hVIVO plc (HVO) Earnings Call Transcript & Summary

Good afternoon, ladies and gentlemen, and welcome to the Open Orphan plc Investor Presentation. [Operator Instructions] The company, of course, given the significant attendance on today's call, will not be able to answer every question it receives, although the company will review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. And I'm sure the company would be most grateful for your participation as usual. And I'd now like to hand over to Cathal Friel, Chairman of Open Orphan. Good afternoon.

Mark, thank you very much. And thanks to all our investors who have dialed-in tonight to hear the joint presentation of myself and Mo. Certainly [indiscernible] we'll split the screens to make it less confusing. But yes, so look, I'm delighted to have Mo here on Board. It's been a lot of activity, a lot of changes in the last 2 years. All for the positive. I think we're at a stage now where we're really grown up company, and we've really grown up and experienced CEO, and Mo and I have worked together closely since mid-October. So we finally decided we could absolutely continue to build this company. And Mo is -- so happy to have Mo as full-time CEO, and that allows me to make up lost time on these spinouts, but let me come to that demand so I've got to have no excuses for not living spinouts after tonight. So let's take you briefly on the presentation to refresh people where we are and what's been happening. First of all, this is a key part. I think some days I don't believe it, can hardly believe it myself, but it's absolutely true, and Mo keeps reminding this that in [indiscernible] we took 2 small CROs that kind of lost their way in, we could say, the valley of darkness and we pull them together and guess what, like division is reality. We are the de facto world leader in the test of infectious and rescue disease products using human challenge studies, addressing this very large growing infectious disease market. And let me remind that sometimes, as Napoleon says, better the lucky general rather than a brave or a bright one. So I think where we are, we put these companies together, this was not the most sexy place, the infectious disease market. Being honest, it was kind of graveyard shift market for 30 years as big pharma just didn't develop vaccines, didn't develop antivirals, didn't develop things for respiratory infections. They roll after cancer, they roll after orphan diseases. Come the pandemic, suddenly, every pharma company in the world, every government, every biotech needs to have an infectious disease product. Basically, deal with the current pandemic, to deal with the current chest infections and to deal with future pandemics. So a fantastic place to be. And ideally with us, we get paid regardless. We get paid for testing these products whether it works, fails or doesn't, we get paid in full. So it's a nice place. We're almost like in a gold rush and we're supplying the picks and shovels and that's people we all know will make the most money in the [ club-like ] gold rush with the picks and shovel people. I'm going to just take you through the first couple of slides and really hand over to Mo for his view on where we are and what we're doing. But look, the big part is to recognize where we are now. This is subject to audit. We're a public company. There's another month or so. These audits take time. But [indiscernible] the audit, last week, we already guided that we're on target to deliver full EBITDA profitability for last year. Really important, we expect to deliver the full GBP 40 million in revenue for last year. That's pretty cool. We also confirmed with cash and cash equivalents on the balance sheet of GBP 15.6 million. That's up about GBP 1 million from June, and there was quite a lot of activity, expansion, new models. So it's very clear we're growing at cash. And as we went into this year, that cash balance actually went up quite significantly in the early days of January as money came in, but more of that in [indiscernible]. Really importantly, last year on the presentation, people said, we announced a lot of studies like we confirmed in December with 95% odd of this year's targets already contracted. And people will say, where the hell you can get all these extra beds? Well, guess what? We've increased our quarantine bed capacity by almost 50%. We now have 62 quarantine beds. That's pretty cool coming up from 43. And that was done in a very, very low-cost manner. A big part of that, we've moved out of the very expensive office we inherited from the previous management. It was the last gift we had to get rid of. And we're moving into a vastly lower-cost office, vastly bigger one, and we're getting 12 beds in there as well as part of that move. Mostly to get back through the very strong pipeline of challenge studies. So the first time that we've actually worked into next year, and they run into the following year. So this is now grown up CRO. We've got a back book that's something we've never had before. I'll leave that to Mo. We're continuing to work towards monetization of noncore assets. Let me come to that in a minute because that's an area I have to deal with. In the past year, I've been so busy with million other things, being CEO, Executive Chairman. Now Mo is on Board, it's my job to deliver on those noncore assets. I really -- before I hand over to Mo, I think I'm very proud of what collectively the whole team in Open Orphan, hVIVO, and Venn put together and have a look at the fast-growing business. And compares, come in for a lot of flak on the [indiscernible]. I think we did a pretty good job so far. A lot done, a lot more to do in the year ahead, I would say. But look, we are a fast-growing business. This GBP 46.6 million started, I'd say, real money, not this euro stuff or dollars, but GBP 46.6 million of real money. That's disclosed contract wins in 2021. We did -- we announced 7 challenge study contract wins in 2021. Bear in mind, under previous management, hVIVO done an average of 1 to 2 studies, the best year ever was a one-off they did 3 studies. So we had 7 last year, and you see the target is about 10, 12 for this year. Our current pipeline weighted more to get into that BD probability awarded of GBP 75 million. Nothing wrong with that. I'll leave at the Mo, that's his expertise. Expansion to facilitate the growing pipeline really of new service offering. That's really important. And most of the company [indiscernible] a lot of new areas such as doing actual Phase II trials because we're always turning those down, doing vaccine trials, but I'll leave that to Mo to explain. QMB, we've added 7 beds by moving into a new admin building virtually around the corner. We've freed up area for 7 beds. The QB's gone 24 to 31 beds. That's our main one. Whitechapel 19 and this Plumbers Row you'll see from Google Maps is literally a couple of hundred meters from the main office. And lastly, say the rent is GBP 1/10 per square foot of what we've been paying for the last 3 years in this office we inherited from the previous managing team. But finally -- the minute we got to break class, we're right up there. And then separately, we've expanded the Manchester facility substantially in a low-cost way for screening volunteers in spin off. So that 45% increased bad percentage. The old Manchester facility was 500 square feet. And basically, we've increased that almost tenfold for the same cost. Again, it's just being smart. And Plumbers Lane, we've now 9,000 square foot, and that includes Green site. And we've done that for about 1/3 of the cost of where we had the existing admin. So what we try and do, we treat the money on the balance sheet as our own money. A lot of public companies burn through the cash and don't treat it as hard on cash. It's hard on cash. So that's how we treat that money. Finally, and it's a time of call, where are you with the monetization of these noncore assets. Being honest with you. I think we did a pretty good job in Poolbeg and on to the questionnaire, I want to talk you through about the dividend piece. But look, Poolbeg, we handed 25 million dividend basis back in June, and people don't realize the values and that will come back, that work is down. That all is done. And from the 19th of April, you're free to trade the shares. I would emphasize, don't rush to trade build back shares because like everything in the first 6 months after the IPO of Open Orphan share price is down 60%. And just bear in mind, within 18 months, we were up almost 10x. So I almost tell people just copy what we did in Open Orphan. I've always said, if you got 3x, 4x, 5x your money in Poolbeg, absolutely take profit off the table. But don't be sad when down 30% at the moment because we have exciting plans afoot there. PrEP Pharma, we had a deal done. We own 62%. It was going in if you use -- we can't say a name of the company, but it had GBP 80 million. It was being reversed in, had a market cap of GBP 150 million, 100% redemptions that deal collapsed because the SPAC is now down 95%, no cash. We will get a new deal, but just to reassure people that deal was done and the plan had been on the 10th of January to hand you all dividend in species shares in a NASDAQ company. My model is we'd love just to hand everybody proper shares in another listed company. That's where we had done with PrEP. Unfortunately -- but we've done it once, give us a little bit of time, and I'm sure we can get PrEP into another vehicle and hand the dividend in specie. The beauty about the Poolbeg, we now have that pathway. Once we get shares, we pass them straight through without paying any additional expense of lawyers or [ accountant's ] advice because with the same structure, this dividend in specie business. Imutex, yes, very difficult, 51% shareholders. I can't emphasize difficult. I now have time on my hands. I was doing 3 jobs last year. I've now got 1 job as Executive Chairman. I'm in the office with Mo here. And my job is to finding buyers for these assets. So that's top of my list, and I will work very hard and give the resolution to Imutex. All of them trying to say, the 51% shareholder, you might have seen some of the presentation, doesn't seem that concerned about trying to monetize the asset. It has probably 2 of the world's most exciting assets: a universal mosquito saliva vaccine and universal flu vaccine. And they haven't managed to cut a deal. But that's up to me, and I say I have no excuses, doing 2 jobs. I've got 1 job to deliver a result in Imutex. Finally, at Disease in Motion, that is now absolutely -- I've got a very much focus that, that will happen in the months ahead. So what I'm trying to say, in summary, the benefits of spinout, there's cost synergies. Poolbeg share the office here, Poolbeg contributes some of the staff costs. So there's synergies. Dividend will come back on all of these. The plan for each one of these as we improve, we can do it with Poolbeg Pharma. So each one then will try and do it. And all that I would emphasize, just think of we've done with the core business. The core business is in absolutely fantastic shape, growing, will -- we've doubled the business in 18 months and Mo has firmly the belief that's a good start. I'm not [indiscernible] what he is going to do, but he now here to go steady at it [indiscernible]. So I do apologize people are disappointed in these monetization on for us. But bear in mind, we've one done, the PrEP had been done and just SPACs have gone away, but give us a bit more time, we'll deliver that plus Imutex and Disease in Motion. Anyway, I think it's time now to look, give me a summary, he's certainly beside me, but Yamin Mo Khan, but known to all of us as Mo Khan is formally appointed our CEO's on the 24th of February this year, a couple of weeks ago. I will -- I know some people are worried, is Cathal going to disappear after the onset, not really. Most of my net worth is tied up with the company until I get that back, I'm going nowhere. It's not like I will get bored. I'm in the office in 3, 4 days every week. Mo will get all the day job. My job is to get these spin-outs done. He has extensive experience in the CRO. And all I would point out -- the last 2 companies is what got successfully sold for a very large return for investors Innovex acquired by Quintiles and Pharm-Olam acquired by PE. So no pressure, Mo. We want to -- a lot of our shareholders would like to see a fantastic result here as well. So without further ado, I'll hand it over to you, Mo.

