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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 1 25 November 2015 Investor Presentation PolyNovo Limited (ASX:PNV) announces an update to the investor presentation released to the ASX on 16 th 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] For personal use only

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Page 1: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 2: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

PolyNovo

We regenerate lost or damaged tissue through patented biodegradable medical devices.

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Page 3: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 4: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 5: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 6: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 7: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 9: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 10: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 11: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 12: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 14: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

Video

In use: Tendon moves freely

13https://www.youtube.com/channel/UCL-B7V8ImJxqDmKiHpmY-TA

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Page 15: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

In use: Debrided forearm ready for BTM

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Page 16: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 17: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 20: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 21: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 22: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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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Page 23: Investor Presentation - · PDF fileInvestor Presentation PolyNovo Limited (ASX: ... We also outline the rationale for the acquisition of ... expectations or plans set out in this presentation

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

funding22

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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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