Futura Medical plc

Good morning, and welcome to the Futura Medical 2025 Interims Presentation. Many of you will have seen Board changes announced over the last 3 months, and I'm the new face to the team.

I'm Alex Duggan. I'm appointed as the Interim CEO since August of this year.

I've got 25 years' experience working in consumer health care and pharma businesses, taking leadership roles in both small and midsized public and private businesses. My remit as Interim CEO is to conduct a full review of the performance and the strategy and put in place strategic and leadership plans that best benefit the shareholders and all other stakeholders of Futura.

Before we start today, can I just draw your attention, please, to the disclaimers shown here. These, along with the presentation and the recording today will be available on our website for you to review.

H1 has been a very active time for Futura on many fronts. So our agenda today is perhaps a little longer than normal for our interims as we'd like to update you as much as possible on where we are.

First, Angela will provide us with an update on the first half financial update and trading update. Then I will follow giving some reflections on what I've seen in my first 60 days and an update on our market launches and a summary of our focus to improve business performance.

Ken will then talk through our NPD pipeline and an update on the status of the patents. And after the summary, we will answer any questions that may have been received during the presentation.

So just before I hand over to Angela to provide the financial update, these are the key outtakes for today. First, we've seen further market launches during H1 in 7 countries but we are seeing challenges around sustaining consumer uptake.

What we see in all markets is the initial trial seems strong, which is very positive. But for various reasons, repeat underlying sales are not coming through as expected.

This has had a direct impact on our supply volumes and our royalty streams. And so the full year 2025 performance is likely to be significantly below market expectations.

As announced on my appointment, a strategic review has commenced with initial findings coming through now and some of these findings I can share with you today. As per the recent RNS on the 19th of September, the shift in performance versus prior expectations has put the company in a challenged position.

However, the Board does remain confident that there is value in the group assets. And development plans for both the Intense and WSD4000 development products will continue to progress.

Although there is always a risk in any R&D project, early indications for these 2 projects are quite positive. Evidently, my job and that of the Board is to ensure that we do all we reasonably can to protect our stakeholders and shareholders to derive as much value as possible from our current products and from our new development products.

I will come back to this again. But first, I'd like to hand over to Angela to cover our H1 financial update.

Thanks, Alex. So let me take you through the results for the first half of 2025.

We generated just over GBP 1 million in revenues during the period. Around half came from royalties in the U.S., nearly half from sales across the EU, including the U.K.

and a small contribution from LatAm and the Middle East. The lower sales this year reflect the channel fill and the stocking that took place during 2024, which our commercial partners and customers are still working through.

On those sales, we delivered an initial gross profit of GBP 0.7 million. However, given the continuing lower demand, we took the prudent step of providing for potential inventory obsolescence on stock that was manufactured last year to meet minimum order quantities when we transitioned to our new supplier.

This provision was GBP 0.49 million. R&D spend remained broadly in line with last year and that was focused on progressing Intense and WSD4000.

And our core G&A costs were GBP 2.6 million. This is down from GBP 3.4 million last year, showing the benefit of some cost reductions we've put in place.

But that said, with lower demand expected in the U.S., we reviewed our manufacturing assets and identified indicators for impairment. As a result, we have impaired the U.S.

plant and equipment and provided for the final installment due later this year and this has resulted in an exceptional charge of GBP 3.6 million. After these items, the loss after tax for the period was GBP 6.6 million.

On a preexceptional basis, that loss was GBP 2.6 million. If you strip out the GBP 0.64 million of noncash share-based payment charge, the adjusted loss after tax comes to around GBP 1.9 million.

Cash at the end of the period was GBP 3.69 million. If we then move on to the trading update released in recent weeks, this provided further clarity on revenue expectations for the full year, which we have confirmed will fall short of market expectations.

Alex will talk in more detail about market specifics later in the presentation. But in summary, we continue to see slower in-market sales of Eroxon than both Futura and our commercial partners have anticipated ahead of launch.

Based on initial partner forecasts, 2025 sales were expected to reach around GBP 5 million. This included a $2.5 million milestone payment, approximately GBP 1.9 million, linked to the granting of the U.S.

patent. We now expect that to be received in 2026 and Ken will cover off the U.S.

patent point in more detail as well. In our recent announcement, we guided that the full year sales for 2025 are now expected to be between GBP 1.3 million and GBP 1.4 million.

As part of that same update, we also disclosed that cash at the end of August stood at GBP 2.7 million. Under current plans and taking into account the cost reductions we've implemented as well as the cost of implementing those measures, this provides runway into January 2026.

