4/29/2026

speaker
Operator
Conference Moderator

Good morning and welcome to the Futura Medical PLC for your 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. Just simply type in your questions and press send. Before we begin, I would like to submit the following poll and I would now like to hand you over to CEO Alex Duggan. Good morning.

speaker
Alex Duggan
CEO

Good morning and a warm welcome to the Futura Medical presentation of its 2025 full year results. I'm Alex Duggan. I've been the CEO since August 2025, and it's my great pleasure to be with you this morning and joined by Futura's two other longstanding executive directors, Angela Hildreth, our finance director and COO, and Ken James, our exec director and head of R&D. Today we're going to cover a number of topics. Angela and I will talk about the full year 2025 performance. Ken will update you on our product and MPD review. I'll summarize some findings from our strategic review and lastly an update on our 2026 key milestone progress. A question and answer session will follow afterwards and we invite anyone to put your questions to us for our for us to answer. Before we get going, can I just draw your attention please to the disclaimers on the previous slide, which will be provided along with this full presentation in the usual way after this event on our website. The key messages we will address today. It will not be a surprise to our shareholders that 2025 has been a year of both challenge and renewal. Financial performance resulting from underlying in-market sales of Eroxon have been disappointing and further details of this and our plans as to how we will improve this performance will follow later today. I've led a full strategic review initiated in August 2025 with clear findings now concluded. Following this review, we have a refreshed vision, strategy and commercial model which is fit for purpose for the next stage of our development. And importantly, development plans for both the Roxxon Intents and WSD 4000 continue to progress. There's a supportive news flow schedule, which adds value inflection points throughout 2026, some already published and others expected to come during the rest of this year. So let's start with a review of the company's 2025 performance. Before I pass over to Angela, I'm sharing here a summary of in-market results from the launch of Iroxon in 2025, which was the brand's first full year of commercialization. This commentary has in part been reported previously, but for context, I think it is worth summarizing here because these results and learnings feed directly into our future strategy. In the EU and UK markets, in-market performance declined following a strong pipeful start This led to lower sales in the period from Futura to our commercial partner than Cooper had originally predicted. In the US, following a high impact launch campaign and gain of significant retail distribution points, progress was slower than Halon had originally expected. However, despite a reduction in promotional pressure, it's reassuring to see that consumer sales are holding up reasonably well and that distribution currently remains strong. The US market, of course, remains a key priority for both Eroxon and in the future for our WSD4000 NPD, which we were going to touch on later. In the Middle East, again, in-market sales were lower than expected after 2024 launch trends, but we do remain engaged with our partner and it was pleasing to see them launch into a new market in May. And lastly, in LATAM 2025 saw a growth in retail distribution and a strong digital campaign from the partner. And we're reviewing our LATAM strategy at the moment with particular focus on how to open the Brazilian opportunity. As part of the strategic review, it's clear that these lower levels of expected consumer repeat purchases are due to a number of factors. The positioning gap where potential consumer over-expectation exists of the benefits from iroxon usage an imperfect consumer understanding of when or how to use the product correctly particularly with regards to using the product with foreplay binary efficacy perception so for many men unlike with consumer healthcare products generally this product has a binary effect it either works or it doesn't the accessibility advantage No prescription or HCP is required, so the product is widely available. However, being open access to all consumers may lead to potential misuse or unrealistic expectations. And the promotional strategy, a high impact activity which is reduced or cut too soon following initial launch alongside too broad consumer targeting doesn't necessarily lead to optimum outcomes. So our strategic reset, of course, takes all these learnings from year one commercialization into account, and there's more on that later. So with that backdrop in mind, it's my pleasure to hand over to Angela, our Group FD and Chief Operating Officer, who's going to cover the financial results for the period.

