Shield Therapeutics (LSE:STX) — Investor Presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the SHIELD THERAPEUTICS investor presentation. Throughout this presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Just simply type in your question in the box below and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company review all questions submitted today and where appropriate, publish responses. These will be available via your Investor Meet company dashboard, and we will send you an

0:32 e mail to notify you when they are available for you to review. I'd also like to remind you that this presentation is being recorded. Before we begin, we would like to submit the following to Tim Watts, CEO of SHIELD THERAPEUTICS. Good afternoon, Mark, and thank you for the the hosting us, and good afternoon, everybody else. So I think most of you will be well aware that that we put out an RNS last week, and I've had plenty of questions and discussions since then. I hope this presentation is going to go a long way to answering those questions. Let me just go through the disclaimer slide.

1:19 And then so this is what I intend to cover. Talk briefly about the company overview and the investment highlights. And then because although I suspect most people on this call do know something about the company and the product, I think in case there aren't that there are people who are not so familiar, I will talk briefly about the product and why it distinguishes itself from the competitors. Most of the discussion then will form around The US commercialization. I'll talk about what's happened over the last eighteen months and why we are now where we are. And then I want to talk about The US market opportunity. Towards the end, I will briefly talk about Europe and China and the cash position, and then bring the presentation to a close. So just moving into the company overview and the investment highlights.

2:10 The so we're a name listed company. The market capitalization as of last night was around £71,000,000 The primary focus of the company is on developing and commercializing the product that we know as Ferrocrew, which is the brand name in Europe, but Aquifer is the brand name in The US. It's a novel oral therapy for treating iron deficiency in adults. It's approved in The USA and in Europe. It's got patent protection out to 2035. We have conducted three phase three clinical trials, which were all positive in their outcomes, and have confirmed the effectiveness and the tolerability of the product. For commercialization purposes, we have out licensed the product to Norgene in Europe that was done in the fourth quarter of twenty eighteen.

2:58 And in China, we've outsourced to a company called ASK Farm. It's not approved yet in China, there's another development step required, but we licensed it to them in the first beginning of this year. We have a product in the development pipeline, so our code name is PT20, that's a phosphate binder for the treatment of phosphoemia, and requires one further Phase three study to submit for approval in Europe and The US. Organizationally, we are semi virtual, We've got 15 people, an experienced management team. And so we outsource most of the heavy lifting of things we have to do in terms of clinical trials, manufacturing, and for example, the European and Chinese commercialization.

3:50 So looking at the investment highlights. So first of all, I think that today's valuation is underpinned by the license deals that we already have in Europe and China. We've it's commercialized by Norgene BV. It's currently on the markets in Germany, The UK and Scandinavia. And launches in the other big countries in Europe, France, Italy and Spain would be expected towards the back end of 2021, 2022. China, as I say, it's licensed to a company that abbreviated is called ASK Farm. And as I said, one third of phase three study required. So those deals, I believe, and I'll explain that a bit later on, underpin the valuation we have today. And then we have very substantial upside from The US opportunity.

4:37 And I'm going to go into this a bit more in due course, but there are ten million patients within iron deficiency suffering from anemia, and around ten million prescriptions sorry, that should be annual prescriptions, not monthly prescriptions of oral products, and around two and a half three two point three million doses each year of intravenous iron in The US. The first line oral products, which are old and generic, are poorly tolerated. The second line intravenous treatment is inconvenient and expensive. And putting all that together, there is a substantial unmet need for a better product. That's where Ferrocrew or Aquifer come in. It's it is a novel product. It's an oral product. It has a broad indication for the treatment of iron deficiency in adults.

5:28 We've done phase three studies in inflammatory bowel disease and chronic kidney disease, so we have very good data for those areas. But it's because it has this broad application, broad indication for all iron deficiency. It can be used in areas like chronic heart failure, women's health, oncology, care of the elderly, and so on. And we have patent protection out to 2035. And the product and these the clinical studies have shown this is effective, and it's well tolerated. The all three phase three studies show showed that, and in the head to head study, which is one of the phase three studies we conducted, and that was against Ferinject or Injectifir, which is the market leading intravenous treatment, Aquifer demonstrated comparable effectiveness over the fifty two weeks, and there's very good evidence to suggest that it would be a more cost effective alternative to intravenous iron.

6:25 So let's look at a little bit more detail about how the product distinguishes itself from its competitors.

6:33 First of all iron deficiency, just a very quick heads up on that. Iron is a key component of haemoglobin. Iron deficiency is the most common cause of anemia, iron deficiency anemia or IDA, which is caused by a lack of hemoglobin. And then the iron deficiency itself is caused either by malnutrition or bleeding, and that is associated with many diseases, which we've already mentioned. So there's IBD, CKD, women's health, congestive heart failure, oncology, aging, and so on. So it's about from that, and I'm sure you most of you know from your own experience, iron deficiency is a widespread ailment. In terms of how it's treated, typically, normally, the first treatment for iron deficiency is the replacement therapy is with oral products, and then followed on with intravenous therapy if needed.

7:32 So oral products, the current products that have been on the market for some time, they are all iron salts. They're inexpensive. They're convenient because they're they're tablets, but they're not well tolerated. We'll come up to this in a in a moment. And that leads to poor compliance, and therefore, they're not very effective at restoring iron levels. And in addition, they're not well absorbed anyway, so that that compounds the problem in terms of lacking of restoration of the iron levels. So patients who can't tolerate the iron salts have essentially two options, either to give up treatment or to move on to the second line treatment, which is intravenous. And in that situation, you are infused with up to a thousand milligrams of iron into your bloodstream, And due to various safety issues, administration, you have to go into hospital for that.

8:27 So there's obviously an administrative cost to that, and it's inconvenient for patients, and it's generally a lot more costly than the oral route. So the poor tolerability of the salt based oral iron therapies and the cost and inconvenience of intravenous iron replenishment together create a significant unmet need and an opportunity for ferrocrew. So in what way is it it different and novel? So although ferrocrew is an oral product, it's not a salt. So what what you can see on the left hand side, it's an Fe three plus iron surrounded by three molten molecules, and that binding is is very tight, and it doesn't break down, and it passes through the body to the point in the duodenum where iron is most of the iron that your body needs is absorbed.

9:26 And at that point, if the body requires iron, the demand from the body overcomes the binding of the ferric molten molecule and pulls the iron out of the the conglomerate and absorbs it. And the maltol molecules, which are left, then are just digested in in the normal way. Maltol is essentially a sugar like substance. It's used in in the food industry. It's it's known to be safe. So it's it's absolutely harmless as it passes through the body. And indeed, the because the complex itself, if it if the iron isn't required by the body, the ferric motile molecule remains as it is, and again is just digested normally.

