PolyNovo Limited (PNV) Earnings Call Transcript & Summary

Well, welcome, everybody. That was -- I think last year, we said we'd make that video shorter. I don't think we achieved that, and we've got another one to come. So strap in and hold on to the reins. But I think there's a little snippet there of why we're so proud about what we're doing here as a company. One of the dissatisfying things about it, I think, is that when I look at how many countries we're supplying right now at the end of this FY '24 financial year, it's 42 countries. So to skip from the U.K., to the Ukraine to India, and so forth. If you saw the sort of things that are happening in Tel Aviv, in Gaza, which is just a horrible war zone in the Ukraine, Namibia, et cetera. And I'll go through a couple of those later. And hopefully, you'll hear a little bit of it from Marcus Wagstaff and Andy Eakins as well. But come back to that, so it's pretty hard to sort of capture it all in 1 or 2 minutes, but there you are. I'm going to open the meeting, and we've got a quorum here. I'm the Chairman. And I declare that 2024 Annual General Meeting of PolyNovo open. I'm delighted to have you all here just saying to somebody walking up that I think we're probably going to be half of what we were last year because I didn't send out the notices until Sunday, myself to shareholders just to give you a reminder. So thank you all for coming. And last year, I think we had 300 people on the line as well, probably going to have 200 or 300 as well this time as well. So it's great to see -- it's great to see you all here and it's great to see you online. I mean it's probably not important to you. But one of the distinguishing things I think about our shareholder base is the passion that the shareholders themselves have got for this company, and not only the shareholders but also the clinicians themselves and the surgeons themselves and so forth. So people are thinking of it more than just being a company. And I myself have this view as well because I think some of the most heartbreaking things that happened during the year were to do with humanitarian efforts that we've undertaken on behalf of countries or specific patients in various jurisdictions and so forth. And some of those just break your heart if you saw them. So to be in a company where you've got a killer technology profitable now, as you saw, with a good margin. But to see what we're doing in terms of saving lives. But at the same time, flipping over that coin very frustrating because sometimes we're looking at somebody really needs us, but you still got to get the surgeon to play ball in that jurisdiction, and they may not have the sort of training that we've got or they may not have the operating theater that we've got, and we get very frustrated, not that we can save everybody, but you sometimes think, jeez, I wish I was there. And again, Marcus might reflect a bit on this because we've had a little bit of this year in Nigeria and some other places, Serbia, almost very recently in the last month or 2. So I think it will give you a sort of sense of not only the humanitarian work we're doing, but more particularly the way in which our product is being used and being recognized by doctors all around the world. So we'll come back to that in due course. Let me introduce you to my directors. And on my right, Christine Emmanuel, Leon Hoare, Robyn Elliott, who's just retired from CSL. Congratulations. Which means that we'll get more of her free time without charge. And Andy Lumsden, who's also Head of the Audit Committee. I should have said Christine is Head of the HR and Remuneration Committee after taking over from me. I'd like to also introduce our CEO, Swami Raote on my left; and Lior Harel, who recently joined us as Head of HR and HR Head well, he might as well be, but Head of Legal. And he comes out of a public company, but before that was at Arnold Bloch Leibler. So he's taken a significant pay cut as the lawyers in the audience would know to sort of come and work for us. And I should just looking at the front row, introduce some people here. I've got Ingrid Anderson sitting in the front row, who is in-charge of HR and has also come out of a listed company. David Morris, who is in-charge of APAC, Asia Pacific, and really driving our current intentions into China and Japan, in particular, and he's been up in Japan just recently preparing for a submission for registration in Japan. He's not on my list of people I was going to talk to, but I may well get him up at the notes just to see how he can handle himself on his own feet. So start panicking is what I would say, David. And next to him is Jan Gielen, who ran like a rabbit when he got the chance to not have to run the video and that question time at the AGM and pass it over to you unannounced. So Lior doesn't know what he's getting himself into either. I'm just trying to see who else I've got here. I've got Ed Graubart, who's sitting over here on the right, who runs North America. And have I missed anybody? Lior, David, nobody? Okay. So -- that's the team. And I'll point them out only because after this is over, you saw there's some case and that and please take advantage of chatting to the management as you see fit. I've also got in attendance our auditors, I'm going to have a bad day, Ashley Butler, [ Enrica ] from EY. And [ Bart Oberink ], who's our lawyer is not here. He's gone to Brisbane for the day after spending about the last 3 weeks in Greece. So I don't know what he's doing up there. But instead, he sent along [ John Steven ], who's sitting in the front row with his arms crossed, no tie because he's a shareholder of PolyNovo and was here when that shares were $0.20. So he's -- and I know that he's got a couple of million shares, which explains why his married is still together. But [ Johnny Stevens ] has been a friend of mine for 40 years, and he's been -- he's one of the oldest serving partners in Minters, 1 or 2 more, but -- so he's got a relaxed lifestyle now sitting on his wealth in PolyNovo. Thank you very much, David. Thank you John. Later in the meeting, I'll introduce a few key staff. And I might seriously, David, I might get you up just for a second just to talk about Japan and what the hell you were doing over there the other day. And -- but before I start, I should just acknowledge Bruce Rathie and Bruce in the audience, oh, there you are. Bruce Rathie, who's just retired from the Board of Directors and to pursue his other directorships. He talking about the sum is just dragging himself away from his beautiful house in Double Bay on the water. And we're going to have a dinner tonight just to say goodbye to make sure he's out of the building properly, and so he doesn't come back. But he's been fantastic. He's been there right from the start for 14 years, and he's been the sole constant in the company itself. And Bruce, on behalf of everybody, including shareholders, thank you, and thanks for coming down for a free meals. It's fantastic. Sacrifices you've made. It's unbelievable. Okay. Notice of meeting. The notice of meeting was dispatched to shareholders in compliance with the company's constitution and is also available on the ASX. I'll take it as being read. Today's meeting is being held online via Computershare meeting platform. This allows shareholders, proxies, guests to attend the meeting virtually. All attendees can watch a live webcast of the meeting. In addition, shareholders and proxies have the ability to ask questions and submit votes during the meeting, which I'll come to in a moment. How to ask a question? Well, online attendees can submit questions at any time. To ask a question submit the Q&A icon, type question in the text box there is many people who are online, obviously. Once you finish typing, hit the send button. You don't have to submit the questions from now on, I will not address them until the relevant time in the meeting. Please also note that your questions may be moderated by Lior, who's, as I just said, very inexperienced. So don't be surprised with some issues there. But he'll moderate them. And if he thinks they're duplicates, he'll concentrate them. And if he thinks they're nonsense, well, who knows what he'll do in experience of this Lior, any plans for treating nonsensical questions? Okay. So -- there's no need to submit or enter a voting button. As soon as you fill it in, it will be confirmed on your screen. I'd now like to declare the voting open on all items after the resolutions have been voted on. The Chief Executive Officer will make a few comments, and then I'll also make a few comments and interview a couple of staff members as well. I'm going to appoint Angela Liapis, who I can't see now, but as the Computershare Investor Services and Returning Officer. She's running around here somewhere, but she is also a shareholder. See how we keep people in the loop. So Computershare, the woman who's been doing this longer than me is a substantial she usually sits right in here in the front row and enjoys the show. Straight after the meeting, we'll release -- Lior will release the voting to the ASX. So you can see it then, but you'll see it more or less now anyway. And you can change your vote and especially people online up until when I declare the voting closed. I'm going to do it slightly differently this year because there's really only 3 motions, and they're all overwhelmingly for. So we thought we'd just get the voting out of the way. Then Swami will say a few words, I'll say a few words. We'll talk to a couple of the staff like we normally do, and then we'll formally close the meeting, but I'll close the voting before we get to Swami in my discussion. All right. The financial statements and reports. Item 1 on the Notice of Meeting is to receive and consider the annual financial statements for the 12 months ended 30 June '24 for the company and its controlling entities together with the reports of directors and auditors. Are there any questions in respect of the financial report or the company's auditors from the audience here today? Do you have anything online? Nothing. If there's no questions or further discussions on this matter, I'll consider the financial report and directors and auditor's reports received and adopted. So let me just remind you again -- I'm sorry, I have to go through this is part of the compliance, but casting your vote. If you've already voted on the resolutions, the subject of this AGM and do not wish to change your vote, then you don't need to do anything today. By the way, when I'm asking the people to vote for the final time, we're going to put up a second video, which will just be a case study on one of our recent patients from Melbourne. So you'll have another 3 minutes to sort of pond to that. If you've already voted, however, and want to change your vote, voting on the resolutions is currently open, and you can vote at any time until I declare the voting closed. The results will not be updated on the screen, as I said before, but will be updated at the conclusion of the meeting and then released to the ASX. Please note that only shareholders, proxy holders and authorized shareholder reps may vote. Any directed proxies given to you by a shareholder will automatically be cast as directed when the poll is closed. The voting tab is available within the navigation bar on your computers. Press the vote icon and all resolutions will be activated with the voting options. To cast your vote, simply select one of the options. No need to hit a submit or enter button as the vote is automatically recorded. You will receive a vote confirmation notification on your screen. You do, however, have the ability to change your vote up until the time I declare voting closed. When voting is closed, your final voting selection will be recorded. For the people attending in the room, please mark the back of your voting cards, you should have one of these, which I've got. And Angela Liapis and her staff will collect these from you at the end of the voting. If you've got any difficulties, you can call Computershare those people online, in particular, the numbers 9415-4024. That's a Melbourne number. Okay. Let me talk about the votes today and the proxy. These are the voting already, as you can see for the resolutions. And before we start, though, given we've got people online and in the room, you'll know that the normal way of doing this is to vote by way of a poll, not by hands, not by just your votes in the room, but by way of a poll and taking into account anybody who's online. So let me talk about the first resolution. The first resolution is the reelection of Andrew Lumsden, who, as I referred to before at the end of the table, is also the Chairman of the Audit Committee. And I'm going to put the following resolution to the meeting that to consider and if thought pass with or without modification, the following resolution that pursuant to and in accordance with Listing Rule 14.4, clause 59 of the constitution and for all other purposes, Andrew Lumsden, Director, retires and being eligible, is reelected as a director on the terms and conditions in the explanatory notes. I'll say something about Andy, but before I do, I'll invite Andrew to say a few words about himself and his experience so far on the Board. So, Andy, over here, if you'd like to say anything.

