Good afternoon, everybody. I think everyone in this call should know who I am. It's [David] Williams, the Chairman of the... I'm hoping that many of you would have met him in my sort of introductory thing with Swami about a month ago. But Jan Gielen, who's our CFO, and been with the company many years. I've got Max Johnston, who was a director for a number of years, and went away, thought he was retiring, and then we dragged him back for three or four months stint running up to Christmas to find... Well, we found a new CEO. Well, we found Swami. We didn't have to look too far because they worked together at Johnson & Johnson. It took a bit longer than Christmas and Max has just got back from a month holiday and will be leaving to go back up north to Byron Bay at the end of this month. Before anything gets started, I'd like to thank Max for holding the fort so well for the last probably eight or nine months. The reason is because we're in unusual circumstances. Obviously, Max has been here for eight or nine months and now going, and Swami's only just arrived. Normally on a call like this where we're just announcing our results, I expect to see the CEO and maybe Jan making much of the presentation and me helping and tailing it. I thought we'd try something different today because I don't think anybody on this call needs a proof that we're an unusual company in the sense that we're only still a start-up, but still capped over AUD 1 billion. There's so many moving parts in this company. We're not a steady-state company where we can come and make a presentation and just talk about what the milk price is or what the flour price is or whatever. There's a number of moving parts to do with sales, to do with new product developments, to do with M&A. In the spirit of openness that we might have a shorter number of slides and open this discussion up to all four of us. It's unrehearsed, I should say. As I said, Max has just come back, but I only wrote the slides up myself last night, and you'll see that they're just a replication of what's in the four G anyway. If you want a bigger presentation, there's one in the four G. If you want a smaller presentation, there's one that's just been uploaded, which is only three slides that I've really dragged out of that four G, plus a final slide talking about things like growth and M&A and direct growth versus organic growth and so on and so forth. I thought what I might do is hit what I think are the high spots of the sorts of things the company needs to do. Then I would pass some of it over. With each one that I hit, I think I'll ask Swami to comment on it and perhaps Max and perhaps Jan, as the case may be. Eventually, we'll take some questions and then I'll sort of hand those around a bit. I think you might find it useful, especially in an unrehearsed way, and especially in a growth company where a lot of these things are live and being considered, just to get a better feel for how we are looking at the company and how the company is growing. That's my way of introduction and, I think, before I get started, you know, in my own mind, this company's about sales, sales, and probably new product development. Under sales, it's a lot more complicated than that. You know, it's about people, how many people we've got on, in what jurisdictions. It's about which channels to market, because at the moment we're mainly hospitals, and it's about new channels to market, such as podiatry or plastic surgery and so forth. Of course, it's also about geography. At the moment, of course, we've had our first sales, as you'll see in our annual report, in probably a dozen or more countries in Western Europe. Now we've finally started to hit our straps in the U.K. and Ireland. You know Swami's background with respect to India. He doesn't need any introduction on the Indian side of it, but Indonesia, Japan, and he has some other ideas about China and the Philippines and Indonesia. I think you'll find a different perspective from him on how we're gonna tackle some of those things. Hopefully a bit like the last conversation we had, which was a bit more chatty, it enables you to get a much better feel for the company itself. With that said, I might just quickly. I'm not gonna use the slides, but I just want you to know what's on them. I'll just quickly go through them for 30 seconds, then get rid of them and you'll see us, the four of us take up the full screen and you can go look at the slides some other time. Chester, if I could just have the first slide. I'm first of all gonna pick apart just, you know, what happened this year. You know, we're not gonna rely on what happened with COVID. We don't really care. We grew pretty well in the U.S., and we're still continuing to grow, and we're still continuing to put on staff. I just wanna pick out a couple of these things, and in particular I'm gonna pick out a little bit about what's happening in U.S. sales, what's happening in ANZ sales, what's happening with BARDA, and our relationship with BARDA. I'm gonna ask Swami and Max to just sort of comment on these things. Chester, next slide. Just moving off some of the financial stuff, I wanna talk a little bit about what's happening in employees. CapEx, there are some things to be interested in there in the sense that we haven't spent much this year, and it wasn't because we didn't wanna spend the money, it's just a capital-light business and, it's not like you know, I'm at Bega C heese. You wanna build a factory in California? Okay, give me AUD 300 million and we'll see how we go. This is, you know, a capital light, capital-intensive industry. I'm gonna talk a little bit about R&D, and in particular, I wanna talk about new product development. I think one of my reflections is that people are worried too much about the timetable on hernia and breast. They're all good, they're going fine, but I want Swami and Max to give us a little bit of a taste about other things that are happening, 'cause there's a lot of things that are happening that are gonna come to the market much quicker than hernia and breast. But I also just want them to give us a bit of a feel about how we're getting surgeon-led here. I mean, I've mentioned this before, but we're playing catch up all the time with surgeons, and we'll give you a couple of anecdotes about sort of things that are happening in the market. And then finally, Chester, just the last slide. I think you're gonna find with this discussion that I expect that it's gonna jump around a bit all over the place. If we haven't covered things off, then I wanna go back to the global footprint because Swami if he is more excited than we are about accelerating global growth. I wanna sort of get his perspective about how he's looking at other geographies that perhaps we haven't even looked at. India would be a good one, and so forth. We'll sort of work our way through some of these. I think by the time, you know, I get to talking about what's on this slide three, we will have covered most of it anyway. These are the important points, I think, in terms of understanding the company. Bear with us. I hope you enjoy this, well, in some ways a more casual approach, but in other ways a more detailed approach, but where we can share with you our thought processes on things that are evolving. I could have done different. We could have waited five months till Swami's work with us on a new strategic plan and a new market entry and given it to you. I appreciate that you're sort of getting a bit of it, warts and all. I think that's a good thing for you, and it's probably a good thing for us as well. I'm going to ask Chester to just get rid of the slides for the moment so that you can get the full impact of us on the screen. I'm seeing something different to you, so I hope you can see that I'm wearing a new red jacket, you know, for the occasion. Let's get started. The first thing I wanted to talk about, you know, just going back to that revenue growth that you'll see in the annual results today, is that the U.S. alone grew 55.1%, in FY 2022. It went from AUD 20 million sales to AUD 32 million sales. We're pretty happy with that. It was a patchy year for in terms of COVID. There were certain states that were shut. There were certain states that were open, but the hospitals were shut. To get, you know, 55%, in that sort of environment, we're pretty happy with. We see more of that. I've said in the past that people need to realize that in many ways this is a cookie cutter approach. We've got a product that works, we've got a product surgeons want, and it's a matter of getting more people on the road. Be aware that not only are we getting more people, be aware that we're only doing hospitals. I think first things first, I don't wanna keep talking all the time, but I think I'd just like to ask for Swami's any comments he'd like to make on the U.S. growth, and what he sees for the U.S. in terms of the important points about accelerating growth in the U.S. market. Thank you, David. You know, before I start, I just need to keep reinforcing what an amazing technology we have here starting out in Australia. Whenever I talk to surgeons, they keep reminding me it's simple, the design is elegant, but it delivers outcomes which are truly extraordinary. I think that is something which we always need to keep at the back of our head. The other thing which I keep hearing from nurses is it's easy to apply. When they look at the amount of dressings and back and forth with the patient, you don't need to spend as much time. It's less complex than what they're traditionally used to. The third delighter of this technology is the cost, and the last delighter is the patient experience and how the technology performs in terms of restoring form, function, and how the patient looks and feels after the product, after the procedure. With such a solid technology, I'm really proud of the U.S. team in terms of what a disciplined execution they have been able to achieve. I always thought they could do more, but it's amazing what they have been able to achieve during the COVID times. It's amazing the amount of talent that they were able to get. They've doubled the sales force in the last six months alone. Throughout last year, they've doubled the sales force. Close to 60% of the people came in the last six months alone, and they continue to keep hiring talent, and they've sharpened the process of talent recruitment. I think U.S. has many more legs to go. It's a very profitable business. Again, sharp execution, focused execution, profitable business, but it can grow multifold. That is what I am truly passionate about. They can take the trajectory up as they get that formula right. I don't know, Max, if you want to add anything, because you're- Yes. speaking to them much more. Yes. Thanks, Swami. I'd just like to echo your comments. I think Ed's done a fantastic job over there, and I'd have to say he's been an absolute delight to work with over the last six, nine, 10 months, whatever it's been. Tremendous professional, and a real guy who focuses on execution. Couple of numbers that I think are interesting is, I think last time I was on a webcast, the average territory was about four accounts per territory. That actually built up to 6.7 accounts per territory. With the increase, we're back to 3.7 accounts per territory. That gives an idea of how Ed's executing against having a solid territory, building that territory up, getting deeper penetration within those accounts, and then repeating that exercise. Wonderful way to build a business. The second number is the proof in the pudding, and that is that existing accounts are up some 88%. The existing account trajectory is actually much, much stronger than what the overall trajectory is because we're still in the acquisition phase. Enormously confident. Ed's been an absolute champion to work with, and I can only see it going from strength to strength. Yes. I've got some numbers to add as well with