Futura Medical plc (FUM) Earnings Call Transcript & Summary

Good morning, and welcome to the Futura Medical Plc Interim Results Investor Presentation. [Operator Instructions] Before we begin, I'd like to submit the following poll. I'd now like to hand you over to James Barder, CEO. Good morning.

I'm James Barder, I'm the CEO of Futura Medical, and I'm also joined today by Angela Hildreth, who is the Finance Director and COO of Futura. I would just like to say Angela is suffering from the BA.2.86 variant of COVID. 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 amnesty company. We're based at 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. Our real skill set is around applying skin science, obviously, 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 very experienced management team. And this year, as I'll talk on a little bit later. We've had a really good start to the year and delighted the way things are going. MED3000 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 it's maintained, if you like, is its fast onset of action, and we can make the claim it helps you get an erection within 10 minutes. Delighted to report, and Angela will talk about this a little bit later. Our first revenue since the launch of MED or Eroxon as it's called under its brand name for 3 months this year in U.K. and Belgium, and also delighted to talk a little bit more about what is going to happen moving forward as the next planned launches go ahead with launches in 10 different countries. This year, certainly, we've been very much achieving our key strategic updates and the 4 that we look at here, FDA approval, which was a big, big win for us, a phenomenal job done by our small R&D team, who are very hard working, but highly specialized. Agreement with Haleon signed admittedly 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 Angela and I further on in the slide. 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 U.S., initial successful launches. And we've also, for that matter, appointed a 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. Eroxon 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've 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 10 minutes. The current regulatory status, as I said, it is now approved in the U.S., EU, U.K., 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 PDE5s and they do require a doctor's prescription in pretty much every market. The U.K. is actually the exception. But even the U.K., if you want to go and buy Viagra, you had to go through an algorithm of a number of questions. In the case of Viagra, 17 questions you may have to answer before the pharmacists can hand you the product. In the case of Cialis, I believe it is up to 41. 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 6 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 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 central health products. 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 MED3000 does have novel and inventive steps, which is key in the approval process. And once granted, that will provide us with protection up to 2040. The U.S. marketing authorization contains special controls. This means that any competition would have to basically adhere to certain requirements in this and meeting certain safety and effective standards before they will be able to launch a product and in the case of us, that takes many years and a lot of time and expense. And that is, of course, assuming that we didn't have a patent. We are looking to launch wherever possible under the Eroxon brand, but that is very much dependent on the regulatory [ parlance ] in those countries as well as what our commercial partners wish to do.

Good morning, everyone. As most of you will be aware, Eroxon launched in the U.K. and Belgium in April. The U.K. and Belgium launch was a full launch backed up with full PR, advertising, promotion and the product was initially sold in Boots in the U.K. 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. The product is now available with other retailers in the U.K., and we expect that over 2,500 stores will stock Eroxon in the U.K. 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 suggest that we currently have secured around a 20% market share in the U.K. and Belgium across all clinically proven ED treatments. The feedback also suggests that sales of Eroxon have been predominantly incremental, which is pretty much as we expected, given the product's key differentiators and the market research that suggested Eroxon would build a new category in ED treatments. And again, very early days, but we are starting to see early signs of repeat purchase data coming through and both Futura and Coupa have received a very low level of complaints about the Eroxon 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 healthcare 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 U.K. by the end of 2023. And lastly, ensuring awareness through PR, advertising both on TV and in stores. 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 6 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, the launch readiness criteria partners recognize that key opinion leader in healthcare professional endorsement and education is highly important when it comes to the product, the credibility of Eroxon. They have to be mindful of cultural differences and regulatory requirements within each country. They have to ensure that leading retailers and online platforms are ready to stock Eroxon and that we have a supply chain to cope with the demand surge. And we previously reported a stock out of boots after day 5 of launch. This was easily rectified, but we were dealing with 1 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. 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 U.K. with Cooper Consumer Healthcare. There's an agreement in place for Latin America with m8 Pharmaceuticals. In the Middle East with Labotec, who have their launch planned in Q4 this year. South Korea with Menarini Korea and most recently, the U.S. with Haleon, one of the biggest consumer healthcare companies in the world. We have also confirmed that we have now terminated our agreement with Co-High on the basis of nondelivery 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. All of the commercial agreements contain KPIs relating to regulatory submission 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 Eroxon as a brand. And we've already appointed a second CMO to provide additional capacity in 2024.

