Slide 1: ImpediMed Limited Investor Presentation May 2012
For personal use only ImpediMed Limited Investor Presentation May 2012 1
Slide 2: Disclaimer
Disclaimer For personal use only 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 res
Slide 3: Presenters – IPD senior management
Presenters – IPD senior management For personal use only Greg Brown, Chief Executive Officer (CEO) – B.Sc. / MBA Director since December 2001, and CEO from February 2004. Over 25 years of international business experience in the healthcare industry including in Australia, Switzerland, England, G
Slide 4: Medical device company – First to market opportunity
Medical device company – First to market opportunity use only Targeting a sustainable, protected Intellectual Property and profitable franchise • Unmet clinical • Limit • Fluid status • Unique and first • Unique code Clinical Validation Reimbursement need competition applications wave FDA reimbursem
Slide 5: Lymphoedema – Major unmet clinical need
Lymphoedema – Major unmet clinical need For personal use only The current ‘gold standard’ for the detection of lymphoedema is water displacement. A 200ml difference can be too late, as irreversible changes may have already occurred. Presently diagnosed when patients can already have irreversible c
Slide 6: Critical difference – Time of assessment
Critical difference – Time of assessment For personal use only ImpediMed’s L-Dex ® U400 can detect lymphoedema at a sub-clinical stage when swelling is not visible L-Dex ® U400 prospective readings Identified at a sub-clinical stage when swelling is not visible Sub clinical Current standard Iden
Slide 7: IPD platform - Bioimpedance Spectroscopy (BIS)
IPD platform - Bioimpedance Spectroscopy (BIS) For personal use only ImpediMed utilises BIS technology in its medical devices for the detection of lymphoedema ImpediMed’s BIS technology directly measures extracellular fluid At low frequency At high frequency Cell membrane Intracellular fluid Extrace
Slide 8: ImpediMed’s L-Dex U400
ImpediMed’s L-Dex® U400 For personal use only ImpediMed’s L-Dex® U400 is FDA cleared and can aid a surgeon or radiation oncologist in clinically assessing the early changes associated with lymphoedema Direct measure for extracellular fluid (ECF) differences of the limbs to aid in clinical assessme
Slide 9: True Innovation - Current detection methods are sub-optimal
True Innovation - Current detection methods are sub-optimal For personal use only FDA clearance for Direct or indirect measurement, Detection Method lymphoedema Reproducibility/Accuracy volume or ECW assessment Tape measure Volumetric calculation of limb by Non-standardised and measuring diameter at
Slide 10: Our opportunity and approach – staged target markets entry
Our opportunity and approach – staged target markets entry For personal use only ImpediMed is currently focused on the US breast cancer market with the L-Dex U400. ImpediMed’s UB500 is targeted for use into the larger pelvic cancer market with legs Today & Near Term Breast Cancer market – Entry Pelv
Slide 11: Targeting a consumable based business model
Targeting a consumable based business model For personal use only Physician pays ImpediMed for the consumables associated with the test and bills the patient’s insurance company for reimbursement Illustrative Device Economics Illustrative charge per reading (USD) Doctor supplied device free of charg
Slide 12: Illustrative only - Potential based on adoption of targeted protocols
Illustrative only - Potential based on adoption of targeted protocols For personal use only Two possible protocols could be (1) in line with HMO guidelines, or (2) NAPBC recommendations Launch year Year 1 Year 2 Year 3 Year 4 Year 5 HMO illustration assumptions: No. of tests each year from launch yr
Slide 13: Our target markets for driving sales
Our target markets for driving sales For personal use only ImpediMed sells to three groups of customers • Estimate top 1000 targets treat 45% of patients Breast Surgeons • Direct sales and marketing • Coverage critical driver for sales • Co-marketing strategies with key chains Radiation Oncologists
Slide 14: US reimbursement overview – Critical to drive sales
US reimbursement overview – Critical to drive sales For personal use only All three components are critical for reimbursement. Coverage often needs to meet a break- even point before a doctor introduces testing for all patients in a practice Coding Payment Coverage CPT codes Clinician fee schedu
Slide 15: Payment and coverage – Delivered through US healthcare payers
Payment and coverage – Delivered through US healthcare payers For personal use only ImpediMed is targeting major insurance groups in the US United Uninsured Humana 6% 16% others 3% 4% Aetna 5% Wellpoint BCBS 12% 33% Cigna 3% Kaiser CMS 3% 15% Source: Harvard University, ‘Health Care Delivery Covered
Slide 16: Our progress – L-Dex placements in the US as of December 2011
Our progress – L-Dex placements in the US as of 31 December 2011 For personal use only ImpediMed has 178 devices placed in the US Key: 15+ L-Dex placements 10 – 14 L-Dex placements 5 – 9 L-Dex placements 1 – 4 L-Dex placements Source: ImpediMed data No L-Dex placements 16
Slide 17: Significant risk to cancer patients - Incidence rates