respect to the U.S., but before I do, Swami, you were at the national sales meeting in California at our office, what, 10 days or two weeks ago? I'd be interested just in terms of your perceptions about the enthusiasm of the sales force, the professionalism of the sales force and their experience. I mean, be open about that. I'm asking you because you've come out of J&J, so you know what a good sales force looks like. Yeah. You know, I mean, I love the sales force of J&J, but I would tell you that the excitement of PolyNovo was palpable. While it's new, they are mesmerized by the technology and the impact it can have on patients, and that is what gives the sales team so much of confidence. When I just looked at the people and where they came from, they came from Integra, they came from ACell, and they were just amazed at the quality of outcomes. They wouldn't wait to go back and start talking to the surgeons about how different, how simple, how cost-effective BTM is and how it's going to make a bigger impact for them, the complexity involved in an operating theater, as well as for the patient. Just amazing excitement. You know, it's almost the sense that you're at the beginning of something new. You're, like, just waiting to get started. Very new team, but phenomenal excitement. You know, that's a precursor of what's to come in future. Ed detailed out the strategy of land and expand, and we're experimenting with, you know, changing the org structure a little bit to see how we can go beyond burns. We are very strong in burns, but how do we now start getting into trauma and some of the other places where we can start involving surgeons in delivering better outcomes for other procedures? That's again, another exciting thing that I can see in U.S. Very profitable business, but I don't think it's a mature business. It still has ways to go from growth, and that's what excites me about U.S. Just a couple of figures that people perhaps might appreciate is, Swami said before, they've added significantly to the sales force in the U.S. Just to reinforce my cookie-cutter approach, I can tell you that this year they added 27 new salespeople. Nine of those, by the way, have started in the last two months, and there's five open positions. That alone just gives you a sense and gives us complete confidence that sales are gonna keep going because, you know, as each of these new guys starts, you know, after six months, we're expecting them to start washing their face. I think that's really, you know, a good thing. There's another five to come on. It just reminded me, and I don't know if we've said any of this publicly before, but we are about to go into Canada, and I think correct me if I'm wrong, gentlemen, just to prove we haven't rehearsed this. Correct me if I'm wrong, but I think we're launching in Canada in around about now. We already have sales in Canada because we've got surgeons buying it, you know, at their own risk and using it. Max or Swami, can you say anything about Canada? We will be in Canada in the last quarter of this year. We have put in process our application, and the license should come through pretty soon. We have a sales team which is raring to go. We will be working on the training programs in advance of everything. Again, very excited about Canada. The procedures that we have done there with some surgeons have had tremendous outcomes. Canada is going to follow the same path of U.S., and can't be more excited about Canada as well. Yeah. Thank you. Just staying on the U.S., again, a couple of numbers. As I said before, one of the big opportunities, expand outside the hospitals, but also to expand inside the hospitals. In some hospitals where we're still, for example, selling to burn surgeons, you know, we now have the opportunity to sell to oncology surgeons, guys doing amputations, guys doing diabetic foot ulcers and the like. There's a fair bit of work to be done there. I can tell you that in the last year we've added another 80 hospitals. Some of these hospitals, by the way, are much bigger than we're used to seeing at the Austin or Royal Melbourne or whatever. They offer us substantial opportunity. It's not. You know, I don't want to make too much of it, 'cause as you put on new salespeople in areas where we don't have anybody living, then we're gonna get that naturally in any case. I think my final comment on the U.S. is, and Swami said it, but you should believe it is that it is already substantially profitable, even after Jan dragged some of it out of him for his various head office charges. There's only more of that to come. It's sort of very exciting. We're not sure, by the way, whether COVID's over yet. I mean, there's still plenty of hospitals with patients, but we do have a much freer environment everywhere around the world, for that matter. It's a nice segue into Australia because you know everybody knows that you know for several months there the whole of New South Wales and Victoria shut down and that did hurt us for once. Whereas in the U.S. we made good of the fact that we had webinars we could go and have coffees with surgeons outside of the hospital setting. You know we still got pretty good growth at 55%. The interesting thing I find about Australia is that if you look at the first half when we had a lot of lockdowns compared with the second half we grew 66% in the second half over the first half in Australia and New Zealand which just shows you that it sort of comes back pretty quickly. Max, do you have a sort of perspective on that? I mean, we're still messing about with Australia in terms of, you know, getting a second person in Queensland, getting our first person. I tell our shareholders whether that's happened, but I know we're about to put somebody on full-time in NZ. Yeah, Dave, you probably think nobody works too hard, but I think we were probably making our Australian territory managers work a little bit hard. We had our main territory managers handling in excess of 30 accounts, which is a ridiculously large number of hospitals for them to be carrying. What we did notice is that we were underservicing regional areas, that we were underservicing some of the smaller accounts. As a result of that, we've actually put associates with these people who also give us a pipeline of good people for the future. If you have a look at Queensland, we've increased our intensity there. We've increased our intensity in New South Wales and Victoria. In New Zealand, we now have people who are captive to New Zealand as opposed to Valerie, who does a fantastic job. She's ultra active, having to go over there and service that market herself. Australia should be our most mature market. We're still seeing good growth there. When we look at how we can do a better job for our surgeons, support our surgeons better, we don't see it as a mature market. We just see it as a market that we can do more work, help more patients in, by increasing the intensity. David, if I can add a couple of points. Australia is where we are a clear, unequivocal market leader in burns, and that's what Australia should be really proud about. Now, having said that, the opportunity for Australia is to again start going beyond burns. We have the right people with the right experience in terms of going beyond burns. There is also an opportunity as we start getting into the regional centers into Western Australia, to serve them with products which would help them with specific situations in those areas so that patients don't have to come back for a second dressing. Those are the things that we need to think through in terms of helping Australia start growing again. As I said, I mean, I don't think it's a mature market. Our growth will be limited by our imagination and our ability to involve surgeons into different surgical problems that they want to solve using BTM. Yeah. Good. Thank you for that. I mean, one of the things you just touched on there, Swami, I was gonna leave it till last, but it goes into new product development, and you've just touched on it by saying, you know, we need some products that help people in certain situations. It's not necessarily geographies, but rather certain types of wounds and coverings where you don't need the laminate. Therefore, the surgeon might be able to do it in one fell swoop, as it were. In other words, where you have wounds that are a bit smaller, where the surgeon can say, "I wanna use the foam, but I don't need the laminate because the wound will heal itself." Or the ability to put the foam on, again, in the small wounds, and put the skin graft on at the same time and not have to do two coverings, or in other things like bones and, you know, joints and so forth. Yeah. I think, it's probably an ideal time, Swami, to say something about surgeon-led, because this is really driven by the surgeons rather than for us, you know? Yeah. You know, as I've gone around meeting different surgeons, there are some unicorn surgeons who already have taken the product to more places than we have thought about. The question for us would be, how do we listen to their voice? How do we prove their thesis in terms of how the outcomes will work? At times change our technology, make it thinner, make it thicker, remove the laminate, change the sizes, so that they feel that they're able to give the patients the best possible outcomes, without necessarily throwing off a big chunk of, you know, what's not needed. That ability to listen to their voices, bring them into our R&D labs, make sure that we're able to follow through with changes, make sure that those are easy regulatory pathways so that we don't have to wait for too long to get the product back to them. That's how I think about how do I give them the access to products and solutions which they want. In the quickest possible way. MTX is a great example. It was started by Max and that, especially in certain markets, in certain areas, would really do well, because that's where surgeons want to do a graft, quickly apply a secondary skin graft on certain procedures where they believe that the patient won't come back or they don't have the time, and send the patient home completely comfortable in the knowledge that the product will deliver the outcome that they have seen in so many other patients before. Yeah. Thank you for that. I just wanna emphasize it to people because there is a section in the annual report which you should read on what we used to call Matrix, but we had some intellectual property issues registering it, and we've changed the name to MTX. MTX is a very useful derivative of our existing technology, but without the laminate on the top. When I said before, don't just concentrate on hernia and breast and, you know, whether that's two years out or three years out, it doesn't matter. There's so many other things happening, and one of the most exciting ones, I think, is Matrix or MTX, which the surgeons have demanded. We don't look at it as being cannibalistic at all. On the contrary, we think that surgeons are gonna carry both. For some wounds, where you need to protect the body and it needs to be a two-stage operation, come back, take off the laminate, put the skin graft on, fine. There'll be many others that the surgeons will have. This product itself has, in my mind, the ability to double the size of our business. 