Well, good morning, everybody, and welcome to the Futura Webcast for our Interim Results for Six- Months Ending 3rd of June 2022. I'm delighted to be joined by Angela Hildreth, our FD and COO, and also by Ken James, our Executive Director and Head of R&D. Without further ado, let's move on to slide four. A little bit about Futura and the corporate overview. We describe ourselves as a virtual organization. We have 13 staff with low overheads. We tend to subcontract a lot out, including our contract manufacturer, and we currently have around 30 consultants that we call on as and when we need them. Our key sort of expertise is applying skin science to deliver novel topical clinically proven treatments, and DermaSys is kind of our brand that embodies that.
We've got an experienced team, and we very much focus on developing clinically proven innovations, which we then look to license that to commercial partners. Our main product, MED3000, is a topical gel for erectile dysfunction, and it now has U.K. and EU approval to be available without a doctor's prescription. It is a highly differentiated treatment with a fast onset of action. Main claim that we can make in Europe is helps you get an erection within 10 minutes. The FDA dossier we expect to submit by the end of September. We are focusing on certainly over the next six months as we go into 2023, initial launches, and further launches again in the back end or back half of 2023.
Our other sort of key focus is very much looking to secure U.S. commercial partner to complement our existing distribution network. MED3000 on a commercial, our real aim is building a long-term profitable global distribution network, and I'll touch on that a little bit more in due course. We do have other products in our portfolio, the main one being CBD100, but Ken will talk a little bit about that a little later, but our main focus is very much on developing MED3000. Turning the page. Six months highlights. Very much focusing on our strategic decision to maximize our R&D pipeline by de-risking the assets through getting approval. We've had successful completion of FM71 in August, but again, Ken will talk about that a little bit more in due course.
Also our manufacturing now is really ready for initial launch supplies and beyond. When we mean beyond, certainly for the next couple of years based on forecasts that we've got today. MED3000, we've also on a commercial perspective, we signed a deal with Cooper Consumer Health for distribution throughout basically all the EU, and the U.K. and Switzerland. We now have, again, I'm pleased to say initial orders have already come in, are ready for the launch, which will be in the first half of 2023.
I think it's important to stress that a lot of this information will become commercially sensitive, and therefore we won't necessarily be able to say that much ahead of the launch other than, as already said, we will be launching in a number of countries in the first half of 2023, and then obviously further countries will be added on during the year. Again, on the clinical data, Ken will talk about the two studies that we've done in the last year, which is critical for the FDA submission to obtain a marketing authorization. With that in mind, we have now appointed specialist corporate advisors, in fact, the same company we've used previously, as we continue to build or hopefully complete our global distribution network to very much focus on finding a commercial partner for the U.S. Angela.
Thanks, James. Not a lot to say really, as financially everything is very much as we expect it to be. We had a net loss in the period of GBP 2.5 Million. This is an increase of around GBP 1 million on the period last year, but also not surprising as FM71 began running in the second half of 2021 and continued to run through 2022 to date. In terms of cash, we ended the period with GBP 6.68 million in the bank. When added to the expected tax credit refunds we expect to be received before year-end, that provides the company with cash of just over GBP 7.5 Million.
We believe, even without further milestone payments under the revenues generated from product sales of MED3000, this should be sufficient to take the company through to expected US regulatory approval and beyond under the current plans. Back to you.
Thank you. Moving on to the next slide. Our sort of core strategic objectives, which as I said earlier, we're very much focusing on, I think we're delivering pretty well on, is gain U.S. marketing authorization for MED3000, over the next or certainly within the next 12 months. Complete our global distribution network, along with a robust supply chain, to enable us to, make MED into a long-term sustainable and profitable brand. Initial country launches of, MED or Eroxon, which it will be branded in certain markets, next year, and to really validate consumer interest and repeat purchase potential and to progress, MED3000 commercial negotiations for the biggest market in the world, which is the U.S. Moving on. A little bit more now about, Eroxon itself.