Yes. So as David mentioned, I joined the PolyNovo Board in June 2021 and was subsequently appointed to Chair of the Audit Committee in, I think, February '22. So a relatively short tenure compared to some of my other counterparts on the Board. My background is predominantly in accounting and finance. So I joined -- I started my career back in Scotland with PricewaterhouseCoopers, spent about 8 years with the firm in the U.K. and also Australia once I became a chartered accountant. And then from there, joined the then publicly listed company, Wellcom Worldwide as a group FC and then was appointed CFO, which was a role I had for about 10 years before I took my current position, which is CEO of the Australasian business for Wellcom. I've enjoyed my time immensely with PolyNovo. It's not often you get the opportunity and life to be involved in such a rapidly growing, expanding business, which also has such a high social impact. And I'm delighted to be standing for reelection today.

Thank you. Let me just say, when we appointed Andy, we had just lost Philip Powell, who was Head of the Audit Committee, and he had an accounting background with Andersons and with a listed company. Andrew was immediately appealing for a couple of reasons. Number one, he's out of the Big 4 himself. So very well trained. And it's now more or less mandatory to have somebody running an audit committee who's got an audit background. So let's hope for you yet, Ashley. There might be a job after he was. But -- and so that was good. He was the CFO of a public company Wellcom which was then taken over a couple of years ago now by Hyundai Kia in Korea, and he was elevated the CEO, but he's also the CFO and the CEO of Wellcom, which has offices in New York, in Houston, in London, in Malaysia, in New Zealand and various parts of Australia. So it sort of mirrored a bit of what we had. His office is only a walking distance along the road from where we are. And he's roughly the same age as young. I'm making that up because I've got no idea how old he is, but I thought the age might sort of be quite good. So he came across as a perfect package as my wife would say, which is sort of the same as her saying, you're not a perfect package. But he's been great for us and he's been great for the Audit Committee. I did have one question about you, Andy, before we came in here online from somebody who wanted to know why you recently sold 50,000 shares in the business. So would you like to answer that?

Yes. So I think 3 or 4 weeks ago, I sold 50,000 of 150,000 holding. I still hold 100,000 shares, hopefully, for the long term. It was just a short-term requirement. I'm actually -- my wife wants to do some development on the house, so I needed the funds to be honest.

Very good idea. Thank you. Okay. Is there any questions from the floor of Andy? Are there any questions online, Lior? Nothing online? Nothing from the floor. Then for the purpose of taking all proxies into account, ensuring all the votes are counted, I direct that the poll be taken on this item. Voting is still open. It will be open until I close it. Resolution 2 is the approval of the remuneration report. The Corporations Act requires a remuneration report to be included in the annual report. Shareholders will be asked to vote to approve 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, chaired by Ms. Emmanuel over here when reviewing director and executive packages. A voting exclusion statement applies to this resolution and is outlined in the notice of Annual General Meeting. Directors, however, nevertheless recommend that shareholders vote in favor of this resolution. I put the resolution to the meeting. and if thought fit, to pass with or without modification, the following resolution that the remuneration report is concerned in the directors' report for the year ended 30 June 2024 is adopted. Just before I put that resolution and ask if there are any questions, I had some online questions to you, Lior. So you can -- you don't need to ask these when I ask later, but it's relevant to this and to the constitutional amendment, which I'll come to in a moment.

But the question online was what was the directors' remuneration in the previous constitution, which we're about to vote on? And what is it in this current constitution? And the answer to that is that the previous constitution had a directors' limit on fees of 600. And at the 2020 AGM, shareholders approved that to go to $800,000, and that is what is hardwired in this new constitution. Lior, do you have any questions online? Nothing. Anything in the room? Yes, please. I should welcome, by the way, the Managing Director of the Australian Shareholders' Association. So please be outstanding.

Thank you. Thank you, Chair, and good afternoon. Look, one of the questions we'd like to ask you on behalf of Australian Shareholders. Firstly, we'd like to congratulate you on the work that done in terms of remuneration is actually a real will report in the annual report. So that is very good that people can actually read it on standard, often they're not. So well done on that one. Can you go through the Remuneration Committee, please tell us how it was benchmarked because obviously, PolyNovo Asia, a very different organization and how you actually benchmark against other like companies, probably is a bit of a challenge. So could you please tell us how it was benchmarked and where the salary advice did come from?

I could do that, but I won't. And instead, I'm going to ask Christine who's Head of the Remuneration Committee, to earn her cake and make a couple of statements on that because this engaged her for the last 2 months in some detailed work.

Yes. Look, I think we've been very, very fortunate. We've got a new Chief of People and Culture, Ingrid Anderson, and she's got a lot of global experience on this. So now PolyNovo is in a unique position at our stage of growth, et cetera, our unique market cap. And so it is a little bit more difficult to gauge where we should be compared with elsewhere, but we've used all of the experiences, engaged consultants as necessary in order to do that. So I'm very comfortable in the position that Ingrid definitely has been spearheading for us as a project.

I don't need to emphasize, I think what would be obvious to everybody that handling remuneration in a really fast-growing company has got its own challenges for obvious reasons. Handling remuneration in a cross-border company where you've got staff in here in New Zealand, Hong Kong, Singapore, et cetera, et cetera, and the U.S. Ed, thank you very much, has got its own challenges. So congratulations to Christine, and thank you to Ingrid, where -- I mean, this is the reason I resigned by the way, as Chairman of the Remuneration Committee. I just want to come out. I want to get the rest of my life a bit more comfortable. But anyway, now the question. That's it. One question from the Australian Shareholders' Association. By the way, just not to pry, but how many shares are you speaking for today? Don't worry. I mean...

So about 1 million odd.

Okay. Thank you. All right. For the purpose of taking -- any other questions from the floor? For the purposes -- I presume the ASA has got other questions right. You just -- I should have known.

Okay. For the purpose of taking all proxies into account, and ensuring that the votes are counted accurately, I direct that a poll be taken on this item. Voting is open, and I'll start until I close it. Okay. The third resolution is the approval of the new constitution. Thank you to MinterEllison for helping with that. but I'll put the following resolution to the meeting to consider a thought fit to pass with or without modification following special resolution. That for the purposes of Section 136(2) of the Corporations Act and for all other purposes, including without limitation, all purposes under the company's existing constitution approval is given for the company to adopt the new company constitution as initiated by the Chairman for the purposes of this meeting in substitution for and replacement of the exclusion of the existing constitution of the company, which is repeal. Not to labor this too much Lior, but for the people in the room and on the line, this is really just bringing the constitution in line with what into think is the current best practice. Okay. Are there any questions from the audience here today? No. And online, Lior?

This is very uneventful.

Okay. For the purpose of taking all proxies into account and ensuring that the votes are counted accurately, I direct that a poll be taken on the item. This was the final resolution to the meeting. So meeting -- voting is now open. [Voting]

I'm going to leave it open for 3 minutes, where we play another small video. And then I'll come back and I'll complete close the voting completely. So take your votes. For those of you who are in the room. Yes. Angela is going to collect those card and the video will play as she does it. Thank you. [Presentation]

I have to enjoy that. We so in my own mind, I don't think we've got these videos quite right yet in terms of the breadth and speed and some other things. But we're trying. So the voting is now closed. Thank you. And I think we'll now move on to the informal part of the meeting. I'm going to invite Swami Raote, our Chief Executive Officer, will give his perspective on FY '24 and beyond, and then I'll make some observations myself about how I'm thinking about the year ahead. So by you up Swami?