speaker
Angela Hildreth
Finance Director and COO

Thanks, Alex. So I'm going to take you through the financial performance for the year and how that translates into our current cash position and runway. But first, Alex has briefly outlined that 2025 was a year of reset for Futura, with decisive steps taken strategically, commercially and operationally to align the business with current market realities. From a financial perspective, that has meant aligning the cost base and operating with a clear focus on cash discipline and capital allocation. Importantly, We are now operating from a position of greater control with a reset cost base and a more focused approach to funding and the delivery of strategy. Alongside that, we strengthened the balance sheet through the fundraise that was completed in December 2025. So just turning to a summary of the financials, revenue for the year was 1.7 million. This was compared to 13.9 million in 2024. The prior year benefited from non-recurring milestone income and initial channel stocking, whereas 2025 reflects a transition to a more demand-led replenishment cycle. Gross profit was 1.2 million, representing a 73% margin and reflecting underlying trading performance with revenue primarily driven by US royalties as other regional partners work through the initial channel stocking. Loss after tax was 9.1 million. This did include 4.1 million of exceptional items, which were primarily non-cash based relating to half a million provision for inventory and the balance and write down of some plant and equipment. In addition to that, there was half a million of non-cash share based payments. So excluding these items, the underlying operating loss was 4.5 million. Cash at the year end was 3.4 million. And the board continues to actively manage cash deployment and cost control, prioritizing capital allocation towards key programs while advancing funding and strategic initiatives. So if we turn to cash and runway, cash at the year end was 3.4 million, with current cash at the end of March of 2.35 million. reflecting trading since the year end. In December, 2025, we completed a 2.7 million pound fundraise. This strengthened the balance sheet and provided the working capital required to support the implementation of the strategic reset. This strategic reset has included a line in the cost base, refocusing the commercial strategy and progressing our key development programs. At that time, the group indicated that together with the receipt of the $2.5 million milestone from Halion, cash runway would extend to December 2026. On a prudent basis and excluding that milestone, current forecasts indicate runway to June 2026. We believe the conditions for the milestone have been satisfied following the US patent grant, although the timing of the receipt remains subject to agreement under the terms of the contract. And we are working closely with Halion and our advisors in progressing that. In parallel, we're actively advancing a number of funding and strategic initiatives. So taking together a milestone and the other funding initiatives that we're progressing These provide multiple avenues to extend the group's cash runway and support our confidence that the business will be appropriately funded to deliver its strategy. Overall, our focus remains on disciplining cash management, securing funding and rebuilding revenues from a more sustainable commercial base. And we remain confident in our ability to deliver the group's strategy following the reset in 2025. And with that, I am now going to hand you over to Ken, our executive head in R&D, who's going to talk to you in more detail around our product range and the NPD overview.

