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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
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25 November 2015
Investor Presentation
PolyNovo Limited (ASX:PNV) announces an update to the investor presentation released to the ASX on 16th November 2015. The presentation summarises the prospects for the PolyNovo NovoSorb™ polymer technology for use in burns, wounds and other reconstructive surgery. It also outlines other applications such as using the polymer in hernia repair, breast implants and pelvic support. The updated presentation summarises the capital raising that the company is undertaking, and the application of the capital raised. We also outline the rationale for the acquisition of the minority interest in subsidiaries which is partially funded via the capital raising. Further information: Paul Brennan Chief Executive Officer Mobile: + 61 427 662 317 Email: [email protected]
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PolyNovo
We regenerate lost or damaged tissue through patented biodegradable medical devices.
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Disclaimer
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
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Executive Summary
1. PolyNovo is the developer and manufacturer of patented biodegradable polymer medical devices
2. The devices are made of our biodegradable polymer, NovoSorb™. The first commercial applications are in a foam-based dermal matrix and wound scaffold for regeneration of the dermis in burns, reconstruction surgery and chronic wounds
3. The devices help generate a new dermis leading to improved survival and superior cosmetic/functional outcomes
4. We do our own manufacturing and research & development on-site in an accredited cleanroom facility
5. PolyNovo has in-house specialised staff in science, regulatory processes, quality assurance, manufacturing and clinical project management
6. Strong product pipeline, outside of burns, with hernia, breast and other products to access USD$8B of market opportunities
7. High margins, no debt, scalable production and focused commercialisation pathway with revenues to begin in 2016
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Agenda
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
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Board and Senior Executives
David Williams – Chairman
An experienced Director and Investment Banker with a proven track record in business development and strategy, as well as in corporate initiatives specialising in mergers and acquisitions and capital raisings. He possesses over 30 years experience working with and advising ASX listed companies in the food, medical device and pharmaceutical sectors.
Dr. David McQuillan – Non Executive Director
David possesses extensive technical, medical, scientific and regulatory knowledge, as well as merger and acquisition expertise. Dr McQuillan was with LifeCell Inc/Kinetic Concepts Inc for 12 years, and served a number of roles of increasing responsibility, including Vice-President for Research and Development at LifeCell, and Senior Vice President of Advanced Research and Technology at KCI. Chief Science Officer for TELA Bio, a VC-funded development-stage biotechnology company from 2013 to 2015. He currently serves as an Operating Partner of 1315 Capital, a private equity partnership that provides capital to commercial-stage pharmaceutical, medical technology, and healthcare services companies
Max Johnston – Non Executive Director
Max held the position of President and Chief Executive Officer of Johnson & Johnson Pacific, the world’s largest Medical, Pharmaceutical and Consumer Healthcare Company for 11 years. During his tenure he also served as Director of Johnson & Johnson Research and was a member of their Research Review Committee. Prior to joining Johnson & Johnson, Mr. Johnston’s career also included senior roles with Diageo and Unilever in Europe. Max has had extensive overseas experience during his career in leading businesses in both Western and Central-Eastern Europe, Africa as well as Asia-Pacific.
Bruce Rathie – Non Executive Director
Bruce is an experienced company director and lawyer holding degrees in law (LLB), commerce(BComm) and business (MBA) having practised as a partner in a large legal firm and then as Senior in-house Counsel to Bell Resources Limited from 1980 to 1985 in aggregate. He studied for his MBA in Geneva and then went into investment banking in 1986. Bruce was Head of the Industrial Franchise Group at Salomon Smith Barney in the late 1990’s and led Salomon’s roles in the Federal Government’s privatisation of Qantas, Commonwealth Bank (CBA3) and Telstra (T1). He now has over 15 years’ experience as a professional non-executive company director. He is currently Chairman of eftpos Payments Australia Limited (6 years), Executive Chairman of DataDot Technology Limited (6 years) and a non-executive director of Capricorn Society Limited (7 years). In the medical device space, he was previously a director of Compumedics Limited (2 years) and USCOM Limited (5 years) and has been a non-executive director of PolyNovo Limited since February 2010 (5 years). In addition, he was previously Chairman of Anteo Diagnostics Limited (3 years)
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Philip Powell – Non Executive Director
Over 15 years experience in investment banking specialising in capital raisings, IPOs, mergers and acquisitions and other successful corporate finance assignments across a diverse range of sectors including pharmaceuticals, financial services, food and agriculture. He spent 10 years in senior financial roles at OAMPS Ltd, an ASX listed financial services group and 10 years in audit with Arthur Andersen & Co. in Australia and the U.S.
