Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
Statistical significance is just that: what is observed is highly unlikely to be due to chance - in other words, the observed result is meaningful. Despite the meaningful result of the first trials, on which the EU based its regulatory clearance for MED3000, the FDA requested further clinical data, parsing the results from the first trial for eg not including certain ethnicities, and not demonstrating efficacy over a longer period of time. The second set of clinical results were even more impressive. Yet, six months after being provided with those results, the FDA is parsing those results again, seeking non-clinical information. Its approach is utterly pointless. All it has done is add to Futura’s costs, delay introduction of Eroxon to the US market, and raise the prospect that Futura will need to raise further equity at a much lower price than if the product had already been cleared and released for use in that market. Ultimately, shareholders suffer through having more shares in circulation. The FDA and many other regulators conduct their work divorced from commercial realities. Delays through seeking costly and pointless further information from companies can really harm those companies, especially those without an established revenue stream. It can be the difference between a cratered share price, making raising equity finance considerably more expensive, and a vastly higher price that minimises dilution.
Rather than adopting a pragmatic approach, the FDA’s request for further information is utterly pointless, especially in the context of having already had six months with the latest clinical results. Statistical significance is the cornerstone of scientific endeavour. The FDA’s attempts to question that of MED3000, not once but twice, are making it look ridiculous. It’s the kind of behaviour that gives regulators a bad reputation, for loving bureaucracy for its own sake, rather than intelligently facilitating economic growth.
I’m genuinely surprised Coopers still has not launched Eroxon in Europe yet. I really thought a marketing campaign would be in progress by now. Clearly, daily trading volume is much higher nowadays, as ‘insiders’ buy ahead of that campaign kicking off. Futura is a £150m company at this share price level. Every year there are the ‘shooting star’ companies, that go to stratospheric share price levels from low levels. Futura could be the shooting star of 2023. A 10x increase to around £5 would still only make it mid cap. Share prices overshoot upwards and downwards. I believe the UK / EU launch will catapult its price beyond £1, and US launch to beyond £2. Extension of the patent adds more. Media froth even more. There will be profit taking on the upside, but those whose are thinking of eg 20% are likely to miss one of the rides of the century. I’m in from 8p. Progress since has been incredibly frustrating, but a 7x increase in almost 3 years for doing nothing other than buying and holding is not to be sniffed at, especially when the real interest rates is now negative. Certainly, if I had a crystal ball, able to see and trade the turns, I’d be richer than Croesus now from Futura. But I don’t have such a ball. 2023 is the year of Futura. Commercial launches in multiple territories. US FDA clearance. US partnership. US sales. Sales in other territories. Possible patent extension. All for 55p now? There are few if any stronger investment stories in the UK stock market in 2023.
Backwardation is relatively rare - it is when the ‘yellow strip’ touch price has the bid price lower than the offer price - a sure recipe to lose money, which is why it’s always temporary. The more straightforward reason is that market makers may offer buy or sell prices on the opposite side of the mid price if there’s sufficient competition for order flow.. They’re still making a positive margin. It’s for this reason that looking at claimed total buys and total sells on sites like this is misleading: some sells are buys and some buys may be sells. Private investors never see the order flow of market makers, and shouldn’t try to understand it, especially when trades can be delayed. AT trades are always what they say on the can: red are sells, blue are buys.
Futura is now fulfilling first orders from Coopers. Coopers is wholesaling Eroxon, so it will be important that it monetises these orders as soon as possible. That, for me, makes retail sale availability of Eroxon closer to 1 January 2023 than to 31 March 2023. But marketing activity will precede retail sale availability, to create awareness and buzz around the product. So I’m now thinking December for this, before January 2023 launch in UK and some other key EU markets. Clearly, Cooper has to make deals with multiple retailers in each territory, to maximise Eroxon’s commercial footprint; and it must also ensure it has enough pipeline supply to satisfy these retailers’ demands. Barber is right that shareholders can’t expect a “running commentary” on what are obviously commercially sensitive deals.
