PolyNovo Limited (PNV) Earnings Call Transcript & Summary
November 3, 2023
Earnings Call Speaker Segments
David Williams
executive[Presentation] Well, welcome, everybody, to the Annual General Meeting. I'm just saying to Swami that my son has 25 employees in India, including some videographers, and one of the problems with the Indian videographers is they spend their whole time photographing weddings, which are 3- and 4-day events. So that was -- there was no bride or groom but obviously we got close to it. That's a fantastic story, though. We've got a few of these to do with India, and I thought we'd just do it as everybody opens up on the AGM itself on their screens at home. We've got a quorum present, and I'll declare the meeting open. I'm David Williams, and I'm the Chairman of PolyNovo. Thank you. I'm David Williams, and I'm the Chairman of PolyNovo. I'm delighted to be able to extend a warm welcome to all of our shareholders here today. Unfortunately, it's about half of what it was last year, but still substantial, and I think that's because of the long weekend and Melbourne Cup. That's a function of Melbourne, unfortunately. But I expect we've got a very large audience as we did last year on the phones and on the screen. Anybody who isn't here today, of course, can see this on the webcast, which is being recorded today, as you just heard, and we'll release it to the ASX as soon as we get it from Computershare, which probably won't be until Monday or Tuesday. Let me start by introducing our Board of Directors. And on my right, I've got Christine Emmanuel. And in the running script it's actually Christine Emmanuel-Donnelly. And since she's got quite a few Board positions, she's become a bit posh. But we couldn't fit the second half of her name on the thing. Welcome, Christine. And she's going to be up for reelection today. So you'll get to meet her in a little bit. And then we've got Leon Hoare; Andrew Lumsden, who's also Chairman of our Audit Committee; Robyn Elliott, also working at CSL; and Bruce Rathie. And Bruce Rathie see a memory of the Board because he was here, well, long before any of us were here anyway. So we rely on him as the sort of the grandfather of the group for memory, although he's getting to an age where his memory itself is getting it a little bit dodgy. I'd also like to introduce to my left, Swami Raote, our CEO; and our CFO and Company Secretary, Jan Gielen. We've also got in attendance Ashley Butler sitting here in the front and [indiscernible] and some guy who's bringing ponytails back, who works for them. But the 3 of them are from Ernst & Young. And in the audience, we've got [ Bart Uberink ] and so to hear from [indiscernible] Alison who kindly allowed us to have this space at no charge. Well, I think it's no charge, but we'll see. In addition, and later in the meeting, and this is the important part, I think, I intend to introduce you to a number of our key staff. Coincidentally, we've got quite a number of our key international staff in town this week. And for the last 3 days, they've been having a strategy session out at the [ RACV Club ] in Healesville. And most of them are staying over for tonight and then back out tomorrow morning. But we've got people here from the U.K., from India, from the U.S. as well as our much extended team in Melbourne, including some new hires, which I'll sort of touch on a bit later. I did it last year, and I don't want to make it -- I don't want this to be a circus. But I think sort of choreographed some interviews later in this meeting with 4 of the people, 1 of them who's not here, which is Professor Marcus Wagstaff, who's operating on a very sick patient at the moment in Adelaide. But we'll call him in anyway on the screen. But the other -- I'm going to interview another 4 anyway. But I want you to get a feel for how the product actually works. So I want to sort of try and take a bit of gee whiz out of it. I want to give you sort of a feel for how the product is growing in terms of sales in North America and in India. There's other markets we could do. Like UK is just carrying it up at the moment and fantastic, and we've got Andy Egan here from the U.K., but I can only sort of fit 4 or 5 people in. So it's a bit more extended than what we did last year. But I think -- I'm hoping that you'll get a lot out of it. Starting -- I started thinking about it as a waterfall. What do I want to know? Well, I want to know have we got the capacity to keep growing. What have we done with our manufacturing capacity and so forth. And so I'm going to have talk to you our Head of Manufacturing, and I'm going to talk to Ed from the U.S. I'm going to talk to Dr. Shastri from India and so forth. And finally, I'll sort of top it off with Dave McQuillan, who's running our R&D section. And I just want to give you a sort of a penal sketch about how we're extending the product in -- not only in terms of the product itself, but variations on the product and new applications and so forth. So it's -- I'm only going to give them for that 5 minutes later, I mean there's an unwritten rule in the company which is never get between me and a microphone. So they're not going to get too much space, but I want you to just get a feel for it and then hopefully treat it more academically because I don't want you -- I think even me has a view of the product that's a bit gee whiz. You've got a bit of fun putting it on wound and it fixes itself. Okay. But why, how? And I'm going to just delve into that and hopefully, you'll be the wiser for it as I have become myself. The Notice of Meeting was dispatched to shareholders in compliance. By the way, because of that, I've sort of changed the order itself. I thought we might just get the business out of the way first, then Swami will say some things. I'll say some things. And then we'll go to the management presentations. And at each stage during this meeting, we'll come back to questions anyway. We have not that many online, but we do have some. And I know some of them are now going to be answered either by me or some of the manager we're talking to. So we'll come to that in a moment in any case. But the notice meeting was dispatched to shareholders in compliance with the company's constitution and is also available from our ASX announcement. I take the Notice of Meeting as read. Today's meeting is being held online by the Computershare meeting platform. This allows shareholders, proxies and guests to attend the meeting virtually. All attendees can watch live webcast of the meeting. In addition, shareholders and proxies can ask questions and submit votes. [Operator Instructions] Please note that while you can submit questions from now on, I won't address them until the relevant time of the meeting. Your questions could be moderated by Jan over here, our Company Secretary and CFO. And if we've got multiple questions, he'll use his discretion to amalgamate them. And if we run out of time, you can be assured that he or I or Swami will answer them by email or phone after the meeting. [Operator Instructions]. Casting your vote. Voting is going to be conducted, as in all these meetings these days, by way of a poll on all items. If you have already voted, then you don't need to take any action. If you have already voted and want to change your vote, you can vote at any time until I declare the voting closed. And I'll do that after I've talked, Swami's talked, the management has talked. And I'll give you a fair warning for a couple of minutes before you do. The voting tab is available within the navigation bar. If you're eligible to vote, once voting opens, press the vote icon and all resolutions will be activated with voting options. To cast your vote, simply select one of the options. There is no need to hit Submit or Enter button as the vote is automatically recorded. You will receive a vote confirmation notification on your screen. The results will not be updated on the screen, but will be updated at the conclusion of the meeting and then released to the ASX. So you won't -- unless you hang around long enough, you won't see those today. But they'll be up probably by the time you get on the train. Please note that any shareholders, proxyholders or authorized shareholder representatives may vote. If you have any directed proxies that have been given to you by a shareholder, these will automatically be cast as directed when the poll is 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 as you see fit. And once the poll is declared, Computershare staff will collect these from you. I now declare the voting open. So for those of you particularly online, you can vote from any time now, if you like. I'm going to appoint Angela Liapis of Computershare Investor Services as the returning officer, and I can see her snuggled halfway up the back there, who also, I might say, I'm not sure if I'm allowed to say for your employment, Angela, but is a shareholder herself. So moved while she -- by the inspiration of the Chairman at the last meeting and obviously went and bought some shares. So thanks, Angela. If you've got any difficulties, please call Computershare's helpline on 613-9415-484. Financial statements and reports. Item one on the Notice of Meeting is to receive and consider the annual financial statement for the 12 months ended 30 June for the company and its combined entities with the reports and -- directors' report and auditor's report. Are there any questions in respect to the financial report or the company's auditors from the audience here today? Jan, do you have any questions sent prior to the meeting or online?
Jan-Marcel Gielen
executiveYes. One question, David, in regards to the financial statements from Stephen Mayne. On Page 8 of the annual report under the substantial shareholders section, you list HSBC nominees as our biggest shareholder with 13.4%; JPMorgan nominees with the second largest holding, 8.5%. Disclosure is meant to deal with beneficial holders not custodians who hold shares on behalf of multiple shareholders. If we have no shareholders with more than 5%, please just say this rather than publishing the misleading suggestion that HSBC is our biggest shareholder. Will you fix this in next year's annual report?
David Williams
executiveWell, first of all, Stephen, thank you for that, and thank you for the question. But Jan, what do you say? You're...
Jan-Marcel Gielen
executive[ That is ]exact requirement, which I'll check, I can make that change.
David Williams
executiveYes. But when we, as a Board, regularly, of course, look through the major shareholders, and so...
Jan-Marcel Gielen
executiveAnd we know there's no one over 5%, which...
David Williams
executiveAnd there are people with over 5%.
Jan-Marcel Gielen
executiveThere isn't. There is not.
David Williams
executiveNot even me?
Jan-Marcel Gielen
executiveNo.
David Williams
executiveNot even Angela Liapis. Good. All right. I now move to -- sorry, if there's no other question...
Jan-Marcel Gielen
executiveA question came through from [indiscernible] I understand that PNV is not required to provide quarterly reports, although I don't understand why. Regardless, can you please start providing quarterly reports? I do not think the cost of reporting can be consider material and used as a reason not to report quarterly.
David Williams
executiveWell, look, it's something we talk about as a Board nearly every meeting. And I think the difficulty we have -- well, first of all, we're not required to, and I'm not here to justify and argue the ASX or ASX opinion on why or why not we don't have to do that. But we've got a more difficult problem, which is that even on a quarterly report basis, it's sometimes inappropriate, in my opinion, and I know in the opinion of the Board, to not say something even on a more regular basis. So we've got some shareholders, for example, in this last month who have come to us, why don't you report on a monthly basis? Well, okay, you get to the stage where you'd do anything you can do on a daily basis. And the thing that's determinant for me, I think, is -- and this is especially true of very high-growth companies like ourselves where you saw, for example, we made an announcement for what our trading was like in July and August where we had the rest of the world, and I can't remember the numbers, but the rest of the world is growing at more than 100%. Australia was growing more than 100%. U.S. was at 60% or thereabouts, don't quote me on it. And the growth is so strong that it seems wrong to allow the market to trade -- to me it seems wrong -- to allow the market to trade without having better information. And so where we've got a clear trend and everybody seems grasping that last announcement, there's a clear trend in number of patients, number of hospitals, number of sales, et cetera, et cetera, and it's substantial. And if that's changed substantially, then I think it [ behaves us ] to let the market know more regularly than even every quarter. So I don't particularly want to be locked into any reporting regime other than what's already there, which is half yearly reports and yearly reports and so on. But look, be assured, it's in our mind. But I think reporting -- people say you're reporting in an ad hoc way as though that's default of the Board. On the contrary, I think it's giving shareholders information a long time before they would get it either on a quarterly basis sometimes or even -- and definitely on a half yearly basis. Okay. If there's no other questions or further discussion on this matter, I'll consider...
Unknown Attendee
attendeeI don't know if it's the right time to ask the question, but last year, I couldn't make to the AGM. I wrote to the company, and Jan responded. Concern that the cash that the company had, what I saw as want of cash for what it's [ plan's worth ]. And the response I received was the company has no immediate plans for capital raise. Within a month, it raised over $53 million. That troubles me that such -- it changes so greatly in such a short time. But I also note in that capital raise, the comment was made, management expects PolyNovo will be profitable in financial year 2024. My question really is how does management anticipate a profit in '24 when in each of the last 5 years, the losses have been significant? And certainly 3 of the last 4 years, it's been well over $4 million, close to $5 million in the year just past. And I guess my sort of concerns about the knowledge within the company of what's happening, it bothers me, saying there will be no capital raise -- no plans for capital raise and then a month later, you're doing it.