Thank you, 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 Ipsos a couple of years ago, very much said that. So 73% of men would not -- are not currently on treatment. And therefore, a product that with the key differentiators that Eroxon have, it does not come with 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, again, this is again going back to the Ipsos research, what we've seen, the key areas where we believe we're seeing interest. Though again, it is early days. But we've got those men who are diagnosed that are not treating because they don't like PDE5 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. And I think that's -- and in some instances, it's probably almost too embarrassed to go into a shop to buy a product. And certainly, we're seeing with the sales to date, it's roughly split 50-50 between retail sales and online sales. And then the newer segments, the younger men, there was a research recently done, which showed up to 14% of men between the ages of 18 and 31 are suffering from a degree of a erectile dysfunction. And again, a product like this, which is very safe, there's real interest for. And then finally, this is the first time you've got a treatment that can actually be bought by the female partner even in U.K. where Viagra and Cialis are available over the counter albeit that there a 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 talked about during 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. And then in turn, 90% of those partners said that if they're female partner brought the product home, they would be prepared to try. So 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 U.S., which is the largest potential OTC market. Again, part of the Ipsos research that was done, again, this was also shared back in June seminar, their sort of analysis, and it was based on certain key assumptions, were looking at sales -- peak sales are potentially worth $409 million. So there is a significant opportunity there. I know one of the things a number of people are concerned about is that as Viagra and Cialis become generic, the cost of buying the product has dropped dramatically and will that have an impact where effectively, a patient can probably go out and buy a tablet of Viagra for a dollar. Reality is in the states, the largest market when you take into account the out pocket cost that those men have to incur by going to see a doctor, including the doctor's visits, you're looking in 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 [ cure ]. So even at $5 a dose and you're looking at -- well, there are different estimates, the peak sales estimates for [ down at 55 tubes used a year ] versus the research that also said that on average, ED men have 70 intercourse events a year, this is a treatment that is highly affordable. Angela.

Well, despite being absolutely bloated with COVID, I'm very happy to report first significant revenues generated in the 6 months ending June 2023. Revenues reported of GBP 1.7 million are wholly related to sales of Eroxon to our commercial partners, and this has generated a gross profit of just under GBP 1 million. As the Eroxon launch continues to roll out to other countries, we do expect to see those revenues rise. Net loss in the period was GBP 1.7 million compared to just under GBP 2.5 million in the period 2022. We have released RNS 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. That is based on expected sales coming from the EU and the Middle East. And with the exception of an upfront payment, which I'll touch on in a moment, does not include any estimates relating to product sales or royalties from product sales in the U.S. Cash resources at the end of June were GBP 7.8 million, reflecting the receipt of GBP 1 million R&D tax credit for the '22 claim. We also received GBP 4.38 million from an institutional investor who exercise warrants at a price of 40p per ordinary share. 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 million upfront payment that we received from Haleon. So if we look to the cash balance at the end of August, we had a cash balance of circa GBP 9.3 million. And I just want to confirm that we also do not have any debt in place. Finally, to summarize, we're really excited to see further Eroxon launches planned during '23 and be able to see increasing numbers of ED sufferer have access to Eroxon. We expect to be able to reach a breakeven position in '24 and become profitable in 2025, and that is excluding any royalty income from the U.S. 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&A.

Thank you very much indeed for the presentation. [Operator Instructions] Angela, if I could just hand over to you just to read out the questions where appropriate to do so and give your response and I'll pick up from you again.

Will do. Thank you. Good morning, everybody. Okay. I'm going to move straight into the first question. James, I think you can answer this one. You mentioned the stock out. How are you planning to manage the supply and demand balance?

