Futura Medical plc

Good morning and welcome to the Futura Medical PLC 4-year results investor presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and they can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Simply tap in your questions and press send. The company may not be in a position to answer every question or issue during the meeting itself. However, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll, and I would now like to hand you over to CEO James Bader. Good morning to you.

Good morning. My name is James Bader, and I am the CEO of Futura Medical, and I'm joined for today's presentation of the 23-year-old results by Angela Hillgrist, who is the Finance Director and Chief Operating Officer of Futura. Futura specialises in the development and commercialisation of innovative and proprietary sexual health products. Our lead product being Evoxon, a clinically proven breakthrough treatment for erectile dysfunction. We also describe ourselves as experts in research, development, and commercialization of topical liver cell formulations. I appreciate that for those longer-term shareholders, this is a change from a future of previous focus. Following the success of Oroxone, this is a deliberate change in strategy to concentrate our efforts and resource exclusively within the area of over-the-counter sexual health treatments. Erectile dysfunction, or ED, is a large underserved market with only a limited number of treatment options. Furthermore, there has not really been any new innovation in the treatment of erectile dysfunction in the past 20 years. Nothing really since the approval of Viagra, Cialis, and Levitra some two decades ago. A group of ED treatments collectively known as PD5 inhibitors. ED impacts roughly 20% of men across all ages. Even though older men are more severely impacted by ED, there is a growing number of younger men presenting to doctors. Even men as young as 18 are now seeking treatments for their rectal dysfunction. And whereas historically ED was always considered an old man's condition, this is very much no longer the case. In 2023, the global market for ED in prescription terms was worth around $3.5 billion. In spite of ED being a multi-billion dollar market, only around 20% of men are on treatments. So why such a low takeout? Viagra and Silo, don't get me wrong, are very successful and effective drugs. However, they do have some drawbacks. Firstly, planning is required for those types of drugs as they can typically at least have an effect, thereby removing the optional spontaneity within the bedroom. Secondly, you generally require some form of interaction with the doctor to obtain a prescription. In the UK, Viagra and SARS are now available over the counter. But it is important to understand this still requires the amount of completed questionnaire, which depending on his answers, can be up to 41 questions in the case of Cialis, before the pharmacist can supply the medication. This has both the cost and embarrassment implications. Some men will just not want to talk about their ED as an admission to themselves they have a problem, let alone discuss it in front of other people in the pharmacy. Finally, on paedophiles and side effects. Paedophiles are effective in around about 75% of men, but up to 20% of men will experience side effects, typically in the form of a headache or flushing. Aside from the issues associated with men using PD5s, we believe the real opportunity lies in the 80% of men that are not treated. We believe the main reason behind this is that around about 20% of men are unable to use the PD5 inhibitors as they are contraindicated because of their existing cardiovascular medication. Many men, as I've already said, too embarrassed to talk about ED. Certainly, they will not want to go and see a doctor, which requires admission that they have a problem. Cost. Even though the cost of PD5s has dropped since their initial launch some 20 years ago, this doesn't factor in the expense of a doctor's consultation, typically twice a year, which can be quite considerable, obviously, depending on the market, especially in markets like America, which is a negative factor when patients are weighing up the options. Finally, many partners want to have an active sex life as well. However, many ED sufferers will simply back away from any form of intimacy. They will not even want to kiss their partner in the fear this will lead in a direction they do not want to go. The partner in turn worries they are having an affair, no longer find them attractive and so on. A treatment where there are no medical restrictions on whether the buyer is a sufferer or not represents a huge opportunity. Eroxon, this is Futura's breakthrough clinically proven treatment for rectal dysfunction. Available without the need for doctor's prescription or any interaction with a healthcare practitioner. So this is truly an over-the-counter treatment and can literally just be taken off the shelf without having to discuss the condition with anybody. And also can be done by your partner as well. Helps you get an erection within 10 minutes. This is a key differentiating claim and also allows spontaneity to be brought back into the bedroom. Again, important, Eroxon is a clinically proven gel to treat erectile dysfunction. Finally, I would like to add that Eroxon has an extremely favourable side effect profile with less than 1% of men experiencing any form of side effect. Andrew.

