Futura Medical plc (FUM) Earnings Call Transcript & Summary

Well, good morning, everybody, and welcome to the Futura Medical webcast for the year-end results 31st of December 2020. I'm James Barder, the Chief Executive, and I'm pleased to be joined today by Ken James, who's Executive Director and Head of R&D; and Angela Hildreth, who's Finance Director and Chief Operating Officer. Can we please turn to the next slide? First of all, a bit of a corporate overview about Futura. We're listed on AIM. We describe ourselves as a virtual organization with 15 staff members and a number of consultants, 30 consultants. Our key asset is DermaSys. Our real expertise is in transdermal science, development of topical gels. We have a track record of clinically-proven innovation, both in sexual health and pain relief. And we have a portfolio of late-stage products with an experienced management team. Today, we're talking about 3 of our products. Obviously, the main focus is MED3000, which is a topical gel for erectile dysfunction. Ken will also talk a little bit later on about 2 other gels that we're developing, one using cannabidiol and one using diclofenac. Can we please turn the slide? Strategic outlook of the company. As we said earlier, really exploring the potential of our transdermal delivery technology, what we describe as DermaSys and really enhancing the company's position as real innovation in research and development. Our priority remains MED3000. This is our topical gel, fast acting, for the treatment of a erectile dysfunction, where we believe there is a potential to have up to $1 billion in sales. To maximize that value, again, very much focusing on the remaining clinical work that we do, especially for America, and again, Ken will talk a little bit later about FM71, which is required to get approval in the states. We'll also talk a little bit more about focusing on our commercial deals that we're doing. And the key thing here is to build sustainable long-term revenue stream and also get market validation for the product ahead of launch in the U.S., which is by far the biggest market. In addition to that, very much focusing on building a manufacturing facility. When I say building, we look to contract this out, but having a reliable distribution and manufacturing capability, enabling us to have a low-cost of goods and also to build a global brand around MED3000. Next slide, please. Year-end highlights. Again, I've already touched on it, focusing on really building value around MED3000, derisking the remaining clinical work for this. As we announced about 4 weeks ago, we've had a recommendation or received recommendation to get the CE mark certificate approved by the end of May, and that is a key moment for us. We've also had clarity from the FDA on the remaining clinical work to get approval for MED in the States. We also announced the signing of a joint venture agreement with Atlantis, and we've retained specialist corporate advisers looking at other commercial deals throughout the rest of the world. There's been quite a lot of progress on our cannabis product. And again, Ken will touch on that as well as our pain relief product using diclofenac. And then finally, we've had a net loss of GBP 2.24 million. But again, Angela will talk a little bit more about that later on in the presentation. Turn the slide, please. So MED3000. Key 4 things here. This is a truly unique product. It is the only rub-on gel clinically proven to treat erectile dysfunction. It is clinically -- it is the only clinically-proven ED treatment that will shortly be available as an over-the-counter product throughout Europe. Some of those shareholders may be aware that Viagra is over the counter. In other words, it's available without a doctor's prescription in the U.K., but that is the exception rather than norm through the rest of Europe, other than I believe Denmark, Viagra remains a prescription-only medicine as is the case in America. Again, it's a breakthrough technology. With the DermaSys technology enables men to get an erection within 10 minutes, which is much faster than any of the tablets. It can be applied by either the man or his partner during foreplay, so providing a more natural and spontaneous experience. It's safe. It is a drug-free medical device. Therefore, there is no systemic side effects, unlike the tablets. And there is no potential for drug interactions, and therefore, we expect minimal contraindications, again, unlike tablets. Broader appeal in the clinical work we've done to date has been effective in mild, moderate and severe men who have erectile function, including both psychological and organic. And there are many advantages to this product, which will appeal to nonusers of current ED treatments. And again, I'll talk a little bit more about this later on. Moving on.