The crucial takeaway from this morning is that Futura is now up and running in terms of selling Eroxon, albeit at the wholesale level. What matters medium and long term will be retail adoption and frequency of use. Trading a share with so much positive commercial and regulatory news momentum over the next year seems a dangerous pastime to me, but each to his / her own.
For me, Futura is now a company whose sales will only grow, hopefully exponentially, over the next few years, as more and more licensees (even China in 2025) turn on their sales taps for Eroxon, Futura brings out improved and lower cost products and adjacent product offerings, and there is increasing retail adoption and frequency of use. This is the big picture.
As they say, keep your eyes on the prize.
So, no commercial launch of Eroxon in 2022 (“plans are at an advanced stage for initial launches in first half of 2023”), but since its approved shelf life is 42 months (3 ½ years), “first manufacturing orders have been received from our European partner”, and there will be “at least 3 years shelf-life at point of sale”, initial European launches will be not later than 1 January 2023- 31 March 2023. Really important point - presumably these orders now mean cash royalties have / will begin for Futura, lessening the need for any placing in 2023. The marketing campaign will begin before sales, so I guess in 2022. The search for a US commercial partner has now begun, another positive. No surprise about China: I didn’t see sales there until 2025.
Futura stated in its full year results (Full Year Results for the year ended 31 December 2021), published on 26 April 2022, that there would be “initial product launches over the next year”. The results are written seen from 31 December, so anything post 31 December falls into the next year, and is described as such. So, the product will be launched this calendar year, 2022. Theories of its launch in March 2023, after approval in the US, are simply wrong in my view, and a red herring. My hunch is it will launch in the last quarter of 2022 - probably October 2022 (ie last quarter of this financial year). No waiting for every territory to be ready to launch. I see sequential launches, as and when other territories, including the US, become ready. These may be in 2022, but certainly in 2023 and perhaps even into 2024 or 2025 in the case of China.
I think there are 5 issues holding the Futura share price back.
1. No date for commercial launch. We’ve several licensing deals signed, but no dates for commercial launch of the product.
2. Even when it is launched, there will be a wide spectrum of views of short, medium and long term product adoption. The lower views will constrain demand for the shares, and therefore share price growth. On the other hand, higher views could lead to explosive share price growth. With mature products, management would give guidance on sales, reducing the spectrum and share price volatility.
3. Product trials. The US has required a confirmatory product trial, and China and some other regions outside the ‘lift and shift’ of EU clearance carry over May require their own trials to satisfy regulators, holding back product launch.
4. Patent protection. Years have now passed since Futura applied for patent protection on its formulation. Patent protection will boost sales, by preventing illegal copycat products.
5. Management ability to deliver supply. We’ve no idea whether Futura has enough manufacturing scale, in the right places, to meet future demand. We’ve also no idea whether Futura’s supply chain will be affected by issues like the Felixstowe strike, or shortages of truck drivers.
We expect news within days and certainly by end September on the US product trial results, and on a date for commercial launch in the EU and UK. This news should boost the share price substantially (I’m assuming there are no surprises in the confirmatory trial results).
But this will be only the start, as there will still remain dates for roll outs in other territories, other trial results, patent protection, and management ability to deliver supply as hurdles to be overcome. As well, medium and long term adoption rates really will need clarification. I expect a lot of share price volatility given all these uncertainties.
Futura could be one of the most exciting and rewarding shares to be invested in over the next few years. Especially with new innovations to support the franchise - new packaging and delivery formats, new indications (premature ejaculation and female sexual dysfunction) - plus exploitation of the topical cannabidiol product.
I’m increasingly of the opinion that the delay in this reaching the shelves is FD71 - the US confirmatory trial. My thinking is that it’s supposed to be done under controlled scientific conditions, and this means zero access to other sources of MED3000 (eg internet purchases) or even publicity that may influence participants’ feedback. On 28 June 2022, Futura reported that “the clinical study, including patient follow-up, is drawing to a close. The Company remains on track to be able to disclose the results in early September.”
“Is drawing to a close” is key here, for me. Until that’s done, sales won’t occur elsewhere. They are dependent events: patient follow-up must finish to trigger the start of marketing activity and sales elsewhere. So, I see the most likely time for the announcement of sales in the EU and UK being from now to end August. I’m thinking Futura shared this timeline with Cooper, who understand and have bought in. Right now, Cooper should be filling its distribution centres with product manufactured by Futura ready to meet projected early demand.