We are actively exploring a number of commercial and financing options to extend this runway and we will update the market when we're able to. I'll now hand you back over to Alex.

Angela, thank you very much. I'm going to share my view now of my first 60 days at Futura and to give an update on the business as it is today.

As announced on my appointment, the Board and I have initiated a strategic review, which is now in progress, covering sales and marketing strategies, product performance and efficacy, the costs associated with running the business and other potential strategies and strategic options open to the company. It's now clear to me what the key issues are, which face the company and its products and our commercial partners.

The key challenge to the company today is that previous forecasts, which themselves were based on our commercial partners' forecasts are no longer realistic based on current data. Launch forecasts, of course, are notoriously hard to get right, especially for a product in a new subsector like Eroxon.

Futura is a small and concentrated business. Its commercial performance is strongly geared to the in-market performance of a single product currently via our 4 current commercial partners.

The downturn we've seen in forecasts versus our partners' launch expectations has had a significant impact on our business and it is this impact we are urgently navigating now. Our partners have continued to launch Eroxon into the new markets.

And as you can see in the time line below, Eroxon now is present in 25 markets with 7 new markets launched in H1 of this year, 6 in Europe through Cooper and 1 in the Middle East by Labatec. Despite a shared recognition that in-market performance has not been as expected initially, we do continue to have an open dialogue with each of our commercial partners.

We are currently in early-stage discussions around the launch in Brazil with our existing partner, Labatec and with new potential partners in markets, including Taiwan and China. Once there is any material certainty around new launches, of course, an announcement will be made in the usual way.

Whilst we're limited in the level of information we can share for reasons of both commercial and partner confidentiality, the table here shows a summary of progress through each of our current 4 Eroxon commercial partners. First, in Europe, we've seen a decline in in-market performance driven by a comparison with a strong H2 in 2024, which itself was driven by heavy investment, particularly in France, Spain and Portugal by Cooper leading to quite a high selling in market.

And although it's too early to assess true like-for-like trends, the drop is steeper than had been expected and consumer repeat sales are not yet coming through at the level required by Cooper. Cooper do, they remain engaged and expect to meet all contractual obligations.

In the Middle East, selling across the region has declined compared with the previous 6 months, where high sell-in activity from the local sales force in Saudi Arabia drove strong volumes. Labatec has expanded distribution of Eroxon into Kuwait this year in May and we await initial results from that launch.

In the U.S., following a high-impact launch in October '24, as previously announced, in H1 of this year, we've seen slower-than-anticipated repeat sales. While distribution levels remain strong, both in e-commerce and brick-and-mortar, market performance has not yet met initial Haleon or company forecasts due to lower repeat sales.

And to minimize theft risk, which is a growing U.S. trend, brick-and-mortar stockists are increasingly using locked displays in around 1/3 of Eroxon distribution points.

Haleon also remains committed to meet their contractual obligations. And lastly, in LatAm, following the August '24 launch in Mexico, H1 saw continued growth in retail distribution and a significant expansion of M8 digital campaign, albeit with consumer sales below the partner's forecast.

Discussions are currently underway around a potential launch in Brazil and we expect feedback within H2 regarding their appetite to launch Eroxon in LatAm's #1 consumer market and what those time lines would look like. As I've said, global demand for Eroxon and topical treatments for mild to moderate erectile dysfunction clearly exists.

So how do we access it? Data from all of our market launches is clear.

Initial sales are strong. Clearly, there's an appetite for a nondrug topical product for those who do not wish to take PDE5 inhibitors due to their side effects or for other reasons.

Our learnings show that the low level of repeat consumer purchases showing in the initial data is due to 4 key factors, the positioning gap with potential consumer overexpectation of Eroxon's benefits, consumers thinking it will act like a PDE5 inhibitor, usage, imperfect consumer understanding of when or how to use the product correctly and why it's important to use the product in full flow. A binary efficacy perception exists.

So for many men, Eroxon either works, you get an erection or it doesn't, which is unlike many consumer health care products where usually a modest improvement would be considered a successful outcome. And fourthly, the accessibility advantage where no prescription or HCP is required in the transaction means the product is widely available.

However, this does mean that Eroxon is open access to all consumers, which could lead to either misuse or unrealistic expectations. So what are we doing and what are our partners doing with these learnings?

We are reviewing our product positioning so that we have a clear positioning that will set realistic expectations versus PDE5 inhibitors. We are reviewing consumer targeting strategies to focus on audiences where Eroxon is most effective, where possible, trying to filter out consumers with severe ED, where Eroxon may be less likely to help.