Thank you. So yes, thank you for the kind words, Cathal. It's a pleasure here to be sitting in front of you as CEO of Open Orphan. As Cathal mentioned, I took on the role formally on the 24th of February. I actually came to join Open Orphan as a Non-Executive Director from October. I guess Cathal took 3 months to make up its mind on what he wanted to do with me. And we finally agreed to come on -- take on the role of the CEO. I have extensive experience both on the biotech side as well as the CRO side. Spent some time at The Liposome Company, which was a biotech based in West London, which was acquired by Elan Pharmaceuticals. But the majority of my career has been in contract research organizations, or CRO. I worked at small U.K.-based CRO, called Innovex, who were acquired by Quintiles or now IQVIA. I didn't spend a majority of my career at a small niche Eastern European CRO called Pharm-Olam. And after a 19-year period, I co-led their growth from a small 20-people, 2-country company to a midsized global CRO with presence in over 40 countries. At the end of that, I co-led the trade sale to private equity. And during my time at Pharm-Olam, I headed up both the project delivery operations on a global level and then also built and led the global business development team. So I have experienced both on commercial level as well as at an operational level. And now very pleased to be taking the helm at Open Orphan. And hopefully, grow in this company as we move forward. So as this is my first time talking to you guys, I thought it would be good to give you an overview of what Open Orphan is. And I truly believe Open Orphan is the world leader, especially when it comes to challenge studies. I know this is an often point you hear in service providers who say we are the world leader in X, Y or Z. But there's no doubt in my mind that Open Orphan is the global leader in challenge studies. And I don't think there's any other commercial organization that can match the depth of experience, the scientific expertise, all the breadth of the portfolio of challenge agents we offer. So we've been doing clinical trials for over 30 years and 20 years plus as in challenge agents. We've conducted more than 60 challenge studies to date. That's more than any other commercial organization. We have, in fact, inoculated over 3,000 healthy subjects as well as some asthma patients. Again, this is a world-record beating numbers. We have the world's largest portfolio of challenge models. And as you can see on the right-hand side there, the different models and the number of trials and patients we have inoculated. So some have been the old traditional ones, but we are always adding and I'll come to that in a little while. We also have a really good, diverse client base, both big pharma. I think we work with 5 of the top 10 big pharma as well as the smaller, midsized biotech companies. And historically speaking, we do go back to the 1940s when the common cold unit first started conducting challenge studies in the common cold and some of the founders of Retroscreen, which then became hVIVO, actually came from the common cold units. So we have a long history, a strong depth of experience in doing challenge studies. And I think one of the key things you have to remember that the challenge studies are extremely safe. We are highly regulated. We have to get approval from the MHRA as well as the relevant ethics committee before we can start the trial. And all the trials that we have conducted to date have been safe and have produced some excellent data. With the addition of the Venn Group to the Open Orphan portfolio, it gives us the ability to be able to offer full service to our customers. That means that we can start from protocol design, write the full protocol. We can go and recruit all the subjects, we can treat all the subjects, do all the clinical management. We impact the data, conduct the data analysis, do all the biostatistics and then write the final clinical study report as well as do all the lab work. So it means that Open Orphan as an entity can conduct full-service challenge studies. And this is something that most customers are asking for. So most customers want a 1 stop shop. They don't want to go to 2 or 3 or 4 vendors to be able to do their trials. So I think this is another key advantage of having the hVIVO Group and the Venn Group under the Open Orphan umbrella. Furthermore, we are an international company. We have a new facility in Manchester. So we are conducting our screening there. So remember, when it comes to doing challenge that is, we have to screen these patients prior to them coming into quarantine. So we want to expand our volunteer base. So we're able now to conduct the screening visits in Manchester or surrounding areas. And then when it comes to quarantine, the volunteers come to our London clinics. But once the quarantine visit finishes, they can go back to the local areas and do the follow-up with it locally to where they reside. And this is important for us to be able to expand our voluntary base. We also have a BioBank facility, and as you know. We're moving to Plumbers Row in East London as of Monday, as Cathal mentioned. This will mean that we have an increase in space. So we're able to screen more patients. We have more beds and it will lead to releasing extra lab space in B&Q facility. On top of that, the 2 Venn facilities, 1 in Breda in Netherlands, where we do preclinical. We also do what's called CMC as well as clinical consulting. And then finally, we have an office in Paris, again, under Venn umbrella, where we do biometrics. That basically means doing all the data management and the biostatistics for studies that we run. But also Venn, Paris Group also -- actually markets of stand-alone biometric studies locally to the French market. Anybody who knows anything about clinical trials knows that the major reason for delays in clinical trial delivery is patient of volunteer recruitment. 61% of trials that are delayed are delayed due to poor or delayed patient improvement. But here again, I think Open Orphan has a world leader with a brand FluCamp. This brand has been utilized and nurtured over many, many years. we now advertise on social media. So you will see us on Instagram, Facebook, Google AdWords, but also in the traditional press and radio too. And we're using our Manchester hub to expand that FluCamp brand. And with over 30 years of history, we currently have over 0.25 million unique subjects in our FluCamp database. We aim to screen around 160,000 volunteers through our FluCamp database. That's more than ever, the highest in the history of Open Orphan. We now have the capacity to screen 1,000 subjects every week. And one of the key things we have to remember that when we do challenge studies, we have to ensure they're suitable. That means that these subjects cannot have antibodies against the agent -- virus agent that we are currently studying or working on. So we lose about 85% of the volunteers from the challenge studies. And what we want to do is to market them elsewhere. So we're finding different ways. So number one the opportunity that we are looking into and currently in discussion with third-party Phase I unit, is to be able to market these ineligible subjects to the traditional first-in-human trials at other Phase I units. We also want to be able to open them to our own services. So for example, we are looking to build our non-first-in-human clinical trials in Phase I, such as bridging trials or even PK trials and utilizing this 85% who are ineligible for the challenge studies to go into the Phase I. Similarly, we want them to be utilized in Phase II environment, and that's something I'll talk about in the coming slides. So one of the key question really is why do people do challenge studies? Challenge studies are not your traditional Phase I, Phase II, Phase III, but they give you some real insight to the mechanism of action and whether your drug is effective or not. So some of the reasons I listed here, but I'm going to pick up some key ones. So one of the reason, for example, is that the results of challenge studies could give you fast track or breakthrough designation when it comes to regulatory approval. This could potentially decrease your regulatory pathway by 2 years and that's a long time when it comes to clinical trial development. And we've seen some recent press releases from cost sponsors who have been awarded breakthrough partly due to the data that has come out of challenge studies. One of the key factor is that in the pharmaceutical development is saying that if you got to fail, fail fast to reduce waste. And challenge studies are a great way of finding whether your drug is efficacious on a small scale. So without having to do a full-blown field-based Phase II trial across 40 or 50 sites, we can actually do that at a single site, and that's important. Another key factor, especially with the biotechs we work with, challenge that mean -- challenge study is a means and a way for biotech companies to get into Phase II very fast and very early. This could mean they get access to additional funding, increase their valuation and potentially go to market such [indiscernible], for example. They can also get a lot of savings by not going straight into a Phase II or Phase III program and derisking that by being able to find efficacy at a challenge study. Expedite your go/no-go decision. I think that's key. We can also potentially reduce the number of patients you need in the Phase III trial, thereby reducing cost and time. And one of the key things about challenge studies is that it's able to answer the question about the mechanism of action that are impossible in field-based trials. Remember, in challenge trials, we're able to study and get samples from patients just prior to inoculation and just post inoculation. And that is really good timing and good data insight for our potential sponsors. Finally, in some cases, clients have been able to obtain approval for an emergency use authorization based purely on challenge studies. These are exceptions, but these have happened. But as we're moving forward, we can see the interest in challenge studies is increasing. The WHO has produced guidelines and a lot of senior people and [indiscernible] that we are working with are talking to us more and more about challenge trials. So what is the potential market? So the first graph on the left shows that there is a good, steady increase in the number of Phase I and Phase II trials ongoing. Why is that important? Well, Phase I is effectively our pipeline. So any Phase I trial is done in ID or asthma or COPD could potentially go into a challenge trial arena that we can conduct. On the right-hand side, we're solely focused on some of the key ID and respiratory trials. Again, we're seeing a consistent increase in number of trials being conducted in Phase I or Phase I/Phase II. Again, this does mean that we have an increased pipeline. And that's one of the reasons why we are looking to expand the number of beds we have, expand in recruitment, investing in new technology, for example, in tracking our new recruits using our FluCamp brand. I see I'm beginning to run out of time, so I will go through this quite quickly because I've heard from Cathal that you guys are very interested in the Q&A session. So I do want to talk about some of the ways we will grow Open Orphan. So there's 3 different buckets that I've put this into. So firstly, increasing our capacity and offering. The new facilities in London and Manchester will increase the number of subjects we can screen per day, per week. We can supplement recruitment for other CROs or sponsors who are slow or behind on the recruitment. We can conduct non-first-in-human Phase I trials. We talked about the field Phase II trials in certain indications, for example, in asthma or for example, in vaccine that we can conduct. We can also act as a clinical site in multinational, multi-site study. So you could have a CRO or a sponsor conducting an international trial in asthma or vaccine, and we could be part of that as a site contributing to their patients. Increased capacity in the recruitment area means that we can enroll more patients. We're also looking at some cross-selling opportunities between them and ex vivo. Challenge studies will remain our core business, and this is something we also will modernize and grow. So we have the STRiVE project going on internally, which is a survey used to identify new viruses and build new viral challenges. We've expanded into parasites via the malaria model, which is now live, and we are marketing this across the globe and have some key workshops next month. We're looking to make the most out of a COVID-19 study that we have done in the past last year. And we're always looking at other opportunities that we can utilize in the challenge model. On the Laboratory side, with the new facilities in Plumbers Row means we have additional space for our labs to expand to. We will have increase in biomarker and molecular testing capabilities. We manufactured majority of the virus models that we use. And this is something we will continue to do, and we're building a number of new models this year. And finally, we will be looking at CAP and UKAS accreditation for laboratory facilities so that we can sell them to third parties. The final slide for me in the main pool really focusing on some of the key numbers. I'm metric-driven person. I'm scientist at heart, I think these are some of the key numbers that I like to measure our performance and how well we're doing. So we are a rapidly growing company. We have projected revenue of GBP 40 million last year, and we still -- guidance is that we will definitely hit that. Of course, these are preaudit numbers. We are projected to hit GBP 50 million this year of non-COVID revenues. We have a good amount of cash. We are in a very good cash position as of end of last year. We are the leader in human challenge trials. I've talked about this, the number of trials that we've done, the number of models we have, the amount of investment that has been put in place last -- in the last 20 years in building these models. And one of the key take-home messages here is that not only do you need the facilities and the resources, you need to invest a lot of money and asset into building the challenge model. So the hurdle to market entry is really quite hard. On the operational excellence side, we screened 84,000 new subjects last year. But the great thing about challenge studies is the value is around between GBP 5 million to GBP 10 million, and the revenue generation period is under a year. A challenge study typically completes between 8 to 10 months. So you can recognize all the revenue on a challenge study under a 10-month period, which is great news for us. And how are we positioned for future growth? While we've hugely increased our bed capacity, which is a key component of driving revenue, we've done -- we've completed 86,000 lab samples last year. We will be higher than that this year. And a weighted pipeline. So just to kind of explain that a little bit for those of you who are not aware of what is weighted pipeline. So from a business development and sales activities, we have a pipeline of future work that's currently unsigned. It's not awarded. What we do is we assign a probability to each project. And then we basically multiply the total value of a project by the probability fact of how well we think we will do in getting that study on board. And that equals GBP 75 million, and that is the highest it has been in the history of Open Orphan. That's my final slide. Thank you. So now we will go through the Q&A.