Thank you, David, and good afternoon, everybody. Healing and redefined our two distinct words but they unite our clinicians and all of us at PolyNovo to push the boundaries of plastic and reconstructive procedures for our patients. Since receiving FDA approval 9 years ago, we have been able to reimagine the healing journey of over 50,000 patients globally. We now provide access to training and our products in over 42 countries, including many who have never had access to advanced skin substitutes. With over 300-plus independent articles and abstracts relating to superior patient outcomes with BTM across a range of multiple acute complex wound indications. We are clearly seen as the new standard of care of soft tissue reconstruction space in developed geographies. The U.S. remains the driving force for our company growing by 49% over prior year. As we expand into trauma, infection and active complex bones, the number of patients healed is expanding at a stronger pace than our revenue growth. We are grateful for our partnership with BARDA, which has seen recruitment for our pivotal clinical trial conclude with 120 patients enrolled. Our conversations with FDA are ongoing, and we are looking forward to securing the PMA approval for 33 months in one of our largest markets. In the U.K., Germany, Australia, New Zealand, we are the overwhelming leaders in difficult burns as well as soft tissue reconstruction procedures. We hope to extend this leadership to the other 3 of the top 5 European markets within the next 18 months. In India, our efforts to develop the thermal substitute category continue at pace. In March, NovoSorb BTM received approval to be included in government e-Marketplace portal, opening access to the use of product across all defense railways and employee state insurance corporation hospitals. Although the market is complex and there are numerous peracetic processes to navigate, we are encouraged by the orders from two prestigious hospitals including the largest burn center in Asia. The momentum of geographic expansion continues with registrations obtained from Thailand, Peru, Bolivia, Ecuador, Nepal, Sri Lanka and Bangladesh. Additionally, we have signed a commercial partner for Japan launch with an initial meeting with regulatory body scheduled in November 24. After a limited market release for NovoSorb MTX, we have started rolling the product out across U.S., New Zealand and Hong Kong. The appetite from plastic surgeons is strong with our U.S. team reaching an impressive milestone of USD 1 million in product sales already. We are looking forward to launching multiple variants of NovoSorb MTX including a particulate variant, which has generated a lot of interest among clinicians for soft issue reconstruction in difficult-to-access and undulating wounds. Our R&D and clinical teams have worked with clinicians across the world to understand various soft tissue reconstruction pain points. With their help and a partnership with universities in U.S. and Australia. We are testing and refining a new product portfolio in burns, trauma as well as implantable products for hernia and other plastic reconstructive procedures. We are grateful for the Victorian government for a grant of AUD 2 million, which is a part sponsorship funding for our R&D lab expansion, new equipment purchase subject to us meeting a great milestones with consistent rollout of new products over next 3-year horizon, we are looking to expand our global reach and patient impact. Our plans for manufacturing capacity expansion are on track for completion by December 2025. The new facility is designed for scale with focus on flexibility, modularity and automation to service 5x of what we produce currently. This will be critical as we continue to advance and to develop as well as developing geographies, well beyond the current reach of advanced skin substitutes. As strong as NovoSorb technology is what truly fuels our success is our people, our culture and our partnership with clinicians seeking meaningfully differentiated patient outcomes. We are proud of having touched 50,000 lives in our short commercial history, but acutely conscious of the need to reach millions more who see it. Our future is promising and your team at PolyNovo will stretch to deliver it responsibly. I'll now hand back to Chair, Williams.

Thanks, Swami. I was going to say a few words for 10 or 15 minutes and then get some interviews going. But I'm mindful that we've got a couple of people online that are out of whack. So I've got Andy Eakins on the line, who runs the U.K. and the EMEA. And it's, I think, about 2:30 in the morning in London. So I might just swing into a couple of these interviews first, and then I'll come back and top and tail what I had to say. So if I'm talking to the webmaster and I pull in Andy Eakins, this is fantastic, unbelievable. So Andy, welcome. Can you see me, by the way?

No real sleep. I'm just back from Australia. So the jet lag has kicked in. So it's absolutely fine. I think I'm still on your time.

No, it's great with me. Will you be having a shave later in the morning, do you think or...

Once I've settled back into U.K. time, I'll make that a priority.

All right. So listen, Pete, I know you've been to 1 of the 4, but you haven't spoken. And I just wanted you to give a brief sort of pin now sketch of the history of U.K. because you had trial by COVID as it were in the early days. And we were looking at your performance here and wondering whether you get off the ground, but you're just kicking goals from all over the park at the moment. So just give us a bit of a history about the last years, let's say, and how you've turned it.

Yes. We love it when you tell everyone we had a slow start, Dave. So yes, let me put some meat on that bone. Just to let everyone know that we are direct in the U.K. We have a direct operation, a sales team. Wonderful sales team led by Nick Harley, and we use a distributor model throughout the -- throughout Europe and have some great distributors and partners. Now we were late to the party. So compared to the U.S. or ANZ, we didn't get our CE mark until December 2019. So I'm sure everyone is aware that a CE mark is, if you like, the passport to start selling into Europe. So we got that in late December 2019. We quickly recruited a couple of people, got them trained up and ready to go. And that was March 2020, which, as everyone, I think, remembers, is more famous for something else, COVID. So we literally had 1 week out in field before we were told to shut down essentially. So -- so that was a batters on the fire really. We got going. And as soon as we got going, we had to stop. So we quickly formulated a plan of how we sort of circle navigate that in very difficult trying circumstances. And what we did is we had a policy of start small, go big. And what we meant by that was let's get the products used as much as possible even if we couldn't travel and see clinicians in the way that we wanted to. So if we started with small pieces and got clinicians and surgeons to really build up their experience carefully and constructively, then they would be able to take that experience from using small pieces into bigger pieces. And the other key thing that we did is because it was driven like that is let's just get it used. Let's get BTM used, let's get that experience. So we never saw ourselves as let's just start with burns because we knew that, that would be really complicated in a COVID situation. But also, we don't really have many burns here in the U.K. and across Europe. We don't have volcanos. We have terrible weather. So we have no barbecues. We don't carry jerry cans of fuel everywhere. It's about 8 minutes away from a service station. So burns is not a big market, if you like, for us. It's very significant and obviously very challenging wounds. But really, there's so many other different areas, whether it's maxillofacial or vascular, trauma orthopedics, where a lot of people on a very small island. So there's a lot of sort of trauma orthopedics. Plastics, obviously, podiatry, lots of different areas. So we don't see ourselves as a burn company. We never have done. We see ourselves as a wound care company, if you like. So the idea was let's go for any wounds, any major loss of dermis. And our mantra is where there's a major loss of dermis, they could be BTM. So yes, it was a slow start. hampered by the fact that we couldn't even get out to a medical meeting until late in 2021. So coming up to sort of 2 years before we could really start conversing in the way that we wanted to. But to bring that full circle, I'd like to trough out this statistic, and that is more BTM was sold or ended up in Europe last -- our last financial year than any other geographical region within PolyNovo. And considering that was literally a standing start 4 years ago, and 2 years of that was really hampered. I think it's an amazing statistic. Now there's some caveats to that. I know Ed's in there with you. And he'll say that in the U.S., they have much higher ASPs and Valerie will say that they have more burns so they sell bigger pieces. And that's all absolutely true. But what I would say is that it did mean that we really helped more patients in Europe than anywhere else last year. And I think it's a real testament to our team here in the U.K. and our European partners that we were able to achieve that in such a small time.

That's brilliant. Thank you for that. You also -- when you and I talked on the weekend, made a big deal out of the fact that there was more publications coming out of the U.K. and Europe. I thought you're going to end this discussion with claiming that Britannia rules the waves, but you stop short of that. But talk to us about the research that's going on over there.

No, I can still tell you that Britannia rules the waves. Clinical papers are the lifeblood of what we do. I mean, from a marketer's point of view, they provide us with the ammunition to talk about why it's such a good product and the outcomes and the way it positively affect lives. But really, clinical data, it's a real peer-to-peer thing. A, really expands the usage. It gives other clinicians the idea of how to use it, how to use it right to the pitfalls to avoid the way to get the best out of the product. And expands the sort of usage of it. So clinical data is a really important thing, both clinically and if you like, from a sort of professional company point of view. And it takes time to produce clinical data. Someone has to find -- firstly find a good suitable patient and then use it, then do a series of patients like that, then go through the follow-up, which takes time, collect that data, write it, send it off to a journal, probably review it and then get a date. So the whole process takes a long, long time. And again, we've come from a point where obviously, 4 years ago, no one had ever used it within Europe. And then we did some quick analysis this year this last financial year just passed. And actually, if you look at the amount of clinical papers published from the U.K. and Ireland, we were sort of #1. We just picked the U.S. and Australia for the amount of publications coming out of an area. I have to add in Ireland because if you took Ireland out, then actually, it was so close. We dropped to #3. So for the purpose of this meeting, I want to be #1. So yes, U.K. and Ireland had more publications. And one other point to that, just last week, 7 U.K. hospitals did our first ever meta-analysis of more than 1,200 patients, reviewing 26 different papers and came out with some incredibly positive results about a whole range of different features of BTM. So that's hot off the press that literally just happened last week.

That's fantastic. I'd be clear to share that with us as quickly as possible. Let's just talk about the EU. And I know you said you're about to sign 2 or 3 new countries, Portugal, Malta and one other, I can't recall. But -- well, first of all, where are you with that?

So the idea across Europe is, as I said, to use distribution partners. And we make sure that we look and work with the best people that we think are going to really help support BTM. So the idea is not to have a sort of scattergun approach and just sign up anyone and everyone. It's really to have the best partners that we can work really, really closely with and get them to the #1 position and then sort of expand slowly but surely keeping pace with that, making sure we get the real sort of -- all of our partners up to the #1 position that we want them to be in. That said, we are looking at literally just closing up three new partners, Malta, Portugal, the Czech Republic and Slovakia, so the old Czechoslovakia. And that's for slightly different reasons. Malta, the government approached us through the for a distributor. They have a national tender. I know it's only a small territory, but with one product on that tender. I don't want to make too much of it, but we know that one of our competitors is having real supply issues. And the same with Portugal, both those countries couldn't get any more product. And we have a big warehouse full of products. So we have to go through the regulatory and quality assurance of that. But it's obviously really important that if we can support patients, then we should support patients. And so that's why we're entering those two countries. Czech Republic is slightly different. They're taking a lot of the Ukrainian patients right now, and that's obviously very important here. And they have very close links with Germany. So they have the training and support from U.K. -- from German surgeons, sorry, being able to come in and support them. And in fact, there was a Ukrainian patient just recently that was supported on a special access where we provided BTM and that made Czech national news. So because of their place geographically and the importance because of the patients from Ukraine, that's why we've decided to enter there. And all three of those hopefully should be sort of signed up within the next few weeks.