We are enhancing consumer education through HCP engagement, either in pharmacy or other settings. A health care professional can advise both on product suitability and usage.

E-com communication improvements will inform consumers better and potentially filter users and improved usage instructions to ensure proper integration into foreplay and to advise on using 3 or 4 times for longer-term successful outcomes. As you can see, we are now working on several areas to improve the underlying product performance in market.

In addition, the Futura team is busy with R&D projects in 2 specific areas and Ken will now provide an update for you on our latest progress.

Thank you, Alex. In the field of consumer health care, it's important to fuel the categories in which you operate with innovation.

And as we previously disclosed, we've got 2 exciting developments that we're working on. The first one, if you could move to the next slide, is what we -- a new variant, which we call Project Intense because it's designed to provide a more intense sensorial effect than the existing product.

And the reason for this is that whilst a number of men like the sensorial effect that they get from the existing product, there are a group of men who would prefer a stronger sensorial effect from the product. And we've conducted a couple of studies already to support the concept.

The first one was a fairly small study, which is depicted in the slide and the graph here. And it showed that there was a stronger sensorial effect at 15 seconds through to 10 minutes with the new variant.

And that's an important period of time, obviously, because that's usually the period by which intercourse occurs. If you move on to the next slide, you can see a time line of progress that's been made.

The study that I've just referred to was reported in early part of this year, 2025 in April. And we are currently in the field to conduct a larger study in 200 subjects.

And that basically will support the premise that we have a really exciting product that improves the overall sensorial effect and therefore, the impressions of efficacy of the formulation in those group of men who want such an effect. We are well on the road to achieving regulatory approval for the development in both the key territories of the EU and the U.S.

and we anticipate getting such approval by the end of this year. If I can move on to the other development, which is we feel very exciting, has a tremendous amount of potential and it's for the treatment of sexual response and sexual function in women who have impaired function.

And the reason that we're excited about it is that no such product currently exists in the OTC category, certainly with regulatory approval and strong claims supported with clinical data and strong IP protection. So when we look at the market opportunity for WSD4000, you can see that it's a really exciting opportunity.

We know that between 40% and 50% of women suffer from the problem that we're trying to treat here and at least 60% have suffered from at least one symptom of impaired sexual response and function in the last 12 months. But only 1 in 4 of the women seek professional help.

And very few women experience an improvement in their symptoms. And in fact, the opposite happens that 37% say that their symptoms get worse over time.

And importantly, as I've mentioned, there is currently no regulatory approved topical treatment for impaired sexual response and function in women available over the counter. So the progress that's been made, we have conducted a successful home user study and we showed that there was a significant improvement in most of the 6 symptoms affecting women, which is very encouraging data, early data.

We are in the process of designing a larger study to support that premise by way of proof -- further proof of concept. Meanwhile, it's important that we bring the key regulators with us on the journey that we're undertaking.

We've had 2 meetings already with the U.S. FDA who have been very supportive and given us good guidance on how to design our program to bring the product successfully to market in the key geography of the United States.

We have, in the fourth quarter, a third meeting arranged with the FDA, which will hopefully guide us to the exact design of our clinical study, which we will plan to kick off from 2026 onwards. And we also, under the previous guidance of the FDA, have been encouraged to conduct an early feasibility study really to test the overall functionality of the product to make sure it does what it says on the tin but also to check out our clinical trial endpoints to make sure that they're both valid and going to give us the information that we need.

So that study has now been initiated and it's due to report in the early part of next year. So exciting progress with the early feasibility study as well.

If I can move now on to our patent update. And with a small company, it's important that we protect our assets with key intellectual property.

And I've highlighted a number of key areas here. You can see that overall, there's a lot of activity going on in the patent area but particularly in China, we expect to get notice of allowance quite shortly for our patent in China.

We already have a granted patent in Hong Kong. In Europe, we already have a granted patent covering Eroxon and Intense.

And last but not least, the United States, we've received an initial patent of fairly narrow scope but we have a continuation patent where -- which we expect to be granted in the first, second quarter of next year. And as Angela has referred to, that should trigger a milestone payment from one of our key partners in the United States.

So if you move on to the patent coverage of WSD, you can see that we have filed internationally with the PCT. So with our new asset coming forward, the female product, we plan to have robust patent protection for that as well.

So I'll now hand you back to Alex for a summary.

Thank you very much, Ken. As you can see, although R&D projects can never be fully guaranteed, there is genuine excitement in the company about these new developments and we're taking all the necessary steps to bring to market new efficacious products, which will resonate with consumers in this growing category of consumer sexual health.