David Williams
executiveAll right. Look, there's a bit to unpack there, but let me start with the profitability. And as you quite rightly said, we said that we expect that we would be profitable in FY '24. And I've also said independently, by the way, and separately on many occasions, I'm not really interested so much in profits. It's not that I'm not interested in profit, but I'm more interested in growth. And so if I had the choice between growing another 100s in Australia or 150s in Europe, I'll take it if it meant -- even if it meant more costs and just deferring the profitability. But I'll say something a bit later about profitability for FY '24. So I won't just say it right now. But be assured that the company has not come off of that view about us being profitable this year. But let's -- we've got to temper it with all of the unknowns of what's happening in the world economy and not only just in terms of war zones and growth and different regulatory structures and pricing structures and remuneration. All of these are the things we have to deal with on a day-to-day basis. And I'm going to talk about some of those in a moment because some of them are relevant in terms of what we're doing now. It's things that couldn't have been anticipated even 2 weeks ago, for example, in the Ukraine or in Israel, for example. And I might touch on some of that in a moment because they could be quite significant for us. But I did know it 2 weeks ago. So if I announce something, don't come back to me next year and say, ****, you must have known that a month earlier. Well, I didn't. And that sort of brings me to the timing question. I mean the truth is we didn't need to raise money when we did that last capital raising, in my opinion. And you can be assured that there was a very healthy debate at the Board about whether we did or didn't and what the sort of dilution effects of that might be. Of course, the share price is quite high. It was $2.50 at the time. And as you know, the market generally figured about what's happened to our price. I'm going to put up a slide at the end of today which shows our share price, INTEGRA's, AVITA's, AROA's, the Biotech 200 index, and we've outperformed all of them over the medium term. But anyway, putting that aside, when we're sitting there arguing about do we need capital, the answer was we don't, okay, but only if everything goes as planned. And if things don't go to plan, then -- and so there's a rightful argument. If things go to custard in the capital markets -- and guess what? Now they have. The last time you would have seen an IPO, a real IPO, is in distant past. So there was a healthy debate. As I said, I personally might have erred on the side of not doing it. But I think wiser heads convinced the Board to do it, and we did. And it was done on a short notice. Well, that's -- unfortunately, that's what happens in business. So what is an appropriate period of time between saying I don't want to do something and having it change? Is it -- if COVID came along again, if a war came along again, if logistical problems, so I couldn't get the product in the U.S., come again, I couldn't get into a hospital in the U.S. again, what's an appropriate time? I mean time is irrelevant. All we're trying to do is respond to the vagaries of what's really happening in the market. I'm going to say something a bit more about profit in a moment and also about some of the other things we're seeing in the market, which I think are, in this case, quite exciting for us. But we're living in a dynamic world. Thank you. Okay. If there's no other questions, a discussion on the financial statements, I will consider the financial report and directors' and auditor's reports received and adopted. I'd now like to move to consideration of the formal resolutions. As I said, we'll try and get this business out of the way first, and then we'll talk a little bit different perspectives from Swami, from me and from our management team in terms of how we're going forward. So I'd like to consider the formal resolutions now, and we'll vote on all the resolutions by way of a poll, as I previously said. And I intend to vote any undirected proxy votes given to the Chairman, given to me, in favor of all resolutions. We'll now move to consider the first resolution. The first resolution is Item 3A on the Notice of Meeting, and it is for the reelection of Dr. Robyn Elliott, who's sitting there in the light blue dress. And I'd like to -- she's eligible, of course, and wants to stand for reelection. And I put the following resolution to the meeting as an ordinary resolution, that Dr. Robyn Elliott, being a Director of the company who retires in accordance with Clause 59 of PolyNovo's constitution and being eligible is reelected as a director. Before I get you to vote on that motion or ask her any questions for that matter, I'd like Robyn to say a few words about herself and what she brings to the Board and her experience in the Board. Robyn?
Robyn Elliott
executiveThank you very much, and welcome, everyone. As a scientist, I had the opportunity to spend the first 25 years of my career in small biotech companies. That's been fabulous because when you're in a small company, you have to learn all of the parts of product life cycle. So to me, it was everything from product development to manufacturing, to quality, to business development, to sales and marketing. And with that, I developed 2 lifelong passions. The first was really understanding the importance of ensuring that you get business value for every dollar that you spend. And in small companies, that's terribly important. The second was that I love regulatory compliance and quality compliance. And David will attest, I'm one of the few people that love the regulatory audit. I love preparing companies for audits. And I love the challenge of delivering flawlessly when it comes to those audits. The last 10 years in my career have been in completely different areas [Audio Gap] delivering multibillion-dollar projects to CSL around the world. And I'm sure some of you in the room think that, that must be very difficult, quite complex. And if you can think about the number of decisions that have to be made to deliver a multibillion-dollar project around the world, it's true. It's incredibly complex. And I can assure you, my children can't work out how I can do it because I'm often asking them how to work out the mobile phone, right? But I've learned over the years that it comes down to really 4 fundamental things. The first is having a clear vision, really understanding what the end game is. What value are you trying to deliver to the business? And then being able to articulate that so your team understands what it is that you need to deliver and that they are, ultimately, accountable for that. The second is in meticulous planning, upfront, ensuring that you have really covered all of the details that you need. And there's hundreds of thousands of them. The third is to be courageous, to really challenge yourself and to challenge your team members to really constantly be saying how are we going to execute flawlessly. And the fourth, interestingly enough, is that concept of the small company, value every dollar, make sure that you get real value for your business and for your stakeholders for every dollar that you spend. So for the last few years, I've had the pleasure of being part of the PolyNovo Board. And I've tried to bring those fundamentals every meeting that I attend because the concept is the same. PolyNovo's had a fabulous journey over the last few years. And certainly, since I've joined, the revenues increased by a factor of 4. The teams increased by a factor of 3. The capacity has increased by a factor of 2. And that's all during the challenging times of the COVID. So I very much look forward to next few years and bringing those fundamentals again as we continue to look at this growth journey. We have exciting times of building new facilities, bringing on that additional capacity, ensuring our processes are efficient and effective as we further commercialize and ensuring our regulatory and quality compliance is state-of-the-art. So I'm very grateful to have this opportunity. I'm very grateful to have worked with the Board as we continue on this journey of commercialization. And I thank the shareholders for their patience and hopefully for their support.
David Williams
executiveThank you, Robyn. Any questions of Robyn? Pretty hard to ask a question after that. I think but I said earlier in the meeting that in interviewing the management, I wanted to get a really quite in-depth view about the company itself. And you might wonder, for example, why Robyn went on for so long, I mean, given my memo, don't get between me and a microphone, since she has got 250 million votes in favor. But when we go back 4 or 5 years and we had one small bit of backyard manufacturing plant, if you like, foreseeing the growth, foreseeing the need for manufacturing, foreseeing international growth and therefore international audits of regulatory authorities, not just the FDA, but the Brits and the Germans and the Australians and so forth, I've known Robyn for some time. And I knew when she was a CEO at IDT out in Bayswater that she was feeling dozens of government regulators coming through every year, regulating that plant, auditing that plant. And that's one reason I know, she may not know, but why she got head-hunted to CSL because they themselves, even though second biggest company in this country, they themselves had issues with their audits. And so Robyn was the one who solved that. And as she just said, she's delivered new manufacturing facilities, the latest one being that $700 million plant that they've just built. And so what better person to have on the Board, not to the management. We want a working Board that have got different skill bases. They're not management, but they are ought to be able to point to people to be introduced to point of ways of thinking about things and so forth. And so that's Robyn. So if no further questions from her today, are there any questions for online?
Jan-Marcel Gielen
executiveThere's one question from Stephen Mayne, which I was advised to read out. Could Robyn comment as to whether she believes PolyNovo should move to a conventional governance model with an independent chair who is less aggressive and controversial? Isn't a time for more sober communications and conventional governance with those hussles and [indiscernible]
David Williams
executiveYes. Robyn, please.
Robyn Elliott
executiveI'm happy to respond. And I think one of the reasons that I joined the PolyNovo Board is because I actually find David inspirational. He is enormously qualified, I think, for Chairman of the Board. He brings a lot of experience in how to grow organizations. He brings a wealth of knowledge, of course, on the financial side. But also, he brings a sense of fun and pride in what the company is doing and an enormous passion for helping out patients. And so with that, I would like to leave the answer there. Thank you.
David Williams
executiveThat's great. Thank you, Robyn. I went to [indiscernible] my vote. And any other questions, Jan? Nothing? 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. The voting is still open, of course, until we close it later in the meeting. Item 3b on the Notice of Meeting is the reelection of Ms. Christine Emmanuel, or Ms. Christine Emmanuel-Donnelly. And I'd like to read out the motion that she's eligible for election and that Ms. Christine Emmanuel-Donnelly, being a Director of the company who is in accordance with clause 59 of the PolyNovo's constitution, being eligible is reelected as a director. Before I open it up for questions, Christine, please?
Christine Emmanuel
executiveOkay. Thanks, everyone. And really thanks for entrusting me with [Audio Gap] managed commercialization teams in that organization and then finally into their equity portfolio, so managing their start-ups and spin-outs of which PolyNovo is one. I have a very clear idea of how IP can be managed and developed to deliver outcomes for business at various stages of its cycle, all forms of IP, so not just patents, but trademarks, designs, copyright law, trade secrets and know-how that can be used and balanced with the registered area in order to really deliver on your strategy. So that's my specialty that I bring to the Board as everyone here brings their own. I'm very proud and humbled actually by the breadth of experience that we have on the Board. And I do assure you that the chair does bring deep discussion that challenges and brings real rigor to the company, to the CEO and to the executive team. So with that, I'm really excited. I just had the pleasant experience of joining the executive team for this couple of strategy days, and it's -- I'm quite excited at the growth prospects and bringing profitability alongside that growth for the organization into the future and the really exciting pipeline that we started to develop as well. So thank you.
David Williams
executiveThank you. Again, just an editorial comment. In the context of building a Board that's a working Board that can help management, looking ahead, one of the things we're doing is extending the products -- extending the application of the products, adding things to the products that make them better performance. And so straight away, you start to think about IP, registration of IP, protection of the company and freshening up IP. So it seems to make a lot of sense to have somebody who knew about corporate governance, of course. But somebody like Christine, who had worked in private practice in Australia in IP, private practice in the U.K. in IP, so the international perspective, and then had been running the IP portfolio and some of their investments at CSRO, which, as she just said, the original base technology came out of. So what better qualifications to have sitting around the Board and engaging in the strategy session that she has done in the last couple of days. Are there any questions from the audience here today about Christine? No? Jan?
Jan-Marcel Gielen
executiveNo questions. None at all.
David Williams
executiveNothing? All right. Well, you've said those nice thing. So thank you for that. 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. Voting is open, as I said, until it's closed. [Voting]
David Williams
executiveRemuneration report, Item 4 in the Notice of Meeting. 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 when reviewing director and executive packages. A voting exclusion applies to this resolution, meaning that the directors are restricted to voting, and is outlined in the notice of Annual General Meeting. However, directors recommend that shareholders vote in favor of this resolution, and I'll put the following resolution to the meeting, that for the purposes of Section 250R2 of the Corporations Act, the remuneration report required by Section 300A of the Corporations Act as contained in the directors' report for the year ended 30 June '23 is adopted. I hereby move the motion. And I'll call on Andrew Lumsden, who's the Chairman -- a shareholder as well, by the way, and the Chairman of the Audit Committee to second the adoption of the remuneration report.
Andrew Lumsden
executiveI second the motion.
David Williams
executiveThank you. Are there any questions from the audience today? And Jan, online?
Jan-Marcel Gielen
executiveNo questions, David.
David Williams
executiveNo? My goodness. 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 until it's closed at the end of the meeting. [Voting]
David Williams
executiveItem 5 is employee share option plan on the Notice of Meeting. Voting exclusion applies to this resolution as well and is outlined in the notice of Annual General Meeting. However, the directors recommend shareholders vote in favor of this resolution. I put the following resolution to the meeting as an ordinary resolution, quote that the issue of securities under the company's employee share option plan are approved for all purposes, including for the purposes of exception 13 in ASX Listing Rule 7.2 and as an exemption to ASX listing rule 7.1. Are there any questions from the audience here today? Jan?
Jan-Marcel Gielen
executiveNo questions, David.