Thank you, James. And I'm pleased to report that we've made very significant and positive progress on MED3000 in both Europe and the United States. But first, if you move to the next slide, a brief explanation of the unique mode of action that the product has. So it's rubbed for 15 seconds on to the glans penis, the head of the penis. And it creates a novel cooling and warming effect as a result of evaporation of volatile components in the formulation. And what you see on the left-hand side here, is a very rapid 10-degree or thereabouts drop in temperature very soon after application, and then a recovery warming effect. And it's the combination of that cooling and warming, which sensitizes the nerve endings, and there are many, many nerve endings on the glans penis, very sensitive part of the anatomy. And that sensitivity ultimately leads to a biochemical chain, which is illustrated on the right-hand side of the chart here, but ultimately, smooth muscle relaxation, tumescence and penile erection occurring. And in yellow on the chart, you can see where the oral tablets, the PDE5 inhibitors come into the chart through a different mechanism that ultimately lead into the same effect. Now this physical mode of action is very important, because it enables us to not actually include a drug substance in the product, and therefore, go down a different regulatory pathway, which is called a Medical Device Regulatory Pathway. And then because of the absence of a drug, the product is inherently safer and therefore, opens the door for over-the-counter nonprescription sale of the product, both of which we're pursuing. So if you look at an illustration of the label on the next slide of ultimately what the product will become. You can see here that is fast acting. We have a key differentiating claim because it's rubbed locally and topically into the penis. And 60% of people who use it get an erection within 10 minutes, which is substantially faster than the oral pills. And of course, it's clinically proven to treat erectile dysfunction based on the clinical data that we generated through FM57, as we call it. So if you move on to the next slide. This is the very positive news that we announced recently regarding progress in Europe. So in July last year, we submitted our Technical Dossier to the notified body for review. And it's been going through that review process over the last few months. We had 26 questions asked of us. The technical file comprised a very substantial amount of information on our clinical study, our safety data and our quality data and the 26 questions included a number of questions around all those different factors and the clinical data as well. We were able to satisfactorily answer all of those questions without actually submitting any more data as a result of it and generating any more work. So they were all answered satisfactorily. And then at the final stage of that review, it went to a clinical panel who gave it the green light. No further questions were raised. And then we learned at the beginning of March that our lead reviewer, the scheme manager, as he's called, had signed off on that Dossier and recommended it for approval for the CE mark. So we're now waiting for that CE mark to arrive. We understand that it normally takes a matter of weeks. It's not a precise process because there are other products that they're reviewing at the same time. But we're anticipating getting that final CE mark by the end of May. Now a couple of important things. The CE mark is acknowledged and recognized by many regulatory authorities around the world. And it will lead to an expedited review process in many, many countries, including countries in the Middle East, Far East, Africa and Latin America. So it does open the door for fast-track approval in these additional countries. I know many of you have questions about Brexit and how does this all work in terms of Brexit. Well, there is an agreement now between the U.K. and Europe that the CE Mark is valid until the 30th of June 2023. And what we have to do in the intervening period is apply for a specific UKCA mark and in discussion with our notified body, this is a very, very simple process. We don't need to generate any more technical data or review our -- and change our quality management system. That is all taken as read. So it's purely a paper exercise and administrative process. And we'll be applying to the U.K. CE mark very soon after we get the European CE mark, which will cover that off. So this will enable us to offer the product for free sale across all countries in Europe, including the U.K. If I turn now to the next slide, which is the United States. It's a different process here. And you go initially through a series of pre-submission meetings with FDA. And the reason for this is laid out very clearly in the FDA guidance document, where they state early interaction with FDA on planned nonclinical and clinical studies and careful considerations of FDA's feedback may improve the quality of subsequent submissions, shorten total review times and facilitate the development process for new devices. So we've been taking advantage of this, and we've had 4 pre-submission meetings with FDA. All the meetings have been very, very constructive. We've heard from their point of view, they're very intensely listening to our point of view. And we've come out of that, I think, with a very good agreement on how to move forward. The bottom line is that there are 2 additional requirements that the FDA have asked us for. There's a small supplementary clinical study, and I'll come on to talk about that in a little bit more detail. And then secondly, because we're applying for OTC status, which would become the first ED product available in the U.S. for OTC, FDA just want a little bit of assurance that consumers will actually be able to understand the label and use the product appropriately. This is a very simple study called a Human Factors Study. But once we've conducted the clinical study and the Human Factors Study, which we anticipate second half of next year, we will be applying for approval and we anticipate U.S. approval or OTC status in the first