Paul Brennan – Chief Executive Officer
Paul has extensive knowledge, exposure and understanding of the health system through his clinical background and commercial exposure with various multinational companies. He has co-ordinated the marketing, global strategy development, new product development and regulatory processes for the Asia-Pacific region for industry leading organisations in relation to medical products and devices. Paul has an intimate knowledge of the manufacturing / production processes. Previously he was the Marketing Director Australia and New Zealand and Sales Director New Zealand for Smith and Nephew Healthcare from 2008 to his commencement with PolyNovo in February 2015. Paul holds a Masters of Business Administration (MBA) from Swinburne University and a Bachelor of Science (Nursing) degree from the University of New England.
Ms Andrea Goldie - CFO and Company Secretary
Andrea has over 13 years corporate governance experience with multinational companies within the Pharmaceutical and Health-care industries. Her areas of expertise include financial accounting, statutory reporting, auditing and tax compliance. These skills have been applied across a number of geographic regions including Europe, Middle East, Africa, Asia Pacific and North America. Ms Goldie is a Chartered Accountant; Chartered Tax Adviser and has a Bachelors of Economics, Finance and a MBA.
Dr Tim Moore - Principle Scientist
Tim holds a Bachelor of Applied Science (Chemistry) degree with honours and PhD. Dr. Moore’s PhD dissertation was in the field of biodegradable polyurethanes; the title was “Design and Synthesis of Biodegradable Thermoplastic Polyurethanes for Tissue Engineering”. He has been with PolyNovo since its inception and is a co-inventor of some of the variants of NovoSorb™. He developed a novel range of biodegradable chain extenders which is included in several of PolyNovo’s patent applications. Dr. Moore is also responsible for the maintenance of PolyNovo’s extensive Intellectual Property Portfolio. He was a co-recipient of the CSIRO Molecular Science Divisional Strategic Action Plan Award for Innovation (2004) and of the CSIRO medal in Research Achievement category (2005).
Dr Paul Cacioli - Commercial Scientist
Paul has over 30 years experience in leading Research & Development teams, conversion of products to large scale manufacturing and enhancing process design. Dr Cacioli is focused on our production processes to drive efficiency and scale. Paul’s experience building and commissioning production plants with Ansell Ltd, Gale Pacific and Textor enhances PolyNovo’s ability to accelerate both production of BTM and the delivery of new products. He has a PhD in Organic Chemistry.
Board and Senior Executives (continued)
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Key Staff currently 10 FTE increasing to 14 FTE
o 2 Full-time Regulatory Managers
o 2 Full-time Development Scientist
o 1 Full-time USA-based contractor Project Manager for BARDA
o 1 Full-time Quality Manager
o 2 Production staff
o Office & administrative support team
Facilities
o Class 7 cleanroom for production and product conversion
o Dedicated R&D lab
o Dedicated quality control lab with on-site testing facilities
o TÜV-SÜD quality audit reapproved February 2015
o EN ISO 13485 (2012)
o ISO 10993 biocompatibility testing
Product Formats & Patents
o Foams, laminates, thermoplastics, thermoset, injection moulding, filament extrusion and spray-on or dipping applications
o Eluting polymers
Capabilities and Team
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Corporate Overview
$A
ASX Code PNV
Share Price 16 cents (close 13/11/15)
Issued Shares 419.5 million
Market Cap. $67.12 million
Net cash on hand $2.8 million (11/11/15)
Major Shareholders
Merchant Funds 15%
David Kenley 8%
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Key Milestones
2004 PolyNovo incorporated (ex-CSIRO)
2006 NovoSkin feasibility study
2008 Port Melbourne facility established
2010 NovoSkin is incorporatedBio-Innovation SA grant ($217K)
2011 Feasibility study on NovoPore NPWT
2013 First BTM human study (Royal Adelaide Hospital)Hernia feasibility studyPelvic floor repair study
2014 NovoPore regulatory approval 510(k) and CE MarkRoyal Adelaide BTM burn trial
2015 New CEO & 2 full-time regulatory staff, additional scientistFactory expansion to enable commercial production BTM CE trials commenceRoyal Adelaide Hospital patient trial enrolment concluded US BARDA contract signedFinal stages of US FDA 510(k) approval process
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NovoSorb is a patented biodegradable polymer that can be utilised as:
o 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
Purely synthetic BTM foam matrix
o No organic remnants, sensitising proteins, no risk of rejection
Competitors are biological based
o 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
BTM Key Attributes
o Unparalleled range of mechanical properties and degradation times
o 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
The product: NovoSorb and its Uniqueness
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Biodegradable Temporising Matrix (BTM)
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
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How the BTM works
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.