We’ve not got too much longer to wait.
I think it’s fair to say that most if not all of those of us invested in FUM before or since it was awarded the CE mark in May 2021 for MED3000 expected the subsequent product (Eroxon) to be in our check-out baskets and beyond by now. Progress to commercialise it, in terms of generating sales revenue, has been painfully slow in the UK and EU, the markets where first sales were expected, based on coverage of the CE mark. Now a deal for these markets has been tied up with Cooper Consumer Health, speed to market (marketing and sales) is now very much in the hands of this third party, assuming FUM can supply manufactured product. Since the deal was signed literally a month ago, it may be a wee bit too soon for Cooper to have worked out a marketing campaign, although it’s had months to think about how this could be done (and to do home testing of the product) and include it in its pitch to Futura for the rights. As well, whatever campaign is rolled out may need to have uniform messaging across the multiple languages of the EU, and this will affect the speed of marketing production.
At the moment, Eroxon is like the proverbial ‘talking horse’ in horse racing, producing spectacular home gallops (ie all the test results), but yet to be seen and replicate that stellar performance on the racecourse (ie commercial launch and success). To extend the horse racing analogy, the great stallions, like Northern Dancer, Sadler’s Wells and Galileo commanded super sized stud fees only after their outstanding success, first, on the racecourse and subsequently, second, as sires of subsequent outstanding racehorses.
FUM’s share price is a small fraction of what it should be because it’s largely based on Eroxon as a ‘talking horse’. Commercial launch, and proven commercial success against the existing erectile dysfunction treatments will propel that share price to a completely different dimension.
Cooper Consumer Health have purchased the right to distribute MED3000 in Europe for 5 years. Intuitively, then, why would this company, which is owned by demanding private equity, sit on those rights for a year? Private equity backers seek higher returns than most other types of investors, so an early launch now is highly likely.
Talk of 2023 for launching MED3000 in Europe seems plain wrong. Futura has the manufacturing capacity in place; and Cooper has had time to think about how to market and distribute MED3000 in Europe, and has the experience of doing so with a large number of other OTC products.
The clock is ticking on its 5 years as licensee; it needs to start to sweat its new asset.
Some investors are grumbling about the lack of financial detail around the deal. Again, intuitively, what would you expect? Four deals were signed previously, and very little financial detail was shared around any of them. More need to be signed. Imagine how cheesed-off each might be to learn of more favourable financial terms granted to some, but not to others? Would they demand a renegotiation? In a simple single deal, the risk isn’t there, but when you’re negotiating with multiple parties, I don’t think it’s realistic to expect much detail.
Some are also looking for forecasts. Again, why make the share price a hostage to fortune? I’m sure Futura and Cooper have their own internal forecasts. But MED3000 is a completely novel product, and will set its own forecasts, based on year 1 sales in each territory: more will be expected in year 2, and more will be expected as sales in other regions occur. Trends will be established, and comparisons can then be made with sales of other erectile dysfunction solutions.
I’m as disappointed as most or all on here by the wretchedly low share price. We need real excitement around MED3000 that brings in new long term investors. Moving the product from clinical testing, and discussion in arid regulatory and business deal settings, to the buzz of consumer launch and consumer experience shared on social and traditional media will, I believe, be the transformative moment for the share price to sharply re-rate to a level deserving of a likely high-growth stock.
I think the muted reaction today simply reflects the continued absence of a firm date on which MED3000 will be available to buy. Plus, beyond relatively few people in the investment and medical community, it’s pretty much unknown. These things should change pretty soon.
Futura expects to submit the results of FD71 in September 2022, at which point it will start engaging with potential US ‘partners’. It will have not just those results, but I’d be gobsmacked if it doesn’t by then have early sales data from Europe. As well, by then, the product should be well socialised and discussed on social media and in traditional media. Helping inform this will be the experience of early adopters.