quarter of 2023. So if you turn to the next slide, I do want to talk about the clinical and the design of that in a little bit of detail. So this is a bit of a mouthful, but it's a multicenter, randomized, open-label, home use, parallel group, clinical investigation of topically applied med and oral tadalafil at a low dose of 5 milligram, the treatment of the erectile dysfunction over a 24-week period. And I want to unpack that a little bit and explain to you how we've been discussing with FDA and negotiating to make this a reasonable and not burdensome study with very high odds of success, and therefore, it's been derisked to a quite considerable degree. So if you briefly look at the headline objectives, 2 primary objectives to show a significant difference over baseline and that difference is clinically important. A number of secondary objectives, but including further proof of evidence that we have a fast onset of action, and we'll be evaluating it at 5, 10 and 15 minutes in respect to that. And then a number of exploratory endpoints, which include a comparison with tadalafil. Importantly, tadalafil won't be included in the primary objectives. A number of study sites, primarily in Eastern Europe, but one in the U.S., and we'll be testing MED3000 and tadalafil at 5 milligrams. So let me break this down into bite-sized pieces, so you can understand how we've been able to derisk it. Move on to the next slide. FDA were a little bit concerned that we had only conducted FM57 for 12 weeks. They wanted assurance that it worked for a longer period of time, given that erectile dysfunction is a long-term chronic condition. And therefore, they've asked for a study of 24-week duration. We don't think the effect is going to tail off at all after 12 weeks. And evidence to support that is in the graphical representation of some of the results we got from FM57 here. This is one of the primary endpoints that we used to ask the question, did your erection last long enough for successful intercourse? And we looked at it baseline pretreatment in the first 4-week period, the period, 4 to 8 weeks and between 8 and 12 weeks. And these are the improvements over the baseline for the first 6 doses within each of those time periods. You can see that from the first dose, actually, that MED effective, but reaches the peak effect after about the third or fourth dose. This is not unusual for erectile dysfunction products, including the oral tablets, where generally, it takes 3 to 4 doses for people to get used to how to use the product. But reassuringly, we're getting efficacy from the first dose onwards. But importantly, you can see here that over the 12-week period, there's really no drop-off in efficacy. In fact, you could say that there's a slight increase in efficacy over time. So we're very confident that this will continue through the a 24-week duration of the study. FDA, the device spoke in CDRH, as it's called within the FDA, operate a principle of least burdensome study design. And this is really to avoid them burdening companies with large, expensive and unnecessary clinical studies. And this has been a key part of our discussions with FDA to manage the study size down to a reasonable level, which is now 100 patients. Importantly, there is no requirement to include a placebo in the study as the study size becomes too large, and it would have been of the order of 1,000 patients in over, very similar in size to FM57. But because this is only a confirmatory study, FDA were comfortable with not including a placebo and only 100 patients, which is great. And the inclusion of tadalafil, as I've explained is for comparative purposes only to look at safety, where we think will probably be better because we don't get any systemic side effects, speed where we think would be better because we're a topical that works within 10 minutes and tadalafil usually takes 1 to 2 hours to work. And efficacy, we think, will be comparative because we're using the lowest effective dose of tadalafil. It's not a non-inferiority design. These -- tadalafil is included for informational purposes only. It's not the primary endpoint. Go on to the next slide, please. So the primary endpoints are actually comparison against baseline. And there are 2 of them. We have to show a significant improvement over baseline, which we got highly significant results in FM57 when we measured that same parameter. And we have to show that, that difference is clinically important. And that really means that you have to get a difference of 4 units on the IIEF scale which has been validated by a guy called Rosen. And that difference of 4 units has been assessed as the minimal clinically important difference. In the FM57, we actually got a difference of 5.1. So we did exceed that parameter in the previous study. So again, we're confident we can meet these 2 primary endpoints. FDA were very helpful. They discussed with us what statistical design would be required to support the speed claim. We got 60% of people getting effect in 10 minutes in the previous study. So again, we're confident that we will be able to get a differentiated speed claim here. They want us to include a mix of mild, moderate and severe sufferers, which we did in FM57. So really no difference there. One nuance is that FDA asked us to justify the population that we were using in the study and how it would be relevant to the U.S. population. But of course, in conducting the study in Eastern Europe, which we plan to do, there's a predominance of White Caucasians. So what we've agreed with FDA is that 20 of the 100 people will be based in America. They will actually be African-Americans who have a predisposition to erectile dysfunction because they have a number of comorbidities, obesity and type 2 diabetes and so on, cardiovascular disease. So we've agreed that the easiest way of making the -- and ensuring that the population is relevant to the U.S. population is to include 20 African-Americans. And we'll be doing this out of the world-renowned medical research center at Johns Hopkins which is based just outside Washington, Baltimore. So move on to the next slide, please. And now back to James.