Thanks, James. We thought it might be useful to summarize some data generated by an Ipsos study in 2022 for the US market. And what we wanted to show you is how huge the opportunity for Eroxon is and how that compares to the overall current ED treatment spectrum. Whilst there was a huge amount of data compiled, we wanted to try and distill it down into something that was quite simple and also show where there are potential upsides on the assumptions used. We know that there are approximately 20 million men in the US who suffer from ED. The exact number is likely to be higher. In fact, the current number is thought to be around 23 million. We also know that the prevalence of ED in younger men is increasing. A recent study suggested that at least 14% of men aged between 18 and 31 now suffer from some form of ED. And with the problem of ED growing, along with the prevalence of anxiety, obesity, causing diabetes and other health conditions, and in addition to that an ageing population who wish to enjoy a healthy sex life later in life than ever before, it is anticipated that an additional 7 million men in the US will suffer from ED by 2042. Moving down, the IPSOS data suggests that iroxon could be a solution for around 7% of men who suffer from ED by year 5. The 7% is based on a number of factors, including purchase intent, adoption rate, response to the iroxon concepts, and it includes an assumption of $5 per dose for the purposes of this survey. I do need to be clear that the $5 per dose is an indicative price used for this research. The price of the US market has not yet been confirmed. The research does suggest a higher price point could be worn before you start to see volume erosion, but the US commercial partner will ultimately decide on pricing strategy for that region. What I can tell you is that it is currently for sale in the UK for £5 per dose and around $10 per dose in the Middle East. Looking at that 7% uptake, this does not seem unreasonable when you consider PD5s, Viagra, Cialis, etc., have an uptake of around 20%. And then add that to the fact that there is around 80% of men with ED who are not treating as James touched on before. The IPSOS study also collected data from female partners. And as the Roxxon is available without the need for a doctor's prescription, the partner would be able to purchase it. And the data suggests that ED sufferers were highly likely to try Roxxon if their partner purchased it and asked them to. And that this could result in around 15% uplift to the 7% just discussed. We have then conservatively assumed that an ED sufferer might use the product on average once per week. The fact is, We really don't know how many tubes or doses per year will be consumed by each ED sufferer. The Ipsos data suggests that the number of uses per year could be on average around 114, especially if the product is used by a younger population who engage in sexual activity more frequently, and clearly this would have an impact on overall peak sales estimates as well. There are other factors that come into play when we're looking at the overall forecast or the overall potential for the U.S. market, such as the level of distribution, the spend on advertising and promotion. But we're quite comfortable that our U.S. partner has the resources and capability to satisfy some of those of the basic assumptions. So you'll see, with the assumptions I've taken you through, Ipsos quite comfortably arrives at a potential peak sales opportunity in excess of $350 million for the US market. We obviously focus that data on the US, but this data can be extrapolated out quite easily for other regions. So how are we going to maximise that opportunity to deliver long-term shareholder value? Well, we've shown you that there is a large addressable market when you look at men with ED and how many of them are currently not treating at all. James talked to you about how Eroxon is highly differentiated against other treatments, especially given its availability, OTC, and its speed of action. We are going to come to our market strategy with leading consumer healthcare companies who can deploy significant marketing expertise and resources. And why that partnering strategy provides us with a low-cost opportunity to broaden the availability of Aroxon globally, and how that de-risks it for Futura. We're currently at an inflection point, given the generation of first meaningful revenues and a clear pathway to profitability. And all of this is supported by a healthy cash balance, an efficient cost base, which provides efficient financial resources for our growth strategy. We continue to use our innovative and highly experienced R&D team to look at ways we can broaden the Aroxon range with you and other extension products. We're not saying too much about this currently, but we will update you when we're in a position to. And finally, Iroxon is well protected from competition with the EU patent granted in 23 and patent applications filed in other key markets, including the US. 2023 was quite the year for Feetora. US FDA granted marketing authorisation of Iroxon as an OTC product and the US is the biggest OTC market in the world. Halion became our commercial partner for the US market with a $4 million milestone already received and further milestones to come. I'll talk about Halion itself in more detail shortly in the presentation. Our European and UK partner, Consumer Healthcare, successfully launched in the UK and Belgium and they followed that up with further launches in other key European markets since. Early data showed that Eroxon obtained a market share of around 20% across approved ED products in the UK. Eroxon received a number of industry awards and Huber then extended their agreement out to 2029. We generated revenues of £3.1 million in 2023 and we achieved a growth margin of 57%. We ended 2023 with a cash balance of £7.7 million, which we believe is sufficient to to fund the business beyond the US launch expected in early 2025. And especially as we touched on before, all advertising promotional spend is borne by our commercial partners. To summarise, the foundations were laid in 2023 and early signs are showing significant potential. We also thought it might be useful to quickly touch upon our commercial partners. Our strategy was always to partner with companies who have experience and track record of launching new products, especially in the OTC arena. And also partners who have the financial resources and expertise to commit to those launches. This is extremely important for a product like Eroxon. It's a new product, a new brand, And in the US and most of the markets, it's creating a whole new category within OTC, as current ED treatments require a doctor's prescription in the main. Firstly, let's take a look at Halien. Halien are a world-leading consumer healthcare company. Anyone not familiar with Halien will certainly be familiar with some of their brands, which include, amongst others, Sensitine and pain relief products such as Voltaren, Advil and Panadol. In particular, Hayden are incredibly experienced when it comes to switching products from prescription to OTC, and this is of huge benefit to Eroxon, which will launch OTC, but given all of the oral treatments such as Viabra and Cialis require a doctor's prescription, that knowledge is going to be hugely beneficial. Moving on to Cooper. Another leading healthcare company in the EU and UK, Coupa have a lot of experience launching OTC products. They're well versed with the nuances of the different routes to market within the individual countries, such as the retail chain store model, like Boots in the UK, and the independent pharmacy model you see across France, for example. The launches so far have gone well. We're seeing some early signs of repeat purchases, but it is still a little too early in the European rollout to provide any solid data. Then, so far across the rest of the world, we have Lavatech, who cover the Middle East and the Gulf states. We have Moksha 8, or M8, who cover Central and South America. And we have Menorini, who will be covering South Korea. It's likely that in most of these regions, iroxan will be sold through pharmacy outlets, but we also know that whilst PDE5s remain prescription only, unapproved purchasing of PDE5s does exist in some of those markets, and that may have an impact on the uptake within those regions. However, these partners have successfully obtained approvals in nine countries, including Saudi Arabia and Mexico, which are the biggest markets, Labrador Tech have launched in some of the Middle Eastern regions and the other partners will be gearing up to launch soon. I'm going to now pass you on to James, who will walk you through the strategic progress that has been made.