David Williams
executiveDear. Geez. Might as well stayed at home. For the purpose of taking all proxies into account and ensuring the votes are counted accurately, I direct that a poll be taken on this item. I'd now like to -- I'm just conscious, Swami. I want to get Marcus Wagstaff on the line soon. But I think what we'll do is go to you. So I'd like to invite Swami, our Chief Executive Officer, to talk about FY '23 and how he sees the year ahead. I was going to say that I will then make some -- my own observations. But I'm conscious that Marcus Wagstaff has taken a break out of the operating theater. So I think we'll get you to talk, then I might get Marcus on. Then I'll say something. Then I'll bring the other management on. So apologies if it sounds a bit hit and miss. Swami, please.
Swami Raote
executiveThank you, David. And good afternoon, everybody. 2023 marks 10 years since NovoSorb BTM was first implanted in a patient. Since then, over 33,000 patients have seen the benefit of our simple, elegant yet very transformative technology. One of this is John Weeks, the first burn patient to receive NovoSorb BTM after an accident left him with burns to 75% of his body. With the persistence of his surgical team, John recovered, started a family, created a life with partner Jade and now works to support other burn survivors. In John's words, "I've gone from flatlining to living life flat out." Stories like John's and Faliha's which were shared a moment ago, are fuel for PolyNovo's ambition. The people who have suffered trauma and wear their scars are the people who drive us. NovoSorb BTM can improve form and function, but most importantly, returns the patient to live a life full of possibilities and reach their maximum potential. Our objective is to bring this life-saving technology to the world. Continued sales growth and geographic expansion reflect NovoSorb BTM's acceptance by surgeons as the next-generation dermal substitute. NovoSorb BTM is fast becoming a standard of care in complex wound management across many countries. Surgeons are excited by the potential of NovoSorb technology, its simplicity, versatility and ability to deliver transformative patient outcomes while reducing the pressure on health systems. We stay inspired to learn from our clinicians and provide solutions to their surgical problems. And thank you to all of you who have joined us in this journey. Earlier this week, the senior leadership team of PolyNovo came together to reflect on the achievements of past 12 months as we gear up for full year '24 -- fiscal year '24 and beyond. We are building on a solid foundation. We are outpacing the dermal implant category growth by a factor of 10 and winning market share across all geographies we operate and focus on. Additionally, insights and talent gathered over the past 12 months have led us to a promising new product pipeline projects, helping us expand our impact beyond our original indications. Group sales continue to accelerate in FY '23 with global NovoSorb BTM sales of AUD 59.6 million, up 58% versus prior year. The U.S. market continued its impressive performance, up 45% in Australian dollars. The rest of world was up 134% with Australia increasing sales by 84%; U.K., Ireland increasing sales by 169%. The distributor performance has also been strong with Germany growing by 193%. In addition to Australia and New Zealand, the NovoSorb BTM enjoys market leadership. We now enjoy market leadership in United Kingdom and Germany. These results demonstrate the disciplined effort and focus of our commercial teams, along with the ingenuity and enthusiasm of clinicians who are now contributing to innovation, new application and education of their colleagues. We are extremely grateful for the continued support and partnership of our surgeons. Total FY '23 revenue of $66.5 million was up 58.8% on the prior year, which includes revenue from the BARDA pivotal trial. With additional funding of USD 10 million announced in October 2023 and 76 enrolled patients, we are past the midpoint of -- in the trial with recruitment expected to be completed in full year in FY '24. BARDA has been a decade-long partner of PolyNovo, supporting and guiding our efforts with numerous regulatory agencies to accelerate PMA approval. NovoSorb MTX received 510(k) FDA clearance during the year and has already received strong support from our surgeons. Our limited market release in the U.S. and New Zealand will develop the clinical evidence to support a full commercial launch planned for FY '24. The innovation pipeline is exciting with the extension of NovoSorb MTX and BTM portfolio to include surgeon-led innovations planned in FY '24. We continue to invest in building our capacity to drive revenue with personnel growing from 152 to 218. The majority of this expansion reflected increases in the head count in the U.S. sales team, manufacturing, research and development and clinical support teams. The capital raise has allowed us to accelerate these efforts with new manufacturing facility design in progress and scheduled for completion in CY '26. Year-on-year sales momentum has continued. And in May, monthly sales exceeded $7 million with total revenue exceeding $8 million for the first time. This trajectory has continued in the current financial year with August revenue of $7.7 million, up 119% versus August of prior year. I just talked about how we are planning to accelerate our global impact. Number one is geographic expansion. The title of our FY '23 annual report was new horizons. And true to that, we increased our footprint in U.S., entered Canada, Hong Kong and India and very recently, Spain and France. Each region warrants excitement for different reasons. Hong Kong as a precursor to China entry, India to prove our market development credentials by satisfying economics of a large middle income economy together with its contribution to the BARDA trial and Canada has an opportunity to leverage the success of U.S. We aim to achieve market leadership in these new geographies within 18 to 24 months. Launching in India, we are ensuring that our simple, transformative and cost-effective technology is available to patients who need it most and were previously constrained by cost, availability and professional education. We are working with Indian surgeon networks to build the dermal implant category underpinned by professional education programs and working closely with federal and state government on tenders. We'll continue to expand the dermal substitute category in Australia, U.K., Ireland and Germany. The team maintains a patient-focus as they outperform the category to accelerate our growth. Our commitment to our communities is strong. And in the U.S. alone, approximately 63,400 square centimeter of product was donated for charitable use. Our U.S. team is energized by NovoSorb MTX and a richer product suite to guide patient care. In full year '24, we plan to put more tools and products into their hands, and we expect to see a swift payoff in customer account value. Number two, I'll talk about indication expansion. Last year, I spoke of our strategy of going beyond burns in our mature markets. I'm pleased to report that use of NovoSorb BTM is increasingly the dermal substitute of choice in trauma and other complex reconstruction cases where we can have significant impact for our patients, surgeons and hospital systems. In Australia and New Zealand, we maintain our leadership of deep dermal full thickness burns with all burn centers using NovoSorb BTM. Revenue outside of burns is accelerating with successful shift to trauma, plastic reconstruction, vascular, pressure ulcers, limb salvage and other indications, with the number of patients treated increasing by approximately 70% year-on-year. Third, I'll talk about innovation and product pipeline. We have redesigned our innovation process to capture the voice of multiple healthcare stakeholders. In addition to our established polymer chemistry expertise, we continue to build out a robust product development team with package engineering and preclinical sciences which encompass animal models and implant evaluation. We are also glad to share that we have engaged with world leaders in textile engineering, hernia mesh development and manufacturing as well as experts in breast reconstruction who are contributing to our internal development programs. In September '22, NovoSorb MTX received FDA 510(k) clearance with broad applicability in burns, chronic and surgical wounds. NovoSorb MTX and NovoSorb BTM are complementary, and the addition of NovoSorb MTX to our product suite offers clinicians increased flexibility for situations where the ceiling membrane is not required. By tapping into the voice of clinicians to get their insights on how and where NovoSorb technology can impact, we aim to accelerate rollout of our advanced wound care portfolio with additional 510(k) submissions. A submission for the NovoSorb MTX -- for extension of the NovoSorb MTX product range was recently submitted, with further submissions planned in 2024. We have focused our approach to hernia repair and are developing a targeted solution for ventral hernia and complex abdominal wall reconstruction. This NovoSorb-based textile will expand the clinical application of the NovoSorb polymer technology with other implantable applications to follow. We also continue to support our partners with novel drug device and cell device combinations which could have substantive impact on treatment of type 1 diabetes and other cell-based therapeutics. The core NovoSorb technology can support other clinical needs, and we are open to partners to help codevelop, commercialize or distribute innovative new products. We recognize that building successful partnerships is vital for PolyNovo to reach more patients faster, amplifying the impact of our technology. Lastly, about capacity expansion. We are investing in scaling our production facilities in Australia as we scale globally. In late FY '23, manufacturing capacity was doubled and efficiencies gained when our second facility adjacent to the existing facility became operational. The capital raising of $53 million in November 2022 further amplifies these efforts with a new colocated manufacturing facility currently being designed, estimated to be operational in CY '26. Employing state-of-the-art process and manufacturing capability along with R&D labs, the new facility will produce around 500,000 devices, approximately 5x current production volumes. A new office space has been completed, supporting enabling functions for global growth, including IT, legal and HR. We will invest in digital and information technology to ensure that we stay connected and agile as we scale globally. The recent hire of Chief Information Officer has seen the rapid advancement of projects, including customer relationship management, website management, cybersecurity and document management systems. Capital efficient and profitable growth. PolyNovo has a history of driving capital-light growth. Our path to profitability is clear, and we'll remain prudent and responsible in investing capital in areas, providing the maximum impact for our customers and patients and superior results for our shareholders. Before I make my final comments and hand over to David, I would like to reflect upon Faliha and the transformative potential of NovoSorb technology. Burns can be devastating injuries, leaving scars long after the original trauma. What should be celebratory and joyful birthday, adding a few centimeters in height, can be accompanied by declining mobility, discomfort and pain caused by scar contracture. Faliha's journey with NovoSorb BTM marked a turning point, relieving 7 years of pain, discomfort, depression and offering an improved quality of life. She has started playing with her friends again and begin dreaming of becoming a doctor. With the highest rate of burn injury across the globe, we know there is much to do in India and in many parts of the world. PolyNovo has touched and healed over 33,000 patients since its inception, 13,000 including Faliha in the last year alone. As proud as we are of our efforts and results, we are not satisfied. All of us at PolyNovo know we need to reach more and heal many more. And with that, I'll now hand back to David.
David Williams
executiveThank you, Swami. Very nice. And it's [indiscernible] -- so I think before me going on and staying to talk, we might drag in Marcus Wagstaff from Adelaide. I'm not sure whether me just saying that's going to make it happen or you're going to make it happen, Jan? Where is he? That's it. Good. Marcus, thank you for taking a few minutes out of your busy schedule. I was hoping you'd be in your surgeon gear. I've sort of made a big deal out of the fact that you've walked out of the operating theater and you look like you just come from lunch.
Marcus Wagstaff
executiveYou're right. I'm now about to go in a surgeon gear, I'm all fine. It is all good.
David Williams
executiveSo Marcus, I don't want to take a lot of your time, but you're acting as our chief surgeon KOL, if you like, and you're spending a lot of time around the world at conferences and thank you for that. But also, I know myself in the last couple of weeks, you and I spent a fair bit of time talking to surgeons in the Ukraine and Israel and elsewhere. That's not my primary job, but I just would like you to reflect a little on what you're hearing out of the surgeons as this year has progressed in terms of the acceptability of the product, the sort of innovation you're seeing, any other sort of reflections that are just off the top of your head coming out of the conferences and your interactions with surgeons.
Marcus Wagstaff
executiveWell, I mean, over the last year, my sort of interaction with the surgeons regarding BTM has gone up considerably and is reflecting some of a much wider penetration across the world. There's naturally a degree of patent recognition after sort of 8 years or so of questions from surgeons, which means that I've become more effective at getting the right support and advice across. And although the questions remain the same, such as how do I know when it's integrated, how do I secure or address BTM, the approach of the surgeons is changing. They're more confident and -- because they're basically trying a new device for them, but they're not seeing it as an untrue or controversial one. So they're accepting BTM as a standard practice, particularly in ANZ and the U.K. and North America. And I'm getting more and more inquiries from Hong Kong as well. And the other one is I'm talking to surgeons who are migrating from BTM using units into other units in other countries, and they're wanting to bring BTM with them to their new locations. And they've also had, perhaps from some other countries, who've seen BTM being presented at meetings and want access to it. And in the meantime, we're seeing in the literature a much larger and larger series -- other than meetings, much larger and larger series from news all around the world with positive results, and that will be published in peer-reviewed literature. So it's just becoming -- it feels like it's becoming an accepted standard of care.
David Williams
executiveThank you for that.
