Good evening and welcome to the hVIVO plc final results investor presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged, can be submitted anytime via the Q&A tab situated on the right-hand corner of your screen. Simply type in your question and press Send. Due to the number of investors joining the company today, we may not be in a position to answer every question received during the meeting itself. However, the company reviews all questions submitted and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. I'd now like to hand you over to Yamin Khan, CEO. Good afternoon. All right, thank you for that. Good afternoon, everyone, dear investors. I'm very pleased to present our full year 2021 financial results. This is my first presentation on annual results, so I'm even more pleased than normal to be talking to you. We'll go through the slides, present you the key highlights for 2021. We'll also provide a very thorough financial overview, and then we will finish by going through the Q&A. We have already a large number of Q&A already submitted, previous to the call. I'm sure we'll get more questions as we go through this call. Without further ado, we'll go to some of the slides. The normal disclaimer. I'm Yamin Khan, also known as Mo. I'm the CEO of the company. I joined as a non-exec for Open Orphan in October of last year. Took on the CEO role on the 24th of February. I have a long history in working in CRO and biotechs, helping growing CRO businesses and also getting them acquired by private equity firms. I'll ask Leo to quickly introduce himself now. Good evening, everyone, and very happy to be here tonight. My name is Leo Toole, CFO. I've been with the company since September 2019. I have over 15 years of experience in life sciences across med tech, pharma, and most recently in the clinical research space. Before that, I spent some time in FMCG across Europe. Mo. Thank you, Leo. Straight on to the numbers as we move forward. Our 2021 numbers, I believe were excellent. I'm not saying that's our goal going forward, but if you look at the change from 2020- 2021, I think you'll agree it's a tremendous increase. We have recognized GBP 39 million worth of revenue. That's a 76% increase year on year, which is indeed good news. We had GBP 2.9 million of EBITDA. That's a GBP 9 million turnaround in EBITDA. These are very good numbers compared to year on year, but of course, I consider these to be baseline numbers and something to build on. We expect to improve on both of these numbers by the end of 2022 and beyond. We had GBP 15.7 million in cash at the end of the last year. All of these results really are in line with the guidance we provided in quarter three of last year. We are the leaders in challenge trials without doubt. We have more than 60 studies to date in execution. We have over nine active challenge models across the respiratory anti-infectives and also parasitic models. We have to date inoculated over 3,000 healthy volunteers. All of these numbers are record breaking and world-leading with regards to performing challenge trials across the industry. On the operational excellence and on the delivery side, as you know, recruitment of healthy volunteers is one of the key challenges. We have FluCamp, a very influential platform to recruit healthy volunteers. We screened over 84,000 healthy volunteers last year through this platform. Typically, the challenge studies are valued between GBP 5 million-GBP 10 million. We've seen an increase in the number of subjects required to complete a challenge study because the sponsors or clients are beginning to see the benefits of the data from the challenge studies, and they're now actually conducting more and more complex studies and increasing the sample size. In other words, recruiting more subjects per study. The other great advantage of the challenge trial compared to a typical field-based phase II trial is that they can be completed within a 10-month period. The sponsor is able to get really good efficacy signals for their products within a year, and we are able to recognize that revenue within the same time frame. As we move forward, I believe we are well-positioned for growth. We have increased our bed capacity, so we currently have a total of 62 beds, and this includes beds to conduct phase I trials. We plan to conduct non-first-in-human phase I trials as we move forward this year into next. We have increased our capacity in March by moving to a new screening facility, and we're now capable of screening up to 1,000 healthy volunteers per week. Our current backlog as of the 1st of June is GBP 64 million, which is a record for the company. We have 100% commitment from our clients for the revenue we have projected for the end of this year of GBP 50 million. We have also already got a significant portion of revenue signed up for 2023. For those of you who may be new to Open Orphan, Open Orphan consists of two subsidiaries. First one is hVIVO, which was acquired in 2020. hVIVO really focuses on conducting a human challenge trial, and I'll go through what a human challenge trial is in a few minutes. The second subsidiary is Venn Life Sciences, and Venn Life Sciences really focuses on the early clinical development for clinical trials and for products, both small molecules and larger biologicals. Between the two companies, we are able to offer a fully integrated phase II challenge program. Venn Life Sciences partners are based in Breda in the Netherlands and in Paris. They provide protocol design and also the biometric services for the challenge studies as well as providing standalone services to their respective clients. hVIVO, the main hub being in East London in Whitechapel, includes the two quarantine facilities with QMB, as well as the Whitechapel Hotel and the screening facilities in Plumbers Row, which is opening in March. We also have an additional screening facility in Manchester. We are expanding the reach of the FluCamp initiative to be able to recruit and screen patients from a greater breadth of area. Where does hVIVO come from? Well, the hVIVO dates back to the mid-1940s when the Common Cold Unit was formed. Two of the leaders of the Common Cold Unit in the late 1980s went on to form a company called Retroscreen. Retroscreen changed its name to hVIVO, which was eventually acquired by Open Orphan. We have a lot of experience, a lot of history in conducting human challenge trials. In fact, the Common Cold Unit was conducting cold challenge