Futura Medical plc

I'm James Bader, I am the CEO of Futura Medical, and I'm also joined today by Andra Hildreth, who is the finance director and COO of Futura. I would just like to say Andra is suffering from the BA286 variant of COVID at the moment, so if her voice sounds a little afk, that is the reason why. First of all, I'd just like to give a brief corporate overview of the company. Putura is an A-listed company. We're based at the research park in Guildford, and we describe ourselves as a virtual organisation. 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 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 for 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 US. 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 in Oiroxon, 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 plan launches goes ahead with launches in 10 different countries. This year, certainly, we've been very much achieving our key strategic objectives. 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&D team who are very hardworking but highly specialized. Agreement with Halion 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 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 US, 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 Angela talk a little bit more about that in due course. Iroxon is the first topical gel that's 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 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. Again, just a little bit about the innovation pipeline. I'm not actually going to talk very much about 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 drive the pipeline. And in particular, we're getting strong interest from our distributors, but not only product extensions, but also innovation in a new exciting new category of OTC sexual health products. intellectual property um 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 uh 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 3000 does have novel and inventive of steps, which is key in the approval process. And once granted, that will provide us with protection up to 2040. The US 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'll be able to launch a product. And as 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 Eroxxon 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, Eroxxon 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 Oroxon 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 Iroxon have been predominantly incremental, which is pretty much as we expected, given the product's key differentiators and the market research that suggested Iroxon 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 Iroxon 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 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 recognise 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 recognise that key opinion leader in healthcare professional endorsement and education is highly important when it comes to the product, the credibility of Reroxon. They have to be mindful of cultural differences and regulate requirements within each country. They have to ensure that leading retailers and online platforms are ready to stock Iroxon 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 AD 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 UK with Cooper Consumer Healthcare. There's an agreement in place for Latin America with M8 Pharmaceuticals, in the Middle East with Labatech, who have their launch planned in Q4 this year, South Korea with Menorini Korea, and most recently the US with Halian, one of the biggest consumer healthcare companies in the world. We have also confirmed that we have now terminated our agreement with Kohai 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 Eroxton as a brand. And we've already appointed a second CMO to provide additional capacity in 2024.

Thank you, Angela. As I was talking about earlier, the key thing that has 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 SOS for us a couple of years ago very much said that that 73 percent 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, again, this 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 and are not treating because they don't like PD5 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 embarrassing 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 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. 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 UK where Viagra and Cialis are available over the counter albeit the number of questions uh that need to be asked um a a woman would not be allowed to buy that product would have to be bought by the male partner so uh 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. And then in turn, 90% of those partners said that if their female partner brought the product home, they would be prepared to trial. So a very significant opportunity here. And I think it is 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. 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, 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 Viagra for a dollar? Reality is in the States, the largest market, when you take into account the out-of-pocket costs those men have to incur by going to see a doctor, including the doctor's visits, you're looking at a range between $603,500. 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, there are different estimates. The peak sales estimates were done at 55 tubes use 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 1.7 million are wholly related to sales of Oroxon to our commercial partners. And this has generated a growth profit of just under a million pounds. 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 1.7 million compared to just under 2.5 in the period 2022. We have released R&S this morning and we have stated that we do expect to be around break even in 24. And then we expect to report a profit in 2025. 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 £7.8 million, reflecting the receipt of million pound R&D tax credit for the 22 claim. We also received £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 recognised as revenue currently. But the cash balance at the end of June does not include the $4 million up from payment that we received from Halion. So if we look to the cash balance at the end of August, we had a cash balance of circa 9.3 million. And I just want to confirm that we also do not have any debt in place. Finally, to summarise, we're really excited to see further Iroxon launches planned 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 24 and become profitable in 2025. That and that is excluding any royalty income from the US. 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 thank you for listening and for your support and therefore bring the presentation to an end.