'Cause surgeons will carry both. I think, you know, we've already, unlike, for example, breast and hernia, we've already applied for a FDA approval of that, and let's see what happens in the near term there. You're gonna find a lot more interesting things happening between now and when you see a breast product, for example, on the market. You know, as I said, the most exciting thing is that a lot of this is surgeon-driven. Now, you might say, "Well, okay, that's great. Put the product out there, we're gonna use it." They will use it, and they are using it for things like, let's say, diabetic foot ulcers. That's a certain percentage who'll take it. There's other surgeons that sit back and go, "I see they're using it, but do you have any data?" One of the catch-ups we need to do with the surgeons is to really catch up with those who want to use it for a certain thing that it is already being used for, but need some data to go with it. That's why we're doing small studies. You saw we did a 10-patient diabetic foot ulcer study recently as not only a precursor to a bigger study we're doing for reimbursement and so forth, but just to prove to ourselves and be able to give, you know, salesmen the toolkit to be able to sell to surgeons themselves. Look, I started off on Australia and I've sort of digressed a bit. One of the other points you'll see in it is just what's happened to our BARDA revenue. It seems to be two-fifths of bugger all. It's, you know, it's grown 4% this year. I think you need to marry that up. That's a sort of, in a sense, an historical one. You need to marry it up with the fact that BARDA are subsidizing the trial that we're doing at the moment to the tune of $15 million. If things go the right way, no promises, but you know, we're likely to get a lot more money out of BARDA. Now, we make a small profit off it, so it's not a profit thing for us. It's a matter of not only getting, you know, more data, but more particularly, if these things work to the way in which BARDA wants them to work, and we're very confident because we know how the BTM works, they will buy a substantial amount of stock to stockpile it for disasters and so forth in the U.S. I think, again, I'm not sure we're gonna have to wait till the end of the clinical trial to get to that stage. Again, there's some timing things here. Swami, you've been having a number of meetings, even in the last few weeks, with BARDA and Max before you and now. I'd just like you to maybe make some comments on what's happening at BARDA. This is not like getting a government grant off the Victorian government. It's all care, no responsibility. These guys are all over us like a cheap suit, right? I don't mean that just in the sense of having phone calls. We have sort of weekly accountability. They will pay to have an accountant on our team who, you know, monitors this stuff with it, within an inch of its life. We're comfortable with that. We'll make some money off it anyway. The prize at the end of the day is magnificent. I'd just would be interesting for people to hear, you know, who we're talking to, how we're talking, and what, you know, what, you know, whether they love us or hate us or Swami. David, if I could just interject, probably first. What I'd like to emphasize is just what a wonderful partnership it is with BARDA. They're probably one of the most progressive government bodies I've ever had the privilege of actually working with. Very focused on what they want to get at the end. If they have a catastrophe in the U.S., they wanna be able to respond to it in the best possible way, and they take very seriously the way they spend taxpayer dollars to get to that outcome. I, you know, I think it's a great privilege for us to be selected as one of those partners, and they go to great lengths to emphasize partner, in providing that underpinning to the U.S. population for disasters. I will hand over to Swami in a minute. I think what is so good about the BARDA relationship. As they want us to succeed. They will do anything possible for us to have a very, very successful pivotal trial. Their involvement with us, it's almost like they're an extension of the company in terms of getting these programs on track. Anyway, Swami, you've been talking to BARDA probably more than me in the last month. You know, what I would probably emphasize is dig into my past, and I was involved in the vaccine trials with BARDA. I mean, BARDA is an amazing agency with a purpose to help citizens of U.S. and military of U.S. with the right medicine, with the right stockpiles, and they are the driving force of innovation for U.S. as well. The resources that they put in that program and the resources that I see with the PolyNovo program are almost identical. I don't see any letup in a $600 million program versus a $15 million program. That to me is impressive. The commitment which they bring to the table, the attention that they pay to detail, and they want to execute this program as quickly as we want to execute this program. There is attention from both sides. We are looking at what mechanisms to be put in place to enroll patients faster. We are looking at when can we start releasing the data. BARDA and our clinical team would approach FDA to make sure that, you know, FDA is a part of the process, and at the end of it, we get the outcomes which we want from a clinical perspective. FDA gives us those PMA approvals for deep second-degree burns, which is what the end goal is. They're a phenomenal partner. What Max said is right. We have one objective, and that objective is how do we get to the endpoints of this clinical program together, and then how do we get the approval, and then how does BARDA stockpile the right amount of product, from their disaster preparedness perspective for all the U.S. citizens. Yeah, that's great. We may be getting into the detail too much here, but I think it's useful just for people to hear how many sites, how many university hospital sites we're using on the BARDA trial. For everybody's benefit, we had a board meeting this morning, and I just learned for the first time that we're gonna add three more sites and perhaps in Canada. Swami, can you comment on that? There are 30 sites in U.S., and then they have agreed to add five more sites. We are having conversations with them, whether we should expand it beyond U.S. and Canada. As I said, I mean, it's just a focus in terms of how involved they are. The head of BARDA personally at times reaches out along with the infrastructure and the team which he has, to all the investigators, making sure that, you know, we are all on top of our A game in terms of enrolling the patients, tracking them through this study program. While we have an endpoint, which is December 25, we are all trying to see if we can bring it forward dramatically in terms of getting early read of the clinical trials, trying to see if we could fast-track that approval with FDA as well. Tremendous partners, and we're constantly looking at how can we enroll faster without losing the quality of the program and the data. Yeah. Yeah. It's probably not that relevant to most people, but the trial is being run by Tina Palmieri from California, who's one of the most influential surgeons in the country and ex-head of the American Burn Association. That in itself, you know, we hope is dragging in a higher quality surgeon under her belt. It just goes to reinforce, I think, our image with the surgeons as well. It's a quality trial. I mean, even though the number of hospitals sounds large, and we may even do some offshore, we're only. I'm just trying to think the size of the recruitment. Is it 138 patients we're doing? 123. Okay. 123 patients. We've got every right to try and think we might be able to bring this forward, but it's still a matter of recruiting patients. Well, before I move off revenue and growth, and you know, we mentioned that the U.S. is now significantly profitable even after Australian charges, we perhaps just should emphasize again the margin in this product, because if you look at some of the other companies in this space, people keep comparing us wrongly to Avita 'cause it's not a comparison either. You have a skin product, but people like Aroa and Integra and so forth. You know, our margin is so significantly higher. That's why we're reaching profitability a lot more quickly. Jan, just to pull you into this, just give people... We're cutting this R&D because the margin's so high, but what is your current thinking on the margin of this product when we sell a product for AUD 1? I guess it is very high by industry standards, but you know, there is room for it to move even higher again. We did have an improvement over the year of 0.2% with our gross margin. I guess where it will go in the future, it can increase further in two ways, either higher pricing and a combination of increased throughput through the facility, and more efficiency gains and so forth. That's largely what we experienced this year. We had a slight increase, and it was a larger increase last year. It helps enormously. I can't say enough, like, with cash flow and so forth and managing this business. I think there's one of the charts on the financial deck where you'll see the growth in OpEx and the growth in revenue, but our net loss is only AUD 2 million underlying loss. You look at some of our peers, and it looks very different. Having a high gross margin certainly helps and helped with the second half. For example, we had a positive cash flow from operations and a similar result to last year at the same time. You're not being very specific, but you know, we're used to seeing a lot of devices and in this industry of, you know, 50%-60% margins, it's fair to say, right, that we're above 90%? Absolutely. Yeah. Yeah. A long way above 90. 95%. Sorry, yeah. Yeah. When you're talking about increasing the margin, Jan, it sounds to me like you're trying to cut the salami too thinly. But it's a very, extremely high margin, and you're quite right that given some of our competitors are way above us in terms of price, there's still the ability to get a higher price as we get more market share and so forth. Yeah. If the margin's 96%, I don't know how much it really changes it, even if you double your price, is my point. Sure. Yeah. I think one thing to keep in mind for everybody, and we have a debate internally, and we might have it now, as to whether you need organic growth or you need a distributor. There's a whole lot of reasons why you might go with one versus the other. Margin is not the only one, and perhaps not even the primary one. It might be just keeping control of your own destiny and so forth. I think one of the interesting things is if you start off with a margin of 95%+ and you're selling a product that you would sell into the market for, let's say, AUD 900, but you're selling it to a distributor for AUD 450, the margin is still so high that your return might go from 95%, but it only goes down to 82%. You still make it, you know, obscene margins all along the way, but you still make an unbelievable margin. I think margin itself shouldn't be, you know, too much of a determinant about whether we go direct or whether we go organic with the distributor, I should say. I think that's really a healthy position to be in. Now, we have a continuing debate, and it's a sort of geography by geography thing about, you know, where, whether we should go direct, or whether we should go through a distributor. It might be just worthwhile sharing a bit of that, Swami, and also just whether it's when you make a decision, whether you're making a decision for good. Yeah. David, if I can go back to the margin question. You know, the way I look at this entire category is, it's today restricted because of the margins of the current competitors, and they're largely restricted to U.S., a little bit Western Europe, Japan and China. Honestly, burns happen across the world, big trauma happens across the world, and we have a potential to go across the world. I see this as an opportunity for us to be, you know, reach out and touch many more number of procedures than where the category lies today. There are 1.7 million skin substitute procedures which happen across the world in a geographically limited, restricted space. I think PolyNovo and this Australian technology can go global. When I look at the total potential, it's close to 10 million procedures. I think about it more in terms of putting it in the hands of more surgeons, solving more patient problems, giving them more surgical solutions. That's what excites me about how PolyNovo is