This will become the first topical gel to treat erectile dysfunction in adult men throughout Europe. It has already gained approval for the EU and also U.K. Available without the need of a doctor's prescription. This is very critical, as in most countries, apart from I think the U.K. and Europe, it is still requires a doctor's prescription and obviously in the States, which is by far the biggest market it is. Again, all oral treatments for PDE5, such as Viagra, which is known to most people, is a prescription-only product. Eroxon is a clinically proven gel to treat erectile dysfunction, and its key differentiating claim is it helps you get an erection within 10 minutes, so therefore removes the need to pre-plan, when you're sort of normally taking an oral treatment. It brings spontaneity back into the treatment of erectile dysfunctions.
Turning on to the next slide. There is a significant commercial potential. Against a backdrop of changing dynamics in the market. The global ED market has grown and continues to grow as volume rises, but it's also becoming more of a generic market. In other words, the main products of Viagra, Cialis have now become what is known as generic and therefore as competitors can come in because their patent has now expired, it has had an impact on dropping price. Obviously, increased affordability drives up volumes, which is a good thing. Nevertheless, even with the reduction in price, there is definitely still a barrier for patients using the treatment, still because of cost, because they have to see a doctor and there are economic costs with the doctor, not just for the cost of the prescription.
As inferred by that, because you have to see a doctor to get the treatment. Certainly, we're in the process of doing further market research at the moment. One of the initial findings we've seen in this is that typically U.S. patients are paying between $600-$3,500 per annum for their treatment for Erectile Dysfunction. Now, while the actual physical cost of the actual medication has dropped, they still have to pay, even taking into account what coverage they can claim back under insurance, the cost of the doctor's visits.
If you then kind of equate that into frequency of intercourse, and again, research has shown that typically, men are having 70 intercourse attempts a year. This still means that typically a patient is paying between $10 and $50 each time they have attempted intercourse. To have a topical, over-the-counter treatment, which is probably gonna launch around the $5 mark, maybe a little bit more, there is still a huge opportunity there as, you know, the barriers of cost and the barriers of seeing a doctor do not exist. Turning the page to the next slide. Again, one of our core strategic objectives is to build a global network, and, we're making very good progress on that. Over the last two- years, we have signed five deals.
The main exception is very much the U.S. Having completed the recent study and the submission shortly, we do expect to focus very much on finding a commercial partner and have already instructed our corporate advisors to move ahead on that. All the deals to date very much focus on some key performance obligations. Obviously, where regulatory costs are required and the submission timelines, we expect partners to adhere to those. There are certain performance obligations around launch timings and advertising and promotional spend, which is going to be critical to really build the brand. As I touched on earlier, our CMC or Chemistry, Manufacturing and Controls is progressing well. We have an accredited supplier.
We now have a 42-month shelf life product, which means that after manufacturing, shipping, we would expect to see at least a three-year shelf life at the point of sale once it gets onto the shelves. Manufacturing is now sort of underway, and we've already received the first orders. We have capacity based on, you know, the CapEx that we made to supply us for certainly the first couple of years, and we are now already focusing on how we expand that as sales build up, looking at alternative sites just to again increase the supply chain robustness. Moving on to the next slide. New research is underway, but I think the key components still remain.
There are kind of traditional and perhaps newer segments that we see where MED3000, you know, there's a big opportunity for. Yes, Viagra, Cialis are effective treatments and for a lot of men, they're happy with this. Nevertheless, there are a number of men who either are contraindicated, in other words, they cannot use those medications, so at the moment, that is a completely untapped market. There are a lot of men who drop out after using these products for, you know, in the first year. The reason cited behind that is the side effect profile and also the requirement to pre-plan before they take the treatment. There's no spontaneity, and therefore a treatment like MED, which has a rapid onset, speed of onset within 10 minutes, can bring spontaneity back into the treatment.
Again, Viagra and Cialis are prescription-only products other than in some markets, such as the U.K. for Viagra only. There's an embarrassment of men going to see a doctor. There's the cost, as we've already touched on, and then the inconvenience associated with that. There is huge interest, huge demand. The research historically has shown that typically this could account for two-thirds of men that suffer from erectile dysfunction. Huge appeal for a treatment that they'll be able to buy over the counter by just walking into the pharmacy or through the pharmacy's online website. There are also newer segments which are coming in.