trials back in the 1940s and the 1950s and so on. For us, we have a long history. We know how to work with the regulators and the ethics committee to get approval. We know how to conduct these challenge trials safely. We've had an excellent safety record over the last 30 years that we have been conducting challenge trials. We were the first CRO to conduct a SARS-CoV-2 challenge trial globally, and that was conducted very safely with some excellent data. In fact, that study was published in Nature, a leading scientific journal. We also utilize FluCamp, as mentioned, to recruit our patients. We have a number of indications already. These include influenza, RSV, malaria, asthma, and COPD. We are continuously expanding the indications we're working on to be able to tap into the increased market. We've already seen an increase in the number of clinical trials conducted in RSV and influenza, but on top of that, we're trying to tap into the respiratory market and be able to conduct challenge trials in areas such as asthma and COPD. We currently have a large asthma trial ongoing. The U.K. really is a great place to conduct the challenge trials. We have a very favorable regulatory framework compared to the United States or the E.U.. In the United States, you require an IND to manufacture a challenge agent and also to conduct the characterization or the dosing study. In the U.K., you don't have to do this. Also in the E.U., again, the characterization study needs to go through a regulatory framework. This delays and costs more with regards to developing a challenge agent. Again, in the U.K., we have the MHRA, and we work with the MHRA very closely. We don't need to obtain regulatory approval for the first part, but of course, we conduct the studies under MHRA's guidance and regulatory approval for the actual challenge studies. What is a human challenge? Well, a human challenge, a challenge that involves three phases. First, there's a screening phase. We have to ensure that the healthy volunteers that we are screening are fit and healthy and able to sustain the inoculation of a potential virus and the quarantine period. Once a healthy volunteer goes through the screening period and passes that, if they're a vaccine trial, they will get vaccinated, and 30 days later, they'll go into quarantine and be inoculated. During that period, they'll be observed very, very closely on a daily basis. Once the quarantine period is complete, the third phase includes the follow-up periods. For antiviral studies we conduct, we inoculate the healthy volunteer first with the viral agent, and then we treat them with the antiviral drug, and then we monitor them as before. We conduct these studies here in London. We have a genetic screening program where we're able to screen patients on an ongoing basis, five days a week, sometimes seven days a week, depending on the demand. We stratify the volunteers into two groups, so the active group and the placebo group. At the end of the day, when our Venn colleagues in Paris, they collect the data, they analyze the data, and they compare the two groups to find out whether the study drug was effective or not. We can do this within a 10-month period in a challenge study, which typically would take maybe between two and a half-three years in the field. This is a really fast and efficient way for our clients to get a really early indicator of the efficacy, the effectiveness of their drug in a given indication. Why do pharmaceutical companies do challenge studies? Well, there's a huge wide array of reasons, which are listed here on this slide. I'm not gonna go through each one, but I'll mention some of the key highlights. One is that these clients can de-risk a phase III program. As an example, Novavax was a company or is a company that conducted a phase III RSV vaccine trial which failed in phase III. Bavarian Nordic were not too far behind them, but they decided to postpone their phase III program and instead conduct a challenge study to get a firm view of whether the drug was effective or not. Following the positive results of the challenge trial, they were able to obtain breakthrough stages within the FDA, okay, which means effectively they save up to two years in regulatory timelines and increase their marketing period for their drug. On the back of that, we've seen an increased interest in similar studies. We have clients coming to us now wanting to do RSV challenge trials to get the same data and to be able to get breakthrough status or fast-track status with the FDA. We have done this a number of times. It's one of the key reasons why there's been an increase in interest in challenge trials as a study program. We've also been able to save significant time by conducting challenge trials for our clients and also, in some cases, a client is able to obtain emergency use authorization by conducting a challenge trial only. Lastly, for our biotech clients or smaller clients, they're able to move into phase II much more faster and be able to increase their valuations in the market. Actually, there's one more important point. In pharmaceutical development, if a drug fails, you want that failure to happen early, not at phase III stage. Our challenge studies are a really good way of ensuring that your drug works before you spend the big bucks on a phase III program. Again, challenge studies have proved to be a very useful tool for our sponsors, both big pharma and small biotechs in their vaccine and antiviral development. We're now expanding this model to respiratory and parasitic research too. I briefly mentioned FluCamp. FluCamp is our recruitment platform, and we have invested heavily in the software and technology used to be able to recruit and engage our healthy volunteers. For those of you who have any knowledge of clinical research and clinical trials, you'll know that 80% of the trials that are delayed are delayed because of poor recruitment. In fact, more than half the trials that are canceled are canceled due to lack of patient enrollment. This is a key obstacle in clinical research. There are not enough people in the world willing to take part in clinical trials, and this is the main reason why we have invested heavily in the recruitment platform. As you can see from the two charts, shown here below, that we have seen excellent results. So far, 100% of our studies have been completed on time with regards to recruitment, and we want that to continue to happen. Our genetic screening