structured, how the technology is structured, and the sheer jobs that it can do going forward into the future. That to me is exciting because as we look at the surgical challenges in the emerging markets, they're slightly different nature, where cost is already a pressure and the surgical skills are not that high compared to the patient population and the challenges that the health systems face in those areas. I see us as leaders in some of those markets compared to the current competition, which is kind of stuck where they are because of the construction of the product and because of the robustness of the product to survive in some of the emerging market operating theaters with all the hospital-acquired infections which go with that. I think our technology is far more robust, and we have every right to go to many more patients and give them those outcomes which they deserve. We can go there ahead of the rest of the competition. That's the way I look at margin. Yeah. I guess if I could just add one thing to that, Swami. I hope I didn't interrupt you. The question of distributor versus going direct is really a question of how well are you going to service your product. We are fortunate that we have a robust margin because we also need to face into the fact that this is a very high service product after it's been manufactured. The opportunity it's created, and the reason we've done so well in entering the U.S., for example, is we can offer that service. We can get it into the hands of more surgeons. We can get it into helping more patients. We can get wider distribution, greater accessibility by investing in those things. Dare I say, we've been very bold in that investment. The big difference between being direct or distributor, if you go into a distributor, that person has to offer the same high service that you can offer yourself. Where we've been less successful with distributors, and I've spoken about our difficulties in some of our distributor markets, is where the distributor thinks that it's a matter of getting it to the purchasing office and the job is done. The job is not done unless we're supporting the surgeons, unless we're supporting better practices. I think that's the big question on direct and distributor. Can you give that high service? Can you utilize your margin to create that accessibility for surgeons and patients? Yeah, that's great. Well, I mean, just to round that off, we've talked about the U.S., we've talked about Canada. It's probably worthwhile people knowing that we're contemplating not going direct in Canada, even though we're direct in the U.S. Just to take your logic, Max, one step further, how would you justify not going direct in Canada versus going direct in the U.S.? I think that speaks to the point of how you use a distributor. Again, you know, top credit to Ed. The distributor model that he's putting in place in Canada is almost a combination of being direct and being with the distributor. What we're doing is we're leveraging, I think it's 17 reps that a distributor has. We wouldn't want to put 17 reps on in Canada. That would be unaffordable even with our margin. What he's doing is utilizing that field force, but he is still within the company accepting the responsibility of helping with the clinicians, making sure that the clinicians are well-serviced, distributing it directly. We will be the people who actually distribute the product in. It's a great combination and I think again, credit to Ed. He's utilizing the best of a distributor model, but not passing over responsibility for actually making it available to the surgeons and educating the market, if you like, on what is the best use of this product. Swami, you've been involved in this. Did you have anything to add? If I can add. It's a terrific win-win solution because the people that the distributor has already have tremendous knowledge about this category and how to do in-service selling to the surgeons, and they have relationships with those surgeons. Now the question is how do we train the distributors' 17 salesforce infrastructure with the fact that our technology is easier to handle and delivers better outcomes. You can imagine that people who know the surgeons, people who know the ORs, people who know the nursing staff around, all they have to go back and tell them that this delivers better outcomes, lesser complexity, lower cost, and they're off to the races. I think that's a truly smart way of accelerating impact. It's not a question of distributor versus direct. How do I accelerate my impact and how do I create win-win solutions, is where the focus should be. Great. All right. Enough on that, I think. Before I go back to some of the things like employees and CapEx and R&D, I think given we're talking about Canada and the U.S. And global footprint, Swami, you know, when I look at global footprint, I'm looking at U.S., I'm looking at the rest of the world, what we're doing in U.K., Ireland and Western Europe and ANZ of course. You're the new boy on the block, and one of the things we found attractive about you is that you've had direct experience running, living, but in environments like India or Korea or Japan or China, and if not living there, you know, supplying in there. You know, give us your early perceptions about where else you wanna be in the rest of the world as a means of accelerating growth. You know, if I were to have a clean white canvas, it would be U.S., Japan, China, Western Europe. These four are must-do markets. India is a torture test market for many medical device companies. It's not an easy market for many medical device companies. When I look at the technology, I look at these are the must-do markets, and if I can also win in India, that would be a great solution for us across the globe. I can start expanding into the rest of world as needed. So I'm looking at the people, I'm looking at the opportunity, and then I'm thinking through how do I expand access in the fastest possible way. You know, where do I pick and choose my battles? Where do I see the strength and capability in the people, and who do I partner with wherever we don't have that? It's a question of setting up the education between us as a company and the surgeons, and not just us teaching the surgeons, but the surgeons teaching us and providing us an input and feedback into our pipeline. It has to be a two-way street of education for how can we help them do their jobs better by making this product even more versatile in their hands and giving them tools to deliver better outcomes. The last thing which I would talk about is then we need to keep thinking about how do we keep scaling this entire category from the current procedures where it is to where it potentially can be. What are the regulatory pathways and how do we try and make it easy by working with surgeons as well as with the regulatory bodies? We need to have relationships in all those three areas and understanding of how to really scale this product globally, and reach as many more patients as we can versus where we are today. When I look at the total size of the number of patients we reached last year, it was around 10,000. And when I look at the procedures, it's 1.7 million. Now the question is, you know, not about getting greedy, but how do I start converting by leveraging the know-how in the system versus trying to build and grow everything organically. And that's how you build a great medical device business. You leverage the know-how and passion of the innovators, not just within our company, but outside the company, bring the regulators into this conversation early on, and start seeing how can we expand our pipeline and path to market and speed to market. Yeah. I think, you know, one of the things that I would say about Swami, if I had to summarize in the last few months, it's all about accelerating global growth, and we already pride ourselves, I think, on having grown this company quite quickly. I was just saying to the board this morning that, you know, I did an index of putting companies like J&J, Integra, Aroa, ourselves, Avita, all on five-year indexes of AUD 1. By the time you get to year five, where we are now, PNV had wiped the floor with them all. You know, like we were AUD 1 turns into AUD 5.40, and with many of the others it's AUD 1.30, and with people like TELA Bio, like Aroa, they're less than AUD 1. We've already prided ourselves on that. I think one of the things we like about Swami is his commitment to accelerate growth in ways that perhaps we weren't even thinking about. India is a very good example. I'm interested, Swami, 'cause people would be interested to know that we just had a board meeting this morning, and one of the papers you presented to the board was your desire to get into the Indian market, but quickly. There's a big conference there in November, and I understand it's your desire, and the board's not getting in your way, that we launch India at that time. Give us your thoughts on... I just wanna emphasize to people that we're not, you know, we're not gonna write a strategy paper and this will last for a year and then, you know, get McKinsey's in and then finally get there in a couple of years. We're prepared to bite the bullet and to push these things very quickly because we know the product works. Yes. Give us your perceptions on India, because it wasn't on our radar, nor was Japan yet, you know? Yeah. I think the value of India is the fact that the sheer number of patients which India presents is much more than the ability of surgeons to handle them. At times it's a very rough environment. It's also an environment where our competition will fail consistently because of the hospital-acquired infections and just the overall difficult, challenging environment within which surgeons work and patients are presented. Now, in this environment, our technology works. Where we have given it to surgeons, they have come back and they've repeatedly told us how robust this product is. They would want to have more variations of the product so that it's able to help them solve different surgical challenges and different patient and wound etiology issues. I see India as a validation of the robustness of this technology, and if it can work in markets like India, it has every right to go global. I see India also as another innovation hub for us in terms of how can we make things easier for surgeons, help them come into our R&D labs and tell us what are the other ways in which we can make things better for them. I'm keen to get into the market before the year runs out, and there is a big conference coming up in November, and if we can launch there, that would be a terrific thing to do, because there are just so many plastic and reconstructive surgeons congregating for that conference. I would not want us to waste that opportunity. That's why it's important for us to keep going, and we will navigate our way out of it. It's a no-brainer. The idea would be we'd launch in any other way. We'd go to India, we'd take our KOLs from Australia and the U.S. Yeah. We'd have some lunches, we'd have a couple of demonstrations and already have on board several people. It's working capital, you know? Yeah. Head of India and some sales people and so forth. I think, you know, for me, that's very exciting. I think it's well-known to some people, I think, that we're also talking to some people in China. Japan and other things are still work in progress. I want everybody to know that we're still going very hard on the U.S. We're going very hard and starting to get some traction now in the U.K. I think there's, you know, the near term is very promising as far as we're concerned. Can I switch pace now and perhaps just talk about new product development and R&D? There's some numbers in the annual report and in the summary that R&D was up 57%, went from AUD 3.6-AUD 5.7. That's fine. We've got a commitment to growing the R&D department. Again, I might ask Max to start off in