I mean, it's a challenge because obviously, this is a new category. And as such, 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 U.K. there's challenge, the stock outing within 5 days. So what do we do? Well, obviously, we learn. The learnings from the initial launches give you guidance on original forecast. But perhaps more importantly, it's managing the contract manufacturing organization. So we have sufficient capacity in the pipeline ahead of any launch to manage just that. We've now actually taking on a second contract manufacturer to give the supply chain more robustness. And it's just saying that we'll watch and we do expect the need to add further manufacturers in due course. Having 2 or 3 not only provide you with a bit of pricing competition between them, but obviously, if anyone had a fire or there was an issue there, then it doesn't mean that you've got other options available to you. So it's time that we learn and we keep close tabs on. The old stock out is actually not a bad thing. If suddenly a product doesn't become available, then people turn and 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 want to have large stock outs wrong time, but it does show that product's [indiscernible] .

Thanks, James. Are there any minimum sales requirements from partners to maintain the agreements you have?

I can't really say too much specifically on the agreements other than say in all agreements we've signed to date there are minimum key performance indicators. And those can range from a number of things. Volumes, E&P spend, timelines and there are a number -- 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 we've had significant approaches for the rights in different markets. And in that selection criteria, obviously, yes, the economics are very important. 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 rocks on is, yes, it ticks all the boxes from a -- all the research that we've done shows strong consumer intent to buy, ticks all the boxes, speed, safety and pretty reasonable efficacy, but you still then got this kind of challenges actually people are going to go out and buy the product. So yes, 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 counted very heavily in selection of commercial partners.

Okay. So I think the next question is for me, James. Given the company appears to be taking no revenue from U.S. in 2024. Do we assume launch on shelves, so to speak, in U.S., 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 U.S. and given it to the market on any time period in relation to the American commercial deal. One, our commercial partner has asked us to be particularly cautious in disclosing any information when it comes to the timing of this launch. And two, there is a lot to do. The U.S. is a big region. Logistically, you're launching the products on a bigger scale across more retailers. And both us and the commercial partner wants to ensure that we have the manufacturing capacity to be ready to launch without having any stocking issues upon that launch, and that just takes a bit of time. The U.S. is a very, very big country. It's a very big market. There are a lot of retailers. So that, along with all of the other activities in relation to the U.S., it's just going to take a bit of time. That being said, Haleon have said that they're excited about this opportunity. They are going to launch as soon as they possibly can. We just, at the moment, can't be drawn into whether that is going to be in 2024 or not. So 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 want to add anything to that? Or do you think I've covered it.

I think the only other thing I'd add is that the U.S. market is different to the U.K., where, if you like, the U.K., we're able 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. So as Angela said, that 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 somebody says an extension, I'm not quite sure what they mean. We have filed a new patent around MED3000 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 then can be considered for patent proof or to be granted a notice of allowance. In the case of MED3000, we filed an initial application in 2019. I won't -- can't go through the whole process. 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 there are novel and inventive steps to the patent. So we remain optimistic that we will be granted a notice of allowance and the patent will proceed to approval. When I can say more to the market, we will do that. As far as we've actually now got onto the PCT application, we far thinking around about 30 countries. And all of those will be going through process 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 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 a repeat order data have been obtained from?

Where is the repeat.

The repeat purchase data that we've released in the RNS to say that we've had an initial indication of repeat purchase. I can answer this. So we've had that indication from our commercial partner. But repeat purchase data for this product is actually it's quite difficult to get a hold of. And then by the time you have it, it's not always as kind of as a recent data as you would like. Our commercial partner is working with the retailers on trying to get more data and in a more -- in a faster way. And we want to say that these are early days and that 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 loyalty cards, so boots have their advantage card. Unfortunately, a lot of men don't own loyalty cards or don't use them. They're predominantly used by females and whilst we know that females are going and buying the products on behalf of their partners, clearly, the product is intended for men to buy. And if they don't use their loyalty card, it's very difficult to assess whether their, what their repeat purchase level is. So I think our partners are working with the retailers to see if they can get more information. And if we have more information, we will update you in due course. James, moving on to the next one. This one is for you. Can you please quantify the level of complaints regarding efficacy raised? And why do you think the online reviews are poor?

