Good morning, everybody, and welcome to the PolyNovo Webinar.
This conference is now being recorded.
The genesis of this was really our nine-month results and end-of-March results that we gave to the market. At that time, we as a board thought we need to just step up the comms a bit, the communications a bit. I think we announced at the same time that we'd do a webinar to explain the results sometime soon. This is sometime soon. Since we did that, there's been a number of updates. There was a presentation made in Macquarie Bank last week, and that was put up onto the ASX and one to Bell Potter. I don't think that went up on the ASX, but it was pretty much the same as went up to Macquarie Bank and in our nine-month results.
Thinking about this from a shareholder's perspective, what we want to bring you more regularly, I think, is just an update on things that we think are key to the business, but things that we also see on social media that we know you think are key to the business, whether they're right or not. I don't propose to use this to go through the results that are already on the screen from Macquarie Bank or our nine-month results. Jan, who's on our screen, the CFO, has updated this morning a couple of slides that we chose not to use today, but we'll just take it as being read. They replicate pretty much what was done last week, in any case. They show what the nine-month results showed, which is we're still traveling along, powering along.
The U.S. was up for the March 90%, but year-to-date was up 30%+ . The world, the group, was up 70% in March, March- on- March, and up again over 30% for the rest of the year. I am always a bit bemused by people who think it is so urgent to know how April is tracking, because if you look at the graphs, for example, that are in the release that we made this morning and the previous two releases, where we are sort of just reporting our monthly growth in the last four years, we have gone from AUD 4 million a month in 2022 to AUD 11.9 million this year already. The growth is one way. Just as advice to people, do not think every month is going to somehow have some surprise, show some sort of great downturn.
We're powering along, and we're taking new accounts, and we're getting new research done, and we're increasing sales everywhere. Just put that in context. Do not think also about this as a comprehensive view of the company. We're going to pick out half a dozen things that we think are interesting or that people have not understood to better understand the business. I'll just go through what they are. I think I do not really want to talk too much about the financials so far, but the thing that seems to still have people a little bit worried is our capital adequacy and our cash. Partly that's our fault because we let our—well, we did not let; we had somebody else doing our debtors. We let those debtors blow out. They've all come back in now, and they'll continue to come in.
I'm going to get Jan in a moment just to talk about our capital adequacy, our cash, and not only what our cash was at March, but what it's going to be at the end of June as best he knows it. I think also we can't get away from the fact that the U.S. is still our engine room. We don't think it necessarily needs to be the biggest market in the world as we go on, and I'll say more about that later. We're going to talk a little bit about the U.S., and Robyn and I'll discuss that. We had hoped to have our head of the U.S. on, but he's flying at the moment. Robyn and I'll carry that. I've got Raghu on the phone, who runs India. Welcome, Raghu.
I'm going to talk a little bit about India because I think people are interested in things like how can people pay for it in India? Who's paying for it in India? How are we winning tenders, and what does all that really mean? Again, not a comprehensive view of India, but I just want to give you the key messages. Finally, I think the elephant in the room is the Betacell presentation that was given in Copenhagen a couple of days ago. I'm going to have Professor Toby Coates on the line from Europe. I think just reading social media, people have this incorrect view about how long this is going to take to come to market. We don't know exactly, but it's a lot quicker than most people think.
I think the other thing that people are not seeing is that this is likely to be a platform technology that would be of interest to all cell owners or wanting a delivery mechanism. We will come to that anyway because I had a discussion about that recently with Novo Nordisk, who have got Ozempic. It is really very interesting. It is the elephant in the room as far as I am concerned. Why do we not get started? Let's start assuming you have read a couple of pages that are up this morning. Read them at your leisure, but if you have looked at the last two releases, there is nothing much new there. Jan is our CFO, and I just want to talk about cash because there is a view that we need to raise cash.
Can you just give us a potted history about where we are, where we're in March, where we'd likely be in June, perhaps a small explanation about how we got to where we are and how the cash is going to adjust? In that context, also, how much we've still got to spend on the factory, which will be finished very shortly.
Sure, no worries, David. I'll just start off by—just want to make sure as well my message is received loud and clear because cash is fine. Data collection in the U.S., it's improved dramatically, as well as cash- flow from operations in the U.S. and for the group, as I said it would when I presented the results back in February. The U.S. data is outstanding. It's fallen significantly and continues to do so, David, at a really fast- rate. Cash- flow from operations for the group is positive for the second half, and we're working really hard towards achieving a positive result for the full year, which is likely. Our forecast cash on hand at 30 June 2025 is actually AUD 28.5 million. This is after spending AUD 17.2 million on the facility so far this year.
When we get to June 2025, the remaining CapEx is only AUD 8.5 million. We're in a good spot there. We're well funded, and we've explained that before, but the U.S. debtors is a significant improvement. The cash on hand is lifted. I did a calculation back in March in the March release, adjusted cash flow, and I just want to run through that again and what that looks like. If we subtract the remaining committed CapEx of AUD 8.5 million that will be paid in FY 2026 as the facility's completed leading up to Christmas, and then add back any overdue debtors as of 30 June 2025, our adjusted cash on hand would be AUD 25.9 million. I reported the same calculation back in March, where the adjusted cash was AUD 21.8 million. It's going up.