10:12 Now that contrasts with the generic oral lines, which are salts. What happens there is that the iron is breaks out of the salt as soon as it's digested, and the iron that's then is freed up forms products in the GI tract, causing a lot of intolerance, the sorts of adverse events that you see would be nausea and constipation, damage to the gut and the stomach lining, and a range of adverse events which cause patients to drop drop off their therapy with. If we just look at the clinical studies that have demonstrated the effectiveness and tolerability, there were two clinical studies that we used for obtaining approval for commercialization in Europe and The US.

11:07 First of all, there was the inflammatory bowel disease study, and you can see from the chart there over a sixty four week period that the iron level sorry, the hemoglobin levels, which are measured in terms of grams per deciliter, You can see they're going up from around about 11 up to between thirteen and fourteen, really over sort of twelve to sixteen week period, and then maintaining at a steady level. So the effectiveness was demonstrated. And in that study, the adverse events were very low. So well, tolerance was demonstrated. And then similarly, in a difficult chronic kidney disease population, again, the primary endpoint there, which is the change of haemoglobin from baseline at sixteen weeks was met.

11:53 Again, it was well tolerated. And that study, in addition to the IBD one was used in US approval. So two very robust studies used for regulatory purposes, demonstrating the effectiveness and the tolerability. And then the third study that reported was the head to head study, which was a comparison of Ferrocura Acrefa against Ferre injector injector, which is is the leading intravenous product. And what this chart shows is the the change from baseline in hemoglobin, again measured in grams per deciliter, over a period from well, initially from naught to twelve weeks, and then it goes out to fifty two weeks.

12:41 And what you can see here is the blue line, which is the ferrocryl or ferric maltol line rises quickly, not quite as quickly as the intravenous iron. But then after about twelve weeks, fifteen, sixteen weeks, they both level off. And you can see that the ferric motor line holds the average hemoglobin levels at around the two and a half to three grams per deciliter above where the patient started. But an important point to make from the point of view of health economics, but also from the point of view of patient preference, is that seventy nine percent of the one hundred and twenty two IV patients who were actually dosed, seventy nine percent of them received more than one infusion before their week twelve visit.

13:33 And for the patients who continued after week twelve, and inevitably patients do drop off these clinical studies, sixty eight patients received further infusions from week twelve onwards. But note that in weeks, you can see it at the bottom of the chart, weeks twenty four, 36 and 52, the number of intravenous patients remaining in the study had reduced from down to eighty five at week twenty four, sixty two at week thirty six and fifty three at week fifty two. So those sixty eight patients represent a very high proportion of those who continued on beyond week twelve. And no ferrocruel or ferric maltol patient received needed to receive any rescue intravenous iron. And another feature of this chart that doesn't jump out of you, those patients who had to be reinfused over the week twelve to fifty two period, in order to be reinfused, actually, their iron levels and hemoglobin levels will have depleted again.

14:29 And so they would have gone through and into back into an anemic situation. And so actually, their their own personal curves for the hemoglobin level would have gone up and down as they were infused, iron levels restored, hemoglobin levels restored, and and then depleted again. Whereas with the ferrocrew, the ferric mortal arm, simply by taking two capsules a day, patients' hemoglobin levels would have remained at a steady level and then not entering into the anemic phase again.

15:02 So with with the evidence of those clinical studies, Ferrocru is is essentially very well placed to target multiple therapy areas because it's approved in for iron deficiency without restriction to therapy areas, and to capture prescriptions both from the older oral iron salts and the intravenous products. So what we would generally expect is that patients will be initially treated with oral iron, but the many who then find they can't tolerate that can have a choice. And and where we believe that Ferrocru and Aquifer will be positioned is before you move from the orals into intravenous, you should try Ferrucru or Agripher next, because it's it because of the the merits that you've seen in the in the clinical studies.

16:00 Okay, so let's move on and talk about The US commercialization and the summary of the last eighteen months. So I guess as most people will know, we gained FDA approval in July 2019. And the intent was at that stage to out license the product for US commercialization. And the thinking behind that really comes from the journey that the company had been on since the start of 2018 when it's had something of a cash crisis, had to abandon the company's own attempts to market the product in Europe. And that's when the strategy changed from launching the product itself in in territories like Europe and The States to an outlicense strategy.

16:53 And, of course, the the outlicense deal that was done with Norgene in September 2018 was immensely valuable in in and in particular at that moment because it brought in an £11,000,000 upfront, which funded the company through 2019 and into 2020. And in that time, allowed the company to submit The US application and to gain the approval. So that outlicense, that European outlicense was immensely valuable for that reason, and many others, clearly for that reason that we were able to keep going. So Board was very minded at that stage to outlicense the product in The US. And we entered into what has been a very thorough process.

17:41 And certainly over the last eighteen months, we've been in touch with, reached out to more than a 100 companies. And there's been strong interest in Aquifer from many of the the companies. The process really got going in the autumn of last year. The product was approved in July, as I said. We did start some initial contacting and and process before we got approval. But because the clinical studies that we were using for the submission were in IBD and CKD, there was a general feeling amongst commentators generally that the the FDA would initially only approve our aquifer for use in IBD and CKD.

18:27 We were beginning to get internally, although we couldn't tell people, we were beginning to get insights during the second quarter of twenty nineteen that actually the FDA was going to grant us this broad approval for all iron deficiency. So what happened when we got the approval in July? Those companies who'd been thinking that, well, maybe this is a product for IBD and CKD had to reset their expectations. And of course, companies became interested. August is inevitably a bit of a holiday period, so not much happens. And so it was really only September, October time when the process got got going. And as I say, there was a lot of interest from from many companies.

19:14 It's probably worth saying that there's been relatively little interest from the big pharma companies, and that's a number of people have expressed some surprise about that. But these are companies who very publicly are focused on, in particular, the sort of more advanced science, leading edge science in some some case, to develop products which address the underlying disease. And then they're not really so interested in the sort of secondary effect, which is the iron deficiency. And we actually ourselves were concerned that had a big pharma said, we would be really interested in taking this, and we're going to give it to our sales reps, we'll ask them to promote it. When they see a doctor, we'll ask them to put it as a second detail or even a third detail in in the meeting with the doctor.

20:04 We were concerned that that actually that might not give Acrefer the the profile that it needed. So we we would have been concerned had big pharma come to us so that that they would have been committed enough to the product. In the event, though, we found that big pharma companies were really not interested. What we where we have seen interest is from smaller companies and from mid sized companies. Of course, in The US, I mean, a mid sized company, you could be talking about anything $5,000,000,000 market cap, $10,000,000,000 market cap. So we talked to some some, you know, by by most people standards, some pretty big companies, albeit still relatively modest compared to big pharma. Many of those companies are focused on essentially on one therapy area. And what they were looking to do very more often than not was to license Aquifer in so that they could build out and expand their own sales and marketing presence.

