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02/2/202311:00RUA Life Sciences - Elast-Eon Enabled MedTech2,637

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Posted at 02/2/2023 08:20 by Rua Life Sciences Daily Update
Rua Life Sciences Plc is listed in the Health Care Equipment & Services sector of the London Stock Exchange with ticker RUA. The last closing price for Rua Life Sciences was 59p.
Rua Life Sciences Plc has a 4 week average price of 45.50p and a 12 week average price of 32.50p.
The 1 year high share price is 67.50p while the 1 year low share price is currently 31.40p.
There are currently 22,184,797 shares in issue and the average daily traded volume is 84,398 shares. The market capitalisation of Rua Life Sciences Plc is £11,868,866.40.
Posted at 31/1/2023 17:07 by bones
cfb, you say "They've been profligate with share options at low prices so no incentive for board purchases."

For the record, RUA share options were issued to staff as well as directors and all of them were at the market price at the time. No nil-paid nonsense like the really bad AIM companies get up to.

The directors' ones are:

- 30p for Bill Brown and John McKenna (issued in 2018 at the time of the 30p placing when the company was all but bust and could only start R&D for the vascular project if they got these rescue funds at the time)

- 92p for John Ely and Geoff Berg (issued 2019 when 92p was the price). David Richmond got some too but those lapsed when he left.

- 155p for Caroline Stretton and a whole bunch of RUA staff (issued 2021 when 155p was the price)

- 44p for the two newest recruits (issued 2022 when that was the price)

None of them have kicked in much since a good chunk of them cannot be exercised until there is an approval for a product given by a regulator. There is a whole heap of incentive for directors to get the approvals through.

Posted at 30/1/2023 19:40 by brucie5
Is Corcym not big enough to help Rua over the line with a strategic stake for a couple of million at say, share price £1? Or are we expecting some regs permissions before Rua goes back to market?
Posted at 28/1/2023 16:01 by spurious
Harogate post 2543
If this deal includes all the grafts that RUA are working on - including the ones that we await FDA clarity on the nature of the trials - why does the announcement talk about approvals in 2025 - 2027. Does this mean that the current FDA approval is not going to be the 6 months of work we hoped. I may have misunderstood this.
Harrogate26 Jan '23 - 13:28 - 2557 of 2591
I don’t doubt that the profitability is fine on the deal once they start selling but with no funding from them and 4 years worth of approval costs we now need a fair whack of dilution. And no one has answered my question on the 2024 / 2025-2027 approval question.

Hi Harrogate

Apologies I noticed your posts (as above)
and meant to respond at the time.
Waylaid as usual

The simple answer to your question is that with everything now in place re distribution agreement RUA will be hoping for FDA approval in 2024 for the root graft part of a $1 billion addressable market It will possibly require separate approvals for some of its other grafts in development 2025/6 and anticipates new regulatory approval for it's elephant graft in 2027
So RUA should be selling it's root grafts (part of $1billion overall target market)from 2025 and generating day one revenue.
As additional grafts are rolled out and approved between 2025 to 2027 then additional revenues will be earned
There will be no 4 year dilution cost penalty as we will have substantial Graft earnings from 2025 (remember also our RUA med contract revenue is forecast to double in the next 2 years) All subject to FDA approval
I hope 2025 could wind up generating substantial profits

RUA will still need to fund the trial cost for the root graft but think this will come in the main from Grant funding and potential equity raise but this may not be required if there are further "partnership " announcements or deals around the heart valve involving capital injection.
If we did have to raise in the market or even funding from Hayfin or Gyrus capital taking a small stake then I see nothing but positives for realising real value for RUA shareholders
The BOD have always said they would most likely offload the heart valve if a suitable offer was forthcoming as this would de risk the opportunity from trials, costs and delays
I believe this will happen as further successful in vivo and bench testing reaches completion over the coming months.
Interestingly we have a company that specialises in the heart valve market that wants to be our close partner. Interestingly too that company is backed by substantial investors in Gyrus and Hayfin who specialise in buyouts and strategic investment
I genuinely don't think we will have too long to wait to see the big picture.
I also think we will be back to 100p+ share price in very short order
Hope this helps

Posted at 26/1/2023 14:12 by spurious
Excellent post Bones( refers to post 2550)
You echo my thoughts since this announcement.
My first thought was if this exclusive heart valve company Corcym is desperate for a partnership agreement on vascular which shows total belief in RUA product in a market it doesn't currently supply then why would it not be tearing its hair out to exclusive rights to our world leading heart valve in the market it currently and exclusively operates in.
Harrogate rightly points out that that RUA were looking for as little dilution as possible to cover trial expense but remember also that the company did not want to compromise its access to grant funding and I hope we can expect an announcement on that shortly though no guarantees.