There's a growing amount of young men who, if you like, have grown up with widely available access to pornography, who have concerns around their performance and a treatment like MED3000 could help them with their concerns around this. Then finally, as an over-the-counter product, we've done market research which has shown that a lot of women whose partners have erectile dysfunction would be really interested in trying to help their partner overcome their issues. Now they will be able to buy a treatment to help him in that regard. We see this as a significant opportunity. Previous research has shown around about $660 million as a global opportunity.
We are doing some further research at the moment, which is halfway through, and we look forward to updating the market in due course, but we still see this as a big opportunity. Then I think finally from my slides on this, intellectual property. If MED is as big an opportunity as we think it is, it's very important that we try and protect this asset as far as possible. For us, the best way of doing that, having taken both corporate and strategic advice, is to have as many different layers of protection as we can do. We're not gonna tell everything obviously to the market for obvious reasons.
Aside from the patent which has been filed in a number of markets, and certainly initial EPO, European Patent Office examination confirmed the novel and inventive nature of the patent application, and that is critical in the process of securing intellectual property or patent on the product, is progressing well. Some other things that we've done, one of the excipients, one of the components in the gel, is under exclusivity to Futura. Even though it's used in other products in the area of sexual health, it can only be supplied to us. This company has two different factories. Again, from a robustness of supply, we feel comfortable around that. Also we're looking for MED to launch under the Eroxon brand wherever possible.
Again, you can build and establish global awareness and consumer trust behind that. On special controls, I'll kind of defer to Ken.
Thank you, James. Special controls are controls which are applied to De Novo medical devices, which ensure the safety and effectiveness of the device, and they're enshrined in the marketing authorization, which is granted by FDA. What they do is create a very high bar of clinical and non-clinical data which generic products have to replicate if they attempt to use our product as a predicate for a 510(k) approval.
Okay, thank you, Ken. Moving on, in fact, I'm going to switch and pass back to Ken again.
The key event for R&D over the last few months has been the completion of study FM71, and this was a study that was requested by FDA for us to, you know, carry out as part of the approval process. We had some very productive pre-submission meetings with FDA leading up to the conduct of FM71. In essence, they agreed the protocol, they agreed the endpoints in advance. On that basis, the study was reported out just over a week ago. Very good news. We met all the primary and secondary endpoints.
Specifically on the secondary endpoint that related to the differentiated claim that we have, which is the first signs of an erection within 10 minutes, which we hope will be translated into more consumer-friendly language of helps you get an erection within 10 minutes, which is the same claim that we're using in the EU. Overall the clinical study, in our opinion, presents a very favorable benefit to risk profile versus a leading prescription product, paving the way for OTC marketing authorization in the U.S.A.. The next slide gives a little bit of color around the primary endpoints. The measure that was used for both primary endpoints is called the IIEF EF domain, which is the internationally accepted gold standard measure for all erectile dysfunction products in clinical studies.
There were two elements of this which comprised the co-primary endpoints. The first one was that at 24 weeks we had to get a statistically different improvement in erectile functionality over the baseline or pre-treatment result. That was achieved. We were highly significantly better than the baseline result. The second element of this was that the magnitude of that difference had to be so large that we exceeded the minimal clinically important difference, which is a value of four units bigger than the baseline. You can see the tabulation on the left-hand side, that through the entire study, week four, eight, 12, 16, 20, 24, we exceeded four units. The critical one in respect of the primary, co-primary endpoints was the last one at 24 weeks, which was 5.73, in excess obviously of four.
As I've mentioned, we got highly statistically significant difference over baseline at that. Both co-primary endpoints were achieved. The graph on the right is merely a graphical representation of the tabulation on the left-hand side. We're very pleased on that. Both MED and tadalafil were clinically effective at all time points, although tadalafil showed a slightly greater improvement than MED. There are some advantages that MED achieved over tadalafil which I'll now come on to talk about. The secondary endpoint focused on achieving a speed of action claim. The criteria for proving this claim was agreed ahead of time with FDA, and I'm pleased to report that MED achieved that onset of action endpoint at 10 minutes, and that difference was highly statistically significant again.
Oral tadalafil, when you apply the same criteria, did not meet the FDA criteria, which is not surprising because the oral medications typically take 30-60 minutes before they start working. Ten minutes was probably never gonna be achieved with tadalafil. It's good to have that data supporting the product, which is a key differentiating claim for our product. Helps you get an erection within 10 minutes. The other advantages that we achieved with MED over tadalafil, again, perhaps not unexpectedly, are the adverse event profile. It's a well-known phenomenon that the PDE5 inhibitors have side effects of headache, backache, and stomach upsets occasionally.