20:59 We over the course of the the last year, we have had discussions with a number of companies, probably somewhere in the region of 10 to 15 companies in great detail about term sheets. We've had conversations with other companies which didn't get quite that far. And we've probably had half a dozen that have actually moved into the term sheet stage. Reasons why we didn't get to agree term sheets were typically that the financial terms were not sufficiently attractive. Certainly, with some smaller companies who were focused in one therapy area, they were not able or didn't want to offer what we would have considered large enough upfront payments to crew really to create skin in the game. And one of one of the things that's contemplating out licensing the product we have to be very conscious of is how much commitment will the counterparty have to the product once you license it to them.

21:59 And one means of judging that is that they're willing to put a reasonable upfront payment down at the outset and therefore, as I say, some skin in the game. And then related to that were concerns that if your counterparty or the out licensed party wants is essentially focused on one therapy area, and is a specialist in that therapy area, How do we gain confidence that if you're going to analyze it to a company like that, that they will actively promote Aquifer across the broad range of therapy areas where iron deficiency is common? And really, it's a combination of those concerns that in many cases prevented us from getting to the point of a term sheet. So it's not the lack of interest in the product.

22:53 It's that their interest perhaps was very strong, but from our point of view too narrow. We did have two transactions which reached very late stage. So these ones where we went to term sheet and then we went right the way through pretty much to the end of the full documentation stage. When you're looking at a license legal agreement, you're probably talking about 120 to 150 pages of legal agreement, plus a manufacturing and supply agreement, which can run 30 to 40 pages. So a lot of work, a lot of effort goes into those documents. But as I say, these two that got furthest along the path failed due to issues arising in the other the other party's businesses. And then so one of the companies, they wanted to license Acrofa to go alongside a product of their own, which they felt and they felt there would be some clear overlap between their sales and marketing efforts and on their own product and with Acrefa.

23:57 But what started to become clear and and and came to a head very late in the day was that their product was underperforming. And ultimately, they decided they were going to change the strategy in respect to their own products in a way that undermined their analysis of the value to them of Aquifer. So at that stage, they said, look, this isn't gonna make sense for us. And unfortunately, and very frustratingly, they pulled out. The second of these was a situation where the company wanted to had a phase three product in development, likely to get to the market around 2023, 2024, and wanted to bring Aquifer in because this would have been the first this this was a non US company wanting to build a presence in The US where they ultimately expected to be able to market their phase three product.

24:48 And so they, as I say, they wanted to bring Aquifer in so they could launch it in The US, and then two or three years later, they would have their own product. Unfortunately, their own phase three product failed in development stage, that was in the autumn of this year. And when that happened, although we had several weeks of further discussions with them to see whether we could rescue something out of the fire. It just proved impossible to complete the transaction. And so that's really a history of what we've been through. We do now have still some potential license partners who we are currently engaged with, but at a relatively early stage.

25:36 So I've probably touched on some of these, but we clearly had the opportunity to learn from many, many discussions we've had, some with with the the the two companies I've just described, company a and company b on the previous slide. Clearly, we had months and months. Both of those processes took six or seven months to get from the initial discussions through to the point of being close to signing. So we would we had many, many conversations with those companies, but we also had many conversations with many other companies who expressed an interest. And we learned from that. We we were able to we're a bit like a sponge. We were able to suck in a wide variety of information about The US markets and how the various counterparties we were talking to proposed to launch and promote Aquifer. So we learnt a lot about the pricing, thinking about pricing and how to interact with the the the in the private market, the insurance company payers.

26:36 We were told a lot about the market research, which those companies have carried out, talking to physicians, talking to prescribers and the payers. People told us what they were thinking in terms of their sales force sizing. They told us what they were thinking about the messaging to prescribers. And also, you know, what about the how do they see the competition against generic orals? How do they see the competition against intravenous products? So we learned a lot over the course of the the last eighteen months. And as I've already touched on, we saw a number of companies which were proposing to use Acrefer as their first product in The US, so they could build a commercial presence and the sort of two models that either that because they were bringing their own phase three product along and and wanted to to launch have another product to launch maybe two or three years ahead to to build up their own infrastructure.

27:39 Or in other cases, companies perhaps backed by private equity companies who saw an opportunity to recruit a US management team and bring in products. So Aquifer might have been the first of other products that they had in mind to license in the future. And and by learning through listening to all these discussions and companies, that really helped us to understand that there's no reason in principle why SHIELD should not also contemplate launching Aquifer. You know, we asked that we we asked ourselves when you look to companies that had recruited three, four, five experienced US managers who were saying to to us, look, we can go and license your product.

28:26 This is what we're going to do. We're gonna take with up with these this core management team. We can go out. We can recruit the the sales reps that we need. We can recruit other people to support the organization. And and we heard all about that. Why why could we not do the the same the same thing?

28:49 So let's look at the opportunity of The US market. There's some reasonably good statistics to say there's around ten million patients in The US suffering from iron deficiency anemia across many therapeutic areas. And the pie chart on the right hand side there shows you the the therapy areas where where it's it's seen most. We think that there's something in the region of perhaps two times that, three times that of patients who are suffering from iron deficiency, but perhaps who aren't yet anemic. And you can take the view that if patients have got to the point where they're anemic, that might be a failure of iron deficiency treatment, and therefore there is a role for aquifer even before patients have become anemic, and therefore there's an even bigger opportunity than this ten million. But it it's actually quite difficult to find solid data to tell you how many non anemic iron deficiency patients there are in The US.

29:51 The the ten million who suffer from anemia, it seem is is is reasonably well established. What we've also got fairly good sight of is around 10,000,000 oral prescriptions, Rx stands for prescriptions. So there's around 10,000,000 prescriptions for the oral products annually in The US, and there's around 2,300,000. So you can see there the types of illnesses, the breadth of illnesses that iron deficiency anemia is seen in. And then market research that we've seen really seems to confirm the unmet need. So the first part of this, the physicians believe that there's an unmet need in the market. And what the chart in the right hand top right hand side here with the blue bars is showing, it's a scale running from one to seven, and where one is the product is not particularly valuable, seven it's very valuable.

30:46 And what you can see there is that the physicians rate the branded intravenous iron therapy as being the most valuable products available for treating iron deficiency. And then they're less impressed with the older generic intravenous products, which are older and earlier generation and not as good as the newer branded ones. And similarly, they don't really rate the existing oral products, either the generic ones, or I think there's one other branded iron salt. And, you know, they use them, they're not saying they're not at all valuable, they use them. Some patients find find them okay and can tolerate them, but they're not overwhelmed by them.

