Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (May 2009)
28 slides from Impedimed's investor presentation, May 28, 2009
Slide 1: ImpediMed Limited
Strictly Private and Confidential ImpediMed Limited Surviving cancer without compromising lifestyle Strictly Private and Confidential
Slide 2: Important Disclaimer
Important Disclaimer The information contained in this presentation and otherwise disclosed to you by Wilson HTM Corporate Finance Limited (ABN 65 057 547 323) (Wilson HTM) or ImpediMed Limited (ABN 65 089 705 144 ) (ImpediMed) prior to a public announcement of all of the information must be kept st
Slide 3: Contents
Contents 1. Executive Summary 2. Capital Structure 3. Management and Board 4. Lymphedema 5. ImpediMed Technology 6. Business Model 7. News Flow – Next 18 Months 8. Key Risks 9. Capital Raising 10. Investment Highlights Draft - Strictly Private and Confidential 3
Slide 4: Executive Summary
Executive Summary • ImpediMed Limited (ImpediMed) - ASX listed company - market capitalisation of AUD $68.1m • Designed, developed & selling a medical device to aid in the clinical assessment of lymphedema • IP protected technology with over a decade of peer reviewed validation • Regulatory cleared
Slide 5: Capital Structure
Capital Structure Capital Structure – ASX:IPD 12 Month Share Price Performance Share price $0.90 100.0 $0.755 ( 22 May 2009 close) $0.80 90.0 80.0 Listed shares on issue (million) 82.5 $0.70 70.0 $0.60 Unlisted shares (million) 7.7 60.0 $0.50 Listed options (million) 12.5 50.0 $0.40 40.0 Unlisted op
Slide 6: Management and Board
Management and Board Board of Directors Greg Brown, B.Sc MBA - Executive Director and Chief Executive Officer Over 20 years of business experience in the healthcare industry in Australia, the USA and in Europe. He joined ImpediMed Limited in April 2004 as Chief Executive Officer and is a substantial
Slide 7: Clinical Assessment of Lymphedema
Clinical Assessment of Lymphedema • High incidence • Patent protected • Support and advocacy • Early detection • FDA cleared • Positive reimbursement allows prevention October 2008 environment • First mover, potential to become standard of care Draft - Strictly Private and Confidential 7
Slide 8: Today’s Situation – Diagnosis is too Late
Today’s Situation – Diagnosis is too Late Stage 2 spontaneously irreversible Stage 3 Lymphostatic Elephantiasis • Presently diagnosed when patients can already have irreversible changes • Successful treatment can occur with early detection (compression sleeve) Draft - Strictly Private and Confidenti
Slide 9: Incidence Rates
Incidence Rates Incidence of Lymphedema in Cancer Survivors Expected New Patients US Breast9 250,000 Source: See reference information at end of presentation Source: American Cancer Society, Datamonitor, Onkos, ROW - Rest of World (JPN, FRA, GER, ESP, UK) • US breast cancer incidence ~250,000 cases/
Slide 10: Current Detection Methods
Current Detection Methods Tape Measure • May not detect until lymphedema is irreversible • Non-FDA approved Water Displacement • Measures only total volume change • Subjective, non-standard measures Perometer • No indication for ancillary swelling • Up to 35% standard deviation • Time consuming Draf
Slide 11: Benefits of Early Assessment
Benefits of Early Assessment National Institutes of Health Funded Study10 • 5 year study assessing lymphedema in breast cancer patients (196 patients) • Preoperative, 1, 3, 6, 9, and 12 month assessment post surgery • 22% (43 patients) identified with sub-clinical lymphedema • Intervention with comp
Slide 12: Bioimpedance Spectroscopy (BIS)
Bioimpedance Spectroscopy (BIS) Illustration of BIS Technology At low frequency At high frequency Cell membrane Intercellular fluid Extracellular fluid • Patent protected technology • 10 years of peer reviewed science on earlier detection of lymphedema Draft - Strictly Private and Confidential 12
Slide 13: L-Dex U400
L-DexTM U400 • FDA cleared October 2008 • U.S. launch in November 2008 Draft - Strictly Private and Confidential 13
Slide 14: Taking a Measurement with L-Dex U400
Taking a Measurement with L-DexTM U400 1. Patient assumes a supine position on a non-conductive surface so fluid levels equilibrate 2. Sites for electrode placement are cleaned with an isopropyl alcohol swab and air dried 3. Clinician verifies with patient that there are no contra-indications (impla