Marcus Wagstaff
executiveIn terms of the innovations, so I don't -- there's no specific new innovations in the last year of the use of BTM, but it's basically becoming standard of care just in burns, but also maxillofacial trauma as well as things like hidradenitis or for tumor surgery which is where you feel very anxious using a biological because of the degree of colonization there. And also reconstructions after tumor surgery. So there's all sorts of developments going on in those areas and modifications of use, such as different ways of securing it, managing it, addressing it, some of which I sort of bring back to my own practice. MTX is also finding its place in surgical practice in the U.S. and is early in this [ section ]. But given the experience from BTM, I'm sure we're going to see more innovation defining sort of further options of its use.
David Williams
executiveYes. I guess -- you and I were talking the other night to the Chairman of the Minister for Health Committee on burns and trauma in Israel. And he had been to at least one American Burn Association conference, I think more than one, and had met you during that. And what surprised me, I think, is that he was still a little scared, I think that's probably the right word, about using it for the first time. And that surprised me only because having seen it myself, I've sort of perhaps trivialized it too much and it looks a lot simpler than that to me. In that case where, for example, if I were to send you, we were to send you to Israel, first of all, you wouldn't have any medical insurance, so you probably won't go. Your wife bring me into the -- has he got a will? But you offered to guide the surgeon through the first operation. And is that -- and right through the process of recovery. But is that a difficult job? And would you think that one case would be enough for somebody to really feel a lot more confident about it? Or is this a sort of a 2- or 3-operation journey?
Marcus Wagstaff
executiveNo. I think -- well, I think it's 2- or 3-operation journey because there are nuances in its care. But if you've got a surgeon who is already familiar with using dermal substitutes, it's quite straightforward to apply sort of BTM to that protocol. The issue is, obviously, taking on a new product in a very hot time, such as a conflict, obviously the -- this is you're going to want to go with what you know. But in terms of supporting them through the adoption of BTM in the trauma scenario, it has clear advantages. So -- and they are keen to tell again. When I met the surgeon, we talked about the ABA back in May, he was already at that point wanting to get BTM into his unit. So it's not something that he hasn't anticipated before. But no, I think -- to answer your question, I think it's -- if you've got somebody familiar with using dermal substitute, which he is, then it's really about generating that confidence in him, which is clearly completely understandable given the situation they're in.
David Williams
executiveYes. In the last week, we've learned a lot about the use of BTM or potential use of BTM in war zones in the Ukraine and in Israel and for that matter, in the Gaza. But do you see any complications? I mean the first thing that shocked me, I think, is the number that I heard in the Ukraine where there's 2,000 -- over 2,000 patients waiting for this sort of technology. The tissue banks are all gone. Do you see any particular complications in the use of the products in war zones, I mean, chemical weapons, that sort of thing?
Marcus Wagstaff
executiveWell, not really against the benefits. There are complications of any device, any surgery. But in comparison to the potential benefits of bringing a synthetic dermal substitute in, I mean, when you see the Ukrainian situation, the BTM was actually brought into the Ukraine in trauma by U.K. surgeons working for an NGO. They brought it in voluntarily because they felt it was a good option. It wasn't brought in by PolyNovo per se. And the problem in the Ukraine is that the resources and the skills to perform complex microsurgical lower limb reconstruction, for example, just isn't there. It's all new stuff, and they're getting inundated with the high energy shrapnel and blast injuries particularly to the lower limbs. And the civilian and military casualty load in the Ukraine is in the tens of thousands at the moment as we see already. The ongoing cost to society of amputees, even after the conflict, is going to be huge. So anything that can be introduced that can take the place of complex microsurgical reconstruction when you have exposed bones, exposed tendons, which is quick and simple and effective is -- clearly gives an advantage or a head start. So it's -- because it is simple, because it's synthetic and it adds obvious advantages to that scenario, you can put the BTM on in the hot scenario after really adequate debridement, then the patient can be brought back behind for -- whilst they integrate and then -- than a simple skin graft. And so it doesn't require the resources or the skills of, say, free flap surgery. And that's reflected in the Ukrainian surgeons themselves because they're actually asking us for more supply. They're requesting it because they've seen the benefits for themselves in that scenario. And like anything we've talked about over the years, the surgeons themselves find the role of this product and then they want to use it more. And that's exactly what's happened in the Ukraine. And Israel is too early to talk about really. But it's -- but certainly in the Ukraine, they're asking for more supply for obvious reasons.
David Williams
executiveGood. One final thing, Marcus, before I let you go. We've seen a lot of innovation in the last 2 years. But you yourself started using it for burns, and now it's widely used for trauma and oncology burns and limb salvage, and necrotizing fasciitis and so forth. When you lay in your bed looking at the ceiling at night, where do you think -- where is -- in 5 years' time, what's the big product, do you think? Do you think we're still going to see it mainly burns and trauma? Where do you think there's a sleeper in terms of its application?
Marcus Wagstaff
executiveI think -- well, maybe with MTX more than BTM, but I think the sleeper is in the clinic scenario for ulcers and foot ulcers and so on in the diabetic area. I think when that gains traction, and I've seen it in cases here, in its simplicity and its ease of use after -- it still requires conditions of good debridement and optimizing of the blood supply, but once that gains traction, I think from what I've seen, that's going to be -- that's going to have considerable benefits for patients also.
David Williams
executiveGreat. All right. Listen, I know you've got a complex patient there, and we really appreciate you coming on and not only that, more particularly, holding our hands throughout the year in particular. And we look forward to seeing you over here or over there. By the way, Marcus is in Royal Adelaide today. Thanks, Marcus.
Marcus Wagstaff
executiveAll right. Thanks, David. Cheers. Catch up soon.
David Williams
executiveThank you. All right. I think I might stay on management. And the next person I'd like to introduce you to is Ahmed Hassan. There he is. Do we have a microphone for him?
Unknown Executive
executiveYes, we do.
David Williams
executiveOkay. Come up, Ahmed. As I said, the purpose of this is just to give you a much more detailed understanding about where the company is, and that was partly from Marcus' stake as well. But Ahmed's been with us for 6 months?
Ahmed Hassan
executive18 months now.
David Williams
executive18 months. It was -- goes very quickly. And he didn't do anything for the first 12 months. I didn't notice him. But -- and interestingly, Ahmed, just by the way of background, came from Bega Cheese, which I happen to be very close to. And we took over the line business, and Ahmed decided that there was too many people who love him. This is me talking about your career, by the way, without you knowing about it. But -- and went off to Fonterra. And it was about a minute after you got there that I announced that we might take over Fonterra from Bega. So I think he thought he was going to go back to where he just left. And so I approached him and said, how would you like to come and work for us? I knew from Bega that he'd done their IQ test and he had the highest score ever at Bega, which probably says more about the other people at Bega rather than you, by the way. So I wouldn't -- don't lap it up too much. But -- so he came really highly recommended by some people I respect at Bega Cheese. I went to him and then to cut a long story short, here he is running our manufacturing. Now one of the things that often comes up when I'm around the town talking to fund managers and institutions is with this tremendous growth you've got in sales, how much capacity have you got? And even in the last year and a bit, we've gone from one little backyard operation factory in Port Melbourne to buying the building next door and building a second factory there. And now we've gone to the stage where we're about to tender for a much bigger factory in the building next door to us where we are at the moment. So first things first. I mean everybody is interested in how much capacity we've got, how sophisticated it is, how we can handle not only just capacity but variations for breast or hernia and so forth. So first things first, what were we producing in terms of units -- pieces of BTM, if you like, a year ago when you came?
Ahmed Hassan
executiveSo first of all, thanks, David, for the introduction and my history of Bega and Fonterra. But last year, probably same time last year, we were about 1,000 devices a month. Just finished the -- what we talk about production, 3 days ago, and we produced 10,000 devices. So this is 10x what we were able to produce last year. But I think the story behind this and how we got there is, I'd like to think about it in 3 different ways. And that's -- the first one, it was the unleashing the capacity in the existing facility. So we've done lots of process redesign or restructure and also workforce reorganization to optimize our supply. The second area was the second facility that we've commissioned May 2021 -- 2023, and this basically gave us the duplication of capacity as well as the redundancy and then more of a risk mitigation policy if anything goes wrong. But the third one, which is very, very important as well, was not just manufacturing, but going through the end-to-end supply chain and unleashing and refining our inbound and outbound. So these are the 3 areas that allowed us now to go from 10,000 -- 1,000 devices per month to 10,000 devices per month.
David Williams
executiveSo we're a couple of years off a brand-new factory. What capacity -- you've gone up to 10,000 units. Congratulations. Fantastic. But what capacity have we got in the 2 factories we've got now, while we're waiting for the new -- the largest factory to come on?
Ahmed Hassan
executiveSo we've got up to 150,000 to 170,000 devices [ paid ]. This is all dependent on the [ SKU mix ], the sizes and also the number of production operators that we would have in the facility.
David Williams
executiveSo that's, let's say, 70% growth on where you are today in October. We've grown over 60% in the U.S. this year. So the question then is how quickly we run out of it. But my question for you is, is that 170,000, is it based on 2 shifts or 3? And is it based on Saturday and Sunday? I'm just trying to think where you could really...
Ahmed Hassan
executiveSo this is basically 2 shifts without running weekends, and we still have the opportunity to actually have another shift.
David Williams
executiveSo in my mind, therefore, and a lot of the analysts are saying, we're going to turn over, put a circle around 100 million this year. Listening to you now with Saturday, Sunday or 3 shifts, we can clearly get over 200 million without worrying about when the new factory comes up. Okay. Now with respect to the new factory, which we're building, it's -- what's the capacity of that going to be?
Ahmed Hassan
executiveSo we are designing for at least 500,000 devices per annum, and this is again dependent on the SKU mix. What we've considered during -- the design is not only the scalability, the flexibility and modularity that we can scale up parts of the process without the need to impact all the downstream of the process. So with David's new product pipeline, we've taken this into consideration, and this is the main area that we focus on in the design.
David Williams
executiveYes. So you're doing 10,000 a month now. You could do 20,000 if you really push it and didn't go home. And the new factory will do at least 5x that. So that could produce everything we need for America and be a very profitable and very large company.
Ahmed Hassan
executiveYes.
David Williams
executiveTell me this, we -- Swami made a point of it, and I've made it before about us being a capital-light company. And so I think people are interested in when you go to 5x or 10x what we're doing at the moment, what does that really cost in terms of the factory? If I -- you may not know the answer to this, but if I came to you and said I want to build a new cheddar cheese plant, my guess is it will cost you $300 million to $500 million. What do you reckon -- give us a ballpark in terms of what you might think a new factory would cost us?
Ahmed Hassan
executiveSo it's dependent on how far -- how automated are we going to go. So with state-of-the-art manufacturing facility that we probably call everything is automated...
David Williams
executiveYes, we don't want to know that one. We want to know what's a good, serviceable...
Ahmed Hassan
executiveFrom -- this is a ballpark figure, but we think from $22 million to $25 million.
David Williams
executiveThat's $25 million.
Ahmed Hassan
executiveYes.
David Williams
executiveFor something that could be supporting us as being $500 million to $1 billion turnover...
Ahmed Hassan
executiveThat's correct.
David Williams
executiveOkay. That's great. Now in terms of the complexity of this manufacturing process, is the last thing I want people to just focus on, I even say it's a bit like baking a cake. Is it -- you've run dairy plants. They're very big, complex and highly -- high-risk environment with pathogens and all that stuff. What -- is this -- do you look at this as a manufacturing guy who topped the IQ test, I should say, do you look at this as being a complex process by comparison?
Ahmed Hassan
executiveIt's a simple process, very scalable. The problem that we had was the inconsistency because it's a fairly manual process. But now we're managing this through the -- making sure that it's very consistent, very quality driven, but it's very scalable process.
David Williams
executiveYes. Yes. And another thing that often comes up for people who are a bit more softer than me, this issue about OH&S. And we know -- I wonder around lots of food plants and I see folks getting their arms cut off and their hands cut off and so forth. What -- this environment sounds to me, compared with what you've come out of in the food industry, to be a relatively safe environment. How do you look at the OH&S issues you've got?
Ahmed Hassan
executiveIt's our top priority. So -- but luckily and fortunately, PolyNovo is a very safe manufacturing environment and with highly-skilled operators and team. So it's -- everyone has safety front and center.