I just want to make myself clear we do not need to raise capital for working capital or for CapEx requirements. We are fine. The business is profitable, growing. Cash- flow from operations has turned around in the second half. We are looking forward to sort of closing out the year with a strong May and June. Historically, May and June are very strong months. We have had some great results in April as well. We have had record sales of AUD 880,000 for MTX in the U.S. in April. Well done to—
You're taking Robyn's thunder, by the way.
Yeah, I'm sorry. That's okay.
A couple of hundred grand in sales, record sales in India as well. Sorry, Raghu, stole your thunder there too. We are in a really good spot. We have over 700 customers signed up now in the U.S. We reported the growth, the sales performance growth in the March update and again at the Macquarie Conference. Looking forward to closing out the year with strong growth, positive cash- flow from operations, and increasing profitability. We feel we are on track.
Jan, to people who had been reading our accounts, there's an issue that might have been us self-inflicted, which is that we had outsourced our invoicing, and the people doing the outsourcing hadn't kept up- to- date with addresses and invoices and such. We had a blowout in our debtors, which I might be crude about this, but I think from my looking at it, it went from 56 days outstanding to 92 days. We've now brought that back inside, right? You're working on getting that back around. What do you think your debtor days are now, roughly?
Down to 70 days now. They did peak around 92 days around sort of Christmas and January period. We are really hard at reducing that. We want to get back down around 55 by 30 June, where it has been in the past. The issue is we use a 3PL in all our markets to distribute our stocks, store it, and also invoice customers and collect payment. We brought the data collection part in-house from our 3PL in the U.S. because we were not satisfied at the time. We soon discovered as well that the master data they were updating was not up- to- date. Invoices were going off into the abyss. We quickly fixed that, threw some temporary resources at it, and we have collected a lot of that cash. I am relaxed about it, and it is heading in the right direction.
It's just a temporary blip. It's unfortunate, but we're on top of it now, and it won't happen again, which is good.
When I say it was partly self-inflicted, we let that get out, but now a lot of the cash is coming back in that you're expecting will be there at the end of June. It's already in the can, and we had a record collections month last month. One other question for you, which I think people need to appreciate, is just tell us what the level of bad debts we've had this year are or any year for that matter.
We never have, except we have provided for one very small bad debt in the current year, just a small hospital in the U.S. It's insignificant and immaterial, to be honest. Over the seven years I've been here, we've never had to write off a bad debt. The hospitals always pay.
Yeah. I just want shareholders to appreciate that because when you're selling to Harvard or Mayo or UCLA, these people pay. We might want them to pay in 30 days, and they pay 60. So what? We're dealing with the blue chips that they're going to pay. I should say, Jan, I'd be interested in your—you and I haven't talked about this, but as we broaden our base in the U.S. into small plastic surgeries and podiatrists and things like that, I'm imagining that we're going to have to be a lot more careful with our data collection and credit.
Absolutely. It is just a matter of utilizing the ERP system for its functionality and also making sure that the master data is always up- to- date, just having the relevant resources to collect on cash. We have had some learnings, and we will apply that to the business as the business grows and the customer base grows.
Yeah. Yeah. Okay. Just as an aside from what you're talking about, the AUD 8 million that we—well, between now and the end of June, we're probably going to spend another AUD 3 million-AUD 4 million, aren't we, on the new factory, and then there's still AUD 8 million to be done in the second half of the calendar year. That's all on track, is it, as far as you're concerned?
Absolutely. The building's on track. There have been really no variations either. They have been fantastic builders. In terms of the milestone payments, it is all in line with what we originally agreed to. It has been quite a seamless process, to be quite honest.
Yeah. Yeah. And just to remind shareholders, not that I necessarily wanted to go here, but that factory is going to give us capacity for another AUD 500 million worth of turnover. We've still got the other two plants next door in a separate building, so risk-adjusted for us, I think. In the context of a company that's turning over, let's say, AUD 140 million, we've got capacity coming out of our yin- yang. I think that's another thing just to remind shareholders about. Okay. Enough. I'm going off a number of tangents here. Jan, thank you for that. I would like to introduce everyone. I don't think anybody's met you before, Raghu, because we had Shantri on last time, but we've got Raghu, who runs India, and talk to him a little bit about what's happening there.
Raghu, it is a happy day because you have had a good month. You had a record month last month. Just for shareholders, what was that record month?
Sure. Thank you, Mr. Williams, and good morning to everyone. My name is Raghu Shenoy, and as Mr. Williams mentioned, I head the India business. Yes, we did have a record sales month in April, which we had been chasing for the last two years. We achieved sales of AUD 201,000 in April. This was possible primarily due to three big government tender orders that we received for which we had been working for almost one and a half years. They finally came into the bag. The second thing is the run rate that we are looking at now, sales have actually doubled in the second half between January to April vis-à-vis H1, the first half. We expect that the growth will continue in the same manner in the months to come. Looking forward to those sales as well. Yeah.