31:33 And then when you ask them about and and this market research was done anonymously and it was done as product x, that when physicians are said are told what the profile of Aquifer is, the chart that with the red bar says, how would you see this product as a possible improvement? And you can see that, again, on a scale of one to seven, there's a very strong feeling that Aquifer would be an improvement over the existing products, both in terms of the tolerability is very important. And the efficacy compared to oral is important. And the fact that efficacy is similar to intravenous over the long term, also seen as very beneficial. And we also have seen payer research where where people have tested where would the insurance companies tolerate pricing for this product? And the pricing essentially is done on a per pack and a pack lasts for a month.

32:38 So the pricing here that you're looking at is essentially for a month's treatment of Aquifer. It's quite complex in The US. Typically, you go in for a price, which is your gross price. And then there's a lot of discounting of one sort or another related to the insurance company demanding sort of chargebacks and rebates. You've also got to pay something to the distribution chain. There's quite a complex mix. And generally speaking, you can see the discounts between the gross price and the net price ranging from anywhere between 3050%. And what we've seen is that a good consensus that the many companies that we've talked to see that a net sales price, so after the discounts, a net price price for Aquifer could be in the range of $200 to $250 per pack, so per month.

33:41 And there are recently other factors which support the use of Acrofa, which go beyond if you like what the clinical studies and the clinical evidence shows. Firstly, there's the COVID pandemic. And it's very obvious, we've seen it obviously here in The UK, that nobody really wants to go into hospital where they might become vulnerable to infection from COVID-nineteen. And so many of the patients who suffer from iron deficiency have underlying illnesses, which would make them vulnerable. And that has undoubtedly had an impact on what patients want to be treated with, what physicians want to treat how physicians want to treat their patients, which is resulting in a preferable to treat patient patients with oral therapies.

34:38 And indeed, there is some evidence out there when when you look at the companies who own the intravenous products, that during the the last nine months, they have seen a significant softening in the the sales and the the amount of infusions of the intravenous product. There's another factor as well, which relates to the launch of a new class of product called HIF inhibitors. HIF inhibitors are for the treatment of anemia in chronic kidney disease patients. And essentially, what they do is to facilitate the production of hemoglobin. And so they use the iron that the patients have better to produce hemoglobin.

35:24 And there is a strong view that that's great, but if for many patients, you will still need supplementary iron. It's the patients that the iron have naturally may work, may be enough for some patients, but in many patients, if you've got chronic kidney disease, you won't have enough iron, and therefore iron replacements will still be necessary. HIF inhibitors are oral products. And again, I think the general questioning is, if you're treating a patient with an oral HIF inhibitor, it's unlikely that you would want to send them to an intravenous iron therapy when there may be a good oral product around. So again, we believe that the HIF inhibitors will be a a useful pull for Aquifer.

36:15 And the first HIF inhibitor is expected to launch sometime in The US, probably in the first half of twenty twenty one. So with all of that, what are now our our commercial commercialized op commercialization options? So we've had a lot of interest. As I've described, we've had a number of term sheets. We've had two deals get very close, the last one of which fell over in the autumn of this year. And really, what we what we the conclusion that we have came to, we started doing some research during the summer, but it was really when that second deal fell over that we and the the board and our major shareholders, clearly, as most of you will be aware, we have a very substantial single shareholder owning around 48% of the group.

37:18 And inevitably through this journey, you know, we have from time to time updated them as to what's going on. And when the second deal fell over, we all came arrived at the conclusion that we needed to consider an alternative to the outlicense process because we couldn't guarantee, although there is still interest, we can't guarantee that we might go all that six six or seven months down the road to to get to towards the end of a process, and and yet again find for for some reason that the the deal doesn't complete. So that's has led us to say, now, we have an out license possibility, but we also have the the possibility of launching the product ourselves.

38:05 And if we just look at what each of those might look like, the typically, the financial terms for an outlicense deal would be a license upfront. So that's a one one off receipt we would receive on signing the agreement. There would be sales royalties based on the annual net sales, and typically, these would be structured and certainly term sheets that we've seen structured anywhere from 10% or 15% starting band, and going up then to on the higher tiers of sales levels up to 25% and even actually one or two cases we saw 30% royalty rates on very high tiers of sales. And then you would also expect to see sales milestones, which are one off receipts when the annual receipts at the annual net sales reach specified targets for the very first time.

38:52 So for example, this might be when when sales first reach a $100,000,000 in in a calendar year, you might get $10,000,000 for the sake of argument as as as a as a sales milestone. And clearly, are the sorts of terms that we've been evaluating on a regular basis when we've looked at and talked to counterparties. So the issues we've been facing, touched on some of these already, the the upfront payment big enough to ensure the licensee is committed and has skin in the game? And and then secondly, will the licensee commercialize the product successfully? And and in particular, will they exploit the full breadth of AgriFit's potential? And and then, you know, what about their commitment for the long term?

39:37 There's a fifteen year life on this on this product. They might be really committed for the first two or three years, but then if they've got their own products or they've got they've got their own product coming through from phase three development, How committed will they be by year five, six, seven? And and would that result in if they're not, would that result in a slackening off of of Acrova Acrova sales? And as I've said, we've got ongoing discussions with with a number of parties. If we launch the product ourselves, clearly, we would retain full control over Acrova in The US. And, obviously, as a consequence of that, we would retain full ownership of the the profits. Although we would have the potential to sublicense to one or possibly two companies to accelerate broadening the reach of Aquifer into specific therapy areas.

40:33 And as a counterpoint to the, you know, would a licensee be committed, clearly SHIELD if it launches the product itself, is is by definition a 100% committed to the success of this product. Obviously, there's some issues here. There there is a natural doubt that SHIELD could execute commercialization as well as a potential licensee. Although we've, you know, we have wrestled with that and thought about that. And and in many, many cases that we've looked at, particularly with the the smaller companies that we've talked to, when you look at, you know, what those companies have got in terms of their management structures, We've come to conclusion that there's no reason why we could not replicate something very similar to that. And therefore, it's not obvious that the commercialization execution risk is is necessarily worse with SHIELD than it would be with a a a licensee.

41:29 And the other significant issue, obviously, is the finance required. And as we said in the RNS last week, we've estimated that we need 30 to $40,000,000, which would finance the launch, but also would cover the other group costs that exist in the business today. And in particular, the main cost we've got will be the pediatric study that we have to undertake as a commitment to both the European and The US authorities on approval. In terms of current activities there, we've got some detailed planning underway, and I've got a slide in a couple of slides time to explain what that looks like. If we just look at the sales and profit potential from Aquifer, on average, we think, we assume that patients would take four to five months of Aquifer.

42:27 And one way of looking at that is, as you've seen from some of the earlier charts, it can take twelve to fifteen, sixteen weeks to restore hemoglobin levels, and then you might want another couple of months to maintain the hemoglobin levels. Alternatively, you may get some patients who maybe just need a top up for three months, and then maybe six months later they'll need it again for three months. So that might be the same patient in two blocks of three months. So there will be a huge mix of patients and different length of time that they take the product for in a given year. But our working assumption is on average, it looks like about four to five months. And then as I said on the slide a moment ago, we we think that we can achieve 200 to 250 net sales price per pack. So if you take those numbers and multiply the number of months by the the sales price, can see that per patient per year, we believe that you could bring in a thousand dollars a year.

