Futura Medical (LSE:FUM) — Interim Results

0:02 Good morning, and welcome to the FUTURA Medical PLC Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the Q and A tab situated on the right hand corner of your screen. Simply click Q and A, scroll to the bottom, type your question and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. I'd now like to hand you over to James Barder, CEO. Good morning.

0:33 I'm James Barder. I am the CEO of FUTURA MEDICAL and I'm also joined today by Andrew Hildreth who is the Finance Director and COO of FUTURA. I would just like to say, Andrew is suffering from the b a two eight six variant of COVID at now. So if her voice sounds a little out of key, that is the reason why. First of all, I'd just like to give a brief corporate overview of the company. FUTURA is an AIM listed company. We're based at the Research Park in Guildford, and we describe ourselves as a virtual organization. We have 15 staff members, including directors, and we have a low overhead base. We have a significant outsourced infrastructure, which includes not only contract manufacturing, but 30 consultants.

1:20 Our real skill set is around applying skin science, obviously, to the skin and novel applications. But for us, what is very important is that we develop clinically proven treatments. Our track record, we've got a a very experienced management team. And this year, as I'll talk on a little bit later, we've had a had a really good start for the year and delighted the way things are going. MED three thousand is a topical gel for the treatment of erectile dysfunction and it is clinically proven and very importantly is available without the need of a doctor's prescription in both Europe and The U. S. It is highly differentiated or its main claim, if you like, is its fast onset of action and we can make the claim helps you get an erection within ten minutes.

2:07 Delighted to report and Andrew will talk about this a little bit later. Our first revenue since the launch of MED in Oryroxon, as it's called on its brand name, for three months this year in UK and Belgium. And also delighted to talk a little bit more about what is going to happen moving forward as the next planned launches goes ahead with launches in 10 different countries.

2:33 This year, or certainly, we've been very much achieving our key strategic objects. And the four that we look at here, FDA approval, which was a big, big win for us. Phenomenal job done by our small r and d team who are very hardworking but highly specialized. Agreement with Halion signed immediately after the end of the period, but in July. We've got further launches on track for this year, and we are now also focusing very much on completing our distribution pipeline in Asia and also strengthening the supply chain. This is really just a summary, obviously, of the highlights, and we will be talking more, both Andrew and I, further on in the slide.

3:24 But as you said, the key things we've done this year, FDA approval, a major deal with the largest OTC player in the world for The US, initial successful launches, And we've also for that matter appointed further contract manufacturing organization to expand supply chain. First revenue, but again, I'll let Angela talk a little bit more about that in due course.

3:51 Eroxone is the first topical gel that is clinically proven to treat ED in adult men. As already touched on, it is available without a doctor's prescription and that is so far in all the approvals we have got and we expect that to continue through most of the countries throughout the world. We're getting a growing number of regulatory approvals, and again, I'll talk a little bit more about that in due course. And the key differentiator is it helps you get an erection within ten minutes.

4:18 The current regulatory status, as I said, it is now approved in The US, EU, UK, Switzerland, and more recently, Saudi Arabia and Australia, and in a number of other Middle Eastern countries. We do expect further approvals during 2023 and also next year as we look to roll out the approvals throughout the rest of the world. I think the key exception to this is certainly China, where we do expect to require additional clinical data, although I'm quick to stress that is not a cost that we are looking to incur, and we do expect our commercial partner to do just that. As I said earlier, the main competition, if you like, in this sector is Viagra and Cialis, the oral PD5s, and they do require a doctor's prescription in pretty much every market. The UK is actually the exception, but even The UK, if you want to go and buy Viagra, you have to go through an algorithm of a number of questions. In the case of Viagra, it's 17 questions you may have to answer before the pharmacist can hand you the product. In the case of Cialis, I believe it is up to 41.

5:31 Again, just a little bit about the innovation pipeline. I'm not actually going to talk very much about that this today. This is something that we will give you much more information, I think, next April, because the focus has been certainly for the six months of this year is getting the FDA approval across the line as well as other regulatory approvals. And we are now turning our attention to the innovation of how we're going to

5:56 drive the pipeline. And in particular, we're getting strong interest from our distributors for not only product extensions, but also innovation in a new exciting new category of OTC sexual health products.

