Good afternoon, everybody. I didn't know when that video was finishing or not. Welcome jt to our announcement for FY23 results. I'm gonna introduce Swami in a moment, who's going to go through the pack that's been released to the ASX. Good afternoon, everybody. I didn't know when that video was finishing or not. Welcome just to our announcement for FY23 results. I'm gonna introduce Swami in a moment, who's going to go through the pack that's been released to the ASX. I'll probably top it at the bottom of it and top it at the top of it, it's, in a sense, more of the same.
The exciting things that have happened this , I think, are the continued growth we've got in the U.S., but the enormous growth we're seeing in Australia, New Zealand, Hong Kong, Canada, and now India as well. That's all very pleasing. Before I go on, I, I presume everybody knows what our product is. I don't, don't want to educate you on that, but everybody knows we've got a synthetic polymer. There it is, that, helps in wound closing. It's biodegradable. That has a number of interesting characteristics about it, in the sense that it's robust in the presence of infection, it's inert, it prevents and certainly restricts contraction as the wound heals, and it generates a dermis, which can then take a skin graft.
I've said before, but I'll say it again anyway, because people do get confused about us and Avita. Avita is closing the wound with a skin graft, we're building that dermis on top of it. We are a different kettle of fish. It's I, I don't need to say , how it's gone in terms of growth. It's still up around 60% per annum, and we'll continue to pursue that in the new markets we've gone into, but also with extra staff in the U.S.. The surgeons themselves, however, I mean, one of the graphs that Swami is gonna share with you, is how the surgeons themselves have done trials and done publications, and how extensive that is.
It's, when I look at the burns trials and the, and wound trials around the world now and, and the, and the big conferences, I, there seems to be multiple papers, at every conference on PolyNovo. That just reflects, I think, the fact that surgeons are not only embracing it, but as I've said in the past, they're taking it in all sorts of new directions other than burns and wounds. I'm talking about trauma, I'm talking about necrotizing fasciitis, I'm talking about diabetic foot ulcers, limb salvage now with, with amputations and so forth, oncology, burns, and spina bifida, and I'm sure some of you have heard me tell, some of that story about, spina bifida in Germany. There's many more, so I won't bore you with it.
I'll come back to what I see the future for this year in a moment. In the meantime, I'd like to introduce Swami, who's here to present the deck.
Thank you, David. Good afternoon, everybody, and thank you for joining the PolyNovo Investor Relations call. It's been a little over a year since I joined, and I'm very happy to share that PolyNovo.
Swami, who's here, to present the deck.
Thank you, David. Good afternoon, everybody, and thank you for joining the PolyNovo Investor Relations call. It's been a little over a year since I joined, and I'm very happy to share that PolyNovo, its tech, and our people, have more than lived up to my expectations, and in fact, over-delivered versus my expectations. I'm even more proud to say that the clinicians are now living up to the expectations of the tech, and probably taking it into directions that we ourselves had, were not aware of when we conceived the product. As many of you would know, this product was conceived as a high total body surface area burn product for deep dermal burns, but now it's being taken by plastic and recon surgeons across the spectrum of plastic and reconstructive surgery.
Many of the general surgeons have learned from the plastic and recon guys are taking it into their practice. Many of the ortho surgeons are recognizing how easy it is to handle, and occasionally they're taking into their practice as well. If we move to the next chart, Mel, if we can move to the next chart, and the next chart. What I am most proud to say that many clinicians today are calling us as the next generation dermal substitute, and it's not something which we have conferred upon ourselves, but it's something which we are being received with, and also BTM is being acknowledged as.
If you look at the graph on the right-hand side, there are many papers and abstracts which are being put together by clinicians as their own case series and the kind of impact that they have observed on their patients. I said these papers are being published across the spectrum of plastic and reconstructive surgery, general surgery, as well as orthopedic surgery, wherever people are seeing that impact. Due to the work which our people are doing, as well as the recognition that clinicians are conferring on us. Mel, if you could move one more chart. All I'm here to share today is the story of PolyNovo's growth. Mel, can you move one more chart, please? Thank you. Surgery, as well as orthopedic surgery, wherever people are seeing that impact.
Due to the work which our people are doing, as well as the recognition that clinicians are conferring on us. Mel, if you could move 1 more chart. All I'm here to share today is the story of PolyNovo's growth. Mel, can you move 1 more chart, please? Thank you. Today, we have grown our total number of employees. Last year, we were at 152 employees. Today, at the end of the year, we are at 218 employees. Our customers are growing. We have moved up to 638 hospitals now, and our revenue growth continues to be extremely strong. We have all-around strength in global performance. Our group revenue is AUD 66.5 million, growing at 59%.
Our commercial revenue is $59.6 million, growing at 58%, driven primarily by U.S. at about 46%, OUS, which has grown almost at 3 times the pace at 135%. Our BARDA revenue continues to be strong at $5.7 million, growing at 49%, our pivotal trial in BARDA crossed the important midpoint mark at 64 patients. Overall, all I would like to say is that it's not just our people, but I'm extremely grateful to our clinicians who are driving the PolyNovo growth story forward along with us. They are now taking us into new markets and helping us identify the hospitals, work with regulators, and work with even customers who are going to help us take our tech forward.
Throughout the year, we have gone to India, Spain, France, Hong Kong, Canada, and we are looking forward to getting into many more markets. But before we get there, let me just pass it on to Jan to take you through our financial results.
Right. Thanks, Swami. Chester, if you could move to the next slide.
Good.