Thank you, Ken. I'm now going to talk a little bit about the commercial opportunity. So please move to the next slide. Obviously, as an OTC product, we believe that this really does open up a huge, large untapped market. Over the years, we've done a lot of research and in different formats, both to consumers and also to position. And the messages that we're getting back are very consistent. As an OTC product, potentially, that opens up the market. 73% of OTC sales would be from patients not currently on treatment. But I think that's a very important message here for our shareholders to understand. If you look at the sort of the 2 segments where we feel there are opportunities, first of all, we have the traditional segments. And in the left-hand side, you look at the PDE5 users. Now don't get me wrong, as Ken already said that these are very effective drugs for a lot of men and Viagra honestly has already transformed their lives. Now having said that, there are certain issues. There are side effects. But again, a lot of men, are happy to take that. But they're also planning issues because you typically have to take the medication ahead of wanting to have sexual intercourse, and that can be an [indiscernible]. We're not looking with MED to, if you like, specifically target this group of men because a lot of these may are very satisfied, and there are, in our view, much greater opportunities elsewhere for men who aren't treating or just generally dissatisfied. So if you look at the middle box, we describe this as diagnosed and not treating. These men who've already been diagnosed as having erectile dysfunction, but to start with something like 20% of this patient group are contraindicated. In other words, they're on other medication, which means that they cannot take any of the existing oral tablets. So this is a group of men who is a pretty easy win because they want to find a treatment. In addition to that, there is, again, a group of men who stopped taking the oral PDE5s, and that's estimated around 50% dropout in the first year of taking. And again, the main reasons cite behind that is the need to preplan and also the cite of that profile. So again, we think this is a significant opportunity there. And then finally, in the more traditional segments, we've got the undiagnosed group. These are men who understand the client, who find it embarrassing to go to a doctor. And therefore, if they can buy a product through a legitimate retailer or a legitimate website to a retailer, perhaps that they already know, that would be really appealing to them rather than having to go and see a doctor. In addition to that, there are now newer segments coming on. We've got an entire generation of men who have grown up with the internet and freely available access to pornography. And there's a perception of the performance, which they feel they have to adhere to. And increasingly, these men are presenting to doctors with, if you like, performance anxiety. We've had a number of our key opinion leaders who are concerned that this group of men who are typically quite young, putting them on to something like Viagra, to be honest, which are very potent drugs, is a real concern for them because that could be, for the next 50, 60 years. So a treatment like MED [ to my opinion ] is very interested in youth. In addition to that, we've also done a certain amount of research looking at women whose partners have erectile disfunction. And we did research both on premenopausal and postmenopausal women. And there's real strong interest again there that these groups of women are very keen to have an active sex life as a part of the relationship they have with their partner. And they're very interested where if the partner is sort of in denial then they can go out and buy a treatment. And as we've said already, a treatment of this can form part of the foreplay. So they're very interested in a product that they can now buy as it is over-the-counter. If it was obviously a prescription product, they cannot do that. So sort of final words on this slide, the research that we did with it also suggested that the OTC opportunity from that is around $660 million. Moving on to the next slide. So globally, we do think this is a huge opportunity. The prescription market is currently worth about $5.6 billion. As Viagra sales obviously becomes more generic, what you're finding is that the overall volume is holding up as the price drops, but -- sorry, the volumes -- the overall value is holding up, but what is kind of reflecting that is that the volumes are increasing. So we're seeing a market worth around about $5 billion. So MED being the first potential worldwide over-the-counter product as a clinically proven treatment, as I said IPSOS suggests you're looking at a market opportunity of $660 million. As I said earlier on, we believe that this could be actually bigger, and we talk about a potential $1 billion asset. Either way, we see it as a very significant opportunity. And with that in mind, we appointed specialist corporate advisers last year in Q3, and they are very much leading a process in out-licensing with potential commercial partners throughout the world. If you want to move on to the next slide. With that in mind, we announced about 6 weeks ago, the first deal. It's a joint collaboration with the Atlantis group, and it is covering the holiday Asian area, including China, two exceptions to that being Korean and Japan. As a company, we have good expertise and capabilities for Europe and America. But -- and as Ken has already said, with the EU, the certificate, CE mark, our ability to be able to get approved in many other countries out of the world will be fast tracked. The exception to that, beside from the work that Ken is doing in the state is we are aware we will need to do further clinical work to get approval in China. And the collaboration that we've signed with Atlantis is they will