PolyNovo Limited (ASX:PNV)
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Sep 17, 2026, 4:10 PM AEST
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AGM 2020

Nov 13, 2020

David Williams
Non-executive Chairman, PolyNovo

Good afternoon, everybody, I welcome everybody to the meeting. Apologies for being a minute late. We're just waiting for one of our directors interstate to get sound, we're going to proceed in any case. We've got a quorum present, I declare the 2020 annual general meeting of PolyNovo open. I'm David Williams, I'm the Chairman of PolyNovo. I'm delighted to be able to extend a warm welcome to all of our shareholders into participating in this online market forum. I'm told just before we went on air a second ago that we had over 200 people on this call, which outguns CSL, believe it or not, even though they long outgun us in market cap

I'm so happy to see the interest, and I noticed that the last one that we did of these, we had quite a number of online shareholders and participants from Finland, a nd Western Europe and U.S. and U.K., and so forth. Welcome to everybody. Thank you for staying up or not going to bed so early, as the case may be. Before I start, and hopefully I've got a little bit of a treat for you today, I think, using this technology, we might try and do a couple of slightly more interesting things than a typical AGM. Before I get started, let me introduce my directors. I probably won't flash them all up on the screen, but starting with Robyn Elliott, who joined the board in October 2018. She is a senior executive at CSL, and she is standing for election today.

Christine Emmanuel, who joined the board in May 2020, and has recently just left CSIRO. I've got Bruce Rathie on the line who's part of our audit committee, lives in Sydney. We've got Philip Powell on the line, chairman of our audit committee and retiring today. I've got David McQuillan on the line from Philadelphia, Australian living over there with wide experience in skin, and just finished getting a change of president in the U.S., so it's probably his vote that counted. I got Max Johnston on the line, hopefully from Kentfield. although he couldn't get sound just before. I've got Leon Hoare on the line. That's our board. It's a pretty full board, but as you know, and I might as well say it now, today, Max Johnston and Philip Powell are both retiring on the board. They're getting old.

They're showing their age, and they want to really retire, they tell me. We wish them lots of luck. They've both been with me for the last five years on this board, and so have seen the whole journey from cents per share to nearly AUD 3 per share, and they've both been fantastic contributors. Sorry to see you guys go, and thank you very much on behalf of all shareholders and certainly on behalf of myself and the board, for your contribution. I'd also like to introduce our Managing Director, Mr. Paul Brennan, and our CFO Company Secretary, Jan Gielen. We also have in attendance Ross Burton and Joanne Lonergan from our auditors, Ernst & Young, and Bart Oude Vrielink from our company lawyers, MinterEllison.

As we're holding the meeting virtually this year, I'm anticipating there won't be any problems, but if there is any technical problems, I'm going to ask Philip Powell, presuming he also doesn't have technical problems, to be my deputy chairman. Let me move on to the notice of meeting, then. The notice of meeting was dispatched to shareholders in compliance with the company's constitution and is also available on our own ASX website as an ASX announcement. I'll take this notice of meeting being read. Voting today will be conducted by way of a poll on all items of business. To provide you with enough time to vote, I'll now open the voting for all resolutions. You can vote as you like. If you want to change your vote as you go through, you can do that as well.

If you're eligible to vote at this meeting, a polling icon will appear at the bottom of your screen. Selecting that icon will bring up a list of resolutions and present you voting options. To cast your vote, simply select one of the options. There is no need to hit the submit or enter button, as the vote is automatically recorded. You can change your vote, as I said, at any time up until I declare the voting closed. Voting is now open on all items of business. The polling icon will soon appear. Please submit your votes at any time. I'll give you a warning before I close the voting. I'm going to appoint Angela Liapis of Computershare, who's been around as long as Max Johnston, and Philip Powell, and myself. Welcome, Angela, and she will be the Computershare Investor Services Returning Officer.

Results will be compiled and released to the ASX after the conclusion of this meeting. I'll close the voting, close the meeting, and Angela and her team will do the work and hopefully have the results up on the ASX within the hour or thereabout. Questions can be submitted at any time. To ask a question, click the speech bubble icon on your screen. This will open a new screen. At the bottom of that screen, there's a section for you to type your question. Once you've finished typing, just hit the arrow, and it will send. Please note that you can submit questions from any time now on. I'll not address them, however, until we get to the appropriate section in the meeting. I'm anticipating if there are any questions, there may be duplicate questions.

Jan, our CFO and Company Secretary, will moderate those, amalgamate them if needed. If, for any reason, we run out of time, we will answer them by email after the event. Financial statements and reports. Item one on the notice of meeting is to receive and consider the annual financial statements for the 12 months ended 30 June 2020 for the company and its controlled entities, together with reports of directors and auditors. Are there any questions in relation to the financial report or of the company's auditor?

Jan Gielen
CFO and Company Secretary, PolyNovo

There's no questions, David.

David Williams
Non-executive Chairman, PolyNovo

Jan doesn't have any questions. If there are no questions, I believe there was a question prior to the meeting from the Australian Shareholders' Association, which was asked of Joanne Lonergan and also of the company, I think effectively answered that well. If there's no questions or further discussion on this matter, I'll consider the financial report and directors' and auditors' reports received and adopted. Let me talk about the chairman's, managing directors, and other addresses that I propose to do today. Before we move on to formal resolutions, I would now like to make some observations about the business, and then I'm going to invite Paul Brennan, our managing director, to talk about the year just passed and the year ahead.

I'm also going to ask Ed Graubart, our Senior VP of Sales in the U.S., who is also online, to say a few words about the business and about how the U.S. is running, and so forth. It's a bit of a treat for you there. As I said, I want to try and do things slightly differently this year and introduce you to a few more people around the business. We have our new COO, Chief Operating Officer, Anthony Kaye, who only joined the business on Monday. He's come from CSL, I'm going to ask him to introduce himself as well. He won't get a big cameo appearance, Anthony, but just to introduce where you've come from, what you've found in the last three days, hopefully that you're not ready to resign.

I just want the shareholders to get a better feel for some of the people on the team. I propose to introduce each of the directors standing for election as well, which will be David McQuillan in Philadelphia, Robyn Elliott, and Christine Emmanuel. When we come to those elections, I'm gonna get them on the screen and just let them introduce themselves so you can get a better feel for the board and the team behind the company. Okay. Before I introduce Paul Brennan and Ed Graubart from the U.S. and Anthony Kaye, our COO, I'd just like to say a few words about the business. I've been thinking about this for the last couple of days because this online presence now allows us to obviously hit and communicate with a lot of shareholders who wouldn't otherwise get to hear this.

The brokers, of course, and the institutional fund managers get to hear us all the time. The ability to get to what is now over 200 people online all around the world is sort of a valuable exercise for us and hopefully for you as well. At the risk of turning this into a sort of broker presentation in itself, we'll get to the formal part of the business, and Paul Brennan and others will talk more formally about the business. I thought it might just be useful for people to hear, from me at least, a little about how we see the business and perhaps how you should look at the business, and not treat this just as a reporting of our accounts and the year just passed from a sort of financial perspective.

I think the first thing I'd say is that I look at this business as a win-win for surgeons, a win-win for patients, for shareholders, and a big win for Australian technology. At the superficial level, as investors, we look at the share price, and when I came into this company, the share price was AUD 0.07. Just to fast-forward two years ago, 13th of November 2018, the share price was AUD 0.56. Last year, 13th of November, it was AUD 2.19. Today, I haven't looked right at this second, but it looked like I put down AUD 2.80 this morning. It's now AUD 2.95 with a market cap of AUD 1.95 billion.

By anybody's standards, from a shareholder's perspective, a fantastic result. I know from the many shareholders that contact me that it's been, for many of you, wealth -making and life-changing, especially for those of you who were around when the share price was seven, eight, 10, 20, or even AUD 1 a share. There's been significant wealth created. The thing that struck me most, I think, from shareholders who have made a lot of money out of this company, is how proud they are of how important this has become as a product in international markets, and how proud they are of the life-changing benefits that it's had for shareholders.

We know from first experience that patients who would have otherwise died with 50%, 60%, 70% burns to their body, patients who would have otherwise had limbs taken off and been able to keep them because of this product, patients who would have been severely disfigured cosmetically, and now walking around in perfectly good shape and cosmetics. We know how important this is, and there's nothing more satisfying than knowing that. If you don't see it, we hear it all the time from surgeons. We hear surgeons saying, "I don't believe what I've seen." We hear surgeons saying, "This is going to change the way in which surgery is done," whether that be for diabetic foot ulcers, or burns, or wounds, or whatever else that might be. It's a fantastic win for patients.