6:16 Intellectual property, we've always looked to try and layer this, have a number of different layers as we possibly can, and we do have a number of specialist consultants and trademark and patent experts that work for us. We have recently been advised that by the patent office in Europe that the patent for MED 3,000 does have novel and inventive steps, which is key in the approval process. And once granted, that will provide us with Protection Act 2,040. The US marketing authorization contains special controls. This means that any any competition would have to basically adhere to certain requirements in this meeting certain safety and effective standards before they'll be able to launch a product.

7:10 And as in the case of us, you know, that takes many years and a lot of time and expense. And that is, of course, assuming that we can have a patent. We are looking to launch wherever possible under the Oroxon brand, but that is very much dependent on regulatory requirements in those countries as well as what our commercial partners wish to do. Good morning, everyone. As most of you will be aware, Oroxon launched in The UK and Belgium in April. The UK and Belgium launch was a full launch backed up with full PR advertising promotion, and the product was initially sold in boots in The UK and independent pharmacies in Belgium. This was a deliberate strategy as our partner wanted to take the learnings from both of these models, given this is essentially a new product in a new category and apply them to the wider European commercial rollout.

8:04 The product is now available with other retailers in The UK and we expect that over 2,500 stores will stock Eroxone in The UK by the end of this year. The product has also been listed online in France, Italy and Spain since June. Early launch feedback, and I want to stress that this is very early feedback, suggests that we currently have secured around a 20% market share in The UK and Belgium across all clinically proven ED treatments. The feedback also suggests that sales of Eroxone have been predominantly incremental, which is pretty much as we expected given the product's key differentiators and the market research that suggested Eroxone would build a new category in ED treatments.

8:50 And again, very early days, but we are starting to see early signs of repeat purchase data coming through, and both FUTURA and CUPA have received a very low level of complaints about iroxan and its side effects and efficacy. What I can tell you is that our European partner is very pleased with the initial launch and they have advised us that so far expectations on a number of KPIs have been exceeded. We talked about their strategy recently at our Capital Markets Day, but essentially, they are ensuring that health care professionals and retail pharmacies see this as a credible treatment for ED. They're ensuring that it's accessible through credible online and retail stores. Their goal is to reach at least a 70% distribution in The UK by the end of twenty twenty three.

9:41 And lastly, ensuring awareness through PR advertising both on TV and in stores.

9:53 As we look to the remainder of '23 and into '24, given the confidence from the initial rollout, we expect at least a further 10 country launches across The EU and Middle East in the next six months or so. Our partners recognize that speed to market is important, but not at the cost of launch readiness. And just to touch on that, you know, the launch readiness criteria partners recognize that key opinion leader in health care professional endorsement and education is highly important when it comes to the product, the the credibility of your Roxxon.

10:25 They have to be mindful of cultural differences and regulate requirements with each in with the within each country. They have to ensure that leading retailers and online platforms are ready to stock Eroxan, and that we have a supply chain to cope with the demand search. We previously reported a stock out at Boots after day five of launch. This was easily rectified, but we were dealing with one store logistically. Our partners can't risk this on a larger scale and want to ensure that they are prepared in terms of demand when launching into other countries. And finally, our partners have to have strong PR and advertising to drive awareness. Again, this is very important, reminding you that this is a new product and a new brand that many ED sufferers will not be aware of.

11:13 We have been focused on building a global network of commercial partners. We already have agreements in place covering The EU, which includes Switzerland and The UK with Cooper Consumer Healthcare. There's an agreement in place for Latin America with MA Pharmaceuticals in The Middle East with Labatec, who have their launch planned in q four this year, South Korea with Menarini Korea, and most recently, The US with Halion, one of the biggest consumer healthcare companies in the world. We have also confirmed that we have now terminated our agreement with Cohai on the basis of non delivery performance obligations and now have the rights for China and Southeast Asia returned to us completely unencumbered with strong interest from a number of other partners interested in those regions.

