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&A tab situated on the right-hand corner of your screen. Simply click Q&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 will 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.
I'm James Barder. I am 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 at the moment, so if her voice sounds a little off-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 outsource infrastructure, which includes not only contract manufacturing, but 30 consultants. Our real skill set is around applying skin science, obviously, to 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 with 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 its main claim, if you like, is its fast onset of action, and we can make the claim, "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 on its brand name, for 3 months this year in U.K. and Belgium.
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, or certainly, we've been very much achieving our key strategic objectives, and the 4 that we look at here. FDA approval, which was a big, big win for us.
You know, phenomenal job done by our, our, our small R&D team, who are very hardworking 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 supply, and also strengthening the supply chain. This is really just a summary of, obviously, of the highlights, and we will be talking more, both Andrew and I, further on in the slide.
But as we 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 the supply chain. First revenue, but again, I'll let Andrew talk a little bit more about that in due course.
Eroxon is the first topical gel that's clinically proven to treat ED in adult men. As I 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.
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., E.U., 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, 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 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. 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 gonna, you know, 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, you know, OTC sexual 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 out to 2040.
The U.S. market authorization contains special controls. This means that any, any competition would have to basically adhere to certain requirements in this, and meeting certain safety and effective standards before they'll be able to launch a product. 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 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 requirements 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 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. The product is now available with other retailers in the UK, and we expect that over 2,500 stores will stock Eroxon 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 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.
Very early days, but we are starting to see early signs of repeat purchase data coming through, and both Futura and Cooper have received a very low level of complaints about 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 UK 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 2023 and into 2024, 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. Just to touch on that, you know, the launch readiness criteria, partners recognize that key opinion leader and 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 search. We previously reported a stock out at Boots after day 5 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. 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, 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 Health. There's an agreement in place for Latin America with M8 Pharmaceuticals, in the Middle East with Labatec, who have their launch plans 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 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.
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, you know, the key thing that's come out of the launches is that sales are largely incremental. You know, 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.
That, you know, 73% of men, you know, are not currently on treatment, and therefore, a product that with the key differentiators that Eroxon 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 is again, we are going back to the Ipsos research, what we're seeing, the key areas where we believe we're seeing, you know, interest, though, again, it is early days. But we've got those men who are diagnosed and 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, 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 that shows up to 14% of men between the ages of 18 and 31 are suffering from a degree of erectile dysfunction. Again, a product like this, which is very safe, there's real interest for. Finally, this is the first time you've got a treatment that can actually be bought by the female partner.
Even in the U.K., where Viagra and Cialis are available over the counter, albeit that there are a number of questions that need to be asked, a woman would not be allowed to buy that product. It 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 their female partner brought the product home, they would be prepared to try it.
So a very significant opportunity here, and, you know, 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, you know, 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, we're 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, 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 tablet of Viagra for $1?
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 of between $600 and $3,500.
The $3,500 being for a patient that obviously wants to buy a branded Viagra, whereas $600 is for a patient who's prepared to have a generic form. So even at $5 a dose, and you're looking at... Well, there 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. This is a treatment that is highly affordable. Angela?
Hi. Well, despite being absolutely loaded with COVID, I'm very happy to report first significant revenues generated in the six 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 a RNS this morning, and we have stated that we do expect to be around breakeven in 2024, 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 US.
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 2022 claim. We also received GBP 4.38 million from an institutional investor who exercised 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 up-front 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. F
inally, to summarize, we're really excited to see further Eroxon launches plans during 2023, and be able to see increasing numbers of ED sufferers have access to Eroxon. We expect to be able to reach a breakeven position in 2024 and become profitable in 2025. That 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. Ladies and gentlemen, do please continue to submit your questions using the Q&A tab situated in the right-hand corner of your screen. To take Q&A, type in your question and press Send. Just while the team take a few moments to review those questions already submitted today, I'd like to remind you that the recording of the presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor dashboard.
As you can see, we, 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 your response, and I'll pick up from you at the end. Thank you.
I will do. Thank you. Good morning, everybody. Okay, I'm gonna move straight into 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?
I mean, it's a challenge because obviously this is a new category, and as such, it's not. We don't always know. We have a lot of forecasts and analysis, but as a brand-new category, you don't really know until you launch. We saw certain UK, you know, this challenge, the stock-out, I think, within five days. So what are we doing? 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 that we have sufficient 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 anyone had a fire or there was an issue there, then it does mean that you've got other options available to you. So it's something that we learn and we keep close tabs on. You know, the odd stock-out is actually not a bad thing. You 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 wrong time, but it does show that products selling. You're on mute, Angela.
Thanks, James. Are there any minimum sales requirements from partners to maintain the agreements you have?
We-- I can't really say too much, specifically on the agreements, other than saying all agreements we've signed to date, there are minimum key performance indicators. Th-those can range from a number of things: volumes, A&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. 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, 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 Eroxon is, yes, it ticks all the boxes from a, 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 pretty reasonable efficacy. But you've still then got this, this kind of challenge: 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 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 the U.S. in 2024, do we assume launch on shelves, so to speak, in the U.S., not until much later in 2024, as any sooner a view 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, you know, particularly cautious in disclosing any information when it comes to the timing of this launch. And two, you know, there is a lot to do. You know, the U.S. is a big region.
Logistically, you know, 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 that just takes a bit of time.