The next one again. Thank you. Hi, everyone. Just touching on what Swami's already mentioned. Really strong growth, quite impressive, to be honest, at 58.8%. Total revenue coming in at AUD 66.5 million. Part of that, obviously, the go- NovoSorb global sales, coming in at 58.3% growth, and the bulk of the difference with BARDA revenue up quite significantly by 49%, coming in at AUD 5.7 million. Some of the standouts in these results, really, obviously, the US doing really well. We've, we've added, a large number of accounts for the year, where we ended the financial year at 299 accounts, and we're, we're over that now as well. We're adding new customers nearly every week.
A great result there, growing by 44.6%. The business continues to expand. Some of the standouts in, in these results, really, obviously, the U.S. doing really well. We've, we've added, a large number of accounts for the year, where we ended the financial year with 299 accounts, and we're, we're over that now as well. We're adding new customers nearly every week. A great result there, growing by 44.6%. The business continues to expand, significantly in the U.S. The rest of the world was a standout as well. As a percentage of overall revenue, it's increasing. Last year, rest of the world sales was 14% of total revenue. This year, it's, it's 22%.
We've seen great performances in Germany, up 192%, and U.K., Ireland, up 169%, which is fantastic. Canada, really strong sales this year. It's great to see that market's doing extremely well. Hong Kong and, and India with first sales as well, so getting some good traction there. BARDA, strong revenue at $5.7 million, up 49.2%, like I mentioned, is an important part of news. We've passed our midway point with the trial. 64 patients now in the trial, out of 120 being the target. That's a really important milestone. Next slide, please, Chester. Great, thank you. This is a great graph. I mean, you can see how we've expanded the business significantly. We've entered numerous geographic locations. We've expanded headcount.
We're investing in a lot of areas that we said we would during the capital raise. You can see by that graph, how much we've expanded the business, but we've minimized the loss, particularly compared to our peers, when you think about what we've achieved. That's really important, and we'll continue to do that. I guess the important thing to take away from this slide is our operating expenses are only up 48.9%, excluding non-cash items. We are starting to get that operating leverage coming in, and we could tip this business into profitability right now if we wanted to, minimize the loss, particularly compared to our peers, when you think about what we've achieved. That's really important, and we'll continue to do that.
I guess the important thing to take away from this slide is our operating expenses are only up 48.9%, excluding non-cash items. We are starting to get that operating leverage coming in, and we could tip this business into profitability right now if we wanted to. The important thing is, is to invest the capital, raising funds or raised, to invest in those areas to future-proof the company and help grow the company and accelerate all, all initiatives. As we've mentioned, we've entered new markets, Canada, Hong Kong, and India. As David mentioned in the introduction, we've expanded the indications that the product's used for, and that's been championed by our surgeons who are innovators in that space.
New products, we launched NovoSorb MTX and had first sales, and we've got more NT, 510 clearances for expansion of the MTX and BTM portfolio this year. Look out for that. Investing in R&D, really important in clinical trials. Both really important all, all initiatives. As we've mentioned, we've entered new markets, Canada, Hong Kong, and India. As Dave mentioned in the introduction, we've expanded the indications that the product's used for, and that's been championed by our surgeons who are innovators in that space. New products, we launched NovoSorb MTX, and had first sales, and we've got more NT, 510 clearances for expansion of the MTX and BTM portfolio this year. Look out for that. Investing in R&D, really important in clinical trials. Both really important areas, and, we'll continue to do that.
You know, by choice, we've had a small loss for the year of only AUD 2.3 million, excluding non-cash items, and last year it was only AUD 2 million. To grow the business the way we have and minimize losses is commendable, I think. Ending the period with AUD 46.8 million cash on hand, so well-resourced to continue to grow the business. Next slide, please. And just touching on the highlights of the P&L. We've touched on revenue already. We still enjoy a gross margin of 93%. You know, employee expenses were only up 50.9%. We do have to take into account that reversal of the share options next year on the face of the P&L, it does look different. That's the reality.
It was only 50.9%, not 84.1%. In light of where sales have grown as well, that leverage is starting to come in, because revenue is growing at a faster rate than OpEx. R&D spend up for obvious reasons and really important reasons to future-proof the company with product development, investing in clinical trials. You know, we're minimizing our corporate overhead expenses, particularly in the second half, and we'll continue to get that leverage out of admin and overhead as the business continues to grow. Overall result, net loss after tax of AUD 4.9, but excluding, non-cash items, only AUD 2.3 million. A good result all in all. I'll leave it at that, and I'll hand it back to Swami.
Thank you, Jan. As you can see, we are excited about the future. We believe we are uniquely situated to drive global impact. We have a genius tech, and surgeons love us for our simplicity and how effectively we help them take care of their patients. Surgeons are driving our innovation adoption across the spectrum into different disciplines. There are many new applications which they keep coming up with, and we are finding it hard to keep up with them. Overall, it is still an underserved market. Today, the dermal substitute market is available, or the category is available only to 800 million people, but there's 7.2 billion people who do not have access to category. That's where we believe our future would be. We will keep growing our team size.
We will keep building a global footprint. We are committed to a capital-efficient growth and scaling. We want to make sure that we deliver profit as per the schedule that we had promised to all of you. With that, I would take a pause and turn it back to David for his final comments. David, you're on mute.
Sometimes sound better like that, but, before I make some final comments, I might just open it up for questions. Jan, are you gonna run the Q&A or is Chester?
We're gonna hear from analysts first, so the operator is gonna patch them through.
All right, great.
Thank you. If you wish to ask a question via the phone, you will need to press the star key followed by the 1 on your telephone keypad. Participants are kindly reminded to consider the other analysts that will also be asking questions. As such, ideally, ask no more than 2-3 questions each. If you have more questions, please rejoin the queue. If you wish to ask a question via the webcast, please type your question in the Ask a Question box. Your first question from Liane Harrison, Bank of America. Please go ahead.