What a beautiful position to be in as shareholders, to be able to say, "Look, I've made really good money off this as an investment," but what a world-changing experience this is for medicine. It's interesting, I think, just for shareholders in particular, just to reflect on this for a moment. How did that happen? Were we in the right place at the right time? Is it a fluke? Was it just luck? I just want to say something philosophically, because I think we've got hundreds of companies in this country that are in biotech, in devices, in pharma, and unfortunately, many of them will go broke. Not because the science is no good. The science, in many cases, in most cases even, is fantastic. People hold onto their tech too long, and they hold it too close, and they underfund it.

I think one of the great benefits that we've been able to derive from this company is not just because the technology's great. The technology's great. The genesis of it came out of CSIRO, the polymer technology, the company itself, and our really fantastic R&D people like Tim Moore and that have developed it into a worldwide product. Everybody can, not everybody, but there's many people who could do this. What we've been able to do, I think, in changing this company is to raise enough capital to really let the tech work for itself, to make the most out of tech. It's a crying shame that we're going to lose so much tech in pharma and device companies in this country that are sort of underfunded because people don't raise enough. They raised AUD 2 million when they should raised AUD 10 million.

They raised AUD 4 million when they should raised AUD 20 million. We've raised enough capital to be able to take this to the world. We now have a product that, when we go into a new market, people have heard about it, people have been to the conferences, people have read the research papers, and they still might want to test it. They still might want to trial it and use it on one of their customers. What I know, and maybe they feed me a lot of the BS as the chairman, but I haven't heard any negative comments. As soon as I hear that a doctor's trialing it, I know in my own mind that the chances of him buying it are nearly 100%. That's the way I see it.

Maybe they've got somebody who says a negative comment that I've never heard of. Wh at a position to be in, so that you know when you put people on the road, and they go to see the best surgeons in Germany or Austria or Iowa, then you know that there's a very good chance that they're going to buy the product. What is the product? I'm not sure, I may be turning this into a show and tell, here's the product, I think. Can everybody see that on the screen, Robyn? I can't. Yeah. Here's the product. I'm a surgeon in a hospital. I'm about to tackle somebody's burn on their arm, or their wound, or a foot ulcer. I open this pack, I pull out the product, this is what it looks like.

I hope I'm not boring anybody. I just want to give people a bit of a sense of this. This is a 10 -by -20 piece of our foam. As you can see, it's probably no thicker than my shirt, and it's a foam, so you can't really see what I can see, which is like it's like any foam that if you looked at it under a microscope, plenty of little holes and so forth, and a laminate on top. That is a 10 by 20 piece of our product. There it is there. That is AUD 1,900 per piece. It's a very expensive product. Trust me, the margins are extraordinary.

The more important thing is it's not only a very expensive product, but it's probably a third or less than a third the cost of its nearest competitor, which are synthetics in the main. It not only gives a superior result for surgeons, but it's cost-effective as well. I don't think the surgeons, by the way, in the main, we know, are interested too much in the cost. They want the best outcome. I'm going to put that on somebody's body. I'm going to debride them of their skin, and I'm going to put it on their body, and this will immediately turn red as the blood and the cells go into the foam, which looks like some honeycomb. After a month, two months, three months, this disappears, and you're left with a dermis rebuilt.

I like to say to people, "Better than when you were as a baby." The result of this and how I cut it and how I form it into a wound, goes to the skill of the surgeon. When surgeons see the results of this, they are over the moon. That's the product. The interesting thing about this product, though, is that it sells itself in many ways, and because most people have heard of it, and they've heard of it through the fantastic work of Dr. John Greenwood, who's just incidentally retired himself from Royal Adelaide Hospital. They hear it from the fantastic work of Dr. Marcus Wagstaff, who's also at Royal Adelaide Hospital.

Unbelievable surgeons, unbelievable product developers who've worked with us on not only making the product right, but in taking it to the world through world conferences and academic papers and through webinars and so on and so forth. That's the product. When we put people on the road to go out and sell, it seems to sell itself. Let me just give you a sort of an anecdote about how that's sort of happened in Australia. You know, when you look at our sales, two years ago, we had our first year of sales. I think they were AUD 9 million last year. I think they were AUD 20 million. What will they be this year? One of the things I noticed is we had one saleswoman, actually, in Australia, Valerie Young, a gun, and she was doing the whole of Australia and New Zealand.

You can probably only get around 15 or 20 hospitals, it's very quickly, you can do AUD 1 million worth of sales as one person, but you're not covering the market. We say to ourselves, "Well, why don't we trial another saleswoman?" We put somebody on in New South Wales. Next thing we're doing AUD 2 million worth of sales. Why don't we put on a third? We put somebody on in Brisbane, and we're not quite at AUD 3 million yet, but we're pretty close. How many can Australia take? Maybe four, maybe five. Before we even talk about other new products, I'm just talking about the core product that I've just shown you. If Australia could take four or five, California can take four or five. You get my drift.

When I look at the business, if we want to make the most out of this technology, and the technology works, forget about what we might do from a research and development and new product perspective, is a matter of getting more people on the street. If you look at what we're doing, for example, in Germany with PMI, where we've got a distributor there, PMI does Germany, Austria, Switzerland, seeing the same sort of KOLs that we would typically see. At the moment, they're servicing 20 hospitals. There's 30 hospitals trialing. There's another 40 that are in the waiting list.

You can see the sort of ramp-up, if you like, and our problem, not so much a problem, but our challenge in each of these markets is to get the right people on the road, as quickly as possible, well-trained, and then to get the sort of coverage. When you go into a hospital, for example, in the U.K., where our sales have been a bit slower than we might have wanted this year, not only just because of COVID, but I think when I looked yesterday, I think we had 31 hospitals trialing the product in the U.K. We've seen some orders this week, but I know where that's going to lead us to. For me, it's a matter of getting coverage, and that's how I sort of look at the business. What does that mean in the medium term?

More people on the road, of course. Product development, and not only product development, but what sort of glues you use and so on and so forth. As you know, we're also working on hernia, and we're working on breast. When we get those products ready for market, we've got a choice about, gee, do I put on a separate sales force or do I ask Valerie Young to stay at Auckland Hospital longer and go down to floor number two and floor number three and see different types of surgeons? We just see those new products as not only giving us new products, of course, but giving us new people to see within each hospital, and so forth. That's how I sort of see the business from a high level. What does that mean in terms of R&D?

Well, let me challenge you. Here we are sitting here right now with a company worth AUD 1.95 billion. What would you expect to see in a company that big in terms of an R&D team? Well, until just recently, our R&D team was Tim Moore, and Tim Moore, and Tim Moore. As a board, we have recently decided we really need to rev up this R&D development ourselves so that we can have some significant input into not only hernia, but breast. There are a number of other products, especially orthopedic products, that we're working on that we haven't sort of mentioned yet to the market. We don't want to sort of overexcite people, even though we're overexcited about it. We need to spend a lot more on R&D.

We've got an active program at the moment looking for people to join Tim in R&D. Anthony, who's just joined as COO, will take over R&D as well as manufacturing in his wider COO role. Anybody who knows anybody who's looking for a job in R&D, especially if they've got experience in polymers, wherever they are in the world, we're open for business. We really want to ramp that side of it up. On the one hand, we're looking at sales, direct or distributors. On the other hand, we're looking at R&D. You might be sitting there thinking, "Well, all these opportunities are there.

Why aren't these lazy buggers doing something about it?" Well, I've heard a little bit of criticism of that from time to time, not much, but I sort of laugh, because philosophically, as I said to you, one of the things that has been our success is that we raised money, and when we came in, sort of five years ago at a seven, 10 share point, there were eight staff. Now we've got over 80. When people say, "Why don't you go harder?" I think, "Jesus, where were you five years ago? Where were you three years ago?" We're going as hard as we can responsibly go because it's still pharma, it's still a medical device. We've got to do it in the right way. You'll see this morning, we announced that the FDA has now approved our IDE trial. It's getting done.

