PolyNovo Limited · ASX:PNV
PolyNovo — Calzada — Investor Presentation (June 2013)
21 slides from PolyNovo's investor presentation, June 2013
Slide 1: Calzada Ltd Investor Overview
Calzada Ltd ASX:CZD Investor Overview June 2013 1
Slide 2: Disclaimer
Disclaimer Disclaimer This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No party other than Calzada has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or undertakings i
Slide 3: Calzada Limited
Calzada Limited • ASX:CZD • Share price: 8 cents • Market Capitalisation: $28m • Current Cash: $2.9m (+ approx $750k R&D refund from ATO expected Q3 2013) • Cash Burn: approximately $2.5m per annum (net of R & D refund) • Major Shareholders: Merchant Funds Management: 19.6% Senior Management: 9%
Slide 4: Calzada
calzada
Slide 5: PolyNovo Mission
PolyNovo Mission “PolyNovo will develop a portfolio of medical devices, based on its NovoSorb™ technology, focussed on delivering superior clinical outcomes for patients and economic benefits to healthcare providers.” 5
Slide 6: PolyNovo: Products and technology, Development, Commercialisation strategy
PolyNovo 1. Products and technology 2. Development 3. Commercialisation strategy 6
Slide 7: NovoSorb™
NovoSorb™ • NovoSorb™ can be used as a wound scaffold for multiple tissue repair applications and dissolves when the repair is complete • First applications in burns and wound management, developed by NovoSkin (80% owned PolyNovo) in partnership with Dr John Greenwood, AM (Director, Adult Burns Unit
Slide 8: NovoSorb™ development history
NovoSorb™ • The NovoSorb™ family of polymers is the result of over ten years of development including : Four years of fundamental research conducted by world leading biomaterial expert Dr Thilak Gunatillake at the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Seven years o
Slide 9: NovoSorb™ key advantages
NovoSorb™ • Key advantages: Excellent biocompatibility (material and degradation products) Cost effective Easy to process Excellent scalability Sterilisation by Gamma irradiation Long shelf life at room temperature 9
Slide 10: NovoSorb™ Safety
NovoSorb™ Safety • Completed ISO 10993 testing to GLP standard Sensitisation, Pyrogen, Irritation, Sub-cutaneous Implantation, Sub-chronic Systemic Toxicity (90 days), Systemic Toxicity (180 days), Genotoxicity (Ames, Mouse Lymphoma), Cytotoxicity • Completed multiple large animal studies (30 pigs
Slide 11: PolyNovo developments
PolyNovo developments R&D Pre-clinical Clinical 510(k) CE mark PMA Partnering Revenues NovoSorb™ Topical Negative Pressure (TNP) Dressing Q4 2013 Q2 2014 Q4 2013 Q4 2014 Diabetic,P ressure & Other Ulcers, A bdo minal Surgical Wo unds Surgical wounds(BTM) Q3 2013 Q4 2013 TBD TBD Surgical Wo unds, Ulc
Slide 12: Biodegradable Temporising Matrix (BTM)
Biodegradable Temporising Matrix (BTM) • BTM is a NovoSorb™ foam coated with a non-biodegradable membrane used as a scaffold for dermal repair in full thickness wounds 12
Slide 13: BTM
BTM • BTM advantages over current products: Reduced risk of infection/ loss of device Improved tissue growth and revascularisation Mechanically robust Cost effective manufacturing Long term room temperature storage Gamma sterilised. NovoSorb Current Products (Integra) Vascularisation At
Slide 14: BTM Clinical Trial
BTM Clinical Trial Patient 1 Free flap full thickness wound donor site untreated BTM implanted in donor site Skin graft >10 weeks 14
Slide 15: Topical Negative Pressure Dressings
Topical Negative Pressure Dressings Rationale • Issues with existing TNP dressings listed in the FDA Preliminary Public Health Notification: Serious Complications Associated with Negative Pressure Wound Therapy Systems Infection Fragmentation Dressing embedded in wound Bleeding The NovoSorb™
Slide 16: Topical Negative Pressure Dressings
Topical Negative Pressure Dressings •Key market data: Cost*: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each pressure ulcer added $43,180 in costs to a hospital stay. D
Slide 17: NovoSorb™ Commercialisation Strategy
NovoSorb™ Commercialisation Strategy • Leverage our NovoSorb™ technology platform • Establish commercial/strategic alliances to commercialise NovoSorb™ based medical devices • Focus on developing medical devices to improve on existing devices and/or to resolve unmet clinical needs Topical Negative
Slide 18: NovoSorb™ next steps
NovoSorb™ next steps • 510K regulatory submission for TNP application Submission Q3 2013 • Seeking a partner to distribute TNP dressing Market size >$400 m In discussions with multiple potential partners • Investigate BTM for surgical wounds BTM for third degree burn Market size > $200 m • Awa
Slide 19: Metabolic Pharmaceuticals
INK. metabolic _— calzada 19
Slide 20: AOD9604 Activity Pathways
AOD9604 Activity Pathways Burns fat, AOD9604 Inhibits storage Growth hormone fragment Fat (only 8% of the GH molecule) Direct cellular pathway IGF-1 pathway IGF-1 and pro-diabetic Promotes repair effects removed Cartilage Bone 2nd hormone - IGF1 & Muscle (made in the liver) Protein Muscle Bone and O
Slide 21: AOD9604 Background & Strategy
AOD9604 Background & Strategy Background • Positive in-vitro and in-vivo data in fat, bone, cartilage & muscle cells • Past clinical development proved AOD9604 is very safe with some evidence of weight loss in population sub-sets observed - 700 humans and >1,000 animals treated • Has been used in Ph