Am I too crude if I said you're doing AUD 200,000 in April? We're roughly at a run rate of AUD 2 million for the year.
That's right. That's right. That's the target that we have, and we are working towards that, and it's all heading in the right direction.
That's fantastic. Raghu, we all know that India is a tender economy. In the past, we've given our shareholders some light and color on how many tenders there are. Just tell us how many tenders you're heading for at the moment. How many tenders are there? Let's do this waterfall. How many tenders are in India? How many tenders are we going for, and how many have we won?
Sure. Sure. Yes. When I look at the Burns market, the Burns patients are primarily treated in all the public hospitals. Most of the public hospitals procure anything that they want for surgery through tenders, which have a validity of either one year, two years, or three years. The only challenge is that they take a lot of time because it's politically driven and funding comes from the government. That's the reason they take a lot of time to finalize. We are talking about almost close to 200 tenders in India across the entire healthcare landscape. For PolyNovo, when we started in April 2023, and it's exactly two- years now, in these two- years, we've been working on 62 major tenders across the whole country, the whole of India.
This is a mix of local purchase, annual tender, and then the current government has got something called the government e-marketplace or GEM, as we call it. GEM is something like an Amazon for procurement of medical devices. We have some tenders on GEM as well. A mix of all this. Out of the 62 tenders that we've been pursuing for the last two- years, we have 25 in the bag already. The balance, we are pursuing very hot. I mean, in the next two months, we should get some more. That's the whole idea. Yeah. Out of 62, we have won 25.
Just for my benefit, how did you dissect the market from 200 down to 62? Have you just ruled off a line on the biggest 62, or are they only government? What roughly is your thinking?
Yes. The 62 are mainly all those Burns centers which have those tenders. We are pursuing the ones where there are a lot of Burns surgeries happening. We are not going to the other specialties as of now. As and when we keep on expanding, we will possibly go to the other tenders as well. Right now, these are the ones that matter the most as far as Burns concerns. That's why we are pursuing them.
Do you have to wait for these tenders to come up? Do they just come up periodically as they roll over?
Yes. We really have a long waiting period. First and foremost is the allocation of funds, which come from either the central government or the state government as far as the tenders are concerned. That is the biggest challenge because it all depends on the government funding. The second one is the process itself is so laborious because they ask you for roughly 200-250 documents that you have to furnish for each tender. It is not only those of BTM that they are procuring. They are procuring everything from gauze bandages to dressings to needles, syringes, sutures, everything. There are about 1,000 items on that tender. They have to scrutinize the paperwork for all the vendors or all the companies that are going to quote for that. That process itself takes about six to eight months for them to scrutinize the paperwork.
After that is when you finally get the.
Yeah. Yeah. It seems from here is that.
The whole process takes roughly between one to one and a half years. That's the challenge.
Sorry, Raghu, I was talking at you because your screen is frozen for me, but it sounds like it's slow for us looking at India from afar. Having got 25 tenders, given how you've just described the tendering process and then the review process and when the tenders actually come up is the biggest problem, but it sounds like you've done a great job getting 25. Do you want to hazard a guess by how many by the end of December this year? Either the question was too difficult, and Raghu was frozen. Raghu, have I lost you? It appears like I might have lost him. I think.
No, I can hear you. I can hear you.
Sorry. Sorry.
Can you just repeat the question? Yeah.
Yeah. Okay. So just saying, do you want to hazard a guess to give us a sense of the momentum in India by how many tenders you might have won by the end of December?
Yeah. By the end of December, I think it should be in the vicinity of about 100. That's what we are aiming for by December 2025.
I thought you said you were only going for 62.
No, no. The whole process that we are going to, it's a dynamic thing. We will be continuously applying for more tenders as well. The 62 will move to 100.
Okay. All right. Okay. All right. So tell me, hospitals, how many hospitals in that are we servicing at the moment, do you think?
Yeah. In the last two- years, we have been reaching out to almost 1,020 hospitals overall across the whole country. Right now, we are selling to 328 hospitals out of those 1,020.
Yeah. 328. So they were obviously, even at your run -rate, pretty small purchases at the start.
Yes. That is what I said, that depending on when the tenders materialize, the results are all depending on that. Right now, the ticket sizes are a little smaller, but as the big tenders come into the bag, that will automatically go up.
Yeah. Yeah. When you describe the difficulties of government, that seems to me to be a double-edged sword because I would have thought if the government is paying, whether it is state or federal government, that that is good news for you and good news for us because we can price it, maybe not at the U.S. level, but quite well. Roughly, if I have got a 10 by 10 that I often show people when I am on the screen, which we sell in the U.S. for $1,200, in Australia for AUD 1,200, what price are you charging roughly in India?
Roughly for a 10 by 10, we're charging AUD 1,000.
Wow. That's amazing. That's why I say I think you can get away with that because government's paying. If you had to get other people to pay, they're not going to go there, I think. I think that do you see that as good news?
Absolutely. Absolutely.
Yeah. Okay. So tell us what you think the main challenges are then for you in the coming year or two.