RUA have previously also indicated they do not wish to dilute shareholders by raising money on a weak share price and despite the recent spike I would still suggest there would be some way to go before considering this option if at all.
I am pretty sure that RUA has its cash base covered re trial expenses otherwise the need for an up front payment for exclusive rights on vascular would be front and centre in any deal.
My thoughts are if you seek genuine partnership with a company then you are looking to mutual long term value building.
It would be inconceivable to me that Corcym didn't see the opportunity in our heart valve as the big prize while viewing the vascular side as complementing their distribution channel
It would be equally inconceivable to me that RUA were to sell out their prize assets on the cheap and the attempt at heart valve valuation by referencing Foldax $120,000,000 recent fund valuation is interesting
How would Corcym feel (as our partner) if an Abbott or other global med tech offered for the heart valve after successful bench and in vivo testing both which are from memory due to complete over next 12 months
I would be astonished if there were not further announcements to come re partnering opportunities and a closer working relationship. Bill did suggest, at last update, of announcements to come re distribution agreements
Corcym would not in my opinion have gone for a structural partnership relationship unless the heart valve opportunity was in play.
There would be nothing to stop them buying shares in RUA, buying us out totally or buying out vascular and the heart valve and we keep Biomaterials and Elasteon rights though I have always thought that any company looking to take us over would want to guarantee supply and product particularly when they are all so complementary
So in summary I do not have any exclusive knowledge other than that gained from being a long term shareholder and this post only shares my opinion for what it is worth
To me this initial partnership announcement with Corcym can only involve a closer working relationship involving RUA Structural Heart and possibly imply a buy out and realisation of real shareholder value for RUA shareholders
Exciting times and hopefully announcements ahead

Posted at 26/1/2023 12:01 by bones
Good points Harrogate, et al. Funding could be BOTH grants and fund raises ultimately. I'm fairly sure they will still have £1.5M - £2M in the bank currently based on £2.5M at 30/9/22.

However, I am more interested in the ramifications of this tie-up in the larger picture. The fit seems perfect as Bill talks about Corcym needing the pipeline to boost their own future business and valuation while RUA needs a solid distribution outlet and to be able to say to future funders that here we have our route to market laid out so there's no need to worry about that.

As I said in an earlier post, what I think is significant is that this distributor also happens to be a heart valve pioneer first and foremost. That suggests to me that the vascular grafts, while adding a welcome new range to their future pipeline, are maybe not the big prize for Corcym; rather the heart valve IP that RUA owns and is still developing is the target. Perhaps?

Recall at the webinar, the description of each of the business divisions concluded with a reasonable stab at the potential valuations of each once they have reached a certain status in their development timelines.

For Vascular, the valuations were based on what the pilot line in isolation could produce, circa £4M p.a. contribution valued at 10x = £40M. That presumably would be the value upon FDA approval. The actual capacity to produce grafts will be much larger based on current capacity at RUA.

For Structural Heart, the valuation was based on the equivalent valuation that Foldax achieved prior to the mini-trial (or IDE) of putting a few individual polymer valves in around 15 people. We are told that was £120M. For RUA, that would require a successful test run of their hybrid material/polymer valves in both benchtop and in vivo trials but before any thought of setting up human trials.

Both of the above processes might take between one and two years, hence the 2025 date (now less than two years away so not as long as people think in the context of Medtech regulations).

My thoughts are that Corcym and RUA will only get closer in time. You can draw your own conclusions of what that might mean ultimately. Corcym is backed by big Swiss bucks.

Posted at 14/11/2022 09:40 by bones
Amt, your view is assuming funds are raised via a distressed placing. RUA are not in a distressed situation nor are they a one trick pony like all these companies with a single oil well, gold mine or pharma drug.

Once RUA agree a trial protocol with FDA, they are not obliged to start it immediately so do not have to look for financing if the conditions for raising funds are not favourable.

In any event, why do you assume that a placing is the way forward?

With an agreed trial timetable, RUA could agree a partnership with a distributor putting in funds in exchange for future profits in grafts. They’ve certainly said they expect to sign up a distributor.

There are other avenues. An industry player with an interest in the graft and heart valve technologies could offer a convertible loan over several years, for example. They might even put in an equity injection for a percentage of the company.

If, as we are led to believe, industry is keen on RUA’s technologies, one of the leading companies could be tempted to do a deal for some of the IP before their rivals.

We just don’t know yet but it’s too easy to say the outcomes will be negative for the share price or to make general derogatory comments about the board, as some resort to like a football supporter wanting a new manager after losing some matches.

