Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (December 2010)
23 slides from Impedimed's investor presentation, Dec 6, 2010
Slide 1: ImpediMed Limited Capital Raising Presentation
For personal use only ImpediMed Limited Capital Raising Presentation December 2010 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: Executive Summary
Executive Summary For personal use only Five key strategic pillars: For protecting long term market Identifying first to Addressing large underserved medical need in lymphoedema market opportunities IP for hurdles of entry Patents, patent applications and trademarks in lymphoedema / BIS / oedema
Slide 4: Targeting Multiple Fluid Status Markets
Targeting Multiple Fluid Status Markets For personal use only Lymphoedema market - Arms Today & Near Term Lymphoedema market - Legs Arms - mainly breast cancer Legs - pelvic cancer Highest awareness 80% of market market, 70% unilateral Estimate - US$150m+ annually Estimate - US$400m+ ann
Slide 5: Current Diagnosis is Often too Late
Current Diagnosis is Often too Late For personal use only Presently diagnosed when patients has visible symptoms y p - at this p point p patient can have irreversible changes Successful treatment and potential prevention can occur through early detection and intervention “Upper extremity lymph
Slide 6: ImpediMed's L-Dex U400
ImpediMed’s L-Dex® U400 For personal use only ® FDA - cleared Class 2 medical device to aid in clinical assessment of unilateral arm of female breast cancer patients Unilateral claim only at present 6
Slide 7: Senior Management
Senior Management For personal use only Peggy Brooker - Chief Financial Officer • Partner E&Y LLP in the U. U S. S & a Principal in E&Y Australia Australia. Served as engagement partner to public & private companies with revenues in excess of $1B. She held senior E&Y positions, both in the U.S. & Au
Slide 8: Key Milestones & Events
Key Milestones & Events For personal use only ImpediMed Events October 2008 June 2009 November 2009 March 2010 April 2010 June 2010 October 2010 FDA clearance for 45 L-Dex ® CPT code filing g Category g y III CPT FDA filingg of 98 L-Dex ® 4 Managed g L-Dex® U400 devices in US with AMA code approved
Slide 9: Review of Recent Progress
Review of Recent Progress For personal use only Updates 106 L-Dex devices placed in the market - c.140 surgeons have access BIS the new gold standard Nov. 2009 - rebuttal published in November 2010 JOL Komen sponsored standard of care pilot for Dr Schonholz Unilateral leg FDA submission fi
Slide 10: Business Model – Reimbursement Critical to Drive Model
Business Model – Reimbursement Critical to Drive Model For personal use only Illustrative Device Economics Assumptions (based on primary target surgeon) Per Test Per Annum Target list price per test US$45 (USD) (USD) Clinician enrols 8 new patients per month Reimbursement¹ $ $100 $ $115,200 Qu
Slide 11: Health Insurance Coverage - Targeting Major Payers
Health Insurance Coverage (covered lives) - Targeting Major Payers For personal use only Approximately 30 million covered lives Targeting a meeting with key Medical Directors for November 2010 Approximately 18 million covered lives Targeting a meeting with key Medical Directors in early 2011
Slide 12: Current Placements in the US – Limited by Reimbursement
Current Placements in the US – Limited by Reimbursement For personal use only Placements expected to increase through building effective reimbursement coverage for surgeon/oncologist/radiologist Poses a viable alternative to the current clinical standard, by providing the means to achieve early
Slide 13: Stanford University Patient Registry Proposal
Stanford University Patient Registry Proposal For personal use only Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Panel meeting held in November 2009: “clinical evidence for the diagnosis & treatment of secondary lymphoedema” Panell suggestions: P ti need d ffor a standa
Slide 14: Healthcare Savings – Economic Model
For personal use only Healthcare Savings – Economic Model Economic Model of Routine Use of L-Dex® Test to Assist in lymphoedema Assessment in Post-Breast Cancer Patients Key y outputs p from the model include: At 1 year, routine L-Dex® (US$600/test) results in savings of ~US$235m in US populat
Slide 15: Healthcare Savings - Model Results for Base Case to Self Assessment
Healthcare Savings - Model Results for Base Case to Self Assessment For personal use only Note - $ in chart above refers to US$ 15
Slide 16: New Products Targeted to Drive Market Expansion
New Products Targeted to Drive Market Expansion For personal use only Status Alpha site trials completed Beta II site trials targeted for first half 2011 – US Gynaecologic Oncology Group Beta II prototype devices are built Pricing List price will target US$45,000 Stand or wall mounted Lo
Slide 17: Target News Flow – 2011/2012
Target News Flow – 2011/2012 For personal use only News Flow Pipeline: 1H11 2H11 1H12 Announcement of 20 million covered lives NCD CED draft decision memorandum - Stanford Arm Registry GOG Clinical Trial for bilateral announced Unilateral Limb (arms and legs) FDA clearance Announcement of NAPBC pre-
Slide 18: Board of Directors
Board of Directors For personal use only Mel Bridges BSc FAICD, Non Executive Chairman • Mr Bridges was a founder of ImpediMed and served as a non-executive non executive director from inception • Mel Bridges has over 30 years of international business experience in the healthcare industry and is cu
Slide 19: Risk Management – Key Risks
Ri k M Risk Managementt – Key K RiRisks k For personal use only Risk to Lymphoedema Applications Major clinical trial outcomes - arms/legs Bilateral lymphoedema approaches No clinical guidelines are published Reimbursement and Regulatory Strategies Maintaining coverage with private payer
Slide 20: Capital Structure
Capital Structure For personal use only Capital Structure as at 1 December 2010 – ASX: IPD 12 Month Share Price Performance Share Pricing in AUD Share Price A$0.82 0.95 4,000 0.90 Listed shares on issue (million) 1 135.87 3,500 0.85 Unlisted shares (million)1, 2 0.21 0.80 3,000 0.75 2,500 Listed opt
Slide 21: Offer Summary
Offer Summary For personal use only Institutional placement to raise A$10 million million, comprising Approximately 14.3 million new Impedimed shares to be issued New shares issued will rank equally in all respects with existing ordinary shares from allotment Wilson HTM and RBS Morgans - Joint
Slide 22: Expected Use of Funds
Expected Use of Funds For personal use only Stanford run US wide arm registry - potentially 3 to 5 years Sales and marketing - Education and demand creation programs Management launch of Health Economic Model - targeting reimbursement coverage UB500 development - expanding market access Su
Slide 23: Indicative Timetable
Indicative Timetable For personal use only Placement Date Trading halt 2 December 2010 Bids into placement book by 4:30pm Sydney time 2 December 2010 Announcement of the Placement and lift trading halt 3 December 2010 Placement settlement 13 December 2010 Pl Placement t shares h commence ttrading di