Yeah. From the beginning, what we have seen is the standard of care for burns treatment is pretty low. We are talking about hospitals using potato peels, banana leaves, allografts, and all kinds of dressings. That is the reason we are trying to create a new category called dermal substitutes. People have not heard of a category like dermal substitutes, and that is what we have been doing. It is all about developing the market for dermal substitutes. After that, it is all about getting this kind of an innovative technology like those of BTM after you have developed and educated surgeons to the benefits and value proposition of BTM to raise the standard of care. The first is obviously the new technology of BTM that is being brought into the country for the very first- time.
The second thing is, in our experience, surgeons who have used NovoSorb BTM, right now, they're using it for the most complex cases where nothing else works. That's when they call for NovoSorb BTM. Even then, they're using it only in the most critical areas, like in grade 3 burns, in joints, which are impacting mobility for the patients. They're being very selective. They're putting these filters. As we go forward, as they keep on using more- and- more BTM and their confidence grows with the positive clinical outcomes that we know that BTM gives them, we expect that the surgeons will continue to expand the utilization of NovoSorb BTM, as we have seen in all of the markets. The same thing is going to happen here as well. That's the second one.
The third one, as I mentioned, the challenge is all around the tendering process, which is a little complex, and it's taking longer than expected. Yes, now we have confidence having 125 of them. We are confident that we'll move quickly to the next 25.
Yeah. Yeah. I mean, shareholders might be interested to know that we've had one of our key opinion leaders, Professor Marcus Wiese from Adelaide over in India a couple of times and recently just came back. And just for your ears, as much as anybody else's, Raghu, he comes back and he said to me, "Look, believe it or not, I think India is going to be a bigger market than the U.S." I mean, and I think now that we understand what you're charging for the product and how the tender system works, I can easily see that happening. The other thing I would say to you is that you just described how surgeons use the product to start with and then they might transition to. So I'd like shareholders to know that that's not an India-specific problem. We saw that in America.
We saw it in Australia, and we still see it. Some of the surgeons just go, "Look, for really complicated things, I need PolyNovo." I think Marcus observes, and I observe when I look at the U.S., that a lot of those surgeons who use it in complex wounds then say, "Shit, it's so easy to use. I'll start using it." Marcus is very optimistic about India, as we have been about anywhere else because we can see this trajectory of case histories. I don't think that's an India problem. Just in terms of staffing, finally, Raghu, how many staff have you got on the road, and what are they actually doing? Are they going to these thousand hospitals you talked about, or?
Yes. We have about 20 people in the sales team today, and their primary role is to create awareness about, as I said, we are creating this category called dermal substitutes. Their primary role is to enlighten our customers around dermal substitutes and then talk about those of BTM and then do a lot of sampling in different complex cases, get into the OR, stand next to the surgeon, and do the sampling exercise. That is the primary role to drive consumption. That is what they do. I can proudly say that in the last two years, what we have achieved is that every plastic surgeon in the country today knows about PolyNovo and also knows about those of BTM. That is what we have achieved. Now, the second part of our journey is all about increasing the usage or utilization or expanding the indications.
Having been very successful in plastic burns and recon in the coming times, we are obviously going to move to the other departments like general surgery, where a lot of hospitals, general surgeons do the reconstructive work. Trauma is handled by the orthopedic division, so we go into the orthopedic department as well. India, unfortunately, is the diabetes capital of the world. We have a lot of diabetic foot ulcers. We are also going to the vascular surgery department. This is what the team is currently doing. They are moving to all these new specialties as well so that in the coming times, obviously, consumption of those of BTM inside that particular hospital goes up substantially. That is what they do.
Yeah. Yeah. I'm about to lose you and talk to Robyn about the U.S., part of which we'll talk about MTX. But you know that we've just been approved in various thicknesses by the TGA and the FDA, which will be a product, the BTM product, basically without the laminate. Has that come across your desk yet, and what do you think the prospects for that are in India?
Absolutely. I mean, the whole India team and all our customers are absolutely excited about MTX. We just got the license a couple of months back, and we are getting into a big sampling drive starting in the last week of May and then all through June because this is one thing where we've been looking for, especially in tunnel wounds or very, very deep dermal foot ulcers where the BTM, because of the lamination layer.
Yep. You froze it on me again, Raghu. That's fine. I've got the answer I need. Just on- behalf of our board, but more particularly on behalf of our shareholders, thanks for the job you're doing in India. I hear reports from Marcus that you're spending a lot- of- time doing tenders and working all hours, so that makes me very happy. Raghu, thanks for coming, and we'll talk to you again. We might get you on now that you've done a fantastic performance. We might get you on at the AGM as well. That was supposed to be a joke, by the way, Raghu, but anyway, that's another story. Raghu, thank you very much. Okay. I'd like to just switch over to.
Thank you so much.
Sorry, Raghu. I told the joke a minute ago, and now you're laughing.
Yes. I will.
Okay.
Thank you.
