LON:FUM | Futura Medical - Med 3000 Approval For EU

20th Mar '21 by mcav82

9 comments 970 reads

Good afternoon, everyone,

I‘m a relatively new subscriber to Stockopedia but a long term holder of shares in Futura Medical. It is a share that has a very low ranking in the Stockopedia world, and quite rightly so. The last 3 years have been a bit of a struggle for the company and the shareholders.

For that reason, there hasn‘t been very much written at all here by fellow readers or experts that I can find. But I would be interested to hear your thoughts on the news that Futura have finally received approval from the EU for their erectile dysfunction MED 3000 Gel which will be sold ´over the counter´ without any need for a prescription whatsoever from GPˋs.

After the news broke on Friday (19.03.21) there has been an enormous amount of interest in the company but what I would like to know is if anybody can conservatively judge, or work out a fair value for the company, seeing as the market for ED is quite significant. (1 in 5 men and a market of £5.2 Billion)

Many men can also not take the typical oral medication eg. Viagra because of side effects and other medical complications.

There have been a number of financial figures bandied about this weekend regarding future valuations of Futura Medical (between £2 and £3) but mostly on the ill-informed bulletin boards. Does anyone here have further insights?

Unlock with Email

Unlock with Google

Already have an account?
Login here

DavidRoss

22nd Mar '21

Hi Mcav82 I'm also relatively new here,the whilst I can't help with insights as to future growth prospects, what I can say and happily admit to is that, I'm also a long time holder, I bought them as one of my first forays into investing, which unsurprisingly enough hasn't, up until I discovered Stockopedia been a success, individual shares being concerned. I frequently thought about bailing out and taking my medicine, So to speak, In this case, I kept seeing the story, and although the fundamentals were awful and the paper losses were, for me, large, a drop to zero and game over wouldn't really have made a big difference so I held.

By luck, it would seem that my rashness and uneducated venture has potentially been fruitful, it has indeed been very bumpy as you say.

Would I have made the same purchase then, knowing what I know now from the very knowledgeable people here and the information available, that would be a no, certainly not until I saw the fundamentals begin to improve, I would have quite happily skipped the rollercoaster ride.

I have seen figures for a sp by Liberum for about the 62p mark but I'm also putting a stop loss in for 10% below Friday's closing price which gives me a small loss of 2%

All the best and good luck

David

extrader

There are some comments (not mine) re FUM in the body of last Friday's SCVR that may be of interest.

jimrog64

I commented last week. I am a long term holder and will explain why later when I have time, For now just to note that a further rns this morning gave minutes of a meeting with FDA last month confirming details of a small additional trial needed including US participants before approval for Status as otc medical device can be given. The requirements are not onerous : 100 patients and outcomes less than the results already shown in a trial of 1000 patients in 2019.

This comes on top of the E U approval last week for status as a medical device, and licencsing agreements announced a couple of weeks ago for China. I expect that when the US markets open later today there will be a further surge of interest for Futura Medical (LON:FUM) now that FDA pathway is clear

GrahamF

There’s a board over at the head bangers’ site (ADVFN) that’s called ‘Futura a winner for 2015’. So that gives you an idea how long people have been waiting for this company to achieve any significant commercial success.

Right now, it would seem that the regulatory approvals needed for the current ED product are pretty much in the bag. So, hopefully that will mean that they will be able to market the product as having proven efficacy. I’ve noted how the marketing of ED products has changed. From a subject that generated a fair amount of sniggering, we’re now at the point where Numan can freely advertise on TV without so much as a Puritan tutting. So, I think that the market for this is potentially massive because there will be many people who will try it and use it as a recreational product who don’t really have a clinical need for it.

So, the answer to the question about the valuation I think is that it’s impossible to tell right now, but they should make hay for a period of time if they get the marketing right before copycat products start to appear.

So, how big is the market? Answer, big enough! There’s no real need to try and value the company itself. I’ve had the company on my watch list for a very long time but finally bought in last week after the positive news.

nicobos

13th Apr '21

having read through the RNS, does anyone have a clear view on whether the product is actually unique with regards its medical properties? or is it just a placebo at work (at hence available OTC).

To me this seems to be critical to whether then have a genuine piece of valuable IP or undifferentiated product which will not be able to compete with the durex of this world....

Thanks

That is one of the crucial questions nicobos, but perhaps not so straightforward to determine. The strapline of the company is 'advanced transdermal technology'. They have been promoting their patented Dermasys technology for some years and claim that it can be used as a vehicle to deliver a range of medicinal products in a way that is more effective than other transdermal systems. They have been developing products to deliver cannabis, and painkillers as well as the one in which they have invested most, the treatment for erectile dysfunction.

The trial of their ED product which drew all of the headlines, was one which measured the effects of GTN ( glyceryl trinitrate) delivered via Dermasys against the effects of what was designed to be a placebo- the Dermasys transdermal delivery vehicle on it's own. GTN is used to treat angina and other conditions. It was thought that it might help ED as once absorbed it converts to Nitric Oxide and this can help blood vessels dilate and assist in erections. In the trial the product which was designed as a placebo had effects which were as good as the product with the GTN.