Okay. Yes, to quantify, and I think I said it yesterday, around about 200,000 packs have been sold. We've obviously distributed more than that, but around 200,000 packs have been sold. And I think at the latest count, we had between -- around about 70 complaints, of which I'd say 60 related to efficacy. For them, the product doesn't work, whereas the other 10 are side effects, all very minor. So 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 generally write reviews when they are happy about something. . So I think we've had about 380. If you're referring to the boots reviews, I think there have 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 responses tend to be pretty binary, either people like the product as it works or they don't like the product because it doesn't work. So this is obviously something that we are still working on. I think for us, the key thing here is to be able to manage patient expectations. Obviously, as an over-the-counter product, there is no interaction with the doctor. Whereas if a man is prescribed Viagra or Cialis, the doctor at the time of prescription will be able to turn around and say, look, efficacy for this is around about 70%, 75%. You might have 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 a solution for everybody. The clinical data clearly shows a 65% efficacy rate. And to 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 by watching news and was disappointed he didn't get an erection. It needs to be understood that you do require sexual stimulation and in some instances, foreplay. And so it's really just managing their expectation. And I think this is one of the learnings that we've had. Yes, we've had a number of reviews which are negative, but it's not really transposing in the amount of volume that we're selling. And certainly, the written feedback that we're getting is mindful that product works in around about 2/3 of the men and we've had a very low level of complaints.

I think as well, part of the learnings, particularly in the U.K. 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. It can be a bit of a double-edge sword. You -- the PR that you garner within some of the more credible newspapers is great because it raises awareness 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 really not be helpful when it comes to managing that expectation. And as James touched upon, there is a bit of a misconception, I think sometimes that this is a magic solution. So part of the learnings that Cooper are going to take into the other markets are in managing those expectations, not only in terms of what the product is intended for and what it can do for 65% of men, but also in the fact that 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. If you've got erectile dysfunction 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 if anyone has seen our Capital Markets Day presentation, we had 2 doctors who both run sexual health clinics, and they both have said that even with PDE5, 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 -- their bodies and their system to kind of get into having sex again. So it may take more than one application. And we definitely saw that with more applications of the product in the clinical trials, efficacy did improve. And I think we have to make sure that the commercial partners are managing those expectations, but also educating consumers in terms 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, and that is something that they're looking at going forward. Hopefully, that's answered that question. James, just another clarification on the patent. Regarding patent, we were told a patent was in place up to 2028. And why did you say there was no extension. I think it's probably important that we just distinguished this because this seems to be kind of an ongoing theme of confusion, doesn't it?

Yes. I think the 2028 refers to the old MED2005 patents. Patents cannot be extended. A patent when it is applied for has up to a 20-year life. Each year, you have to maintain that. Once it is 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 2 or 3 years depending what country, you have to pay a renewal fee and each -- every 2 or 3 years, that fee tends to go up. And at the end of 20 years, the patent expires. There are some extensions -- there are some instances where a patent may be a little longer, like in the U.S. But if the U.S. patent office takes 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 20 years from a PCT application. So in the case of the 2019 patent for MED3000. That was filed in 2019, moved into PCT applications in 2020, and you're looking at a lifetime therefore, if granted between 2039 and 2040. The 2028 patent relates to MED2005, which was a different formulation and content an active, pharmaceutical ingredients. So the MED3000 patent, which covers Eroxon was filed in 2019. 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 want to add to it once I've answered it because it's fairly detailed. The share price is a litmus test of a company's success. Two years ago, after EU approval of MED3000, Futura share price topped 80p, Today, it's less than 50p. What's your view of this decline? What steps are you taking to improve share price performance? So yes, this is a bit of a detailed one. So first of all, I would just like to say, I think James, I can, where all is frustrated with the share price is what you guys are. The market is a very, very different place today to where it was 2 years ago when we had the approval of MED. But that being said, I think the performance of the company in the last 12 to 18 months, pretty much everything that we've said we're going to deliver, we have delivered, and we've usually delivered it either on time or sooner than expected. And 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 ensuring that we continue to deliver on everything that we say we're going to deliver on. 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 Eroxon a success. So that's the first thing. The second thing is where are -- and we're talking to potential investors a lot at the moment. The company is going through a huge transition, especially yesterday, we reported our first revenues. We have also reported a clear pathway that we have to profitability. On a really cautious basis, I might add as well, that pathway to profitability is only based on what we can see coming out of the EU and the Middle East and it doesn't factor in any upside from any of the other regions, so as we transition into revenue generating on the path to profitability, the profile of the company changes and the profile of the company in terms of investor profile also changes. And we need to make sure that 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 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 our pathway. And that's all that we can do. We can't do anything about 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 retail investors are aware of what we're doing. That's where our focus is. I don't know if you want to add anything to that, James.