Yeah. Thanks, Raghu. I should have said to the shareholders, it's 5:00 P.M. Thank you again for coming on so early. Robyn, we thought we might have Ed Grobat on the line, but we do not. I thought you and I might just have a brief chat about the U.S. I thought we might just start with a number of people in the field and where Ed's taking the team in the next little while or where he would like to take the team anyway.
Thanks, David. Look, today we have over 80 sales team members in the field servicing, obviously, our patients, our surgeons, and our hospitals. We are constantly looking to grow that number. I think there are five or six positions that we are actively recruiting for today. As we are going through the budgeting process, we have a minimum of 16 positions that we will be filling for the next financial year. We expect all of those roles, of course, to be adding to our top line. We are working hard to make sure that they are adding to our bottom line as well as we look at the year ahead.
Yeah. There are two things that shareholders are constantly asking about. One of them is how long it takes to get a salesperson up to speed and to be paying for themselves. This goes to the argument that I always use, which is when we talk about putting more people on, if you're very focused, then for me, it's not an investment. It's working capital. Because if somebody can get themselves up to speed and pay for themselves very quickly, just keep employing. What do you think is happening in the U.S. now in terms of that trajectory?
Firstly, I think, and thanks to Ed and the team in the U.S., PolyNovo has really been seen as an employer of choice from a sales perspective. That is really helping us recruit very talented sales team members and often with very good experience. That really helps us bring those team members up to speed quickly and understanding our product because they already understand the market and the marketplace and have relationships with many of the surgeons and hospitals that we're looking to service. We say on average somewhere between three and six months, depending on the experience of the person we recruit and the territory that they're going to be working in. Honestly, we're very happy with the quality of our sales team today. We are looking to continue to increase their skill sets and capabilities.
We've got some amazing sales enablement training courses that we run across the U.S. and, in fact, the globe that really help support those people as they move into PolyNovo and learn about our products so they can share that with the surgeons going forward.
That's great. I mean, I'm a man of rule of thumbs, and I encourage shareholders to think about it this way as well. I often say, "I expect that every salesperson should be able to generate a million-dollar in sales." The way I think about it is we're paying them $100,000. There's the cost of the goods. There's the support staff and so forth. We should see a lot of money dropping to the bottom line. People used to say, "It takes 12 months to get people to pay for themselves." I've never seen that. I saw it six months.
Ed will say to me, he said, "Look, I employed somebody the other day who was from Integra in a certain area where they knew all the surgeons already, and they paid for themselves in one month." I think the more successful we're becoming, we're attracting people who already are in the industry and who already have a database and can even bring that down to in that what you described as three to six months. That's pretty impressive. If Ed says he's going to put on 16 more people this calendar year, in my head, I'm thinking, "Okay, there's AUD 16 million run -ate after six months, not necessarily AUD 16 million." I think when people are looking at growth and how we're going to grow in the U.S., that's a nice rule of thumb to start with, in any case.
I just said to Raghu, Robyn, talking about MTX, which everybody knows is our product without the laminate, and for obvious reasons should be of interest to plastic surgeons or anybody who wants to put it inside the body where you do not want the plastic to still be around. We have been approved, as I just said, by the FDA and the TGA for size up to 6 mils. How are the sales going there? We have only been there one month, but just give us a feel for that.
MTX is an amazing product, and we're starting to see real excitement, particularly with the surgeon community about how they can use MTX. Surgeons are amazing in the sense that they have great curiosity and great innovation. They really drive forward where we can use some of these products. MTX is really interesting in the sense that its properties are such that it's really fabulous for filling wounds that have a larger deficit, so a larger hole to fill. It really helps with wound closure, get amazing results for the patient, great cosmetic outcomes. It's also because of its great vascularization properties, it's very good for providing areas of robust tissue. Where we need something like tissue over an amputation, it's going to provide a great opportunity for the surgeons with a new way of dealing with these sorts of traumas.
As you say, for plastic surgery, it is a great way of filling areas where you want to have a great cosmetic outcome. Head and neck areas particularly are of interest. Same as Raghu is saying, when you think about diabetic foot ulcers, which unfortunately are on the increase in the modern world, this provides a really interesting opportunity to get good closure of very difficult deep ulcer wounds.
Yep. Yep. And sales for the first month?
Sales for the first month? Put it this way. We're very excited about hitting our first a million-dollar month for MTX, but we've just started the journey with MTX. What we're seeing now is just the beginning of a very steady climb for this product as we find more indications and the surgeons find other ways that they can utilize this product. It's just the beginning of the journey for MTX.
Yeah. Yeah. I mean, one of the things that I'm excited about that you just described is the use of MTX with BTM, not- against BTM. Now, I always was thinking about MTX for plastic surgeons only for filling. I had a flap done on my nose recently, so take the skin off, fold it back, cut out some things, put some MTX in, put the flap back over. For bulking up, that sort of thing. The plastics are very excited about it in Australia. Even though we've been approved, we've still got it. People have been using a bit of it, but they're now calling out for it. I'll come back to that in a moment. I think the interesting thing you described is the use of it with BTM.
In a very deep wound where you might have BTM at 2 mils, but you need 6 mils, we can do MTX with BTM over it and so forth. I do not look at it as cannibalizing BTM at all, and I look at it as opening up a new market.
