Polynovo Limited · ASX:PNV
Polynovo — Macquarie Emerging Leaders Forum 2019
30 slides from Polynovo's conference presentation, Jun 19, 2019
Slide 1: PolyNovo Investor's Update
For personal use only PolyNovo Investor’s Update Macquarie Emerging Leaders Forum Melbourne 19-20 June
Slide 2: Disclaimer
Disclaimer For personal use only This presentation has been prepared by PolyNovo Limited and is provided for general information purposes only. No party other than PolyNovo has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or u
Slide 3: NovoSorb polymer: A unique platform technology
NovoSorb® polymer A unique platform technology For personal use only NovoSorb® • Base polymer developed by the CSIRO (Australian Government research) and spun out as PolyNovo • Unique polymer technology, Carbamate, that is programmable for reabsorbsion rate and product attributes. • Excellent biocom
Slide 4: Addressable Markets - Near term
Addressable Markets - Near term For personal use only NovoSorb BTM is currently on sale • Unique biodegradable purely synthetic • Market expansion for the use of dermal scaffolds Pipeline development – a platform technology • Hernia devices preparing for manufacturing scale up with equipment purchas
Slide 5: Growth and Development
Growth and Development For personal use only Continued sales & marketing expansion • Well capitalised to accelerate market penetration in the US, building revenues will be reinvested • Aust/NZ/UK/Ireland expanding sales in response to market penetration • Investment in additional resources in sales,
Slide 6: BTM NovoSorb
For personal use only BTM NovoSorb
Slide 7: NovoSorb BTM current market entries
NovoSorb BTM current market entries For personal use only Europe Middle East ⚫ CE mark expected any day….. ⚫ Israel Sept 2018 ⚫ UK direct entry 1 sales person today ⚫ Saudi Arabia Sept 2018 ⚫ Germany distributor PMI trained India and SE Asia ⚫ Other EU markets consider direct & distributors ⚫ Myovat
Slide 8: NovoSorb BTM fully resorbed
NovoSorb BTM fully resorbed For personal use only Flexible, smooth normal tissue!
Slide 9: When BTM is placed in a wound
When BTM is placed in a wound For personal use only NovoSorb BTM applied to debrided wound bed 1 The wound is ‘physiologically closed’, limiting contraction and risk of infection. NovoSorb BTM fully integrated 2 Full thickness tissue deposited within the foam. Once integrated, the seal is ready for
Slide 10: How does NovoSorb BTM Dermal Scaffold work
How does NovoSorb BTM Dermal Scaffold work For personal use only The BTM foam breaks up a large wound (marcrowound) into a series of small, interconnected microwounds. The body easily heals microwounds, promoting organized regenerative healing. Normal Healing: The body’s natural Healing with BTM: Th
Slide 11: Foam structure
Foam structure For personal use only • Yellow segments demonstrate what you see in the histopathology- edges of foam structure • Red circle highlights communicating pores • Yellow circle highlights the cellular chambers of the foam • Blue circle demonstrates the artifact of cutting the foam chambers
Slide 12: Free Flap Application
Free Flap Application For personal use only Day 36 - Prior to Day 75 Post NovoSorb delamination BTM, Day 39 Post skin graft 12
Slide 13: Team expansion, investment
Team expansion, investment For personal use only • Double US sales team from 8 to 16 July 2019 • Increase Aust/NZ sales team from 1 to 3 June 2019 • Increase UK sales team from 1 to 3 by January 2020 after CE and initial revenue in flow • Establish UK/Ireland and DACH then look at expansion through
Slide 14: Production Capacity
Production Capacity For personal use only • Production capacity in existing BTM facility/cleanroom is adequate for all projected demand with increased capacity possible with a second shift, further automation of some processes and a new hi volume packaging machine • Currently hold 3 months forward i
Slide 15: Trademarks and I.P.