Last year, here I asked everybody I talked to roll forward 5 years and you're getting your helicopter and you look down your territory, what are you sort of anticipating in terms of the usage of the device, but also the countries themselves. Are you sort of expecting France, the boom ahead, the Eastern bloc. I mean, how are you sort of thinking about -- if you had to think about it 5 years hence?

Well, I think there's a lot going on really. So France and Spain are good examples there. We signed up them just over a year ago, and they're already going absolutely fantastic. And I think we just need to continue that relationship, support them and help them. I know the first French clinical papers are currently being written. And I know you've got Marcus on later, and he's helped support the surgeons with that, which is also fantastic. We're doing a lot of work with regards to where does BTM fit into that continuum of care, whereas previously, free flaps, which I think was just mentioned in that video, and so we're looking at some cost calculator work where the use of BTM rather than flats, we're seeing a sort of transfer there, which would be fantastic and with allograft. I think we definitely add new countries. We've got about 80% of the population of Europe covered. We look to obviously want to cover the rest of that. There's some key countries in Africa and particularly the Middle East is sort of on our radar absolutely. We've got new products coming through from Josh and his team, which look absolutely fantastic. And I think we will continue to see ourselves as a major wound care company, but certainly the #1 dermal matrix company and keep pushing that way.

That's great. Now you mentioned Africa didn't sort of limit what that was. and the Middle East. But is this grab have you told anybody in the head office that this is where you're going?

We have discussions constantly about what to do and when to do it and how to do it in a way that is sustainable. Can we get the product there? Can we get the registrations there? Can we train the surgeons? Can we support them? So it's really important that we do it properly and carefully. And certainly, we're already in South Africa. I think we're already looking at sort of Egypt. Ed sponsors a surgeon into the UAE. So there's some product going there. And I think Saudi Arabia, Kuwait, et cetera, are obviously areas that we will look at. But as I say, in the right responsible kind of way.

Yes, yes. And just one final question then on your staffing. You mentioned we were talking over the weekend about differences in performance and in particular, some superstar that you had in Ireland, I think. But how much more work do you have to do on your staff in U.K., Ireland as opposed to what's happening with the distributors? Where do you see your holes at the moment?

Well, again, I think it's about expanding as quickly as the sales and your partnerships move forward. And you have to sort of just keep pace with that. So, in Ireland, we have a distributor and per population, they are most successful distributor anywhere in the world. They do an amazing amount with a small population of about 6.6 million people. So they benchmark where we need to go, which is absolutely fabulous. With regards to the U.K., we've got a very good team, a very stable team. We've just added a clinical specialist to that. We will add more people to help manage the distributors going forward. And from the U.K. domestic point of view, I mean the team did fantastically. We'll definitely need to add one person -- one salesperson into that, I think, as the months and year roll on to make sure that's probably covered. But we've also been given the green lights to add a business manager to help take some of those administrative tasks away from the salespeople. That's great because that gives them the ability to concentrate more on the sales. And I know Jan is working on putting a finance person into the U.K. as well. So we'll have some of those financial aspects also covered. So again, we're we are expanding, and we're doing it as we need to. But certainly, the way that sales have really taken off in the last year or so, it's HR or human resources is definitely the area that we're concentrating, so we can keep up with that expansion.

And do you see that extending to clinical people? I'm just thinking about when you were talking before about supporting new countries coming on, do you see that being done by people like the German surgeons and Marcus or do you see yourself having a dedicated team?

It's both. So I mean, we do -- we have recently reorganized and we have a global PolyNovo clinical team. We've just promoted one of our people to be the European clinical liaison, and she is already doing a fantastic job in helping supporting, training, getting these distributors and new distributors up to speed as quickly as possible. It's not my place, but I'm sure we will absolutely increase that function as we add more countries, we will need to have to do that, and that would also include professional education. But a lot of it is also peer-to-peer. It is having those surgeons that we can rely on for their support. And we do a lot of symposia here at a lot of major burns and plastics meetings. We'll continue to do that. We brought various Australian key opinion leaders over to do that kind of stuff. We are generating our own, obviously. We recently took a U.K. surgeon over to France at their national burns meeting. So I think it's a real joint effort really. I mean, yes, we work really closely and need to work even closer with the key top surgeons who use BTM, but also support that ourselves of our own clinical liaison group that can help support those surgeons to generate that clinical data.

Yes. Yes. So listen, thank you very much. I let that run on a bit too long because I wanted to make it worthwhile as you get up in the morning. But on behalf of everybody in this room, which is about 100 people at least and a couple of hundred people online, all shareholders, but thank you for your service, as they say, in the U.S. But in particular, we're blown away by the way in which you're growing. And I wish you every success in trying to the rest -- Middle East from Ed and Swami and set North Africa from whoever that try and keep it. But listen, call in again when you're on. And thank you very much for everything.

Real pleasure. Any time. Thank you very much.

I'd probably let that run on for too long because I had a number of things I wanted to just get off my chest. I think we might drag Marcus in. He's in Adelaide, so he's only half an hour behind. But he does have a patient today who just lost an arm in a motorbike accident. So we might pull Marcus in. Were you listening in on that, Marcus?

I was, yes.

Good. So just a couple of things. I don't want to keep you as long as I did, Andy, but you and I have had a lot to do this year together in terms of war zones and charities and so forth, you a lot more than me. But I was saying when I started this today that it's one of the most heartbreaking yet at the same time, the most fulfilling aspects of the job and of what we do, not necessarily to make money. But I just wondering your reflections now in terms of -- because a lot of this came as a surprise to me, not only war zones, but the charitable contributions and then the World Health and Médecins Sans Frontières, this whole sort of fruit salad, if you like, of the things that are happening. But what's your take on it? I should have said, by the way, that Marcus has just made a paper in Brisbane to the -- I don't know what it was, Marcus, the World Military Medicine Conference (sic) [ World Congress on Military Medicine ], or something like that. But maybe start with that and then talk about the sort of things you said and how you see it relating to Gaza and Tel Aviv and so forth.

Okay. So the meeting I went to was the International Committee of Military Medicine. That was in Brisbane. That's a World Congress that's been going for over, I think, 60 years.

I might have to get you just to put up your voice a little bit, Marcus.

Sure. Valuable people involved in the military across the world. And so there were 94 current countries or so represented there. And what -- and I learned as much as I brought, at least. I mean it was all about not just providing health care to the military, but also the austere environment. Now that can be divided into people who travel with humanitarian organizations such as MSF, civilian hospitals that are in an austere environment, such as the civilian hospitals that are in the middle of Ukraine, or also, civilian hospitals, say, in Czechoslovakia, like Andy was discussing, which have taken casualties of war into their environment, and of course, military hospitals as well. And then, of course, there's the hospitals, the repatriation of hospitals, say, for example, the QEH in Birmingham that takes the forces from the U.K. forces. So there's a -- it's a whole world of -- different world aside from the general emergency nonactive patients that we see on the day-to-day in the developed world. And what -- so what I did in preparation for this meeting was effectively send out some questions to surgeons working in all those environments, saying where are you working? What are putting BTM on? And what's your feedback? I left it very open and basically they view it as positive. And I've got some amazing responses. People have been using it in Gaza, in North Gaza. People are using it in Israel, in Beersheba and in Haifa. People are using it in Ukraine. And overall, the responses were extremely positive. And the photographs I got sent back, which I wasn't really expecting, were really quite moving, with children who had the cement blocks land on their feet and they would normally be amputated. And they've kept their feet using BTM. These are in hospitals that you wouldn't expect to even function, let alone preserve these limbs. These are the most challenging hospitals, I think, in the world. It's been a real eye opener for me living in such a privileged world. So there's definite strength that BTM offers to those areas and just getting it there. And we've had some tremendous support from the Government of Taiwan through the Christian Medical Association to deliver BTM to Ukraine for burn patients. And that is a program that's stretching across 3 cities: Lviv, Donetsk and Kyiv. So -- and then, of course, there's the trauma as well. And we see continued interest from humanitarian surgeons traveling from the U.K., from London, to Gaza. And it's just been a real eye opener. We're in a time of geopolitical unrest. And I think it's a worrying time. And I think, certainly, the civilian and military partnerships that we're seeing forming are looking for solutions for the casualties. I think BTM, certainly from what I've seen, offers them. And they're looking for better training, better support, and that's the challenge for PolyNovo to deliver into these austere environments. Very difficult.

Yes. We talked a little bit before with Andy about supporting new jurisdictions and so forth. We went into the Ukraine, and I know that you talked with 1 or 2 surgeons there through the first use. And then I know that you went in later and did education, an hour or so, for 30-odd surgeons in the Ukraine. Does that -- is that -- did that work fine? Is it -- I mean it's not ideal, obviously, but...

It's very well received. It's very difficult because, generally, in austere environments, data collection and data aggregation is very poor. So it's very difficult to see and to quantify the effect. But certainly, it was very well received, and the feedback I had personally was excellent.