12:06 All of the commercial agreements contain KPIs relating to regulate resubmission timelines at the cost of the partner where applicable and other obligations relating to advertising and promotional spend. This is crucial given the investment that will be required to build a Roxxon as a brand. And we've already appointed a second CMO to provide additional capacity in 2024. Thanks, Angela. As Angela was talking about earlier, the key thing that's come out of the launches is that sales are largely incremental. In some respects, this is not surprising. And if you look at the last bullet point here, the research that was done by a couple of years ago very much said that, that seventy three percent of men

12:59 you know, would not are not currently on treatment, and therefore, a product that with the key differentiators that Eroxan have, it does not come as a great surprise to us that we're growing the market. And not only is that good for us, but retailers love that because you're not seeing cannibalization across existing brands, you're just seeing increased sales. And for us, and again, this again, again, going back to the Ipsos research, what we've seen the the key areas where we believe we're seeing, you know, interest, though, again, it is early days.

13:37 But we've got those men who diagnosed and are not treating because they don't like PD five inhibitors. Again, also the undiagnosed, those men that suspect they have erectile dysfunction, but quite frankly are too embarrassed to go and see a doctor.

13:54 And I think that's and in some instances, they're probably almost too embarrassed into a shop to buy a product. And certainly, we're seeing with the sales to date, it's roughly split fifty fifty between retail sales and online sales. And then the newer segments, the younger men. There was a there was research recently done that shows up to fourteen percent of men between the ages of 18 and 31 are suffering from a degree of erectile dysfunction. And again, a product like this, which is very safe, there's real interest for. And then finally,

14:26 this is the first time you've got a treatment that can actually be bought by the female partner. Even in UK where Viagra and Cialis are available over the counter, albeit there are number of questions that need to be asked, a woman would not be allowed to buy that product, would have to be bought by the male partner. So we feel this is a big opportunity. And, again, I think as we we talked about during the the seminar back in June, in the recent research, 85% of women said that they would be interested in buying a product if it helped their partner.

15:03 And then in turn, 90% of those partners said that if their female partner brought the product home, they'll be prepared to trial. So a very significant opportunity here. And I think it's no surprise that a lot of the sales are incremental, and we're growing the market. In The US, which is the largest potential OTC market, again, part of the Ipsos research that was done. Again, this was also shared back in June at the seminar, their sort of analysis, and it was based on certain key assumptions.

15:40 We're looking at sales peak sales are potentially worth $409,000,000. So there is a significant opportunity there. One of the things a number of people are concerned about is that as Viagra and Cialis become generic, you know, the cost of buying the product has dropped dramatically, and will that have an impact where, you know, effectively a patient can probably go out and buy a a a tablet via for a dollar. Reality is in The States, the largest market, when you take into account the out of pocket costs that those men have to incur by going to see a doctor, including the doctor's visits, you're looking at a range between 600 and $3,500. The $3,500 being for a patient that obviously wants to buy branded Viagra, whereas 600 is for patients prepared to have a generic form. So even at $5 a dose and you're looking at, well, are different estimates, the peak sales estimates were done at 55 tubes used a year versus the research that also said that on average ED men, have 70 intercourse events a year.

16:45 This is a treatment that is highly affordable.

16:51 Angela?

16:52 Hi. Well, despite, being absolutely loaded with COVID, I'm very happy to report for significant revenues generated in the six months ending June 2023. Revenues reported of 1,700,000 are wholly related to sales of Oroxan to our commercial partners, and this has generated a gross profit of just under GBP 1,000,000. As the Oroxon launch continues to roll out to other countries, we do expect to see those revenues rise. Net loss in the period was 1,700,000 compared to just under 2.5 in the period 2022. We have, released r and s this morning, and we have stated that we do expect to be around breakeven in '24, and then we expect to report a profit in 2025.

17:46 That is based on expected sales coming from The EU and The Middle East. And with the exception of the, of an upfront payment, which I'll touch on in a moment, does not include, any estimates relating to product sales or or royalties from product sales in The US.

18:07 Cash resources at the end of June was £7,800,000 reflecting the receipt of million pound R and D tax credit for the '22 claim. We also received, 4,380,000 from an institutional investor who exercised warrants at a price of 40 p per ordinary share.