BTM fully integrated The sealing membrane can be removed when donor sites are available.
Sealing membrane removed when the wound is ready for skin grafting. To date the longest period to delamination is 45 days.
Wound closed with split skin graft (SSG) and the matrix biodegrades within 12 months.
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Current standard of care BTM - Innovates the standard
o Note the lack of scar/contracture and topography.
BTM in use
o Note the scarring and the tendons in this example of the traditional approach
o Note tendons and poor skin quality
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Video
In use: Tendon moves freely
13https://www.youtube.com/channel/UCL-B7V8ImJxqDmKiHpmY-TA
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In use: Debrided forearm ready for BTM
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In use: BTM Implanted (Day 0)
o Full coverage of the arm
o Cut and contoured to fingers
o Staples retain BTM in position
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In use: Before Delamination of BTM (Day 33)
BTM achieves full cellular integrationNB: Silver on the external film is from Acticoat™ and antimicrobial
protective dressing. 16
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Video
Key advantages:o Neo-dermis
regeneratedo Quality and elasticity of
the new tissueo No “pie dish” effecto One piece easy
removal
In use: Delamination of the BTM (Day 33)
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https://www.youtube.com/channel/UCL-B7V8ImJxqDmKiHpmY-TA
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In use: Forearm with Split Skin Graft
BTM has regenerated the dermis shown in the even pink colour and SSG closure (in operating room).
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In use: Healed Forearm (Day 180)
o Results in smooth and “full” nature of the healed forearm
o Minimal “diamond” effect from the SSG mesh o Smooth and normal cosmetic appearanceo Fully functional armo Note: in the background the abdomen which is
not treated with BTM is not as well healed as the arm.
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BTM’s key competitive advantages
Lack of scar and skin contraction
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Product Pipeline and Regulatory Approvals
Product Application Market SizeUS$
Commercial Status 1st Regulatory Approval Expected
NovoPore Negative pressure wound therapy (NPWT)
~$450m of foam and gauze component supply
Discussions with multinationals building their business case, sales to start 2016
Now have CE & FDA 510(k)
BTM Surgical wounds Surgical wounds ~$800m
Multinational partner interested in US rights – first sales in 2016CE will lead to licence rights negotiations
FDA 510(k) Jan 2016CE Mark end 2017
BTM Full thickness burns Full thickness burns ~$80m
USA rights as aboveCE as above
USA FDA PMA 2022CE Mark end 2017
Hernia repair Surgical repair of hernias ~$1b Refining design, working with Key Opinion Leaders
FDA 510(k) pathway ~2018CE Mark clinical ~2018
Breast sling Breast reconstruction and augmentation
~$2b Refining design, working with Key Opinion Leaders
FDA 510(k) pathway ~2018CE Mark clinical ~2018
3D Breast form Breast reconstruction Defining design and development with potential partner
Animal study 2016
Bladder sling/pelvic floor Incontinence and pelvic floor repair
~$1.56b+ Early design specifications with multinational collaboration
Currently FDA 510(k) 2021/2CE Mark 2021/2
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Current focus
BTM ~$800M market 2016
Breast $2B market 2018
Hernia ~$1B market 2018
Bladder
$1B + market 2021/22
Opportunities further outStem cell and organ tissueregeneration within the polymer
Coatings/ Antimicrobials
2018
NovoPoreWound ~$2B market with Negative Pressure Wound Therapy foam interface ~$450m component supply opportunityEarly negotiations in progress
Bone Void Filler$2.3B market 2020/21
USD$8B+ market
Projected Developments and Markets
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Capital raising
PolyNovo has completed a $8.5m placement to institutions and sophisticated investors at $0.135 per share within the Company’s placement capacity under ASX LR 7.1 and plans to raise further capital through a non-underwritten Share Purchase Plan (SPP) at the same price as the placement.