Posted at 28/10/2022 11:33 by spurious
Hi the Surgeon
Your opinion is as valid as the rest of us however I will take issue on a number of points you raise
You say " the heart valve is at too early a stage to sell or do a JV "
What do you know that we all don't. The coming months would IMO be precisely the right time to do a deal and the company have stated in previous presentations they would be prepared to offload parts of the business if the price offered was attractive
The company said in their last investor presentation that they are still talking to a global med device player they had visit them in Feb. This may or may not result in a JV or any other financial arrangement but Bill's comment that talks have progressed to corporate discussion around exploring potential opportunities and suggesting there was an obvious deep respect for RUA is very positive
You also say "I cannot see a rights issue succeeding" What do you know that we don't
If the story is right then the company will be backed.
In the latest investor presentation in August, and I suggest you listen to it, Caroline right at the end of the Questions and Answers responded to the issue of funding and timelines.
She suggested "there are a number of balls in the air" and before addressing any funding they would want to complete the process with the FDA to gain clarity around trial cost, validation of route to market, as well as seeing the share price higher to minimise dilution.
When Caroline talked about validation of route to market she stated there were a number of distributors identified, both global and regional and hoped "at least one would be signed up prior to any fundraise in future"
The Company appear more than relaxed over having the funds to "manage the runway" also see previous excellent post by Bones on current assets/cash/prospects
To sum up
The company have stated they have 3 issues to resolve before raising funds
(1)Complete the process with FDA,
(2)Validate the distribution channel/sign agreements with global/regional players (they hope to have at least 2 signed up and they have intimated they already had agreements in place prior to 510K submission last year)
(3) See a rerating of the share price.
The company cannot control the share price but positive news around FDA clinical trial costs and any signed distribution agreements will rerate the share price automatically
I have continued to add to my investment of over 200,000 shares and I remain positive on the future prospects

Posted at 27/10/2022 14:47 by hedgehog11
I am counting on when they need to raise money it is from a positive perspective, the testing route, we are led to believe, is low risk (FDA testing programme all but agreed, just some minor changes) and it should result in approval for what is likely to generate an incredible jump in revenue. IF there is agreement with the FDA and RUA can raise the money, they are back in a similar situation as when they were last valued at 30+mil (albeit dire market sentiment and some damage to credibility). My thinking being the benefits far outweighing the dilution in time.

The company currently has a market CAP of 8.65mil and generates revenue of almost 2mil. This is before any revenue from component manufacturing agreement starts to come in. Although that is dwarfed by the total overheads, I see it as a positive for RUA. Difficult to tell, but I don't think RUA is wildly overvalued on this part of the business alone.

The delay isn't doing my nerves any good at all but if something has gone wrong with the FDA I hope that we would find out sooner rather than later. I am hoping for positive news re: FDA, component manufacturing and a positive quarterly report (although last report was four months to end of July) to push the share price ahead of a placing.

Just my thoughts. Some communication (reassurance!) from RUA would be welcome.

Posted at 18/8/2022 18:08 by boysie72
There's some good posts here today, and some good open minded logical thinking as to the prospects of RUA. To add to these is that in the RUA update they were very explicit in the FDA process, so with that RUA has a few tweaks to do to meet the FDA approval of going into clinical trial, and as such, the FDA will only be reviewing the tweaks they have asked for, thus the process to reach the decision to go ahead with a clinical trial will be swift, end of Sept being the timeline for going back to the FDA with the mitigating approach. I will not claim to have huge experience on the FDA workings, but I do know from experience that reaching clinical trial go ahead will give the share price a big kick north, but likely that movement will happen prior to publicising. I'm expecting funding, but as per my subjective opinion yesterday, impact will be low due to shares in issue, mcap and share price
Posted at 27/7/2022 15:01 by bones
I have had another watch and listen of the recent Equity Development webinar with Bill and Caroline now that the sound has been cleaned up. The Q&A was still a bit unwashed so one or two words were drowned in static but I did my best. Here are the main takeaways for me, the majority from the Q&A’s:

Recent final results to 31/3/22

RUA Biomaterials is basically an annuity business with >90% net margin. With c.£500k pa income, this could be valued at 10x or £5M which is (ex-cash) what the whole of RUA Life Sciences is currently valued at on AIM!

RUA Medical Devices is in a growth phase, turned over >£1M and has net margin of nearly 50% contributing over £500k to group costs. Similar contract manufacturing businesses have been changing hands at between 10 and 20x EBITDA, so RUA Medical Devices could easily be valued right now at £5M to £10M alone. Again, well in excess of the whole group’s value on AIM.

RUA Vascular is the first of the real areas of interest to investors, developing products that stand to overhaul a product line that has barely changed in 40 years. The current plans aim to target, at a very minimum, 10% of a total addressable market of $1Billion. Included in this is the aortic root graft and, later down the line, a product called a frozen elephant trunk graft. The latter sells in the current market at an equivalent £18k each in the US and £11k each in the EU. These are products sealed with animal derived material which RUA are hoping to eliminate and make obsolete.

