Polynovo Limited · ASX:PNV
Polynovo — H1 FY2020 Earnings Presentation
17 slides from Polynovo's earnings presentation, Feb 26, 2020
Slide 1: Half Year Results December 2019
PolyNovo Half Year Results December 2019 26th February 2020 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 has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or undertakings in this pr
Slide 3: NovoSorb polymer: a unique platform technology
NovoSorb® polymer A unique platform technology 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 re-absorbsion rate an
Slide 4: H1 Results snapshot
H1 Results snapshot Sales Revenue H1 $8.57M Total Revenue H1 $10.18M 4
Slide 5: NovoSorb BTM Commercial Revenues
NovoSorb BTM Commercial Revenues Half Year only 8.45 9.348 $M AUD 1.747 0.13896 FY17 FY18 FY19 FY20 H1 BTM NB: Excludes all other revenues- only BTM sales 5
Slide 6: Market Milestones H1
Market Milestones H1 • Expansion of the US sales team – Strong sales performance in US market with growing account penetration • CE Mark approval December 2019 – Allows for full Western European market entry – Initial markets UK/Ireland and DACH Region (Germany, Austria, Switzerland) – UK/Ireland- P
Slide 7: Regulatory approvals
Regulatory approvals 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 7
Slide 8: Hernia Factory Development
Hernia Factory Development • Builder contracted – Foundation reinforcement – Steel structure erected – Electrical supply upgrade – Cleanroom completion scheduled End May 2020 • Production equipment delivered – Custom built production machines have been delivered with only a couple of machines outsta
Slide 9: Hernia Development
Hernia Development • 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 ~ June 2021 9
Slide 10: Other Research & Development
Other Research & Development • Breast product – Working with Establishment Labs for first product design – Regulatory strategy being finalized, which will determine timeline • IP- Patent filings – 4 new patents in “contestable phase” we will announce these once this phase is concluded • BetaCell – T
Slide 11: Clinical Trial update
Clinical Trial update • CE Burn trial is complete publication March 2020 • BARDA funded Feasibility trial publication March 2020, sites were – Wake Forest Baptist Health, Winston-Salem, – University of Tennessee Medical Centre, Memphis – University of California Davis Medical Centre, Sacramento – Ta
Slide 12: Offices Refurbishment & Expansion complete
Offices Refurbishment & Expansion complete • Port Melbourne – Combined Unit 1&2 office areas and refurbished – Allows for future team expansion – Collaborative areas and meeting rooms • San Diego – Moving into enlarged area, in the same building, to accommodate expanded team – Additional resources i
Slide 13: The Board
The Board PNV Mr David Williams (B.Ec (Hons), M.Ec, FAICD) 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 business development an
Slide 14: The Board (2)
The Board (2) 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 Limited in its early ye
Slide 15: Management
Management Mr Paul Brennan (MBA, BSc (Nursing) RN RM) Chief Executive Officer Mr 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
Slide 16: Management (2)
Management (2) Dr. Tim Moore Principle Scientist 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 Syn
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