So we've got a number of questions from the audience. So I'll go through some of them myself and then hand some over to Cathal. The first question is, is the appointment of Yamin Mo Khan as CEO a good move? Is he awarded any free shares in Open Orphan? I think it's an excellent move. I hope Cathal agrees. And will I be awarded any free shares? No, I will not be awarded any free shares. And will the new CEO be buying any shares? Yes. As you guys know, I'm restricted to a certain time window. And when the window opens up, I do intend to buy shares in the company. I truly believe I need to be part of the company and in line with my shareholders. That's important.

Actually, sorry, folks, Mo, I'm just jumping in. I think Mark or somebody, there is only 2 mics, there's 1 here. Mark, can we check there is a live mic maybe your end that there's a good bit of noise in the background there. I think people can hear it, so just in case. We're sharing our laptops, so any one live mic between this. And that is gone again, the background noise is gone. Over to you again, Mo.

Okay. The second bucket of question is on facilities. So this is a 2-part question. Are you able to recruit enough healthy people to meet all your current and potential facilities in London? The answer is yes. With the FluCamp and the initiatives we have on the marketing and recruiting, we invest a lot of time and effort. We actually have got a new software that we implemented last in January in fact, which basically means that now volunteers can make appointments for themselves, and we can track them through the voluntary journey, which is important to us. So in fact, we believe that we can recruit so many that we are now looking to market these volunteers to third parties such as Phase I units. The second part of the question is, you have suggested the most efficient way to expand is in your existing facilities in Whitechapel. Isn't this likely to cause problem with sufficient improvement? Well, not really because we are expanding to increase the screening facilities. London is a large, diverse city. So it has a really good patient population pool that we need to tap in. We are nowhere near saturation. But in addition to that, we also opened up our Manchester facility. So that gives us access to an additional patient or subject pool that we can utilize for future chance that is true. Are you expecting any work from the U.K. government in 2022? I'm not expecting any direct work from the government, but I do expect for the COVID work to follow on. But that will come from commercial organizations rather than nonprofit or any government organization. The next question is a 3-part question. Is the company seeing any signs of new contracts or repeat contracts work for 2023? Yes, we are. In fact, we are already placing trials into our quarantine clinic for 2023. So we had a good amount of demand coming from our customers and some of the studies that are currently ongoing will go from '22 into '23 and other new studies will go into study -- into 2023 alone. How close is the company hitting 100% contract target for 2022? We are pretty close. We are very confident that, that will happen. Are you expecting new contract wins anytime soon? Absolutely. We are expecting some new contracts soon. I ask for a little bit more patience and watch this space, we will be making some announcement in the coming months. Okay. On the second page. Are there new challenge models being worked on now in March 2022? Absolutely, we have to move with the time. We can't stand still. I said we are the world leader, but that doesn't mean we can rest on our laurels. We need to keep moving with the market, come up with new innovative models. We've just completed the malaria model. That's one of our first non-viral models. But even into Q2, Q3, we will be looking to build additional models in different viral indications. Now that Omicron is seen as less potent, will big pharma pull back on investing in infectious disease solutions? Well, I don't think they will. The current market states otherwise. We've seen a strong interest in COVID. There are currently 400 ongoing Phase I trials in COVID-19. So these are Phase I, very early trials. So it shows that the interest is still strong. And we expect the infectious disease market to grow into excess of $250 billion by 2025. Bucket -- next bucket is COVID, where are you with COVID contracts? While we are currently negotiating with multiple customers on that. As you know, we completed the COVID dosing trial last year. That will be published in Nature Medicine this month, in fact. And I expect us to see a lot more interest after that. But even already, we have published some of the data already, we're seeing a lot more interest, and we expect to be doing more COVID work this year and next year. Next bucket talks about financial position. So what is the current cash position? If healthy, when can shareholders expect the dividend? As of end of last year, the preaudit, we've seen -- we've shown GBP 15.6 million in cash. So that's a great place to be, especially for AIM company. I think we're one of the healthier companies on the market. And all options are currently on the table as to what we would do with this cash in the coming months. For year 2022 noncore revenue target of GBP 50 million. It was previously stated that the majority is already secured. Is this still the case? Yes, it's still the case. In fact the revenue is already secured, and we are continuing to build on that. And we have given guidance last September and now that we will hit the GBP 50 million non-COVID revenue for this year. The next one is a 2-part question. In a recent presentation, you were -- you said there was a GBP 75 million weighted pipeline of contracts. Can you clarify that? I hope my presentation clarified that. Any of the GBP 75 million included in the 95% '22 secured revenue? No. So the difference between the 95% we mentioned earlier, that's signed work. The GBP 75 million of the weighted pipeline that unsigned work currently in the sales pipeline. So those are 2 different categories. On communication, questions have been raised via Investor Relations as directed on the Open Orphan website are not responded to, why not? And this is one for you.