43:29 So if we then speculate about what would it take to generate, say, $200,000,000 of sales per annum, net sales per annum, and let's say we could reach that by year five. Well, obviously, 200,000 patients by a thousand pounds per patient a year would give you the 200,000,000. So is 200,000 patients a realistic target for Aquifer? But it's it's only 2% of the 10,000,000 US IDA patients. It's around ten percent of the current level of oral prescriptions, and that's not allowing for any expansion of the market. And it's less than the 2,300,000 of intravenous infusions, which we would also hope to be able to get into that market.

44:18 So it doesn't seem to us that 200,000 is at all unreasonable. And in fact, you could say it's extremely conservative. So we believe this product does have substantial sales potential. As I think we said in the RNS, potentially several $100,000,000 per annum over time. So if we look at each of those in the context of either a license scenario or a SHIELD launch scenario, what would it look like in year five? First of all, we would expect something like a 90% gross margin on this product after the manufacturing costs, you should all be aware that the original owner of the intellectual property is a company called Vitra, who are allowed a 5% royalty on net sales. So if you take the the costs and the Vitra royalty together, we should get a a 90% gross margin.

45:12 So on sales of 200,000,000, that would give you a 180,000,000 gross margin. Now we are start I'll come to this in a minute, but we are starting to look at the the cost base, and we believe that they will start in the region of twenty five to thirty million, but they should rise to 40 to 45,000,000 by year five. So if you just round that 45 up to 50 and take that off the 180 gross margin, it it's eminently conceivable that by year five, The US profits, and which essentially it's cash because there's very little non cash items in this, could be generating 130,000,000 free cash a year at that stage. Conversely, if you look at the license scenario, again, on the same numbers, if you assume that the average royalty is is 20% when you get to 200,000,000, so that might be a starting royalty on the, for the sake of argument, the first £100,000,000 of sales. A starting royalty may be 15% and then maybe ratcheting upwards. So perhaps the average is on £200,000,000 is an average of 20%. Well, that would give you a $40,000,000 royalty.

46:20 But we have to pay away then 5% of net sales, so 10,000,000 is pay away to VITRA. So that would mean the net income to us in a license scenario on those sales would be around 200 sorry, around 30,000,000. And so you can see that the potential of the SHIELD THERAPEUT launch for generating cash is, by comparison with the license, is is in is is very substantially greater and and, you know, clearly very attractive from a net present value type of analysis. So how do what is the planning work we're doing at the moment in the event that we might go down a SHIELD US launch? We've been able to bring into the organization four experienced US commercial executives to plan and hopefully to lead the launch if if that's the direction that we decide to go go in.

47:20 We've we've brought them in at the moment because we can't actually commit to them that we can recruit them because we don't have a commitment to go down this route. They've currently joined us on fixed term consultancy contracts pending a firm decision for us to launch. And if we go down that route, the intention is that these managers will become, if you like, our core US employees. And the specific areas, they they they cover the the the pretty much the full gamut of what is needed in commercializing the product. But each of them has a specific area of of expertise, and those cover market access, marketing, medical affairs, and the operations and supply chain logistics area. And they've each got many years of experience.

48:06 They actually also built up a lot of knowledge of Aquifer because they previously been working for a company which was seeking to license in Aquifer, which didn't come off. And we were able to say to them, would you like to come on board on the basis that I've just described? And they were willing to do so. So they are now engaged in a lot of planning work, very little spending cash at the moment, but a lot of detailed planning. And we're thinking about a a launch sometime in the second quarter of twenty twenty one. And they're looking at the supply chain and operations, so looking at how do we get packs from Europe right the way across The Atlantic into pharmacies throughout The USA, looking at warehousing and wholesalers, logistics providers, and and actually actively going out and talking to those sorts of organizations and saying, you know, this is what we might want to do and, you know, we we we we've signed confidentiality agreements with with them and and so on. Similarly, work going on in market research and marketing, talking to potential marketing agencies and so on.

49:16 Salesforce planning and thinking about where we think we need we will be what we think we'll be doing in terms of targeting is to to look towards the top 20 to 30% of of the who prescribed prescribers who prescribed the most iron. So you can the the one of the joys of The US is the ability to analyze what is going on in the market and who is prescribing what is immensely granular. And so it's possible to identify down to individuals names who is prescribing iron. And so we can identify, and we have identified about 15,000 doctors and physicians who in aggregate are writing at least 70% of all iron prescriptions.

50:03 So the intent is to is to target to target them. And that's likely to need somewhere between initially 30, probably growing to 60 reps in order to reach those prescribers. And that will utilize both face to face, which is MeetMeetings, which is the traditional way of sales reps promoting to doctors. But more and more, and again accelerated by COVID, the use of e detailing online meetings, remote marketing, and and so on. And I think that is another feature of, in fact, factor behind why we are confident that a small company and small company like SHIELD can contemplate launching a product like this. In terms of the the reps, we're we're going through some assessment as to whether we should try and recruit them in house, or does it make sense to outsource to a commercial sales organization who could save us the time and the effort of recruiting and probably accelerate the process?

51:03 And we're developing training materials for the reps and so on. Market access, discussions about the pricing discussions that we've I talked about on an earlier slide, and how do you go about pitching to the insurance companies and so on. Medical affairs, we would be looking to set up key opinion leader advisory boards, how do we get the scientific messaging right? And of course, you've got to think about how do we implement the pharmacovigilance in case there are any adverse events that we need to record. So a lot of work of our own going on there. We're also looking at the potential that we might have to sublicense or to co promote, as I said on an earlier slide, maybe to one or two of those companies who have previously expressed a strong interest in in promoting this product, who perhaps didn't feel that they could take on the entire product, but but that would be willing and interested to to promote in their own therapeutic area, and and that might be of of value to us.

52:06 So I hope that's given you some sense of, you know, why we remain very excited about The US opportunity, whether we go down the license route or whether we launch the product ourselves. Briefly on Europe and China. So in Europe, we launched a license to Norgene. This is we've mentioned all this in the part announced all this in the past. We have sales royalties ranging from 25% at the lower end up to 40% on higher sales tiers. Those rates sound high, but you do need to bear in mind that we pay the cost of goods out of those royalties. So the net to us is clearly not as high as those percentages would suggest. Under the contract, when they hit when Noregene hit particular annual sales milestones, we could potentially earn up to €50,000,000 of milestones.