The capital raised will be used to fund:• Operating and regulatory costs in FY16 and FY17• The acquisition of minority interests in its subsidiaries (see slide later)
*Capital raising:• The amount raised under the placement represents a significant
proportion of PolyNovo’s funding requirement • Additional funds raised through the SPP will be applied to further
working capital. The Board reserves the right to scale and close the SPP offer early
Application of proceeds & pro forma cash positon
($m)
Minimum capital raised 8.8
Costs of raising (0.7)
Total capital raised net of costs 8.1
Cash on hand - 11 November 2015 2.8
Pro forma cash balance post-raising 10.9
Used for:
Business as usual opex & working capital (4.1)
US trials to obtain FDA approval (1.3)
CE Mark trial (0.7)
Additional staff (0.8)
Regulatory and new projects (1.5)
Buy out of minority interests (2.5)
(10.9)
Cash surplus at 30 June 2017 0.0
These numbers exclude gross margin on expected sales and are net of BARDA
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Timetable
Date (2015) Item
25 November Recommencement of trading
30 November Settlement of placement
2 December SPP offer booklet despatched and offer opens (2 week offer period)
16 December SPP offer closes
22 December Settlement of SPP
23 December Allotment of SPP shares
24 December Holding statements despatched and SPP shares commence trading
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Proposed Acquisition
o PolyNovo is proposing to acquire the 20% minority interests in subsidiary companies NovoSkin Pty Ltd (NovoSkin) and NovoWound Pty Ltd (NovoWound) owned by Professor John Greenwood AM and Julian Burton OAM; subject to due diligence
o NovoSkin and NovoPore are JVs established to conduct the non-clinical development of the BTM and NovoPore and hold the marketing rights for all wound applications (PolyNovo owns the IP)
o The proposed consideration will be:
o $2.5m cash (in phased payments)
o 32m PolyNovo shares (escrowed until 31 May 2016). If the placement is successful, PolyNovo will need shareholder approval (under Listing Rule 7.1A) to issue the consideration shares
o Benefits of the roll up are:
o It enables PolyNovo to be entitled to 100% of all future revenues including up-front payments, royalties and sales
o Professor Greenwood’s and Julian Burton’s interests will be directly aligned with all other shareholders
o Organisations like BARDA and large distributors have expressed a preference to deal with PolyNovo with full control of its assets
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Market Projections and 2016 Work-plan
Path to revenues starting 2016
o Income from H2 through BTM sign-up rights and sales
o Europe sales expected to commences 2018
o Further milestone and sign-up payments each region
o Hernia and breast sling anticipated to reach FDA 510(k) filing in H2 2017
Regulatory/Clinical
o Achieve USA FDA 510(k) approval leading to commercial sales of BTM
o Continue CE Mark trials in Australia & France
o Begin clinical trials in USA with BARDA funding support
o Commence regulatory processes in India, China, Brazil, South Africa, Indonesia
o Begin animal studies for hernia & breast sling products
Manufacturing
o Scale-up production infrastructure for commercial sales in the US
o Establish design requirements for automated production and map validation pathway
R&D/Marketing
o Advance BTM licencing discussions with chosen multinational
o Achieve a design freeze on the hernia and breast sling products
o Establish/finalise formal co-development agreements in customised breast prosthesis
o Progress Smith & Nephew bone void filler towards design freeze25
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2/320 Lorimer St, Port Melbourne Vic 3207
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