David Williams
executiveYes. Okay. That's all we've got for you.
Ahmed Hassan
executiveThanks, David.
David Williams
executiveThanks for coming along. I'd now like to introduce Ed Graubart. Before I do, I just noticed sitting in the front row here, I'm not going to get you to speak today. Philip Scorgie, maybe you can just stand up for a second. Philip's only been onboard, I'm going to say, 6 months, but don't tell me it's 18. Okay, 6 months. I knew one of you had been here 6 months. And Philip's our new Head of IT. And we had a couple of questions, which we now won't need to answer, but Philip's got really essentially 2 roles as far as I'm concerned. One is in business, helping the business with CRM systems and getting America to talk to Australia and having that sort of consistency, so we can share the load and share the knowledge and share the applications and so forth. But the second one, which we've got a couple of questions on, which we seem to get every year, is on cybersecurity and privacy data, which we don't have that much. But I just wanted to introduce Philip and just to say that he's been doing a lot of work on cybersecurity and on privacy. We've had a couple of outside agencies come in and give us a test to see whether they can get into our system. And that's come out looking pretty good for us so far. But to emphasize, I think, where Philip's come from, and again, just to give you some comfort about this, he's come out of mainly the legal profession, working for one of the largest law firms in America and then one of the largest law firms in Australia, even bigger than [ MinterEllison ] even bigger. And so these guys are also in marketing. These guys are also, as you might imagine, very interested in privacy. So he's well versed in all of that. I mean Swami still can't work his laptop, by the way, but he's concentrating on higher levels. So -- but anyway, welcome, Philip. Maybe you'll get [indiscernible] next year. So -- but Ed, please come up. So I think everybody -- Ed runs the U.S. We call him the President of Sales and Marketing. He changes his titles all the time. But -- and the first question -- I'm going to ask you a question off script because it's come out from somebody on the screen. But somebody, believe it or not, has asked a question to say that they believe the U.S. health care system is very corrupt and what have we got to say about that. And I noticed he's got a new jacket. So I'm just wondering how that got paid for. That's the first thing. But -- it's a serious question, by the way. So just -- I mean, I've never heard it before.
Edward Graubart
executiveNo, listen, you look deep enough, everything's got a little bit of fringe. Our goal is to stay compliant to what our true values are and to make sure that we're doing business with the people we want to do business with. And we just don't play in that space. If there's -- and I would say, there are certain aspects of it that are corrupt, and there are certain aspects that are not. And the places that we really focus our business, I would not put in that corrupt space right now.
David Williams
executiveSo that would be hospitals, for example?
Edward Graubart
executiveNo, I'm not going to get specific for you, but...
David Williams
executiveCould you name them...
Edward Graubart
executiveI'm not naming names.
David Williams
executiveNo. Okay. That's great. That's a serious question, though. So we'll take that as an answer. But I imagine that any corruption in any health service these days, the way I see it referred to is what people are doing with the doctors themselves, not what they're doing with the institutions. But in any case. So we -- Ed, you were here last year, so you don't need any introduction. But we've raised over $50 million last year, as you just heard. And that's no doubt given everybody a little bit more leeway to grow their businesses. And what, if anything, has it meant to your business in terms of where you've gone from last year to where you are now?
Edward Graubart
executiveYes. I think it's significant. And Robyn, I appreciate what you say. The U.S. has a large responsibility to this organization as far as the revenue goes and as far as profitability goes. So everything that we do has to be very measured and very thought out and value for every dollar because of that responsibility that we have. So everything that we did with the money that we were entrusted with was to invest in the commercial team, anything that would push the business forward either directly or indirectly. So obviously, we hired a number of sales individuals, both management and associate level, as well as territory managers to build out the teams. We invested in strategic accounts. So a lot of questions that we get about GPOs and IDNs and other contracts, how do we leverage those to get more out of what we currently have? And then how do we go after the new ones so that we -- so we broaden our opportunity across them? We've built out some of the marketing team. As has been noted, there's new products coming. So how do we work with the upstream marketing? And then how do we train our people? So we've hired some people on the sales training team. We have a sales analyst. So it's all about efficiency, really driving the effectiveness for every dollar that we spend. We have a responsibility to it, and we take it seriously.
David Williams
executiveYes. And so do you look at yourself, we ended last year when we said in the annual report, we ended last year with 56 sales staff in the U.S. You're probably now well over 70, but let's say it's 70. Do you see yourself as taking a breather for a little while and settling everything down, new trainers, new staff? And I mean, you must have a dozen people that have been there less than a few months. So I imagine we're going to see some sales come through.
Edward Graubart
executiveYes, so we're calling this internally the year of execution. You can keep building, keep building, keep building, but when do you actually take the time to get your feet back underneath you. So we're still going to grow. We're still going to add people where we need people. We're not going to skimp on that. If the market is growing and there's the opportunity to put people in that market to continue that growth so that we don't flatten out, get stale and then have to try to rise from that, if we're rising quickly there, we'll take a chance and we'll hire in those markets quickly. So a lot of the bigger cities where we've seen, and we went -- and with our new structure -- or we're not a new structure, but with our structure, we've been able to go get some extremely talented people that have turned the tables within a month being here. And so to me, that's a good investment. It's a good opportunity for us to get our -- like I said, we hired 25 salespeople. 6-, 7-month tenure for a lot of those people at this point. So we're getting our feet underneath us, and we're starting to see based off the first quarter going into October, now November, December, we're starting to see people really fit into the roles that they're supposed to be doing.
David Williams
executiveGot it. You'll know better than I, but my guess is that there's about 120 burn centers or thereabout in the U.S. And the last time I looked at that figure, we're probably in about 110 of them, give or take. But how much success are you having in -- and there's no doubt a couple of holdouts like there in the way the normal is than you were to do another product or some. But how much success are you having in other hospitals outside of the...
Edward Graubart
executiveSo we don't focus on burn. So let's be clear. We're an organization that has all the indications, except full thickness burns, which is why we're doing the BARDA trial. So the burn that we see is referral. It's from peer to peer. It's from the meetings. So it's from surgeons hearing from surgeons about the clinical value that we bring as well as the economic value. So we're there to support them, but we don't actively go out and pursue trying to get their business. Our business comes from the trauma side where we can go in and really demonstrate how we can provide a value to another group of surgeons within those same hospitals having access to the product.
David Williams
executiveYes. Last year, when we talked to Marcus, he just come out of the Canadian Burns Association Meeting, and he reported to this meeting that there was a real excitement amongst surgeons and they really wanted the product. This was in December that we were going to go in formally. We'd already been selling into parts of Canada on a special access program. But do you still have -- have you still got responsibility for Canada? And if so, what do you see that doing this year in terms of distribution? Because I think we're distributing in the West Coast, but not the East, or vice versa.
Edward Graubart
executiveYes. So we had distribution from Toronto West. So we just recently extended that distribution into Quebec. So now we're going to start entering the Quebec, and we put on a new sales agent in the east up in New Brunswick area. So we're just starting to get that up and running.
David Williams
executiveNew Brunswick, that's where you got salmon, seals up there.
Edward Graubart
executiveSee, that's the other side, but this is more the lobster and...
David Williams
executiveLobster. Yes. Yes. Yes, that's great. But seriously, what's the difference, though, between what you've got there and what you've got in your team in California when you see -- is it a direct employee? Or is it a...
Edward Graubart
executiveIt's a sales agent. So we still -- we run the fit manufacturing. We run the facility. He's a commissioned salesperson, but he is an independent. So we call him a sales agent versus a distributor, where you sell them the product, and then they will sell it to whoever they want. We still maintain control of the product focus to the end user. And I like that because we get -- we work very well together. They have a full resource of our marketing team and anybody else within our clinical team through our medical affairs group. So they feel like part of the team. They come to our national sales meeting and spend time with us. We spend time with them. But at the same time, they're independent.
David Williams
executiveYes. And so what's the time period to cover Canada? Have you -- are you ready to put somebody on in the east of Toronto?
Edward Graubart
executiveI'm full now. I just got to get them moving.
David Williams
executiveOkay. That's a good idea. I don't know why you're here. All right. Trends. Do you see any trends that is worth sort of sharing with us?
Edward Graubart
executiveWell, I think we're creating the trends. As Swami noted, and we talk about where do we go next, and I think when we start to talk about the trauma and the ability to really affect -- Andy was here from the U.K. and was talking about 200 limbs are amputated every day. So really focused on that, and that's in the U.K. And I don't have the number for the U.S. I should have looked at it before I came up. But that's a real opportunity because as has been mentioned earlier, that's a true cost to the society. And anybody who has ever known somebody that's been through that, that's an important factor. And if we can work with them through limb reconstruction surgeons and continue to build on our reputation, we have a clinical compendium which you've seen, which outlines 172 articles, we're now up to 230 independent articles. And how do we use that data to go into a myriad of surgeons across one center to continue to build the business, and I think our reputation is allowing us to do that.
David Williams
executiveBeautiful. All right. That's all I got for you. Thank you. And Ed's available for coffee after this if you're interested. Now I'd like to introduce you to Anand Shastri. As I just said, we had Andy Eakins here, who's running the U.K. and Ireland. Is he still in the room? Oh, right down the back. And we've got [ Raghu ], who runs India, and he's down the back as well. So there's plenty of people to talk to after this. But I've asked Dr. Shastri to talk. He's our Chief Medical Officer in India. And as you can see, he's got a beautiful yellow thing, whereas I've got a BTM in mind, just to show the sort of commitment. Commitment, Dr. Shastri, that's what it's called and -- anyway. The reason I asked Dr. Shastri up is that I was -- I called into the strategy session 2 days ago when you were talking. And he had a rather elegant way -- first of all, he gave perspective on his long years in medicine and what he thought of the product, which I'll come back to. And then he gave a rather elegant way of describing how BTM works. And I was ashamed, I think, in my own head that I still had a sort [ GV's ] approach to it. Look at this, put it on the arm, it works. And Dr. Shastri had, by way of an example on the screen, which he hasn't got now, but I wonder if you could just share with the people here today how you describe how it is that this is a game changer and how it works physically?
Satyanand Burra Shastri
executiveThank you, sir. Good afternoon. I've been a surgeon for more than 35 years, and I've worked in the United Kingdom, Japan, Korea and in India. And in these 35 years, I've seen only 2 transformative innovations. One was 30 years ago, and one was last year with BTM. And that's because of how it works. And I can demonstrate that just with this little 10 by 10-centimeter paper. I wish I had BTM, but it's paper. There you are. So this little piece of technology has got about 20,000 little air cells in it that are connected to each other with micropores. And what that does is allow this wound to heal up in 20,000 little spaces, all independent of each other, but connected to each other just enough to allow nutrition, oxygen and the cells that we generate tissue to get them. And once it completes its work, just like a sakura flower or cherry blossom, it silently floats away. It doesn't stay back. There is no animal protein in it. It's purely handcrafted with materials that medical scientists are very, very familiar with. They're entirely medically compatible and compatible to the human body. They're excreted through the breath, through the urine. They're not metabolized in the liver. They're not heavy on the liver. And they don't induce any reaction from the body. And finally, because it's not made of animal protein, the risk of the device falling off or being needed to take away because of an infection, they're never 0, but as close to 0 as possible. So to my mind, I saw a great transformative innovation 30 years ago. It was the ultrasonic technology for surgery. And I saw this on the 3rd of October 2022.
David Williams
executiveAnd have you used it yourself so far?
Satyanand Burra Shastri
executiveYes.
David Williams
executiveI should have said, by the way, we haven't announced this for the market, but we have now had our first sales, and quite substantial sales as it turns out, into India. So -- but I've forgotten to announce that to the market. And that's been, I think, all in the private area that we have some work we're doing at the moment on tenders for public hospitals, which will be very large sort of type orders, but we're off and running. And so you've used it. What's your experience?