52:59 Currently, the product is on the market in Germany. I said earlier on The UK, in reality, it is England only because because of the need for gaining access to formularies in Scotland, Wales, and Northern Ireland is not yet on the product there. And unfortunately, that process has been slowed up recently by the the COVID pandemic and and the the obvious need of the NHS to focus on other priorities. And pricing reimbursement negotiations for France, Italy, and Spain are expected in 2021. For China, we've licensed the product to ASK. I think I mentioned earlier on, it's likely to require only one phase three study in inflammatory bowel disease.

53:46 We believe that could law lead to a product approval launch in 2023. We are due to receive an $11,400,000 milestone when the product is approved in China, And the royalties there up range from 10% to 15%. But in that situation, ASK will be paying for the cost of goods. So that sales royalty is is our net receipt. And in China, there are sales milestones up to $40,000,000. And if you make the assumptions that in those two continents, sales over by 2030, you assume a sort of sales curve which rises up to a 150,000,000 to 200,000,000 by around 2030, which for the given the size of those two continents, again, seems eminently achievable.

54:32 The the current market value today is supported entirely by the finances of those two those two deals. I'll conclude very quickly now by the summarizing the cash position and and then and wrap up. So the cash at the end of November was £3,800,000 And in the absence of anything else, that runway, which we'd originally said would take us into the first quarter of next year, actually was going a little bit further. It was going into the second quarter of next year. That obviously assumes very minimal US expenditure. So in order to take the the the pressure off and to make sure we didn't have a cash crisis, We've been looking at a number of ways of extending that number of sources of finance.

55:26 And in the end, we agreed some convertible loan facilities with two of our shareholders, AOP, sometimes known as MARU, and they own 10.7% of the company. And then Christian Schweiger, who is also a board member and who owns three three and a half percent, he's also contributed to this. And one of those is priced in euros, the other's in Swiss francs, but in aggregate comes about 4,400,000 sterling. And the first tranche is available to us from the beginning of February, and then the second tranche, each tranche being 50% available if we needed it during the rest of 2021. We did obviously benchmark the terms of these agreements to make sure that they were absolutely reasonable and fair, that we weren't unduly favoring AOP and doctor Schweiger.

56:18 So there's an interest rate of 10%, an arrangement fee of 2%, which is very much the sort of norm that you see for the sort of loan facilities that, you know, are are available in the marketplace. So as I said, those loans extend the cash runway until the end of twenty twenty one without any significant US spend and protect the company in the event that we don't do a license deal or there isn't any other sort of fundraise in the short to medium term. And, of course, it does show the commitment of those two shareholders to to the the future of the business. So to wrap up, ferrocrew has unique attributes of efficacy, tolerability, and the breadth of application in iron deficiency. And iron deficiency is a low large market globally, and it's certainly a large market in The US.

57:11 Perversely, these positive attributes have contributed in some ways to The to why it's proved difficult to secure the outlicense transaction, particularly because of the breadth of use when many companies are focused in focused more narrowly. We've gained a lot of evidence and knowledge through The US process, and it's been pushed along and accelerated by the pandemic, which has given us the confidence to consider launching the product in The US. We do continue to have license discussions with third parties. In order to help us though think about the option of a launch, we've been able to bring in those four commercial managers. I believe that through the course of the first quarter of next year, both of these paths will clarify themselves and the board and the shareholders will be in a position to make a decision as to which way forward.

58:06 And we've got the loan facilities, which give us a bit of breathing space. So with that, I'm going to wrap up and hand you over to questions. Thank you very much indeed, Tim. Ladies and gentlemen, just while I am, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen. But I would like to remind you that a recording of this presentation along with a copy of the slides and the published Q and A can be accessed via your Investor Meet company dashboard. And just to try and give Tim as much time to review some of the questions that have been presubmitted, I'd also just like to remind you that your feedback is important to the company. And immediately after this presentation has ended, you'll be redirected for the opportunity to provide your views, and expectations, to the company. Tim, we we, you know, that's a a very con you know, a very detailed presentation, and I'm sure, without any shadow of a doubt, that both the questions that have been submitted during the event you've touched on and certainly those that were presubmitted. But there are number of presubmitted questions I'd like to start off the Q and A with. And then perhaps we can look at those that have come in through the live event.

59:11 The first question, which I guess, and I've seen a number of these come in as well during the live event, I guess, all around confidence, etcetera. So can you please tell us what the actual reasons were for talks to close without a deal? This makes a huge difference to how shareholders view the viability and an alternative route to market and hence their investment. Yeah. Mark, I'm going to I'll put my I'll put my camera on now so people can actually Yeah. Sure. See me sort of in the flesh. So I think that the answer to that is is that the that the two deals that I talked about which got very close, you know, they were genuinely due to issues which took place in the other in the other companies, and it was very frustrating for us.

1:00:00 In one case, it was because their product wasn't performing, you know, as as they'd hoped and planned, and therefore, changed tack. In the other case, the product fell over, and it it made it impossible for the counterparty in that situation to to to to move forward. And although we did work with them because we we actually like them a lot, and we thought they would do a good job with the product, we spoke we kept the dialogue going for around about another three or four weeks after that happened, but it it just became impossible to to to find a sensible way way forward. And then as I hope I explained, you know, we have spoken to many other companies who didn't get as far as that. Some of them didn't quite get to the term sheet stage, one or two extra ones did. But the concerns there were, particular, how do we make sure that companies which are focused in one, perhaps two therapeutic areas really were going to maximize and to give us the fact if even if they did maximize it, were they going to be passing that on to us, particularly if they were to sublicense to somebody else? So those were the reasons why we found that we haven't been able to do deals.

1:01:17 Thank you. A question here. Are the financiers in The UK, what is the estimated cost and what timeframe to implement? We've talked to financiers who are based a lot of them in The US, a lot of them in Europe and The UK. Most of these outfits are they are all specialists in the pharmaceutical healthcare world, so they understand the nature of the risks. I mean, of them have experience in iron deficiency and so we're talking to we're talking to specialists. And generally, those sorts of organizations, they may be you know, they may have offices in more than one country. So I don't think that the geographic location of the lender is particularly relevant.

1:02:07 In terms of the financial terms, I'm not going to go into that at this stage. It's not going to be as inexpensive as just going to your average high street bank. They that sort of organization simply does not lend to companies like us. And the risk that they would be asked that they'd be looking at is more like an equity risk. We don't have a lot of other income for them to fall back on if the launch fails, and which is obviously something they look at very closely. So that is one reason why you were going to pay more for this sort of facility than you would with a high street bank where maybe you've got a lot of security of assets or other revenues that they could rely on. And I think there's another question, which is, is there likely to be an equity portion?