keeps our quarter million active volunteers in an existing database. As I mentioned earlier, we're able to now screen over 1,000 healthy volunteers per week, and that's a huge amount. One of the constraints of challenge studies, of course, is that you have to have seronegativity to be able to enter the trial. In other words, you can't have antibodies against the challenge agent that we are studying. For this reason, we typically lose 80%-80% of our healthy volunteers. One of my key goals going forward is to be able to monetize these healthy volunteers, and I'm pleased to say that we have this year been awarded a site study. A site study is basically a field-based non-challenge trial and doesn't have the same restrictions for serostability. We're able to utilize the same resources and the same facilities to be able to conduct a non-challenge trial in a phase II field-based environment. This is something we had aimed to do this year, and I'm pleased to say we have delivered. Now we have an ongoing non-challenge phase II trial in the company. Our client base is extensive and variable. We work with four of the top 10 big pharma on a repeat business. They have been loyal customers and have got really good results from the challenge studies we've done to date. There's a whole variety of small to mid-sized biotechs and biopharma, both in hVIVO and also in Venn Life Sciences. Finally, we also work with some leading academic sites and nonprofit organizations who have shown keen interest in our scientific knowledge and expertise that we use to build our models. One of the key things about challenge studies is that the powering of the sample size and the design is really key. We have over 30 years of experience and over 60 studies, which we use to make sure that we optimize for the design and make sure the client gets the most out of a challenge trial. Okay. We have over 60 clients that we served last year and 80% repeat this. Again, excellent numbers. One of the things I'm extremely pleased with that we have started doing is the fact that we are now cross-selling between Venn Life Sciences and hVIVO. Two of the challenge trials that we have been awarded this year have been previously Venn Life Sciences clients, and that's wonderful to see. We are also now utilizing Venn Life Sciences resources in conducting the challenge trials, both in protocol design and also the biometry, the data management and the biostat services at the back end. Again, as I mentioned earlier, I'm also pleased that we were able to get our first site study awarded. This will make sure that we're able to recognize additional revenue from the same resources and facilities as I mentioned, but also through the same screening process, more or less. I think this is key for us. We wanna build on this and continue to add more revenue streams and improve our profit margins moving forward. Some of the added value we're bringing into the company. We've added the malaria model as mentioned earlier. We're now aggressively marketing this across the different companies working in this area. We hope to have a parasite related study either this year or maybe towards the beginning of next year. We're also working on additional recruitment strategies to make sure that we can monetize the 85%, not just by doing our own site studies, but also maybe working with third parties and selling some of those leads and volunteers. We also launched our phase II site services, as mentioned, and expanding our laboratory services. One of the key things, a key skill set really is that we have a very extensive and knowledgeable laboratory staff, especially when it comes to virology assets and biomarker development. This is something I'm looking forward to developing further. We are looking to get the CAP certification in Q3 of this year, followed by UKAS certification. As soon as we have the first certification, we'll be able to sell our lab services to third parties in non-challenge trials. At the moment, most of the work conducted by our lab services is done through our challenge studies. This is something we can expand. There's no reason why our lab cannot perform assays for non-challenge studies on behalf of third parties. Finally, we're making sure that we are complementing the hVIVO and the Venn Life Sciences services. One of the things we're also adding is ATMP services or advanced therapy medicinal product services to their armory. This is something that we know the market will continue to grow, and Venn Life Sciences is placed right in the right time to make sure that they make the most out of this area. I'll now hand over to Leo to give an update on the financial aspects. Thank you very much, Mo. This slide gives a snapshot of our key financial performance that we touched on at the top of the presentation. Firstly, revenue. We delivered GBP 39 million in revenue, up from GBP 22 million in 2020, and that represents a 76% revenue growth year-on-year. We'll touch on the drivers of that in a moment. In relation to EBITDA, as well as been driven by revenue growth, we also worked hard to deliver a restructuring that we had started in 2020 and deliver additional productivity gains, which drove a swing of GBP 9 million in terms of EBITDA. We'll touch on that in a few moments. All told, that led to an operating profit of GBP 600,000 and significant improvements on our earnings per share. Our year-end cash was GBP 15.7 million. Again, very, very healthy balance to work with as we go forward. That was down from the prior period, and that reflected some one-off costs related to the capital reduction that we did in June last year, as well as costs related to the spin-out. It also reflected CapEx, normal maintenance related CapEx for our facilities and some equipment we acquired for our trials and the normal cycle of cash and timing related to R&D tax credits and client payments. Lastly, in relation to our order book, we finished in a very strong position of GBP 46 million, and that number is actually increasing right now to GBP 64 million at the end of May and puts us in a very, very strong position going forward to deliver revenue for the end of 2022 and into 2023. Lastly, just to note, as I touched on a moment ago, we completed a distribution in specie to the company's shareholders by spinning out assets that eventually became part of Poolbeg Pharma. Now, just to give a little bit more color on our revenue growth of 76% year-on-year. Critical to this was the broadening of