Okay. Maybe time gave Mo a hand here. Normally, this quiet is the new Cathal. He's got to focus on the spinouts, Mo does the hard job of running the business. So communications, question is why. Generally as a company, I think, even tonight, we've got every pre-submitted question and then there's been other 40 of them we're going to have a crack and answer and everything. Yet sometimes, when there's a steep fall, rise or drop in share price, we get daily sometimes 50, 60 questions over a 24-hour period. It does take a little while to answer them. So what we've done, we generally hand them to our IR company because our [indiscernible] we've grown is kind of keen that they're handled that way. And then anything comes in directly. So I think there've been answered questions come in, generally they are problem. There had been brief periods that may be when they want me to answer for 3 or 4 days. But look, they're getting answered. I think there's another group of shares that maybe I'll try, there share price, share price performance. What has happened to the share price? I'm thinking of selling. When do we go from here? And my answer here was something my advice is that we've now built a fantastic business as a world leader. And we're one of the few companies on the AIM that's subject to an audit that's going to do the GBP 40 million last year, and we're on target to do GBP 50 million plus-plus-plus this year. We're absolutely profitable. People say, what's EBITDA profit, we are profitable. The cash pile is growing with huge expansion plans on all fronts. So I personally have a huge part of my net worth tied up in the company, and I remain exceptionally optimistic of the prospects, particularly now, there's 2 broad sets of shoulders here to build it going forward. We've done a lot on our own, myself and couple of colleagues. So I was the expert in this field. So I think we have a lot more there. Thus, an answer to that question, I would say show me any other company on AIM that has better credentials to invest your money. Yes, the share price is not what we wanted. I bought a lot of shares, GBP 300,000 at 27p last year. I'm not the slightly worried because I know that's a very safe investment. So I think, yes, it's disappointing share is down. There's a lot of shares trading, but I'm absolutely convinced that people who sold out at 30p, 35p, 40p, can't believe their look. For every share that gets sold, there's a buyer, so that's where some of our buyers are coming from. Will the new CEO and Chairman buy, increase their shareholding at the current low price? So maybe I'll quote for myself first. First of all, to be clear, I've written checks all along every time we've ever raised money at full market price at GBP 300,000 starting at 26.5p June last year. In January, the previous year, in January, we did a placing. I put in GBP 300,000 in market price. And as part of the IPO and pre-IPO, put GBP 1.5 million. So I think there's very few AIM companies that the founders put so much money in at market price. I think in regards to Mo, I think he's made it very clear, he's going to invest. He's not saying the whole. We've sat through 1 or 2 presentations recently where the promoters [indiscernible] "Oh, you know, it's [ compliance ], I can never [ earn ]. Look, there will be a window pretty soon where Mo is keen to buy shares the last couple of weeks. I think that probably brings us on to where is the contracts, the common waves, as soon as there may be a way of coming through and since they're true Mo will buy shares. So he's very keen to actually buy shares and real money. So I think answer that one. Question 3, that is coming in advance. And we bundled some of these questions, similar questions that come in. Are Nasdaq listings for Open Orphan and Poolbeg now off the table following the collapse in many Nasdaq share prices? No, Nasdaq has got more interest than ever. For instance, Poolbeg, we've got Nasdaq biotechs that used to be worth GBP 300 million. They've got no cash. They're now worth [ GBP 3.30 million]. They've got really good products. They've got listed in their offering to merger for Poolbeg to take them over. So likewise, in the case of Open Orphan, absolutely Nasdaq is a great place for life science companies. All we see is that the lots of possible options. We're open to [indiscernible] it to any at the moment. But I want say don't rule out Nasdaq for either Open Orphan or Poolbeg. Another question, do you know who is selling the shares and what are they in the low millions? Are the institutions left? I see on average, there's been 3 million shares that have been sold for the last 9 months. Well, my answer to that is do we know? Most time, we don't. We have a number of institutions that are below the 3% disclosable stake. There's 1 institution we can -- I'll go through this on the online question, that's sold off. But our other institutions are there. Myself, my own family investment Raglan Cap will sit in tight. But just I do bear in mind ever since there's 3 million sellers, share sold every day. But bear in mind, for every seller, there is 3 million shares being bought every day. So there's an equal and opposite buyer for every person selling. And it's clear that we regularly have new investors coming back on our share register. And look, my feeling is there's a lot of people made -- somebody made profit at 30p and 40p. I've always said, don't be afraid to take profit from when we were back down at 5p, 6p, 7p. So I think there's people selling out, there's people buying in. We have a very liquid stock. I just think last Thursday of Friday, 5 million shares traded at an average 15p and there's the issue in Poolbeg. We're trying to generate liquidity. Hopefully, that liquidity will come now when we free up the shares. But on the same day, whether it's 5 million shares traded in Poolbeg at over twice -- almost more than twice as a Poolbeg would trade maybe 25,000. So look, liquidity is good. It allows people to trade in and trade out. Some investors, and it's very clear, we can see, had bought up very big stakes in the last 12, 18 months using CFD and spread betting. And it's clear they're the ones that are dumping because we don't see the investor, but we can see the CFD provider regularly at times when the share [indiscernible] the market was down. So to answer your question, we don't know exactly who the sellers are, but it keeps it for every seller, there's a buyer. A question is -- and this is actually probably an important one for [indiscernible] as well, it'll take a few minutes. As regards to Poolbeg -- and you all who were in the share raise here last May will hold -- so the holdings in Poolbeg dividend specie. Let me break down these question by -- question one, can I hold my Poolbeg Pharma dividend specie share in the ISA account? Well, fortunately, we have had discussions just today with Interactive Investor on this. So we've been in touch with Interactive Investor. And there was some confusion in recent weeks: Could you hold in your ISA account? This is now being clarified. And you can hold your Poolbeg share dividends -- when you get -- and I emphasize, people have not got these dividend specie until 19, so you can hold them. They are qualified and that's good news. That will be going up on our website tomorrow morning under, it would