Slide 15: Indicative Testing Protocol
Indicative Testing Protocol Pre-Operative Tested every 3 months Tested every 6 months Patient Baseline Year 1 Year 2 Year 3 Year 4 Year 5 Test in conjunction with post- surgical follow up consultation with surgeon / oncologist • Indicative practice for L-DexTM presently in clinical use – no recommen
Slide 16: Business Model
Business Model Illustrative Device Economics Assumptions Per USD Per Test • target consumables price per test USD 25-45 Annum Tests 1 768 • surgeon enrols 8 patients per month Reimbursement 100 76,800 • quarterly testing over the first two years Consumables 25-45 26,880 • builds to annual test volum
Slide 17: Positive Reimbursement Environment
Positive Reimbursement Environment • Legislated coverage of lymphedema care in Women's Health and Cancer Rights Act of 1998 mastectomy patients • Demonstrated benefits of early detection National Institutes of Health www.nih.gov Patient Advocacy Foundation • Lymphedema CareLine www.patientadvocate.o
Slide 18: Reimbursement Strategy – Category One
Reimbursement Strategy – Category One Reimbursement Status Status Current Category One AMA Code1 Miscellaneous lymphedema BIS of a Limb2 Some Private Insurers Includes CMS Coverage No CMS (Medicare/Medicaid) (Medicare/Medicaid) Payment $2003 $70 - $1204 3 months payment / Advantage Automatic payment
Slide 19: Submission Criteria
Submission Criteria Category One Code Submission Requirements* FDA clearance Billed on a miscellaneous code; show that no other code is available > 5 years US peer reviewed science validating technology Professional society support Demonstrate widespread adoption (targeting greater than 100 users of
Slide 20: Pelvic Cancer Related Lymphedema
Pelvic Cancer Related Lymphedema L-DexTM UB500 Lymphedema of the Leg Approach to Market • Unilateral and bilateral assessment • US Government organisation funded clinical trial • FDA submission exp. Q4 2009 for unilateral • FDA submission targeted Q4 2010 for bilateral Draft - Strictly Private and C
Slide 21: News Flow – Next 18 Months
News Flow – Next 18 Months Near Term Catalysts Ahead… News Flow Pipeline Targets: 3Q09 4Q09 1Q10 2Q10 3Q10 4Q10 Formal offer for ASBS registry Expansion of sales team and managed care team United Kingdom key hospital announcement Category One reimbursement code submission Commence clinical trial for
Slide 22: Risk Management – Key Risks
Risk Management – Key Risks • Risk to Lymphedema Opportunity • Major clinical trials • Bilateral lymphedema approaches • ASBS Registry • Reimbursement and Regulatory Strategies • Maintaining coverage with private payers on miscellaneous code • Securing FDA unilateral and bilateral leg clearance for
Slide 23: Offer Summary
Offer Summary • A$12M (approx 18.75 million shares at $0.64) to be raised via a combination of placement and entitlements issue Offer size • Fixed Price of A$0.64 for both placement and entitlement issue • Lead Manager and Underwriter - Wilson HTM • Placement Capacity of approx 10.7 million shares (
Slide 24: Expected Use of Funds
Expected Use of Funds • The funds raised under the Capital Raising will be used primarily for: • expanding the U.S. sales, technical support and managed care team • funding of a potential lymphedema patient registry in association with the ASBS • continuing market development including maintaining &
Slide 25: Indicative Timetable
Indicative Timetable Placement Date Trading Halt Tuesday 26 May Bids into placement book by Wednesday 27 May Announcement of the Issue and lift trading halt Thursday 28 May Placement settlement Tuesday 02 June Placement shares commence trading Wednesday 03 June Entitlement Offer Date Lodge Rights Is
Slide 26: Investment Highlights
Investment Highlights • Lymphedema represents a large & underserved market Large Market • Multi-hundred million dollar annual consumables market opportunity First Mover • ImpediMed has the first technology to enable routine pre-emptive care IP Protected • Strong intellectual property protection Clin
Slide 27: Thank you
ImpediMed Thank you ImpediMed Limited info@impedimed.com www.impedimed.com www.L-Dex.com ASX:IPD Draft - Strictly Private and Confidential 27
Slide 28: Reference Information
Reference Information 1. Warren A, Brorson 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 incidence and severity