Would we love to go harder and faster? Of course. Like in R&D, we're out there looking. We just need to get the right people on the field or the right players on the pitch, as we say. What does all this mean in terms of board and management structure? As I said, where did all the success come from? Of course, it requires a good board. Of course, it requires good management. First and foremost, it requires good tech. Secondly, and probably more importantly, it requires a good capital structure to make the most out of that tech. That's what we've been sort of busying ourselves, and it's a constant source of challenge to us. Let me just say something about the board who I've just introduced. We are solidly of a view as the board that we need a working board.

We're not interested in having an all-boys club. We're interested in having people who've got very technical experience, but also board experience. We need people like Philip Powell, 10 years Arthur Andersen, 10 years finance director in a listed company, 10 years in investment banking. We need people like that, of course, on the audit committee. We need people like Robyn, who's come out of CSL, or was in CSL, in manufacturing, controlling audits, controlling risk profiles. We need people like Christine, who's come out of CSIRO, in charge of IP, who spent her life in legal firms in the U.K. and Australia in IP. We need people like Max and Leon, who have come out of commercial organizations, running J&J in Australia, running Unilever in Europe, and so forth.

We've got a real working board, and I think one of the things that I hear most from institutional shareholders in particular is, "Shit, how'd you get those people?" Some of those people are on AUD 500,000 , AUD 1 million salaries, and you've got them on your board for AUD 60,000. You're buying a lot of experience and a lot of enthusiasm for a small amount of money. Ladies and gentlemen, I could go on forever, I just wanted to use this time, given especially we're online, just to give you a sort of a slightly different view about how we see the business and how perhaps you might want to look at the business in terms of where the risks are and where our growth is going to come from in terms of what's important in this company. Thank you for that.

I haven't finished talking yet because I've got a lot of people to introduce and perhaps some questions to answer, and so forth. Before I go on, let me introduce you to Mr. Paul Brennan, who's our Managing Director, and he's going to say a few words. I should say before I introduce anybody else that because this is now live, we will take this and hopefully within some time this afternoon, all these speeches will be up. I've asked Jan whether we can edit it so that you'll see it on the screen to say, "Look, I only want to see David Williams, and he's at two minutes 57." I imagine everybody's going to say that. Some people might want to look at Paul, and he's at five minutes 57 or whatever. Don't take notes.

You can replay it over and over again to your friends and family. Let me introduce Paul Brennan, the Managing Director, who will bring this back more or less to a normal type of AGM presentation. Paul, it's over to you.

Paul Brennan
Managing Director, PolyNovo

Thanks a lot, David. Thank you, everybody, for your attendance at this AGM. It's been a very challenging year, one with continued growth of the business, and we've been building the new factory, and we've been juggling all the challenges of COVID. I'd like to thank our staff from the outset for their flexibility, their determination, and perseverance, particularly through working through the COVID challenges. Thank you also to all the investors for your ongoing support. Sales revenue for NovoSorb BTM continues to be very strong, from AUD 9.3 million in FY 2019 to AUD 19.06 million in FY 2020. This has been achieved through a H2 impact of COVID, and travel restrictions, and hospital access challenges, and head office lockdown for 120 days for all of us in Victoria.

The ability for us to pivot and conduct our business from a digital platform, supported by a sales team that's made face-to-face visits wherever they could safely do so, has been fantastic. We stand out amongst medical device companies for the continued growth under such difficult circumstances. What enables PolyNovo to achieve this? Talented and flexible staff, early and comprehensive action to protect our production facility and staff, early investment in the upgrade of our ERP system, and the establishment of a centralized CRM. The ERP system actually feeds live data into our CRM. Integrating some of our IT platforms has actually enabled us to do this pivot. We purchased reinvestment databases from the U.S., which is loaded into that CRM and gives a very clear roadmap to our sales force of where to go and who they need to be talking to.

Our established key opinion leaders have extensive experience in BTM, and they've been very willing to share that experience with their peers through webinars. Continued account acquisition, which has been central to the business being able to grow, but also the deeper penetration within those accounts, along with the expansion of the geographical reach by bringing on new heads and entering new markets. Good intellectual property management is also central to our ability to perform. We'll continue to harness this energy and drive and to keep the momentum towards doubling our business in FY 2021. Embracing change should be seen as an opportunity. Change is not a negative thing to be afraid of. We need to embrace change and adapt. For the commercialization of BTM, I'll run through some of the highlights of each of the markets, starting with the U.S., purely because the U.S. market is our largest market.

The U.S. business continues to grow despite the COVID challenge. That is under further challenge. As you would have seen today, the U.S. is running at 150,000 new cases a day. The thing to understand from the outside with the U.S. is that they are 50 markets. They're not really 50 United States operating as one market. Our team did very well negotiating the challenges of the U.S. market. The team have continued to open new accounts and gain deeper penetration within their existing accounts. These two strategies are not binary. We must and can do both. The revenue outside of burn continues to grow. Many of these complex cases can be seen in the various webinars that we've published. The competitive response has been largely unchanged in the past year. We remain focused on our value proposition and execution of our sales and marketing strategies.

We continue to work with GPOs and IDNs for agreements, and we have two signed to date, and Ed will cover some of this a little later. This has been interrupted by the COVID restrictions on the GPO side. Recently, those meetings and forums have reopened, and we have re-engaged. We're looking forward to having some further significant GPOs join the PolyNovo family shortly. The sales team will continue to expand throughout the year. We're currently sitting at around 21. We expect that number to be circa 30 by June of 2021. Our geographical reach has expanded, and the existing sales teams have smaller territories to enable greater account penetration, and they've added new accounts within the same state. We increased the regional sales managers' positions from two to four, and this enables managers to coach and mentor their sales teams more closely and drive revenue growth.

This approach also ensures we stay close to our customers, and we're able to respond quickly to any business initiatives or needs. In Canada, just to the north of the U.S., we've actually had several surgeries done, some of these on children. These have been done under the Canadian Exemption Approval Scheme, and we're working on our Canada registration and hope to have further news on that in H2. I'd like to personally thank Ed Graubart for managing the logistics and interactions of those Canadian cases, which were done exceptionally well. For Australia and New Zealand, both Australia and New Zealand have had good sales, and they continue to grow. The White Island volcano tragedy did have a H1 FY 2020 impact, a positive impact. Our teams, logistics, sales, finance, management were highly responsive to the tragedy.

The surgical teams did an awesome job of caring for those patients and continue to support them in their long-term recovery. It's humbling for all of us, and motivating, to be working with clinicians around the world who are focused on the outcomes of their patients. We've seen NovoSorb BTM use expand through public and private hospital sectors, and a wide range of indications has been especially encouraging. One teaching hospital vascular department recently presented to the PolyNovo team their experience of BTM on 35 patients with ischemic limbs, vascular wounds, and diabetic foot ulcers. The outcomes are extremely positive, and many saved limbs. The savings to the health system and the quality of life benefits to these patients is enormous. Our sales team have expanded to four during the past year, and we're looking for further expansion within this financial year.

Valerie and her team are very customer-focused, and they're great ambassadors for the company. For some of our other markets, we entered Europe, so with our CE mark approval in December of 2019, this enables sales throughout Europe, U.K., and Ireland. In the DACH region of Germany, Austria, Switzerland, we appointed PolyMedics as our distributor. They've had an existing customer base, and they've had very good relationships with these key opinion leaders. The first surgeries were actually completed in January, and sales have been very strong and building every month since. Several surgeons within the region have also conducted their own private webinars, sharing their experience with peers, extolling the virtues of BTM. We are extremely pleased with PMI's performance to date, and we'll have further news on PMI in the coming period.

The U.K. and Ireland, we expanded our U.K., Irish team this year, and we have three salespeople, one marketing person for the European and Middle Eastern markets, and a regional business development manager to manage our European distributor relationships and expansion. NovoSorb BTM has been evaluated in more than 37 surgeries across 13 NHS hospitals through 22 surgeons, and these numbers are growing. We have achieved only modest sales to date. However, the range of uses of BTM and the positive feedback augurs well for significant lift in sales once the current COVID lockdown period ends in Britain. We've appointed our first Irish-based salesperson, based in Dublin, and he will commence on the 30th of November this year, further enabling us to reach our Irish cousins.