Yes. That's great. One of the things that's worried me a little is knowing more about the quality of the operating theater. We had -- we just had a report overnight from Avita, who had attended to that young boy in Belgrade, who was 85% burned, and they reported back that the theater was very professional, 20 people in the theater, very keen, technically good, big caseload, et cetera. But the opposite end of that spectrum -- I think, Marcus, a lot of people in this room might know this. But the Nigerian marathon runner after the Paris Olympics came home and was doused by her boyfriend in petrol, 75% burns to her body and 40% to the -- to her boyfriend, both admitted to a regional hospital in Western Nigeria. We were able -- I was able to get to them through the ambassador within an hour and to the head surgeon. But trying to get the surgeons to let us have better information about the state and sophistication of the operating theater is going to limit us in some jurisdictions, I think, and I'm thinking more about Africa.

I think that's right. Look, it's difficult to -- and I think it's very difficult to deliver BTM effectively in the hot situation when you have that patient -- those 2 patients that we all want to react to and we want to help. But without the setup and the planning and the support and the training in advance, it's very difficult to be effective as a company. And I think that's something, again, we need to look at when we're delivering to these areas. But it's -- like I said, with Nigeria and with Belgrade, Belgrade, this guy is doing pretty well from all the things I can see. But Andy mentioned that -- or Ed was sponsoring somebody who's -- or supporting somebody who's now in Bahrain -- Abu Dhabi, excuse me. And she arrived in Abu Dhabi, and she'll tell you she arrived to a burn service that really wasn't contemporary. And she spent the time building a contemporary burn service in UAE and, as such as, is now using BTM. So it's so much more than just delivering the product. We need a contemporary unit that can get the best out of it.

Just a question on India. You went up to India this year and came back very enthusiastic. I didn't talk to you about it, I don't think. But I heard reports of others you talked to. How long were you up in India? What did you do? And what were your sort of feelings coming back about the future?

Look, it was a very -- it was an extremely moving experience. I was there for about a week in India alone, and it was to go there, to go to Mumbai and see a PolyNovo office with a PolyNovo branding in it. And everything else was just like a maturation of the company and something that I have never really seen. So that side was amazing. But then to see the enthusiasm of the physicians working in India across public, private, military, all came to help the patients and looking for solutions. They're looking for ways to do better and to get better results and get their patients treated better, and they see BTM as a way to do that. And since I've been to India, I've been consulting on cases. They've been sending me narratives on them and asking advice. And the results they've been getting have been startling. So it's -- there's definitely -- they see the value of BTM. They want it in their practice, and they are -- and there is a company all set up there to deliver it. So it's a very exciting prospect. But the sheer numbers of patients in India is just huge. The potential for helping so many people so quickly is there.

Yes. I think it was Valerie who quoted you as saying that you thought India could be the biggest market in the world in 5 years' time. What -- you're in your helicopter in 5 years, what are we looking like?

I still stand by that, but I'm not a market analyst. It's -- I think in -- look, we've got so many models we can look at that we've been through. We started off in Australia and New Zealand, from Adelaide to Melbourne, from Melbourne and then Concord and then Auckland and so on. And it starts off with enthusiastic terms with junior surgeons, but then the senior surgeons are taking on BTM. The ones who think maybe they're established in their ways, why would they take on a new product? But they're seeing its benefits. So we see these -- the presence of societies [ they still bring on ] and they completely shift what they're doing and move to this product because it's good. So we've seen that happen in Australia and New Zealand. We've seen it happen in the U.K. We've seen it happen in the U.S. where the established units, with the established methods of care that they've been doing for 10, 15, 20 years are changing. So I have no reason to think that wouldn't happen in other jurisdictions and territories. It certainly happened in Germany. Heidelberg, we just published 300 cases in burns and plastics and burns and wounds. And so we're starting to see really large numbers coming through in the literature. So I can't see why that wouldn't happen against financial restraint or constraints, why that couldn't happen in India. It's just the need is so great and in other jurisdictions because that's the evolution we've seen through Australia and New Zealand, U.S., U.K., Germany, wherever we've gone, with conviction, surgeons have adopted it. And it's part of now the general surgical parlance. It's an accepted and discussed option for burns and wounds.

Okay. Marcus, I'm conscious that you've got a patient there to look after. And thank you on behalf of everybody in this room, more than 100 and a couple of hundred online. But thank you for your service. I'm not sure if I should have introduced you differently. But Marcus is effectively a walking, talking KOL for us, and he spends a lot of his time on the road and a lot of his time on Zoom, talking to other surgeons and so forth. I really thank you for that. I should have also said that you're quite a large shareholder. Well, not you, your wife. She's [ one of the ] brains. So -- but I just thank her for being a large shareholder anyway. And Marcus, we'll see you when you're next over here.

I will do. Thank you, David. Thank you, everybody. Thank you.

Thanks, Marcus. Dave, can I drag you up for just a second? I think people would want to hear -- you got that microphone there, please. Don't tell me you didn't expect to be called up. You've got a tie and a suit on, so first thing -- first time I've seen that. So is that microphone on?

Can you hear me?

Yes. Okay. So Dave Morris, just give everybody just a brief one sentence where you came from and what you've done with your sorry life up to now before you fell on this gold mine.

Yes, absolutely. So I've been in medical devices for the last 25 years. And I've actually been fortunate enough to work for PolyNovo, the #4 of the biggest medical devices companies in Australia, all invented in Australia. So I'm actually proud and privileged to work at PolyNovo. I was at Cochlear, Monash IVF and Nanosonics, and now at PolyNovo, another great Australian invention.

Good. So I already announced you as being Head of APAC, which, for us, really means focus on China and Japan. It means much wider than that, of course. But that's your near-term brief. You've been recently up to Japan in the last 2 weeks, I think. And so what were you doing out there apart from eating Wagyu?

Look, Japan is a very interesting and complicated market. It was the #2 medical device company market in the world after the U.S. It's now #3 after China. So they really are the most important markets and the biggest opportunity for us in the long term. In terms of Japan, as Swami mentioned, we've recently engaged with a commercial partner there, and we're working with them to get registration. Also during my time there, I've met with a number of KOLs, one in particular, Prof. Matsumura. He is the Head of the Tokyo Medical University Hospital and very influential. So as Swami also mentioned, we're preparing for our first meeting with the PMDA in Japan, which is the equivalent of our TGA or FDA. And that's what we're working on at the moment. Once we have that initial meeting, there will be some time before we actually get registration and start commercial sales. But as we engage with the various key opinion leaders and attend the various conferences there with our partner, we'll start to build momentum when we're ready to sell.

Is our existing registrations and history of any assistance, do you think -- does it give us any sort of fast track? Or is it a standard procedure that's going to take us 2 years? What's your best guess?

It's being registered with FDA and TGA, and having the CE Mark in Europe helps a lot. The Japanese follow a very rigorous process. And so we have to be compliant with that. The Japanese also take a while to change their clinical practice. But once they do, they do it on the dime and then things should be good. So we're doing everything that we can to expedite registration, and we'll have some more information after this initial meeting at the end of November.

At the end of November. Well, that's good news. And just briefly, how are you thinking about China?

China is, as I mentioned before, is the second biggest market in the world for medical devices. I've been there many times before and most recently on my trip to Japan, I went to China. We are working through our planning for registration in China. That also will take some time, but there are some interesting mechanisms in China to start selling before we have NMPA approval, which again is the equivalent agency to like the FDA, in Hainan province or in the Greater Bay Area. These provinces are predicated on having sales in Hong Kong, which we do. We have a really strong business in Hong Kong, a growing business in Hong Kong. So we can potentially expedite commercial sales in those markets in China without having a full registration.

So just for everybody here, really what China had done is replicated some little Hong Kongs where people can get foreign medical treatments and so forth. But I didn't realize it was a necessary part of that, that you had to have sales in Hong Kong already. Just since you've raised it, how are our sales going in Hong Kong? The last time I talked to Valerie, we're selling to the 2 biggest hospitals there, but I'm not sure where it's got to since then.

So things are going well. I also recently went to Hong Kong and visited those 2 big burns and plastic hospitals. They're very strong supporters of our product, both, in particular, BTM, but also MTX. And we are now also selling in many more hospitals in Hong Kong. Just in addition, the reason why China has done that, especially in Hainan and GBA, is because they're so close to Hong Kong. They wanted to be able to provide the same level of care to people living in those provinces they do in Hong Kong. And as a result of that, they fast track that.

Yes. Yes. Okay. That's beautiful. And so how long you've been here? Six months?

Six months.

Six months. Okay. And how are you finding it?

I'm loving it.

You're so good. Thank you. Very nice. Very nice. Ingrid, come up for a second. We might -- come on. Okay. Ingrid Anderson, in charge of HR. Is anybody finding this interesting? I can always cut it short. Again, like Dave, just a pen and sketch on where you came from. She's a surfer, as you can tell. So I'm just building up to her answer. I've accused her of living in Torquay, but she doesn't live anywhere near. But anyway, where did you come from?

Yes. So prior to PolyNovo, I came from a manufacturer out in Clayton called BWX, ASX-listed. Sukin was our most well-known brand, so natural skincare space. And prior to that, I spent 15 years at Billabong. So...

See, what I was talking? Billabong.

Yes. So ended my career there, in the U.S. I spent 4 years in California, living in Laguna Beach, very lucky, looking after HR for the Americas. So medical devices is very new to me, but yes, learning so much and absolutely loving it.

So now you've probably got -- I don't know what we've got now, 260 staff?

Nearly 270.

270 staff. And what did you have at Billabong, for example?

At Billabong, we have more. We had about 5,000.

Really?

Yes.

No wonder they went broke. Okay. So what are you busying yourself with since you got here?