speaker
Ken James
Executive Director and Head of R&D

Thank you, Angela. I wanted to start with a brief overview of the current Eroxon product and the two new product developments that we're very excited about. So we continue to believe that Aroxon is a strong proposition. It's unique because it's a fast-acting topical gel for erectile dysfunction, faster than tablets, which typically take one to two hours to work. And that means that the product can be used for spontaneous intercourse rather than the need to pre-plan one to two hours in advance. It has minimal side effects, and that means that it's available without prescription in all markets. It's a non-drug way of treating erectile dysfunction, which many people prefer. And to protect our intellectual property, we have patents granted or pending. And the expiration of the key patents is in the year 2040. It's been launched in 27 countries since March 2023. And it's a significant market opportunity. It's estimated, for example, that 24.2% of men in the US have ED and 82% of those have what we describe as mild or moderate ED. Now, we know that some men, not all men, would like a stronger sensorial effect from Oroxon. So we've developed Oroxon Intense, which has faster and stronger sensorial action. It's covered by the same patents as the base product, and we're targeting launch in early 2027. The second significant development, a very exciting development, is taking us into the area of female sexual health, starting with the creation of a range of topical gels under our unique platform technology. Again, we have patents granted or pending, And we see this as a major market opportunity because 60% of women experience at least one symptom of impaired sexual function or response at any point in time. So moving on to talk a little bit more about a forensic analysis that we've done. This is the next slide. A forensic analysis that we've done of the relatively disappointing market performance of Oroxon. Now we've looked at details in each of the markets that we operate, the marketing campaigns, we've looked at feedback from our marketing partners, and also we've consulted a range of scientific experts in the field of ED. And we've created the hypothesis that our target audience previously has been too broad. And we think we'll be more successful going forwards if we narrow that user group to men under 60 years of age who have mild to moderate ED and encouraging people to involve their partner as part of foreplay in using the product. Now, we have tested that hypothesis in a home user test, which was completed in March, which showed high efficacy rates for both neroxon and intense. This was a study conducted in 223 men under 60 years of age with predominantly mild to moderate ED. It was a four-week treatment period using either Oroxon or Intense on a minimum of four occasions. And it was truly in a real-world setting. People were recruited through the internet and we monitored them very carefully through the course of the study. We asked them a number of questions on efficacy, and we got a high degree of consistency across all those questions. But two critical questions we asked were, were you satisfied with your erection? We got results of 70% and 71% for basal roxon and intense, respectively. And we also asked people, did the erection last long enough for intercourse to occur? Rates were very impressive, 84% and 85%. We asked people to rate the product through star ratings and 49 and 53% would have given the product a four or five star rating. To put that into context, our current Amazon four and five star ratings in the US is approximately half that level. And at the other end of the scale, the current one, two star ratings on Amazon in the US is round about 65%. We've reduced that through the hut that I've just described to 23, 24%. So the results do fully validate the hypothesis that a more targeted audience delivers stronger results on efficacy. And over 50% of subjects said that they would be likely to use either product. So, the second part of the HUT study was geared up to look at whether intense delivers faster and stronger sensations, and we fulfilled both of those briefs. You can see on the graph on the left that, particularly over the first two minutes, people did notice the sensations much more prominently than with the parent product. The majority of subjects in the study rated Eroxon Intense as moderate, strong or very strong sensations. So, insofar as the development timeline is concerned, we've accomplished a number of milestones leading up to this point in time, development and testing the development in the HUT study. The next key step is to get marketing authorisation through approvals in Europe and the US, which is currently slated for June and July this year. And that would put us in a good position to launch the product first quarter next year. And now I want to move on to WSD 4000, which is our code name for the product for treating female sexual dysfunction. This is a product that will target six key symptoms of sexual dysfunction. Desire, arousal, lubrication, comfort, orgasm and satisfaction. Independent research, which has been conducted by Ipsos in a thousand women in the United States, has indicated that this is a very substantial market, as 60% of women suffer from at least one symptom of impaired sexual response and function over the last 12 months. And yet, only one in four women seek professional help. And therefore, the availability of a product over the counter would provide greater access and help for this particular group of women. Few women experience an improvement in symptoms over that time. For 37%, they're getting worse. Currently, there is no regulatory approved topical treatment for impaired sexual response and function of women available over the counter. So we think the commercial opportunity for WSD4000 is quite substantial. We calculate that there are 33 million women in the US who are motivated to try to use such a product. Moving on to where we are with the development, we've conducted a successful proof of concept study with the prototype formulation. We've had a couple of meetings with the FDA to shape the development program. And at the beginning of this year, we reported on an early feasibility study, as we call it, A relatively small study, but yielding very impressive results on efficacy across the six symptoms that I described earlier. We're in the process of conducting a clinical study looking at the sensory effect of our product versus a placebo, which will be a requirement for the clinical study. And in field at the moment is a home user test in approximately 200 women with symptoms of sexual dysfunction to help prove the hypothesis that the product is truly effective in our user group. That will lead to the initiation of a phase three clinical study, which is due to report in third quarter next year. And that will follow with an FDA submission and approval by the end of next year, leading to launch in 2028. So you can see that both on Intense and WSD4000 that we've made good progress so far and put us in a position to launch Intense in 2027 and WSD4000 in 2028. I'll now hand you back to Alex to talk about the strategic review that we've conducted.