basically run and pay for all the R&D costs to get approved in China. That is estimated to be around about GBP 4 million. And then once that is achieved, we will split profits from the region on a 50-50 basis. Outside of China, obviously, the other countries around that we believe and they believe there's a good opportunity or chance that we will be able to get approval of the EU CE mark. So whereas China will be 2 or 3 years down the road before we expect to get approval, we do expect to have a launch product in the region much earlier on that because we had a piggyback of the EU CE mark. Turning the page to the next slide. So kind of in summary, as we said, the specialist corporate advisers are working with us, and we're going through a process. We've had already a number of nonbinding expressions of interest. And as we go through this process, we then go to due diligence. And we do expect during this year to announce further deals in addition to the one that we've already signed for Asia. Obviously, the EU certificate clearly strengthens Futura its credibility. And clarity around the product claims and contraindications that we have with the product. And I think one of the important things I want to stress at this stage is our objective here is to build long-term sustainable value. We're not necessarily so much targeting huge rate upfront. It's about being able to generate long-term growth and good-sized royalties for duration rather than getting a large amount of money upfront. It's about building sustainable brand to give long-term value to shareholders. I think and with that, very much in mind, the U.S. does represent the biggest commercial opportunity we have. At the moment, the U.S. is roughly 50% of all erectile dysfunction product sales. So if we can launch ahead of Ken being to get approved in the state, made in a number of other markets, and we see really good sales and sales traction from that, that will help strengthen the value proposition for the state, which is clearly the biggest opportunity for us. Next slide, please. So just briefly, patent strategy. We filed a new patent back in 2019, that is going through -- there are a number of steps on this process to get patent proven in a number of different countries. We filed after 2019, a further U.K. patent, which is then consolidated into what is known as a PCT application in the fourth quarter last year. And then this year and next year, we'll be moving into a national phase filing where you go to individual countries, which you name to strengthen and protect you from a patent perspective. Assuming that is successful, we're looking at potential -- patent protection up to 2040. In addition to that, again, with this, you're looking to have as many different layers of protection you can do, special controls, when you get approved from the FDA, they allow you to look at specific things to the product which are unique. And as Ken's touched on one of the unique assets of this product is the rapid drop in temperature. And you can build that into -- when you get the product approved that that's a key characteristic to the product. And then you wrap it around the IP to make it more difficult for competitors to get into the product. In addition, for example, one of the other things that we've done is we have exclusivity on one of the key excipients or components in the product where that can only be used in sexual health care by us. So again, it's all around about building, protection, layers of protection to stop competition getting in there. In addition to that, as we build the brand as an over-the-counter product, first-to-market mover has huge value, and frankly, 5 years down the road, a patent is of less consequence because brands are so important, especially in this sort of area. Moving on to the next page. So really, in summary, for MED, first over-the-counter gel to treat erectile dysfunction. Key differentiator with the rapid speed of onset. We've got a clear regulatory approval for the key remaining large country of the U.S. with a strong prospect of getting OTC approval in the U.S. as well. We've signed a joint venture collaboration in Asia, and we are in advanced discussions with other commercial deals for other countries and regions in the world. Next slide, please.

If I can pick up on the next 2 slides. If you move on, our pain relief portfolio. So we are in the process of developing a topical cannabidiol formulation using the DermaSys technology. So why are we doing this? Well, as you will know, there's been an explosion of interest in cannabis and its derivatives, and in particular, medical uses thereof. And when you look at the state of the art for topical cannabidiol, which is not a psychoactive form derivative of cannabis, and it's very commonly found in topical products. If you look at the state of the art, it's very poor in terms of how well these products have formulated and whether they stand a chance of actually getting through the barrier of the skin to the site of action. And also, the observation that many of these products are dirty yellow or brown in color, which is a discoloration because the cannabidiol loses its potency through storage. So the level that they put in there to start with is not maintained through the shelf life. So the process that we've been going through was, firstly, signing a joint venture with a company called CBDerma Technology, who have funded development of a DermaSys cannabidiol formulation. And we see this potentially as a near-term opportunity under cosmetic regulations as a superior product in terms of absorption. But longer term, with investment and strong clinical evidence, it stands a very good chance of being registered as a drug or medicinal product. Patent application for the use of DermaSys in combination with cannabidiol was filed in August 2020. And we've retained specialist advisers to explore the commercialization. The 2 graphs here