18:27 The cash balance also includes the revenues received, which I've just touched upon, along with other smaller milestone payments from commercial agreements, which have not been recognized as revenue currently. But the cash balance at the end of June does not include the $4,000,000 up from payment that we received from. So if we look to the cash balance at the end of August, we had a cash balance of circa 9,300,000. And I just wanna confirm that we also do not have any any debt in place.

19:00 Finally, to to summarize, we're really excited to see further Iroxon launches planned during '23 and be able to see increasing numbers of ED sufferers have access to Eroxone. We expect to be able to reach a breakeven position in 2024 and become profitable in 2025, and that is excluding any royalty income from The U. S.

19:26 We expect to conclude further out licensing agreements to regions not yet licensed, and we expect to provide some color to the market in terms of innovation next year. On behalf of FUTURA, I'd like to bring this part of the presentation to a close. Thank you for listening and your support. And I'll now open up the platform to the Q and A.

19:49 You very much indeed for the presentation. Ladies and gentlemen, do please continue to submit your questions using the Q and A tab situated in the right hand corner of your screen. Just while the team take a few moments to review those questions already submitted today, I'd like to remind you the recording of the presentation along with a copy of the slides and the published Q and A can be accessed via your investor dashboard. As you can see, we've had a number of questions that have come through throughout today's presentation. Thank you for all the investors who've submitted those. Angela, if I could just hand over to you just to read out the questions where appropriate to do so and give you a response, and I'll pick up from you at the end. Thank you. I will do. Thank you. Good morning, everybody.

20:25 Okay. I'm gonna move straight into the the first question. James, I think you can answer this one. You mentioned a stock out. How are you planning to manage the supply and demand balance?

20:38 I mean, it's it's a challenge because, obviously, this is a new category. And as such, it is not we don't always know. We have a lot of forecast and analysis, but as a brand new category, you don't really know until you launch. We saw certain UK, you know, that this challenge for the stock out, I think, within five days. So what Well, obviously, we learn. The learnings from the initial launches give you guidance on original forecast. But perhaps more importantly is managing the contract manufacturing organization so we have sufficient capacity capacity in the pipeline ahead of any launch to manage just that. We announced we've now actually taken on a second contract manufacturer to give the supply chain more robustness, and it's just something that we'll watch. And, we do expect the need to add further manufacturers in due course. Having, you know, two or three not only provides you with a bit of pricing competition between them, but, obviously, if if anyone had a FAR or there was an issue there, then it doesn't mean that you've got other options available to you. So it's something that we learn and we keep close tabs on.

21:47 You know, the old stock ad is actually not a bad thing. Know, if suddenly a product doesn't become available, then people tend to want it more. Now, obviously, if you have it for too long, you can actually piss a lot of people off. But, clearly, we don't wanna have, you know, large stock outs from time, but it does show that product's not

22:10 You're on mute, Angela. Thanks, James. Are there any minimum sales requirements from partners to maintain the agreements you have?

22:25 We I can't really say too much specifically on the agreements other than saying in all agreements we've signed to date, there are minimum key performance indicators. And that those can range from a number of things, volumes, a and p spend, timelines, and there are a number of there's a number of things in there, and they do vary from one agreement to the next. But, yes, there are certainly obligations on all commercial partners to do certain things within a certain period of time. I think it's also important to stress that, you know, we've had significant approaches for the rights in different markets. And in that selection criteria, obviously, yes, the economics are very important.

23:12 But for us, the most important thing is the execution capability of that commercial partner, the ability to build a brand. Because the problem with the Roxxon is, yes, it ticks all the boxes from you know, all the research that we've done shows strong consumer intent to buy, ticks all the boxes, speed, safety, and, you know, and and pretty reasonable efficacy. But you still then got this this kind of challenges. Actually, are people gonna go out and buy the product? So, yeah, it's very important that you have a good commercial partner who knows how to build that credibility and knows how to, if you like, switch a product from a prescription product to an OTC product. So that has has counted very heavily in selection of commercial partners.

24:05 Okay. So I think the the next question is for me, James. Given the company appeared to be taking no revenue from US in 2024, do we assume launch on shelves, so to speak, in US not until much later in '24 as any sooner review on sales may have been taken. We haven't taken a view on revenue from The US and given it to the market on on any time period in relation to the the American commercial deal. One, our commercial partner has has asked us to be, you know, particularly cautious in disclosing any information when it comes to the timing of this launch.