In summary, I'm clear about the issues facing the company and its products and we're working with our key partners where possible to improve underlying in-market product performance. The company is in a challenged position currently, as you have seen.

And as previously announced, we initiated a cost-cutting exercise and we are exploring a number of different avenues to extend our cash runway further, including considering commercial options such as licensing or divestments and/or opportunities for financing. The Board does believe that there is significant long-term value in the group's assets and so development plans for both Eroxon Intense and WSD4000 will continue to progress.

We continue to undertake a thorough review of our business and its operations to deliver a clear view on how best to take the Futura business forward and you can expect a full update by the end of quarter 1, 2026. Now I fully appreciate that some of the messages today are difficult to hear for our long-standing, supportive and patient shareholders.

It's regrettable that this patience is going to be further tested. But I can assure you that the company will do all it can do to get the best value from both our current and our new products.

Clearly, there is an appetite for products like Futura's and the data all supports this. We will continue to press for a return from these innovative products.

As and when there are any further updates, we will, of course, announce in the usual way. But for now, I'd like to thank you all for your time today and thank you for your continuing support.

Good morning, everybody. So we -- as part of our review, obviously, we are considering all options.

My view in life is very much that any business relationship has to benefit both parties. And it's evident that some of the results are not as expected so far by our partners or by us and we're doing all we can to remedy that with the strategies that we've talked about a few minutes ago.

So as part of a wider review, then yes, we are considering all options right now. But we remain confident in our current partners.

And obviously, all of our partners are committing to their contractual obligations.

So I can take that. They -- so Haleon has done, as you would imagine, from a company like Haleon, they have had an excellent launch.

They put a lot of pressure, particularly in the early phase of the launch at the end of 2024. And they've had a fully integrated campaign using TV, social media, digital influencers, HCP support and they've invested heavily into the product.

So -- and that's continued through into 2025. So we are hopeful, obviously, that, that will continue and they have certainly done a great job so far in the initial launch phase.

So I think that is an area that we can't go into too much detail on. But we, as part of the ongoing review, it's one of the areas we need to consider because obviously, we need to provide at some point some guidance for next year.

But the -- it's under review very much at the moment.

So we don't have any -- our partners don't have any launches in H2 of this year. As we alluded to earlier, we are in discussion in LatAm for a potential launch in Brazil.

That does require some regulatory agreement and a suitable commercial plan agreed with our partner there. Beyond that, we are in discussion, in early stage discussion in a number of markets, Taiwan and China, for example.

And that's where my focus will be going forward on the larger markets, which can move the needle.

I think as I just mentioned, I mean, obviously, the U.S. is the #1 consumer health care market in the world.

So it's important that we get that market right. And the second largest consumer health care market globally is China.

And I'm confident that if we can get through the regulatory hurdles in China and we can find a partner that is suitable and we launch in the right way, then this has a -- the Eroxon and potentially the WSD4000 products going forward would have great opportunity in that market.

Ken, would you like to pick up on that?

Good morning, everyone. So if I start with Project Intense, as I showed on the slide, regulatory approval in the EU and the U.S.

is scheduled to occur by the end of this year. That's an important and necessary step on the journey.

But you will appreciate that post approval, there are a couple of areas where we have to get things in place before we can consider launching. The first of that is to ensure that we've got an adequate shelf life.

And the minimum, generally speaking, for a consumer health care product is a 24-month shelf life. And the data for that will be available towards the middle, third quarter of next year.

The second area is manufacturing logistics. You have to ensure that you have the supply chain all geared up and a critical part of that is ensuring that you've got labeling, which is consistent with the regulatory approval.

So you can't initiate the construct of that labeling until after you've got regulatory approval. So the manufacturing supply chain is another critical factor.

So we anticipate the earliest that we could launch the Project Intense would be third, fourth quarter of next year. Insofar as WSD4000 is concerned, it's a longer time frame.

The reason for that, as I explained, is we think the only viable way to success with the product is to have very strong claims, which are clinically supported with strong IP and regulatory approval. Any potential shortcuts to market would compromise any of those 3 things and the company decided that we won't do that because it will lead to failure.

So when you look at the critical path there, the clinical study is definitely on that critical path, as is regulatory approval. And therefore, we anticipate launch of WSD4000 being in the latter half of 2028.

So it is unlikely that the cost reduction plans that have been implemented already and are underway to further implement will materially extend the runway beyond January '26. Some of them have already been factored into that runway and some of them we won't receive the benefit from until beyond January.

There's also a balance in terms of the cost reductions that we are making versus retaining value in the business. So the runway is likely to -- the extension of runway is likely to come more from commercial or from financing options, which we're currently exploring.

