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PolyNovo Limited FY 19 Annual Report Brokers’ Presentation 22 August 2019 ASX: PNV

New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

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Page 1: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

PolyNovo Limited

FY 19 Annual Report Brokers’ Presentation

22 August 2019

ASX: PNV

Page 2: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

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. 2

Page 3: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

Highlights of FY19 to August 2019

Page 3

Page 4: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

• Purchased adjacent building for hernia and breast device manufacturing

• Purchase / commissioning of new machinery for hernia and breast device manufacturing

• Appointed direct sales person in UK sales pending CE Mark

• New regulatory approvals in India, Malaysia and Singapore

• Appointed PMI as distributor for Germany, Austria & Switzerland in anticipation of CE Mark

• Sales in Saudi Arabia and India

• Team expansion, building the depth of talent and capacity within the business in US, Australia and UK

Page 4

Driving expansion

Page 5: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

Depth of Talent

• Increased headcount to 36 (June 18) 47 (June 19) 60 (August)

• Appointment of Jan Gielen CFO

• Appointment of Ashok Srinivasan COO

• Appointment of Monica Benyk as HR manager

• Appointed 1st sales person in UK/Ireland in anticipation of CE Mark approval (imminent)

• Appointed Senior Vice President Americas to drive sales and marketing in US

• Appointed East & West Regional Sales Managers (US) to support sales team expansion

• Expanded US territory sales people from 5 to 12

• Expanded Australian sales team from 1 to 3

Page 5

Total August '19

Aust 38

US 21

UK 1

Page 6: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

Noah doesn’t remember the sound of the explosion. But he does remember waking up on fire as the flames burned through his gasoline-soaked skin. Noah received 3rd degree burns to over half of his body potentially altering the trajectory of this young man’s life. Thanks to the capable hands of his surgeon and NovoSorb BTM, Noah fully recovered and walked out of the hospital 51 days later. Learn more about his incredible story.

• Watch his video through this QR Code link

Page 6

Improving patient’s lives

NovoSorb® hassignificant advantagesover competitorbiodegradablepolymers in termsof its design flexibilityand biocompatibility.

“About a month after I got out of hospital I had complete range of movement…I know if it wasn’t for BTM I wouldn’t be how I am today..Iknow that for sure.”

Page 7: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

After the train crushed his foot, Malcom was told a below

the knee amputation was the only solution. That outcome

wasn’t acceptable to Malcom or his surgeon. BTM helped to

re-cover his exposed structures so his body could heal.

Today he stands tall despite the injury that knocked him

down. Learn more about Malcom.

• Watch his story at this link via QR Code

Page 7

Improving peoples lives

“The idea at the time was to proceed with a below knee amputation…We looked at his foot and said , I don’t think this is something a biologic is going to do well on. I would like to try a new form of dermal substitute..BTM” Dr Jeff Carter

PolyNovo’s principal activity is thedevelopment of innovative medicaldevices for a number of applications,utilising the patented bioabsorbablepolymer technology NovoSorb®.”

Page 8: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

• CE Burn trial is complete with final publication of results due by end of CY 19

• BARDA funded Feasibility trial results will be published ~ March 2020 sites were

• Wake Forest Baptist Health, Winston-Salem,

• University of Tennessee Medical Centre, Memphis

• University of California Davis Medical Centre, Sacramento

• Tampa General Hospital, Tampa

• Arizona Burn Center, Phoenix

• Lehigh Valley Hospital, Allentown

• BARDA funded Pivotal burn trial will commence once US FDA approves protocol. Expected October/November 2019

Page 8

Clinical Trial update

Page 9: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

• Significant expansion of sales of BTM in the US, Australia and New Zealand.

• Expansion of sale territories

• Exciting new product pipeline in breast and hernia.

• Increasing manufacturing capacity

commission hernia production

• File Hernia US FDA 510(K)

• Achieve US DoD sales

• Drive EU/UK/Ireland sales with CE Mark

Page 9

Strategy for FY20

Page 10: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

Page 10

Top 20 shareholders

Shares %

1 HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED 58,830,306 8.9

2 J P MORGAN NOMINEES AUSTRALIA PTY LIMITED 33,667,129 5.09

3 MOGGS CREEK PTY LTD 16,000,000 2.42

4 MERRILL LYNCH (AUSTRALIA) NOMINEES PTY LIMITED 14,962,331 2.26

5 CITICORP NOMINEES PTY LIMITED 14,626,121 2.21

6 NATIONAL NOMINEES LIMITED 11,368,395 1.72

7 LATERAL INNOVATIONS PTY LTD 10,924,103 1.65

8 MONASH INVESTMENT HOLDINGS PTY LTD 9,607,520 1.45

9 THE TRUST COMPANY (AUSTRALIA) LIMITED 9,500,000 1.44

10 DR JOHN EDWARD GREENWOOD 9,457,864 1.43

11 SANDHURST TRUSTEES LTD 7,890,796 1.19

12 MR ANTHONY SHANE KITTEL + MRS MICHELE THERESE 7,620,000 1.15

13 BNP PARIBAS NOMINEES PTY LTD 5,788,011 0.88

14 J A B INVESTMENTS (SA) PTY LTD 5,055,555 0.76

15 MS SIMONE MAREE BEKS 4,185,095 0.63

16 MR PAUL GERARD BRENNAN 4,185,095 0.63

17 MR LAURENT FOSSAERT 4,110,694 0.62

18 CSIRO 4,081,250 0.62

19 MR DAVID KENLEY 3,860,000 0.58

20 BNP PARIBAS NOMINEES PTY LTD 3,850,330 0.58

Total of top 20 239,570,595 36%

Page 11: New PolyNovo Limited · 2020. 1. 17. · This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in

It takes a team