our client base in hVIVO as well as ongoing steady growth in the Venn business. All told, we had 10 active studies in 2021 versus 5 active studies in 2020. That drove the significant growth. Now, COVID, our work with the UK Vaccine Taskforce with Imperial College was an important contributor to that growth, but it was far from the only element that drove the growth last year. While COVID was an important part of our mix, we are not dependent on COVID going forward into 2022, and therefore we're now focusing on our broad portfolio of challenge models and other service lines going forward. I touched on Venn a moment ago. Now, Venn, if we stripped out some of the old clinical operations revenues that we restructured, the Venn business grew a single digit, solid single digit growth last year. Both of those businesses in Paris and in Breda are contributing strongly to help us deliver our challenge models and are delivering important cost savings to the bottom line. Some more graphs here just to give a flavor or more color on revenue. Clearly our mix shift has changed. hVIVO is now 80% of our mix. The Venn division is 18% of our mix, but contributing very, very strongly, as I noted a moment ago, in relation to doing data management and biostatistical services. Importantly, we're also seeing our existing client base within the Venn division as being an important source of leads for challenge work in London. That's what we had expected when we merged both businesses, this notion of cross-selling. Another important measure that we're seeing is the profile of our client base is improving steadily over time. We now have 11 clients who are doing in excess of GBP 1 million in revenue, and we expect that to continue as we broaden our client base, as we maintain and build these recurring relationships with big pharma. That's a really important measure as we go forward. Similarly, we're looking at our revenue per employee growing 50% year-on-year, and that's really important because it's demonstrating that we're getting increased billability of our employees. We're getting increased utilization across our employee base, and over time, we're also working on how we drive increased productivity of our teams. I'll touch on that in a moment. To touch on our net EBITDA performance. Overall, we delivered GBP 2.9 million in EBITDA for 2021. That reflected an important swing of GBP 9 million year-on-year. Now, that GBP 2.9 million represents an EBITDA margin of about 8%. Standalone, that is not where we want to be, and we want to continue to drive and grow that EBITDA margin, notwithstanding that we had an important turnaround year-on-year. Now, our target for the coming year is to deliver double-digit percentages in terms of EBITDA margins and continue to grow that progressively over time. We're gonna do that by focusing on driving utilization of our facilities, driving utilization of our core team, and driving productivity of our core team. If As we look to grow revenue, we're also gonna be trying to keep our overheads and SG&A flat as much as possible. In so doing, we get really strong operating leverage on our business, and that will further contribute to drive our EBITDA margins up over time. We're happy with the progress made to date, but we think there's a lot more to come as we target to grow our EBITDA margins in the near future. I'll now pass back to Mo to share some perspective on market opportunities. Looking at the potential market opportunity. One of the things you need to be aware of is that the challenge is in itself, you know, we are creating the market as we go along. We are educating, you know, academia, scientists, as well as pharmaceutical companies into the usefulness of the data that the challenge studies are providing in the development of antiviral and vaccine and other products. This is something we're now seeing in the field. I mentioned the three companies that have already obtained fast track or breakthrough status with the FDA following good challenge study data. Overall, infectious diseases, the market continues to grow. In fact, the infectious disease clinical trial market currently stands at $5.5 billion. We're seeing two key triggers for increase in challenge studies. One is a change in the regulatory attitude with regards to challenge studies and the ability for clients to shorten their timelines when it comes to registration of the product by using challenge study data. Secondly, the COVID pandemic, okay. The COVID pandemic has raised the profile of viruses and antivirals and vaccines to the highest level possible. We're seeing an increase in funding from biopharmaceutical companies, nonprofit organizations, and so on. The number of clinical trials currently being conducted in this area is higher than ever, and we think this will continue. I believe that the increase in interest in influenza and RSV has been triggered by the COVID pandemic. Most scientists agree that a potential future pandemic will be due to an influenza variant, and this is one of the reasons that we're seeing a huge increase in the number of influenza studies we are conducting. I think this will continue for the foreseeable future. Looking at this growth in vaccines and antivirals. You can see before the COVID pandemic, because the COVID pandemic itself has increased the sales market of the antivirals and vaccine. Prior to the pandemic, you can see vaccines and antivirals were always second to oncology. Already we have a large market base. The number of clinical trials in phase I and phase II in antivirals and vaccines is huge. Now, this is our key market. We target medicinal products, antivirals or vaccines that are in early phase. From this, we look at what indications these products are in. You can see on the right-hand side, the four key areas that we look to work in. There's currently 144 influenza vaccines in the pipeline. 