1:02:58 I think the reality is there is likely to be some equity portion. Not sure yet what the split would be between the debt and the equity. I think an assumption of perhaps in the fifty-fifty range would be would not be unreasonable. Well, I think just a couple more of the pre I'm sorry, Mark. I think there's a question about how long it would take. Yeah. By and large, I think I think most of these debt providers would say from term sheet to final documentation somewhere between four and eight weeks. Perfect. Sorry to cut across you. Another question here. Where do you envisage the company being by the end of q one in twenty one? And what percentage of confidence do you attach to this? I think I as I said, I think it was the tail end of the presentation.

1:03:45 I think during the first quarter of of next year, we will learn a lot more about the discussions that we're having with potential license partners. We will do learn a lot more about the the launch plans and the details and so on that we that that are for US contractors, consultants are working on. We'll learn a lot more about the debt. So I think we'll be in a position sometime during the first quarter to make that decision. So I can't actually answer the question of which of those we will be at by the end of the first quarter because those those we've got to go through that process. Okay. Well, thank you very much indeed, Tim. Look, I am mindful. I mean, see every time you answer a question, another one comes in on the Q and A tab. So on the basis we've been going for an hour and five minutes, and there are a lot of questions on the live session, I wonder if I could just ask you to click on the Q and A tab. If you could start at the top and I'll work with you going down and perhaps a lot of these questions are similar in nature. So to all investors that have submitted questions, firstly, you. And obviously, we will review all these questions after the meeting just to make sure that there aren't potential areas that we may have missed. But if I could hand back to you, Tim, and as I say, I'll catch you the end. Yes. So I've not had a chance to go through these, but so I will go down from the top and see how quickly I can get through them. So the first one's about the risk of going alone in The US, the the risk of execution, and and the senior team have no experience,

1:05:17 so there is is a risk. That's absolutely right. That's why we have brought in the four very experienced managers that I've been talking about. And the so that the launch, you know, we we would I'm not I am not going to be designing the launch in The US. They they are and and it's we'll leave it to them and and we'll not leave it to them. They'll see this there is a supervisory process. But we will, of course, be bringing in the expertise that is needed. And and they will and they will be recruiting further people as well. Sorry, Tim. I I forgot to mention. If you could also and as you just have read out the question, perhaps even who it's from, that would be fantastic. Thank you. Well, that was from somebody called Russ. Next one from Tony. Trust and confidence are essential requirements in business with regards to small private investors. How do you think you've scored in these areas?

1:06:13 Yeah. I know people are unhappy that we thought we would do a deal, and we said we thought we would do a deal by the end of twenty twenty, and we haven't. And I understand and clearly the frustration and the clearly, that frustration has been demonstrated by the movement in the share price. And, yeah, I'm I am I'm sorry for that. What I would say is, you know, we are working extremely hard, know, in the business. And and I would add to that the board, the directors are all, you know, heavily involved and and significantly more heavily involved than you would normally expect non exec directors to to to be involved. I I genuinely believe that the reasons why we have not done a deal so far are valid.

1:07:02 I don't think that we have materially screwed up in any way that has met has led to a a deal that would otherwise across across the line failing. I think it it it really does relate to the nature of the product and how we're trying to fit that into the type of companies that that actually exist. And I think, you know, we're doing the right thing, and started to do the right thing in the late summer and early autumn and starting to think, how can we come up with an alternative? And the alternative is to contemplate a a SHIELD launch in in The US. And had we not been doing any of that, you know, I think we would be in a more vulnerable position. So, you know, I think we're doing what we can, but we understand the frustration.

1:07:53 But I would say that I still think there is huge extra value to come from this company and that the the value today, as I say, has probably got next to nothing in it for The US. And, you know, I I I remain very confident that we will get either a deal or SHIELD launch away and and the value will will will go up substantially the moment that becomes clear. I've got a question here about the ferrocrew penetration in in Europe. I'd prefer to deal with this at a later stage. We we would contemplate doing a trading update in in January when we know what the Norgene sales for the second half of the year are. So I I hope you don't mind. That's from Chris, if we if I leave that for for another day.

1:08:47 With a market cap of 70,000,000, company must be very vulnerable to a takeover. Do you agree? Yes and no. I mean, we've been obviously around in a similar position, for eighteen months now. Had we had a, you know, any any meaningful real offer, it's something we would almost certainly have had to put to shareholders and the fact we haven't obviously suggest that that right now up at to date, we haven't had a a takeover approach. Of course, if we did, then hopefully, we can extract, you know, a a lot more value from that. But if if it happens, we'll have to react. But from Paul, when will the peer reviewed head to head study be published?

1:09:34 It'll be sometime next year. It's got to be my understanding is that the authors and the investigators are who are obviously the primary responsibility for authoring the study are working towards finalizing it, then it'll have to be submitted to the journal they want to publish it in. That journal will then have to look at it and consider whether they want to take it on seriously and then push it out for the peer review process. So I think there's a it's a number of months yet. And I'm no expert in this area, but from what I have seen in the past, it's difficult to be too definitive about what the timeline for that sort of process will be. Next question is from Tony. I'm not sure if it's the same one or as before.

1:10:24 What form of communication with institutional investors? How often how often how does it differ to the private investor segment? So we do talk closely with WHealth, sometimes known as Inventages, who own 48%, and with AOP who own 10%. They are big shareholders. And, you know, as a result, they know and they're clearly, you know, inside and and, you know, we have we have not frequent, but but regular dialogue with them. As far as the more conventional funds and institutional shareholders on our register, you know, we make ourselves available to them as much as they want.

1:11:10 And so, you know, whenever we put news out, generally through our brokers, we'll see whether they want to talk to us. We do talk to them. It differs from the private investor segment in that it tends to be a one to one discussion. But, you know, clearly we are bound and they are bound by insider trading regulations and so on. So we are very careful not to say things that we shouldn't say. And, you know, I hope that by and large over the last eighteen months, investors would agree that, you know, we have been reasonably active in the forums and communities of private investors so that, you know, we we we can talk to people there. So there are differences, but but I I, you know, I don't think it it confers any any particular advantage on the institutional shareholders if if that's what is being implied.

1:12:09 Paul asking if we're planning to have two teams in The US and other countries. Well, certainly, if we go down The US route, yes is the answer to that. We'll have a management team, whatever backup organization is needed. And then, as I mentioned, we will have somewhere perhaps between thirty and sixty sales reps with appropriate regional management and so on. And other countries, probably not. I mean, we're clearly not in The in Europe and China where we've got commercialization partners. We do have some discussions going on in some other countries. We are a little bit limited by the bandwidth for being a small team. But I think in all likelihood, we're much more likely to out license in the smaller countries around the world, which aren't in The US, Europe, and China blocks.