I still feel there’s a determined seller of these shares in the background, through the order book, with their iceberg order, replenishing the order book and selling in round lots. We need much more sustained and determined buying to overcome the weight of these sales, and re-rate the shares. It’s ridiculous that they are still trading at less than a third of Libernum’s estimated value, despite huge progress on the commercial front.
Investors have become Doubting Thomases in the extreme.
We now (almost) have the news we have been waiting for. We also now know the reason for the protracted delay - due diligence, in the form of in-house research to validate Futura’s claims. No release date, as “Cooper will be responsible for all launch and marketing expenses”, so that will be down to them. Guess there will be more news soon about this, as the marketing is rolled out. Cooper seems an ideal fit, though not the multi-billion pharma some had hoped Futura would partner with. Whilst it has been growing rapidly, its revenues are still only €500m pa. So, a high-growth product like MED3000 will benefit both parties. Exciting times ahead.
We now (almost) have the almost news we have been waiting for. We also now know the reason for the protracted delay - due diligence, in the form of in-house research to validate Futura’s claims. No release date, as “Cooper will be responsible for all launch and marketing expenses”, so that will be down to them. Guess there will be more news soon about this, as the marketing is rolled out. Cooper seems an ideal fit, though not the multi-billion pharma some had hoped Futura would partner with. Whilst it has been growing rapidly, its revenues are still only €500. So, a high-growth product like MED3000 will benefit both parties. Exciting times ahead.
I believe anything less than either (a) news of UK and / or EU product launch or (b) award of a patent for MED3000, and FUM will track down tomorrow. We really need more than the thin gruel the master offered Oliver Twist - further news of US regulatory progress (yawn) or more licensing deals covering, eg Japan, that require further domestic regulatory clearance (yawn). Ultimately, any company has to make money to survive. Making money requires sales. The board must stop providing thin gruel, of tyre retreads in terms of information, and provide shareholders with a proper meal of product launch date and / or the patent. Preferably the former.
There seems to be a determined seller of FUM shares. At one point today, there were 13 x 25k lots to sell on the order book. These accounted for the majority of sell order volumes. As one lot is filled, another pops up to replace it. Hence the muted share price progress yesterday on news, and the decline today on no news. The beat down of the share price has been occurring through the order book. At one point recently, around 70%-80% of the daily volume were trades executed through the order book. The hard selling always seems to be early afternoon. With no news on actual launch, so light buying, the shares remain vulnerable to the determined seller. Interestingly, the CEO did hint in yesterday’s interview that a deal was being negotiated “closer to home”. Did make me wonder whether that means either a single UK distributor, a single EU distributor, or a single UK-EU distributor. Of course, that news can’t come soon enough now, to blast that seller away, and turn this share sharply north.
In last week’s The Apprentice, neither team managed to sell any baby food, triggering a double firing of the candidates by a disappointed Lord Sugar. I do wonder what he would make of Futura’s leadership. Handed a green light around 10 months ago to sell in the EU and UK, the leadership team has failed to deliver any product onto high street shelves. This would have had two benefits. First, it would have brought bring valuable cash into the company. Second, it would have enabled the product to market itself elsewhere through demonstrating commercial success in Europe. Instead, the leadership team has put a home market launch seemingly way down the list of priorities. And the added value attributed to the company by excited investors through the 84p price last spring has been gradually emaciated to 25p today. Around ¼ of its valuation by one broker. I’m pretty sure a self-made billionaire like Lord Sugar would have some rich and colourful words to say to Futura’s leadership if they were candidates for his investment. And I don’t think they would make pleasant hearing.
20 December 2021: “Futura is in advanced discussions for other commercial out-licensing agreements covering additional major regions and countries of the world with multiple interested parties. The Company looks forward to providing further updates in 2022.” So advanced that, almost 3 months later, there’s been absolutely no news. This is damaging the company’s credibility, with some skittish private investors bailing out of the stock at even 24p today. Each passing day of no positive news on near-term product launch dates in the UK and EU is breaking credibility with new individuals, turning them from holders to sellers of the share. The stream of potential good news has always been out there for Futura. But, going on for 10 months since EU certification of the product and still nothing on high street shelves anywhere, questions over the board of directors’ ability to execute in a timely manner, and translate science to high streets, are increasingly in many investors’ cross hairs. ‘Advanced’ is certainly not an accurate characterisation when we’ve now reached day 78 and still counting, with still nothing to see.
