Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (April 2010)
27 slides from Impedimed's investor presentation, Apr 1, 2010
Slide 1: ImpediMed Limited Entitlement Offer and Placement
ImpediMed Limited Entitlement Offer and Placement March 2010 1
Slide 2: Disclaimer
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 materia
Slide 3: Executive Summary
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 und
Slide 4: Capital Structure
Capital Structure Capital Structure as at 30 March 2010 – ASX: IPD 12 Month Share Price Performance $0.90 300,000 Share Price A$0.75 $0.85 250,000 Listed shares on issue (million) 108.8 $0.80 $0.75 Unlisted shares (million)1, 2 0.4 200,000 Share price A$ $0.70 Listed options (million) 12.5 Volume $0
Slide 5: Targeting Multiple Fluid Status Markets
Targeting Multiple Fluid Status Markets Lymphoedema market - Arms Today & Near Term Lymphoedema market - Legs Arms – mainly breast cancer Legs – pelvic cancer Highest awareness 80% of market, 65-70% unilateral Estimate - US$150m+ annually Estimate -US$400m+ annually Fluid Technology Status platform
Slide 6: Lymphoedema – Current Diagnosis is Often Too Late
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) 6
Slide 7: L-Dex U400's Initial Target Market is Breast Cancer Survivors
L-DexTM U400’s Initial Target Market is Breast Cancer Survivors Breast cancer incidence in the US Lymphoedema association with breast cancer survivors US breast cancer incidence: After mastectomy: 24 - 49% Currently c.250,000 cases/year After lumpectomy: 4 – 28% Forecast to grow to c.420,000 cases/y
Slide 8: True Innovation - Current Detection Methods are Sub-Optimal
True Innovation - Current Detection Methods are Sub-Optimal Direct or indirect FDA clearance for Detection Method measurement, volume or lymphoedema Reproducibility/Accuracy ECW assessment Tape measure Volumetric calculation of limb by measuring Non-standardised and No diameter at prescribed subject
Slide 9: Key Milestones & Events
Key Milestones & Events ImpediMed Events April 2008 October 2008 June 2009 November 2009 December 2009 March 2010 FDA application for L- FDA clearance for 45 L-DexTM devices devices in CPT code filing with 70 L-DexTM devices in Category III CPT code DexTM U400 L-Dex L-DexTMU400 U400 inUS US AMA US a
Slide 10: Current Device Placements in the US – Limited by Reimbursement
Current Device Placements in the US – Limited by Reimbursement 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
Slide 11: Business Model – Reimbursement Critical to Drive Model
Business Model – Reimbursement Critical to Drive Model Illustrative Device Economics Assumptions (based on primary target surgeon) Per Test Per Annum Target list price per test USD 45 (USD) (USD) Clinician enrols 8 patients per month Reimbursement¹ $100 $115,200 Quarterly testing over the first thre
Slide 12: Roadmap for Effective US Reimbursement – Three Critical Components
Roadmap for Effective US Reimbursement – Three Critical Components All three components are critical for effective reimbursement Coding Payment Coverage CPT codes Clinician fee schedule National & local I,III or Miscellaneous Medicare & private payers A product that can deliver the following key cha
Slide 13: Coding – Category III CPT Code
Coding – Category III CPT Code Previous Position – Miscellaneous 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
Slide 14: Payment & Coverage – Delivered Through US Healthcare Payers
Payment & Coverage – Delivered Through US Healthcare Payers US Health insurers by covered lives (2007) United Uninsured Humana 6% 16% others 3% 4% Aetna 5% Wellpoint BCBS 12% 33% Cigna 3% Kaiser CMS 3% 15% Approximately 800 plus payers of US Healthcare, multiple delivery systems 14
Slide 15: Coverage Strategy - Targeting Major Payers
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
Slide 16: Estimated Health Economics of L-Dex Aids Coverage & Payment
Estimated Health Economics of L-Dex Aids Coverage & Payment TM 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 signif
Slide 17: External Factors Supporting Coverage - Legislative Support
External Factors Supporting Coverage - Legislative Support State by State Coverage for Third-Party Payers to Offer or 1999: Federal Provide Lymphoedema Treatment (Mastectomy only) Women’s Health Rights Act - Mastectomy 1999 – 2009: State Numerous state laws have been put in place requiring specified
Slide 18: How IPD Builds Coverage on its Code to Drive Placements & Sales
How IPD Builds Coverage on its Code to Drive Placements & Sales 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 –
Slide 19: Targeting Broader Lymphoedema Patient Registry
Targeting Broader Lymphoedema Patient Registry MEDCAC panel meeting – “clinical evidence for the diagnosis and treatment of secondary Medicare Evidence lymphoedema” (September 2009) Development and Coverage Advisory Key suggestions: need for a standardised metric & patient registry (arms/legs) Commi
Slide 20: Patient Awareness – Will Work With Avon / Susan Komen
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
Slide 21: New Products Targeted to Drive Market Expansion
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 St
Slide 22: Estimated News Flow – Next 18 Months
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 Clini
Slide 23: Risk Management – Key Risks
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 pr
Slide 24: Offer Summary
Offer Summary Up to A$20.1 million to be raised via a combination of a placement and non- renounceable pro-rata entitlement offer Offer Size Fixed price of A$0.65 for both placement and entitlement issue Wilson HTM and RBS Morgans – Joint Lead Managers Placement to raise approximately A$10.0 million
Slide 25: Expected Use of Funds
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 devel
Slide 26: Indicative Timetable
Indicative Timetable 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 Entitlement Offer Date Announcement of the Entitlement Offer 1 April 2010
Slide 27: Summary
Summary Large Markets Several hundred million dollar consumables market First Mover First technology for routine fluid status monitoring IP Protected Patent protected technology platform (BIS) Validation Over a decade of clinical peer reviewed science FDA Clearance First FDA cleared device for lymph