I think that's exactly right, David, because the number of ways that we can utilize MTX is vast and outside areas where we would typically use BTM. We certainly see it as significantly additive to our product range and certainly will be very additive to our revenue. We do not see it as being a huge cannibalization of our BTM market.
Yeah. I think one of the other things you mentioned, which we've never really given much attention to and shareholders need to understand it, is the vascularization of BTM or MTX for that matter. When people contemplate, "Why is it so successful, let's say, on diabetic foot ulcers where without it, you might get an amputation in two years?" Because the blood's cut off because of diabetes. One of the things that BTM does and MTX will do is it revascularizes the area, which enables the wound to heal. I want to sort of emphasize this because it's very important for things like diabetic foot ulcers to understand that. It's also very important, more important, to understand the next topic we're going to talk about, which is Betacell, which is putting our product under the skin.
The vascularization, even though you've got blood running anyway, but the additional input to vascularization is very important for pushing cells around the body. That is good. The final thing I've noticed that the board pack and our shareholders won't have seen this yet is that we're starting to get a few sales in places that I was surprised about. I'm talking about Mexico, talking about parts of South America and so forth. How do you see that?
Again, the one thing about our product range is the surgeons are incredibly excited and supportive. What happens is that surgeons from different countries around the world are going to Burns conferences, whether it is in the U.S. or in the U.K. They are hearing about PolyNovo's products. The surgeons are sharing case studies. They are sharing amazing outcomes for patients. Of course, the surgeons are going back to their countries, whether we have seen it now in Peru and Mexico. They then are really wanting for us to bring the products into their countries so that they can get good outcomes for their patients as well. We are seeing this driven very much by demand.
are there to do our best to keep up with that demand and get that product into the countries as quickly as possible and also provide the educational support that is needed as we bring our products into new markets. That is an exciting time for our teams globally as we are seeing that our products can go out and really support many more patients than we have today in some really exciting areas. Our surgeons are really, really very supportive to help us make that happen.
Yeah. I mean, on the same tangent, I think, Robyn, is that we are getting approached by quite a number of companies around the world where distributors want to take our product. I give two recent examples. One, I was in Manila with the Australian government, and they introduced me to the biggest military hospital there. I was talking to the chief surgeon. In that meeting, he had a guy from Melbourne who had been working at the Alfred Hospital for two- years with Heather Cleland, who's the biggest user of our product in the state. He knows it back- to- front. There were a couple of other guys from Boston who had been using our product in Boston. You are quite right.
What happens is they either know a surgeon in the U.S. or they've trained in the U.S. or Australia or somewhere else, and they come home. This is particularly true of India, by the way, where you're getting a lot of doctors coming out of Australia and a lot of doctors coming out of the U.K. That's really exciting. I think the other thing, which also goes to India, is who pays what. We gave some free product to Serbia to a 16-year-old kid who was trained surfing, held on to the electricity, 95% burns to his body. He's in a coma for three- months. We got approached. We gave them, out- of- our London office, product for the boy. He's now up and walking and rehabilitating. The state insurance companies are poor country, Serbia, and all around, it's poor, Romania, and so forth.
The state insurance company has come out and said, "Look, we'll pay for any future product." This issue about who pays for what is sort of quite interesting because what we're seeing, let's say, in Ukraine, for example, where the Taiwanese government paid for our product, there's a whole lot of people who are paying for things that wouldn't necessarily you might have thought should exclude us from those markets. Nobody's going to pay for facial fillers to go into Serbia. For trauma like us, we're not short of people who are interested in it. All right, I think that's good, Robyn. I'm sorry this is taking so long, but the final thing I just wanted to cover was this Betacell update. I've just talked to Professor Toby Coates.
This was a product, so Chester, I'll get you to bring up the video of me talking to him. This is a product that's being developed by Professor Toby Coates and by Professor John Greenwood, who are both at the Royal Adelaide Hospital. John is now retired but still working on this project. He, you'll remember, was one of the people that helped us, was instrumental in BTM being finally approved and used. He was a big user of it himself. He is a friend of the family, as it were, and he loves us and he loves our product. There are reasons for why they use our product. I mentioned vascularization before, but there are a number of other reasons which hopefully will come out of this short interview with Toby Coates. Chester, are you there?
Yes. We're ready.
Let's go. Here in Australia, and I appreciate the fact you've just come off a stage in Copenhagen talking about this very exciting study that you and John Greenwood and others have put together on using our foam for diabetes cell implementation. It's a bit cumbersome. Before we even start, there's a number of things I think that shareholders might want to know. Toby's a quick update, but just historically, where did this come from? Where did the idea come from?
Thank you very much again for the opportunity, David, to talk to the shareholders. Betacell Technologies is a company that we formed a few years ago with John Greenwood. The idea was his idea that having developed the material that treats wounds so effectively, the NovoSorb, he thought we would be able to grow cells or have cells be supported by the same polymer structure. Betacell exists to do that, to take a cell and see if we can make it survive in the skin. Of course, we know that this works because it works through the same mechanism that it works for skin grafting. The vessels that are created are functional, persist long-term, and therefore, when the foam disappears, are capable of supporting other structures within the skin. That was really the initial basis of it.