You know, 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 relation to the US, it is just gonna take a bit of time. That being said, you know, Haleon 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'd add is, is that the U.S. market is different to the U.K., where, if you like, the U.K., 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. 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 patents, 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 can then be considered for patent approval or to be granted a notice of allowance.
In the case of MED3000, we filed an initial application in 2019. I won't kind of 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 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 the—we've actually now, again, under the PCT application, we've filed, I think, in 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 been obtained from?
Where is the repeat?
The repeat purchase data that we've released in the RNS to say that we've had a, you know, an initial indication of repeat purchase. I can answer this. So 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, and then by the time you have it, it's not always 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 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 while we know that females are going and buying the products on behalf of their partners, clearly, you know, 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, 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 if we have more information, 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 obviously distributed more than that, but around 200,000 packs have been sold. And I think at the latest count, we had between 70, but around about 70 complaints, of which I'd say 60 relate to efficacy. 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 the 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 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 'cause it works, or they don't like the product 'cause 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 a, 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, you know, efficacy for this is around about 70%-75%. 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 our 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 65% efficacy rate.
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 there watching the news and was disappointed he didn't get an erection. Yeah, it needs to be understood that you do require sexual stimulation, and in some instances, foreplay.
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 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 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. 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 'cause it raises awareness, but it also could-- can really, not be helpful when it comes to managing that expectation.
As James touched upon, you know, there is a bit of a misconception, I think, sometimes, that this is a magic solution. You know, part of the learnings that Cooper are gonna 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 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. 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 I, you know, 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 PDE5s, 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 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, you know, with more applications of the product in the clinical trials, efficacy did improve. And I think, you know, we have to make sure that the commercial partners are managing those expectations, but also, you know, 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. 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. Why did you say there was no extension? I think it's probably important that we just distinguish this, 'cause this seems to be kind of an ongoing theme of confusion, doesn't it?
Yeah, I think the 2028 refers to the old MED2005 patent. 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'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, and at the end of 20 years, the patent expires.
There are some instances where a patent may be a little longer, like in the U.S., where if the U.S. 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 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 of therefore, if granted, between 2039 and 2040. The 2028 patent relates to MED2005, which was a different formulation that contained an active pharmaceutical ingredient. 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 wanna answer it once I've answered it, 'cause it's fairly, fairly detailed. The share price is a litmus test of a company's success. Two years ago, after EU approval of MED3000, Futura's 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, yeah, this is a bit of a detailed one. So, first of all, I would just like to say, I think James, Ken, we're all as frustrated with the share price as what you guys are. You know, the market is a very, very different place today to where it was two years ago when we had the approval of MED.
But that being said, I think the performance of the company in the last 12-18 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 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. 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 Eroxon a success. So that's the first thing.
The second thing is, is 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 clear pathway that we have to profitability on a really cautious basis, I might add as well.
You know, 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 profile of the company changes, and the profile of the company, in terms of investor profile, also changes.
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.
You know, 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. You know, 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, Angela. I mean, 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 done well. Though, again, I absolutely agree with everything you say and obviously fully understand investors' frustration with the share price. You know, we thought it would be hard, but it is what it is, and we're working to address it.
I think the other thing that I probably would add to that, which is slightly linked, is, you know, from a balance sheet perspective, we have no debt. We have a strong cash balance. We've said that the, you know, existing cash is sufficient to get us, you know, beyond the U.S. launch, which we haven't come out and, and appreciate, we haven't said the timing of that.
You know, I'm very, very comfortable where we are in a cash position. 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 got really strong fundamentals in the business, but they do not have the cash flow to be able to, you know, implement and execute their strategy.
We are in a fortunate position in terms of cash because, you know, 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, 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, are partners under obligation to launch within a certain timeframe?
Yes. I think it's a short answer, yes, they are. The one caveat I'd put on that is obviously, depending on the country, there may be regulatory constraints, i.e., product's 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 institutional investors is 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 TR-1 issued, so you would see that. I don't know what Lombard are doing, but I haven't seen a TR-1 as of this point now. You know, Lombard have been an incredibly supportive and long-term shareholder. You know, they have their own interests 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 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 GBP 1.7 million revenue and GBP 0.9 million profit, which is a healthy margin on sales? I'm not sure I fully understand that question.
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, 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 GBP 4 million in warrants? How much interest is there in institutional investors wanting to invest?
I mean, Angela, let me just answer that.
Yeah.
The reality was that, at the time, we did a fundraise a number of years ago, when, you know, the company was, the share price was around, I think, 7, 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.
Those warrants would have expired, I think, next year, and they exercised them after the FDA approval. From a financial perspective, you know, Angela's already commented on that, but they are the only warrants that were, that were ever granted. There are no further warrants that have been... That are an issue.
So that was kind of done and dusted. It's only provided cash flows, which is, you know, 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, 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 it's a work in progress.
Will there be any further launches in 2024 other than Europe and the Emirates?
Yes, we think that that's highly likely, but at this stage, we're not going to comment any further than that.
Can you give a timeline for the USA launch? I think we touched upon this earlier. Currently, no, we can't.
As soon as possible. But as Angela said, there are a lot of ducks you got to put in a row, if you like, and we're working very closely with Haleon to do that.
That's fantastic. Thank you. You have covered up 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 is particularly important to you and the team, can I just ask you for a few closing comments?
Well, yes, I think... Well, 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 a hold of management.
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 under stock market regulations. 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. Can I please ask investors not to close the session? You 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.