Thank you, Angela. For me, this slide, there are really three key taking messages. One, Evopson has essentially been in development since 2014, with over 20 studies completing in order to achieve EU and ultimately FDA marketing authorisation. This robust development programme allows us to make clinically proven claims and represents a significant hurdle or barrier for any potential competition. Secondly, as Andrew has already mentioned, we have also achieved our first patent approval in the EU in September last year, and are progressing patent applications, including examinations across all major ED markets, and expect further approvals in both this year and obviously beyond that. You will appreciate the competitive reasons. I do not want to reveal too much about our IP strategy, other than to say that in the past six months, we have filed a further three new patent applications. Thirdly, our launches are progressing well, following on from the two test launches in 2023 in the UK and Belgium. Further launches have already commenced this year, and I'm confident that Roxxon will be launching at least 10 further countries in the first half of 2024, with further launches also in the second half of 2024 and obviously going into 2025. For example, France launched at the beginning of March this year, and our inclusion report, again early days, but a very positive initial feedback. This is quite a busy slide and has been put together in response to a fair amount of shareholder challenge around the length of time it is taking from signing agreements with commercial partners to the point of launch. I do not plan to specifically talk through this whole slide other than to say that there is a huge amount of work required ahead of any launch to optimise the chances of success and this does take time. I would also point out that the advertising and promotion can run to millions of dollars and no distributor is going to commit to this level of investment until they have all their ducks in a row. All our agreements have strong commitments around launch, but equally so, our commercial partners are very experienced OTC players, and they need to make sure everything is in place to optimise the chances of success or not before they start. And this is something that we strongly support. The next slide, this is a global graphic of the markets where we currently have licensing deals. Again, key message for this slide is we basically have covered all the top ED markets other than China. This market represents a different set of challenges, especially on our rates requirements, and we are actively considering our options at the moment, whilst not being distracted from the launching. Moving on to the next slide. This shows those markets we've launched and the majority of markets we expect to launch in the first half of 2024. Angie.

Thanks James.

Taking a closer look at the financial results for 2023, as we've previously noted, we have generated our first meaningful revenues of £3.1 million and as the Oroxone rollout continues, we expect this to rise. The $3.1 million does not include the $4 million upfront payment, which we received in 23, and I can confirm that this will be recognised in the first half of 2024. We delivered a growth margin of 57%, and that resulted in a net loss after tax of $6.5 million. If we strip out the non-cash share-based payment charge, which was a lot higher in 23, this is due to the EARL tip awards, we see an adjusted net loss after tax of 3.8 million. The cash balance at the end of the year was 7.7 million. Given the company's efficient and cost-effective operating model and added to expected sales, provides us with sufficient funding to the expected U.S. launch and beyond and to profitability.

Looking ahead, our strategy is, very much, address the growing demand for rock songs through strengthening our supply chain and launching through our commercial partners across the world, whilst having those also gain any remaining regulatory approvals. We have a highly experienced and creative team and we're keen to broaden our product partner. Although as, and before Angela says it, this is mindful of costs and return on investment as it moves the company to profit. We are also committed to future recovery as soon as we can and we are making very good progress in this regard. To sum up, 2023 has provided us with a solid foundation with huge achievements and significant de-risking of the regulatory and commercial pathways. 2024 represents a year of execution on those foundations, as well as further research and development on the eroxone range, which we look forward to updating shelves in due course. It just remains for me to thank our entirety of the future and also our shareholders as we move into what I will believe will be a period of significant growth as we move away from being a pure R&D loss-making company to a profitable consumer care company with a huge growth potential in the short term. That concludes the presentation. Thank you very much for listening.

That's great. James, Angela, thank you very much indeed for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the top right corner of your screen. While the company take a few moments to review those questions submitted today, I would like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via our invested dashboard. James, Angela, as you can see, we have received a number of questions throughout today's presentation. And if I may now hand back to you and kindly ask you to read out the questions, give responses where appropriate to do so, and I'll pick up from you both at the end.

Thank you very much for that.