24:51 And two, you know, there is a lot to do. You know, the The US is is a big is a big region. Logistically, you know, you're you're launching a product on a bigger scale across more retailers. And both us and the commercial partner want to ensure that we have the, you know, the manufacturing capacity to be, you know, ready to launch without, you know, having any, stocking issues upon that launch. And and that just takes a bit of time. You know, the The US is a very, very big country. It's a very big market. There are a lot of retailers. So, you know, that along with all of the other activities in in relation to The US, it's just gonna take a bit of time.

25:37 That being said, you know, Haley and have have said that they're excited about this opportunity. They are gonna launch as soon as they possibly can. We just, at the moment, can't be drawn into whether, you know, that is gonna be in 2024 or not. So it's it's not about taking a view on sales. It's just about, at the moment, we just can't say much. James, do you wanna add anything to that, or do you think I've covered it? I think the only other thing I would add is is that The US market is different to The UK where, if you like, The UK, we're able to to accelerate launch through the Boots chain. In America, that is a very, very unusual approach. It is normal for launches in The States to be across the whole of The States, across all retailers.

26:23 So as Andrew said, that just does take time. We did have another question that came in earlier. When can we expect to hear more on your progress to obtaining extensions on patent, please? And how likely do you think that they will be obtained? Is this largely form filling, or is there more risk to process? When so this is an extension. I'm I'm not quite sure what they mean. We have filed a new patent around MED 3,000. And any patent that is filed, what you have to be able to demonstrate to the examiners is novel and inventive steps of the application before it can then can be considered for for for patent approval or or to be granted a notice of allowance.

27:16 In the case of MED 3,000, we filed an initial application in 2019. I won't kinda go through the whole process. It it's quite a convoluted process. But in the case of Europe, under the PCT application, we went for an accelerated examination. That is progressing at the moment. The examiner has confirmed the novel and inventive steps to the patent. So we remain optimistic that we will be granted notice of allowance, and the patent will proceed to to approval. When I can say more to the market, we will do that. As far as the we've we've actually now get under the PCT application. We filed, I think, in around about 30 countries, and all of those will be going through process.

28:05 The EPO patent, the European patent office patent will be the first one that we should be able to give more guidance to the market on. But these can these these things take time. There's a process. And when we can comment more, I will do that. Okay. Moving on. Where has the indication of repeat order data been obtained from? Where is the repeat The repeat purchase data that we we've released in the RNS to say that we've had a, you know, an initial indication of of of repeat purchase. I I can answer this. So we've we've had that indication from our commercial partner. But, you know, repeat purchase data for this product is actually it's quite difficult to get a hold of.

28:56 And then by the time you have it, it's not always as as kind of as recent data as you would like. Our commercial partner is working with the retailers on trying to, you know, get more data and in a more and in a faster way. And, you know, we wanna say that these are early days and that the the data is only early days. But it's quite difficult to get a hold of. Usually, retailers such as Boots, they would obtain their repeat purchase data through through loyalty cards. So Boots have their advantage cards. Unfortunately, a lot of men don't own loyalty cards or don't use them. They're predominantly used by females. And whilst we we we know that females are going and buying the products on behalf of their partners, clearly, you know, the product is is intended for for men to buy.

29:48 And if they don't use their loyalty card, it's very difficult to assess whether they're you know, what their repeat purchase level is. So, you know, I think our partners are working with the retailers to see if they can get more information. And and if we have more information, we will we will update you in due course. James, moving on to the next one. This one's for you. Can you please quantify the level of complaints regarding efficacy raised? And why do you think the online reviews are poor? Okay. Yeah. To quantify, and I think I said it yesterday, around about 200,000 packs have been sold. We've always distributed more than that, but around 200,000 packs have been sold. And I think at the latest count, we had 70 between 70 but around about 70 complaints of which I'd say 60 relate to efficacy.

