PolyNovo Limited ABN 96 083 866 862 2/320 Lorimer Street, Port Melbourne VIC 3207 Tel: +61 3 8681 4050 Fax: +61 3 8681 4099 For personal use only 16 November 2015 Investor Presentation PolyNovo Limited (ASX:PNV) has released an updated investor presentation for shareholders, fund managers and other investors interested in the sector. The presentation summarises the near- term prospects for the Company’s polymer technology for use in burns, wounds and other reconstructive surgery. It also outlines that the Company will quickly pursue other applications such as using the polymer in hernia repair, breast implants and pelvic support. Viewer discretion is recommended as photographs and videos in the presentation are graphic in nature. For further information please contact: Paul Brennan Chief Executive Officer Mobile: + 61 427 662 317 Email: paul.b@polynovo.com 1
For personal use only PolyNovo We regenerate lost or damaged tissue through patented biodegradable medical devices.
Disclaimer For personal use only This presentation has been prepared by PolyNovo Limited (PolyNovo) 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 presentation. This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment objectives, financial situation or needs of any particular investor. PolyNovo makes no warranty or representation (express or implied) as to the accuracy, reliability or completeness of the information contained in this presentation. Specifically, several matters referred to in the presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation. Further, any opinions (including any forward looking statements) expressed in this presentation are subject to change without notice. PolyNovo and its directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent misstatement) for any statements, opinions, information or matters (express or implied) arising out of, contained in or derived from or for any omissions from this presentation, except liability under statute that cannot be excluded. This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect of shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other jurisdiction in which, or to any person to whom, such an offer would be illegal. This presentation may include forward-looking statements. Forward-looking statements are only predictions and are subject to known and unknown risks, uncertainties and assumptions, many of which are outside the control of PolyNovo. Actual values, results or events may be materially different to those expressed or implied in this presentation depending on a range of factors. Given these uncertainties, recipients are cautioned not to place reliance on forward-looking statements. No representation or warranty (express or implied) is made by PolyNovo or any of its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this presentation will be achieved. Warning: Graphic Medical Images in this presentation 2
Executive Summary For personal use only PolyNovo is the developer and manufacturer of patented biodegradable polymer medical 1. devices The devices are made of our biodegradable polymer, NovoSorb™. The first commercial 2. applications are in a foam-based dermal matrix and wound scaffold for regeneration of the dermis in burns, reconstruction surgery and chronic wounds The devices help generate a new dermis leading to improved survival and superior 3. cosmetic/functional outcomes We do our own manufacturing and research & development on-site in an accredited 4. cleanroom facility PolyNovo has in-house specialised staff in science, regulatory processes, quality assurance, 5. manufacturing and clinical project management Strong product pipeline, outside of burns, with hernia, breast and other products to access 6. USD$8B of market opportunities High margins, no debt, scalable production and focused commercialisation pathway with 7. revenues to begin in 2016 3
Agenda For personal use only o Corporate overview o The product: Biodegradable Temporising Matrix (BTM) o Product pipeline and applications o Path to market and 2016 work-plan o Board and senior executive team 4
Corporate Overview For personal use only $A Key Milestones ASX Code PNV 2004 PolyNovo incorporated (ex-CSIRO) Share Price 16 cents (close 13/11/15) 2006 NovoSkin feasibility study Issued Shares 419.5 million 2008 Port Melbourne facility established Market Cap. $67.12 million 2010 NovoSkin is incorporated Bio-Innovation SA grant ($217K) Net cash on hand $2.8 million (11/11/15) 2011 Feasibility study on NovoPore NPWT Major Shareholders 2013 First BTM human study (Royal Adelaide Hospital) Hernia feasibility study Merchant Funds 15% Pelvic floor repair study David Kenley 8% 2014 NovoPore regulatory approval 510(k) and CE Mark Royal Adelaide BTM burn trial 2015 New CEO & 2 full-time regulatory staff, additional scientist Factory expansion to enable commercial production BTM CE trials commence Royal Adelaide Hospital patient trial enrolment concluded US BARDA contract signed Final stages of US FDA 510(k) approval process 5
The product: NovoSorb and its Uniqueness For personal use only NovoSorb is a patented biodegradable polymer that can be utilised as: a foam wound scaffold o a thermoplastic extrusion o a filaments for weaving or knitting o a solution for spray or dip coatings of other devices o Purely synthetic BTM foam matrix No organic remnants, sensitising proteins, no risk of rejection o Competitors are biological based Animal sourced: Pig, Cows, Shark, Sheep, combinations o Human: cadaver skin, placenta /amniotic o Complex manufacturing and expensive to scale up o Higher risk of failure/rejection o Scarcity = high cost o BTM Key Attributes Unparalleled range of mechanical properties and degradation o times Excellent biocompatibility and harmless degradants o Can be utilised as a foam, coating or a thermoplastic structure o Patents on drug and antimicrobial elution properties o Scalable manufacturing process o Significant revenue and margins o 6
Biodegradable Temporising Matrix (BTM) For personal use only o Regenerates a new dermis o Superior cosmetic and functional outcomes in wounds, burns and reconstruction repair o Patented technology developed by CSIRO o Excellent safety profile o Significant trade secrets in production and difficult to reverse engineer o Scalable production process o Cost competitive, high margin product 7
How the BTM works For personal use only Full Thickness Burns and Surgical Wounds BTM in full thickness burn post surgical debridement. The wound is ‘physiologically closed’ limiting contraction and the risk of infection. 1 BTM fully integrated The sealing membrane can be removed when donor sites are available. 2 Sealing membrane removed when the wound is ready for skin grafting. To date the longest period to delamination is 45 days. 3 Wound closed with split skin graft (SSG) and the matrix biodegrades within 12 months. 4 8
BTM in use For personal use only BTM - Innovates the standard Current standard of care o Note the scarring and the tendons in this example of the traditional approach o Note tendons and o Note the lack of scar/contracture and topography. poor skin quality 4 9
In use: Tendon moves freely For personal use only 10 https://www.youtube.com/channel/UCL-B7V8ImJxqDmKiHpmY-TA Video
In use: Debrided forearm ready for BTM For personal use only 11
In use: BTM Implanted (Day 0) For personal use only o Full coverage of the arm o Cut and contoured to fingers o Staples retain BTM in position 12
In use: Before Delamination of BTM (Day 33) For personal use only BTM achieves full cellular integration NB: Silver on the external film is from Acticoat™ and antimicrobial protective dressing. 13
In use: Delamination of the BTM (Day 33) For personal use only Key advantages: o Neo-dermis regenerated o Quality and elasticity of the new tissue o No “pie dish” effect o One piece easy removal Video https://www.youtube.com/channel/UCL-B7V8ImJxqDmKiHpmY-TA 14
In use: Forearm with Split Skin Graft For personal use only BTM has regenerated the dermis shown in the even pink colour and SSG closure (in operating room). 15
In use: Healed Forearm (Day 180) For personal use only BTM’s key competitive advantages Lack of scar and skin contraction o Results in smooth and “full” nature of the healed forearm o Minimal “diamond” effect from the SSG mesh o Smooth and normal cosmetic appearance o Fully functional arm o Note: in the background the abdomen which is not treated with BTM is not as well healed as the arm. 16
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