Some interpreted the trial as a failure, as the product with a medicinal ingredient did no better than what was thought to be a placebo. At that point the share price dived. However, both products produced good results in terms of meeting the primary end points of the trials- improvements on internationally recognised scales measuring improvements in ED.

The company, and others, were surprised but took this as an opportunity and have concluded that the Dermasys delivery vehicle on its own has a useful mechanism of action. I bought in at this point as I felt that people were misunderstanding what had happened in the trial and the nature of placebo effects.

The company are now claiming that the unique method of evaporative action with volatile solvents stimulates nerves in the glans penis and leads to erection. By using this product without a medicinal ingredient such as GTN added, the company have managed to have what is now called MED3000 approved as a medical device . They now have European approval for this , with the certificate to follow in a few weeks. As a device, and not a medicine it can be sold OTC without any need for a prescription.

There has been a lot of debate on the bulletin baords about what exactly Futura have and have not patented and whether others will copy what they do. On their website they say this:

"DermaSys^® is a proprietary transdermal technology platform with very strong IP offering a high level of product differentiation compared to existing marketed treatments.

Each new unique formulation offers the opportunity for additional patent applications and potential patent protection. We protect this valuable IP and ensure that we maximise both the strength of our patents’ protection and their duration. Aside from our current patent lawyers, Futura recently retained a specialist biotech IP and strategic advice company to assist in maximising the robustness of the MED3000 intellectual property."

Clearly the two products in the clinical trial both had a positive impact on ED. Was some of that placebo effect in both cases? Placebo is about meaning and expectation, and many things can produce strong placebo effects, which are different from any biological effect of an active ingredient. The nature of the trial, with a person or their partner applying a gel might have produced some strong placebo effects but the trial did suggest that, whether or not partly placebo, MED3000 can produce benefits similar to those produced by Viagra, but without the side effects.

I think that they key thing now is the marketing. Futura appear to have learned from past mistakes and have appointed experienced advisers and are looking carefully at licensing deals. With the European approval a formality in the next few weeks, and licensing deals signed for China and other parts of Asia, it is now all about whether they can market the product and get some sales. As others have pointed out the global market for ED products is huge. Getting even a tiny share of this market could lead to a strong future for Futura and they may able to follow this with further development of their Cannabis products -obviously that is another potentially large market. But the risk remains that the marketing is ineffective and sales do not follow. Luckily I got in near the bottom and have taken some profit so have little to lose whatever happens from here. I do remain optimistic and it will be interesting to see what happens when results are announced tomorrow.

Harry Hindsight

9th May '23

Re-energising the discussion. MED3000 now available for purchase in UK. I suppose a bit difficult to obtain personal recommendations on here as to if it actually works.

Perhaps we could say "a friend highly recommends it ......".

21st Jun '23

Now that FDA approval has been granted for their main product, it will be interesting to see what happens to Futura Medical (LON:FUM) shares now. I think that many people were surprised at the lack of reaction to the FDA news last week, although the share price did start to spike upwards yesterday. I think that there is some recency bias as people are pointing to other medical products which have not done well following FDA approval. This is different in that it is an over the counter product gel for erectile dysfunction, with a large known market, and the product has a clear USP, in that it does not have the side effects of drugs for the condition and is much faster acting. As I see it, there remain risk and uncertainties in the sense that we have no hard data on sales since the produce started being available in the UK ( via Boots and amazon) and in Belgium. As a few people have noted it is possible to go into Amazon and Boots websites and see how many sales have occured in the last 24 hours and this indicates that the product is selling well. I know that some commentators are skeptical as to whether the product actually works. There has been more than one clinical trial which shows that it does work- not for everyone, but for the majority. The FDA insisted on an additional trial with data about efficacy in different populations and have been satisfied enough to grant approval. The efficacy has been shown in properly conducted trials. Yes, the real world is different to clinical trial populations but with the additional trial and effectiveness in different groups, we can be reasonably confident that a good proportion of users will get benefit. It is then down to how well the product is marketed and disrtributed. Hopefully news of US distribution partners will follow soon. Just to note , then, that for anyone interested in exploring further there are investor presentations coming up -

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce that it will be hosting an Investor Seminar on the 22 June 2023 in London for analysts and institutional investors. Following the Investor Seminar, an Investor Meet Company meeting will be held for Retail Investors on Monday the 26 June. The Retail Investor event is scheduled for Monday 26 June at 10:00am with Investor Meet Company. Retail Investors can sign up to Investor Meet Company for free via www.investormeetcompany.com.

I hold and made this my stockpick for 2023. I am sticking with it......

FOMO_mike

6th Feb

Would be interested in your views to all that contributed previously, RNS out today and there has been positive news last 6 months.

Futura Medical - Med 3000 Approval for EU

Unlock the rest of this article with a 14 day trial

About the Author

Mcav82

9 comments

Unlock the metrics for all these stocks and more...

Unlock the metrics for all these stocks and more...