30:41 You know, for them, the product doesn't work, whereas the other 10 are side effects, but all all very minor. So, you know, it's it's a it's a pretty low number. The second question about reviews. Well, men tend to complain when they're not happy with something. They don't tend to write reviews when they are happy about something. So, you know, we I think we've had about 380. If you're referring to the Boots reviews, I think there've been about 380 reviews. Some of those reviews are clearly contrived. If you look at some of the other websites selling the product, you'll see a much more sensible, if you like, response to some of those. As you would expect, the the responses tend to be pretty binary.

31:29 Either people like the product because it works, or they don't like the product because it doesn't work. So this is obviously something that that we are still working on. I I think for us, the key thing here is to be able to manage patient expectations. Obviously, as a an over the counter product, there is no interaction with the doctor. Whereas if a man is prescribed via GRUCIALES, the doctor at the time of prescription will be able to turn around and say, look, you know, efficacy for this is around about seventy, seventy five percent. You might have a headache. You might have this. You might have that. In this case, there is none of that. So we are working and commercial partners are working on how we can try and manage expectation to say this is not going to be the solution for everybody. The clinical data clearly shows a sixty five percent efficacy rate. I'm gonna give you an example. We have had a complaint in where a guy bought the product, went home, put it on his penis, turned on the news, and sat there watching news and was disappointed he didn't get an erection. Yeah?

32:30 It it needs to be understood that you do require sexual stimulation and in some instances, foreplay. And so it's really just managing that expectation. And I think this is one of the learnings that we've had. Yes. We've had a number of of reviews which which are negative, but it's not really transposing in the amount of volume that we're selling. And certainly, the the written feedback that we're getting is mindful that the product works in around about two thirds of men. We've had a very low level of complaints. I think as well, part of the the learnings, particularly in The UK, you know, I I think most of our investors will have seen all of the PR, which was basically a PR dream, the amount of PR that was garnered when the product launched.

33:18 It can be a bit of a double edged sword. You know, you the the PR that you garner within some of the more credible, you know, newspapers is is great because it raises awareness of of of the product. And, actually, some of the PR that you garner in the tabloid newspapers is great because it raises awareness. But it also can can really not be helpful when it comes to managing that expectation. And and as James touched upon, you know, there is a a bit of a misconception, I think, sometimes that this is a a magic solution. So, you know, part of the the learnings that that Cooper are gonna take into the other markets are in in managing those expectations, not only in terms of what the product is intended for and and what it can do for for 65% of men, but also in the fact that, you know, you may have to use the product more than once. The first time that you use the product, you're probably concentrating on the instructions and getting the tube open.

34:16 If you've got erectile dysfunction and and and you've had ED for some time and you've not done anything about it, then you probably haven't been having sex for a long time. And I you know, if if anyone's seen our Capital Markets Day presentation, we had two doctors who both run sexual health clinics, and they both have said that, you know, even with p d e fives, if if men are presenting and they haven't had sex or attempted sex for some time, it does take a little bit of time for them to you know, their their bodies and their system to kind of get get into having sex again. So it it may take more than than one application, and we definitely saw that, you know, with more applications of the product in the clinical trials, efficacy did improve. And I think, you know, we we have to make sure that the commercial partners are managing those expectations, but also, you know, educating consumers in terms of of of how to use the product. And I think out of the launches so far, and I think, James, you would agree with me, that probably is the biggest learning.

35:16 Mhmm. And and that is something that they're looking at going forward. Hopefully, that's answered that that that question. James, just another clarification on the patent. Regarding patent, we were told a patent was in place up to 2028. Why did you say there was no extension? I think it's probably important that we just distinguish this because there this seems to be kind of an ongoing theme of of confusion, doesn't it? Yeah. I think the 2028 refers to the old MED 2005 patent. Patents cannot be extended. A patent, when it is applied for, has up to a twenty year life. Each year, you have to maintain that. Once it's granted, even before it's granted, you have to maintain the application, and then the application moves once it's granted each year or every two or three years depending on the country, you have to pay a renewal fee. And each every two or three years, that fee tends to go up.