be, the frequently asked question session on both Open Orphan and Poolbeg, but that's a clarity. So you can absolutely hold your Poolbeg dividend specie in your ISA account and particularly your Interactive Investor, and that will be confirmed on our website tomorrow. Another question, can I trade my dividend specie shares in an online interactive way? Absolutely. First of all, you can't trade them at the moment because you don't have them. And nobody has the dividend specie shares. When they're released, you can trade them anywhere you like, [ .com, ] through Crest. [ They'll come through everyone. ] So there was no problem. If they're ISA, you can trade in your ISA accounts. So there's no issue. So that -- this will be clarified tomorrow. Question three, what tax will I pay on my Poolbeg dividend basis shares? So you hold them in an ISA. For instance, you hold Open Orphan share in an ISA. You will now have got income on your Open Orphan share that you held back in last May. The income happens via dividend instead of cash -- it's a share dividend. So your Poolbeg share [ will win. ] Within your ISA, there's absolutely no tax you have got to pay. So no capital gains, no incomes, if it's with ISA. If you're a U.K. resident and you held your Open Orphan share day 1 in your personal account or other vehicle, the good news is, as we've always said, we had advanced clearance from the HMRC that you have no income tax and the only tax you will pay is capital gains tax. You will only pay the capital gains tax if and when you sell your Poolbeg shares, and so you won't get them until after 19. They will be distributed for the 19th of April and then you're free to sell them. But my suggestion is you watch what happened to Open Orphan. The first 6, 9 months, our share price went down by 50%, 60%. And the following 18 months, it went up 5, 6, 7, 8, 9, almost 10x. So we would advocate our Poolbeg dividend specie shareholders bear with us and see can we repeat history. The next question, if my Poolbeg shares are in my own name, what is the base cost for the capital gains purpose? So no base cost, no relevance in ISA, so you won't have tax. But if they're in your personal name, the base cost for your Poolbeg, well, you didn't pay anything for them. So your base cost will be 0. So for capital gains tax purposes, a Poolbeg share, if you got them in your personal name through Open Orphan, you will unfortunately pay capital gains on the full consideration. I say, these shares were awarded virtually free and such the full capital gains. Please note, there will be no capital gains or other tax due until the seller actually sells the shares. So why do you sit on them? They're a tax-free asset. Another question, the market feels that Open Orphan dividend specie shares are going to create an overhang in the Poolbeg share price. What are you doing to mitigate that? Let's be honest, we're not hanging around. We're doing lots of things. We announced we're having an over-the-counter premium listing -- the same listing at Vodafone and [indiscernible] underway. We're seeking permission at the general meeting. This was published on the 4th of April, that the company may be in a position -- that is, Poolbeg use some of its GBP 21 million to buy back some shares and/or pay a dividend. The reason we're not doing that and I think I can almost see the question, well, why are you not doing that in Open Orphan? Well, the reason we're not doing that is in Open Orphan we have vastly bigger daily trading and liquidity. So if we were going into the market to try and buy shares, we [ could throw enormous amounts ] to buy them back, whereas Poolbeg is tiny. We can deploy a small bit of cash to buy back shares in Poolbeg. Bear in mind, 25,000 shares through the day at GBP 0.06, GBP 0.07 . We invest a couple hundred thousand, we could really drive the Poolbeg share price up very substantially, but we couldn't do that with Open Orphan. But we have guided in Open Orphan that we have very good plans and ideas for that cash. So all I can say is, for the moment, we would like to sit on the cash and we want you to trust us with it. We're not burning through it. It's not going to go to waste, and we've got some a particularly good idea of that cash. More to be said at another time. On the spin out, I'm conscious of time as well, but a lot of questions have come in on the online. But let me go through the spin outs, because I think that's one area that most [indiscernible] is right, you take care of these. So first question on the spin in [ community advance. ] Any updates on future spin outs and timing? Would be perfect -- as I said at the start, I've had a horrendously busy of people [indiscernible] and we're a tiny team in the last 2, 3 years, and it's only starting now. I will ensure we're all -- target the spin offs, but the plan is let's get cracking. Try and make them happen in the months ahead. So that's all I'm going to say. I've got lots of time on my hands. I'm 100% focused on delivering the spin out. Another question, why is SEEK, Imutex still not able to announce progress on the 2 key assets that Open Orphan has a 49% stake? Well, I would love somebody to ask that to the management team of the SEEK group because I'm struggling to answer the same question. And all that I can say, we find the SEEK group very difficult to engage with. I can hear the lawsuit coming. And it's surprising and disappointing to us that they have not managed to commercialize these exciting assets. That's all I'd say. But guess what, I have a lot of free time in my hands. So I'll be trying to shift that Imutex asset very soon. Another question. If it's difficult to spin off Disease in Motion, why not put it in a subsidiary company? And I would answer, good point. Watch that space, Disease in Motion could start moving sooner than expected. That's all I can say. What are the barriers for Imutex and PrEP Biopharm spin outs? Market conditions being adverse? Something else? We said PrEP was done. The NASDAQ SPAC collapsed on us. So we -- at least, still retain the assets. We will do it again. We won't put a SPAC back -- SPACs are toxic at this stage of the business. So we'll put it into a normal. There's over 100 NASDAQ companies in life science trading below cash. So we will do our best to put PrEP in, get NASDAQ shares and pass it to you, our shareholders, via a dividend specie and you can decide what to do with those shares then. Can you not use some of your cash pile to buy out the difficult 51% shareholder, SEEK group, in Imutex? Because Open Orphan certainly seems to be able to move faster and commercialize things much faster than the management team at Imutex. Yes, that's a good point. So I don't think we're going to spend our cash that way. But let's say, I've got time and effort and interest now to sort the Imutex situation there. So bear with us now. That's the advanced questions. I'm just trying to look how many more. We've got a lot of online ones. Let me pull -- we'll actually do these here, easier if we can meet them here. So how about we take them both, we'll alternate them over and back some of these -- there's a lot of repeats. So that one -- first, I'll just take from the top, actually. They're coming in at -- we'll do them reverse. This one just came in there now. [ 634 from HEG. ] I guess 1 for you Mo is the...