terms of just what we've done in the last 12 months. We've gone from sort of 1 person to, I don't know, eight or nine or something now. Look, we've got a good critical mass in the R&D department now. But I think the most significant thing that we've done, David, is Swami has refined this, even in the short time that he's been here. That is, we've focused on our advanced wound care area, and we've looked at the product that we currently have here and looked at how we can extend that for greater use by the surgeons. Again, we're probably repeating ourselves, but a lot of that was surgeon-led and then translated within our R&D facility into new products that perform specific jobs against specific indications. We then have what we call the implantables area. We're already advanced on four prototypes within hernia. We're obviously looking at breast sling, but the implantable products is the second, if you like, pillar that we've got. We've got the therapeutics, and the work that a very good friend of the company, John Greenwood, and Julian are doing in that therapeutic area is of enormous interest. Hopefully, we can play a bigger role in supporting them in that. If you like, we've got three pillars that we can build on. One is very advanced. We took a decision a little while back to concentrate on how many more indications and surgeon needs can we serve with that base platform. We've got the second, which is looking to the future. Four prototypes in hernia. Working feverishly, if you like, on the breast sling. External partnerships, which we hope we can do more with in the therapeutics area. Mm-hmm. Very interesting. Swami, any comments on R&D? David, I will not belabor what Max said, but, you know, more and more we need to have the entire world as our R&D, extension of R&D team. I think innovation is not just a company sport, but also involving our surgeons in that entire conversation. The more we identify surgeons who are passionate about taking this technology into different surgical areas, and then we start engaging FDA upfront along with those surgeons in terms of how do we do those experiments, how do we get all the ethical bodies aligned behind those experiments, and how do we get faster approvals. Because there is an approval pathway which is for skin substitutes, which might be a little bit easier. Let's make sure that we do everything that we can for speed to market. We get into the implantables, which has a slightly elongated regulatory pathway, and let's make sure that we're bringing the right people in from outside, whether they're surgeons and universities who are willing to host trials for us and who are willing to be our partners when we start opening conversations with FDA. This is where we need to open our aperture wider and make sure that we're engaging with broader number of partners, bringing them into our company and expanding our pipeline. The last would be therapeutic, because then you also have to work with the drug regulatory, you know, channel in U.S., which tends to be a little bit more complex. A little bit more thought needs to go into that. Those three platforms is how I would think about R&D. One switch which I would want us to think about is: How do we involve the external world much more into what we do in our R&D labs? Because that's when we can truly exploit the robust nature of what we have, but the versatile nature in terms of, you know, how it can be contoured and shaped to deliver multiple surgical needs, not just where it is today. Yeah. Thank you. Thank you for that. Just a couple of comments on new product development I think people might find very exciting. I've talked about. Everybody knows about hernia and breast. I've talked about MTX and essentially the derivative of what we've got is that base tech and without a laminate and where that can be used. We'll do more on that at the AGM, and I would plan to have Marcus Wagstaff or one of the surgeons, you know, give a very brief presentation at the AGM about how that expands our market and why surgeons will use it, quickly. Just two quick anecdotes that I think will probably shock people. There was a pediatrics conference in Munich about four weeks ago. It was in German, but they asked Marcus Wagstaff from Royal Adelaide to open it, just to give a history of BTM and how it came about and why it's used and so forth. He did that, and then it was a Friday night here, so he went away and had a red wine. I was lying in my bed at 8:00 A.M. on Saturday morning trying to catch up on my sleep, and he rang me and he said, "David, you won't believe what happened at this conference." He said, "After I left to go and have a red wine, a surgeon in Germany gave a paper where she looked at one of her patients who was pregnant, and in the scan she noticed that the spinal cord was not covered and the baby's gonna be born with spina bifida. She makes a decision to go in utero, into the womb, and she puts our BTM on the baby's back. The baby is then subsequently born. He takes off the laminate. He doesn't do a skin graft 'cause it's not needed. It's fully integrated. Baby's fine." He said, "Everybody was just going, 'Holy hell.'" I give you this example because, you know, we're spending a lot of time talking about how we adapt this product for hernia and breast and, you know, what happens to the laminate and what happens to the foam and that. We know how the foam works, but this has just taken the world by storm. I'll just give you a sense of how quickly these things take on. At one stage, I was on the board of Monash IVF as the doctor's rep. I ring up the busiest doctor who does 800 women a year, and I tell him this story that Marcus has just told me. Now we're at 8:10 A.M., and he said... He then gives me the stats on, with IVF in particular, how many spina bifida babies are born, but he says, "You don't understand the most of it." He said, "Monash University is about to start a study on spina bifida, where they're gonna try and cure spina bifida or protect the baby from spina bifida with stem cells." He said, "I'll ring you back. I'm ringing up the professor at Monash." He rings up the professor at Monash. He rings me back. It's now 8:20. He says, "The professor at Monash says, 'Why the hell do we need to do our study? This is unbelievable.'" I ring Marcus back, and Marcus says, "Don't tell him to stop the study. We'll put the stem cells in the foam. This is now 8:30 in the morning., but I just want to give you a sense of the excitement about, number one, we don't even know about this. These surgeons are taking these things and running with them. And who knows where some of it's going to end up. But, you know, when you get a few key surgeons who then want to take that risk themselves, it's very, very exciting, I think. The second one I just want to share with people is, and Max mentioned, what John Greenwood is doing in Adelaide with Toby Coates, and that is, impregnating the foam with diabetic islet cells. Swami and I were there last week. I'll ask Swami to kinda comment on this in a moment, but I think they're just putting in their third and fourth patients. They introduced us to their first patient, who was a headmaster at a school, very articulate guy, came in, had very extensive diabetes. What they do, I'll probably get this wrong, but just to give people a sense of it. He hasn't got a wound, but they cut. They placed a patch, smaller than this actually, in his arm, and then they with their fingers close it together like that, so it's. I don't know if anybody can see this, but anyway. Then they inject into that incision. They cut, they placed a patch, smaller than this actually, in his arm, and then they with their fingers close it together like that. I don't know if anybody can see this, but anyway. They inject into that fold, like it's a fold in your arm, the diabetic islet cells. Over the next month or six weeks, like our foam normally does, it disappears. The question was, do the diabetic islet cells, which stimulate the pancreas and so on and so forth, do they still stay there? The answer is yes. The guy comes in and because of this, his insulin need disappears. His sugar levels come right down, and he's now got a very manageable. Well, I think the diabetes is essentially gone. I'm just giving you a sense, again, we're supplying the BTM for that, obviously, and, Swami, give us your comments on what you saw the other day when we're in Royal Adelaide with that patient. Yeah, I mean, what struck me most was how the patient fared, how much less of insulin he used to give to himself compared to what it was in the past, and the hope that he felt that he would be going beyond diabetes Type 1. I mean, that's a difficult challenge for any company to take on. Most importantly, his personal story was, you know, there is a guilt that all of us feel when our children have the same disease which we have. He was trying to educate his daughter who had diabetes, you know, Type 1 diabetes, that there is a procedure which is coming up, which most likely will work for her, and she might have a better life, you know, not necessarily titrating her insulin every now and then, for those episodes. It's more about, you know, how he fared, and it's more about what a legacy he felt he was leaving for his daughter. That was the most touching moment for me. Yeah. Very good. Again, just to emphasize, I think, where NPD is going and how much is happening outside the company as much as it is inside the company, which is a good segue, I think, into clinical trials, where, as I said earlier, we're playing catch-up oftentimes with surgeons and, you know, then we're selling. The number of pieces we now sell for diabetic foot ulcers, off the back of the original studies that were done with six wayward patients that were done with the person surgeons, I think, out of New Orleans. You know, but we still need to go and do some trials in order to either get insurance reimbursement or, but more particularly just to convince surgeons who don't wanna take any risk whatsoever. We're playing catch up, and so we've got a number of clinical trials going on, and I'm sure when we have this discussion in a year's time, we'll have many more still. But some of them are real clinical trials in the sense that we're doing them for Avita or we're doing them for reimbursement reasons or we're doing them for some other reason, but some of them will be just to get good data to pass on to surgeons and our salespeople. I won't spend any more time talking about clinical trials. Max, is there anything we need to talk about on clinical trials? I don't wanna gloss over them if there's something. I don't think so, Dave. Suffice to say that during the course of discussing with Swami, we both recognize this is an area we probably haven't supported our surgeon population as well as we should have. It'll be an area of focus going forward. We're very appreciative of the work that, to be quite frank, we've got gratis from enthusiastic people who are trying to help patients. I think it's behooving on us to step that up. I know Swami's got some big ambitions in that area. Good. Okay. Well, people got questions on this, send them to us in separately, and we'll answer them in a more technical way, but I don't necessarily wanna spend any more time on it now. One thing that has come up since Swami and I had our sort of tea together with shareholders a month or so ago is, he mentioned just in passing mergers and acquisitions and acquisitions. I notice in a lot of the blogs that are around that people have grabbed on to that. Yeah. I just wanted to put a couple of things to bed. I'll also ask Swami just to reflect on it. First of all, I don't need any more shareholders ringing me up and saying, "Why don't you take over Avita?" Right? We ain't gonna do it today. We could have done it when it was worth AUD 20 billion, and we're still not gonna do it. It's not because we don't like what they do, it's just another skin