36:13 And at the end of twenty years, the patent expires. There are some extensions of there are some instances where a patent may be a little longer like in The US, but if the US patent office take a long time to review a patent, they may extend the life of the patent at the end mindful that they took so long to review the document. But otherwise, normally, you're looking at twenty years from a PCT application. So in the case of the 2019 patent for MED three thousand, that was filed in 2019, moved into PCT applications in 2020, and you're looking at a lifetime of, therefore, if granted between 2039 and 2040. The 2028 patent relates to MED two thousand five, which was a different formulation that contained an active FUM two ingredient. So the MED three thousand patent, which covers Iroxan, was filed in 2019.

37:10 So that should, if granted, take us out to 2039, 2040, give or take. Okay. I think this one is for me, James, but you might wanna add to it once I've answered it because it's fairly fairly detailed. The share price is a litmus test of a company's success. Two years ago, after EU approval of MED 3,000, FUTURA share price topped 80 p. Today, it's less than 50 p. What's your view of this decline? What steps are you taking to improve share price performance? So, yeah, this is a bit of a detailed one. So first of all, I would just like to say, I think James, I, Ken, we're all as frustrated with the share price as as what you guys are.

37:59 You know, the market is a very, very different place today to where it was two years ago when we had the approval of of of MED. But that being said, I think the performance of of of the company in the last twelve to eighteen months, pretty much everything that we've said we're gonna deliver, we have delivered, and we've usually delivered it either on time or sooner than expected. And, you know, we've we've we've not we've not compromised on that. In terms of steps that we are taking to improve share price performance, well, first of all, we're we're ensuring that we continue to deliver on everything that we say we're going to deliver on. You know? And our focus at the moment is ensuring that our commercial partners do what they say they're going to do in terms of making the launch of a success. So that's the first thing.

38:55 The second thing is is we're we're out, and we're talking to potential investors a lot at the moment. You know, the company is going through a huge transition, especially, you know, yesterday, we reported our first revenues. We have also reported a a a clear pathway that we have to to profitability on a really cautious basis, I might add as well. You know, that that pathway to profitability is only based on what we can see coming out of the EU and The Middle East and doesn't you know, it doesn't factor in any upside from any of the other regions. So, you know, as we transition into, you know, revenue generating on the path to profitability, the the profile of the company changes.

39:42 And the profile of the company in terms of investor profile also changes. And we need to make sure that, you know, new investors that would look at a company with a different profile that we're moving into are aware of us. But these things take time. You know, you don't meet with one large institutional investor, and then the next morning, they start wanting to buy stock in the market. These things take time. The results that we put out yesterday will be helpful. The updated research that came out from both of our in house analysts is also very helpful because it does set out, you know, our our pathway. And that's all that we can do. We can't do anything about, you know, externally the conditions in the market, but we can continue to deliver. We can continue to make sure our partners deliver, and we can continue to make sure that institutional and and and retail investors are aware of what we're doing.

40:39 That's that's that that's where our focus is. I don't know if you wanna add anything to that, James. No. I think you pretty much summed it up, Andrew. I mean, I I think the only thing I would say is if you look at the performance of AIM as a market over the last year or two and you compare that against our performance, we've we've done well. Though, again, I absolutely agree with everything you say and and, obviously, fully understand investors' frustration at the share price. You You know? Know? We thought it would be hard, but it it is what it is, and we're working to address that. I think the other thing that I probably would add to that, which which is slightly linked, is, you know, from a balance sheet perspective, we have no debt. We have a strong cash balance. We've we've said that the, you know, existing cash is sufficient to get us, you know, beyond The US launch, which we we haven't come out and and appreciate. We haven't said the the timing of that.

41:30 But, you know, I'm very, very comfortable where we are in a cash position. So, you know, it does take a bit of pressure off. There are a lot of companies out there at the moment that fundamentally, you know, they've they've got really strong fundamentals in the business, but they do not have the the cash flow to be able to, you know, implement and execute their strategy. We are we are in a fortunate position in terms of cash because, you know, we're not looking to go out and and and and raise any any funds on a on a desperate basis. So and I think that has been helpful in terms of, you know, being able to maintain where our share price is today. But other than that, you know, we we just have to continue doing what we're doing and continue banging that drum and continuing delivering. Okay.