For Finland and Greece, we've added new distributor markets this month, and you've seen those announcements, and there are several others in progress that we'll announce in due course. Suffice it to say that our expansion throughout Europe, Mediterranean, and the Middle East is accelerating. For Asia, we appointed our own salesperson in Singapore to manage Singapore and Malaysian sales. We have achieved sales in Singapore, and surgeries are being conducted in several hospitals on a wide range of indications. NovoSorb BTM, again, proving itself to be significantly different to biologic products and has been readily accepted. We announced Taiwan regulatory approval and the appointment of Evermed as our distributor in the past month. This is very exciting for us. We'll also be working to enter the Korean market very shortly.

Our Korean regulatory authority audit has been complete, and we're now awaiting them to issue us our compliance in H2 of this financial year. In India, Myovatec have achieved surgeries throughout the year, and some surgeons have presented at international conferences and webinars. We're currently looking for additional distributors within the Indian market to further our geographical reach within that market. For Africa and the Middle East, we've got Ascendis Medical as our partner in South Africa, and this has been a very difficult market without reimbursement in the private system. However, we have provided significant clinical data to them, and we're expecting to hear news in H2 of South African reimbursement. In the public system within South Africa, we have had several surgeries done, and BTM continues to show remarkable results in all cases.

For Saudi Arabia and Israel, we are currently actively looking for new distributors in those markets. Kuwait and the UAE are markets that we'll be entering in H2 of FY 2021. We'll continue our expansion throughout Europe and Asia, and we'll announce those in due course. For our manufacturing facilities, the clean room facility in unit one has been complete, and that is a very nice facility, and when COVID is over, we'd welcome visitors to tour our facility. We've also built redundant capacity within that facility for manufacturer of NovoSorb BTM, and this gives us good backup if we need to do maintenance within unit two and further production capacity, if required, in the future.

The final stages of the film extrusion and stretching facility will be concluded around March of 2021, and that's not slowing our program down with those activities being housed at the UBA facility in Scoresby, but we will be moving those machines to Port Melbourne around March of next year. COVID has caused some delays in commissioning some of the machines and delivery of some of these new production machines.

We've anticipated having our first central hernia device available for surgical use sometime around Christmas of 2021. Our U.S. office in San Diego has been expanded and now houses an enlarged infrastructure of HR, sales, marketing, and clinical support, and we'll be adding a finance function to the U.S. team in the near term as well. We've had capital- intensive FY 2021. However, that drops off significantly in this current financial year of 2021 as we conclude these capital works.

For our BARDA program, I'm very pleased to say that this morning, as you're all I'm sure aware, we've announced that the FDA came through with the approval of our IDA for the pivotal trial. This is extremely exciting, and we'll begin recruitment of 150 patients in 20 sites once the protocol's approved by their local IRBs. For those not familiar with the clinical process, there are several steps you go through before you can actually, even though you've got approval, use it on a patient. One of those is the ethics committees of the hospitals approve the trial, which is fairly rudimentary. You've finalized your contracting, and you have investigator kickoff meetings, et cetera.

There are some technical things, which is why we anticipate we should be able to recruit patients into the trial fairly early in 2021, and we estimate that it will take three years to complete that recruitment of 150 patients. We will issue further details in the weeks ahead. We have also announced that we have had the very generous and ongoing support of BARDA to the tune of $15 million to support this program. We have brought in-house a lot of the outsourced clinical functions for this program, and that will optimize our ability to stay close to our customers, facilitate the recruitment of patients, and provide good, close clinical support to the program. The NovoSorb SynPath reimbursement for chronic wounds in the U.S., we have contracted a CRO to conduct this health economic study. This is to generate information required by the insurers for private health reimbursement.

That is now with the IRBs. We anticipate that we'll have patients recruited into this study in January of 2021. Once complete, the data will be used by the health insurers to provide health insurance coverage to those patients who are not in-hospital patients and will enable us to expand to the alternate care market, where the total addressable market is circa around $400 million. We anticipate that program will be concluded in calendar year 2023. I can move on to research and development. Our central hernia devices have been covered elsewhere in this speech. F or the breast products, as David said, we'll be looking for expanding of our R&D team. We'll be drawing on the increased research and development capacity that we have to accelerate our breast development.

This development will draw on other in-house programs and focus on products that have more direct pathways to market. We're looking at how we can truncate our actual revenue generation, timelines for breast. For other aspects that we'll be focused on, we have drug elution and sports medicine devices that are in proof -of -concept stage. Some have had early laboratory tests, and some early animal work done. However, we need to accelerate these programs, and the expansion of the R&D team will facilitate this. We appointed a dedicated project development manager, and in addition to that, we have our new COO, Dr. Anthony Kaye, who has commenced this week, and a new scientist who's joined the R&D team, and we're not finished yet. We've got further recruitment to add to that side of the business.

We've added four patents to our IP portfolio in the past year, and we've also filed many trademarks around the globe. We are well-placed to drive these programs with the conclusion of the central R&D hernia program, that will free some resource to move on to other products as it enters the manufacturing phase. With Beta Cell Technologies in Adelaide, this program utilizes NovoSorb BTM as a dermal implant to support islet cell implantation that may release insulin into the bloodstream, negating the need for type 1 diabetics to require regular insulin injections. The Adelaide team have been working through some technical aspects with the stem cells that are used to derive the islet cells and their cell sourcing. They've also applied for some additional funding grants to support the human trial, and we're ready to support that team as soon as they secure their funding.

I'm happy to take questions at the end of the segment. I'll now hand back to Chair David Williams. Thank you for your attention.

David Williams
Non-executive Chairman, PolyNovo

Thank you for that, Paul. That was great. As you rightly said, look, let's hold the questions until we've heard from Ed and we've heard from Anthony Kaye. One of the interesting things about your talk, Paul, is just the breadth of countries that we're talking to, have been approved in, have started selling in. I think one of the other interesting aspects of this company, compared with others and compared with many other Australian companies, is everybody seems to be fixated on the U.S. I think the reason for that is that with many drugs, the U.S. is the primary market. With our device, if I can put it that way, our market is a trauma market worldwide. Sure, in some countries, there will be an affordability aspect to it, but I wouldn't necessarily make wild assumptions.

Now, if you were making Botox, and I'm gonna make up these numbers, it could be that 60% of the world market is in the U.S., and it could be 75% of that's in California. For us, we see a much wider world market and, again, with reimbursement and other methods of payment, I wouldn't assume that we're not gonna have significant markets in other countries, as we're already seeing, by the way, in Austria and Germany, and so forth. Just as an aside, we have our own employee in Singapore and Malaysia, and we wondered to ourselves when we let him loose, how the pricing would be affected there. One of the first things he came back and said to us was, "We think your pricing might be too low," believe it or not.

We've got a product that will pay for itself, and that's significantly cheaper than the next best alternative. Coming to the U.S., I think the other thing before I introduce Ed is that this is a product that's been adapted and adopted by the key opinion leaders in all of the major countries we're going into, and the U.S. is no different. For all of you sitting in Australia, and by the way, we're now over 300 people on this call. For all of you sitting in Australia, this is not like saying, "I've just been adopted. My first hospital is the Bundaberg General Hospital or the Frankston Hospital." Not that there's anything wrong with those hospitals, by the way. We have been adopted in the U.S. by the major key opinion leaders in the major hospitals.

Think Mayo Clinic, think Harvard, think UCLA, think UC Davis, the major hospitals with the major and the acknowledged key opinion leaders. That's the sort of base we're working off. We have an office in San Diego or outside San Diego, and Ed Graubart is our man on the ground, and he has a team of people with him and a team of people around the country and a team of people that he's trying to grow. I'd like to introduce Ed to you as our Senior VP Sales in North America. For those of you who've been on the register for a while, he was here last year, and he made a speech in Melbourne. You won't recognize him because it looks to me like he's lost about 200 pounds, and what's turned out under that skin is a very handsome man.

Ed, it's over to you. I'd just like you to give us a brief sense about how you're running the U.S., who you are, what your vision is for the next few months. I don't want you to take all of my time. I'd love you to talk to our shareholders and give them a sense of what's happening in North America.

Ed Graubart
SVP of Sales, PolyNovo

Sure. Thanks, David. Good afternoon, everyone. Last year, I stood in front of you. I just started to dive in. I'm really excited to share our progress with you tonight here, your afternoon. Paul's already provided you a number of the details on the U.S. performance. I've been asked to speak to a few points specific to what and how we're doing it. I'm going to stick to the points as David mentioned below. You're going to hear a little bit echoing in the messaging between David, Paul, and myself, which is a good thing. In the past 12 months, we've doubled the U.S. sales force, creating smaller localized territories, allowing for more time to be spent on new account acquisitions, and allowing us to go deeper in penetration with existing accounts with different pathologies.