So my initial -- I'd say most of my time is actually being spent in the compensation space since I joined PolyNovo. So no surprises, small business that's growing quite quickly. So there's been a lot of work to do just on working out using our annual STI plan. Is it fair? Is it equitable? Are we being market competitive in terms of our fixed remuneration and spending a lot of time on a long-term incentive plan, wink to Christine, which will hopefully get signed off this week. So moving to a different plan from what we currently have, which is our options plan.

Have you -- how long have you been here now? Nine months, I think.

5th of Feb, I joined.

5th of Feb. Okay. And so are you experienced enough yet to sort of have a view about where we're heading to?

In terms of...

As a company. I mean you've been through a big growth company with Billabong that sort of fell over.

They got bought.

They got bought. You got a view about where -- with your Billabong experience hat on, where we could go to?

Yes. Look, I think PolyNovo is right on the cusp of that point in time where, speaking from a people perspective, it's really important we retain the flexibility, the agility that we have. We stay lean, so we don't overinflate our organization and be careful in terms of layers and things like that. I'm speaking to this because we spoke about it very recently at our strategy off-site last week. But I've never worked for an organization -- and if you think of somewhere like Billabong, you can imagine the company pride there. The company pride at PolyNovo is beyond anything I've ever seen. So the confidence that our people have in our product and what we do is our secret sauce in not just attracting people but retaining people.

So it's pretty powerful that we use the sort of things that Marcus was talking about, the case studies we've got. It's a pleasure to come to work when you -- it just sort of knocks you out when you see what's happening.

Nice and easy. It does.

Yes, it does. So all right. Well, I won't take that any further, but welcome anyway. Thank you. Lior, I'm not going to deal with you because I want you to not mess up those slides. We'll interview Lior next year. Ed Graubart, up you come. First of all, would you like me to lend you my red jacket?

I know I'd get myself in trouble.

It's good. It's good. So I'll start off where Ingrid left off, which is the off-site. Just stay a little bit closer because I noticed when I was looking at last year's, you were sort of in and out of the [ pick ]. But just starting with the off-site, I've heard some very good things about it from different people and what they got out of it. What did you get out of it? Did you learn anything from anybody else? Did you teach them something?

Of course. Listen, this is my sixth AGM. So I think what you heard from Andy, what Valerie is doing, what we're doing globally, they like to think they're competing with me. I'm thrilled to death to see the progress that we're making in places outside the U.S. because when I stood up here 6 years ago, which I think was October of 2019, we represented over 90% of the global business. So to see how we've transitioned as an organization to go to the different markets, to go to the different countries and to have the impact that we're having, I'll take that competition from my internal any day of the week. I still want to recount on the numbers, but that's a whole another thing, and I don't give up quite that easy. But it really does show from a perspective of the impact that not only we've been able to have, but that the product has. And it is about patient outcomes because surgeons aren't going to make the changes that they make and make the decisions that they make for their patients if they don't have as good or better outcomes and they're delivered economically. And I think we deliver on both of those.

Yes, yes. What are your sort of hopes and plans for MTX, do you think, in the U.S.?

I'm learning more and more about MTX. And like I said, we reached that $1 million milestone very quickly. I think it's got the potential someday to outdo BTM. I really do. I think there's a need for it. We have a lot of milestones from a proof standpoint, from a regulatory standpoint that we have to overcome for this really to be what we think it can be. But remember, we also -- we don't have full thickness approval for burn in the U.S. for BTM yet, which we're working on through the BARDA study. We're going to have that same type of opportunity when it comes to MTX, I believe. And I think it's a bigger -- ultimately, I think it's a bigger market.

Yes. And tell us something about Canada? Last year when you were here, that was just moving to sell in the East Coast as well as the West. And is that -- how is that sort of tracking?

Yes. So we just started doing some cases on the East Coast finally. It's taken a little while. I mean the government, it's a little bit different. They're funded. They have a capped amount they're allowed to spend every year. And so we've come in and we've disrupted the system a little bit. So now when you come in and disrupt a system like that, you come under a little bit more scrutiny when you start spending more money with somebody. Even though you might be saving them money, you're still spending money on something they weren't spending money on before. The good news is that with a lot of the clinical economic data that were coming, we're able to sit down and present our data on a different level to them. So the opportunity is -- continues to grow there. And I expect this year to be the best year out of Canada still.

And heading south into Central and South America, I noticed that we've started supplying to Ecuador, Peru and Bolivia. And I think somebody told me Guatemala, but maybe not. But so are they under your umbrella?

No.

So where do they get control from?

They're controlled out of here. It's a different -- their approval is a little bit different, number one. And our focus is, as the largest market from a revenue standpoint, our focus has to be North America, at least my focus has to be North America to stay engaged with what we're doing there and still have some of my reaches elsewhere.

Yes. And how are you feeling about your staffing? I forget what you've got now, but you must have 120 people in the States and 80 on the road or something like that?

Yes, over 80 on the road, 120 total. When I stood up here in October of 2019, I think there were 15, 16, 17, something like that.

Yes. But you told us you were doing all the work, actually. But now that's all right.

I got a great team.

And so same question I asked everybody else. Five years from now, what do you see the Americas looking like? Do you see a separate sales force under you for breast or...

Yes. I think that's what we have to decide, right? As we continue to develop products, what fits the profile of the current sales force and then what is going to be the best way for us to approach those other markets. Is it going to be from a strategic relationship with somebody who already has relationships and has contracts and access to hospitals? Or are we going to forge our own pathway? And I think as each new product comes and we evaluate the opportunity, that's something we're going to have to just make the decision on.

Yes. But I mean, sitting here today, what would you guess, podiatry? You're not going to build up a sales force on your own, are you? Or do you think that's possible?

It depends on if we get -- I think if we look at something from a procedural solution standpoint, meaning a patient-centric device, we've got a single device now. If we start complementing that with other products, other parts of a procedure where we can own a patient from the minute they enter the ER or the hospital to the minute they're discharged, then it could be a model that we would want to keep because then we really -- that patient becomes a PolyNovo patient from the minute they assess, debride or size, temporize, put skin on back, everything out the door. If we were able to offer a complete solution, I think we could look at it a little bit differently. So again, it's hard to commit to something right now, but I think we're open to all the options.

Yes. Yes. Got it. All right. Well, look, thank you, Ed. Thanks for coming on. And did I introduce you as Head of North America? I can't remember. But [ Joseph ] would have given it away anyway, I think. All right. Well, we're nearly done. Let me just make a few comments. I think I put myself in the helicopter as well from time to time and think about what is it that really has wowed me. And I mean, as much as it sounds a bit trite, the humanitarian things that we've seen have really surprised me. They came out of the blue with things like the Ukraine. But what surprised me was not only the size of some of these opportunities, but the people who are supporting them. So in the Ukraine and elsewhere, we've got charities from around the world. We've got other countries that might or might not like Israel or Lebanon or Putin or whatever it happens to be. And then we've got a whole host of World Health-type organizations, WHO, of course, but a lot of the UN and operations as well that are looking to support these things. And some of the size of the markets, I think, just blows you away in terms of even the sales we've had into the Ukraine in a very short period of time compared with some other countries. We're not sure where -- I'm not sure anyway where some of the stuff ends up. I was in Manila 2 weeks ago with the Embassy up there. And the product that has been coming in there, you'll be interested in this with some U.S. surgeons carrying it in. There's a guy up there who spent the last 2 years at the Austin Hospital [indiscernible] and he wants it in. So there's -- wherever you go in the world, there seems to be people who are finding a way to get the product into the country. But I think I'll come back to that because I think, as I said to Marcus, it's really heart-wrenching. I read in the paper this Olympic champion in Nigeria gets doused with petrol. She's in the hospital. We can get to her within an hour. The surgeons are well-meaning, but they don't really want to supply you the photos straight up, not that I need them, but Marcus needs them. And letting us get involved in the whole infrastructure of the care of a patient as opposed to just sending up a bit of product, which is what we did in Tel Aviv, which is what we did in the Ukraine and so forth. But when -- that woman died with 75% burns to her body and her partner died with 40% burn to his body. And it just made me -- I never had such a bad day, but it was the worst thing that ever happened to me. And then I was up in Manila and I'm with the head surgeon at the military hospital there, military hospitals, an old [ gaucho ] like me. And he said, what's your rule in Australia? Our rule here in Manila is if a person is 40% burned, we don't treat them. They're dying. That's the end of it. Marcus has got -- we had this guy in -- we just finished this guy in Serbia, 85% burns to the body, and 6 months later, he's doing just fine. So it's the most frustrating thing. But when they live like this little boy in Serbia, for example, it's so heartwarming, and that's what sort of brings you to work really. We've got strong sales growth. Everybody knows that. We ended up the year with $49 million cash in the bank. When I'm reading these notes, by the way, they're already out of date. We've gone from staff of 218 last year to 254. I've now found out, it 270. My notes show we're in 41 countries. Well, as of last night, it's 42 countries. And that in itself is very interesting. Jan Gielen produced this for me the other night, which I thought was great. But if I go back to 2019, we had 5 countries that we were supplying. In 2020, that gone to 13. In 2021, that was 19. In '22, it was 25. Last year, financial year '23, it was 29. And now it's 42. The number of countries is just growing astronomically. And it's a bit like a question I asked Ed some years ago, you put on staff. What's the complexity of your staff? How long have they been there? And what sort of run rate can we sort of think? If they're only 3 months in the job, then how much they're going to produce in 12 months? But some of these countries are free, but the Ukraine was free. We gave them $0.5 million worth of stock, and then we got orders. So some of them are going to turn into customers for us. So this whole issue about our geographical spread is fantastic. I think I must be getting too late because [ John King ] is leaving. John, where are you going? He lives in [ Daylesford ], by the way. Okay. Look, I could go on and on about what we're doing. And I think it's more important to hear from some of the management, to be honest, than me just listing out what I think we're doing in Japan or China or India. But I might just turn it over quickly to questions. There were a couple of questions that already came through. So to save me all reading them out, one was, would we ever consider taking over Avita? This is a perennial question. And the answer is we'd never say never to anything. But be very clear, and I've made it clear for 4 years, that Avita is not us. They're complementary to us. We rebuild the dermis and Avita supplies the skin on top. So the boy, for example, that we're treating in Serbia and Belgrade, he's had BTM for the last month or 2 months. And Avita went in there 2 days ago, sent to a surgeon and a nurse, and they've treated him with RECELL. So they're complementary. Does that suit us or not suit us? I don't know. It's -- the thing is because it's complementary, my own -- you can imagine what my concerns might be. Well, we don't care really who puts the skin on. It doesn't matter to us. We want to rebuild the dermis and then if the surgeon wants to grow the skin in a test tube, put it on with RECELL, take it off your ass or any other method, fine, we don't care. And I'll save you asking the question because there's a lot in the press in the last 2 days about a new skin that I think is coming out of Melbourne University and saving lives of blah, blah, blah. Well, I must have had 50 e-mails and phone calls on it. And people are sort of saying, well, the share price is down, and that's because of it. It's a skin. Any time you read that there's a skin, just think as a default that it's really complementary to us, not a substitute to us. So I don't think -- would we take over Avita? Who knows? Never say never, but it's not -- I can tell you now, it's not on our radar, even though everything is on our radar. The second question I had that I haven't yet answered was somebody said -- well, I got 2 questions. One is, when do you intend to pay dividends? I answered this last year. I said I'm not really concerned about dividends. The Board hasn't even considered it this year. If there's a choice between dividends and growth, we're going to take growth every time. And even though we've now turned to profit and we should become more profitable, it's thin still. And we've got a lot of jurisdictions to conquer, and we've got a lot of new product pipeline to conquer. So I don't think I or the Board certainly hasn't got a view on this that we're going to start paying dividends anytime soon. The second question on financials was how you're traveling. Can you give us an update in terms of how we're going? And again, I'll answer it like I always answer it, which is we don't give guidance. It's pretty hard for any of us to judge how fast we're going to grow. You've seen what's been happening 40%, 50%, 100% in some jurisdictions and so forth. We've done pretty well. And sitting here today, all I'd say to you is that we're on budget. And for that reason, I'm happy. And if I'm happy, then Jan Gielen is even happier. But that's what's happening at the moment. So how much will we grow this year? I don't know, but we're growing. I think it's not going to surprise anybody that if we grew 50% last year, we're hardly going to drop off a cliff on the 1st of July. So the company is going well. And as you can see by some of these discussions we've had today in terms of new jurisdictions, new products and so forth, we've got a fair bit of traction with the surgeons. I will just -- having said that, I'll just take some questions on the floor, and I'll go to the ASA first, just to finish you off.