So it's not the first question, but we have had a question around some of the sound on the presentation and whether we are going to invest in better sound production. The answer is yes, we are doing something about that. Apologies if the sound wasn't clear on the presentation today. But the good news is it's also not going to cost a lot either, so don't need to worry about the cost. So anyway, moving on. We've had a number of questions around break-even and profitability. And I think rather than kind of repeating the question, it might be easier if I just take that as a whole and try and explain that. So it really is about the U.S. in the near term. I think trying to differentiate between break-even and profitability becomes a little bit blurry because essentially when the U.S. launches, we will become profitable. And Halian, as James said, has confirmed in their results on the 29th of February that they will be launching within 12 months. They have not confirmed whether that would be within 24 or whether that will be within early 25. But what I can say is that at the point that the US launches, that's at the point that we'll start to become profitable. We're having to respect Hayley's wishes in terms of not disclosing the launch date. I know that there's also a number of questions been asked around the US launch. We are having to respect that. We are fully supportive of them not disclosing too much commercially. And we are working very, very closely with them behind the scenes in terms of all of the activities that they're going through pre-launch. And it is all very exciting.

I think I'd also add to Andrew's comment. This is no different to any of our other distributors. There are some, you know, very important commercial sensitivities around disclosing ahead of launch when you're going to launch. Because competitors, they may not be specific in this area, but they will do things to try and make life difficult for them. So none of our commercial distributors want us to disclose ahead of a launch when we are going to launch. So you'll see we've made some announcements today, but we will not be disclosing ahead of any launch when it's going to happen, because none of our commercial partners want to do that. Because basically, it could actually potentially damage the launch. And all the commercial partners are spending a lot of money. They are responsible for the advertising and promotional spend, and this can run into millions of dollars, and we have to respect their wishes.

Next question. So again, we've had a number of questions around repeat purchases, so I won't read out any specifically, but the general theme is, can you tell us what the repeat purchase levels are? The short answer is, we can't give you any definitive data on it at the moment. Because the product was launched in the UK and available at OTC, The only real data that you can get around repeat purchase is if the individuals use an advantage card for boots or a loyalty card elsewhere. And first of all, because this is a predominantly male product, predominantly males don't carry advantage cards or other loyalty cards, making it difficult. Coupa also launched in all of the other major retailers towards the back end of the year. So if someone has bought a pack of Oroxone in boots and then gone to Superdrug or Tesco for another pack, that also doesn't get captured under repeat purchase. We are working with our commercial partners to see if there is anything that we can do to try and, either through customer surveys or the market research, to try and get a little bit more accurate data. But at the moment, I won't be drawn in to give a repurchase rate because I just can't be certain that that won't change. And I would rather only provide data to the market that is accurate and backed up by other data that we believe.

I think also, you know, we have discussed this with Cooper. And they want to know, and he's going around, well, they would like to have a better clarity around this. And as I just said that there are other ways that you can get this data where you go out and just basically do a mass survey. So it's not specific to loyalty cards for all the reasons that somebody might buy it once in Boots, they might go somewhere else, might be the partner buying it and so on and so on. But the reality is until you have got to a certain size and spend a certain amount of time on the launch and sales being out there. The data you're going to get from that just will not be accurate. So it's going to achieve nothing. And the number's going to be wrong, either high or low, and it's going to react accordingly. And for us, it's very important that information that we do provide is not misleading. So when we have accurate data, we will share that with you. So we're not trying to hide behind anything. It's just until we have that data, This is early days. We've only really had two test launches. Now we're into very much the big rollout of launches. We will share that information, but it's just too soon.

Next question.

What is the approximate launch date for each country where MED3000 has been approved but not yet launched? Countries with clinical data have been submitted to the regulatory authorities, but approval has not been granted yet and is pending. In what countries has partial or full launch actually occurred? This is data that should be readily and easily accessible on your website, but it is not without digging through numerous press releases. And even then, it is not all there. Yes, we appreciate that the website has not been as up-to-date as it should be. We are going to make some small updates to the website this week, but we do have some plans in place to give the website a full refresh in the next few months. It is a time-consuming process, but as we get more data and as we get more updates from commercial partners, we will have more data to put on there. In terms of countries where regulatory... where regulatory submissions have been made but not yet launched. I think James has spoke previously about not providing a running commentary every time we get a small regulatory approval or every time there is a launch in a specific country. The partners are launching.

I think I can say that in every market where we have a commercial partner where the product has not been approved yet, a submission has been made. This does vary from market to market on the time it takes to get approval, but a submission has been made in every market. Again, when we sign the deals, not only are there financial commitments around the launch, the AMP spend, and so on, there are also commitments where the product, for example, is not approved, there are commitments around timelines towards getting reg each submissions approved or filed. So I'm pretty certain just to my head, we had filed in or our commercial partners filed in every market where we had an agreement in place. So was there anything else from that question?

No, the website will update shortly. Yeah, okay.

Okay, what hard info is there on sell through and rate of sale? First of all, we can't really answer that. We get a lot of questions around how many units have you sold. So there are two things. One, we are selling products to our commercial partner in Europe, for example, and we're not going to publish how many units we've sold to them because we don't want to disclose what our margin or the equivalent of the royalty rate is via the transfer price. James touched upon that before. We're still in commercial negotiations for a number of other regions, and we just do not want to put any of that commercially sensitive information in the public domain.

I think in some instances, there were potentially obligations under the agreements anyway.