While this is also reducing our time and expense with travel. I'm pleased with the quality and commitment of the 23 members of our sales team and our marketing team. Yes, I said 23. Paul said 21. What he doesn't know is we extended two offers that were accepted today. Through their efforts, we have accounts now that have made BTM the standard of care for their patients. Expect us to keep expanding as we grow to meet the opportunities. The surgeon marketplace support remain overwhelmingly positive. If you've had a chance to go onto our website and watch the patient videos and our surgeon webinars, which I really recommend that you do, you'll see that surgeons remain excited about BTM and their results.

It's truly uplifting to hear from surgeons about their successes, mainly because of something that David said, which is there's patients on the other end of that success, and to know that we are treating patients and turning them into survivors is truly meaningful to all of us. In my 30 years, I've never had a product that has generated the positive response and feedback the way BTM does. As it relates to COVID and the impact of COVID, our group has navigated a bit better than expected, but we've also learned it remains unpredictable. We did see a slowdown in hospital approvals as they understandably shifted their focus, but I'm happy to say we've seen improvement the last 30 days. There are continued challenges associated with travel restrictions and base closures, but we have found ways to engage through digital and in-person, but only when requested or required.

Our main concern remains the safety of the team. As I move to the military, we've hired an experienced military consultant to help us identify and meet with the decision-makers. We've had some early good meetings, and I intend to keep pushing this forward as this is still a work in progress. Lastly, to build a little bit upon what Paul said, I'm pleased to share that we've recently signed with two group purchasing organizations, and as he alluded to, these buying group agreements expand our reach in the market, and we expect to see quicker access into member accounts and save time in their assessment of BTM for approval. More to come with these two specific as well as the future ones that we're working with. We continue to focus on what we believe supports our goals of taking market share.

Not knowing how COVID will impact the future, we remain diligent and focused on the business drivers. We have an aggressive target this year, and I'm optimistic that as long as we are able to keep our team and PolyNovo in front of our customers, we'll meet that target. Lastly, I just want to thank the U.S. team. I am really proud of your dedication, your commitment, and your effort. We had a good year. We got a lot of work ahead of us, and I'm glad to have this group with us. I appreciate the opportunity to speak briefly with you today. David, back to you.

David Williams
Non-executive Chairman, PolyNovo

Ed, thank you for that. On behalf of the board and all the staff here and the shareholders, thank you for your attention and speedy direction to get to 40 or 50 staff from your 23. We want to see that, and we really appreciate all you're doing over there for us. Good luck with that, and it's good, I think to hear not just are we heading into hospitals but into Group Purchasing Organizations and into the military. What Ed didn't say, I think, is that the number of hospitals, the lesser-known hospitals, many of them under those GPO organizations. I think the two that you're signing, and correct me if I'm wrong, Ed, but one of them has got over 1,000 hospitals under its umbrella, and the other one is in the hundreds. Ed, are you still on the line?

Ed Graubart
SVP of Sales, PolyNovo

Yep. Yes, sir. About between the two of them, they're just under 1,500 hospitals.

David Williams
Non-executive Chairman, PolyNovo

In addition to the sales force that we've got, these GPO networks and the new ones that you're still working on, Ed, that gives us a lot of scope for growth, I think, outside of the direct sales force. Thank you for that, and thank you for your team. Thank you to Jake. We hopefully look forward to seeing you both back here next year for the AGM.

Ed Graubart
SVP of Sales, PolyNovo

Looking forward to it.

David Williams
Non-executive Chairman, PolyNovo

Finally, just in terms of talks, we've got Anthony Kaye on the line. He's just come out of CSL, started on Monday. We really employed him to really run the manufacturing process, and as you know, we're building a plant at the moment. It's about ready to go. Well, I think it's about ready to go. Anthony might tell us differently now. I thought, what a chance with this online meeting to get Anthony on the line and just let him introduce himself, tell you where he's been and what he's been doing. He's probably not going to have too much to say about his first three days or four days, five days, actually, in the job. Anthony, if you're on the line, welcome.

Give us a little bit of a thumbnail sketch about who you are, what you're actually gonna do at PolyNovo outside of manufacturing, and any initial thoughts you've got pre-starting or in the last five days.

Anthony Kaye
COO, PolyNovo

Okay. Thanks, David. First of all, I'd like to thank you and the board and the wider management team for the opportunity to lead the operations group through the exciting next phase of PolyNovo's development. Obviously, as you've said, I've just very recently started with very recent experience at CSL up to about six o'clock last Friday evening. I've hit the ground running. I'm getting to know the team. I've been out to the Scoresby site and really just starting to get a sense of where we are in terms of development and where the program's sitting. I'll be able to report further, I guess, as I get my feet under the table. In terms of an introduction for those on the call, my initial training was in synthetic organic chemistry, during which time I worked on the development of a novel class of anti-tumor agents.

I guess I was very fortunate. This work was of commercial interest at a very early stage, and the intellectual property was purchased by Biota Holdings. This led to an 18-month postdoc, and it was really focused on the scale-up of the key drug candidates at that time to support the early -stage in vivo and in vitro studies. I guess from a very early stage, I've been involved in medical development of pharmaceutical products, and I've continued that through the career. From university, I transitioned to an R&D chemist role at IDT Australia. In that role, I worked on numerous medicinal chemistry and scale-up programs, and that was an exciting training ground. We had access to a whole range of different technologies on that site and a whole range of different scales.

At IDT, I undertook stints as an R&D project leader, product development manager, and R&D manager, which ultimately led to the operations manager role, which saw the oversight of the commercial active pharmaceutical ingredient manufacturing. That was seven products registered with the FDA, and all of the new product development that went through the facilities on scales up to about 4,000 liters. It also saw a capital expansion at that time for the 400-liter and the 4,000-liter plants. That was around a 15-year timeframe, which I've managed to pull down to about 30 seconds. I subsequently moved on to Boron Molecular as general manager, and continued my interest in chemistry and commercialization. We undertook a range of contract development and manufacturing, was undertaken for the pharmaceutical, medical device, and, really interestingly, the electronics industries, which I did learn a lot from that experience.

For the past six years, as you've mentioned, I've worked for CSL Behring. I went across there as a manufacturing lead, initially, to work on a couple of key programs and to run a manufacturing facility. I transitioned from that role into the oversight and the leading of a base fractionation capital expansion program, which, if anyone's traveled up the ring road in Melbourne, you'll see that new build being deployed on the Broadmeadows site. That was quite a large program. It really has given me an insight into what it takes to deliver a large-scale facility and to maintain, I guess, the control that you need to manage large capital programs in terms of budget and schedule. That was a fascinating experience.

I have a passion for research and development, commercialization, and a very strong patient focus, and I'm really excited to get to know the PolyNovo operations team, and I look forward to leading that group in delivering the boards and the management team's strategy for PolyNovo's continued success. With that, David, back to you.

David Williams
Non-executive Chairman, PolyNovo

Anthony, thank you so much for that. On behalf of everybody, welcome. I'm sure I don't need to emphasize it to shareholders that a few years back, when we had eight staff, we didn't have really specialists in anything. To see somebody just in charge of manufacturing, let alone R&D and a COO, it's something that we didn't sort of even imagine back in those days. Now, critically important to the manufacture of hernia products and our other products as well, by the way, that we manufacture right here in Melbourne at Port Melbourne. Anthony, welcome on board. Hope it goes great for you. Before I go on to the formal part of the business, I'll just ask Jan if there are any questions.

I know there are four, and Jan's already sent me through one, which he thinks I should answer, which is from a shareholder saying, if I've got it right, Jan, "When are you guys gonna report quarterly earnings, as opposed to half-year earnings?" Have I got that question, Brett?

Jan Gielen
CFO and Company Secretary, PolyNovo

You have, David. Just to add to that, it's been explained quite well, and with good reason, in the past as to why sales figures have been previously announced. As sales accelerate geographically and soon via different product lines, is it not appropriate to keep the market and shareholders more informed on sales growth?