We decided, because my interest, obviously, as a transplant specialist, long-term interest has been type 1 diabetes, huge market, and also huge unmet need, huge unmet need, that diabetes would be the right thing for us to start with. We took my expertise, which is islet cell transplantation and kidney transplantation, immunosuppression, and John's expertise, which is the PolyNovo, the Burns material, and combined the two together with the vision that we might be able to do something in cell therapy for the benefit of type 1 diabetes. That's really how it started. That's about nine or ten years ago now. It has been a long journey, well-supported along the way through the Juvenile Diabetes Research Foundation, which is now called Breakthrough T1D, multiple grants around the world to make that happen.
Obviously, these fantastic patients who agreed to be in this first in-human study that I presented here in Copenhagen just yesterday.
Toby, we often think about PolyNovo as being a platform technology for wound care. That's a bit too crude because we now know for hernia and inside the body, spina bifida, breast, and so forth. To what extent do you think this is a platform for cell or medicine delivery?
100%, David. It's the vessels. It's the vasculature. This is the remarkable thing about this product that you have, the NovoSorb. We actually see it exactly the same way at Betacell. We see it as a platform to delivering cell therapy for a variety of indications. Now, type 1 diabetes is obviously the one that is closest to my heart, but other things such as adrenal cell replacement, which can be done. We've shown that and published that as well in the Journal of Endocrinology. Also, other endocrine cells that could potentially go in there, so parathyroid cells. I wouldn't exclude really any cellular source that is secreting a hormone or secreting a product, potentially even neuronal cells that might secrete dopamine for Parkinson's, for example, could be delivered using this platform technology.
We see it very much as a platform and things that we could optimize, other treatments for other diseases that as yet do not have a cellular therapy treatment.
Yeah. You haven't picked diabetes because it's the easiest one. It could have been anything.
Diabetes is actually the hardest one, to be honest, David. There are millions- and- millions of years of evolution to get those beautiful cells to do what they do. For us to be able to take them now and be able to put them in this material was always going to be the tough one. The fact that we've got results that are as good as this that last out to three years, that's quite extraordinary in the skin for a cell to survive like that. With optimization, we think this is going to be a very powerful delivery platform. It is a platform technology, not just a one-trick pony at all.
I think most of us know a lot about diabetes in recent times because of the proliferation of drugs like Mounjaro and Ozempic and so on. To what extent is this potentially a replacement for those? Because they're quite expensive and a lot of people have compliance issues in terms of injecting themselves every week. Is this complementary or an alternative? I mean, it's probably too early to know, but what's your feeling?
Everything is complementary in my world. I think what we do is we pick the best treatment for the best patient. There is absolutely no doubt that having a cell that regulates the production of insulin and also the other hormones that people do not think about, such as glucagon, the counter-regulatory hormone, you take away all of that variability when you actually replace the thing that is missing. Insulin is terrific. Yes, it is, but it does not replace all of the other stuff that the islet cells actually do. That is why a pancreas transplant or an islet cell transplant is actually very, very good treatment for these diseases. Of course, we are limited by the number of cells, etc.
As we're moving to a situation where we can have more cells as stem cell-based therapies come online, then being able to replace what's missing, I think, will be a huge advantage. People won't have to worry about injecting themselves or compliance with medications because you're replacing what's needed.
Yeah. Yeah. And so what is it that's unique, do you think, about PolyNovo for use as a carrier? I mean, why not any other bit of foam or?
It fundamentally comes down to the blood vessels. I mentioned that before, the robust nature of the vasculature that's created, which persists for years. You are creating a platform where if you can get something in there, it's got the supporting structure. It's got the highways to be able to deliver the product that you need to the body. That's the first thing. The second thing is that we've certainly got some data that suggests that the foam itself does not excite an extreme immune response. This is what John developed originally, the fact that this does not produce a scarring effect. That's the big difference between PolyNovo's foam and other devices. It's also the big difference with encapsulation devices, which people have been looking at and universally haven't worked because they excite a scar reaction within the skin. We know that the NovoSorb does not do that.
It has those particular advantages. That potentially an immunological privilege and the immune system does not see it quite the same way. The fact that the blood vessels persist for a long time is really what attracts me as a transplant person to using this as a platform for cell therapy.
Yeah. That's great. You know, one of the things that's come out of social media is, well, this is all very interesting. That's great. Everybody loves the idea. Yeah, it's 10 years for another drug, treating it like any other drug for FDA approval. It seems to me, when I think about it, some of these cells have already been approved. Certainly, we have approval at various regulatory authorities around the world for various things. What do you say about the regulatory pathway here? I mean, I know it's not tested, but we ourselves have product where people are using it outside of indication. I'm just thinking that if I were a cell, if I was doing cell therapy, I'd be tempted to, and if my cells were approved, they could be replicated and well-designed and so forth.
I was using my foam, I might be able to use it without regulatory approval. I mean, I do not put that as a proposition. I just say, how do you think about it?