graft. It's complementary to us. It's not the same as us. Put that out of your mind once and for all. We're also not gonna take over Aroa. We're rowing our own boat with synthetics. We don't want a biologic. We think our product is so much superior, so much more efficient, and so much better in margins. It's not on our radar and won't be on our radar. Take those away. Just in terms of the things that so you get a better sense of it that Swami would be thinking about and maybe I'll leave this to you, Swami. Is that just conceptually what sort of acquisition do you think would interest us? David, I'm thinking about this technology, and I'm constantly thinking about how do I access and scale it, and how do I get it faster versus later. I mean, the reason why I want to do that earlier versus later is because there are so many patients who need this technology today, they don't have access to it. If I can you know, now this is where I need to be creative to identify the right company with the right access points, with the right relationships, where I can add this to the procedure and clinicians that they're covering. My job is to come up with the right ideas for you, and then you know, hopefully, we get to work on it, and we are able to explore the access of this technology to many more patients, surgeons than we have today. I don't want to wait for five years for that to happen. You know, to your point, I'm not asking for McKinsey to do the paper on this. We have to find a way of getting there faster. Hopefully, there should be some ideas for us to work upon. Access would be the number one idea versus a product which is at a similar stage of development like us. You know, because I'm thinking of access and scale first, almost simultaneously. Just to put that a different way, if there was a company out there that had 100 salespeople selling to podiatrists, and our product could fit into their bag, and we could get the right amount of airtime with the. Yeah. podiatry, podiatric surgeons. Yeah. A very different market in the U.S. than it is here because of that reason, but that might be something that's at least worth contemplating. Yeah. It's a channel access or a market access that, you know, might take us out of the hospital sooner with a base that could work. Yeah. Is that fair comment? That's a very fair comment, so thank you. All right. We could keep talking for a while. Perhaps we'll take a few questions. Just let me emphasize again that I think we'll probably do something different from the norm at the AGM as well. We'll do the normal AGM, but I think I'm contemplating that we get one of our surgeons a lot, like Marcus, to talk about new products and how the products are being used and so forth. We've had him before, but we may well get Ed along as well, who runs North America. Who knows? Like a show bag. We'll see what we can do to make it a bit more interesting. Okay. I think I'm done. Max, do you wanna say anything else? Yeah. I was just going to say, and of course, part of the reason that Swami is looking at acquisitions is so that we've got some things for our chairman to work on, so that he's not creating too many show bags. Thank you. Very nice. Jan, anything you want to say about numbers? Don't wanna be wasting money on show bags, for one. Look, results are very pleasing. It's good to see how we've grown through what was a couple of years of, you know, tough conditions with COVID. With the year ahead, with, you know, not many lockdown or no lockdowns, we hope, that should give us some tailwind. Jan, anything you want to say about numbers? Don't wanna be wasting money on show bags, for one. Look, results are very pleasing. It's good to see how we've grown through what was a couple of years of, you know, tough conditions with COVID. With the year ahead, with, you know, not many lockdown or no lockdowns, we hope, that should give us some tailwinds with our growth numbers. Looking forward to FY 2023. I think they're pretty pleasing results given the circumstances over the last two years. That's right. Okay. Thank you. Swami, any final comments? No. I just want to thank Max and also thank the team of PolyNovo. It's doing incredible work. It's just not apparent, but amazing people, amazing technology. I couldn't wait to get it in the hands of more surgeons so that we're able to reach more patients. I still feel that we're just getting started. I mean, you're right, we are at a very early startup phase. How do we acquire that maturity quickly without losing our innocence and speed and agility? That's what I'm concerned about. We don't want to be too bureaucratic, and speed is going to be of essence if we have to do our job with patients. Pleased to be here. Thank you, Max, for bringing me in. For those who are interested in hearing this again, if this hasn't been too boring, there are quite a number of broker presentations coming up. I know Bell Potter is doing one, Macquarie is doing one, Bank of America is doing one. I'm sure you'll find somebody that'll let you in the door if you wanna hear it. Maybe we'll trip ourselves up and come up with a different story. Listen, while we're still here, and I don't wanna keep people too long on notice, it's already an hour and a quarter, but Jan, are there any obvious questions that we need to That's right. We've gotta hear from the analysts. I've got all the covering analysts that are dialed in and gonna ask a few questions. If the operator, if you could patch them through and we'll fire away. Thank you. Just a reminder, if you're on the phone line and would like to ask a question, please press star one on your telephone. Your first question is from Rachel Harwood with Macquarie. Please go ahead. Yeah, good afternoon. Thanks for taking my questions. First, just on sales staff. I mean, you've added a number of sales staff in the U.S. Could you maybe just talk to how long these sales staff take to ramp up? And then the proportion of those still in the ramp-up phase? Just trying to get an understanding of the conversion of sales staff to sales in FY 2023. I'll get Max or Swami to answer this, but just so you know, in 2021, we had 106 people. We've now got 152. And with respect to the U.S., just to reiterate the numbers I gave before, we got nine in the last two months, another five to come. In terms of the question about ramp up, which we debate all the time between ourselves and Ed. Max, do you wanna give a perspective on this? Yeah. Look, the simple answer is, it's quicker than it used to be, Rachel. The time to get a rep up and running will vary depending on the territory that they're going into, how many accounts they're taking over versus how many new accounts they have to acquire. That's a long-winded way of saying it's not a perfect science in terms of how long it takes. In terms of our modeling, we don't really expect a rep to be productive under six months. We expect that we're making very, very good progress by the time we hit the 12-months mark. It really is a matter of which territory they go into, how much established business is already there to ramp up. I guess the simple answer is, it's probably a six-12-month process, and a lot of our reps haven't really got through that hurdle yet. I think the interesting number is, you have an average of four. You go up to an average of, call it six or eight, and then you come back to four, and then you rebuild it. It's more the methodology behind being very systematic about how you train them, how you onboard them, and how you set the territories up so that they can grow. Yeah. The number, and I'm repeating myself, which really gives me heart, is existing accounts to be up nearly 90%. That is a great number. That shows that we're going deeper. It shows that we're getting more indications, and it shows that where we go in, people are staying with us. Yeah. One thing which I would add is also the recruitment process in terms of how we are selecting and picking our people so that they can be more productive faster. Just their sheer experience and where they come from, that process has been fine-tuned. That's why I think we are getting into a place where U.S. is becoming an execution machine for us. I should say, Rachel, that the stats are that just over 50% have been with us less than a year. Now Ed himself in the U.S. says, "Look, I can get somebody washing their face within six months." Max has got a different experience out of J&J. Leon Hoare is on the board at Smith & Nephew, got a different experience, but certainly we, you know, we're gonna be pretty disappointed if they're not more than paying for themselves by the time they get to month 12. Yeah. Understood. That's great. Just next question. How are you seeing sales in July and August? You spoke to better access for hospitals in Australia and the U.S., but how are sales going in the rest of the world? Jan, do you wanna just give us a pen and I'll sketch on that? Yeah, sure. Look, June and July and August is not closed off yet, so we do get a lot of sales in the last week of the month just due to the hospital ordering process. June and July were really strong months, butting up against that AUD 4 million threshold, which we achieved back in January. We're pretty pleased with that result and we will reach that and hit that threshold, and we've done- How are sales going in the rest of the world? Jan, do you wanna just give us a pen and I'll sketch on that? Yeah, sure. Look, June and July and August is not closed off yet, so we do get a lot of sales in the last week of the month just due to the hospital ordering process. June and July were really strong months, butting up against that AUD 4 million threshold, which we achieved back in January. We're pretty pleased with that result and we will reach that and hit that threshold, and we've done it before. We went from AUD 1 million - AUD 2 million to AUD 3 million. Now we're sort of about getting close to being consistently above AUD 4 million. Pleased with the June result and July, but August isn't quite over yet, it's looking good. Yeah. That's great. Last one for me. There was a step up in R&D costs this year. You've got a couple of clinical trials underway. How much costs are associated with those trials going forward? Before we went from AUD 1 million- AUD 2 million to AUD 3 million, now we're sort of about getting close to being consistently above AUD 4 million. Pleased with the June result and July, but August isn't quite over yet, so but it's looking good. Yep. That's great. Last one for me, just as there was a step up in R&D costs this year. You've got a couple of clinical trials underway. How much costs are associated with those trials going forward? Yeah. The increase you see in P&L there is due to the trial. We've got obviously the two trials going on, the DFU trial, which is just kicked off. We've got three patients enrolled. We've also got the pivotal trial for BARDA that gets categorized into that one item in the P&L, so that's why you're seeing the increase. But in terms of going forward, the increase you see in the P&L there is due to the trial. We've got obviously the two trials going on, the DFU trial, which is just kicked off. We've got three patients enrolled. We've also got the pivotal trial for BARDA that gets categorized into that one item in the P&L, so that's why you're seeing the increase. In terms of going forward, the DFU trial costs upwards of $2 million to run the trial. The BARDA program, as you know, is being funded to the tune of $15 million to help us fund that trial. That's great. Thanks very much. Thanks very much. Your next phone question comes from Shane Storey with Wilsons. Please go ahead. Afternoon. Yeah, afternoon. Just one clarification for me. Could you help me understand the trajectory of what you saw in the second half in the U.S.? Just clarifying what the third quarter and fourth quarter sales looks like in U.S. dollars respectively, and then actually I'll just cap it off