No, I think you pretty much summed it up, Angela. I mean I think the only thing I would say, if you looked at the performance of AIM as a market over the last year or 2 and you compare that against our performance. We've done well. Though again, I absolutely agree with everything you say and obviously, fully understand investors' frustration to share price. We thought it would be high, but it is what it is, and we're working to address it.

And I think the other thing that I probably would add to that, which is slightly linked is from a balance sheet perspective, we have no debt. We have a strong cash balance. We've said that the existing cash is sufficient to get us beyond the U.S. launch, which we haven't come out and appreciate we haven't said that the timing of that, but I'm very, very comfortable where we are in a cash position. So it does take a bit of pressure off. There are a lot of companies out there at the moment that fundamentally, they've got really strong fundamentals in the business. But they do not have the cash flow to be able to implement and execute their strategy. We are in a fortunate position in terms of cash because we're not looking to go out and raise any funds on a desperate basis. So -- and I think that has been helpful in terms of being able to maintain where our share price is today. But other than that, we just have to continue doing what we're doing and continue banging that drum and continuing delivering. Okay. Are partners under obligation to launch within a certain timeframe?

Yes. I think is a short answer. Yes, they are. The one caveat I put on that is obviously depending on the country, there may be regulatory constraints, i.e., product is not approved in that market. But in the case where the product is not approved, then there are obligations around trying to get regulatory approval and then once regulatory approval is agreed, there are obligations around when they must launch. So yes, there are timelines in all instances.

Okay. 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 institution investors, the fact that they can have large control over stock movements? Well, first of all, if Lombard were selling or buying in any significant volumes, there would be a TR1 issued, so you would see that. I don't know what Lombard are doing, but I haven't seen a TR1 as of this point now. Lombard have been an incredibly supportive and long-term shareholder, but they have their own interest to look after. And 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 do to control what they decide to do when trading stock. 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's the part that we can control. But as I said, I've got no reason to believe that Lombard don't continue to be supportive with a longer-term view. Can we take a cautious view on margins given 1.7 million revenue and 0.9 million profit, which is a healthy margin on sales? I'm not sure I fully understand that question. But given that we have just brought another CMO on stream, I've got no reason to believe today that margins will differ significantly from where they are now. I hope that answers the question. Are you able to comment on why the institutional investors sold 4 million in warrants? How much interest is there in institutional investors wanting to invest?

Angela, let me just answer that one. The reality was that at the time we did a fund raise a number of years ago when the company was -- the share price was around I think [ 7p or 8p]. Part of the condition of Lombard to basically support and to be frank, maintain the survival of the company because we were pretty tight on cash in those days was they wanted warrants at 40p. And those warrants would have expired, I think, next year and they exercised them after the FDA approval from a financial perspective, and Angela has already commented on that. But they are the only -- they are the only warrants that were granted. There are no further warrants that have been -- that are an issue. So -- so that was kind of done and dusted. It certainly provided cash flows, which is -- helps the balance sheet. How much interest is there in institutional? Yes, we're working, talking, as Angela said, to a number of institutions at the moment. That is what we can do. And as long as we keep delivering, we think there's -- well, there is growing interest from institutions, but they won't invest overnight and it's sort of work in progress.

Will there be any further launches in '24 other than Europe and the Emirates?

Yes. We think that is highly likely. But at this stage, we're not going to comment any further than that.

Can you give a timeline for the U.S.A. launch? I think we touched upon this earlier. Currently, no, we can't.

As soon as possible. But as Angela said, there's a lot of ducks you've got to put in a row, if you like, and we're working very closely with Haleon to do that.

That's fantastic. 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 publish responses where appropriate to do so on the Investor Meet Company platform. James, ma'am 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 think we'll thank you all for joining. This is kind of, for us, 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. And so it is something that both Angela and I 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 send in mindful of, obviously, commercial sensitivities and what we can and can't say on the stock 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 to you all.