Well, that was what I was going to come to next. In terms of sell-out to consumers, they're not our numbers. We are not able to disclose the unit sales that our commercial partners are are selling into consumers. And we are working very closely. We've been fortunate so far with Cooper, for example, who have, at our capital markets day, did let us release some information. We're working very closely with them. And when we have information and when it is what we believe to be accurate, we will try and update you as much as we can. But we're going through a launch phase and it is very commercially sensitive.

Do you have anything to add to that, James?

Customer ratings are poor, partly as a result of poor expectation management. How is that being addressed?

Yeah, I mean, I think that the first thing, and this is one of the learnings, one of the reasons we want to do a test launch in the UK and Belgium or a commercial partner. There are a lot of people out there, don't get me wrong, Viagra, Cialis are effective drugs, but they work in around about 80% of men. So there are a lot of men where these products don't work, and they are invariably the first to try. So we have seen a number of men be disappointed, and generally they complain when things aren't right, they don't complain when they're not. You know, we've solved significant numbers of facts now. Certainly the complaints we're getting are very, very low. Yes, the main area of complaint is around efficacy, but I think we're getting one complaint per, I think, 20,000 facts that have been solved. So, yes, it is something, and for us, what is important is trying to get the education, right, the managing the expectations of potential users, the efficacy rate in this is around about 63%. What is more, if there is foreplay involved, then the efficacy rate improves. And so it's trying to manage that, trying to improve the education, and we're certainly working on that with a number of the other launches to manage that expectation and also PR. When the product launches, papers love, and we've had very good PR on the past, they love talking about sort of sexual health products like this. The challenge is trying to keep the journalists in control. They don't kind of advertise this as a product that is kind of a miracle cure for everybody. They're still only working around about 80% of them. So it's trying to manage their expectations as we move forward. And we're working with the commercial partners to do that. But yes, we're seeing some complaints. But overall, we're pretty happy the way we're seeing on the sell-through rates and people buying the product.

Okay, next question. Why is it taking so long for the product to be released in the US? So I appreciate when the webcast was on the screen, James didn't go through every single element of one particular slide, slide 16. What we have tried to do is give you some information on the different activities that the commercial partners need to complete in relation to supply chain, market engagement, and then their retail and launch advertising promotional plans. I'd encourage you to take a look at that once it's on the website because it does give a good picture of what is actually involved in getting a product to market like this that is a new product, a new brand, And essentially, particularly for the US, a whole new category in sexual health.

Yeah. I mean, it just takes a long time.

And we're supportive of what they're doing.

Absolutely. Absolutely. These guys are going to be spending millions of dollars on that battalion promotion that was said earlier on. And it's very important that they get the positioning right, education, rolling out to the different distributors, the manufacturing, getting that in line, getting the resource in line. advertising. Again, retailers only look to typically refresh their range probably once a year. And it's not like, well, we're just sticking on the shelf. They've got to take something else up. It does take a long time, especially when you look in the advertising and promotion. You want to be able to, you know, when you switch that expense on, you want to make sure you've got at least probably 70% distribution through a market so that if a consumer goes out and buys it, that they can find the product. 65% to 70% is typically the sort of going rate because somebody will go into one shop and if they can't get it, they might go into a second shop. They certainly might go into a third shop. Therefore, you do want to have at least two-thirds coverage. So it does take time.

Obviously, you've got to have enough stock manufactured for that 70% distribution.

And you've got to get the tubes and there are all sorts of things behind it. So it does take time. Trust me, there's a lot of work going on at this stage. And we're seeing nothing with any of the commercial partners that they're dragging their feet and it's just getting a lot of work in place ready for those launches. And again, this is an embarrassment product for a lot of men and positioning is very critical and it will be different from one market to the next, depending on the cultural issues, In some markets, we will have certain challenges around creating a new category. We have challenges around culturally and from an advertising standards perspective, what can and can't be said. So there's a lot of work that goes on to make sure that you've got all of that correct and signed off before you go out and market.

Okay. Next question. I think this is just a slight repeat. What would the US$350 million retail sales equate to in terms of revenues for Futura after retailer and distributors' margins? Well, first of all, the agreement with Halian is a royalty agreement, and we've not disclosed that royalty rate at all, and we won't. And as I said, similarly, we are in the middle of negotiating for other commercial agreements in other regions where agreements are not in place. and we just don't want to set a precedent for that.

I think it's worth going back to the announcement we made last summer. We get a royalty on all sales, as Anki said, but that is not to be disclosed. We also receive milestones, and up to £45 million in performance and sales-based milestones. So performance may be less related to the physical sales, around obviously rectory approval and so on, branding of patents, and then there are sales-based milestones I think one thing that I would say is these milestones, that's just part of the deal, but these are achievable. I've certainly seen before where you have companies that come out with quite eye-catching milestone payments where they don't disclose the triggers, if you like, for the release of those funds. And in some instances, they are completely unrealistic. Certainly, we believe that those $45 million are all readily achievable in the short to medium term based on what we believe and what Ipsos believes sales could be.

This one's for you, I think, James. Every announcement by Futura causes a stock price crash. Is there anything more that could be done to avoid this?