Is your weighted current pipeline annualized? If not, over what period is this pipeline expected to deliver? So it's not annualized. It's based on our total pipeline in the sales pipeline and that will depend on when the study will close, when the clients are expecting to start kicking up the clinical trial. Do Open Orphan have any Russian and Ukrainian clients that we won't be expecting more revenue from in the future? Well, it is very unfortunate and horrific what's happening in that region. But for Open Orphan, we have no customers or clients or employees from that region. So it won't impact us directly. Have you thought about buying challenge models of universities or research associations? Small fee and expands the portfolio greatly. Well, we have a very strong scientific expertise. We are very careful and strict about the purity and infectivity of the challenge models we manufacture. So we keep that in-house. In addition, not all universities produce their models according to good manufacturing practice, GMP. So we need to be careful, and we have the expertise and the know-how to do this internally. And in fact, a lot of the cases, it's sponsored by our clients, too. So it's not something we would be looking to outsource. Why does it take nearly 6 months to announce the audited final results, as many companies are able to complete theirs in 3 to 4 months? Hopefully, we can beat the 6 months. So watch this space. It's something we look to as a challenge. We look to beat that. It has been noted that North -- Thornbridge Investment Management sold down their remaining holdings at the start of March. While not a cornerstone investor for ORPH, what is the feedback from your remaining institutional investors, especially given the share price performance in the last 2 weeks? What is the interest like from other institutional players not currently holding?