Satyanand Burra Shastri
executiveYes. 80 patients, I've either assisted surgeons or done it myself, and the results are phenomenon. The quality of skin, the return of function, the return of mobility that I've seen, 21 days is when you put the top layer of skin back and 3 weeks after that, say, 6 weeks, patients are walking, moving, using their limbs, have much less need for scar management, much less need for rehabilitative physiotherapy. The patient can take their own time in getting final treatments done, and the surgeon has got a lot of time on their hands as well. So I've seen phenomenal results. I've put BTM on scalps that have been completely denuded with accidents. I've used BTM in areas where the bone has been exposed, where otherwise somebody would have had to have an amputation. Microvascular surgery has got a very steep learning curve. It takes 3 or 4 years before plastic surgeon can be trained to become a microvascular surgeon. This one has got a very short learning curve, and it's very flat. You can train a physician assistant. You can train a very experienced nurse. It possibly will be used in the outpatient clinic. And its application across specialties, not only burns, trauma, injury, loss of skin, it's really, really big. As far as you mentioned about tenders, in India, the peculiarity of government tenders, if I may take 30 seconds more, is that the tenders always go to the lowest bidder. We call it L1. When there are 3 or 4 companies that bid for it, the lowest tender always wins, and BTM is lowest by far, is less than half of one of the biological competitors, about 2/3 in price of the second biological competitor.
David Williams
executiveYes. I want to come back to the operations you're doing. But just before we go off, the technology and how it works, I hope everybody understood it. But I just want to emphasize that when I was listening to you, I was thinking to myself, how is it that when I cut my arm with a knife, let's say, that it heals itself? Okay. I might not have a scar, but it heals itself. But how is it that if I have a wound that's 2 inches by 2 inches, it doesn't heal itself? And the answer is, well, when the skin is close together and maybe the dermis isn't destroyed, it can -- the cells can come together again quite quickly and in a big one, that can't happen. And so how is it that it does happen when you put BTM on? Because BTM is not a piece of foam [indiscernible] each little cell, 10,000, 20,000, whatever. And I think that's really important for people to know about when we're trying to figure out how long is this going to last, why is it different, what's the competitors like and so forth? Can I just -- do you want to say something?
Satyanand Burra Shastri
executiveYes. Just wanted to make a comment on that. The little piece has 20,000 little cells that are less than 1 millimeter in size. For those of you who donated blood or have had blood taken out of your arm for blood tests, you'll find no scar there because that wound is less than 1 millimeter. It regenerates. A bigger wound, like you said, 2 centimeters by 2 centimeters, heals by scarring. So what BTM does is replace scarring by regeneration, almost like a lizard grows its tail back.
David Williams
executiveYes. Yes. Great. One question which I came out of that video we saw this morning and one I saw the other day a little boy that was done in India as well, is that in both cases, you've done an operation on somebody that's had a wound 5, 6, 7 years before. And so you're trying to repair something that was badly done at the time. Are you doing that as an experiment? Or are you doing it -- what is it that's driving? Because everybody else in the world is just waiting for the next burn patient to come in. But you're going back and getting people. And is that to prove a point? Or is it a charitable thing? What's going through your mind when you...
Satyanand Burra Shastri
executiveNo, no. It's -- we're using the appropriate indications for technology. So when you lose your skin in its entirety, that is the upper layer of skin as well as the foundation, the best method to replace it is to use the foundation, which is BTM, and strengthen it with superficial layer of skin. Most of our burn patients go into government hospitals, where BTM will come in through the tender process. So that's on its way. And hopefully, in a month or 2, at least by the end of the year, we should have them in the government hospitals where the acute burns will be treated as well. That's going to be probably 1/3 of our target.
David Williams
executiveYes. So that's good. That gives people a sense of -- I don't think anybody here needs any convincing that India is a big market. And I think one of the things I observed is that burns in the west are diminishing, and the burns that are there are either from people trying to top themselves or more particularly, they are industrial burns, and they might [indiscernible]. When I go to India, country China, Indonesia, there's a lot of children and women who are burned because they've got fires in their home and so forth. But we know how big the market is. It's probably 10x as big as what America is in the burns. It's the same as in parts of Africa. But can we really make it work there? That's what I want to ask you. Can we meet the market, do you think? The market is there. But when they're choosing between snakeskin or fishskin and us, how are we going to make that market? How optimistic are you and why are you optimistic?
Satyanand Burra Shastri
executiveYes. there are 2 routes by which devices are available in government institutions, which treat about 80% of acute burns. One is through the tender process, where the lowest tender bid always wins. There's no competition for it, and we are nonbiological. Second route for government hospitals is through CSR, or corporate responsibility, where our sales team actually is so focused on patient first that they enable patients to connect directly with these organizations to get them in as well. We've got a big sort of public insurance scheme, which covers about 400 million patients in India through these 3 hospitals. So there's no doubt that burn patients will be treated with the latest standard of care, which is BTM.
David Williams
executiveBut do you think those tenders are going to be done on functional lines or on characteristics? So for example, will there be a tender to do wound care and they don't care whether it's biological or not biological? Or would there be a tender to do nonbiologicals, for example?
Satyanand Burra Shastri
executiveIt doesn't matter because biological wound care products are much more expensive. So in either case, in one of the tenders that I saw, it specified biodegradable. So it includes everything, but it basically is part of our name. BTM is biodegraded.
David Williams
executiveYes. That's great. Dr. Shastri -- sorry, there's a question, for goodness sake. This is good.
Unknown Attendee
attendeeI'd like to ask a question about robotic surgery, which is done on limbs and other things. And do you see that as a future for the industry? And do you think PolyNovo would lead that if it came close?
Satyanand Burra Shastri
executiveYes. I don't know, Swami, if I'm permitted to speak about the pipeline that you had mentioned.
David Williams
executiveWell, I think David will say something about it when he comes up, but just -- maybe just a general comment.
Satyanand Burra Shastri
executiveYes. I think, yes, PolyNovo will. There are specific indications in which this technology can be used through keyholes to be able to repair defects that are inside the body in comparison with what it's being used currently to repair defects outside the body.
David Williams
executiveYes. I thank Dr. Shastri for coming all the way from -- from where? From Delhi? Or -- Dr. Shastri, where are you from?
Satyanand Burra Shastri
executiveI'm from Mumbai.
David Williams
executiveMumbai. Thank you. Good. Thanks for coming all the way. Give me that back. You can't be trusted. Beautiful. And finally, just to give you a sense, I think, of where the pipelines are going to, I've asked Dave McQuillan to come along, who's going to come up. And those of you who know, he spoke last year, but he was also previously on the Board of Directors. And he's lived in both places, Melbourne and Pennsylvania, and probably other places for all I know, but he has now been leading our R&D effort for the last more than 6 months anyway -- 12 months, sorry. And so David -- first of all, how big is your team now? We started -- we had $2 million of [indiscernible] about 2 years ago and now what do we got?
David McQuillan
executiveIt was a very small team. I think when I came on board September 1 of last year, we probably had 4 or 5 people, don't quote me, but somewhere around that. We're now up to about 14 folks, expanding the capabilities. So we were certainly very focused on polymer chemistry, which is our core technology. So that was appropriate. But as we expand into developing new products, we need product development engineers. We need packaging engineers. We need folks with expertise in developing new products, new prototypes, testing in animals before we go into the clinic. So it's a work in progress.
David Williams
executiveSo give us a sort of -- think about our product range as being a waterfall. We start with BTM, come down to MTX, come down to what -- just how do you look at that waterfall yourself?
David McQuillan
executiveYes. All right. Waterfall wasn't the analogy I would use, but we think in terms of -- well, I have to say 2 buckets. So where are we playing, where Dr. Shastri talked about it is graftable application. So anything on the surface of the body is sort of where we're playing commercially and where we're extending our reach and all sorts of graftable applications. And then the second bucket is implantable applications. And then when you talk about robotics, it's implanting materials inside the body. And the places that we've talked about and continue to talk about is hernia, [ abdominal wall ] reconstruction, post-mastectomy breast reconstruction, orthobiologics, repairing, reinforcing tendons and ligaments.
David Williams
executiveRotator cuff?
David McQuillan
executiveAnd rotator cuffs, yes, rotator cuffs. So the 2 buckets. And we're looking to develop products to address both of those opportunities.
David Williams
executiveYes. Yes. And so what do you see as your next registerable IP, do you think? I mean -- or is this just a continuum work in progress? I mean is there a big -- what would be the next thing that's going to excite people, I think that you will be registering?
David McQuillan
executiveRegistering IP or registering products? So we continue to play with the chemistry of the polymer. As magic as the BTM is and the foam is and the performance in the body, no product is perfect. So we continue to explore what we can do to enhance its activity. And of course, long term, you can think about adding growth factors or stem cells. Shorter term, we look at coating materials. So we know about our material, particularly in implantable applications, like hernia, for instance, will drive adhesion formation, for instance. So if we can coat that material, we can change the surface chemistry of that material to prevent adhesions, then that's obviously protectable and something that we're looking at very closely, and also application of that material to hold a variety of different applications. But short of that, and that's sort of taking some significant leaps, we also remain very focused on extending the current portfolio of products, taking BTM and MTX and listening to what our surgeons need and making changes, line extensions to that. So different shapes, different clinical applications, wrapping around the finger, wrapping around an arm, wrapping around a torso, managing different contours and even though the dermis that we're replacing, it's a dermal replacement, varies in thickness across the body anywhere from 1 millimeter up to 4 millimeters. At the moment, we have a 2-millimeter product. So we're going to be producing thinner and thicker versions of the product. So that's short-term opportunities to address surgeon clinical needs. And then we go into implantable applications like hernia, breast reconstruction.
David Williams
executiveYes. So let's just dwell on hernia for a moment because it's probably the most common question that comes up in terms of promises we've made. Promise is probably too strong. But the indications that we've made on the back of your advice, by the way, I might say, just to take myself. But where do you see us in our sort of hernia and apart from other implantables? They're all different, I suppose, and all the same in another way in the sense that we don't want the plastic on the top of the -- lemonade on the top. But what do you say to somebody who says, 2 years ago, David, you said we're a year off hernia and then 18 months ago, you said the same thing? I mean where are you, David McQuillan?
David McQuillan
executiveYou shouldn't have said it.
David Williams
executiveYes, quiet right.
David McQuillan
executiveResearch is fraught with risk and the occasional failure. In my mind, the opportunity in hernia, and hernia is not just a single opportunity. There's simple hernia. There's ventral hernia. There's complex abdominal wall reconstruction. All require slightly different products. And I think as we've seen in the performance of BTM, the regeneration of BTM continues to convince us that we can play in those places to reinforce and regenerate abdominal wall, in hernia application. So we've had a couple of missteps, but I'm pleased to say that we've made significant progress this year. I think when I answered a question last year at this time, I said we were developing a number of different prototypes, but didn't give much detail. I can say now that we've taken our NovoSorb polymer, which is quite a special resorbable polymer. We've turned that into a monofilament and high tolerance. We've taken that monofilament, and we've now developed a net of woven meshes, which will address simple inguinal hernia, for instance. We can take that mesh and then use that to reinforce the NovoSorb foam material. And as Dr. Shastri elegantly described, the magic of BTM is not just in the polymer itself, but it's also in the architecture of the foam. So we can take that foam, reinforce it with the knitted mesh. And now we have a material that meets the biomechanical demands of hernia ventral wall repair. And we can put that foam on both sides of the mesh. So we see a portfolio of products coming out.
David Williams
executiveAnd when you're talking about mesh and meeting the technical requirements, you're really talking about strength right? Because with the laminate on top, that was going to be great strength, but we don't want the laminate to stay in the body. So what's the alternative?
David McQuillan
executiveCorrect. So we're now -- the approach at the moment among others is to take the knitted mesh, use that to provide the strength and then take advantage of the regenerative capability or potential of the NovoSorb foam.
David Williams
executiveGreat. And so just one final comment, a bit like what I asked Marcus. It's 5 years on, what do you sort of -- how do you see the company in terms of its hierarchy of products, if you like, if you could guess?