I mean, all I think we can say is we can control what the company does. We can't control what the share price does. You know, I think there's a lot of excitement for people. I think it's worth mentioning that any material information or news that we have, we are under an obligation to announce it without undue delay. So, for example, to say the year end results, if there's going to be any material significant update. We can't wait until today to do it. We have to announce it, but it is. I think there's quite a lot of speculation. People try and look at, well, yes, try and second guess what it is. We are certainly getting more and more interest from institutional shareholders, and certainly as the company moves from a R&D loss-making company to a consumer healthcare profit company, I think we'll increasingly see the greater interest in shareholders or institutional shareholders. I think what we can do is keep working on this. We'll keep delivering. Yeah, we'll keep delivering. And I think the share price will make its own mark.

Okay, what minimum offtake sales targets are there in current distribution agreements? We've talked about this before. We could have put some unrealistic sales targets and minimum purchase requirements into the agreements, but actually for a product like the Roxxon, which, as I've said, is a new brand, a new product that no one's ever heard of that's getting launched into essentially new categories in most of the key markets. It is more important for us to get commitments around advertising and marketing spend, resources, expertise. What we didn't want to do was partner with someone with minimum obligations have them buy the product, stick it on the shelf, and hope for the best. We have intentionally partnered with companies who are able and have a track record of building a brand. We want Eroxon to be a long-term, sustainable brand. I'm sure that you're going to have something to add to that, but that is what we've focused on in the main in the agreements, and there are some very, very fixed obligations in respect of advertising, marketing, and building that brand.

I think I can add further to that in that when the Ipsos research was done, apart from the financial forecast, there was a lot of analysis done around what the key takes from a consumer perspective or consumption perspective versus the negatives. We scored extremely highly on the speed, safety, all the key kind of criteria, the fact that it can be used as part of the portfolio. One area where we were quite weak was in the area of credibility. Nobody's ever heard of the product, is it too good to be true? So that has very much influenced and will probably continue to influence how the product roll back. For example, very important that when the product launched, it launched with a in the UK with a credible distributor like Boots, which is a very trusted brand. Equally so, as Angie has touched on, all the commercial partners, it was very important for us. Now, this is a product going straight to over-the-counter, so there's no legacy, no history, if you like, behind it being a prescription product. So it's very important we find distributors where we felt that they had a proven, credible track record of building a brand from the start. I mean, to give an example, And I know I touched on earlier, you know, deals that we're looking at in China. We've had at least 70 approaches from different companies wanting the whites in that region. And I don't apologize for us taking time, finding the right partner who's got the credibility, the patience, and the commitment to build a brand in an exciting new country. You know, yes, we could have licensed in pretty much every country in the market, very quickly, but you're dealing with a lot of, there are a number of those, what I call flighty type entrepreneurial distributors who today will be a lot, some tomorrow will be something else. So it's very important for us to build a credible distribution network with commercial partners who know what it takes to build a brand. And if there are some challenges, because there will be some challenges in some markets because of the cultural differences in the positioning of a product, it's very important that they have the willpower and the staying power and the commitments that we put into the commercial agreements to deliver on that over the period of time.

Okay, this is actually a good question there. Boots from the rocks on from behind the counter where it sits with PD5 treatments. Yeah. This keeps going on.

Apologies, the screen keeps clicking up. With PDE5 treatments, and does involve an interaction with its staff, does this approach optimise sales, and is it sold this way at other retailers in the UK, Belgium, and Middle East? So I think this has got quite a lot of, this is a really good question, but it's got quite a lot of components to answer. Do you want to start?

Yeah. I mean, the answer is a sort of a, yes, it does, in some boots, sit behind the counter. but it is also on the shelf. So in, I think it's meant to be all the boots, both behind the counter, which was more driven by credibility because it's sitting next to Viagra and so on. So again, it's the fact that it's seen, if you like, in the same context as those two products is adding to the credibility. But the key differentiator here is there are no questions. You can go in there and you can buy it. So it was very important that it's also available and it should be in all boots available off the shelf. So you can walk in, partner can walk in, pick it off the shelf, put it in their basket and go to the checkout and go to the self-service checkout. They do not need to have any interaction with any healthcare practitioner or any other human being if they do not wish to do that. That is a key differentiator because Viagra and Salis, again, the UK I think is the only market in the world where both products have switched. You still need to go through an algorithm. I think in the case of Viagra, you have to answer up to 17 questions. In the case of Cialis, it's up to 41 questions, depending on the responses you give. So there is still an interaction. And for us, the real opportunity is for those men who do not have that interaction, do not want to admit they may have a problem and just be able to buy the product. And we've certainly seen that with sales to date that in the UK in particular, and Belgium, the sales are largely incremental. In other words, we are not taking sales away from vibrant sales, which we never thought we would do. The real opportunities in the 80% of men who don't treat, And of course, the likes of Boots, they love that. They love the fact that they're not seeing, if you like, cannibalization, that a customer is switching from one product to the next, which to a large extent probably doesn't make a hell of a difference to them. The fact is we're increasing footfall and we're generating additional sales, so we like that. And we expect to see a similar thing in other markets, though again, you will find, depending on the market, cultural differences, the way products are positioned, maybe slightly different. But again, the key differentiator for this product, and again, you've got America, which is the big market, that is the fact, because again, in America, there is not actually this sort of halfway house. In the UK, it's an unusual market in that you could have GSL, so you can pick it off the shelf, you've got behind the counter, which invariably involves the interaction with the pharmacist, and then you've got prescription. In America, there is not that midway house. You either have interaction with the doctor, or it's It's over the counter that you just walk into the supermarket and buy it off the shelf. And so that is a key differentiator. And I think we'll have significant opportunity and potential for sales in the States because of that.