I'd probably answer that. So maybe on the -- I think the question is 6 months -- sorry, I was looking at -- yes, look, we will get it out. We have a Dutch company, a French company, an Irish company and an English company. It does take 3 or 4 months, those audits. And our Irish and our U.K. audits, we get them in 2 to 3 months, but we can't publish until we get our French. So that can take 3 to 4. So we will have audited accounts. But bear in mind, we have guided the market. We're more or less hitting the numbers as guided. So I think people shouldn't be panicking about the audited accounts. We're not going to say we're on target and in the audit say something different. The audit is a formality. Yes, Thornbridge Investment Management. We've seen that, that's the only institution we can see in the last 6 months has sold down. Yes, naturally, people have their own reasons for selling down. We have a bunch of other institutions who haven't moved. And actually, the really interesting part with Mo on Board -- that's not to be derogatory to myself, but institutions probably like people like Mo rather than maybe people like me. So yes, so Mo certainly has an institutional following. And we're now -- he's doing a series of institutional meetings. I tried. Brought institutions in at the places, that did well in its day. But I think this is the ideal time for Mo and I to outreach, and I think I'd be surprised if you don't see -- you've seen it in a number of other AIM-listed companies. A new CEO comes in, the founders around brings it so far. And then you have actually substantial buying activity. So I think Mo's getting a great reception from institutions saying, "Oh, wow, we looked at that company at 25 and 30 and 35. It's really interesting at 15, 16, 17, 20." So I think -- yes, I think you will see real institutions come in because Mo has a lifetime in clinical trials. I'm not. So I think institutions have great comfort with both the spin around and would say, "I'm going absolutely nowhere". So that one might be for you, [ Thomas B ] at...

Does the GBP 35 million pipeline include the anticipated full year 2022 GBP 250 million? No, GBP 50 million is projected revenue; GBP 75 million is the sales pipeline. It's 2 different numbers. 7 challenge study contract wins last year. When are we expecting to see 1 sign [indiscernible]?

Folks, I'm probably jumping in there. What I would say, again, they come in waves. It takes 2, 3, 4 months. We had a large wave in the run-up to Christmas, people. And then we -- yes, we've had very few. But let's say the wave might be very far away. That's all I can say. And when you see one, there's always more. So that's just the nature of business. They come -- they're always GBP 5 million, GBP 6 million, GBP 7 million, GBP 8 million, GBP 9 million, GBP 10 million. So all I can say, watch this space. And yes, we're disappointed. There's none in January, February. But let's say, I think, to hopefully the next wave of contracts -- and it's not 1 or 2 -- should be kicking off. And as soon as that wave comes, you'll be -- you'll see them as soon as we do.

I think there's quite a few here. I don't think we'll have time, but this one is a quite important thing for you.

Oh yes, [ Allan A at 619. ] Cathal, you only committed to staying until 2022. Will you commit beyond this? Folks, bad news for you. If you're still [ coming ], I'm going nowhere around here. So it was hard going on my own. With Mo here, it's actually great fun because I can get my head up for air and do stuff. So I'm going to be here for a lot longer than 2022. What else have we? [ Michael W. ] Maybe that's for you, Mo, it's probably mRNA drugs.

With mRNA drugs being granted instantaneous regulatory approval with no liabilities, why would big pharma choose to submit their new product for HCS? I don't think that's going to be in the long term. We're getting different companies doing kind of the mRNA studies. So remember, a challenge study gives you efficacy data in a very short time frame. And that's the key reason why this company would do a challenge study. We're currently actually in contact and negotiating with a number of companies using mRNA technologies for challenge studies. So this is something that we will see more going forward.