The steady dribbling down of Futura’s share price is definitely incredibly frustrating. Since it touched 84p last spring, I had expected far more in terms of news, rather than the ‘retreads’ of old news represented by far too many of its RNSs since. Bigger companies have been taken acquired in less time than it has taken it to bring MED300 to our wallets and handbags.
I guess that’s what comes of asking 10 employees to spread themselves across identifying, evaluating and signing up commercial partners in multiple geographical territories, developing sales and marketing, including manufacturing facilities and scaling supply capacity, and overseeing a US trial to satisfy the FDA.
Every trading day that brings no real news leaves the share price vulnerable to marginal sellers. Thankfully, in the background, Lombard Odier has been steadily hoovering up some of these shares, but not enough to prevent slippage of the share price now into the high 20s, and unease and frustration among some small shareholders.
I’m convinced news of actual sales beginning in the UK or in any part of the EU will be the start of a sustained catapult north of Futura’s share price.
Sex sells. Always has, always will.
This board completely lost its value months ago - since you-know-who (‘The Clown’) appeared. I filtered them months ago, but many haven’t, believing engagement with them is a better way forward. So, since they appeared, probably over 95% of the postings on this board have been about this particular person, addressed to them, etc. An exercise in futility.
Circa 40% of Futura is held in publicly known ‘safe hands’, then there is ownership by directors, and sensible long term private and institutional shareholders. The ruminations of The Clown don’t hold any appeal to any of this group.
It’s unfortunate that the commercial alliances, in particular those for the EU, have taken so long /are still unknown. Rather than build on the momentum since the share tested 83p/84p in Spring, the information vacuum about the (in short term) all important EU alliance(s) in particular has seen the share drift down to the low 30s.
In the words of Luther Vandross, potential new money is begging “give me the reason” to invest in Futura, or to trade its upward momentum. That will come with firm EU news, launch dates, publicity on traditional and social media ahead of these dates, and news on patent protection. Once Eroxon is actually being successfully used by men, Futura will become a key growth stock, supported by fundamentals, rather than one individuals like The Clown attempt to trash talk down.
The raft of good news is moving inexorably closer with each passing day…..we are clearly much closer to the end of Eroxon’s pre-commercial stage than we are to the beginning. Like the pennies in old ‘penny pusher’ slot machines, Futura’s coins in terms of good news are just about to start falling, rewarding patient investors.
Life is so very precious. Something many appreciate far too late. Each grain of sand flows one way inside the hourglass: once it’s gone, it’s gone. It is therefore completely bizarre to me that there is one person on this board who spends - no, wastes - their precious gift of time in this world posting about a share, Futura Medical, they don’t believe in.
Why not spend that time with your partner, children, friends, forming social relationships, developing a skill, volunteering, travelling, gardening, learning a language, enjoying nature, reading great literature, creating a business, keeping fit, expanding the mind and soul.....It’s such an utter waste of belonging to the human race to spend so much precious time negatively posting on a bulletin board about a company you don’t believe in. The saying “get a life” has never been more apt.
There’s a rodent in the house creating a damaging and unhealthy board environment.
I don’t read its repetitive drivel, which so many on this board have got drawn into responding to over the last three weeks. Ignore it, filter it, but don’t directly respond to it. Create an empty echo chamber for this person and their ilk. Don’t engage with their negative energy: it won’t pull you up or push you forward in life. I am all for fair, measured and balanced discussion: I make my point, positive or negative, may come back to support it in some way, but eventually I move on. I’m not going to anchor my precious life around a single idea. No one wins all battles.
Futura’s gel has been statistically successful in trials. It’s on the verge of successful EU approval. Whether it is commercially successful will become evident once the product is available to buy and experience. Some men will not find it useful, but all known statistical evidence indicates more will than won’t.
Now for me to get on with living a full and positive life, away from that rodent in human form, so that I can give a good account of my time here on this earth to St Peter....