Thank you. So I've watched Futura's development from the sidelines for a number of years and I've always been impressed by the R&D capability of the team.

And I do genuinely believe that there is a terrific market for products like those of Futura and despite the first challenging results from the market, I do believe there is a strong future. I stepped in as the Interim CEO in August to help with an urgent short-term leadership gap.

And the basis for me joining was to conduct an immediate review and assessment of the strategic plan for the company. So as you might imagine, part of that review and that strategic plan will be to put in place a leadership team that is appropriate for the company going forward, however we deem that should look.

So I don't want to avoid the question but actually, between the Board and myself, we need to determine who is the best person to lead the company forward and that absolutely forms part of that review.

Ken, would you take that up?

Yes. We're making good progress with ANVISA.

They've conducted inspection of contracted manufacturing plant. That audit has gone very well.

And it's our belief that we will be getting approval from ANVISA in the not-too-distant future.

So I think we can't really get drawn into too much detail on questions like that but I appreciate where the question is coming from. What we've said and we have announced is that we will consider all options as part of our review.

So there's nothing off the table. But at all times, first and foremost in our minds is how do we deliver best value to all stakeholders and to our shareholders.

That is absolutely our ambition.

So I think in a launch like this, hindsight is wonderful. What we've shown clearly is that there's absolutely an appetite for this type of product.

We have seen in the market that the real-world performance does differ slightly from the clinical results that we achieved and our partners achieved prior to launch. So our expectation -- but it is obviously tests are underway at the moment.

Our expectation and hope is that the Intense product will be slightly better in terms of sensorial effect than our original first Eroxon product but that is yet to be determined. So we've listened to the market.

We have developed the Intense formulation and strategy on the basis of feedback from the market. In consumer health care, continual development is essential.

And so we will continue to do that. And no doubt there will be other products beyond the Intense as well.

So I think -- watch this space. We've said that we're expecting results during quarter 4 for that Intense product.

And when there's any material information to release and update the market, we will do that.

So that's not the case, no. And obviously, I can't divulge confidential information between us and our partners.

But evidently and clearly, Futura will meet its contractual obligations.

Interesting idea. One of the areas that we have picked up on is that we need to provide clearer guidance, I think, to consumers to try to help them get best effect from the current products and we will take that forward to our -- those learnings forward to how we apply to our new products as well.

So whether tactically we use a QR code or other means, the intent very much is there to ensure that consumers have got best knowledge and understanding of how to use the product to get best outcomes from it.

So at the moment, the production for the U.S. market is done in the U.S.

but it's done under license and so Haleon manufacture that themselves and pay us a royalty. And we're not importing products from the U.S.

So I think we've covered that off. We are -- we continue to have a very open dialogue with all of our partners.

And I have seen over the last few months, the messaging through our partners have adapted a little bit, as you would expect in a launch phase with learnings from the market. And I expect that will continue.

Again, the clinical data supports very much the doses that we currently use. Ken, you might have a view on this from a technical point of view.

Yes, I do. The short answer is no because you then would run into potential safety issues.

It's a very fine balance between achieving high consumer acceptability in terms of safety and achieving efficacy. And we think we've got the dose right.

As we've explained with Project Intense, we think the way forward is with a new variant, which creates a stronger sensorial effect through the same dose as previous.

So that's quite an involved question. I think that in the U.S., what we've seen is a large company, Haleon going out and doing a great job of launching the product in a high-intensity way.

They've managed to achieve terrific distribution across the U.S., across all brick-and-mortar accounts and very strong on Amazon. And they have pressed hard on the launch to make it as effective as possible.

The mismatch that we see between the clinical results -- the studies done by Futura but also prelaunch studies done by our partners, including in the U.S., we believe that's really down to a number of factors. It could be the product itself a little bit but it's also down to the positioning and the usage, which we've touched on.

And so we continue to work with Haleon in the U.S. as with our other partners to try to make sure that, that positioning is adapted and the usage is adapted so that we can get best results in the market.

Thank you. I think I just want to just repeat my thanks to you all for joining today and for your interesting questions.

I hope that we've been able to clarify at least some of the questions and the points that you may have. I appreciate that they are quite uncertain terms -- uncertain times.

But I do want you to be assured that the Board and the company is doing all it possibly can to get the best return possible for all of our stakeholders, including our shareholders who have -- many of you who have been very patient for many years and we do appreciate that. So we're looking at a number of angles in our review, our strategic review.

And as soon as we have an update, we will announce that to the market in the usual way. So thank you again for your continued support and I hope you have a good rest of your day.