speaker
Alex Duggan
CEO

Ken, thank you very much. As I'm sure you will all have heard, we continue to have a very high level of confidence in our products and in our strategy for a laser focus on delivering both Eroxon Intense and the new WSD4000 platform. And we believe firmly that that is potentially a category game changer. We've got very high hopes for positive real world efficacy of that new product platform and the significant market potential given that there is Independent research now showing 60% of women having experienced at least one symptom of impaired sexual response or function over the last 12 months. My first role on appointment in August was to assess the company's underlying strategy and put in place any changes needed for the company to grow and develop in a stable and secure manner. Broadly, I've taken a four-step approach to this. first a rapid assessment of the business what's working what isn't where there is future value and where there are future inhibitors i reviewed input from end consumers from our commercial partners supply partners shareholders and of course from our own internal team following an immediate review of the cash flow position we put in place a new broker who was able to raise 2.75 million pounds for us in december And Angela has already talked about the impact of that investment on the business. From January this year, we started the process of adaptation and action. This action plan includes applying cost-cutting measures, updating positioning and strategy, setting new business priorities, adapting the commercial partnership model, optimizing supply base, focusing and accelerating R&D projects, and adjusting internal resource to be fit for the next stage of development. The focus of the Futura team now is sustainable growth with a focus on global revenue growth in key markets for Eroxon and Eroxon Intense, and we hope going forward for WSD 4000. Our growth strategy is supported by enhancing our supply efficiency so we can provide best service to our customers and to end consumers, as well as improving on our own internal gross margin. We have refreshed our vision and strategy from an R&D company focused on topical gels and perhaps an over-reliance on a single eroxone product to a new vision to be recognized as a global leader in the development of clinically proven, innovative, consumer-focused sexual health products. How will we achieve this? Through our experienced R&D, regulatory and business development team, we will continue to develop innovative, insight-led, clinically proven, effective products for the growing consumer sexual health market. We will partner with and support leading consumer healthcare commercial partners to deliver long-term, sustainable global market growth. We aim to deliver strong, long-term returns for our shareholders and for our business partners. we aim to create a thriving working environment where all team members and external partners feel valued, motivated and empowered to contribute their best. And we will achieve our goals with both integrity and with respect. As I mentioned earlier, the strategic reset includes an evolution of our commercial model. Essentially, This is a move from a launch and step back approach characterized by an R&D full out license model. To an actively manage and optimize approach. Characterized by being a hybrid R&D and commercial model with continual feedback loop. The five areas of change which illustrate this revised commercial model. Our our commercial structures with partners might vary. and will be selected on a market by market basis. We will have increased strategic input and the ability to share best commercial practice with our partners. Knowledge and learnings can be shared more effectively across our global territories. The group can benefit more directly from our commercial success with higher net margins per selling unit. And we will aim to reduce cost of goods through a shared global supply resource benefiting both the group and also our partners. To support this improved commercial model, Futura has already strengthened its marketing capability with a clear focus on driving in-market performance. We've initiated a comprehensive review of global brand identity and positioning to ensure clarity and consistency across markets. And we've undertaken targeted consumer research to inform portfolio development, pricing strategy and a more effective consumer communication a question certainly in shareholders minds is how futura plans to create value going forward within our new vision to be recognized as a global leader in the development of clinically proven innovative consumer-focused sexual health products we're focusing specifically on two development areas in the near term first eroxon and eroxin intense following detailed research we will be applying new positioning messaging around the core product and around the new intense product a review is underway with our us partner in relation to alternative commercial and distribution strategies to stabilize sales grow margin and the potential launch of the intense product from early next year we're reviewing with our eu partner the best commercial and IP pathway forward, including the potential launch of a rocks on intense and the potential opening of the German market. And we plan to appoint a China or APAC partner, ideally in quarter two this year with secure forecast and launch timing likely to be in the beginning of 2027. And secondly, the WSD 4000 platform, which Ken has covered earlier in more detail, We are preparing the positioning, the packaging, and the launch strategy for our first platform products by the end of quarter two this year. We're preparing steps towards the phase three clinical trial and the funding model, and that will support claims and build product credibility with HCPs and with consumers. We are exploring commercial arrangements and license models with regional and global partners and hope to have some news on that at the end of this year. And we're exploring funding options to support the WSD 4000 phase three clinical trial. And alternatively, considering potential divestment of WSD 4000, should that provide a more financially attractive offer for shareholders. So how are we measuring our progress? Well, in November, we provided a guide to expected milestones for 2026, and I'm happy to report good progress is being made. including the wsd 4000 early feasibility study results which support a favorable phase 3 design strong indications of efficacy and a favorable safety profile the us continuation patent has been granted the china patent has been granted and we've applied a further divisional patent and the eroxon intense home user test results support a commercial decision to launch key milestones planned for the remainder of this year include the halion patent milestone receipt clearance from the fda for eroxon intense we expect that in quarter three as ken's described earlier to continue the selection of commercial partners for new markets across all products with apac being a priority focus WSD 4000 HUT home user test results to support phase three and a potential launch. And we're excited to see this following the very positive results from the EFS. And assuming positive HUT results and subject to funding, the WSD 4000 phase three first patient first visit, which is currently planned to start before the end of this year. In summary, then, just before we open the floor to any questions, The key issues facing the company are now clear with plans in place to mitigate or to manage. Management believe that there is a long-term value in the group's assets and therefore development and launch plans for both the Roxxon Intents and WSD 4000 continue to progress. A supportive news flow schedule adds potential value inflection points throughout this year, 2026, And now with a clearer, more refined strategy in place and clarity over NPD pipeline, the focus of the Futura team is first to grow underlying business and increase commercial opportunity through enhanced in-market performance of Eroxton. And secondly, to take a high-paced approach to insight-led NPD projects with specific focus on the WSD4000 female sexual health platform. Just before we answer any questions that might be arising, I'd like to take this opportunity to thank you all for listening today. And I'd also like to offer a thank you to our shareholders for your continued support. And a big thank you to the internal Futura team and all of our partners for the support and the dedication over the last year. Thank you.