144 in influenza, 104 in COVID, 39 in malaria, and over 30 in RSV. We have a large pool of potential studies to work at. On top of that, we know that the number of challenge studies per product is also on the up. This is where I see exponential growth in the number of challenge studies being conducted. Our pipeline at this moment in time is the highest it's ever been. I think that says a lot due to the COVID and also the FDA change in view. We're now able to increase the number of trials we are seeing. A quick summary. We're giving our guidance for our year-end of GBP 50 million positive EBITDA. We expect the EBITDA margin to be double digits percentage-wise, and we're continuing to drive efficiencies and increase productivity to achieve that. Of course, my goal, my main message to you is not to say that 2021 was a wonderful year. No, it wasn't a wonderful year, but it was a great step from 2020- 2021. It's a major step in the right direction, and we hope to build on that going into 2022. That's where we'll begin to see better margins, increased margins, able to show higher revenue and also higher EBITDA. My last slide is really an investment case of why invest in Open Orphan. Well, Open Orphan is the world leader in this field. There's nobody who comes close to what we do. The scientific expertise we have, the number of years of experience we have in conducting challenge trials, the number of challenge trials, the portfolio of challenge agents, and the number of healthy volunteers we have in our places is second to none. We are, without doubt, the world leader in designing and executing challenge trials. There's now an increased adoption of challenge trials globally, and we're seeing clients both from Europe and from the United States. We have already a developed infrastructure. We know that the market entry hurdle is really high for someone to come in to develop a challenge agent, to establish a quarantine facility, and then to be able to get enough data to show that the challenge model actually works is very hard. We have already shown multiple times that our challenge models work, and we have been able to show that a drug is effective or not in some cases, okay, but we know the challenge model does work, and we use that to assess the efficacy of a product. We continue to expand our recruitment efforts with regards to FluCamp and also the screening capacity. Our client base is really has good variety. We're not relying on any one single client to provide us with major amount of revenue. We have breadth across both small biotechs and mid-pharma, as well as large pharma. On top of that, we also are currently working with some really key leaders in academic sites. With regards to growth, I mentioned with regards to our pipeline, our backlog is GBP 64 million as of 1st of June. That is significant, okay? We now, of course, need to work on ensuring we deliver those studies, but at a starting point, this is the best position that Open Orphan has been in its history. On top of that, we're now able to identify new revenue stream and recognize revenue on top of what you already have with the same infrastructure, same resources. I'm talking about the site studies that we are currently running. That is the end of the presentation. Thank you. That's fantastic. Mo, Leo, thanks indeed for the presentation. Ladies and gentlemen, do please continue to submit your questions using the Q&A tab situated on the right-hand corner of your screen. Just while the team take a few moments to review those questions submitted today, I'd like to remind you the recording of the presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor dashboard. Obviously, due to the number of investors on the call today, we have had quite a few questions come through, so, the team may not be able to get around to answering all of those, but of course, we'll review them. Mo, Leo, as I say, we've had a number of questions submitted both prior to the event and throughout today's presentation. Thank you to everyone for submitting those. Can I please ask you just to read out those questions and give responses where appropriate to do so, and I'll pick up from you at the end. Absolutely. No, thank you for that. Okay, so we have multiple pages of questions, to be honest, so I'll be surprised we'll be able to go through all of them, but I'll try my best with help from Leo. So starting with this one. How are you going to increase margins in the core business? The one for you, Leo. Thanks, Mo. Well, we touched on it in the presentation, but really there's two things. Firstly, driving operational efficiencies by increasing quarantine occupancy, increasing productivity of our work, and using new technologies to speed up the way we work. We're continuing to invest in technologies in our labs and in our recruitment processes. The second area is really, as Mo touched on earlier, how do we broaden our services and get better utilization out of our facilities. Site services covering how that we can utilize our resources, using new accreditation for labs and, you know, working to sell unused recruitment leads. Mo? Thank you, Leo. Second question we have is considering the previous announcement of a GBP 7.3 million influenza contract, I see this was part of a potential GBP 75 million weighted pipeline. Have there been any discussions with new contracts outside of this weighted figure? Well, I think you have to kind of appreciate to understand that the weighted pipeline is, it's a living document. It changes literally every day. The new proposals are added, a loss is removed, as well as proposals that we are converting to an award. It really depends on the current status. I can assure you that the current pipeline is the highest it has been. The current weighted pipeline is also the highest it has been in the history of Open Orphan. We're in a healthy position. I think the backlog figure is especially significant in the fact that that is signed work that we have in-house that we now have to execute on. I think we have a very healthy pipeline. I have visibility over the next nine months with regards to ensuring we have sufficient utilization of the capacity of the beds we have. I believe in the short to mid-term, we are in an excellent position. Of course, that doesn't mean we rest on our laurels. We'll continue to sell aggressively and continue to build on the pipeline and the backlog as we move forward. As regards to the GBP 7.3 million influenza contract recently awarded, will there be any more of this value to be signed this year? Well, after the GBP 7.3 million, we did sign a GBP 14.7 million contract. This was the largest single contract in the history of Open Orphan. This contract included a characterization study and also a challenge study. On top of that, a month before this, we also signed a manufacturing contract with the same client. All in all, we have the contract to manufacture the challenge agent, conduct the characterization study to find the right dose, and then conduct the actual challenge study. Now, this is a first in the