Good morning, all. Good afternoon, David, Swami, and Jan. Can I start with where you ended up in terms of exit run rates for the 2023 year? I know you called out a $7 million month in May, but if we think about that sort of cadence and going into 2024, consensus numbers of $93 million top-line revenue still assumes a, a 10% lift on that cadence. W hat are your thoughts in terms of, likelihood? Good morning, all. Good afternoon, David, Swami, and Jan. Can I start with where you ended up in terms of exit run rates for the 2023 year?
I know you called out a $7 million month in May. If we think about that sort of cadence and going into 2024, consensus numbers of $93 million top-line revenue still assumes a 10% lift on that cadence. You know, what are your thoughts in terms of, likelihood? I know you're not providing guidance, but is that within the realms of possibility and sort of mindful that there were some very strong FX tailwinds in financial 2023 as well?
Well, I'll, I'll, I'll answer that first, and if anybody else wants to jump in, fine. Leanne, you're quite right. We announced a $7 million month in May, but it was better than that because it was 7-point something, and with BARDA, it was actually over 8. We didn't announce it as 8 because we didn't know at the time there was some late accounts in and so forth. You know, it , can we keep that run rate up? Well, I think if you look at the graph-
Of what we've done in the last three or four years, it's still pretty lumpy. I mean, we keep using that term, but it's, that's the truth. So, we did, AUD 7 million-AUD 8 million, depending on how you wanna run it, whether it's sales or, or total revenue in May. You could extrapolate that out, but, that's gotta, that's gotta get higher because that's what's been happening for the last three or four years. But it's not gonna be consistent. This month it might be AUD 6. Well, I can already tell you it's more than AUD 6, but, so, but I don't know exactly how smooth that's gonna be for, for the rest of the year.
It's You would think that as we grow in the U.S. and as we grow in new markets, that it'll somehow smooth itself out. You know, when you think about where we're going, in terms of, putting on extra staff in all of these jurisdictions, but also we've just released in France and Spain, for example. You know, China and Japan are still on our radar. You know, where will we end up? Y our, your guess is as good as mine, Leanne. In fact, you're a better guesser than me. S o, I think, where we ended in May and June, is very pleasing for us.
I would just reiterate.
Thank you.
Reiterate by saying that it will be lumpy, but it will be consistently upward driven. We could have a growth of 30%, we could have a growth of 100%, and most of it would be characterized by how the business is constructed. Even today, almost 70% of our revenue comes from burns, and occasionally when there is a strong burn season, it just takes off. We're trying to smoothen it out as we start investing in other areas of opportunities in plastic and recon space. Thank you.
Mm-hmm.
Yeah.
Okay.
Again, I mean, just to embellish that, I mean, I see the analysts saying 95, 100. I've got no reason to, to disagree with that at the moment, but I just don't... I don't know, and it probably doesn't make any sense to, to guess it better than anybody else. We can, we're announcing just for interest's sake. I mean, it's, I think it's very important in a company that's growing like this, to announce when we get a new milestone, and we've sort of taken that to be a new milestone in terms of sales, like AUD 5 million a month, AUD 6 million a month, AUD 7 million a month, et cetera.
Some people criticize me for that, but, I mean, I, I think it's entirely what the shareholders want to know, but also need to know when you're growing so quickly. Your question itself is just a, a reflection of that, Leanne, that, people do wanna know what is the run rate, and we wanna know it as well, but all we see is that apart from the lumpiness, it keeps going up, and there's no reason why it should stop.
Okay. Thank you. Just a, a second question around, there was a comment in the, in the financial, with 2024, financial 2024 and beyond, where there was a, a, a sentence, which is a one-word sentence, which is profit. You know, how should we think about that? Should we expect 2024 to be a, a profit year and, and PolyNovo returning to the black, or, or is it something that we would more likely expect in 2025? How does that line up with, some of your earlier comments about continuing to invest in the growth of the team, and the geographical footprint?
Yeah. Yeah. Jan, do you wanna answer that, or I'm happy to?
Yeah, I can answer that. That's fine. We did say at the capital raising last year that we do expect FY24 to be profitable, and that is still the case. The standout year will be FY25. You know, this, this first half, again, we'll invest in the business as we have and come out strong in the second half, like we have again this year. We'll have a really strong Q4 profitable run rate at the end of next year, but a, a small profit for the full year. That's where we're expecting things to land at this stage, which is consistent with what we said at the capital raise.
Yeah. Yeah.
Okay.
I mean, the other thing I'd add to that, Leanne, is that, I wouldn't say I'm not interested in profit. Obviously, we're all interested in profit, but for me, the bigger prize is to keep expanding the geographical base, both in country, like in the U.S. and, keep increasing that sales force as quickly as we can, and also in new geographies as well, because as you can see, they grow very quickly. The other thing that happens with some of these new geographies is, and you don't see this, is that, for example, in the U.S. and Australia, our primary sales are in burns, but other things are, are increasing quite quickly. In the UK, for example, our, our primary sales are in trauma, and now we're moving, into burns.
Some of these new geographies are going to be quite interesting for us in terms of how they grow. Some of them are really unknown. I mean, one of the slides that Swami put up, for example, was how much of the world is underserviced at the moment. You know, there's big swathes of the world in India and China, rural, and Indonesia and so forth, that don't have, a product like ours. No competitors, because it's just too expensive. It's gonna be great to see, I reckon, how we go in India. We've got first sales, so that's a good sign. I think if we cut our cloth, we're gonna introduce a product to...
You know, when you look at those countries that are not, don't even have a dermal matrix, you're talking about $7 billion. I'm getting back to your question, Leanne, and that is that, as the year goes on, we can and as Jan just said, we can be profitable now if you want to. At the moment, we're saying you're gonna see it in 2024. If something great comes up, and there are some great things sort of happening in terms of new territories, but there's also some very great things happening with regulators like FDA and BARDA and so forth. Some of those things will, will change the, the trajectory of our growth in sales and BARDA in particular. There are other things as well.