David McQuillan
executiveYes, that's tough. I think NovoSorb BTM will be our flagship product going forward. We are looking at modifications to that, as I said, surface modifications to perhaps drive more rapid incorporation. We're looking to coat it with antimicrobials because infection is a clear issue in any surgical procedure, whether it's acute wounds or chronic wounds. So it will be a mix of BTM, similar perhaps to what we have today, and I think that will continue to be an exceptional product. But there will be variations on that theme. And then I think, again, 5 years, then I think we'll be having a significant impact in the hernia space and perhaps in breast reconstruction.
David Williams
executiveAnd do you think we're doing enough to protect ourselves from competitors with freshening up our IP, registering new IP? And do you have an interface with, say, Christine and others on this issue?
David McQuillan
executiveThe sure answer is yes. I think we are doing enough. I think it's -- IP, as Christine mentioned in her introduction, it's a mixture of patents and trade secrets. So we're extraordinarily careful about not sharing too much about what we do and how we do it. And the downside of filing patents is if you don't get the broad claims that you would like, you have taken the risk of disclosing how you do what you do. So we have a significant portfolio of trade secrets, and we've got a great efforts to protect that. And we're very careful about what patents we file. We take a very hard look at what claims we think will get issued. And if the claims aren't broaden up, then we'll withhold that, and we'll retain that as a trade secret. So that's a short answer, I'd say. I think we have a broad intellectual property portfolio, and we continue to build on that.
David Williams
executiveGreat. David, thanks for your service, as they say in America. And let me give that to Jan. Yes, please. Thank you for that. Just some final words for me instead of going through right up my presentation, I hope everybody got something out of that and really want to concentrate on the detail about our capacity, what the surgeons are thinking about us, how we're growing and more particularly, what we're doing to give ourselves some blue sky and product development as we go along. FY '23, we grew roughly by 60%. But when you scratch the surface of that, it was over 100 in Aus, 100 in overseas. I particularly called out Andy in the U.K., which I thought was going pretty slowly for a few years and this -- just this last year and in particular, this last quarter, they're really kicking some goals over there. So U.K., Ireland, Scotland, fantastic. Didn't do that well in the World Cup, but they're looking pretty good on the sales. So I think the other thing I'd say is the U.S. is profitable. It has been profitable, and it's still growing. And I'd like to apologize in advance of our profit that we're in danger of making a profit for the first half. So apologize for that because I'm not necessarily proud of it. If we've got growth opportunities, we want those growth opportunities, but we're growing so quickly and the margin is so good that there's every chance we will be profitable without giving any guidance, by the way. You take that and we'll come back and talk about it next year. But I think we ended the year with $47 million on hand. So it's not plenty of cash, and we don't really need it anymore in any case, although we've got Ahmed building a new factory, and we got David sneaking 14 people under his wing, which I thought was 6. So yes, there's a lot -- there's a bit going to happen there. The hospitals are going through the roof. So at this time last year, we were servicing 470 hospitals. This year at 30 June, it's higher now, 638 hospitals around the world. Staff is going from 152 to 225 in the last year. And that's come largely from sales expansion, one, especially in the U.S., but more particularly, Canada, Hong Kong, India now as well. And India could be a big sleeper depending on how these public company contracts go on and so forth. And we still got up our sleeves China and Japan. And I, in my own personal sleeve, have Indonesia as well. So lots of potential out there. And we had -- we haven't announced India as having our first sales. But I think -- and I'll probably get the countries wrong, but I think in the last couple of months, we've had our first sales into [indiscernible] Turkey and Finland or some -- anyway some godforesaken countries that are not in the World Cup of Rugby. So we're getting expanded R&D team. We're getting new indications all the time. I've said it before, it's the most amazing business really because we're being surgeon-led. There isn't a month goes by where some surgeon doesn't come up and say, I found a new use for it. And so we're sort of playing catch-up in the sense of saying, that's great. And then we're passing across to Dave McQuillan, going, is there anything in this? Or is this just a one-off and leave them on their own? Or do we make it into a product? So it's really quite an exciting place to work for that reason. I think we're doing great on our pivotal trial. We're up to 76 out of 120, as Swami said, which puts us on our way to PMA. I mean one of the things that Ed's got with his hand behind his back is that he's really -- he's not selling in -- because we're not indicated in burns, he's not selling into burns even though the burns surgeons want it. So this will formalize a lot of that for us. And we've still got Canada, of course, Japan, China. And there are some things that are happening there. I think we've got a whole lot of new staff. So Phil Scorgie has been great. Well, so far. But -- and by the way, I used to teach in the university with his father. So I've got -- I knew him from when he was a little baby, and he still looks pretty young, but he's a good unit. And we've got a new Head of HR, who starts on December 11, [ Suzie ], and she's coming out of a couple of public companies as well. So it's great. We've got great diversity, got great engineers, got cybersecurity handled, all of those, what I'll call, software issues anyway, we've got well and truly under control. And we've got very good support out of BARDA and FDA. So I couldn't wish for anything better at the moment. It's going as well as it could be ever everywhere. And that's the short story. But I'd like to really thank all of our shareholders because many of you are rusted on and -- last slide. And I'd like to particularly thank our surgeons because -- and Marcus, in particular, who spends all hours of the day and night talking to surgeons and educating them and bringing them on and so forth. He and I have been -- and Swami and a few others have been spending a lot of time on the Ukraine and Israel in the last just couple of weeks. We've been approached by the Ukraine government. I don't want to say too much about it, but there's quite good prospects for us supporting them and [indiscernible] into Israel. And I've got a feeling, some of that's going to come to a head in the next days or weeks in any case. And I can't think of anything better to end the year than by helping people in desperate need for their lives with more wounds and stuff whatever the side of the river or to the sea they're on and whatever side they are on in Eastern Europe. We don't make any decisions about the politics. What we care about is making sure our product gets into those areas really quickly. And I think it's heartening even if we want to cut our cost in terms of how we charge for that since there are people around the world who will also contribute to that cost outside of the countries themselves in their own diasporas. So that's really sort of quite exciting, I think, for us. So going back to my point about profitability, we're on track to what we said last year. And I think it's going to be a great year for us in more ways than one. So I'm going to close the voting now. So Angela, if you could pass around your cards. I just did this, this morning on my way into the office. Oh -- but I just wanted to -- because we're messing around comparing ourselves to a number of different companies. One is TELA Bio; Integra, of course; AROA, of course; AVITA, of course. And I just did this on the way down in the trend. But down below, you've got AROA, you've got TELA Bio, you've got Integra, and you've got the ASX 200. And the 2 above, the blue is AVITA and the red is us. And we're right at the end there at the moment. So it was quite interesting for me because I thought AVITA was sort of lagging the whole way along and it just recently spiked up, which it has. But anyway look, lies, lies and dam statistics could be anything. But I just thought I'd leave that up while we go to the voting. You okay, Angela?
Unknown Attendee
attendee[indiscernible].
David Williams
executiveOkay. Great. While we're just waiting to close the meeting and for the voting to finish, is there any other questions that you'd like to ask? Yes?
Unknown Attendee
attendee[indiscernible] David, this time last year, a gentleman got up at the meeting. And I think he talked about his experience where he'd actually traded stock 5 or 6 times and made a lot of money out of it. And your comment was put it in the bottom of a drawer and leave it. At the moment, it's sitting in the bottom drawer.
David Williams
executiveYes. That's right.
Unknown Attendee
attendeeSo is your comment still the same? We leave it in the bottom drawer and watch it go up?
David Williams
executiveWell, I can answer that in a couple of ways, but I can answer it by telling you that that's what I've done with my own stock. And I still -- I mean this is what's happening to the market. So Integra, which was $7 billion, is now $2.5 billion. This is who we would consider our main competitor. AVITA, we don't consider them as a competitor, but complementary. But TELA Bio, AROA, they're all -- they've gotten nowhere really. So I still think it's put it in the bottom drawer. But I'm just looking just here for a second. So I like to look at my screen as I'm talking to see whether it's going up or down, whether anybody is listening to me. But in the last week, the stock's gone from 1 10 to 2 29. Now [indiscernible] bought 30,000 shares just 2 days ago, just announced this morning to the stock exchange. So I imagine that people are going to see Robyn buying or me buying and say, yes, there's something coming. So I think you will see the story today is great. And we're probably underdone, but so are all our competitors. So my advice a long way around of saying, put it in the bottom drawer. And I know your son-in-law as well. So he would love you to have it in the bottom drawer. Okay. The voting is closed. Oh -- sorry, go ahead.
Jan-Marcel Gielen
executiveJust online question if that's going to get through. So I'll fire away. There are still a number of major GPOs to be signed in the U.S.A. Are we getting close to having an agreement with the remaining GPOs?
David Williams
executiveWell, I'll let Ed answer that.
Edward Graubart
executiveSo like I said before, the goal is to maximize relationship with the current GPOs. We're mid-cycle with 3 large GPOs in the U.S., meaning they sign you 3-year contracts when somebody gets in there. People who sign those 3-year contracts expect a commitment from the GPO and the hospitals within that GPO that that's their business. And when they let somebody new in mid-cycle, it usually throws it off a little bit and creates a lot of hassle. The good news is all 3 are up for RFP, or I think what you all call tender here, for early to mid-next year. And we have already submitted one, and we have the other 2 that we're in the process of submitting too. So the goal is by the middle of next year -- and working with the GPO does not restrict us from doing business with all of their hospitals. There's still -- we still -- we do a lot of business, a significant amount of business within the 3 GPOs that we don't have signed up. So there's always that risk a little bit that we're going to take a step backwards to take a step forward. So it's got to be right. The deal that we work with them or the deal that they work with us, it's got to be mutually beneficial. So the focus has got to be that it works for us and it works for them. And so the deals that we're putting together, I feel, do meet that our strategic accounts team and someone who's got a lot of experience with this that we just recently brought over from a competitor. She's absolutely fantastic. Her and her team are working on this. So I am expecting that by the middle of next year, if all the terms and everything meets, we will have the final 2 to 3 large GPOs on board. And we are renegotiating. The current 1 is coming up for renegotiation, and we've already stepped up on that one.
David Williams
executiveBut Ed, I've always had a view that people overstate the importance of these GPOs. And I noticed in the analyst reports yesterday on AROA, AROA themselves are making a big deal out of -- oh, we've got -- we just signed [indiscernible]. We just signed this one. Yes, but so what? I mean it makes it easier to transact with the hospital. But you still got to get the account though. And so how much of the 3 GPOs are really helping you sell as opposed to bringing up the [ real ]?
Edward Graubart
executiveYes, the surgeons still have to want the product, number one. Number two, you still have to go through what's called the VAC process, which is the Value Analysis Committee. So signing the GPO does not shorten that period of time. I can tell you that it might take 3 months to get through a GPO -- or I'm sorry, through a VAC process. I will also tell you, it took us 2 years to get through one that we just got in last month, in October. So that still varies whether you're signed with that GPO or not. All the GPO does is assign pricing per tier level. So if you use X amount of product, you get this price. If you use this amount of product, you get the Y price. That's really all it does. And like I said, some hospitals do hold it a little bit more. We use that as a way to keep you out. But what we've learned is if a surgeon wants something bad enough and they can commit to the product and they can convince their peers, they can go to the hospital and we can work around the GPO. So it is a bit overstated of what I like to have. The answer is absolutely yes because it is a license to go and hunt. But we still have to -- you still have to do the hard work.
David Williams
executiveYes. Got it. Thank you for that.
Jan-Marcel Gielen
executiveAnother one for you, Ed. Breath in. On all metrics, It would appear BTM is a superior product when compared to its competitors. Why is it then that we compete so aggressively on price in the U.S., notwithstanding the fact that the price of BTM was raised earlier this year in the U.S.?