Significant risk to cancer patients - Incidence rates For personal use only There are approximately 250,000 new breast cancer patients in the US each year Incidence of Lymphedema in Cancer Survivors Expected New Patients US Breast9 250,000 Source: American Cancer Society, Datamonitor, Onkos, Source:
Slide 18: Third party validation – Early detection/intervention & outcomes
Third party validation – Early detection/intervention & outcomes For personal use only Insurers typically review for a new diagnostic test on three principle grounds 1. Technical Performance? 2. Diagnostic Performance? 3. Outcomes Data? Van Loan 1993 Early Treatment: Hayes 2005, 2008 Van Loan
Slide 19: US Year early detection/intervention trial
US 5 Year early detection/intervention trial For personal use only A NIH study shows that intervention with sleeve resulted in reversal of symptoms in all patients National Institutes of Health (NIH) Funded Study – 2008 * 5 year study assessing lymphoedema in breast cancer patients (196 patients)
Slide 20: Support building for prospective care in US
Support building for prospective care in US For personal use only Support for BIS is snowballing in the US with physicians, advocacy groups and survivors National Accreditation Program for Breast Centers (NAPBC) clinical Standard 2.15 “Support and Rehabilitation” This standard strongly recommend
Slide 21: Social media – lymphconnect.com and international.l-dex.com
Social media – lymphconnect.com and international.l-dex.com For personal use only Targeting support for prospective care in US market with physicians, advocacy groups and survivors Lymphconnect.com website launched in December 2011 to support lymphoedema sufferers with information and a space to s
Slide 22: Our progress - Key milestones and events
Our progress - Key milestones and events For personal use only ImpediMed is focused on building coverage to support effective reimbursement September 2010 January 2011 CPT June July 2011 2009 November 2011 December 2011 March 2012 Category III code MCO contracts announced 45 Avon L-Dex White devices
Slide 23: Next generation consumable for breast and pelvic cancer
Next generation consumable for breast and pelvic cancer For personal use only The UB500 will allow ImpediMed to protect and build the larger consumable revenue potential in the pelvic cancer market UB500 Beta II prototype Active electrode system Consumables model Commercialisation continues
Slide 24: Offer summary
Offer summary For personal use only 1 for 4 accelerated non-renounceable rights issue to raise up to approximately $13.7 million Offer structure Up to approximately 39.1 million new ImpediMed ordinary shares to be issued (25% of existing shares on issue) $0.35 per share Offer price 18.6% dis
Slide 25: Expected use of funds
Expected use of funds For personal use only Sales, marketing and training Expand reimbursement support Instrument development - continue commercialisation of the UB500 Clinical trial support Inventory growth General working capital purposes 25
Slide 26: Indicative rights issue timetable
Indicative rights issue timetable For personal use only Timetable* Institutional Offer period (under trading halt) 1 - 2 May 2012 Institutional bookbuild opens 1 May 2012 Institutional bookbuild closes 1 May 2012 Ordinary shares recommence trading 3 May 2012 Record date 4 May 2012 Retail offer opens
Slide 27: Risk factors
Risk factors For personal use only Early stage company with limited revenue ImpediMed is at an early stage in its commercialisation of it’s L-Dex medical device. To date, it has operated at a loss and has an operating history of losses. ImpediMed’s ability to generate sufficient revenue in the fut
Slide 28: Risk factors
Risk factors For personal use only Sales and marketing There is a risk that ImpediMed’s direct sales and marketing efforts may not be successful. ImpediMed has a direct sales and marketing capability to Surgeons, Radiation Oncologists and major insurance companies (Managed Care team). Third party
Slide 29: Risk factors
Risk factors For personal use only Ongoing regulatory issues Even after medical devices receive regulatory clearance, ImpediMed may still face developmental and ongoing regulatory compliance difficulties. Regulatory agencies subject a marketed device, its manufacturer and the manufacturer’s facili
Slide 30: Risk factors
Risk factors For personal use only Manufacturing ImpediMed, or its contract manufacturers and suppliers, may fail to achieve and maintain required manufacturing standards which could result in device recalls or withdrawals, product shortages, delays or failures in product testing or delivery or ot
Slide 31: Risk factors
Risk factors For personal use only Enforcement and infringement of intellectual property Third parties may own or control patents or patent applications that ImpediMed may be required to license to commercialise product, that IMpediMed may infringe, or, that could result in litigation that would b
Slide 32: Risk factors
Risk factors For personal use only Share price The market price of ImpediMed’s shares historically has been, and ImpediMed expects will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to ImpediMed, to changes in anal
Slide 33: Reference Information
Reference Information For personal use only 1. Warren A, Bronson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery • Volume 59, Number 4, 2007 2. Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of