Okay. Just, just one last thing around that cost structure. I n 2024, you added quite a fair number of headcount. I think it was 21 in the first half, and a bit heavier, probably around 43 in the.
Happening with regulators like FDA and BARDA and so forth. Some of those things will, will change the, the trajectory of our growth in sales and BARDA in particular. There are, there are other, other things as well.
Okay. Just, just one last thing around that cost structure. I n 2024, you added quite a fair number of headcount. I think it was 21 in the first half, and a bit heavier, probably around 43 in the second half. How should we think about that in 2024? Are you going to continue to add headcount at that sort of cadence, or are you likely to re- bear in terms of headcount in key markets?
Yeah. Well, I, I think there's 2 parts to the headcount. One is: What are we doing on the sales side?
Mm.
And, um-
Mm
I've made it pretty clear in the past that one of the great things about this company is you put on a salesman, and he or she pays for themself very quickly. We argue internally, and we argue with Ed in the U.S. about, is that 3 months? Is it 6 months? Is it 9 months? The answer is, it's all of those, because if he takes a salesman out of Integra, they might be making a profit month 1, and if he gets somebody cold, it might take him 6 months ? The short story is that that, for me, is working capital. So it's gonna pay for itself real quick. So I don't have any problems about that whatsoever.
On the other side of it, so I'm talking about non-sales rep staff and, and, and especially some of the higher level ones, like head of HR, head of tech, head of , law, et cetera. Some of the positions that we don't, at the moment have, and they're pretty expensive people, but they're not out there selling. Now, we've still working capital, so it's gonna pay for itself real quick. I don't have any problems about that whatsoever.
On the other side of it, so I'm talking about non-sales rep staff and, and, and especially some of the higher level ones, like head of HR, head of tech, head of, law, et cetera. Some of the positions that we don't, at the moment have, and they're pretty expensive people, but they're not out there selling.
Now, we've, we've still got a little bit of work to do on that. There might be another two, three, four positions. We're still sort of debating that internally. F or example, we may have an internal legal officer, before the end of the month, as, as the case may be. We're gonna add some more more heads there, but that... There won't be many heads, but they'll be expensive ones. We'll add a lot of heads in the U.S. and hopefully in, in other jurisdictions we're in, even, for example, in, in India, where we have 20 people on the ground. But I, I wouldn't be focused on those. If I was you, I'd be focused on: What are we doing to build the capital base?
What are we doing to build the building blocks that are gonna enable us to scale even further? That's the sort of.. That's the real cost as far as I'm concerned.
Okay. Thank you very much. I'll leave it there.
Thanks, Leanne.
Thank you. Your next question comes from Rachael Harwood with Macquarie. Please go ahead.
Yeah, good afternoon, David, Swami, and Jan. Thanks for taking my questions. Just firstly on gross margin, I mean, how should we think about gross margin going forward just as you expand outside of the U.S.?
Happy to answer that, Swami?
Harwood with Macquarie, please go ahead.
Yeah, good afternoon, David, Swami, and Jan. Thanks for taking my questions. Just firstly on gross margin, I mean, how should we think about gross margin going forward just as you expand outside of the U.S.?
Happy to answer that, Swami. We do enjoy a really high gross margin in the, in the U.S. market, compared to other markets. A nd we've also recently increased prices globally. We never had done so in the last four years and, and it's time to do so. That will help with, with margins. I guess as we have more sales from the rest of the world, like we indicated in the graph, we have 22% of sales rest of the world this year compared to I think it was 14% last year. That will sort of dilute the overall margin a little bit, but at the same time, the, the growth in the U.S. that's left for the taking is significant, and the margin is so great.
It won't be that dilutive even with the rest of the world growth. I expect to still to see the gross margin in the sort of 93%-95% range. And what will impact it as we move forward is just the facilities that come online. We just had unit two come online in May, and then we're carrying a little bit more manufacturing overhead, and that does have an impact. When the new facility goes live in a couple of years' time, again, it won't be fully utilized, and that will drag down the margin a little bit, but we're setting ourselves up for success. It will be in the 90s for some time yet.
Yeah, that's great. That's really helpful. Thanks. Just secondly, could we maybe just talk about your entry into the Indian market? Maybe just comment on how this is progressing and maybe expectations into FY24.
Sure, I, I can take that. In India, we have launched from the month of April. We trained our people, our reps, in the month of April. We have started trialing the product across all the 29 states that we have in India. In India, the big burns go to the public sector, and public sector works through tenders. Literally, we are writing out the tenders along with the state governments in each of the key markets. Most of those tenders would get approved over a period of the first six months. I expect that our revenue would take a sharp northwards trajectory from the Q1 of next year.
Right now, we are getting majority of our sales from the private sector and the people who are trialing this across the multiple private nursing homes and the private hospitals which dot India.
That's great. Thanks for that. Just, just last one. I think you've, you've given us an update on the chronic wound recruitment. Do you have any expectations of how long you expect this trial to ramp up and, and you'd be able to gain reimbursement?
Yeah. We are doing the trial for reimbursement, but what we have discovered in the first 25 patients and the first set that we did, was the mechanism of action of NovoSorb BTM is completely different from what clinicians are used to doing, and that's the reason why our trial would take a little longer than what we had anticipated at the beginning. Most likely, it would take another 1.5 to two years for us to completely calibrate the clinicians who are going to do the trial for us, and then who are going to apply it and enroll the patients on our behalf. It will take longer than what we had anticipated, but we are pretty sure that eventually we'll win with the trials.
Understood. Thanks for that.