Trademarks and I.P. For personal use only • Trademarks for PolyNovo, NovoSorb and BTM files in China, Mandarin and English • Entry into China is a few years away however we are ensuring we have all IP and Trademark protections in place now • 聚新 PolyNovo • 塑新 NovoSorb • 47 Patents- Multiple countries
Slide 16: Manufacturing
Manufacturing For personal use only • Purchased adjacent building February 2019 • Fit out will office space will be complete October 2019 • Fit out of the new cleanroom production facility will be complete end 2019 with validation and GMP certifications complete ~May 2020 • Hernia and Breast manufac
Slide 17: Factory scale up and cost efficiency programs
Factory scale up and cost efficiency programs For personal use only • Hernia & Breast production area in schematic • Architect appointed and commission build in the next 2 months • Validated & certified GMP operations by April/May 2020 • Hernia product in US market via 510(K) approval September/Octo
Slide 18: NovoSorb Hernia
For personal use only NovoSorb Hernia A radical approach to hernia device
Slide 19: NovoSorb Hernia
NovoSorb Hernia For personal use only • Two products in development • Design input from US surgeons • 2 separate surgical implantation areas – Intraperitoneal – Retro rectus muscular space • Initial studies very promising • Polymer formulation refined for extrusion and strength • Commissioning of pl
Slide 20: Hernia Rest of World
Hernia Rest of World For personal use only • Use US post-market trial results for CE and Australia regulatory filings • Variety of sizes targeted at large hernia segment • Market driver is desire for resorbable products verses permanent mesh due to infection, pain and litigations • Launch New Zealan
Slide 21: NovoSorb Breast: Partnership with Establishment Labs
For personal use only NovoSorb Breast Partnership with Establishment Labs
Slide 22: Breast Program
Breast Program For personal use only • Utilising NovoSorb film and foam in 3 devices for breast reconstruction and augmentation – The devices will assist in the positioning of prothesis and also reduce the risk of capsular contraction. – The development of these is on track with a PMA regulatory pat
Slide 23: Division of accountability for Breast
Division of accountability for Breast For personal use only • PolyNovo holds all the IP in regards to the polymer and manufacturing processes • PolyNovo R&D team work with Establishment Labs (EL) team to refine design based on market feedback from EL customers/surgeons. • Establishment Labs will fun
Slide 24: Our Teams
For personal use only Our Teams
Slide 25: Management
Management For personal use only Mr Paul Brennan was appointed Chief Executive Officer (CEO) of PolyNovo Ltd on 13 February 2015. Mr Brennan has extensive knowledge, exposure and understanding of the health system through his clinical background and commercial exposure with various multinational com
Slide 26: Management (2)
Management (2) For personal use only Dr. Tim Moore completed a Bachelor of Applied Science (Chemistry) degree at Swinburne University of Technology, followed by an honours degree and PhD degree. Dr. Moore’s PhD dissertation was in the field of biodegradable polyurethanes; the title was ‘Design and S
Slide 27: The Board
The Board PNV For personal use only Mr David Williams was appointed as a Non-executive Director on 28 February 2014 and Chairman on 13 March 2014. Mr Williams is an experienced Director and investment banker with a proven track record in business development and strategy, as well as in mergers and a
Slide 28: The Board (2)
The Board (2) For personal use only Mr Bruce Rathie is an experienced Company Director with a finance and legal background. He practised as a partner in a large legal firm and acted as Senior In-house Counsel to Bell Resources Limited from 1980 to 1985. He studied for his MBA in Geneva and embarked
Slide 29: PolyNovo Top Investors
PolyNovo ASX : PNV For personal use only Top 20 Investor % Equity No: Shares 1 FIL Investment Management Limited 4.24% 28,053,173 2 David Kenley 3.10% 20,473,958 3 EFM Asset Management Ltd. 2.72% 17,997,446 4 David Williams 2.51% 16,600,000 5 Merchant Funds Management Pty Ltd 1.89% 12,473,402 6 Wils
Slide 30: Thank You
For personal use only Thank You www.polynovo.com.au