1:13:01 Philip has asked how patients are getting hold of Aquifer in The US currently, and unfortunately, they're not. We we we we have manufactured The US packs now, although they've they've yet to be formally released. But so we will have packs available. But I think until we launch, if that's the route we choose to go down, patients in The US are not getting Acrefa. Question from Paul about what are we doing to accelerate reimbursement for the remaining UK commissioning groups and Europe. It's really Norgine's responsibility. It's clearly not helped at the moment by COVID because the obviously, the health services around the world in Europe are distracted by what what they need to be doing for that.

1:13:49 But at the end of the day, it's Norgeen's responsibility to do that. Has the board considered recruiting an experienced heavyweight, an American heavyweight pharma executive? I think, as I say, we have recruited appropriate senior management currently on a consultancy basis, and they would be the people that we would want to need to lead the launch. Next question, COVID changing market changing practices, how Norgene changing their working practices to promote ferrocrew in Europe? Again, I think for now, I want to pass on that. It's difficult for me to talk explicitly around nor about Norgeme without getting their consent to what I what I say. So I I'm I won't deal with that question now.

1:14:46 So I'm just reading the next question, which is a bit long. Is it reasonable, acceptable to present a strategic revolt fast to shareholders while announcing a failure to execute the previous strategic plan? So what I think we've announced is is not a complete about face. We still have license conversations ongoing. We are looking for an alternative just in case those don't work. We we felt that we had to say something, before the end of twenty twenty about that we that there wasn't going to be a deal. So, you know, whether people are happy about it is another question, but I think it it is both reasonable and acceptable to say to announce that this what we were doing and inform people what we were doing.

1:15:40 Let's move on to there's another one about Ferrocrew in Europe, so I'm going to pass on from that. The reasons Charles has asked the reasons for both companies a and b, which are described to withdraw, don't seem to ring true. Well, I'm afraid I'm afraid they were. That is true. I mean, I yeah. As existing iron salt treatments are cheap, how will your treatment compare on a cost basis? And will fret mortal treatment be kept in reserve? So that's a good question. And I think the answer to that is, yes. It is it is eminently likely that, and I think I showed this on one of the slides, that most patients will continue to be offered and prescribed a cheap generic oral iron first.

1:16:41 Where we hope to gain is that, you know, the statistics show that fifty to seventy percent of patients prescribed the generic oral salts fail. And the so the first step for us is to say, right, we're going to position Aquifer so that instead of that patient going straight to intravenous, then that that they are put onto Aquifer or Ferrocru next, so as to intercept patients before they get to the the intravenous. But also, you saw the market research, once we think we think once the prescribers really get accustomed to the tolerability and efficacy of Ferrocryl or Aquifer, then where they can, and there have been places particularly in Europe where they they are obliged by the the healthcare systems to prescribe continue to prescribe a cheap diuretic first, But where they can, and there's probably more optionality about this in The US, they may be encouraged to go straight to Aquifer rather than through a a generic. But I think it is quite likely that in many cases, it'll be generic first, and then hopefully, Aquifer second before a patient ever gets to intravenous.

1:18:05 Regarding the statement we currently engage with credible potential licensees, how large are these farmers and what timescales are you working to? Well, they are they're not they're not massive, but that that they're well established, and they're not they're not minor, they're not small, they're not starting with nothing. And they are credible. They are in fact actually companies or two of them are. They are companies that we have approached earlier in the process And both of them said to us at the earlier stage, we're sorry, we're interested, but we're working on other stuff at the moment, completely unrelated to to Acrefa. We can't engage with you. And and then more recently, they've come back to us and said, you know, we are still interested. So can we talk to you? In terms of timescales, the as as I say, I think during the first quarter, we will get to the point where we know whether there's a a credible possibility of getting a to a term sheet or not. And therefore, that's when why, I say, during the first quarter, I think we'll be able to make some decisions about the course of action.

1:19:16 Tim, I I'm mindful of time, both your time and and investors' time. Obviously, for every question that you do answer, there's another one that follows it. So I I don't know whether it's worth just perhaps scouring down some of the chat. Obviously, we will make all of these questions available. And and as I say, there is a a number of commonalities between that. But I wondered if it might be useful to pick up Yep. Couple. Okay. So I've seen one said, would we consider selling the company? Yes, of course. If if if we were to get an offer, you know, we have many times over the course of the last eighteen months thought, you know, should we just put the company up for sale through what's known as a formal sale process? But, you know, we've never and we've had banks of various sizes advising us on that, and we've never felt that simply launching ourselves out there that that that would necessarily give us any any chance of success and and actually might might put us into a significantly worse worse position because it might it might, you know, look like we were desperate. So we don't think that a formal sale process is the right route.

1:20:25 And I think I said earlier on, you know, we haven't yet had any offers that we thought we should put to investors. Question of who's launching the HIF inhibitor. We think the first HIF inhibitor is likely to come from AstraZeneca. How come some shareholders receive more information about the ongoing licensing process? Well, I think the only ones who do are those two big shareholders who are, as a result, completely inside and therefore, you know, are not allowed to trade. I can see you scrolling down, Tim. I mean, that there are there are a lot of questions that There are there are there are So so perhaps what what I would would ask, and and I think it's probably beneficial that we we just take a bit more time to reflect on those questions. Perhaps I could, Tim, if it if it's okay, perhaps I could ask you to just close a few few closing comments just to wrap up. And I I know, as I said earlier, investor feedback is important. You know, we provide the opportunity for them to provide it directly. It's undiluted, and it would really help shape, I I guess, expectations and views. So perhaps, Sam, I could just ask you to wrap up and Yeah. So I'm gonna wrap I think I'm just gonna wrap up by clearly, I hope I've already covered this.

1:21:49 I believe that as of well, first first of all, yeah, I am obviously sorry that the share price has done what it's done in the last week. I I understand the reaction. I think it's been an overreaction, And I think today's market cap is completely underpinned by Europe and China. And there is huge upside the moment we announced either a license deal or that we've got the route to a SHIELD launch announced because both of those clearly and and you saw the, you know, the sort of potential financials based on that year five, you know, that the the the cash flows in either scenario are, you know, very significant. But in but in particular, if we if we were to be able to launch the product ourselves.

1:22:39 And and, you know, I I continue to believe very much. And a number of the comments that I've been reading in the questions about this is a fantastic product, I completely agree with that. And therefore, firmly believe that we're going to find a way of getting it to the market. That's brilliant. Tim, thank you once again for the time, particularly through the Q and A as well. I'm sorry we've extended past the hour coming up to one hour and twenty five minutes. But can I please ask investors not to close the session as you'll now be redirected for the opportunity to provide feedback? If you access this meeting via our website, then the feedback page will appear. If you access via the link sent to you by email, you'll be asked to simply log in and then provide your feedback, but, it is incredibly important that the company understands your views and expectations.

1:23:25 On behalf of Tim and the management team at SHIELD THERAPEUTICS PLC, we'd like to thank you very much for attending today's presentation. That now concludes today's session and good evening to you all.