speaker
Operator
Conference Moderator

That's great. 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 read 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 investor dashboard. um alex angela ken we have had a number of questions today that cover a number of different themes so rather than duplicating questions let me try to group these into topics so apologies if we don't read your exact question and so with that let's start with the first one here are you seeing any gains and repeat in repeat purchase of eroxone yet

speaker
Alex Duggan
CEO

thank you for your question so i think it's uh it's worth noting we know that 2025 was quite a challenging year for the business but we mustn't lose sight of the fact that the products do actually work well so uh as ken was saying a few minutes ago uh there are a high level of satisfaction high level of satisfaction from users uh if the product is targeted well and used correctly so uh that's why very much our focus now going forward is on execution so ensuring that targeting is precise the consumer communication is clear and practical and the expectations and usage are properly set out from the beginning so i think if we can get these elements right we believe uh absolutely that will be real world games in repeat purchase and obviously leading from that long-term value

speaker
Operator
Conference Moderator

Thank you very much, Alex. And the next one is on Oroxone. Will Intense cannibalize the original Oroxone product?

speaker
Ken James
Executive Director and Head of R&D

We don't think that will be the case. We think there's room for both products. What we've learned from the HUP testing and some of the analysis that we've done in market is that whilst some men would prefer a stronger sensorium effect, there are some men for whom the product is too strong. And therefore, we think that there is room for both products in the marketplace.

speaker
Alex Duggan
CEO

I think also just building on that as well, I mean, it's quite a well-trod path within consumer healthcare that one plus one equals three. So technically you probably will see a little bit of cannibalization, but actually you're going to gain far more by building shelf presence, consumer choice and brand credibility.

speaker
Operator
Conference Moderator

Fantastic. Thank you. And the next one here is as part of the evolution of the commercial model, will you be reviewing relationships with all current partners?

speaker
Alex Duggan
CEO

Yes, we will. And as announced back in November, that's been a core part of my strategy review at Futura. We won't shy away from making any changes if needed. And of course, we continue to seek new partners in new markets as well, with a specific emphasis on the larger consumer healthcare markets globally. And obviously, as and when there's any news on that, we will update the market in the usual way.

speaker
Operator
Conference Moderator

Thank you. Moving on to the next question. Given that the special 510K for Oroxone Intense was filed over 30 days ago, can management confirm if they have received substantial equivalence or a clearance letter from the FDA and how this impacts the H1 2026 US launch timeline with Halion?

speaker
Ken James
Executive Director and Head of R&D

Right. I'm pleased you corrected yourself because I know R&D can seem to be slow at times, but 30 years is probably the next dream. So the special 510 has been submitted to FDA. It's gone through the administrative stage. We have received some questions from FDA. These are fairly routine nature and we're working through those. And our current timing expects for us to get clearance for the 510K in July this year. The launch timing beyond that is under discussion. We've normally put down first quarter next year, 2027 for launch. Anything to add on the commercial side, Alex?

speaker
Operator
Conference Moderator

Perfect. Thank you. Next question is, what is the current status and timing certainty of the 2.5 million US dollars Halean Milestone?

speaker
Alex Duggan
CEO

shall i take this um so i think as angela has already discussed uh we've got very firm legal advice uh we believe that the conditions uh under the terms of the contract with halion have been met which trigger that milestone payment uh following the granting of the latest continuation patent so we are uh as we've said we're currently in discussion with halion about the invoicing and the payment of that milestone payment and once that's concluded an announcement obviously will be made

speaker
Operator
Conference Moderator

Thank you very much. The next question asks, beyond the standard board fees, what are the directors doing to align themselves with the shareholders who have weathered the recent volatility?