What are predicted sales targets for 24 and 25? As a company, we don't provide forward-looking sales targets. We're not allowed to. But we do have three analysts who are covering us. So Stifel initiated coverage this morning. Librem, our in-house broker, had research out for some time. And Trinity Delta also have some research out. They will make their own estimates around sales, but it's not something as a company that we provide. What are you doing about, I'm glad someone's asked this as well, what are you doing about the fake reviews on websites?

I mean, I think, well, to start with, we have, we've trained a company some time ago to take down fake websites and the like. I think today, and I'm a little bit out of touch, I haven't checked the last couple of weeks, but we are up to about 860-odd websites that we have had removed. So I suppose it's frustrating on one hand. I look at it almost like a backhanded compliment. If people weren't interested in the product or saw there was an opportunity to exploit it, they wouldn't be trying to do that. But certainly at the moment, we're very much on the case of taking down websites wherever possible. We are seeing, for example, people buying the product in the UK and then putting it on eBay in countries where the product hasn't launched. at a huge markup, typically $100 or $150. There's not a hell of a lot we can do about that. We certainly, we've been talking to Amazon and eBay, trying to get it taken down wherever we can do. But it is a bit like whack-a-mole. You're not one down, another one pops up. As the product launches and rolls out across the world, I think that will become less of a problem. But I think it goes into territory, the fact there is such a pent up demand for a product of this nature. it's inevitable you're going to get some people trying to do that.

I think the crucial thing is, though, that we are aware of most of it. And when we become aware of it, we do take action to try and get it taken down. Just sometimes taking these products down, some products take longer than others depending on where they're listed. But in general, if there's any trademark infringement or any, fake products, we take all the steps that we can to kind of get them removed. In the trading update, 10 countries were to be announced by April. Why the delay?

I'm not sure there was a delay. Well, that was not true. We said we expected to launch in 10 countries or so, or 10 countries by April or so. We didn't say we would specify which countries, Now, I can certainly say the countries where we've now launched or our commercial partners have. Going back to my earlier comment, we're not going to tell you ahead of launch because we've been asked not to do that. I touched on in my interview, it's launched in France, it's launched in Belgium, Netherlands, Germany, Italy, Spain, Norway. I think that's, and then there's a number of other launches going on this month and next month. So there is no delay on that. Again, as I said earlier, or I think I said in my interview, we expect to have launched by the end of the first half of this year in 14 countries. And that remains on track and we expect further launches later this year. So, you know, we can't give an absolute precise running commentary until after, you know, which countries will do it. We will tell shareholders once it's launched, but again, I guess I'll just please be respectful of what our commercial partners want. They do not want us disclosing ahead of launch where we're going to do it for commercial sensitivities. At the end of the day, what it's going to do is it could impact sales forecasts or sales, because can competition try and move in and do things?

Are you able to disclose who will be responsible for the distribution payments to the eventual manufacturer for USA Supply when and after launch? Futura as elsewhere now or Halion? Again, we've talked about this before. The commercial agreement with Halion, they are responsible for manufacturing, quality, regulatory, marketing, and distribution of the products in the USA. And in return, we will receive a royalty and event and sales-based milestones. Now, we are working with Halium in ensuring that supply chain is set up. But after all of the technical transfer and the setup has been completed, Halium will be responsible for ensuring manufacturing.

Again, I think it's important to stress that is for the US. This is a contract manufacturer, and we will also be using the contract manufacturer for other markets, so that we're trying to develop the robustness of our supply chain. But again, everything we're trying to do with Futura is, there's no point creating work for the sake of it. And it seemed crazy in many respects for Halion, based out of the States to ring us up in the UK for us to then ring up a bit of manufacturer in the US. So it is much easier, a much more efficient use of time and from an economic perspective, nothing else, if they deal directly with that. So everything we're seeing do as a company is to leverage the expertise we've got, we're really good at R&D, but that we outsource wherever possible, all economics around commercial distribution

I'm just conscious of time James. There is one question that's come through that's quite interesting and it's around someone who's purchased the product and said that two of the tubes in the pack had to be squeezed before two thirds by about two thirds before any liquid came out. It seems like the filling mechanism by the producers is haphazard and it feels like you are paying for mostly empty tube. Can this be addressed? That is disappointing.