Rachel, can I just, just emphasize a little bit of that and perhaps demonstrate my lack of education in mathematics, from Boronia High School, and, and that is this: if you imagine our company as having a cost of sales, it doesn't matter what it is. Let's say it's $40 to make a bit of 10 by 10, and we're selling it for $900. We might have a margin of 95%. Now, when we tell you we might go... We are going into India, obviously, but we might go into Indonesia or China or something like that. Let's say we decided, and we haven't decided yet, but let's say we just decided to sell it for $450 instead of $900 or $950, which is what we sell it for at the moment.
You know, well, guess what? The margin's still over 80%. I mean, it's still better, and that's why I think we can dollars, but make a bit of 10 by 10, and we're selling it for $900. We might have a margin of 95%. Now, when we tell you we might go-- we are going into India, obviously, but we might go into Indonesia or China or something like that. Let's say we decided, and we haven't decided yet, but let's say we just decided to sell it for $450 instead of $900 or $950, which is what we sell it for at the moment. W ell, guess what? The margin's still over 80%.
I mean, it's still better, that's why I think we can add to people who are underserviced at the moment in poorer, developing countries. We can add a product where it's still profitable for us, we can do a good public service and social good by introducing something that they don't already have at the moment. I think that's, you know, that's the most important thing, and I, I think Swami and Jan have probably already captured this. The other thing is that, you know, as we get more and more into, let's say, diabetic foot ulcers, I had somebody on, on the phone this morning talking about whether it could be used as a filler in nasal problems.
You know, I've got some feedback from our guys already saying, "Yep, that could be done." Well, you know, they're, they're small pieces. You know, spina bifida in an unborn baby could be as big as your little nail on your, on your tiny finger. You know, so, you know, so trying to get the price off those, that you'll get off a burn where you might be trying to cover your whole arm is, is another thing.
For me, it just adds, it adds to the, the versatility of the product, just adds to the revenue. You know, we're gonna get to a situation where a lot of our salespeople are selling, you know, down that, "You know, I'm selling something to burns, I'm selling something to trauma, I'm selling something else to oncologists." For me, it just adds to the richness.
Understood. Thanks for that, David.
Thank you. Your next question comes from Madeline Williams with Wilson. Please go ahead.
Hi. Good, good afternoon. Sorry, I hope you can hear me. I just wanted to ask maybe Swami and Jan, just a question in regards to the US growth and just wanting to know, you know, sort of your perspective of how that's sort of coming through. Obviously, you've added, added a lot of US sales reps, and just understanding, is that growth coming from the new account additions, and are you seeing sort of that inter-account growth now coming through? Whether or not you're getting sort of the benefits from the Integra recall. If I can just add to that, just a comment that was just made in regards to pricing.
We sort of had in our head that, you know, maybe there was essentially a fifth of the pricing of some of the competitors, and has that pricing uplift come from, from the recall?
Jan, you go first, and I can top up.
Sure. I think the first part of the question was on, additional hires and so forth and, and, and where we see the growth going. We, we did get a lot of the planned hires, 28, in fact, that we hired since the capital raise in the US, which is what we said we would do, and that was on top of some hires, U.S. sales rep hires earlier in that FY23 financial year. The year ahead, there'll, there'll still be a few more, but we've got a pretty established team of about 70 in the sales team over there, including sales management and so forth. We are seeing, I guess, orders growing at a faster rate than what revenue is.
That means that, you know, the hospitals are reordering more. We're also, expanding, you know, where the product's being used.
You're, moving, you know, across from burns into trauma and smaller indications, and that's, that's reflected in the high order numbers and the, and the repetition of orders, coming through as well. That will continue and, and, and, outside the burns business, that part of the business will continue to grow even at a faster rate. We are seeing the, you know, accounts, that penetration occurring, particularly within groups of hospitals and so forth. And the, the longer the reps have been with us, they're, they're just getting, I guess, more coverage across their customer base, and getting that penetration as well. It's, it's evolving as we, we hoped it always would, and it will continue to evolve and improve even, even further in terms of penetration, increasing orders and, and overall sales.
I think your next question was on pricing. The pricing increase we put through was a strategic decision, not related to the recall of Integra. That was something we've decided to do after four years of promising, no price rises, and we went through COVID and so forth. Now was the time to do it, given the inflationary pressures, and we lived up to our promises with our customers, and we've gone and implemented that. It's been well received, but not related to Integra's recall. Did I answer all your questions, Madeline? I'm not sure if I.
Yep, yep. No, thank you. Just in regards to the Integra recall, just, did you see sort of any benefits in sort of the back half of the year, or?
Madeline, the Integra product, which was recalled, was PriMatrix. We are already well ahead of PriMatrix in the burns space as well as in the trauma space. We saw a little bit of bump, but I would not attribute too much to it. Again, if I were to square off all your questions, we are growing in existing account with existing surgeons. We are growing in existing account with PriMatrix in the burns space as well as in the trauma space. We saw a little bit of bump, but I would not attribute too much to it. Again, if I were to square off all your questions, we are growing in existing account with existing surgeons. We are growing in existing account with new surgeons, and we are getting into new accounts as well.
We are seeing growth all over from U.S. and we expect U.S. to be a growth driver for us even in 2024.
Okay. Thank you. That's very helpful. The only other question that I had was just in regards to the mention of the new sort of product in regards to hernia and breast. That's obviously sort of been put on the back burner for the last year or so, and just wanting to know sort of where they're at and what your expectations are for the year ahead.
We continue to have a program which is going on, and it will take more time to develop and bring the product to the market. We continue to invest in hernia, we are continue to look at breast, but that will take more time versus what we had promised before.
Okay, the, the product is finalized for hernia or, or not at that stage yet?
We are at the stage where we are doing through multiple iterations. We're testing those.
Okay. Thank you. That's very helpful. That's all for me.