industry, as well as a first for Open Orphan. I think this is something that shows that the big pharma have got real confidence in our abilities, not only just to conduct the challenge studies, but to be able to also to manufacture the actual challenge agents. Nobody else as a single provider can perform all these services in-house. I think this is one of our key USPs. Another one for you, Leo, I think. How is Open Orphan being affected by inflation? Where are costs increasing in the company? Yeah. Thanks, Mo. Look, everyone's aware of the macroeconomic environment right now in the context of coming out of the COVID pandemic and the situation in Ukraine. We're monitoring that situation very, very carefully. You know, we are seeing some pressures across our cost base. Our reaction to it is twofold. Firstly, where possible, and we are adjusting our pricing and our bids to make sure we're maintaining our appropriate margins on our contracts. That's working with our clients and working, doing that proactively. Secondly, very, very importantly, prudent cost management across all business areas, and that's just business as usual for us. We judge that those two actions will help us mitigate inflation as much as possible. Thank you, Leo. Next question is, will demand for challenge studies drop off if a recession hits? How much of an essential cost are the studies for healthcare companies? The answer to the first question is, I don't believe that at all a recession will have a major impact because of the current pandemic and the potential for a future pandemic. I think infectious diseases is one area where we'll continue to see increase in funding, both commercial and non-commercial. I do see a sustained growth in further research in vaccines and antivirals especially. With regards to the essential cost for the biopharmaceutical companies when they conduct a challenge trial, I guess the real answer is, what are the future benefits? If you look at companies like Bavarian Nordic, who are able to cut their development timeline by two years, how much is that worth? You could argue that a year in marketing a blockbuster drug is $1 billion. That's a potential additional revenue of $2 billion based on a challenge study spend of between GBP 5 million and GBP 10 million. You can see the return on investment is potentially huge. When roughly will the CAP and UKAS accreditation be recognized? The CAP audit will happen in July, and we expect to get accreditation within 60 days of that. The UKAS audit is currently penciled in for Q3, so we hope to have that certification by the end of the year. Next question. Why have investor comms gone so quiet over the past six months? What's stopping the progress in business? I hope I haven't been so quiet. I think we've got 20 RNSs already this year. That compares to 29 for the whole of last year. We've announced six different contract awards. But going forward, though, we will be more selective with regards to our announcements because I think we are now mature as a company. We need to behave as a mature professional company, and we'll make announcements on key significant milestones, not everyday signings with regards to GBP 1 million or GPB 2 million contracts. That's something we want to do going forward. We want to attract institutional investors in addition to our retail loyal investors. Going forward, we will be more selective in the RNS announcement. That's not to say we wanna communicate with you less. We wanna make sure we give you quality rather than quantity. As regards to the World Vaccine Congress and Investor Meet Company event lately, are we likely to see anything as regards to potential new business or institutional investors buying shares? Yes, the World Vaccine Congress, in fact, was a very positive event for us. We talked to a lot of current clients as well as new customers. I attended that myself. It was also the first global congress on vaccines where challenge studies were discussed at the main stage. I think the big step with regards to the acceptance of challenge studies in the vaccine arena. For your second question with regards to institutional investors, I'm glad to say that we have a new NOMAD on board, Liberum. I have met with them already a number of times. With their help and our other brokers, we will be targeting institutional investors this year. So watch this space. We hope to have more institutional investors on board. This one's a fairly direct question. Where are the malaria contracts? Okay, so the malaria model is something new to us. It was finished developing in Q1 of this year. We're currently and aggressively marketing this. Of course, as you can imagine, this is a new model for us, so it takes a while to win our first contract. But I have no doubt that in the near future we will be able to obtain malaria or any other parasitic related studies. This is something that, you know, we're looking forward to develop and continue to work on really hard. Where are the COVID contracts? I just wanna state that we're not a COVID-only CRO. I don't believe that 2022, for example, will be a year where a substantial amount of our revenue will come from COVID. COVID did help us in the way that it highlighted the fear of a pandemic through a virus potentially, and an increase in research in RSV, influenza, and other such indications. I don't believe that COVID will be our mainstay. We will be working more on COVID in the coming months and years, but I still see in the short term influenza making a major contribution as well as RSV. On top of that, I've talked about the asthma, the malaria, and the site studies to generate additional revenue too. RNS 1st June includes the phrase, "The study which is sponsored by hVIVO". Please explain. When we conduct a characterization study, we typically sponsor that study. It's not a freebie, but it's still fully funded by the client, okay? We act as a sponsor as a separate for regulatory terms. We act as sponsor in the fact that we take responsibility for the delivery of the study, but it's totally funded by our customer. If I'm not mistaken, the move to the current location was not a budgetary matter, lower rent, larger service area. It was also the intention to bring together the entire team in one location. How did the synergies work out, and does this have consequences for future profits? Absolutely correct. The reason behind the move, one, was to increase capacity, so now we are able to screen over 1,000 healthy