speaker
Angela Hildreth
Finance Director and COO

So as part of the reset, we've taken a really joined up approach to aligning the business with shareholders. We've completely simplified incentives across the entire organization and removing annual cash bonuses with the introduction of a one-year equity plan. And this is for all employees, not just management. And the conditions around the LTIP are entirely driven by share price performance. So in reality, if shareholders don't see value, neither do we. And whilst it's shorter than a typical LTIP, it does create clear alignment during this reset phase, helping to drive a real ownership mindset across the business. And at the same time, we've taken a disciplined look at the cost base. We've removed inefficiencies and non-core spend, being careful to protect the capabilities within the business. We still want to deliver on our commercial and our R&D strategies. So overall, it's about creating a leaner and more focused business aligned to deliver intangible value for shareholders as we look to rebuild revenues and expand the product offering that we have with the development products.

speaker
Operator
Conference Moderator

Perfect. Thank you, Angela. Next one is a two-part question. How much stock do partners have and how long will this last at current sell-through rates?

speaker
Alex Duggan
CEO

OK, I'll take that if you like. So stock is held and managed generally by our commercial partners, not by Futura. But obviously it's something that we at Futura monitor very closely because it is a key indicator to underlying demand and therefore future revenue for us. At the moment, the picture varies quite a lot by region, which is not unusual at this early stage of commercialisation. But just to give you an idea, in Europe, our partner, Cooper Consumer Health, have been working through the initial orders of pipeful stock from 2024 and 2025. So we've had, as expected this year, a slow replacement of orders for Europe. In the US, it's a slightly different picture. So the US is a model where Haleon manage fully under OutLicense. So they manage all of the supply chain. um and demand over recent months from consumer has been stronger than the partner had forecast So Halion is currently increasing production at a pace in order to keep up with the sell through requirement. And so importantly, we're advised by Halion that there is sufficient stock in trade level, both in store and in distribution to support sales while that supply comes through. And of course, we're working closely with Halion to make sure that's the case and to monitor that ongoing situation.

speaker
Operator
Conference Moderator

Thank you, Alex. A question here asks, are there any new launches planned for the second half?

speaker
Alex Duggan
CEO

So the next launch that we would expect would be early 2027, as Ken has alluded to earlier, and that would be the intense product. And most likely that would be the US market where we would start. The launch, the actual specific launch date is not entirely within our expectations. uh remit because the stock availability date uh isn't necessarily the date that we can launch because you've got local operational issues like dates of uh key retailer uh planogram resets etc but stock will be available towards the end of this year subject to obviously fda approval uh which we're expecting in around about july um and we hope therefore to have um stock in the market in the us from uh during or during certainly quarter one of next year

speaker
Operator
Conference Moderator

Perfect. Thank you. And moving on. Outside the US, which territories are next in importance for scale of opportunity?

speaker
Alex Duggan
CEO

So after the US, obviously the world's next largest consumer healthcare market is China. And as I mentioned earlier, APAC generally is a priority for us. I strongly believe that there's a significant opportunity across APAC in a very fast growing consumer healthcare market broadly. I've got many years personally experience in that territory, particularly in China. And I've recently actually just returned from a trip visiting potential partners in China and in Korea and in Taiwan. And I was really reassured, in fact, by the extremely positive response I've had in all three markets from potential partners, both for Iroxon and potentially for Intense, once we have those details and clarity on that. and particularly for the WSD 4000 products, where there is a lot of excitement for that once we have the HUT study results through this summer. So we are aiming to be in a position to announce a new partner in at least one of those APAC markets in the next two or three months. I'm hoping it will fall into H1 or early July, but that's certainly my ambition. Optimal selection of a partner is critical for good execution and long-term success. And the work we've been doing over the last few months around the reset and reassessment and reset of the brand positioning for Eroxon has been really helpful in helping us ascertain what type of partner is best to take this forward in local market on the long term. So we've set a number of specific criteria out that will help us select ideal partners, as you would expect. But I think perhaps most importantly of all those criteria is what I've learned after many years, best part of 30 years of managing international relationships with distributors and commercial partners is that sometimes it's better to be a significant part of a smaller or medium sized business rather than a small part of a large business. So the hunger of the partner is perhaps the most critical of all. And that's very much front of mind as we select these new partners in APAC and elsewhere.