David Williams
Non-executive Chairman, PolyNovo

Yes. Well, Jan and Paul have been telling me that a shareholder's insisting they don't want to hear it. Everywhere I go, I'm hearing the same question. The irony is that in this corporate world that we live in, our size dictates that we don't need to produce quarterly reports. The irony is that even though you're close to AUD 2 billion, we're in a growth industry. People do want to know what is happening to our sales. While I'm not committing to quarterly reports. I will commit to the fact that the board will discuss it at its next board meeting, because I am sympathetic to giving more information to the shareholders. Everywhere I go in the city, I'm getting the same thing, whether it be from minor shareholders or from institutions.

Let me take that as a work in progress for the board at the next meeting. Jan, you're our Company Secretary, so you can put that on the agenda.

Jan Gielen
CFO and Company Secretary, PolyNovo

Sure.

David Williams
Non-executive Chairman, PolyNovo

We are in a silly situation where companies in this country have to report quarterly earnings or better because they're so much in growth mode and because they're running out of cash, and all those usual reasons. Sort of things that we have anyway, but because of our market size, don't need to necessarily comply with it. It's time to reconsider that, I think. Jan, you've got a couple of questions for Paul, I think.

Jan Gielen
CFO and Company Secretary, PolyNovo

Yeah, I've got a few more. Next question, regarding the FDA pivotal trial IDE announced today, I understood BTM was already approved in the USA, or is this a different use?

David Williams
Non-executive Chairman, PolyNovo

Yeah.

Paul Brennan
Managing Director, PolyNovo

Thanks for the question. The FDA have two styles of approval. One is what's called a 510 approval, which PolyNovo's NovoSorb BTM is approved for surgical use. What it doesn't have is what's called an on-label claim, that we can take in open marketing for use in full -thickness burns. To be clear, we do have full -thickness burns claim and ability in all markets outside of the U.S. In the U.S., you need to complete a clinical trial, which is the pivotal trial that the BARDA organization is underwriting for us. That will, on its successful conclusion, allow us to apply for a PMA registration to have an on-label promotional claim for BTM to be used in burns. Surgeons in the U.S. currently do use NovoSorb BTM in burns, but they do that at their clinical discretion in what's called off-label use.

This is to give us on-label use.

Jan Gielen
CFO and Company Secretary, PolyNovo

Brilliant. Thanks, Paul. Next question. Would you be able to explain the differences of our product and that by Aroa Biosurgery and AVITA's product, and how we are competing with those products?

Paul Brennan
Managing Director, PolyNovo

Sure. I will start with AVITA, with RECELL. We are not competing with them at all. What the NovoSorb BTM regenerates a lost dermis. The underlying structure of your skin is where the vasculature is, the elastin, your ability to lay down fat, and all of those things. RECELL is the surface skin, which are called keratinocytes, which are sprayed on to the surface when you use a skin graft in a large burn, and the NovoSorb BTM provides a nice vascular bed for surgeons who wish to use RECELL over the top of BTM. If you like, they are complementary. If anything, they are not competitive. With Aroa and their products, they are not currently in the burn space, so they are no competition to us in that space. In the chronic wound space, they would be a competitor for us in that alternate market in the U.S.

To put it in context, it's just another biologic. It's a sheep's stomach versus Cook Medical have a sheep's bowel, a pig's bowel rather. ACell have pig's bladders. There's a range of products that are available out there. Their product is a nice little product. I think our product is significantly differentiated by being 100% resorbable polymer. I don't see any particular competition there. When we enter the hernia space, the TELA Bio product, which is sourced from Aroa, would be a direct competitor to PolyNovo. Again, there's a suite of biologic products in that space, and we'll be the only pure resorbable synthetic of a polyurethane in that market space. We'll continue to maintain our own value proposition and our own point of difference in the marketplace. Thanks, Jan.

Jan Gielen
CFO and Company Secretary, PolyNovo

Great. Thanks, Paul. Next question. Can you please tell us about any possible current IP challenges?

Paul Brennan
Managing Director, PolyNovo

No real IP challenges on the face of it at the moment. We keep a close eye on IP challenges through a system called PatSnap. We also meet with our IP lawyers, Griffith Hack, every three months, and we go through those. Yeah, there's no significant IP threat to PolyNovo's position, and we've got very strong patents wrapping up our fields of use, application, and device designs.

Jan Gielen
CFO and Company Secretary, PolyNovo

All right. Thanks, Paul. Next question. What are your thoughts about how you might manage your products in countries which have no respect for patent and trademark law?

Paul Brennan
Managing Director, PolyNovo

We'll choose whether we enter those countries or we don't, frankly. PolyNovo takes IP management extremely seriously, and for anybody who watched my speech at the AusBiotech conference, we'll see that it was very heavily focused on IP and trademarks. We don't engage with our IP lawyers on a quarterly basis with significant depth with our R&D team if we didn't take it seriously. As for you, as shareholders, you can be reassured that we do take it seriously. I think having Christine Emmanuel on the board, with a strong IP background, should demonstrate to you that we will continue to take IP extremely seriously.

Jan Gielen
CFO and Company Secretary, PolyNovo

Great. Thanks, Paul. Next question. Are there prospects in osteochondral reconstructive surgery in military trauma settings?

Paul Brennan
Managing Director, PolyNovo

I won't get into specifics of what we're doing in some of those spaces. We are working on various things for joints, et cetera, with some partners, but it's too early to share that at this point.

Jan Gielen
CFO and Company Secretary, PolyNovo

Okay. Thanks, Paul. Next question. Have you commenced any studies into the health economics of BTM versus standard of care?

Paul Brennan
Managing Director, PolyNovo

That data will be collected within the pivotal trial program, that will generate some good, robust data. There are several clinical sites who have done some of that. For those of you who watched on our webinar, Alisa Savetamal presentation from the U.S., that gives a good indication of the health economic benefits of BTM versus what's called allograft or cadaver skin use, which can be a standard of care. The true standard of care is an anathema in that there is no standard of care for treating burns. Each burn surgeon and each burn facility design their own protocols. T hat's been one of the challenges in designing our IDA protocol as to what's the comparator. We'll be sharing more of that data in the coming weeks. We've got a collection of data in that we've got Royal Brisbane have done some work on health economics.

Royal Adelaide have done some preliminary work on health economics. We're also doing the SynPath study in the U.S. on chronic wounds, which is very health economic -focused for the insurers.

Jan Gielen
CFO and Company Secretary, PolyNovo

Thanks, Paul. Have another question. Reference has been made to the fact that NovoSorb is a platform technology. Can any flavor be given to the possible new product developments in the orthopedic arena, and has any consideration been given to revisiting the development of a biodegradable heart stents, an area in which PolyNovo worked in collaboration with Medtronic during the 2005 to 2009 period?

Paul Brennan
Managing Director, PolyNovo

Sure. It is a platform technology, and yes, it can be readily applied to a wide range of areas. As I've said in the past, due to prior board and prior management activity, some of the orthopedic routes are not viable for us to pursue because of the agreements that were signed at that time. However, the sports medicine area is something where we're actively working on some projects, but it's too early to get everybody too excited and focused on those. For the cardiac stents, the cardiac stent market went through significant change when J&J lost any market advantage on drug-eluting stents. The investment in that space has been a little gun-shy since.

We still remain able to do those developments, but it's lower on our priority list, and it'll be dependent on the further expansion of R&D team and what the commercial business case looks like for making such investments in the future.

Jan Gielen
CFO and Company Secretary, PolyNovo

Thanks, Paul. No further questions at this stage.

David Williams
Non-executive Chairman, PolyNovo

Great. Thank you, Jan, and thank you, Paul, for fielding most of those. If there's no further questions, I propose to move on to the formal resolutions. As I mentioned at the start of the meeting, voting on the resolutions is currently open. Y ou can vote at any time until I declare the voting closed. I'll give you a one-minute warning at the end of the meeting if you need it. The results will not be updated on the screen, but will be updated at the conclusion of the meeting by Angela and her team, and then released to the ASX. Please note that only shareholders, proxyholders, and authorized shareholder representatives may vote. Any directed proxies given to you by a shareholder will automatically be cast as directed when the poll is closed. The voting icon is available within the navigation bar.

Once you click on this, the resolutions will appear on your screen, along with for, against, and abstain options. Simply select one of these options to cast your vote. When voting's closed, your final voting selection will be recorded. If you have any difficulties, please refer to the user guide, which can be accessed through the platform. I now move to consider the formal resolutions. I advised at the beginning of the meeting that we will vote on the resolutions by way of a poll.