volunteers a week. We have consolidated the office space. I'm, for example, sitting a floor above our screening facility, which is downstairs, and I go down there on a regular basis just to make sure everything's going okay. We also have a quarantine facility and the Whitechapel across the road. Our rent now is lower than before, and we have a larger area. With the move, we're now being able to add the site services I talked about earlier. All in all, I think the move has been very successful. On top of everything else, I do expect to see synergies and hopefully increased productivity because we are located in the same office. As regards to our bed capacity, Mo, do we need to have enough to turn around business in a timely manner? Also as regards to turning over more revenue to increase profits. Our current bed facilities are sufficient to make sure we hit our revenue targets for this year. Going forward, I believe by 2023, you know, we have yet to finalize our revenue target, but when we do, I think we have sufficient capacity. One thing to note, though, is that in early 2021, we were able to build and implement a completely new quarantine facility within a four-month time span. Now, typically, a new challenge study takes six months from award to quarantine. We will be able to build and fit a new quarantine facility in time if the demand requires it. I don't believe that capacity will be a constraint in increasing our revenue. Okay. Next question. Will you be looking for more facilities to support revenue growth? We always have a pre-identified list of facilities that we know we can move into. We have a facilities group in-house, and that's one of their jobs is to make sure that they have a list of pre-identified facilities nearby that we can move into or convert to quarantine at a fairly short notice. Absolutely. This is something we're always on the lookout for. As I mentioned, right now, there's no such demand. These are some of the questions on the share price. What concrete steps are you going to take to get the share price back on the road and deliver shareholder value? What would you call a success as new CEO regarding getting back Open Orphan on track? My goal is to make sure we have a sustainable, steady growth in revenue, a sustainable, steady growth in EBITDA and profit. I believe if we can deliver this quarter by quarter, year -on -year, it will be reflected in the share price. As you guys know, share price has a lot of external factors that we can't control, okay? What I can control is us converting our current backlog into revenue, getting new sales, more clients, and increasing revenue, our profit margin. I believe at the end, the market will reflect that. Our share price will increase if we're able to show a sustainable delivery. 2021 was a good year. I'm hoping 2022 will be a great year, and 2023 even better. Why has there been no share buyback or dividend? Personally speaking, I don't think this is a good idea at this stage. We believe we have some really good, strong initiatives going forward that will help us to return on investment that will be greater than giving back dividends. We've invested in new models. Malaria, for example. We are building the COPD model. We have built a new revenue stream in site services. We're investing in labs. We're hoping the increased capacity in lab will generate more revenue, especially after we receive the certification for the accreditation. A few questions for Leo on finance. EBITDA was GBP 2 million at six months. Full year, it was GBP 2.9 million. Can you explain why we only generated GBP 9 million in H2? GBP 0.9 million in H2. Look, as context, in terms of revenue, last year was a record year, and we, you know, 75% up on the prior periods. That's really important context. Within that year, probably the growth was slightly more heavily weighted towards H1 than H2. When you look at the balancing of the profit performance, H1 was gonna perform slightly better than H2, and that's reflected in the net margin numbers. Now, we know that we actually could have done better in Q4 because we had a postponement of a challenge study into 2022 because of slightly delayed regulatory approval. Right now, what we've been working on this year is how do we make sure we're overbooked in terms of the amount of pipeline or amount of orders that we have, so that if there is a delay in any particular client study, we can replace that with a study that's already ready to go, and therefore we mitigate that risk. What's critical here is that we're trying to load balance our studies more evenly across the year so that we don't have the highs and lows that can affect our profitability numbers. That's what drove this slight imbalance on profitability between H1 and H2. Second question: What will you do with your cash? I think, Mo touched on it in terms of new models, potentially new facilities and new revenue drivers. We wanna really explore how we drive revenue going forward, and we think that will deliver very strong returns for investors in due course. Has the company now received sufficient orders to achieve 2022 revenue target of GBP 50 million? Yes, we have. We're now 100% contracted for 2022 revenue. We're now focusing really on the important recruitment work and staffing work in our facilities to deliver those studies. What are your projected revenues profit for 2023? If you want to get a P/E ratio comparison to your peers, that is needed. Listen, that's a really good point. I mean, we know the benchmarks in the market. While we've had a good year in 2021 relative to earlier years, we're not satisfied with where we are, and we want to continue to grow. Firstly, we are very well-positioned for growth in 2023, and we're gonna guide on that towards the end of the summer. We touched on profitability as well, a few moments ago. We're targeting to improve our productivity and our operations to deliver double-digit% EBITDA margins and continue growing those into the long term. We're not satisfied at all with where EBITDA is, and we're gonna continue working towards improving that. Mo? Thank you, Leo. A couple of more questions. Well, there's a number of questions on spin-out, so I'll give you a brief summary. Why have the other spin-out not happened yet? What is causing the delays? Considering the economic climate, will actually anything be done this year as regards to spin-outs? Look, I think the current market is very difficult when it comes to IPOs and spin-outs, and