RUA Structural Heart is still regarded as the crown jewel of RUA’s products in R&D with an addressable market of $8Billion. The regulatory environment here is necessarily rigorous and expensive so the intention is ultimately to partner, license or sell the technology at the right time, most likely once animal trials have commenced or ended (being the point when the technology has been somewhat “de-riskedR21;).

RUA Medical Devices contract updates

Contact with existing key customer (US based) suggests they are seeing “very significant growth” in the US whereas European business (a much smaller element) has yet to catch up with pre-covid levels of sales.

The pricing structure with the US customer has been changed to secure a good increase in selling prices. Previously a large discount was offered by RUA in exchange for cash prepayments. Now turnover will improve somewhat with business on normal credit terms. Caroline suggested that this will result in an improvement on the 11% growth seen in the recent year just ended.

Further growth in this division may come with a potential new customer with which RUA MD is in talks. This entity is a “well-renowned medical textile company” and it is believe RUA MD would represent the first time this company has outsourced any of its manufacturing elements. This is regarded as a “feather in the cap” for RUA to be trusted to take on a small part of the bigger company’s processes. Hope is for the go-ahead to be given in the next couple of months (currently going through legal processes). Hope is also that this will be a foot in the door for further work going forward.

Heart valve representative visit in Feb 22

At the previous webinar, Caroline had alluded to a visit by a representative from a major heart valve company. Five months on, what can be reported?

According to Bill, it went “extremely well”. The visitors were looking at “two or three different project opportunities mainly around textiles, what we are doing on grafts and our polymer expertise”. Bill felt they left “pretty impressed”.

An OEM opportunity is progressing well and discussions that were at the operational level have now moved to the corporate level where they are exploring if there are any “touch points” where they can work together in the future.

Nothing can be said to have been achieved so far since the visit but there is great respect for what RUA has done to date.

Heart valve in general

There are two parallel products being developed.

- The 100% polymer leaflet heart valve about which RUA is very excited given its excellent design in reducing stresses on the leaflets.
- The hybrid textile/polymer leaflet heart valve which came “out of left field” following the research work done on developing the grafts for RUA Vascular. The impression given is that this combines the low stress factor of the pure polymer valve with a near “unbustable221; material for the leaflets. The excitement here is even higher.

My understanding is that one of these will be chosen to go forward to in vivo animal trials in 2023 when they have enough data to make that decision.

Vascular graft 510k process

The FDA requirement for a clinical trial has resulted in new outlooks and, despite the delays to market, offers potential advantages and accelerations in other areas.

At point of launch (2025 in US projected), RUA may have “data that will be hugely important from a marketing perspective”. For example, the clinical data that the market could use might include:

- Grafts will be “substantially less inflammatory” than current products (due to the body not having any animal tissue to attempt to reject);
- Grafts will leak less than the current technology (the patient would spend less time on a chest drain leading to earlier discharge and a significant cost saving to the hospital).
- While the RUA products in the main are similar to existing products (hence the 510k route), the above benefits may be so significant that the projected aim of a 10% share of the market could prove highly conservative in practice.

Clinical data will be readily available for use by regulators in other territories and continents.

Finance and cash requirements

Clearly, there is an acknowledgement that the clinical trial and other work being carried out in R&D cannot be solely financed by the profit centres of RUA Biomaterials and RUA Medical Devices alone.

At this current moment, several options exist but there is little that can be said until the final decision about the structure of the clinical trial on the vascular grafts has been cleared by the FDA. Currently, the talk is of an August decision. Once that is known, it is “de-riskedR21; and a better idea of costs and timing will be known.

Cash was at £3Million at 31/3/22 so there is headroom for now (and RUA Bio and RUA MD continue to earn profits all the while). Cash will have to be managed carefully nonetheless to support the clinical trial.

Discussions have been ongoing with several potential distributors of the vascular graft, both regional and global. RUA would hope to have at least one of these signed up prior to [inaudible, couldn’t make it out!].

Caroline also said it would be good to see a better share price!

I think that’s the gist of the important points discussed. Clearly, there are potential catalysts here to improve that share price over the next three months, before any funding becomes critical.

For example, if they can report the signing of a new contract manufacturing deal with a new customer, that would have significance for the cash flows of the group as well as help to reduce dependence on one major customer at RUA Medical.

I also hope they can get a good agreement with the FDA on the structure of the clinical trial. Once there is certainty there, that should give the market more visibility and eliminate the kind of uncertainty that crushes a share price.

I hope the above is a useful summary. If you want to listen to it in full, the Youtube link is in the header near the top of the page.

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