Given all the things that we've been hearing about today, I guess my questions sound a little bit mundane. But nevertheless, we'd like to talk about some of the directors in terms of -- I think you indicated that you are putting together a policy for directors in terms of the skin they hold in the game, in other words, the company shares they may hold. Would you like to -- would you share with us what that policy is how?

I can share with you that. And this has been a bugbear of mine for a few years, and it's increasingly taken up in the U.S. I wouldn't say it's widespread yet, but the requirement that if you're a director, then you should have some skin in the game. So we have taken a rule that's been approved by the Board, recommended by the Remuneration Committee, thank you, Christine, that any director has to have in shares the equivalent of his or her director's fees. Now we've given them 3 years to sort of get to that stage. But for example, I don't even know what the director's fees are. But let's say they're $80,000, then you got to have at least $80,000 worth of fees that were your directors' fees on the day you joined the Board. So that is now approved, and that will now happen, I think. But if I -- I mean you know that I've got millions of shares, so that's not an account. And I think most -- well, Andy just said he's still got 100,000 left. So anyway, look, it's the principal accounts, and we want it to gel. So we haven't announced that, but we probably should have tagged it on somewhere.

Okay. Well done on that. The other question is about the skills metrics of directors, and there's certainly a need, I think, in terms of the skills metrics, so I think you've also worked on. Does it show the individual director skills? And how might that be assessed?

Well, I was going to answer it flippantly and just say, look, we don't have the skills to put the skills metrics together.

I don't mean that.

But we have done, I think. Have we have done it, Christine? Okay. We have done it. Do you want to answer that, Christine?

Yes. So we've always kind of had it bubbling under the surface. But I think, again, with Ingrid joining, it became a much more formal affair. So we do have a skills matrix that everyone's contributed to, and so we can highlight where there are any gaps, et cetera. Yes. No, it's been formally done.

A separate question that came to us today was, do we intend to replace Bruce? Because we haven't made an announcement about that, but the answer is probably yes, we haven't just talked about it definitively as a Board. And to the extent that we are going to replace him, what sort of person would that be? And I think we've talked in the past about having a working Board where not that the Board is doing the work, but rather with some expertise that came out of their recent experience and so forth. And so there's a number of places that could lead us if we're looking for a director, and that will be obvious to everybody here. It might be U.S. sales and marketing, it might be [ reg ]. There's a whole lot of things. So that's a work in progress.

Well, thank you, Chair, for sharing that with us. That was my next question. So well done. Thank you very much. And can I also ask you on the skills metrics and the shareholdings, I know the shareholdings is in the annual report. But next year, is it possible to put the skills metrics in the annual report for us to have a look at because we do reelect directors?

Yes. Yes. I just need to make sure there's a lot of skills attached to my name. So we've got a doctorate first. But yes, we'll do that. Other questions? I saw one right down the back, sorry.

I noticed you've now rounded out comprehensively your senior management team. So just a couple of questions, please, about that. Do they all report to Swami?

I'll let Swami answer that, but I think the answer is yes.

The answer is yes.

Yes. Okay. So you've got a fair few direct reports.

Yes.

And my other question is, now that you've rounded it out comprehensively, can we expect that level to remain while you build up sales of many multiple times what you've got now?

I think the senior management team will always be a work in progress. It's not that we have completely filled it out. There are certain skills which are still lacking within us. But over a period of time, we'll start filling them up comprehensively. We take an approach of a responsible growth. So what are the skills needed? Can someone stretch to do it? The moment before we would take a look at the scale that we have reached and then we would try and see how to fill up the -- because if you compare ourselves with the benchmark, and someone asked that question about benchmarks, we are appropriately staffed for the scale that we have. And we just have a right balance between very skilled people and young people who are directly reporting to me.

Look, I think just a bit to add to that. I don't think if I put myself 5 years from now, there's every chance we're going to have a bigger executive team. And I'll give you a couple of what-ifs. What if we make an acquisition of a company that's already got a sales force of 200 people in a particular area that we're not hitting at the moment? It might be podiatry. Maybe it's breast. Maybe it's hernia. So there may be a senior leader in that area. There may be a senior leader in a different jurisdiction. One of the things that I've got in my own mind, which I haven't talked to anybody about, but I've just seen such an opportunity in this whole war zone thing that we're not even touching in South Sudan and Sub-Saharan Africa and everywhere in the world. And I can see us having a position that was doing nothing else than talking to the World Health and Bill and Melinda Gates and scurrying up that sort of business. So this is just me babbling on. But I think expect if we double ourselves in size and part of that doubling might come from an acquisition, then there will be a bigger base.

But look, I'm not being critical, but you've got now the same virtual management team as CSL. And CSL managed many billions of dollars in revenue with a management structure of the same number. So I'm just asking from that point of view because it seems pretty comprehensive to me now.

Well, we could go on a long time about CSL, but I did the original privatization back probably 30 years ago. Brian McNamee was there then, and the company was valued at $30 million. I valued it. And today, it's the second biggest company in this country, at about $130 billion -- so they don't have anything like the same management team as they had. And the comprehensive sort of management team you talked about has changed quite dramatically. Gordon Naylor was running Seqirus in the U.S. He was the first employee even before Brian McNamee. Then Brian came and said, you can be CFO. And he goes, I'm a biologist, I know anything about the -- go back to the university and do it. And he became the CFO. So there's been -- the deck chairs on the Titanic have been moving around all over the place. And it's now significantly different, by the way, in terms of senior management team in the U.S. than it was at the start or even 10 years ago. I could ask Robyn to talk about this, but -- and she will, don't worry about that, but it's probably better to get her after a red wine.

[indiscernible]

CSL has been unbelievably successful. There's been times like every company where I could have gone broke. By the way, it's another story in itself. But it's very different than us. And I'll tell you the other big difference, and I keep saying it, and I hope people will remember it, is that we are, even by CSL standards, capital-light. Young Robyn over here is just building a new factory in Broadmeadows, which was supposed to be $700 million. I got a feeling it was more like $1.2 billion. But that's what she's building. We're building a new factory that can do 5, 10x what we got and it has cost us $25 million. We don't -- we've got a capital-light balance sheet, which is unbelievable. Yes, sir, please.

David, just one question in production capacity per square meter. How much do we produce currently per square meter of products? And what's our turnover per square meter? How much...