[ Mark Z, ] I think he says, when do you -- where do you see the ORPH share market capital? Look, I've guided it very wrong loads of time, so I'm not going to answer that, other than I've never been more excited. Shares are very cheap currently. The business has never been better in better shape, loads of revenue streams. So there would be something very wrong if our share price wasn't much higher in 12 months' time. I can't become a share adviser and try to do this or do that and go other than 12 months' time, absolutely, we will certainly -- they have to be a lot higher. What can shareholders look forward to in Q2 and Q3? I would say wait for the next wave -- it's a wave of contract signings. And then maybe Mo may be rolling out some of the new product here. Is that the right [ wrap? ]

Absolutely. Yes. I mean we've seen an increase in revenue. The quarantine will be full, and we will be looking to market our Phase I, Phase II site capabilities across the board. So -- and with the addition of Manchester screening center coming on, we expect to see more volunteers coming through the gates.

[ Ken Harold. ] Do you have a target number of beds you're aiming for? Any ambition for geographic expansion? Look, the beauty of what we had, we started off 2 years ago with 24 beds without spending very much money -- like less than maybe GBP 1 million, GBP 1.5 million. We've got it up to 61 -- 62 beds today. Our model is we can add beds in a low-cost manner. And yes, international expansion that has to be always in the cards. But look, East London rents are cheap, there's a huge catchment area in Greater London of volunteers. We're not rushing anywhere beyond that for the moment. I think sometimes you charge overseas, do the expansion and it costs more money. So at the moment, we've got an awful lot to do from where we are.

Just to add also, the regulatory environment in the U.K. is the best in the world. We can get approval in challenge studies much faster than anywhere else. We can build challenge models much easier in the U.K. than anywhere else. So we do have a huge advantage over the rest of Europe as well as the U.S. when it comes to starting and building challenge studies.

And then [ Barry C. ] Has Open Orphan received regulatory approval of a COVID study yet? If not, when will you get an approval? How many companies have presented sort of an interest in doing COVID? The big issue there is -- look, being honest with you and Mo says that -- I would have been holding back. We didn't want to go charging out, signing contracts we couldn't deliver. The study is now being published, peer reviewed. I think it's in Nature Magazine next week. And that reassures our customer that this is a safe study. The government [ pumped prime ] but [ government ] going. So yes, a key, key part of our delivery this year will be doing COVID challenge studies. We're guiding that we'll be on top of what we're guiding The GBP 50-odd million this year. So I will be the probably the most disappointed if perhaps we don't sign them. I think we're working hard on signing challenge studies that -- we believe there should be COVID challenge studies -- a number of them every year from this year forward, and we don't need the government anymore to pay for them. I think the government is a wonderful partner but I think now we can move much faster and swifter as treating the COVID studies as we do with flu, RSV, malaria and everything else. [ Barry C. ] What has happened to the GBP 40 million government -- are you -- still received? Believe it or not, the government spent quite a bit of that in some of the partners. We got a certain slice of it. So I think where we are, government-wise, we would prefer now to go and sign up a lot of studies with third-party companies. We've always guided the market the COVID challenge studies will be GBP 8 million to GBP 10 million. And the funny part is our flu and RSV studies are almost getting up there [ as many ] as well. So yes, so there will be -- we're not chasing government contracts. I think we're chasing COVID for commercial purposes. Yes, this is an interesting one from [ ML ]. Says there's a lot of good work done under the banner of hVIVO is lost on potential investors. As hVIVO isn't a tradable company in the market, open Orphan has always referred to publication. It's a tricky one. We acquired hVIVO. It was unknown. We've kind of made it known now. That's something [ with real worth. ] Do we run, I think, changing the company? Look, our customers around the world knows hVIVO. You, our retail shareholders know -- so look, sort the name out. Work in progress. [ Kieran R. ] Cathal, are you still locked into Open Orphan for some years to come? Are you looking to sell Open? Absolutely not. The problem with being a director, if you know what will happen -- to declare it, and the share price will certainly collapse. So no, the only thing I'd do is potentially buying shares. I'm not really -- absolutely no plans of selling Open Orphan shares. So -- I reassure that. There's no need to lock me in. But while you're a director, if a director sells, I think that's a sign for everybody to get out. So I think the only time is Mo will be buying shares. And I think if you see me selling shares, I would -- in Open Orphan, if I sell shares, I think the stampede would come in pretty heavy. So absolutely no intention of selling any shares in Open Orphan. Next one, [ Greg W. ] Given the human challenge [indiscernible] institutional investors? Yes, again, I think, look, institutional investors, I think we're getting there. That's Mo's job. Look, I was probably fooling myself trying to bring them in and they'll say, Cathal, when have you run a clinical trial company before, what's your experience? So now the institutions are much more comfortable. We've now got a really professional management team. Maybe I'll leave you the last one, maybe this one?

Yes. Yes, what's your average weighted percentage for the [ GBP 10 to 5 million ] project? It seems the weighted probability has shown a lot of interest. So yes, they do go from maybe 10%, 20% to 75%, 80%, so there's a whole rainbow of probabilities there.

That's I think I think that's -- we got through all the presubmitted questions and all the questions online. So Mark, really appreciate that. So I think we're in good shape.

Thank you.

Cathal, Mo, thank you very much, and thank you for being so generous with your time. Look, I know the investor feedback is particularly important to you both, and I'll shortly redirect investors to provide you with their thoughts and expectations. But before doing so, perhaps if I could just ask you for a few closing comments.

Mo?

So I mean, look, I'm new to Open Orphan, and this is my first time to speak to so many people in a meeting. I'm really excited, very honored to be here. From the outside, when I first talked to Cathal, I was wondering whether it's actually ethical to do these challenge studies by inoculating healthy volunteers with the viral challenge model. But now having read up and looked at the benefits of these trials, I'm kind of amazed why -- why not all of these ID companies that are doing research in antivirus and vaccine, why aren't they all doing it? So that's one of my key goals -- is to try to educate smaller biotechs and other big pharma to make them understand the benefits and the speed with which we can get really useful results. And I think on the back of that, I expect us to grow across the board, across all the businesses. And then also, build the new service lines. We talked about the Phase I and the Phase II and the site abilities. And then together with the Venn Life Sciences and [ hVIVO build up, ] I've got a world-leading full-service CRO as an enterprise, which I think will be hugely beneficial to all of us. And yes I'm very optimistic for the future.

That's great.

Cathal, Mo. Thank you very much indeed for your time, and thank you once again to all the investors for their participation and the questions that they submitted. Could I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order that the company can better understand your views and expectations. This will only just take a few moments to complete, but I'm sure it will be greatly appreciated by the company. On behalf of the management team of Open Orphan plc, we'd like to thank you for attending today's presentation. That now concludes today's session, and good evening to you all.