Thank you, Madeline. To develop and bring the product to the market, we continue to invest in hernia. We are continue to look at breast, that will take more time versus what we had promised before.
Okay, the, the product is finalized for hernia or, or not at that stage yet?
We are at the stage where we are doing through multiple iterations. We're testing those.
Okay. Thank you. That's very helpful. That's all for me.
Thank you, Madeline.
Thank you. There are no further phone questions at this time. I'll now hand the conference over to Jan Gielen to address the webcast questions.
Great, thank you. There's a quite a few questions. Some have already been answered, so if I haven't answered your question specifically, that is why. Is, economies of scale, and that's starting to come through, and we continue to work on that. To answer your question, it's yes. Moving on to the next one, we have another question about the recall. What impact, if any, are you seeing in the U.S. following the Integra product recall, from the Boston facility earlier this year, including SurgiMend?
We do not have a product which competes with SurgiMend. SurgiMend goes into the breast, space, but we do have products which go for PriMatrix. There is some degree of help which we have got in the space of trauma and to an extent in burns, but not a lot.
Thanks, Swami. Next question. How is sales tracking this quarter so far?
We continue to do better than expectations, the breast space, but we do have products which go for PriMatrix. There is some degree of help which we have got in the space of trauma and to an extent in burns, but not a lot.
Thanks, Swami. Next question. How is sales tracking this quarter so far?
We, we, we continue to do better than expectations. It's been a dry spell in major part of the Western Hemisphere. We are seeing more burns than what we would have normally seen. It's an extremely good start to the year, but it will be lumpy. We are not going to lay too much of effort at that. We're just interested in serving the patients and the demand as it comes through.
Thanks, Swami.
The only thing I'd add to that is, doesn't give you much information, but in July, which is the only complete month, we have made or just done better than budget. If you go back to Leon's question about run rates and so forth, we're pretty happy with where we are at the moment, but, one spring doesn't make a swallow. We're, we're, we're happy. The, all of the signs, as I said previously, with respect to new geographies and new staff, are, are heading in the right direction.
All right. Thanks, David. Where do you see the most significant opportunities outside the U.S. over the next few years? What headwinds, if any, looking to overcome?
I see us getting a lot of help from Europe, in the way European surgeons are using us in many more innovative ways, whether it is in craniomaxillofacial surgery, in cancer excisions. Many European surgeons are taking more liberties with BTM and how it performs when it comes to flaps. Because especially in U.K., you can see significant pressure on the entire health system, with some degree of nurses and doctors going on strike. Surgeons are looking for simple solutions, and NovoSorb to them provides a very simple solution, and they can up shift and down shift. I was quite impressed to run into a term by a British surgeon. He called NovoSorb as providing him the reconstructive elevator options. He can use it as a dermal substitute.
He can use it also in case of flaps, where he doesn't have the experienced staff to support him in the microsurgical procedures that he would have needed in the past. We are providing many more options to surgeons in terms of the sheer versatility of the tool. We expect to see a lot more literature come through from European surgeons as they continue to grapple with some degree of constraints in the health system there. I do not see too many headwinds as of now, just given where we are in our journey and our maturity, and as long as we continue to be humble and keep learning and listening to surgeons, and keep involving them in how we want to progress our business, I see tremendous upside for PolyNovo and NovoSorb BTM going forward.
Thanks, Swami. Regards to the BARDA, BARDA trial, when do we think the trial will be completed, the recruitment? What does it mean for our business model once the trial is completed?
The trial so far in U.S., we used to get 2.4 patients per month, but there have been months when we have suddenly got 4 or 5 patients. What is exciting is...
NovoSorb BTM going forward.
Thanks, Swami. Regards to the BARDA, BARDA trial, when do we think the trial will be completed, the recruitment? What does it mean for our business model once the trial is completed?
The trial so far in U.S., we used to get 2.4 patients per month. There have been months when we have suddenly got 4 or 5 patients. What is exciting is the FDA approval for us to take the trial to India. With that, we hope that we are able to accelerate the trial significantly, as well as get a cohort of 30 odd patients from India. Our ideal aspiration is to complete the trial by this year. If I were to give you a timescale, it would go into the Q1 of next year. We are really hoping that we are able to complete the BARDA trial by fiscal 2024.
The share market didn't appreciate today's results, announced. What's the near-term milestone for PolyNovo? There's a number, isn't there, really? Happy to go answer that, Swami, but kick it off. We've kind of covered them, I guess so. You know, this year will be a really important year. We'll continue to grow at a very strong rate and get penetration in all our geographic locations that we've recently entered. We've already demonstrated that this year. We've talked about profit, and what we're gonna live up to that, is what we said at the capital raise as being an important milestone. We recently passed, just the midway point of the BARDA trial, and that's why Swami just touched on that, and that's really important as the rate of recruitment is increasing.
Getting that recruitment finished is a really important milestone as well. Continuing just to build on what we've been doing, and expanding the current portfolio of BTM and MTX. Expect to see more 510(k) clearances this year for expanded range of those products. Quite a number of milestones, and we hope that adds value, and I'm sure it will. Mm-hmm.
Well, I mean, the, the short sellers look like they've gone. I mean, there was still about 2% or something, but there doesn't seem to be much action there, and I don't expect them to come back. H ow can I explain it? I can't explain it, and frankly, as much as I've got a lot of shares and I'd like everybody else to, to be higher, there isn't a, there isn't a silver bullet on this in terms of how you value these types of companies. It's not like, we're making fizzy drinks, and you could point to 20 other people and tell you what the EBITDA model is or what the revenue model is. You know, we're doing everything right with, 1 step in front of the other, and, I'm pretty happy.
Share price aside, pretty happy about the way in which we're going.
Great. Thanks, David.