42:17 Are partners under obligation to launch within a certain time frame? Yes. Yeah. I think it's a short answer. Yes. They are. The one caveat I've put on that is obviously depending on the country, there may be regulatory constraints, I. E, products not approved in that market. But in the case where product is not approved, then there are obligations around trying to get regulatory approval. And then once regulatory approvals agreed, there are obligations around when they must launch. So, yes, there are timelines in all instances. K. In regard to the share price, it does feel that Lombard are selling down. What is the relationship here as the downside with such large institutional investor is the fact that they can have large control over stock movements?

43:05 Well, first of all, if if Lombard were selling or buying in any significant volumes, there would be a t r one issued. So you would you would see that. I I don't know what Lombard are doing, but I haven't seen a t r one as of this point now. You know, Lombard have been an incredibly supportive and long term shareholder, but, you know, they they have their own interests to to look after. And, you know, we have no reason to believe that they won't continue to be supportive and take a longer term view. But there's not a lot that we can we can do to control what they decide to do when trading stock. What what I can say is that all of the other things that we're doing in the background in terms of talking to other investors, that that's the part that we can control.

43:57 But as I said, I've got no reason to believe that Lombard don't don't continue to be supportive with a longer term view. Can we take a cautious view on margins given 1,700,000 revenue and nought point nine profit, which is a healthy margin on sales? I'm I'm not sure I fully understand that question. But given that we have, you know, just brought another CMO on stream, I've got no reason to believe today that margins will will differ from from, you know, significantly from where they are now. I hope that answers the question. Are you able to comment on why the institutional investors sold 4,000,000 in warrants?

44:46 How much interest is there in institutional investors wanting to invest? I mean, Angela, let me just answer that. Yeah. And reality was that at the time, we did a fundraise a number of years ago when, you know, the company was you know, the share price was around, I think, $7.08 p. Part of the condition of Lombard to basically support, and to be frank, maintain the survival of the company because we we were pretty tight on cash in those days, was they wanted warrants at 40 p. And those warrants would have expired, I think, next year, and they exercise them after the FDA approval from from a financial perspective. You know, Andrew's already commented on that, but they are the only they are the only warrants that were that were ever granted. There are no further warrants that are being that that are an issue.

45:44 So so that was kind of done and done done and dusted. It's only provided cash flows, which which is, you know, helps the the balance sheet. How much interest that is there in institutional? Yes. We're working, talking, as Andrew said, to a number of institutions at the moment. That is what we can do. And, you know, as long as we keep delivering, we think there's well, there is growing interest from institutions. But they won't invest overnight, and and it's sort of work in progress. Will there be any further launches in '24 other than Europe and The Emirates? Yes. We we think that that's highly likely, but at this stage, we're not gonna come any further than that. Can you give a timeline for The USA launch? I think we touched upon this earlier.

46:30 Currently, no. We can't. As soon as possible. But as Andrew said, are a lot lot there's a lot of lot of ducks you gotta put in a row if you like, and we're working very closely with Hayden to to to do that. Fantastic. Thank you. Look, you have covered off every question that we've had come through. And, of course, any further questions that do come in, the team will be able to review those, and we'll publish responses where appropriate to do so on the investor meet company platform. James, before redirecting investors to provide you with the feedback, which I know is particularly important to you and the team, can I just ask you for a few closing comments? Well, yes. I I think well, thank you all for joining. This is kind of for us. Yeah. This is our second investor meet presentation, and, hopefully, investors find it helpful. I appreciate certainly, for retail investors, at times, it can be a little frustrating trying to get hold of management.

47:22 And, certainly, this is something that both Angela and I, you know, are planning to do in the future so that there can be more interaction, and we can certainly do our best to answer the questions that you you send in, mindful of, obviously, commercial sensitivities and what we can and can't say on the source market regulation. So I think we're ready to say thank you very much for attending, and we look forward to speaking to you again in the not too distant future. Fantastic. James, Angela, thank you indeed for updating investors today. Could I please ask investors not to close the session? Should be automatically redirected to provide your feedback in order the management team can better understand your views and expectations. This will only take a few moments to complete and I know it's greatly valued by the company. On behalf of the management team FUTURA MEDICAL PLC, we'd like to thank you for attending today's presentation. That concludes today's session and good morning. Thank you.