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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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1 September 2015
Investor Presentation PolyNovo Limited’s (ASX:PNV) Chief Executive Officer Mr. Paul Brennan will present to an investor group in Sydney and Melbourne on the 1st and 2nd September 2015. Attached is a copy of his presentation. Viewer discretion is recommended as some pictures are graphic in nature. For further information please contact: Paul Brennan Chief Executive Officer Mobile: + 61 427 662 317 Email: [email protected]
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Corporate Presentation
Biodegradable, Regenerative Polymer Technology
Changing the Standard of Care
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Paul BrennanCEO
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PolyNovo Limited ASX:PNV
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
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 Limited 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, or 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.
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PolyNovo Limited ASX:PNV
A Solution to a Surgical Challenge
o PolyNovo develops Regenerative Devices for
reconstructive surgery and tissue repair with our
patented biodegradable polymer technology,
NovoSorbTM
o Technology origins from CSIRO, patented and spun
out.
o NovoSorb is a family of medical grade polymers
used to form medical devices that facilitate the
reconstruction or repair of failed tissue. NovoSorb
can be tailored to a desired strength, elasticity or
degradation profile.
o NovoSorb has significant advantages in terms of
safety, toxicology profile and strength.
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Repair of Surgical Wound - BTM
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Current Standard of Care BTM- Innovates the standard
Note the lack of contracture and even topography with the BTM
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Tendon is free to move
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BTM for Burns
o BTM offers a reconstruction which produces a result similar to a full thickness graft
o When there is not enough donor skin available it allows the wounds to be temporised, creating a neo-dermis while donor sites recover for the harvest of further skin grafts or whilst skin is cultured in the Lab.
o These images demonstrate the integration at Day 6 and the outcome of the finished tissue, note the smoothness and lack of contraction.
o A Five (5) patient clinical trial in progress at Royal Adelaide Hospital by Principal Investigator, Associate Professor John Greenwood AM. Three (3) patients completed to date.
o Results outstanding
Day 6
Day 146 BTM Day 96 Graft
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Adelaide BTM Burns Trial Patient
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Delamination of BTM
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Bringing NovoSorb BTM to market
o Regulatory paths through clinical trials
1. Achieve 510(k) approval for use in Surgical Wounds anticipated January 2016
2. Establish Clinical trials for FDA PMA approval in Burns, February 2016 ;
• Contingent on BARDA funding.
3. CE Mark trials commenced in Australia & France
o CE Mark anticipated Mid-2017
4. Prioritising jurisdictions where access can be achieved with existing data.
o Commercial execution
o We will initiate direct sales to establish market penetration where we have regulatory approval
o Establish commercial partnerships or licence agreements with KPIs around sales performance and revenue generation
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We anticipate commercial sales in US Market Early 2016 once 510(k) approved
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BTM
2016 US Sales Opportunity
o All surgically clean wounds
o Repair post melanoma, or tissue excision
o Free Flap surgical repair
o Partial & full thickness burn – skin
reconstruction
o Diabetic Foot Ulcers
o Venous Leg Ulcers
o Pressure Injury
o Trauma
o Reconstructive Surgery
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How does the BTM work ?
Full Thickness Burns & Surgical Wounds: 2 stage closure
BTM in full thickness burn post surgically 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 longest 45days.
Wound closed with split skin graft and the matrix biodegrades within 12 months.
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What makes NovoSorb unique?
o Purely synthetic matrix.
o No organic remnants, GAGS or other proteins
o 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 NovoSorb advantage:
o Cosmetic outcomes, lack of contraction
o Fully regenerates the dermis
o Resilient against infection
o Robust product that is easy to handle, cut and apply
o Fat cells do grow within the matrix (O’Brien institute study)
o Fully biodegraded in ~12 months (e-Plasty paper)
o Ease of manufacture, scalable and reduced cost
o Stable product with simple transport and storage requirements
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Capabilities
Key Staff
o 2 Full time Regulatory Managers
o 1 Full time Principal Scientist
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 onsite testing facilities
Accreditation Standards
o TÜV-SÜD quality audit reapproved February 2015
o EN ISO 13485 (2012)
o ISO 10993 Biocompatibility testing
Product Formats
o Polymer Foams
o Polymer Foam Laminates
o Thermoplastic Polymers – Thermoset, Injection moulding, Filament Extrusion
o Polymer solutions for spray on or dipping applications
o Eluting Polymers
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The NovoSorb™ Foam
PolyNovo’s lead products are based around the NovoSorbTM biodegradable foam which has applications as a tissue scaffold in:
Developed:
o Burn and wound repair
o Biodegradable Temporizing Matrix (BTM)
o Negative Pressure Wound Therapy
o NovoPore negative pressure wound dressing
In-Development:
o Hernia repair
o Pelvic Floor repair
o Breast Reconstruction
o Breast Augmentation
o Breast Slings
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Barriers
o Biodegrades
o Proof of full degradation. Clinically proven in free flaps and published in e-Plasty paper.