there. Okay. Jan, do you wanna give us a- Yeah, sure. It's probably worth starting the third quarter. I thought third quarter was a lot higher than what we originally expected. We did have that first month where we exceeded AUD 4 million sales for group, but that was largely underpinned by the U.S. result. April and May were a bit softer than expected. We've experienced that with just large cases not presenting, and that was evident even with recruitment in the Actually I'll just cap it off there. Jan, do you wanna give us a? Yeah, sure. It's probably worth starting the third quarter. I thought third quarter was a lot higher than what we originally expected. We did have that first month where we exceeded AUD 4 million sales for group, but that was largely underpinned by the U.S. result. April and May were a bit softer than expected. We've experienced that with just large cases not presenting, and that was evident even with recruitment in the BARDA program. But that's since changed. We've had a strong June, as I just mentioned, and also our patient recruitment's increased in the BARDA program. One thing to also remember is we do recruit patients into BARDA into the pivotal trial. They're patients that we otherwise would've had as patients, ourselves and invoice the hospital BARDA program. That's since changed. We've had a strong June, as I just mentioned, and also our patient recruitment's increased in the BARDA program. One thing to also remember is we do recruit patients into BARDA, into the pivotal trial. They're patients that we otherwise would've had as patients, ourselves and invoice the hospital accordingly for treatment. We do miss out a little bit there, but it's planned for and we budget for that. The results overall for the half were good. We're up 23%, yeah, 23% on the first half in the U.S. We've had a really strong June and July. Great. Yeah, I just wanted to check that $6.9 million number that you called out in the third quarter was still accurate? The fourth quarter compared to the third quarter was a little bit flat in the U.S. overall, but the month of June itself was very strong. That was about- Okay. About right there. Yeah. Okay. When you look at the 55% growth in the U.S., are you able to talk about any clinical expansion that you were able to see outside burns? I just wondered whether, I mean, given your plans to hire new sales resource, whether that was something you were going to be committing some dedicated sales resources to. I guess absolutely. In terms of other indications, Shane, outside of burns, you know, that's. It's a multi-pronged approach. Burns are really important and getting into all the burn centers. There's still a few more to get into, but winning all those cases, but at the same time, you know, penetrating hospitals and getting product used for many different indications and that's increasing. We're seeing a continued smaller piece of the pie in terms of the number of large pieces sold, which are predominantly used for burns. We're seeing a larger proportion of smaller medium devices being sold, and they're always used for the other indications generally outside of burns. It's improving over time, but it's. Our reps go into every hospital targeting all, you know, all the indications where the product could be used. That is all I had. We were gonna talk about hernia, but we've all been here a while, so we might do that next time to catch up. Thanks. Thanks, Shane. Thank you. Large pieces sold, which are predominantly used for burns. We're seeing a larger proportion of smaller medium devices being sold, and they're always used for the other indications generally outside of burns. It's improving over time, but it's... Our reps go into every hospital targeting all, you know, all the indications where the product could be used. That is all I had. We were gonna talk about hernia, but we've all been here a while, so we might do that next time to catch up. Thanks. Thanks, Shane. Thank you. Your next question comes from Andrew Paine with CLSA. Please go ahead. Hi, Andrew. Thanks for taking my question. Just wanna know how you're looking with cash flow as you exit the financial year. I think earlier in the year you said you were hoping to be cash flow neutral as you exited FY 2022. Just seeing if you've achieved that. I see better sales in June probably helped. Yeah, sure. Yeah, for the second half, we're actually cash flow positive from operating activities. The June of AUD 1.2 million. The first half it was AUD - 3.2 million. So the June sales- FY 2022, just seeing if you've achieved that. I see a better sales in June probably helped. Yeah, sure. Yeah, for the second half, we're actually cash flow positive from operating activities. The June of AUD 1.2 million. The first half it was negative AUD -3.2 million. The June sales being strong did help, and July was a good month. I think if you look back over the past three years, there's a real pattern as to what we're doing: we put on more reps and invest in training them and getting them onboarded, and they start to get traction. You know, the second half always tends to be stronger than the first half as we get that tail of performance and once they're bedded in. That's happened again this time round. As we come into FY 2023, cash flow from operations is quite healthy. We also entered the AUD 6 million cash on hand, so I'm relaxed about cash as I have been on every other call. Hope that answers your question. Yeah. That's great. And just one other one. Obviously a high margin product, but you need quite a large sales force to kinda get that penetration going. I'm just trying to think, when do you start to get that real leverage going from your sales force and kinda converting that into, you know, stronger sales growth and I guess getting even margin expansion or profitability on that side? I'll go ahead, David. Feel free to jump in, anyone. I guess a really good example of the evidence of the growth, if you look at July alone, we signed up 11 accounts in the U.S., and we signed up 75 over the whole year. It globally. With the more reps on board, the pipeline we've got, we're in just over 200 hospitals now in the U.S., but there's 6,000. There's a lot of headroom to go. With the bigger team, it's just gonna be like a mushroom effect. That's what we're experiencing, and that's why you're seeing the revenue growth that you're seeing, even through challenging times. 33.8% last year for FY 2021. 47.6% this year. With a year of less impact of COVID, that's gonna be worth 10%-15% more in terms of growth rate. In terms of the reps and onboarding them and the impact you get from them, it's evident in the numbers and the account growth, and it'll continue to grow stronger, I think. The increase in revenue in the States is already dropping to the bottom line. You know, as I- You know, 10%-15% more in terms of growth rate. In terms of the reps, and onboarding them and the impact you get from them, it's evident in the numbers and the account growth, and it'll continue to grow stronger, I think. Yeah. The increase in revenue in the States is already dropping to the bottom line. You know, as I said earlier, we're already significantly profitable. As we need to add more staff it'll just be disproportionate. Yeah. I think, just to add to that, David, the growth in terms of account acquisition and the growth that we see once an account becomes an existing account, that multiplier effect is yet to come through. But our momentum in terms of account acquisition's increasing. The momentum within existing accounts is increasing. It's a very, very solid foundation, particularly that Ed's building on. Yeah. Yeah. The one thing which- That's great. I might want to add is, remember, it's a very disciplined execution, and to reach that kind of profitability gives us the trust and belief in the business model. We have reached 200+ accounts now, and the potential is 7,000. Even with this 200+ accounts is increasing. It's a very, very solid foundation, particularly that Ed's building on. Yeah. Yeah. The one thing which- That's great. I might want to add, remember, it's a very disciplined execution, and to reach that kind of profitability gives us the trust and belief in the business model. We have reached 200+ accounts now, and the potential is 7,000. Even with this 200+ accounts, we are still in operation theater. We are not in outpatient department. We just need to keep thinking about different ways in which we can access different channels, different surgeons, and different care settings. We're not even talking about home, or we're not even talking about wound clinics. It's a very disciplined execution, but it just gives me faith that if you think creatively about partnerships, alliances, we can take this business, and we can touch many more lives than what we are able to do today. Yeah. That's great. Thank you. Thank you. Channels, different surgeons, and different care settings. We're not even talking about home, or we're not even talking about wound clinics. It's a very disciplined execution, but it just gives me faith that if you think creatively about partnerships, alliances, we can take this business, and we can touch many more lives than what we are able to do today. Mm. Yeah. That's great. Thank you. Thank you. There are no further phone questions. Jan, anything. I'm sure. Yeah, quite a few actually, David. I've just been collating them while I've been on the call, so, I'm far away. Few questions here. First question being: Has there been any thought on bedding down current markets and turning the business to profit before attempting to expand further into other markets? Well, we're always thinking about that, but the U.S. is now profitable, and we've just gotta keep making it more profitable. It's a very well-known formula now, and just in terms of, you know, how many more people we need to put on to blanket the whole of the U.S. If you look at Australia, we're pretty convinced that you're seeing the same sort of markets and. Thought on bedding down current markets and turning the business to profit before attempting to expand further into other markets. Well, we're always thinking about that, but the U.S. Is now profitable, and we've just gotta keep making it more profitable. It's a very well-known formula now, and just in terms of, you know, how many more people we need to put on to blanket the whole of the U.S. If you look at Australia, we're pretty convinced that you're seeing the same sort of markets and the same sort of performance in the U.S. There are some minor differences which I won't bore everybody with at the moment in terms of the way in which medicine operates. Like, for example, podiatry. There are podiatric surgeons in the U.S that we could sell our product to, but not so much in Australia. I think we, you know, we really wanna accelerate world growth, and we don't see by, you know, employing some people, for example, in India, and setting them on a call program, that it's detracting in any way from what we're trying to do in U.K. and New Zealand and the U.S. and so forth. Great. Thanks, David. Next question. With the war in Ukraine- Podiatric surgeons in the U.S. that we could sell our product to, but not so much in Australia. I think we, you know, we really wanna accelerate world growth, and we don't see by, you know, employing some people, for example, in India, and setting them on a call program, that it's detracting in any way from what we're trying to do in U.K. and New Zealand and the U.S. and so forth. Great. Thanks, David. Next question. With the war in Ukraine, there must be many injured soldiers needing your products. Are you able to provide your products in that country? Look, it's a complicated answer and the short answer is we are supplying hospitals in the U.K. and Germany that are taking you know injured people and where there's surgeons that know how to use our product. We have had some of our U.S. KOLs in the Ukraine who