show the advantages that we've achieved over a popular comparative product. And there are 2 measures that we've used. Firstly, breaking through the skin barrier. This is penetration. And we show that our formulation CBD100 achieves around 8x more penetration in getting into the skin. But of course, for deep seated conditions like pain, arthritic pain, sports injuries, you have to get through the dermal layers to the site of action. And that's the second measure. We found the competitive product did not get permeated at all, actually. So it's a zero absorption there. But we see that our formulation achieves very significant levels. And therefore, it stands a very good chance of working therapeutically at the site of action. So that's the first development. And then moving quickly on to the second development, which is topical diclofenac, which we call -- go on to the next slide, Please? which we call TPR100. Now the market for topical analgesics is approaching $5 billion. And that market is likely to be expanded because what has happened in the U.S. very recently is that GSK have managed to switch after many, many years of trying, Voltaren or Voltral, as it's known in Europe, from prescription to over-the-counter status. So it's opened up a whole new market segment for topical analgesics in the United States, which is the single largest consumer health care market in the world. Now what we have developed with TPR100 is a superior version of topical diclofenac. And you can see that quite clearly from the graph down the bottom there, where we compare it with Voltral, we get much more significant permeation across epidermal membranes when we measure it. Now a little while ago, we signed an agreement, specifically just for the U.K. with Thornton & Ross, which is part of STADA. And we've been in discussions with the MHRA around licensing that for some time now. We did conduct some additional lab work based on some questions that we had from MHRA. And fairly recently, we had a scientific advice meeting with MHRA, and it became clear from that meeting that they required us to do further efficacy and safety work. But we think that with the explosion of interest in the U.S. now, there's a good opportunity to be able to fund that work on a broader basis. And therefore, we're exploring the possibility of doing a global efficacy study to satisfy FDA requirements, MHRA's requirements and possibly other markets requirements as well. And that will be subject to resource requirements going forward. So if you move on. And at this point, I'll hand over to Angela.

Thank you, Ken. So financial highlights. Well, we ended the year with a net loss of GBP 2.4 million, of which GBP 1.9 million related to R&D, the losses were significantly lower than in the prior year, which was around GBP 8.9 million. This is not surprising given the focus in 2020 shifted away from clinical development and external clinical studies and switch towards regulatory approval and commercialization strategy for MED3000. These activities were predominantly conducted by existing internal headcount. In terms of cash, we ended the year with just over GBP 1 million. And the reduced cash burn during the year is indicative of our ongoing strategy to keep costs low and to deploy financial resources carefully. In addition to the closing balance, a further GBP 2 million investment was received from Atlantis in March and April. And this related to the JV arrangement that James touched on earlier in the webcast. Of course, we expect to receive our usual refund of R&D tax credits in the middle of the year. The tax credit this year is estimated to be around GBP 0.5 million, and this is lower than it was last year. But as the R&D tax credits are related to the level of R&D spend, again, this is not surprising. given the current cash burn, that provides us with sufficient cash through to Q1 2022, we would like to start FM71 in the second half of the year and are currently exploring options in terms of funding that study. First of all, this study will cost significantly less than FM57 for the reasons Ken touched on earlier, especially when you consider really top line, this is a 100-patient study versus 1,000 patients that we recruited for FM57. James described earlier where we are in terms of commercial discussions, but we also explore -- continued to explore a range of other funding sources, which include both non-dilutive and dilutive options. Next slide, please. So that brings us to our outlook. I hope you agree, our outlook is incredibly positive. Firstly, the recommendation from the EU regulator to approve MED3000 has been an important milestone, both for the product and ED and for the company. With the certificate expected before the end of May, this will allow us to launch MED3000 across the EU and fast track other approvals in other regions outside of U.S. and China. The agreement reached with the FDA relating to FM71. So the design was also an important achievement. The least burdensome approach gives us a clear way forward to approval in the U.S., but also allows us to complete the study in a timely and cost-effective way. The JV agreed with Atlantis allows us to conduct the clinical work in the region of China and Southeast Asia. With a strong partner in a region where the opportunity is significant, but where we, as a company, have limited expertise. And following on from the JV agreement that we reached with Atlantis and in conjunction with our specialist advisers we engaged last year, we're expecting to announce further commercial deals and provide information relating to the initial market launches for MED3000. And finally, whilst MED3000 remains very much our core focus, we also hope to provide further updates on CBD100, our topical cannabidiol formulation. And that brings us to the end of our webcast today. On behalf of James, Ken and myself, I'd like to thank you all for listening. Thank you. Goodbye.