speaker
Operator
Conference Moderator

Perfect. Thank you very much. And a few questions on WSD 4000. Will you need to raise money again to complete the development of Intense and WSD 4000?

speaker
Angela Hildreth
Finance Director and COO

So in terms of Intense, the development is largely complete. The remaining activities within TENS are primarily regulatory and commercial, which will be undertaken by existing internal resources. For WSD, we have consistently stated that we will require further funding, particularly to fund the external clinical trial costs for the Phase 3 programme. We're currently finalizing that study design. So I'm not able to provide any guidance at the moment in terms of what those costs looks like. But in terms of the funding strategy, we're evaluating options. which includes self-funding, potentially partnering early stage. But I do want to emphasize that the opportunity for WSD, we believe, is significant. And the anticipated phase three study costs for WSD are going to be extremely modest in comparison. We've said that with the milestone payment, we've got cash till December. We recognise that there may be some variability in receipt of that payment. So broadly, we're also actively considering a broader funding strategy to ensure that we can fund the business beyond this near-term horizon.

speaker
Operator
Conference Moderator

Perfect. Thank you. And the next question is, why do you think WSD 4000 is such a significant opportunity?

speaker
Ken James
Executive Director and Head of R&D

Yeah, maybe I can pick that one up. We continue to be very excited about it. I mean, firstly, we think there's a huge market opportunity there because there is no female version of Viagra, in very simple terms. But we've conducted Ipsos research in 1,000 consumers in the United States. And what we learned from that is that this is a very significant widespread problem. 60% of women suffer at least one symptom of sexual dysfunction. When you look at the current landscape, we think that there is a big gap in the marketplace. At the high end of the market, there are two prescription products which are sold in the United States. These are designed to try to impact sexual desire, but only sexual desire. through treating sometimes the psychiatric problems associated with sexual dysfunction. I think this does many women a disservice that sexual dysfunction is regarded by some people as being a psychiatric problem. Far from it. It's part of routine life for many women. These products, by the way, are not very effective. and they have a side effect profile and there's been very poor uptake of them one is a tablet one is an injectable so that's at the high-end prescription market and then at the other end of the scale you have a number of fringe products which are unregulated sexual enhancement products often very poorly supported with with data to support the claims that they make And then in the middle of that, you have just sexual lubricants. And they're just designed to improve lubrication and therefore sometimes pain associated with sex. So our product goes well beyond any of these products that are in the marketplace because we treat the six common symptoms of sexual dysfunction. So, sexual desire, arousal, orgasmic function, sexual satisfaction, lubrication and pain. And that is a clear differentiator which we will underpin with very strong clinical evidence. So, big market, unique product in a unique positioning with strong clinical data. So, we firmly believe that WSD4000 is a very, very important product.

speaker
Operator
Conference Moderator

Perfect. Thank you, Ken. I'm going back to Oroxon and Intense. What gives you confidence that Oroxon and Intense will have better success than what you have seen previously?

speaker
Ken James
Executive Director and Head of R&D

Yes, well, we touched upon this in the presentation, but to reiterate the key points, we've now launched Eroxon in 27 markets around the world. And it's a new product with a new brand name with very poor brand name recognition because it's new. in a new category in most markets actually around the world as an OTC category. The category doesn't exist in many of the countries that we've launched in. And often a new user base as well because we are now able to treat people who perhaps haven't gone to a doctor to seek remedies for their rectal dysfunction. So we've been on a tremendous learning curve and as we've analysed it and we've consulted with our marketing partners as well, and we've consulted with a number of thought leaders in the area, we think that a product being marketed to everyone who has ED is a little bit too broad. And as we've broken that down, many people over the age of 60 have what we call organic ED. This is often the result of comorbidities such as diabetes or obesity or heart disease. And it's very difficult to treat this user group, particularly with a product like Aroxon. We think our sweet spot really is in men under 60 years of age who have essentially mild to moderate ED, often of a psychological nature, sometimes called performance anxiety. And that is still a substantial market that we're going to be much more targeted with, particularly if we can improve the repeat purchase. And we've tested that hypothesis, as I explained in the presentation, through the home user test, and we get very good efficacy rates, 70%, 80%, much higher star ratings. a much higher inclination to repeat purchase. So we think this refined positioning is still a substantial opportunity for us and will therefore lead to success going forwards.