I intend to vote any undirected proxy votes given the chairman in favor of the relevant resolutions. Voting is already open and will remain open during discussion of the resolutions. I'll also provide you with notice that the polls are about to close. We will move to consider the first resolution. The first resolution is the re-election of directors, item three on your notice of meeting.

The first of those is Dr. David McQuillan, who, as I said before, is sitting in Philadelphia, a long way from us. I'll put the following resolution to the meeting as an ordinary resolution, that Dr. David McQuillan, being a director of the company who retires in accordance with Clause 59 of PolyNovo's Constitution and being eligible, is re-elected as a director. David is on the line from the U.S., and even though you've seen him before, if you've been a shareholder for longer than a year, I am going to introduce Robyn Elliott and Christine Emmanuel when we go to re-elect them. I thought, just for equal opportunity, I should let him say some words about himself, just briefly. Who knows what's happened to him, given what happened to Ed Graubart's weight? Anything's possible. I'm expecting a beard. I'm expecting a loss of weight.

I'll invite David McQuillan to say a couple of words about yourself, David. There's over 300 people on the line. Some of them definitely won't know you, but welcome. What have you got to say for yourself?

David McQuillan
Non-executive Director, PolyNovo

Well, thank you, David. I think if Ed lost some weight, I think I may have found it. We've solved that issue. It's certainly an honor to be nominated to be re-elected to the board. I've been on the board of PolyNovo for the past seven years, and as we've heard today, significant growth and success of the company. It's been extremely exciting to be involved with PolyNovo over the last seven years, and looking forward to continued involvement. My technical background is in regenerative medicine, wound healing, and soft tissue repair. I grew up and was trained in Australia. In fact, graduated from Monash University a very long time ago, but have certainly spent the better part of my career in the U.S.A. I spent 15 years in academia, including time at the National Institutes of Health, the University of Melbourne, and Texas A&M University.

In the last 20 years, have managed research and development at a number of public and private U.S.-based medical device companies, including LifeCell, KCI, Acelity, Humacyte, and TELA Bio. Through that, I've been involved in the development of a number of market-leading biologics that are used in the treatment of wounds, hernia, abdominal wall repair, breast reconstruction, and orthopedics. Very well-versed in the sort of things that PolyNovo are focused on and will be focused on into the future. My understanding of these markets lets me understand that there are still huge opportunities in many of these markets. They still are not well-served. I think PolyNovo has very exciting opportunities ahead of them to address some of these unmet clinical needs. With that, David, that's my background. I'll pass it back to you.

David Williams
Non-executive Chairman, PolyNovo

Thank you very much, David, thank you for that, and a very worthy member of our board. Going back to what I said about describing the depth of talent on our board, clearly a man with a lot of experience in regen medicine, but also in skin, along the lines of what we're doing. Also, our eyes and ears in the U.S., and I think you'll probably all agree that as we become more of a worldwide company, we need to probably think about the population of our board from a geographical basis as part of our questions of diversity as well. Is there any discussion? I'd normally ask this in the room, but Jan, do you have any questions of David or myself?

Jan Gielen
CFO and Company Secretary, PolyNovo

No questions, David.

David Williams
Non-executive Chairman, PolyNovo

Okay. Everybody, look, voting is open, and will remain open for the time being. If you haven't voted for or against David, please do now, and good luck, David. Thank you. The item four in the notice of meeting is the election. David, of course, was a re-election, but the election of Robyn and Christine. I'll deal with Robyn first. Robyn Elliott was appointed a director on the 28th of October 2019 and retires in accordance with the company's Constitution, and being eligible, offers herself for election. I put the following resolution to the meeting as an ordinary resolution, that Dr. Robyn Elliott, being a director of the company who, in accordance with Clause 58 of the PolyNovo's Constitution and being eligible, is re-elected as a director. Robyn's on the line in Melbourne, and I propose to ask her to say a few words about herself.

Well, she'll tell you about herself. I know her from when she was managing director of IDT Limited, a listed company based in Bayswater in Melbourne. She's subsequently gone and had a long career at CSL. I was on the board of IDT, so I know her extremely well. Robyn, tell us something about yourself, where you fit in, what you've got to contribute.

Robyn Elliott
Non-executive Director, PolyNovo

Thanks very much, David. Firstly, let me give a personal welcome to the shareholders today. I think it's great that you've taken the time to really hear a little bit more about the amazing PolyNovo journey. As David said, I've spent the last 30 years really committed to improving patients' lives through focusing on the technical aspects of pharmaceutical product development, registration, commercialization, operations, and my greatest passion, which is quality audits. During that time, I've been really fortunate enough to work in small local companies and, of course, the large organization that CSL has become today. Currently, I am responsible for quite a large capital expansion portfolio in the order of around AUD 1 billion of capital. Really, my job is to think about business strategy and value realization.

What that means is, on a daily basis, I am thinking about business growth, and I'm really trying to work out how to deliver business growth, optimizing project plans, timelines, budgets. In the current world, of course, that ensures we have to be agile. Along the way, I've learned a couple of really interesting things. As David said, for teams to be successful, you have to have capital. PolyNovo has really been at the forefront of that thinking. They also have to have some other fundamentals. They have to have a clear strategy, and one where every member of the team knows what their role is in delivering. There needs to be processes in place where the decisions that are made are based on data. As a scientist, I'm really passionate about using data well.

Most importantly, teams have to have a culture where that's really valuing high performance and recognizing the commitment of the team members. I've really been delighted over the last 12 months working with the PolyNovo board to see that PolyNovo has a very clear vision for the future. The technology platform is talk about having a platform. In PolyNovo's case, it really is a platform technology that can deliver great value and change people's lives. I think the thing that you've seen today already is that PolyNovo has an amazingly passionate chairman, really an experienced board, and they are out to make a difference in the world. I am really grateful for the opportunity to continue to contribute to the PolyNovo board.

I am a very hands-on board member, and I continue to be excited about the opportunity to support Paul and Anthony and really the entire operations team as we look to deliver against the really expansive growth strategy that we have at PolyNovo over the coming months and years. Thanks very much, David.

David Williams
Non-executive Chairman, PolyNovo

Robyn, thank you for that. Again, as I said of David, and I said previously about the depth of talent on the board, I think all of you will know a couple of things. That we're manufacturing, and we're building plants, and Robyn's an expert at that. As we expand our geographical footprint, we're also dealing with audits. At IDT and at CSL, Robyn's an expert at dealing with audits from all around the world, in a way that Australians typically have not had to do. The audits that you'll get from Korea or Malaysia or anywhere else, she's going to be a fantastic resource in that sense.

I know already that she's talked to me on many occasions, saying, "I'm on my way to work, but I'm going to drop into the factory and see how the factory's going," or, "I'm going to drop into Port Melbourne and see how the air conditioning's going." Again, just assisting management and really giving us some depth. Jan, are there any questions of Robyn or myself of Robyn?

Jan Gielen
CFO and Company Secretary, PolyNovo

No, not at this stage.

David Williams
Non-executive Chairman, PolyNovo

Okay. Please vote if you haven't already voted. It's still open. Vote for or against Robyn. Robyn, good luck with that. I now turn to the election of Christine Emmanuel. Christine Emmanuel was appointed a director on the 13th of May 2020 and retires in accordance with the company's Constitution, and being eligible, offers herself for re-election. I'll put the following resolution to the meeting as an ordinary resolution that Ms. Christine Emmanuel, being a director of the company, who in accordance with Clause 58 of the PolyNovo's Constitution and being eligible, is re-elected as a director. Christine is also on the line. She recently retired from CSIRO. For other reasons that I'll explain and no doubt she'll explain, she adds some tremendous depth, as Paul has already indicated, in the areas of IP and commercial, from a different perspective to some of our other directors.

I welcome Christine. Christine, please just give us a thumbnail sketch about your background and what you bring to the table apart from the normal director skills.

Christine Emmanuel
Non-executive Director, PolyNovo

Okay. Thanks, David. I'll interpret your pen nail sketch request to say be brief. Yes, it's been a real pleasure and a privilege, really, to have served on the board so far since May with some really experienced board members, as you've mentioned. It's wonderful to join the board of a company that, as articulated by David, is distinguished by such a life-changing technology and has that pedigree of being founded at our much-loved CSIRO, but really has been developed extensively by PolyNovo and its partnerships since then. Not just that technology, but it's got such an ambitious plan for global expansion. I'm really just looking forward to the future. To be able to help with my skill set in the challenges that you will inevitably face on that journey of global expansion, with a technology that's clearly a platform technology like ours.