o NovoSorb / BTM delivers a better outcome than current standard of careo Compared to biologic products it is easier to handle, cut
and applyo It is resilient to infection verses current matrix optionso The elasticity of the healed skin is considerably better and
the scar formation significantly reducedo No cross species or antigen responses due to no proteins –
completely synthetico No ethical concerns around cadaver skin or placental
harvesto No concerns for sharks with shark fin harvest.
o Market accesso Initially targeting plastic surgeons- defined groupo In discussion with multinational device companieso Can scale sales force with partnerships and geographical
rights assignment.
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Corporate Overview
Board
David Williams Chairman
Bruce Rathie Non Exec.
David McQuillan Non Exec.
Philip Powell Non Exec.
Max Johnston Non Exec.
ASX Code PNV
Share Price 11.5 cents (27/8/15)
Issued Shares 418 million
Market Cap. $48 million
Cash on Hand* $3.5 million
Major Shareholders
Merchant Funds 16%
David Kenley 8%
*As at 30 June 2015
Management
Paul Brennan Chief Executive Officer
Tim Moore Principal Scientist
Chris Mews CFO/Company Secretary
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2 year Share Price Trend
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Development through to Commercialisation
o 2004
o PolyNovo incorporated ex-CSIRO
o 2005
o Medtronic licence (stent)
o 2006
o BTA agreement (St Vincent, Bionics Institute)
o NovoSkin feasibility study
o 2007
o Biomet licence (cartilage, CMF)
o 2008
o S&N licence (fracture fixation, bone void filler)
o BTA agreement cancelled
o Port Melbourne facility established
o Metabolic acquire 60% of PolyNovo
o 2009
o Medtronic licence cancelled by PNV
o 2010
o Biomet licence cancelled by PNV
o NovoSkin is incorporated
o Bio Innovation SA grant ($217K)
o Focus on wound management
o 2011
o Feasibility study on NovoPore NPWT
o 2012
o NovoPore (NPWT) clinical trial
o 2013
o First human study (BTM in free flap – Royal Adelaide)
o Hernia feasibility study (TelaBio)
o Pelvic floor repair study (Coloplast)
o Capital raise of $4.5m
o 2014
o NovoPore regulatory approval 510(k) and CE Mark
o Royal Adelaide BTM Burn Trial
o 2015
o Divest Metabolic for $1.5M plus future 20% Royalty stream
o New CEO & 2 full time Regulatory staff
o Factory expansion and higher volume production equipment fit out
o CE Trials commence
o BARDA agreement in discussion
o Final stages of FDA 510(k) approval process
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Markets
o USA will be the first market with Surgical Wound approval,510(k)
o Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Injuries, Trauma, Reconstructive Surgery (including Burn reconstruction- contractures)
o Europe, Australia and others that rely on CE Mark Certification as a regulatory basis
o Current trials are 12months recruitment & 12 months follow through
o Toulon, France and The Alfred, Melbourne
o July 17 expected CE Certification
o India, China, Indonesia, South Africa and S.E.Asia are the next focus points for regulatory approval scoping
o All countries have significant volume of burn injuries
o BTM offers significant shift in clinical outcome.
o Large scale will reduce production and in-market cost
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Board and Senior Executive
David Williams – ChairmanDavid is 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 raising. He possesses over 25 years’ experience working with and advising ASX listed companies in the food, medical device and pharmaceutical sectors.
Dr. David McQuillan – Non Executive DirectorDr McQuillan was appointed a Director of PolyNovo on 6 August 2012 and Joint Acting Managing Director on 15 July 2014. Dr McQuillan 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 DirectorMax 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 DirectorMr Rathie 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 eftposPayments 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 DirectorPhilip has 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 utilities, IT, financial services, food and agriculture. He spent 10 years in senior financial roles at OAMPS Ltd, a former ASX listed financial services group and 10 years in audit with Arthur Andersen & Co. in Melbourne, Sydney and Los Angeles. Philip has been involved in numerous IPO engagements, valuations and venture capital related raisings.
Paul Brennan – Chief Executive OfficerPaul 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 in NSW, General Nursing and Midwifery Certificates.
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Board and Senior Executive (continued)
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