Approaching National Lymphatic Disease and Lymphoedema Patient

Registry

� Feinstein Institute – supported by LRF – looking to collaborate with broader registry

� Objective - a central database of patient history & clinical outcomes

� Stanley Rockson MD (Stanford) is LRF Principal Investigator for the registry

The establishment of a patient registry using BIS technology for assessment of lymphoedema is likely to support adoption of the technology among clinicians across the US market

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Patient Awareness – Will Work With Avon / Susan Komen

“Upper extremity lymphoedema is one of the most dreaded sequelae of breast cancer (BC) treatment”J Clinical Oncology, Vol 27, 2009

“The psychosocial impact of lymphoedema has been described to be as distressing as the initial diagnosis of BC”

J Clinical Oncology, Vol 27, 2009

“Patients with breast cancer–related lymphoedema (BCRL) have been found to have a lower quality of life, a higher level of anxiety or depression, a higher likelihood of chronic pain & fatigue, & greater difficulty functioning socially & sexually compared with BC women without lymphoedema”

J Clinical Oncology, Vol 27, 2009

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� Locked in active electrode� Patent protected

� Stand or wall mounted� Retractable arm

New Products Targeted to Drive Market Expansion

Status

� Alpha site trials completed

� Beta site trials targeted for second half 2010 – US Gynaecologic Oncology Group

Pricing

� List price will target US$35,000

� Targeting US$30 per reading (purchased device )

� Targeting US$45 to $49 for L-DexTM agreement

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Estimated News Flow – Next 18 Months

News Flow Pipeline: 2H10 1H11 2H11

Unilateral Leg Filing

Announcement of first coverage statement

Expansion of sales team and managed care team

Publish Category three code in AMA coding book

Announcement of 20 million covered lives

Registry announcement

GOG Clinical Trial for bilateral announced

FDA clearance of unilateral leg

Announcement of 50 million covered lives, first 500 surgeons

FDA filing of bilateral leg assessment

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Risk Management – Key Risks

� Risk to Lymphoedema Opportunity

� Major clinical trial outcomes - legs

� Bilateral lymphoedema approaches

� Registry and CMS reimbursement

� Reimbursement and Regulatory Strategies

� Securing FDA unilateral and bilateral leg clearance for U400 and UB500

� Maintaining coverage with private payers on miscellaneous code & transferring to category three

� Category three coverage by US third party payers – critical to drive sales

� Payment of $100 on the category three

� Intellectual Property

� Ability to protect position

� Competitor challenges to intellectual property

� Advancing Technology

� Competitor threat of new technology approaches

� Competitor launch a BIS device

� Supply threat – key component redesign due to end of life parts

� Sole third party manufacturer at present

� Product Liability

� Liability risks that are inherent in research & development, preclinical studies, clinical trials, manufacturing & the use as a medical device for assessment/monitoring conditions

� Fluctuations in currency exchange rates

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Offer Summary

Offer Size

� Up to A$[20.1] million to be raised via a combination of a placement and non-

renounceable pro-rata entitlement offer

� Fixed price of A$[0.65] for both placement and entitlement issue

� Wilson HTM and RBS Morgans – Joint Lead Managers

Placement/Entitlement Offer

� Placement to raise approximately A$[10.0] million

� Placement participants are eligible to participate in the entitlement offer

� 1 for 8 non-renounceable pro-rata entitlement offer to raise up to A$[10.1] million

� Discounts based on close 30 March 2010 (A$0.75):

� 21.8% to the 1 month VWAP (A$0.83)

� 24.3% to the 10 day VWAP (A$0.86)

� 18.9% to the 5 day VWAP (A$0.80)

� 13.3% to the last close (A$0.75)

� 10.7% to the TERP (A$0.73)

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Expected Use of Funds

� Expand reimbursement and sales teams in the US

� Expand the training and technical support team and the senior executive team in San Diego

� Marketing program (including for a patient registry to potentially include ASBS members, SSO and Stanford)

� To complete the research and development of the UB500

� General working capital purposes

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Indicative Timetable

Entitlement Offer Date

Announcement of the Entitlement Offer 1 April 2010

Record Date to determine entitlements for the Entitlement Offer (by 7:00 p.m. Sydney time) 15 April 2010

Offer opens 19 April 2010

Offer closes. Last day for acceptance and payment (5:00 p.m. Sydney time) 7 May 2010

Expected date for despatch of holding statements for New Shares 17 May 2010

Expected date for commencement of trading of New Shares 18 May 2010

Placement Date

Trading halt 31 March 2010

Bids into placement book by 4:00 p.m. (Sydney time) 31 March 2010

Recommence trading 1 April 2010

Settlement 8 April 2010

Allotment of placing shares 9 April 2010

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Summary

� Several hundred million dollar consumables market

� First technology for routine fluid status monitoring

� Over a decade of clinical peer reviewed science

� First FDA cleared device for lymphoedema

� Cat. 3 technology code - US Federal & State laws

Large Markets

First Mover

Validation

FDA Clearance

Reimbursement

IP Protected � Patent protected technology platform (BIS)