The major strength, whenever I give a presentation, the most important thing I say is FDA 510(k) approval about the NovoSorb. That side of things is absolutely fine. Again, on the cellular side of things, if you have a cell that is, at the moment, that is proven or accepted as to be therapeutically appropriate, there should not be any issues with actually combining the two together. That is what we did in this trial. Provided there is a regulatory pathway for the cell, the PolyNovo platform will be cell-agnostic to what is actually happening. We do not see, John Greenwood and I, that there will be any major issues on the regulatory side from that point of view at all.
Yeah. If you thought about, how do I supercharge this work that I've done, first in-human, very impressive, congratulations. If I had to supercharge that, would you choose voluntarily to put another dozen patients on using diabetic cells? Could you be inclined to do that with adrenal cells and one or two others at the same time?
Oh, look, I think all of those are options. Betacell Technologies are open, fully funded at the moment, and quite capable of moving further forward. To supercharge, yes, it would be nice to have a partnership with any company that is interested in working with this. I think with PolyNovo, particularly, we have got a good long-term relationship built up over many years. We know the product works. I think we could supercharge this and do a variety of different cells that could be tried. Diabetes, I think, when you look at it, there are 134,000 Australians living with type 1 diabetes. That is a long-term condition. It would be really ideal for the future to be addressing that issue first and using that as proof of principle for other cell therapies.
It's an exciting time for Betacell Technologies with these preliminary results and our excellent relationship with PolyNovo.
Yes. We had a very long relationship initially with John Greenwood, and he got equity out of that, and it's been to everybody's benefit. One of the things on social media is, well, we've been supplying foam to you free of charge, I believe. That's great. Very happy to do that. What I'm hearing you say is that you're very open. You as a team are very open to some sort of collaboration, I mean, in order to help you supercharge this.
Absolutely. I think it's important. We value our relationships with all of our collaborators, and we have an excellent relationship with PolyNovo. We could see that this would make a lot of sense for us to have a more structured relationship going further forward at whatever. We're open, really, to anything that includes collaboration or acquisition, depending on what the terms are.
Yeah. Toby, I've probably got ahead of myself, and we're running out of time. Just for the layman like myself, just a very brief description about what you did with the patients, and in particular, one patient that's now three and a bit years in. I just want to give people a sense of the simplicity of what you've done.
Absolutely. This was all done as an outpatient. That's the most important thing. That was John's original vision. He actually wants this to become a general practice therapy. That's what he said all the way through from the very beginning, that this shouldn't be something that's done in big, complex hospitals. Essentially, the BTM foam, NovoSorb foam is implanted. It's implanted in the upper- forearm over here. It could go anywhere in the body, but the upper- forearm here is the right place for it. It goes in. It has to create the blood vessels, the cells for where the cells are going to be transplanted, which takes anywhere between 16 and probably 40-50 days, something like that. There is a nice broad window in the middle. The patients come in, have the cell implanted. They're wide awake.
is all undone, done with a local anesthetic. They go home the same day. The next bit is waiting for the cells to be available. In this particular case, these were deceased donor cells from human organ donors who were then implanted. There is a site sealed off, and that was done. We monitor them on a daily basis after that. We can measure how the cells are working in the peripheral blood. Very simple procedure.
Toby, we've got a webinar tomorrow that I thought would go for under an hour. It looks like you're going to chew up most of it. I'm going to cut you and welcome you back next Monday. I look forward to talking with you and also hearing the outcome of the discussions that happened after the presentation. Thank you for your time. Congratulations to you and the team. See you soon.
Thanks very much, David.
Okay. As I said on the video, I thought we were going to have a 20-minute presentation. It has turned out to be exactly an hour. For those of you who stayed on, I think we had 250+ at the start of this. I am not sure whether it is any more than just Jan and Robyn and I now, but I hope you got something out of that. We, as normal, will video this and put it up on the ASX in any case. For those of you who are on my database, I will send around the video separately in the next half an hour or so, in any case. I am sorry to cut this off at an hour. Let us do this again soon and cover some of the same and some new products.
I should just say, with respect to Toby, there was quite a number of things that I danced around there because there's a number of collaborators in this, some of which are very, very, very large companies. He hasn't got permission to use their name until he publishes his article. He's given the paper. The article will be published in the next two weeks. When it's published, there'll be a lot more revealed about who's who and where this is going and so forth. From my perspective, this is the way I look at it. We have a silo in our business, which is essentially wound care, but a bit wider than that, as you know, because we're talking about hernia and breast and so forth. This is potentially a completely different silo and a silo that's for cell delivery or medical delivery.
I will just say one thing. I had a chat to Novo Nordisk the other day, and they said to me, "Look, what we see in the next two- years is that every cell company is going to need to have a delivery vehicle like you." That is really heartening because it could be that we have got two different businesses here and two different platform businesses, which is the most exciting thing. Okay. I have got to go. I am sure you have got to go as well. Robyn, thank you. Jan, thank you. And Raghu, I think, is gone. If you are still there, Raghu, thank you very much. Good luck to everybody.
Thank you.