Firstly, about the Maui Fire, most of them were inhalation injuries, and then the people who were impacted unfortunately passed away. There was no real demand for the deep dermal burn insults that we see. With regard to the BARDA stockpile, right now we are focused with BARDA on making sure that we keep our part of the deal. That is, making sure that the enrollments get done, and we try and drive-
Can you detail how Europe and the U.K. are performing?
Yeah. UK has, I think Jan read out the result. If it, was it 190% growth you mentioned?
Yeah, Germany, 192% growth, and UK, 169%.
Yeah. Both UK and Germany are doing quite well, and in fact, in the U.K. as well as in Germany, we are now the market leaders in the dermal substitute market. When it comes to Germany, we get real data from the government in terms of the number of square millimeter or square centimeters of the product used. We have got a 56% market share in the last fiscal year, the last full year. We're very happy to declare the market leadership in Germany, and likewise, in the U.K., we are now number 1 at close to 45% market share in U.K. We'll continue to keep growing the market, because now the job for us in the dermal substitute market.
When it comes to Germany, we get real data from the government in terms of the number of square millimeter or square centimeters of the product used. We have got a 56% market share in the last fiscal year, the last full year. We're very happy to declare the market leadership in Germany, and likewise, in the U.K., we are now number one at close to 45% market share in U.K. We'll continue to keep growing the market, because now the job for us in European market is not to take share away, but to find out ways of growing the market for us.
Great. Thanks, Swami. Do we expect to complete another capital raise anytime in the near future?
No.
Easy one. back onto Integra recall as well. Has this changed the clinician sentiment toward, or regarding biologic, medical devices versus synthetics, and has it opened doors for our sales team?
Yeah.
All, all I would say is, clinicians are already adopting us in droves, so I would not say that this particular incident has changed the clinician attitudes towards us. As someone asked before, we today do not have a CPT code, and we are not reimbursed by majority of the systems. As we get the Premarket Approval for burns, along with the other deep dermal insults, I would see our own adoption curve go up even more dramatically. I'm not necessarily attributing our adoption to the Integra recall. I think people are adopting us because they see that we are a very robust tool in their hands, and we are extremely versatile, and they are in control. It's a very simple device which acts simply and which reduces the burden on the operation theater environment, including the circulating nurses.
Those are the reasons why our adoption curve is going up versus the recall.
Great. Thanks, Swami. We've still a couple more to go. What is our China strategy? How do we plan on penetrating that market? Will we use a partner?
Yeah, we will use a partner in China. We are working on the regulatory strategy versus the recall.
Great. Thanks, Swami. We've still a couple more to go. What is our China strategy? How do we plan on penetrating that market? Will we use a partner?
Yeah, we will use a partner in China. We are working on the regulatory strategy for China as well as Japan. In terms of our regulatory strategy, we are probably closer in Japan than we are in China, but those two are-
Thanks. Thanks, Swami. One comment just about our share price, are we prone to a takeover bid?
Please, God.
No.
It's a market. Anybody can come at any time, I said it recently, even with the share price down a little bit today, it's a big bite for somebody. D on't think one of the things I would say to shareholders and the analysts is, "Go have a look at the market. Go and have a look at our competitors, and have a look." The reason I-I'm not saying that to bag anybody, but rather they haven't got the wherewithal to keep going with other capital raisings, let alone make a play for somebody like us. Even for somebody like an Integra, even though it's quite profitable, there are other products than those that sort of compete with us. It's also...
It, it, it could be a problem for them, where you're going to a surgeon and you're selling a biologic, and you're selling a. It's like selling VWs and Mercedes-Benz at the same. You all know as well as I do that it's likely to be another big pharma company that wants a new silo for their business, and not necessarily in the business at the moment. Listen, all, all we want to do is keep one baby step in front of the other, keep the sales going, get into new geographies, and that'll be. That's all we can do.
Thanks, David. Another question here: Do we plan to expand our European, European operations in that?
listen, all we want to do is keep-... one baby step in front of the other, keep the sales going, get into new geographies, and That's all we can do.
Thanks, David. Another question here: Do we plan to expand our European, European operations and add more sales staff and so forth?
Yeah.
Yeah, we are looking at how we can keep expanding our momentum in Europe. We have got the top 2 geographies covered. We are working with distributors in the next 3 geographies. We're looking at what other options could we have to make sure that we are able to have a better impact than what we are able to do with distributors there.
Great. Thank you, Swami. Just a question here. Avita's product has been approved for full-thickness skin defects. Does this application extension make it a direct competitor to PolyNovo in some areas?
Avita always has been a complementary product to us, but surgeons look at us as the primary product to rebuild the dermis, and then they have an option of using a split-thickness skin graft, or they can use an Avita product. It does not necessarily compete, but that's the clinician's view that I'm sharing with you. There could be someone else who could be thinking differently. I would not know.
Yeah
Thanks.
What's more, I don't think Avita is thinking that way either.
Yeah.
Thank you. You are expanding your facilities to service AUD 500+ million revenue with the new facility build versus current capacity of AUD 100 million. Why are you expanding capacity so significantly? Do you expect to fill that capacity in the medium term?
Yeah, of course. I mean-
Yeah.
It's not cargo cult theory. We're not building a port in Papua New Guinea and hoping the ships come. We're building it because growth is so strong and there's so many markets that we're not yet servicing, so we don't wanna get caught short.
Yeah.
Leads into the next question. Would there be a need for a manufacturing facility in Europe or, or the U.S.?
Well, not in the immediate term, but, it's, it's possible that sometime in the future we might want to put something up in the US or in Ireland or somewhere like that. At the moment, we've got a few years of runway in front of us, even at a growth rate of 60% plus year-over-year.
Thank you. A couple more to go, and we're coming up on the hour, so we'll get through these. What are we doing in terms of monitoring distributors versus the opportunity to go direct in, in markets in Europe and, and so forth?