Edward Graubart
executiveYes. So we didn't raise the price on BTM. What we did is we lessened the discount from -- the discount that they had prior. We did not touch the list price of our product. We just went back and renegotiated the discounts with a majority of our hospitals. Those that are not signed up for GPOs or on other contracts with us. So we work -- the U.S. system is a little bit different. I don't want to get into it, stand up here for now and explain how this works. But the hospitals don't get any more money dependent -- regardless of the product they use. They get a set amount of money for surgery. It's our job to partner with that hospital to make sure that we provide the economic value so they get clinical value. So this is a strategy that we employ. We did not employ a pricing strategy during COVID to be good partners. These hospitals were focused on a lot of other things other than dermal substitutes. So they were treating COVID patients and all the things that came along with that. So we decided to be good partners. We held firm on our pricing. We came back, renegotiated discounts with the majority of the hospitals, and as their contracts come up, we're renegotiating with them. And what we are finding is, as we sit down with them and have the discussion -- the business review with them, they're actually opening up additional hospitals within their systems to us. So it's a great opportunity for us to partner with them through the DRG system, which is that set amount of money, so that we do provide them a value. And we do have a strategy that we're employing over the next 3 years to make the most of those to take advantage of the pricing and the value of the same.
David Williams
executiveYes. Look, pricing is very sensitive, obviously, from a commercial point of view. Suffice to say, we're very much aware of where we sit in the market and how much that we've got to play with. But as Ed implied then, I mean, the first thing is first, let's get the product in, let's get it used, let's prove the value, and then we'll talk more seriously about pricing around the world, not just in the U.S. So I don't think we're playing the pricing game at the moment. We may be paying a bit of catch-up for ourselves, but we're not meeting the market or matching the market because we don't need to.
Jan-Marcel Gielen
executiveThanks, David. When does PolyNovo envisage the production capacity will be at 100% at our current manufacturing facility in Port Melbourne?
David Williams
executiveWe've already answered that.
Jan-Marcel Gielen
executive[indiscernible] this question because I've got no idea. But I've got my shares in the bottom drawer because, look, unlike most of my investment, I looked at this one, fundamentally, like what are they actually trying to achieve? And what's the goal? And how are they operationally getting there? And I'm very happy with what you've done. The rest of my investments are all based on market, what the market is actually doing and markets, it's driven by market sentiment, and market sentiment is completely illogical. It doesn't recognize the things that you value, and the thing -- great things you've done. When will it wake up? When do you think that market settlement will turn and say, s****, look at what they -- how much growth?
David Williams
executiveYou know what? Look, it's not all market sentiment. And I'll just give you a couple of what ifs. I mean, first of all, interest rates have gone up and will likely go up again next Tuesday, and that raises the cost of capital, which pulls down value. So that's the first thing. Second thing is because the markets have been tanking, a lot of the smaller fund managers who are some of our shareholders are getting their funds withdrawn. So I'm sitting there as a small fund manager with $0.5 billion, and I've made negative returns. So the [ Meyer ] family rings me up and goes, "give me that $50 million back because you've lost me 10%." So they're losing their funds, which what does that mean when they lose their funds? They've got to [indiscernible] shares repay. So there are a couple of fundamentals that are happening that are not really to do with market sentiment. And it's very easy for these things to get oversold and to come back pretty quickly. So today, the stock's traded at $1.30. Okay. it's hardly much when it comes up from $1.10 to $1.30, but it's heading in the right direction. And all we can do -- I mean, look, I don't have to apologize for where we are. But what we can do is just keep putting one step in front of the other, one baby step in front to keep doing the right things. We will be profitable, whereas sales are going through the roof. But I think the fundamentals in terms of our competitive position are amazing. But the thing that people should, I think, also take into account, which affects me, is to say, "you know what, if you get burned today, I don't care how bad the recession is. You're getting fixed." And so it's a defensive stock in many ways. Whereas I can take you -- people say, "oh, you always got to eat food." What I can tell you from [ Coles' ] own data that in the last, say, 6, 7 weeks, the branded sales of nearly every product are off about 15% because people get working up, and they've got $500 on their mortgage. So they don't buy branded product. They buy their own brand of product and they buy a lot of fresh stuff and they cook it home. And then they don't have as much waste. So the whole market is being sort of dragged back. But we're defensive. You can get away without having to eat Bega Cheese, for example. You can't get away without having to eat [indiscernible]. You've got to eat that. But apart from that, we're defensive. You get burned, you're getting fixed. And I can't think of a better stock to be in now that's competitive in the price already, but defensive. It's fantastic.
Jan-Marcel Gielen
executiveThanks, David. Why is Australia and U.K. not declared as profitable given they are more mature in terms of being standard of care compared to the U.S?
David Williams
executiveWell, first of all, you can tell me whether it is profitable or not because I'm imagining that U.K. must be pretty tight right now.
Edward Graubart
executiveThey are. U.K. and Australia are profitable.
David Williams
executiveYes. So -- but it's to do with the cost allocations as well. And so Ed's -- he complains a lot. So we can't give you too much overhead cost, or he'll just make my life a misery. But seriously, it's a cost allocation game around the world. But with the current sales rates, Australia and the U.K. should -- because they're both turning over, well, similar amounts actually. But they're both getting -- they're both should be pretty profitable. Certainly, it's the contribution line then, definitely be profitable.
Jan-Marcel Gielen
executiveThanks, David. What has happened to the appointment of the Head of Legal mentioned during the annual report or annual reporting season?
David Williams
executiveYes, it hasn't been settled yet. We've got -- we've interviewed a couple of candidates. We just haven't quite found the right fit. We missed a couple because we're a bit slow. It will happen. I mean there's a lot of people coming on. And as you can see by Philip, I mean, we're not taking second class. We want the top of the tree.
Jan-Marcel Gielen
executiveWith regards to India, can we share the sales to date?
David Williams
executiveNo.
Jan-Marcel Gielen
executiveNo. Very good. [indiscernible] Why do we continue to investigate partnership opportunities when, in my opinion, the past partnerships seem to stagnate with little news on advancements?
David Williams
executiveWell, I don't know what that's referring to. So I don't agree with it necessarily. But we've got an open mind about how much we can do ourselves and how much we -- and how quickly can we do it with others. PMI, let's take PMI as a good example, right, which is our distributor in Germany, Austria, Belgium, et cetera. We went there in partnership and within a month or so, we had our first order and a big order because they're talking to surgeons, the sort of surgeons we're talking to. So it was an easy sugar hit. You get 2 years down the track and you think, "s***, could I do it better direct?" Well, maybe. And these things are work in progress for us all the time. We're happy with PMI at the moment. But it could be that if it doesn't suit us, we take that agreement away, and we go direct. We've got -- we know the surgeons and so forth. But I think the partnerships can definitely work, and they can work on a number of levels because I think in the PMI case, we've got a partnership that allows us to distribute in countries before we would have got there ourselves. Now if somebody comes tomorrow and says, can I be a distributor in the Ukraine, a bad example, but we might say, you know what? We were never going to go to the Ukraine in the next 10 years. So what have we got to lose. But the other partnerships that we'd be open to people who bring some sort of technology that enhances our product, enhances the products we've got in our bag, that we're going to the same surgeons for. So there's all sorts of ways to cut that, but I don't think they've been a failure in the past. There's always hard work for anybody in any sort of partnership, but we've got an open mind.
Jan-Marcel Gielen
executiveThanks, David. Can someone comment on the revenue value of the donated 65,000 square centimeters of BTM? I can tell you, that's about $600,000 worth of product that was donated.
David Williams
executiveDo you want to...
Unknown Executive
executiveI've just answered the question.
David Williams
executiveSo you've answered it. Okay. $600,000. That's it?
Unknown Executive
executiveIt is, yes.
David Williams
executiveThat's cost?
Unknown Executive
executiveRetail value, [indiscernible], yes.
David Williams
executiveWhich retail that was done? Australia or U.S.?
Unknown Executive
executiveAustralia is the lowest [indiscernible].
David Williams
executiveOkay. So maybe...
Unknown Executive
executiveIn U.S. dollar here, slightly higher. I'm just taking of 65,000 square centimeters [indiscernible] the Aussie dollar, lowest price.
David Williams
executiveGreater value than the U.S., no doubt. Yes. Okay. Very good.
Jan-Marcel Gielen
executiveManufacturing question. As you progress to expand the manufacturing facilities to support $500 million in annual sales, how is the Board considering the concentration risk of having all production in one location?
David Williams
executiveWell, it is something we've thought about and -- but not something we've done anything about except to buy the factory next door. So if one burns down, we're hoping the other one doesn't burn down. But Robyn is the expert on concentration given she's just built something to $700 million. So what do you say, Robyn?
Robyn Elliott
executiveI think it's always [indiscernible]
David Williams
executiveI would say, we've discussed it very lightly over the years. And we will get to a stage growth where we might decide to put a plant up somewhere else in the world. Where that will be, will be a bit dependent on how the markets have developed. But it could be in Ireland. It could be in Germany. It could be in Pennsylvania. Not sure. Any more?
Jan-Marcel Gielen
executiveLast one, David. Is there one thing keeping management up at night where the company is heading? What would that be? Is there something management sees as a headwind?
David Williams
executiveWell, let's just test that. Philip, you don't have a microphone, but what keeps you up at night on the IT side?
Philip Scorgie
executiveSecurity [indiscernible].
David Williams
executiveSecurity. That's common. And -- but you're doing a lot of things to mitigate it?
Philip Scorgie
executiveWe are, yes. As it is [indiscernible].
David Williams
executiveThat's good. And he's using a lot of outside help. In fact, I was a bit surprised at the strategic planning session when -- we did have -- we used to have an IT person. Now we've got an IT person. And I heard you say I think we should keep outsourcing all these things. And I thought, what did we actually hire you to do for Christ's sake? Anyway, security is [indiscernible]. David, what keeps you up?
David McQuillan
executiveI think we have obligation to think about obsolete [indiscernible]
David Williams
executiveSo yes, from R&D's perspective, it's about being prepared to obsolete if we need to. But in the context of competitors and keep -- as you said before, keep building new products and new variations. Ed, what keeps you up at night?
Edward Graubart
executiveOur people. Just making sure we keep the people that we want here happy, keep them functioning, minimize turnover.
David Williams
executiveSo this is Ed, he wants to keep his people and minimize turnover and keep them happy. And this is coming out of the mouth of a man who 4 years ago, probably had 10 people or 12 people and now got 90 or 7...
Edward Graubart
executiveStarted with 7.
David Williams
executive7 people.
Edward Graubart
executiveClose to 100 now.
David Williams
executiveAnd close to 100. Ahmed?
Ahmed Hassan
executiveI think it was everything happening around us at work is what keeps me awake at night, another COVID, another pandemic, another war, supply chain disruptions in general.
David Williams
executiveYes. Yes. Okay. Jan?
Jan-Marcel Gielen
executiveI think it's just the execution of all our projects, just making sure that we get -- do deliver on time, and everything is in place to make sure that happens on a daily basis.
David Williams
executiveYes. Yes. And doctor, I should have asked you first, in India.
Satyanand Burra Shastri
executiveCreation of the category and awareness as far as India is concerned. That's what keeps me awake.
David Williams
executiveYes. But you know you've been doing that...
Satyanand Burra Shastri
executiveAlthough we know we can do it.
David Williams
executiveYes. Yes. Okay. Swami, finally.
Swami Raote
executiveWhat keeps me awake is the opportunity to reach maybe 100,000, 500,000, 1 million patients because I know the patients are waiting. How do we manage our short term and long term to get there without really burning our people down because I think we -- I see significant upside in growth. I agree with you that we are a defensive stock. It's an extremely disruptive technology. How do we grow? And how do we also carry the people along with us, including surgeons and everyone. So I see upside.
David Williams
executiveAll right. Ladies and gentlemen, I'm sorry that took a long time. It's 3.25 -- 2.25 hours. But I hope it worked for you. I'm a bit nervous about turning this into a circus with all these people talking. But I'm hoping you'll go away with a much deeper knowledge of the company and what we're doing in a much harder conviction on that we're heading in the right direction. But thank you all for coming. Thank you to our surgeons. Thank you to our staff, in particular, not just the fat cats who are sitting here, but the people who are doing the real work. And thank you to my Board. And I'll close the meeting. You okay, Angela?
Unknown Attendee
attendee[indiscernible].
David Williams
executiveOkay. Great. All right. Done. The meeting is closed.
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