Polynovo Limited · ASX:PNV
Polynovo — Bank of America Healthcare Conference 2020
28 slides from Polynovo's conference presentation, May 14, 2020
Slide 1: PolyNovo Bank of America Healthcare Conference
For personal use only PolyNovo Bank of America Healthcare Conference 13 May 2020 US Virtual Meeting ASX: PNV
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by PolyNovo Limited and is provided for general information purposes only. No party other than PolyNovo For personal use only 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 Organisation) • PolyNovo developed the polymer further with foaming process and new formulations for medical devices • Polymer that is programmable for
Slide 4: Addressable Markets ~USD$7.5B+ near term
Addressable Markets ~USD$7.5B+ near term For personal use only Dermal Scaffold Market • US market largest, CAGR 10% • Global market ~$1.5+B, conservative Hernia Market Drug Elution/ Chronic disease management • ~$3B TBD • CAGR 9% with synthetic resorbable 34 %CAGR Breast Market Breast Augmentation/r
Slide 5: Current Products
Current Products For personal use only • A dermal scaffold/matrix allowing for cellular • Registered brand name for NovoSorb hernia product range integration, organisation in the repair of dermal loss • Made of NovoSorb foam and our own unique NovoSorb film, it is not BTM • Pure synthetic, has no pr
Slide 6: NovoSorb BTM how it works
NovoSorb BTM how it works 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 remo
Slide 7: Regenerative Healing with NovoSorb BTM
Regenerative Healing with NovoSorb BTM Patient biopsies For personal use only BTM membrane closes the wound Minimal granulation tissue Regenerated healthy dermis Minimizes foreign body response Fibroblasts synthesize ECM BTM foam thins and breaks down Cell migration and neo-angiogenesis Vascularized
Slide 8: Blanching & Delamination, Video
Blanching & Delamination, Video For personal use only 8
Slide 9: Allows for Staged Grafting
Allows for Staged Grafting Note the maturity of this graft 7 days post- application. The mesh For personal use only spaces are closed. A truly outstanding result. Pt 5 Day 31 post-NovoSorb BTM Pt 5 Day 38 post-NovoSorb BTM 9
Slide 10: Necrotising Fasciitis
Necrotising Fasciitis For personal use only Three months post grafting 11
Slide 11: Clinical Trial update
Clinical Trial update • CE Burn trial is complete with the results released 7 April 2020 For personal use only – Excellent take of NovoSorb BTM – Excellent take of skin grafts – Excellent cosmetic and functional outcomes • BARDA funded Feasibility trial publication of results 21 April 2020, sites we
Slide 12: Regulatory approvals
Regulatory approvals For personal use only Approved Class III Medical device ✓US FDA 510(K) ✓CE Certification Europe, UK, Ireland ✓TGA Inclusion ✓NZ MedSafe ✓South Africa In Process ✓India o South Korea o Taiwan ✓Malaysia o Mexico ✓Singapore o Kuwait ✓Israel o Sri Lanka 13
Slide 13: Current markets
Current markets For personal use only Europe Middle East ⚫ UK direct sales with 3 sales people and 1 PolyNovo direct market dedicated Marketer ⚫ Israel Sept 2018 ⚫ DACH region distribution partner PMI ⚫ Saudi Arabia Sept 2018 Distributor markets launch and already placed 3 stock orders India and SE
Slide 14: H1 Results and current snapshot
H1 Results and current snapshot For personal use only • Cash on hand per March ASX announcement $7.4M • NAB Finance facility $9.3M, capitalization of hernia factory and production machines freeing cash for investment in Sales Revenue H1 sales growth • Ascending revenues with US March a record month
Slide 15: Q3 FY'20 update
Q3 FY’20 update For personal use only • Record sales month in US March 2020 • Australia and New Zealand strong Q3 • DACH region launch was strong with BTM now in 8 Hospitals and further accounts to come on board once virus lock down eases • Some German and Swiss Surgeons have done many paediatric an
Slide 16: Hernia Factory Development
Hernia Factory Development • New Factory build For personal use only – Contractor on schedule – HVAC ducting, electrical, structural work advanced – Completion estimated ~July 2020 • Production equipment delivered – Custom built production machines have been delivered – Machines installed in an off-
Slide 17: Global Hernia Market
For personal use only Global Hernia Market Market Drivers • Resorbable segment growing (34% -3 Year CAGR) Global Hernia Market $3.1B • Steady increase in obesity driving increase in ventral hernia repairs • Technological advancements (e.g. materials - less US Hernia Market $1.5B inflammation, infect
Slide 18: Hernia applications
Hernia applications For personal use only Targeting 2 major planes of placement • Intraperitoneal with Syntrel ® SS • Retro-muscular with Syntrel ® DS 19
Slide 19: Hernia Development
Hernia Development For personal use only • Significant engagement with key opinion leaders • Marketing plan refinement • Once machinery installed in Port Melbourne commercial validation processes will run till end of 2020 • Regulatory dossier on track for US FDA filing • US Market entry ~ July/Augus
Slide 20: Other Research & Development
Other Research & Development For personal use only • Breast product – Working with Establishment Labs for first product design – Regulatory strategy will be US FDA 510(k) with clinicals • IP- 4 New Patent , total now 51 – 2018403989 Oriented biodegradable polyurethanes • This patent relates to how p
Slide 21: Offices Refurbishment & Expansion complete
Offices Refurbishment & Expansion complete • Port Melbourne For personal use only – Combined Unit 1&2 office areas and refurbished – Allows for future team expansion – Collaborative areas and meeting rooms • San Diego – Moved into a larger office space, in the same building, to accommodate expanded
Slide 22: CoVid19 update
CoVid19 update For personal use only • Little impact on PolyNovo supply chain – Adequate raw material supplies – ~6 months forward inventory holdings, US warehouse is Owens & Minor Louisville Kentucky – Running 2 manufacturing shifts • Sales continue with March and April strong performances – Digita
Slide 23: Appendix follows
For personal use only Appendix follows 24
Slide 24: The Board
The Board PNV Mr David Williams (B.Ec (Hons), M.Ec, FAICD) For personal use only Non-executive Chairman Mr Williams was appointed as a Nonexecutive 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 b
Slide 25: The Board (2)
The Board (2) For personal use only Mr Bruce Rathie (B.Comm, LLB, MBA, FAIM, FAICD, FGIA) Non-executive Director Mr 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 Corporate Counsel to Bell Resources L
Slide 26: Board (3)
Board (3) Mr Leon Hoare (GradDipBus, AssocDipAppSc(Ortho), GAICD) For personal use only Non-executive Director Mr Hoare was appointed a Director of PolyNovo on 27 January 2016. He is the Managing Director of Lohmann & Rauscher, Australia & New Zealand (ANZ), a private EU based medical device company
Slide 27: Management
Management Mr Jan-Marcel Gielen (CA, Bachelor Bus (Acc)) Chief Financial Officer and Company Secretary For personal use only Mr Gielen joined PolyNovo on 13 December 2018. Mr Gielen holds a Bachelor of Business (Accounting) degree from Monash University, is a member of the Institute of Chartered Acc
Slide 28: NovoSorb BTM over tendon
NovoSorb BTM over tendon For personal use only Degloving injury with tendons missing the paratenon. NovoSorb BTM was left on for 9 weeks before grafting. Day 316 29
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