We constantly keep reviewing our business with distributors, and as long as distributors or sales agents keep driving the impact that we want them to have, we will continue to support them. There are times when the business direction could diverge. Those are the times that we would want to take control back of our business from distributors and then invest in building the business ourselves.
Swami, question on Ukraine and Russia, would it be beneficial for PolyNovo to give both Ukraine and Russia some product as a humanitarian gesture, as it may pay dividends in the future after all?
We, we support the clinicians who actually go there with training and with the product, but we normally don't want to give the product away because it will be a travesty if it does not get used appropriately. There is a difference between how our product gets used versus the predicates, and that's the reason why we insist on training and making sure that the clinician is always available to support the clinicians who are going to use the product in Ukraine.
I mean, just on that, not for general distribution, as I say, this was 300 people on the call, I have a message from the Ukrainian ambassador this morning, and he and I have been having some discussions over the last week about the Ukraine. I, I should emphasize what Swami just said, is that nobody's talking to us about gifting. There are certain companies and governments and so forth that are thinking about, how relevant we are. It's those who... Them who approached us, not the other way around, and we would be delighted to help. I mean, we already are helping, by the way, for airlifted people that have got trauma and they've been airlifted into the U.K. or into Germany.
We know we're getting used there, but we'd be delighted to help in the Ukraine itself. There's some, there's some green shoots. Let's see.
Thanks, David. Just two more questions left. Can you provide more explanation around the comment that burns demand is seasonal?
Yeah. Different geographies in the world have different seasonality to burns, and, it's the summer season and barbecue season in U.S. Similarly, I've heard different stories in different parts of the world, and that's the reason why we say that burns are seasonal. They're not necessarily all year round. Trauma continues to be all year round. And that's how we are trying to build our portfolio of indications as we keep moving forward, into the future. Our birth was in burns, but our future would be everywhere, wherever the surgeons want to take us. We're just grateful for how they are innovating on our behalf and using the product to solve many clinical issue, issues that we, we did not even think about.
Mm-hmm.
Look, I think the other thing is that we're going to see very different evidence coming out of some of the countries like India and rural China and India and so forth, where there's a lot of people who are living in flats or not so much flats, but huts that have got a fire in them. You know, there's a lot of women and children who fall in those fires. Their sari catches catches fire or whatever. Well, I think we're gonna see a very different complexion of cases coming out of out of, say, India or China than we see in North America, where burns are. And Australia, where burns are largely men and industrial. I think it's gonna be quite exciting. Well, exciting.
I mean, I think we're gonna be able to provide, a fantastic product for women and children in particular, at, at the right price.
Great. Thanks, David. Just one last question. How's the diabetic foot ulcer trial going in the U.S.?
Yeah.
Which we just shared at the beginning, we have close to 25 patients that we have already completed. While we completed 25 patients, we realized that the protocol which was followed for these patients was not in line with the mechanism of action that we want for our product. That's the reason why we are rewriting the protocol and recalibrating the clinicians who will be working with us into the DFU trial. It might take a little bit longer, but based on everything that we've seen across the world, we have got an exciting product for DFU as well. We want to make sure that we do it right, even in U.S.
Yeah. Yeah.
The protocol which was followed for these patients, was not in line with the mechanism of action that we want for our product. That's the reason why we are rewriting the protocol and recalibrating the clinicians who will be working with us into the DFU trial. It might take a little bit longer. Based on everything that we've seen across the world, we have got an exciting product for DFU as well. We want to make sure that we do it right even in U.S.
Yeah, yeah.
Great. Thanks, David, Swami. That's all the, all the questions we've got online. It's on the hour as well.
Listen, thank you all for attending. A couple of things. What can you expect to see in 2024? In my answers early on, that's $7 million month, $8 million month, 7, 8, depending on how you count it in May. We don't think it's a one-off. We see our, our average, revenue and our average sales just continuing to increase the way they have been done for the last four years. What you'll see therefore, in 2024 is us, reaching profitability, or not, if we chose to, to pursue something other that, that was very prospective. You're gonna see a lot more staff, not only in the U.S., but wherever else.
You're gonna see us entering new geographies, not just France and Spain, but about some other things in Western Europe and perhaps China and Japan. That would be very exciting. I think we're going to see. We, we think ourselves that we're gonna see some pretty interesting regulatory decisions in our favor, which might cause BARDA to, y act more quickly than, what you might think. I think people like BARDA signing off will be, a great thing for us. So I think there's, there's a lot to, to be looking for, I think in. We're still gonna get support from surgeons. Y ou can't go to a conference now without seeing those papers and trials and drafts and so forth.
For those of you who are on my email list, you, I'm sending a few of them around as they come through. There was another one out of the U.K. yesterday, so enjoy those. J ust in, in behalf of all the board and the management, yeah, thank you for giving us your support. You may be interested, but we're one of the most attended AGMs, in, in the top 200. Some people really are interested in this. In particular, I'd like to make a shout-out, just to add a little bit of levity to it, to the Qantas cabin staff, because I don't know what it is, but every time I'm on a plane, I'm getting accosted by ladies who all seem to have shares in PolyNovo and recognize me.
I'd like to, like to say to them, "Thanks for being on board, but, you could upgrade me every now and again," is what I would say ? Look, I think the, the year ahead looks great, and pretty happy about it. Thank you all for coming, and we've, we've got some ideas for how the AGM might run as well. I know you, that in the last couple of years we've had one or two staff members from either US or here or a surgeon. We, we plan to do that again, and give you a much deeper insight, I think, into how people are using the product and how they think about it. Thank you very much.
Thanks, everyone.
Thank you.
That does conclude our conference for today. Thank you for participating. You may now disconnect.