speaker
Operator
Conference Moderator

Thank you very much, Ken. And perhaps a few more questions here. Following the strategic review, do you believe there is a sustainable business here?

speaker
Alex Duggan
CEO

So I think that's exactly the right question to be asking. The short answer is yes, I do fundamentally believe there is a sustainable business here for a number of reasons. And I think first, as you're hearing from Ken and from all of us, there is a strong conviction in the underlying products. There's a clear demand for a well-positioned, non-drug topical ED product. There is no doubt about that. And we are getting good results when we, the tests that Ken has described, we are getting strong results. So when that product is well positioned, we really do have strong confidence in that. And similarly, for the female health product in development we have a lot of confidence from the early tests we've done on that and from the research we've done in market that that is going to be a successful market launch so these are all large underserved growing categories secondly my view as i guess the new boy here is the that science is the science is a genuine strength for futura and the depth of expertise at an r d level and the commitment from the r d team is really is generally genuinely extremely high and i've been nothing but impressed since i've started here about the team's capability uh experience uh and adaptability um Thirdly, we're strengthening the skill set of our team, particularly at a commercial level. And I talked earlier a little bit about that. Success for an R&D business can't be driven only by science. There has to be an effective translation from scientific innovation into consistent, scalable revenue. And that's very much a focus for us. And I think finally, my reflection would be, as Angela has just talked about funding, the board is super focused, as you would imagine, on ensuring that we have sufficient funding to secure the business as it transitions towards being a self-sustaining business in the future. So that does have full focus and we're confident in that regard. So the board's focus and very much my focus is to build a self-sustaining company developing clinically proven sexual health products, delivering real-world consumer benefit and therefore long-term shareholder value.

speaker
Operator
Conference Moderator

Thank you very much, Alex. And perhaps one last question here as we approach the hour. You talk about having more involvement with partners post-launch. What does this mean in reality and what expertise do you have within the company?

speaker
Alex Duggan
CEO

So that's also a very important question because post-launch execution is really where value is either created or lost. So when I talk about increased involvement, what I really mean by that is a more structured, proactive approach to both supporting and, where necessary, challenging our partners in market to maximize in-market performance. So to answer your question specifically, We are first of all with with investing into deeper much deeper consumer insight and we're, including our partners within that research and that will help us refine. Both three rocks and wst 4000 the positioning, including messaging claim set target audiences price points, etc, we are. turning then that into those insights into clear commercial guidance for our partners and developing practical data driven recommendations to adopt locally. And then we'll have an implementing a continuous feedback loop, if you like, where we'll continue to track in market performance, sharing learnings, best practice across markets and using that data to improve the execution over time. so this is quite a change of approach for futura and i talked earlier about moving from what i've termed a launch and step back approach under a full-out license model more towards an actively managed and optimized model And that approach really stems from my experience, having worked most of pretty much all of my working life within consumer health care, global markets and commercial and BD particularly. And to support that further, I've recently appointed a new interim global marketing director. So this is somebody who I've worked very successfully with before, who has deep consumer healthcare and MPD experience in the geographies and the channels that we are particularly focused on. So in summary, I think combined with the existing MPD and R&D strengths that the business has, We're strengthening our capability then to bridge science with commercial execution, which is critical in my view to unlocking the value of these products.

speaker
Operator
Conference Moderator

That's great. Well, look, guys, you have covered a lot of questions there. So thank you very much indeed. And of course, the company can review all questions submitted post the call and we'll publish those responses on the platform where appropriate to do so. But Alex, before we direct investors to provide you with their feedback, which I know is particularly important to yourself and the company, could I please just ask you for a few closing comments?

speaker
Alex Duggan
CEO

Yes, of course. Well, just quickly, because I know we're up for time, but hopefully what you've heard today is continuing belief and full commitment from the team at Futura that we are strongly driven to deliver long-term value for the business. And I would just like to reiterate my thanks to you all for joining today and for your good questions. Thank you very much. And particularly, thank you to all of our shareholders for your continued support, which is not taken for granted. So thank you all very much and have a good rest of your day.

speaker
Operator
Conference Moderator

Fantastic. Thank you once again for updating investors today. Could I please ask investors not to close the session as you will now be automatically redirected to provide your feedback, which will help the company better understand your views and expectations. On behalf of the management team, we would like to thank you for attending today's presentation and good morning to you all.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-