My career, just briefly, 30+ years so far, spanned the sectors of research and development, IP, and business development, and commercial. Initially, R&D at Ciba-Geigy in the U.K. and CSIRO in Australia. IP experience in-house at Unilever in Europe and in private practice in Europe and Australia. Finally, the last decade in the leadership team at the business development commercial team at CSIRO, managing the equity portfolio most recently. With that kind of skill set and experience, I'm just hoping to be able to contribute as much as possible to that growth of product offering across the platform and our global expansion. Thanks.

David Williams
Non-executive Chairman, PolyNovo

Hey, Christine. Thanks for that. Are there any questions of Christine or of me of Christine? Jan, do you have any?

Jan Gielen
CFO and Company Secretary, PolyNovo

No questions, David.

David Williams
Non-executive Chairman, PolyNovo

Okay. For the purpose of taking all proxies into account, ensuring the votes are counted or accurately are directed, a poll be taken on this motion. Voting is open. Please vote for or against Christine as you like. Good luck with that, Christine. I might say just, again, just to emphasize her background in IP and her willingness to do other than just turn up to board meetings. She just said to me yesterday, "I'd like to have a little special project to look at all of our IP." I mean that in the widest sense of the world, not only what IP we've got, perhaps, but what things she sees where we might be able to strengthen our IP and take it in different directions, and that. She's not management, but that sort of skill base on the board just takes us in a different direction.

I hope the shareholders are getting a sense as I describe some of these directors about why I think our board is different, and why I think it is much more inclusive and comprehensive and has the depth of skill to take this company, not from its measly little AUD 2 billion market cap, which I notice has now gone up to, but to a much bigger company building, not only in our core products, but on the sort of R&D that we've been talking about. Ladies and gentlemen, I'll move on. I know Jan's got one further question, which I'll deal with right at the end. Jan, please remind me. I'm going to move on to item five on the notice of meeting, which is the REM report. The Corporations Act requires a remuneration report be included in the annual report.

Shareholders will be asked to vote on this report. Please note that this vote is not binding on the company, but the result will be taken into account by the remuneration committee when reviewing director and executive packages. Voting exclusion statement applies to this resolution and is outlined in the notice of meeting, but it effectively means that people like me and key management cannot vote. However, the director recommends us directors, that is, recommends that shareholders vote in favor of the resolution. I put the following resolution to the meeting. That, for the purposes of Section 250R(2) of the Corporations Act, the remuneration report required by Section 300A of the Corporations Act is contained in the directors' report for the year ended 30 June 2020, is adopted.

I hereby move the resolution, and I call on Philip Powell as a shareholder and as Chairman of the Audit Committee to second the adoption of the Remuneration Report. I don't know if you're on-

Philip Powell
Chairman of the Audit Committee, PolyNovo

Happy to second that, David.

David Williams
Non-executive Chairman, PolyNovo

Thank you. That's your last speaking role before you retire. You've done that very well. Is there any discussion on this resolution? Jan, do you have any questions?

Jan Gielen
CFO and Company Secretary, PolyNovo

No questions, David.

David Williams
Non-executive Chairman, PolyNovo

I think the voting is open. Lodge your vote. I'll make some comment about it because I think for those of you who are on the screen, you will see that the vote is lost. There are a number of some significant institutional investors who have voted against us, which means that the board has a first strike. We've got various feedback after those votes were in from three, I think, of those institutional investors. One saying that Paul Brennan's LTI is too high. One saying that they don't like it being retested over three years. One saying that they think he should have a higher base salary and a lower LTI. Anyways, we'll see you next year on that. Go figure. Vote away, and we'll see where that ends up. It's definitely lost as a resolution, which requires really a 75% vote.

Let me move on to item six on the notice of meeting, which is non-executive director fees. I put the following resolution to the meeting as an ordinary resolution. That for the purposes of Clause 62 of the Constitution of the company, ASX listing rule 10.17 and all other purposes, the aggregate maximum of remuneration that may be paid to directors of company as a whole, other than executive directors, that means Paul, of course, to be increased by AUD 250,000 per annum from AUD 600,000 per annum to AUD 850,000 per annum. Is there any discussion on this resolution? Jan, do you have any questions?

Jan Gielen
CFO and Company Secretary, PolyNovo

No questions, David.

David Williams
Non-executive Chairman, PolyNovo

I'm sure those of you who have been shareholders of public companies know that this doesn't necessarily mean that we're paying AUD 850,000. We have a large board, and we were banging up against that limit. This is for safety's sake, as much as it is about what ultimately the directors will be paid themselves. I think if you check the director remuneration, that we would be in the lowest quartile of anybody in our size by a long way. If you haven't lodged your vote, please do. Voting's still open. I'll move on to item seven on the notice of meeting. Put the following resolution, has to do with the employee share option plan, which, by the way, we passed last year, but because of changes in the ASX listing rules, we thought it prudent to just refresh it.

I'll put the following as an ordinary resolution, that the issue of securities under the company's employee share option plan are approved for all purposes, including for the purpose of exception nine in ASX listing rule 7.2, and as an exception to ASX listing rule 7.1. I hereby move the resolution. Is there any discussion on that resolution?

Jan Gielen
CFO and Company Secretary, PolyNovo

No questions, David.

David Williams
Non-executive Chairman, PolyNovo

No questions. I direct that a poll be taken on this item and ask you to vote on it, and everything else for that matter, if you have not. I'm going to leave the voting open just for a minute. I'm going to move to the conclusion of the voting. I'll announce it when it's closed, but you've got a minute to sort of fix up your voting. If you want to change it, if you haven't voted, please do. While I'm waiting for that minute to pass, Jan, you've got one further question?

Jan Gielen
CFO and Company Secretary, PolyNovo

I do, David. The question is, "Has there been any interest in a takeover from other companies?

David Williams
Non-executive Chairman, PolyNovo

I've got a minute to wait, so the flippant answer is I've thought about it myself, but I just didn't have the readies. Is there anybody else? The answer is, we've heard nothing from nobody, unless other directors know something that I don't know, but I'd almost certainly know. Ultimately, somebody might come looking. Think about it this way, we're already today, as we sit here right now, AUD 2 billion. Even for some of our competitors, certainly, the smaller competitors just are not in the race. AVITA's not a competitor, or Aroa is slightly a competitor. They're tiny by comparison with us. The bigger players, like Integra, it's got a bigger market cap than us, but not all of that is to do with our type of business.

In addition to that, if they were thinking about it logically, they might say, "You know what? We might be just cannibalizing our core business." Even though they're a direct competitor and giving us a whipping, they might say, "Look, they've got a synthetic and we've got a biologic. That sounds like cannibalism to us." I think ironically, in the way I think number one, the answer is no. Number two, the way I think about it as an investment banker myself is that in a way, even though we're AUD 2 billion in market cap, I think we're in no man's land. I think once we start to really kick some goals in Western Europe and in North America, then we might find one of the very big majors coming to us and looking for a new silo in their business.

It doesn't distract us one bit. There's nobody talking to us, and we're having a good time. We're very happy with the effect that it's having on surgeons and patients, quite apart from our shareholders. Ladies and gentlemen, that's the meeting. I'm going to close the voting now. The poll is closed. As I said before, the results will be compiled by Angela Liapis and her team. Jan will put them up as soon as he can. Jan is going to take a video of this performance today, and hopefully edit it so that you'll be able to see where, in that video, pieces you might want to divine out and show to other people, please do. There's no other business.

I'd like to close the meeting. I really want to thank you for not only coming on to the meeting, as I said, over 300 people, but I want to really thank you for being shareholders and for staying with us. You've seen, we've had a lot of shorters in the stock. It was up at 7% only a week or two ago. It was 6% last night. I reckon when you go and have a look on Monday, well, it's 2 + 3 on those shorting screens, if you're looking. Probably won't see it till Wednesday, Thursday. That's going to drop off and I think that's a pretty healthy thing if we see the backside of the people who think that our share price is going to go down when it's heading in a northerly direction.

I wish you all a fantastic weekend, especially those in Victoria who are finally free and can go down the coast or whatever you want to do. Hopefully, I'll see you next year, and thank you for coming.