I mean, I think we part of the obligations around the NDR we have on a monthly basis reports from our quality management team. And I said earlier, we've had a number of, we get all complaints that come through, but we're seeing around about one complaint in 20,000 packs that are sold. This has been flagged a couple of times, and we think there's a misunderstanding here. We are putting a 300, or we're actually putting 800 mils of gel into a tube that potentially can hold up to, I think, two times more than that. So the tube, yes, when you start opening it, you may find that there's a bit of air in that. That is deliberate. It is not a misfill. It is the fact that this is the smallest tube that we could go to. If you go too small, then people can't handle it. So the fill is correct. There is not a problem in that regard. Certainly every batch that is quality checked And where we do get complaints, we go back, because we have to hold back a certain amount of tubes in each batch. So if there are complaints, we can double check to make sure that it was filled correctly. It is not haphazard. Those tubes are correctly filled. I think one other thing I would stress, and again, it's one of the learnings that we want to get out there, and we're working on it with the commercial partners, is that the first time men use a treatment of this, it doesn't always work for them. And this is no different to things like Viagra. Viagra, for example, recommends or state that it takes up to eight tablets before optimal efficacy is seen. Certainly we saw in the clinical data that efficacy takes time, it takes up to four doses before the patient becomes, or the man using it, it reaches optimal efficacy. And if you take a step back and think about it, for a lot of men, they're nervous, they've got a clearly an erectile dysfunction problem, they're not sure whether the product's going to work, So it does take times for people to get comfortable and familiar with products. So I think it's important to stress, and again, it's something that we're trying to get greater education, greater communication out there to explain to people that it will take maybe more than one dose. Typically, we see up to 20% improved efficacy once you get up to using four tubes. Again, this is one of the reasons why Why don't you sell just a single dose pack? And that is, again, the reason behind that is that optimal efficacy is used after four tubes have been used by five times.

Just one final, final question that I can quickly answer. I appreciate that you can't disclose too much information around sales. but could you let us know whether sales are in line with your expectations? The answer is yes. And Quebec extended their agreement out to 2029, and the fact that they've rolled the launch out into all of the other key markets in Europe, I think should suggest some level of confidence that the European partner has in respect of those sales.

Can I answer that one as well? Sorry, let me just read that. What do you mean by considering your options with respect to China? Look, China for us is, and again, I'll touch on it earlier, we think in very simplistic macro terms, we've now covered with our distribution partners 75, 80% of the global market. If you compare that to the prescription market sales data that we can get over, which is the only real indicator that we can look at. China is a huge market. Again, culturally it is slightly different, and there are regulatory challenges with getting approval in China. And when we say considering our options, so we had 70-odd approaches, and it's very important that we don't dismiss a lot of them out of hand. We study that. We learn a lot going through that process because different companies will give you different estimates on what can be done. And with our previous experience with Kohai, where we got mucked around, it's very important from a board perspective that we get this right. As I said earlier, 23 was a year of really building on delivering on key things. 24, it's about execution. What is much more a priority for us is to launch in those markets where we've got commercial partners, and we're working as hard as we can do with the commercial partners to achieve those aims. Yes, we're looking at new R&D, and we're also looking at what we can do in China, but that will require additional regulatory options. And for us, therefore, it's not just about the distribution capabilities, it's also about the capabilities of guiding us through a pretty complex regulatory pathway to get approval in China. So that's kind of what I mean by considering our options. And again, I don't want to put a timeline on this. If I put a timeline on it, it's disclosed, and then commercial partners know there's a timeline on it, then they will exploit it. If I say, look, we're going to do a deal by July, they sit on their hands because they know then I'm under pressure if we don't sign a deal by July. So, you know, we are considering our options and we will sign a deal But for me, the priority, I know the whole board's priority is execution this year on the areas where we've already got regulatory approval and launching with our commercial partners as soon as we can do on a successful basis.

That's great. Yes, James, Angela, we have just gone past the hour. And thank you for addressing all those questions that you could for investors today. And of course, the company can review all questions submitted today. And we will publish those responses on the Investing Company platform. But before we direct investors to provide you with their feedback, which is particularly important to the company, James, could I please ask you for a few closing comments?

Yes, thank you for that. I appreciate, I sense that for some shareholders it's a bit frustrating, you know, why can't you tell us more information? And I suspect that some of the answers you've given today may be in terms of being defensive. At the end of the day, for me, what is most important is for us to deliver and execute on what we're saying we're going to do to optimise sales, and we're going to do nothing in the short term which damages that by, frankly, upsetting our commercial partners if we start to just So again, I just have to say to Cheryl, you need to bear with us. We've been working on this a long time and we are very pleased the way things are going and we deliver as soon as we can do and we will share information as soon as we can do that. So really just to wrap up, thank you very much for listening. Lots of very interesting questions. I'm sorry, haven't been able to answer all of them, but we look forward to meeting again online, hopefully in due course. And really, as the company moves forward and moves away from being a loss-making R&D company to a profitable consumer-held company. So on behalf of Andrew and myself, thank you very much for dialing in.

That's great, James. Angela, thank you once again for updating investors today. Could I please ask investors not to close this session, as you will now be automatically redirected to provide your feedback, in order that the board can better understand your views and expectations. This will only take a few moments to complete, and I'm sure will be greatly valued by the company. On behalf of the management team of Vitura Medical PLC, we'd like to thank you for attending today's presentation, and good morning to you all.