The differences that we got here were certainly the instance of headaches where 19.1% of tadalafil subjects had headaches, only 4.3% on MED. Back pain was a significant issue with tadalafil and also non-cardiac chest pains. There were two subjects, just happened to be the U.S. subjects who achieved that particular side effect. On MED, we got two instances of nausea and three instances of female headache. Given the product only works topically, we think that that's purely idiosyncratic. We got virtually no local side effects on MED. We got a mild burning sensation in one subject on MED and no instances in the female arms in the study. Very clean from a local or topical side effect profile.
Of course, because MED is a medical device that contains no drug, there's no potential for MED to have adverse drug interactions, which is a problem with the PDE5 inhibitors, the oral medications, where they're currently precluded from using a number of prescription medicines such as nitrates while they're on the erectile dysfunction medication. We have a very favorable side effect profile compared to the PDE5 inhibitors. Turn to the next slide. In summary on FM71, we've shown that MED3000 is a clinically effective treatment for erectile dysfunction. In contrast to the PDE5 inhibitors, the oral medications, MED has a fast onset of action with a 10-minute onset claim. No significant side effects, no potentially serious drug interactions.
Therefore, in our opinion, has an ideal benefit to risk profile for OTC classification. In the EU and the U.K., it already has OTC status. If we move finally on to the regulatory status, we've gone through a number of pre-submission meetings with FDA which are designed at FDA's behest really to help companies get an understanding of what FDA's requirements are and to discuss areas of potential differences of opinion and agree the program going forward. We had a number of productive meetings with FDA already. They identified two key areas that they wanted us to develop data in. The first was a human factors study, which is designed to test the adequacy of the OTC label leaflet. That was successfully completed at the end of December. We got excellent results in that study.
Of course, the additional clinical study, FM71, which is now complete, that protocol for that and the endpoints were fully agreed with the FDA prior to the conduct of that study, and we met the requirements there, we feel. We're now on a very fast track, actually, to wrap all that information up into a submission, which is going into FDA at the end of this month, the end of September. If FDA keep to their timeline for approval, and there are no major issues with that submission, which we don't think there will be, we are optimistic that we will get approval at the end of Q1 next year. Thank you.
Now, moving on beyond the first product in the pipeline, which is MED3000, we do intend to follow on MED with a number of pipeline initiatives. We've got the lead product here, the one which is coming in a tube, a unit dose tube. We think there is scope to potentially improve the packaging and even reduce the cost of goods even further by using some more elegant sachet or snap-pack packaging that's already in the development pipeline. Beyond that, we think that there is scope to improve the sexual experience with new delivery devices such as a mousse or a spray. Longer-term, potentially going into new indications such as premature ejaculation or female sexual disorder.
We're already doing some exploratory work with our key opinion leaders on that. We don't just see this as a one-trick pony, we see this as a succession of products coming off the pipeline over the next few years. That concludes the discussion on MED. I just wanted to mention very, very briefly another development that we have in our pipeline, and that's topical cannabidiol. Now, the focus very much of the whole organization has been on MED and the Eroxon and conducting the clinical study and applying to the filing in the U.S.. This work is really only out of the exploratory stage.
We do have an excellent prototype which has been developed of cannabidiol using the DermaSys technology, and it's able, as you can see here, to deliver cannabidiol into the skin and through the skin very, very effectively. We're seeking potential licensing partners on that as part of the exploratory work that we're doing.
Looking out to next year and beyond, with positive FM71 results in hand, our first priority is for us to submit the dossier for MED3000 to the FDA, and this is scheduled for the end of this month. We're also looking forward to initial EU launches of MED3000 under the Eroxon brand, with other regional launches throughout next year. We also expect the FDA to grant marketing authorization in Q1 2023, enabling MED3000 to be available as a clinically proven treatment for ED, which is available without a doctor's prescription. Finally, and very importantly, we look to progress securing commercial agreements for MED3000 in the U.S., which will allow us to deliver long-term sustainable value.
Thank you, Angela. That concludes the webcast for today. Thank you for listening.