took product into the Ukraine to be used. I don't know how to put this delicately, but there's a large number of surgeons in the Ukraine that can't use the product. It, it's you know for it to have enormous penetration in the U.K., we'd have to spend a lot more time than we have done in terms of training surgeons to be surgeons in a way that our product could be used. Great. Thanks, David. Next question. Are you able to provide any updates in relation to discussions around securing supply agreements with other major U.S. GPOs? Max Johnston, anything on that? Surgeons to be surgeons in a way that our product could be used. Great. Thanks, David. Next question. Are you able to provide any updates in relation to discussions around securing supply agreements with other major U.S. GPOs? Max, anything on that? We've got two that are very close to landing, and I don't think that we wanna really go into the detail of that. We are expanding in that area. I think the thing that we have to appreciate that getting it into the GPOs creates greater access. But it's really the work that our people are doing within the hospitals. Yeah. That increases the penetration and use of the product. We're getting to a point where we're getting quite happy with the access that we're creating for hospitals through the GPOs. Two significant ones we hope will land. We've got two people working specifically on that area of GPO development. Yeah. Great. Thanks, Max. Next question. Can you expand about the applications outside of burns? Do you expect this market segment to outstrip the burn- Quite happy with the access that we're creating for hospitals through the GPOs. Two significant ones we hope will land. We've got two people working specifically on that area of GPO development. Yeah. Great. Thanks, Max. Next question. Can you expand about the applications outside of burns? Do you expect this market segment to outstrip the burn segment? Oh, definitely. Well, look, I'm not sure when that question was written, but I think we spent a lot of time really talking about other uses for the product and they're expanding very quickly. Yes, the answer is that it'll be. Well, with one proviso, but the. -segment. Oh, definitely. Well, look, I'm not sure when that question was written, but I think we spent a lot of time really talking about other uses for the product, and they're expanding very quickly. Yes, the answer is that it'll be. Well, with one proviso, but the answer is that those uses will far exceed what we do in burns. Now, you know, don't underestimate it. Burns is our hero product in a way, and it's how we make our reputation, whether they be from bombings or volcanoes or whatever, fires or whatever. The rate of growth in things like diabetic foot ulcers and venous leg ulcers is enormous, so I expect that to keep growing. The one proviso I would make is that, you know, if anything, burns are diminishing in the West. Even then, some of them are to do with people trying to top themselves. Whereas in China, in Mongolia, in Indonesia, in India and a number of other countries, the number of burns is by a factor of ten compared with what you'll get in Australia and the U.S. That's because a lot of people are living in huts with fires, and they fall into them, their dresses catch fire and so forth. You get a lot more women and you get a lot more burns. As we expand to those areas, hopefully we can help those people as well. Good stuff. Great. Thanks. Thanks, David. A few more questions. Next one. Are you expecting growth in Canada to be as rapid as it has been in the U.S.? Wow. I don't know. Swami? Just because of. With fires, and they fall into them, their dresses catch fire and so forth. You get a lot more women and you get a lot more burns. As we expand to those areas, hopefully we can help those people as well. Good stuff. Great. Thanks. Thanks, David. A few more questions. Next one. Are you expecting growth in Canada to be as rapid as it has been in the U.S.? Wow. I don't know. Swami? Just because of the distributor partner that Ed has selected, I'm feeling very comfortable. If you would have told me just a distributor, I would have hesitated. The partner that we have selected, this is where I feel we can ramp up pretty quickly. I don't know how quickly, I won't comment on that, but I'm feeling very confident about it. There's two answers to it. The distributor partner that Ed has selected, I'm feeling very comfortable. If you would have told me just a distributor, I would have hesitated. The partner that we have selected, this is where I feel we can ramp up pretty quickly. I don't know how quickly, I won't comment on that, but I'm feeling very confident about it. There's two answers to it. One is that on paper, with the sales force that these people have got, which is roughly 17, and where they've come from, the pedigree of some of those people, on paper, this should ramp up very quickly. Yeah. Question always with distributors is how much air time do you get when they go to see a client? Yeah, the proof will be in the pudding, but at the moment it looks very, very attractive. Great. Thanks, David. Next question. Given where rest-of-world sales are, particularly in the EU, does this demonstrate the distributor model is not generating the level of momentum that might be achieved with a direct model? Um- I think, if I take that one. I don't think you can draw that conclusion necessarily. Using distributors is relatively new compared to us going direct into markets. We struck COVID when we first went in there. It's much easier to turn around a situation as we have in the U.K. when it's your own direct force. I think it's work in progress. Yeah. Look, I think there's a couple of things that people and we think about as well, is that when you put on a distributor, you get into the market a lot more quickly than you would if you were on your own, right? So I call it, is it a good thing or a bad thing? Because it's a sugar hit. I think it's work in progress. Yeah. Look, I think there's a couple of things that people and we think about as well, is that when you put on a distributor, you get into the market a lot more quickly than you would if you were on your own, right? I call it, is it a good thing or a bad thing? Because it's a sugar hit. You know, you put on a distributor and he gives you an order for hundreds of thousands of dollars, and you get into quite a lot of surgeries to start with. Unless you keep getting your share of space, you know, it might not work as well as being direct in the longer term. One of the things that we're mindful of is that when we're writing these agreements, we wanna try as best we can to write them in a way where if we wanna take it back, we can. When I say take it back, you know, you always do that with a normal distribution agreement where you have minimums, let's say, and they don't make the minimums, say, "Okay, bugger off, we'll do it ourselves." Here it might work the other opposite way. To the extent that the distributor is very successful, we might say, "Well, you built the market for us. Thank you very much. Why don't we kind of like going direct now?" We are trying to get the best of both worlds. Great. Thanks, David. Another question here: Is the total opportunity for PolyNovo in India comparable to the U.S., bigger or smaller? Hmm. I can take that. From a number of procedures, India will be much bigger, but from the revenue per procedure, it will be much smaller. Number of insights that we gather, we will. Tough situations that surgeons today sell in, that's where I think. Smaller. I can take that. From a number of procedures, India will be much bigger, but from the revenue per procedure, it will be much smaller. Number of insights that we gather, tough situations that surgeons today face in, that's where I think the PolyNovo technology will truly get tested and will get wider appeal and recognition across the world. That would be the value of India. In terms of revenue per procedure, it would be less by a mile. Hmm. Very good. Thanks, Swami. I've got two more questions here. Have we got the ability to scale up production to meet future demand? Well, you're as good at answering that as anyone. I suppose. No worries. Short answer, yes. What will help enormously is the unit next door to the current unit two, which we fitted out last year and it's just gone through internal qualification, and that will double the footprint and double our manufacturing capability. Short answer is yes, we're all good on that front. Yeah. Short answer, yes. What will help enormously is the unit next door to the current unit two, which we fitted out last year and it's just gone through internal qualification, and that will double the footprint and double our manufacturing capability. Short answer is yes, we're all good on that front. Yeah. I think the other thing, just to add, is this is a relatively capital-light business, and we're future-proofing ourselves consistently, and it's not a huge capital burden to do that. Yeah. No worries. Last question here, and all the other questions that I have received, thank you for sending them in, but, by the looks of it, we have actually covered throughout the presentation or through some of the other questions answered. The last question I've got: Could you comment on whether there is sufficient capital for expansion plans? There is that. Yeah. No worries. Last question here, and all the other questions that I have received, thank you for sending them in, but, by the looks of it, we have actually covered throughout the presentation or through some of the other questions answered. The last question I've got: Could you comment on whether there is sufficient capital for expansion plans? Well, I think we've sort of commented on that, you know, every time we have a meeting over the last two years. But as you can see in front of you, we've got a new boy on the block, so I've no doubt he and I and the board will be having quite a number of discussions about, you know, whether our budgets and whether our existing plans is something that might change. Now, one of them we've just heard about today, for example, is India, but, you know, best case in the world. Well, I think we've sort of commented on that, you know, every time we have a meeting over the last two years. As you can see in front of you, we've got a new boy on the block, so I've no doubt he and I and the board will be having quite a number of discussions about, you know, whether our budgets and whether our existing plans is something that might change. Now, one of them we've just heard about today, for example, is India, but, you know, best case in the world, it might take another AUD 10 million working capital. So let's see. It's a work in progress. No worries. That's pretty much all I had. A lot of the questions pretty much were answered by the looks of it, so. Okay. Well, look, everybody, thanks for coming. If you feel you didn't get your question answered, send us an email. We'll send Jan an email or one of us anyway, otherwise, we look forward to seeing you at the AGM. We are just FYI gonna run a hybrid program. The questions pretty much were answered by the looks of it, so. Okay. Well, look, everybody, thanks for coming. If you feel you didn't get your question answered, send us an email. We'll send Jan an email or one of us anyway, and otherwise, we look forward to seeing you at the AGM. We are just, FYI, gonna run a hybrid program, so we'll have an in-person face-to-face, and we'll also have it online. Given that we had 312 people on the last call, I'm imagining we're gonna probably fill both of them up. Jan, is there a location yet for the AGM? Not yet, but it's on the 28 of October. Friday the 28th, 1:00. It will be in Melbourne, and for those of you who wanna come down and see us in the flesh, we look forward to seeing you and otherwise online. Thanks for staying with us and, thanks for coming online. Thanks, everyone. Thank you.