I'll ask Swami to answer that. But we had Ahmed here last year answering that sort of question. And just before Swami answers it, I remember vividly Ahmed saying, look, we're doing -- we've got an ability the way we're going to do 100 million this year. We did 100 million. The question was asked to him about the 2 factories we've got up and running now. How much can you do? He said, I can do 200 million turnover. So we doubled from what we just reported. The new factory that we're building at the moment, which won't be done until next December or something, that will do 500 million. So we've got -- if the question is you've got plenty of capacity. But if you're asking about per square meter, I'm not sure what the answer to that is.

The reason I asked that was that we had 40 by 20 centimeter matrix. And the perception was that we were slicing and dicing into smaller packages and increasing the value.

Okay. All right. Do you want to answer that?

In terms of devices, we look at it from a device perspective, not just from a square centimeter perspective, and then what are we going to do with the core polymer matrix. So that's the reason why we are building a new factory, which is not just the plane block which we cut in different sizes, but there would be a particulate which would go into the same factory, different sizes, different thicknesses, which can be done in the same factory. So from a per square centimeter perspective, it will be difficult. But what we look at is the number of devices that we would be able to supply to different surgical procedures. And that's where we are currently at about 110,000 devices. We are building a capacity, which would be almost 5x as much.

Yes. Lior, can I just ask you what you've got online that hasn't been answered?

Thanks, David. We've had 15 questions submitted online. So kudos to all of those who are online. The vast majority of them have related to an update in relation to sales. So you've answered those. So apologies to all those who have submitted bespoke questions on that subject.

Okay. Just to emphasize what I said, though, that we're still growing. We're on budget. I'm not going to give any more guidance than that because, frankly, we don't know.

Yes. And some of the questions have more specifically asked if we would be looking to do intermediate, say, quarterly updates around revenue.

So we've talked about this in the past as well. And I think this was as much a reaction to announcing monthly sales that went over $1 million hurdle. I think we're probably getting a bit too mature to keep doing that, but we'll think about it as we go. But look, we're not required to do quarterly reporting. And frankly, I'm not sure I want to give that to management to bog them down, but we'll take it on board. It was asked last year, and I gave the same answer.

Great. One of the questions relates to the BARDA study. Perhaps, Swami, could you please give an update on how things are going with BARDA and how things are progressing there.

So the BARDA study has concluded. All 120 patients have been enrolled. And we are having conversations with FDA in terms of when do we submit the package, how do we submit the package, what kind of data would they like to see. So that conversation is ongoing. And hopefully, we should be able to wrap it up soon.

I think just to make sure people's expectations are roughly right. We finished recruiting 120 patients. We've got all the data and analysis for the first probably 60 or just a bit over 60. The sort of -- the chronology is finish recruiting, get all the data, do the data analysis and then observe the patient for at least 3 months. So even though we've just finished the 120, there's still a bit of data analysis to be done, still a bit of observation to be done. And at the same time, we're talking to the FDA about what it is we want. So in other words, the fact that we've got 120, don't expect it's going to be done tomorrow.

Great. This question is from [ Dr. Peter Seddon ]. Could we please hear a little about the breast and hernia programs, how they're going? Why are they taking longer than originally projected? And when do you expect to begin clinical trials?

The breast and hernia programs are on time and on track. We will be doing preclinical studies starting by end of the year. And they are on track. In fact, they are probably being advanced a little bit as we speak. We feel pretty good about how the products look and where they are today.

I think it's slightly wider also than hernia and breast. I had breakfast yesterday morning with one of our better plastic surgeons in Melbourne who mainly does noses and breasts. And we were describing to him the characteristics of our breast mesh that we've decided to use, and he found that particularly intriguing and useful for his practice. So I think it's not just one product that can't be used anywhere else. I think we're going to find it to be serviceable across a number of applications.

Great. The last question is it's an amalgamation of a few, but varying questions along the same theme of our involvement with war zones, particularly Israel, the Ukraine and Gaza. So I'll try and summarize the questions. One was, can we give an indication as to what the value of the sales were to the extent that we made sales? Two is, is it true that we made a donation of products to Israel and not to Gaza? And if so, why? And three is, are we going to consider any of these markets as potential markets for future sales potentially absent the war?

Yes. All good questions. The fact is we gave about $500,000 worth of product to the Ukraine. And we gave about $500,000 worth of product to 2 hospitals in Israel. And in both cases, we gave it because we were asked to give it. And we know that we've been sending product, and I'm not sure how much we've given because I think it's come out of the U.K., but we've certainly sent a lot of product into Gaza. And I believe that's free. Now of those 3 markets, I know for sure that the Ukraine has started buying or we've been selling at a profit to the Ukraine, not bought by the Ukrainians, but by others who want to support the Ukraine. We haven't had any sales into Israel. They're still using, by the way, the $500,000 worth of product we gave. And as for Gaza, I'm pretty certain we haven't had any sales there either, but we have had surgeons from other parts of the world going in there to help them. It's a nightmare. I mean it's hard enough to send something into the Ukraine, as you might imagine, or to Israel. But those hospitals in Gaza, it's just people laying on the floor and trying to operate in that environment. It's a nightmare. I know I was talking last night to Marcus about it. We've got a 4-year-old and a 6-year-old children that we're trying to help fix up there, but it's -- you're going to shake your head. But look, the short answer though, Lior, without being too mushy about it is that, yes, we do look at these markets as being future markets for sales as well. And even if not paid for by the countries themselves, there's a lot of countries, for example, that want to help the Ukraine because they don't like Russia. And you'll be shocked if I told you who they were, but there's also a lot of charities. So we don't care. And if the question is to imply Lebanon versus Israel, it's not for us, Lior. We just want to save lives. And the sooner we can get stuff in there, the better.

Just to reinforce that we send product from all parts of the world, including the U.S., U.K., Western Europe, Australia, and it goes through a lot of military surgeons who go in and help the patients. And very often than not, we don't know about it. We know about it only after they come back. Occasionally, we might know about it in advance. But again, because of secrecy, we don't talk too much about it.

I mean I'm learning about this after the event, by the way, because I now only know today that we've been sending some product into Namibia and Botswana. Well, most of the Board, including me, don't know how to get to Namibia. But anyway, our product is going in, and we're very, very happy, very happy. Thank you. I've already lost 3 of -- sorry, one more question down here, too.

[indiscernible]

It's coming on. Don't worry. The blue one just arrived and my wife said, if you wear that, it looks disgusting. And then I wore it, and somebody said -- I think it might have been you, Ingrid. You said, "I think the color suit you."

[indiscernible]

It's the end of my marriage. A question down the back. This is the longest meeting ever. This is chargeable times for you, too, [ Ash ], [ John ]?

Thanks, David, for the presentation. Just a quick thing. Project yourself forward, say, June '26. The factory is online. It's fully operational. What's the world look like then for PolyNovo? Do you give up margin? Do you expand? What's going on?

My God, it's -- I mean there's a lot of sensitive ways to answer that, but starting with the fact that some of our competitors are much more expensive than that. So somebody would say, well, you've got a bit of fat to play with. Some of our competitors have got their own supply issues at the moment. I think the more important thing is not to dwell on that, but rather than dwell on the upsides so we're not seeing at the moment. So when I talk to surgeons like the one yesterday at breakfast about MTX, he's over the moon. He just thinks in the whole plastics and reconstruction side, MTX, which is, as you know, is really like BTM without the plastic on the top. So fillers in plastics and reconstruction surgeries is going to be much bigger than BTM. Is it? I don't know. But everywhere, there's new opportunities that surgeons are leading us into. And frankly, this time next year, I bet I'll be able to tell you a half a dozen things that people use it for that we didn't even think about. And will some of those turn into markets? Maybe. I mean I'll give you one more if. We've been talking to the recently retired Head of the PBS, the Pharmaceutical Benefits Society (sic) [ Pharmaceutical Benefits Scheme ]. And he's saying, you guys are missing a big opportunity in aged care because the aged care companies don't have doctors on staff. So many of them, like Regis, for example, it's -- there are no doctors on staff. And to have doctors in the hospital or in the aged care facility, the patient has got to have their own GP, right? So he says, a lot of DFUs, a lot of VLUs, a lot of pressure sores. You've got to be in there. And there's no subsidy for it, but I can show you where there's pools of money. So I haven't never thought about that. So we went and saw Regis, and we're about to start something with them just in terms of seeing what we can do together. But I talked to our distributor in Germany, and he said, we're already thinking about this because we think there's a market there as well. And I talked to Andy Eakins about it in the U.K. yesterday, and he said that's on our radar as well. So I talked about Regis, 7,500 residents, and they're just third biggest. So there's a lot -- there's -- I'm giving you a what-if that might be a nonsense in 12 months' time, but I'm just saying that there are sometimes some big markets that we haven't even seen yet. So where will we be in '26? I know I might not be here myself, so you have to ask somebody else.

I hope you're still here. Also, I think it's a really laudable proposal on the Board owning shares. I think that's a great thing. That, I would presume, would apply to senior management as well. Is that the case?

No, it's not the case.

Please explain.

Please explain. Well, we have -- and Ingrid, in particular, has bled tears over this in the last couple of months. But we have an STI and LTI program for senior management so that they can own equity directly by their efforts. Okay. I've had enough of you all. Thank you very much for coming, and thank you very much for all those people online. It's been great to see you here. And really, thanks for your support. And thanks for your suggestions. I mean I don't say this lightly, but I said last year, give me suggestions for what you want to see at the AGM, or whatever, and I got plenty. So most of them are crazy, but give me more nevertheless.