I'm sure you guys are very educated in that. I don't know whether anything will happen this year, in fact. One of the great things of me coming on as the CEO is that Cathal is now free to concentrate on spin-outs. I know he's been working diligently on making sure that we have the right offerings when it comes to an IPO or spin-out in the future. He will be working very hard to make sure that the next spin out comes out. Of course, the current market really isn't optimal to do this IPO and spin out right now. This is something that, you know, we'll wait and see. When the market changes, we'll be ready to go. When do you think we will list on Nasdaq? Again, to be honest, maybe a boring but a similar answer. I think in the current market, I don't think I expect to see something happen in the short term. We are focusing on ensuring we deliver the key fundamentals on the business. I think that was all of the previous questions. We've got a large number of questions on the current. I try to go through as many of these. I don't think I will be able to, unfortunately. Good news on the increase in EBITDA, but there was also cash burn in 2021. Can you explain uses of that cash? Leo, do you wanna take that? Yeah, I will. I touched on that in my piece. Look, we had some one-off stuff related to the capital reduction and the spin outs, and we had a reasonable spend on CapEx related to, you know, maintenance on our facility and some equipment that we were using for our studies. On top of that, you had some timing differences in terms of R&D tax credits that we recognized as revenue, but the cash for that was only gonna come this later on. You also just some normal ebb and flow in terms of cash receipts from clients. Some questions down the road is how's cash right now? Look, our cash outlook is very good. It's very strong behind the client wins that we have had in recent weeks. The GBP 14.7 million contract is gonna give us a really strong cash contribution because of the prepayment element there. We're well on track in terms of managing cash with our clients. Our receivables are in good shape, and we see the normal cash cycle is really healthy in line with the improved performance of our business. We feel we're in good shape there. Mo. Thank you, Leo. How many new challenge models are you anticipating to have by the end of this year? Well, look, we're ongoing in our development of challenge models. I'm not gonna give a number. To be honest, I think that's a competitive intelligence in a way. Suffice to say that, yes, we have ongoing development with regards to new challenge agents. We have a very strong scientific team that have, you know, over 30 years experience at developing these challenge agents. We'll continue to look at this. The 14.7 million contract we signed, well, that was a new challenge agent that we developed for that. That was the last one we've done, but there will be more on this. The question is, what is the U.S. IND regulatory constraint? To develop a challenge agent in the U.S., you have to submit what's called investigational product dossier, effectively, because they treat a challenge agent like a study drug. Effectively, you need to collect and submit all the documents that you would as if you were developing a new drug. In the U.K., those regulations do not apply. A challenge agent is not considered a study drug. That's the main difference. Is the non-challenge phase II trial being used as a test and learn, or is the ambition to build this as a regular offering? No, there's definitely ambition to build this as a regular offering. That is not to say it will become our core business. We are and will always be a challenge study CRO, and that's key, okay? Because that's our greatest strength. There's no reason why we cannot bolt on and add on additional revenue streams. You mentioned using recruits that wouldn't be eligible for challenge trials due to antibodies for phase II. Can you please elaborate? Effectively, to conduct a challenge trial, let's say in influenza, we need to make sure that the individual doesn't have antibodies in their body against influenza. Because when they go into the quarantine and we inoculate them with or expose them to an influenza virus, they will not become infected. Effectively, they can't take part in the trial. As part of a screening process, we exclude all healthy volunteers who have antibodies against the challenge agent we are studying. These patients or these healthy volunteers can now be diverted into a field-based phase II trial, which doesn't have the antibody restriction. Please indicate the trajectory of growth of cost per employee versus growth of revenue per employee. I'm sure Leo can add to this, but just to say that the revenue per employee is increasing at a much steeper level than the cost per employee. If you wanna add anything to that, Leo. Yeah. Look, we're focused on driving billability of our permanent employee base, driving utilization across the board and driving productivity. Our goal is to continue to drive our overall EBITDA margin up even while growing revenue. Net cash EBITDA, so to speak, or absolute EBITDA, will be impacted by not only revenue growth, but the increase in margin. They all go hand in hand. That's how we know that we're delivering the real impact of those productivity improvements. Thank you. Double-digit growth in EBITDA could be welcome, but still modest at 10%-11%. There was early talk of a target of 30% for 2022. Are you planning near the former or near the latter? Okay, look, I'm gonna be very realistic here. I don't want to overpromise and under-deliver. I rather under promise and over deliver. Realistically speaking, from where we're coming from, okay, to never being able to show a profit to a GBP 2.9 million EBITDA, and this year increasing that margin even further. Okay. I don't believe we'll get to 30% this year, but we're gonna push well into the double digits. That's our goal. Long term, there's no reason why we can't push towards the 20s and 30s, okay? This is not a short-term strategy. I think we have a good base. We need to make sure we win more studies, we execute more efficiently. Every department has KPIs and targets, so we are monitoring what we're doing, how long it takes us to do this. I want us to be a very efficient service provider, and that's key. Once we're able to do that and deliver our studies on time to budget, we'll be able to realize much greater EBITDA and profits. How much is Cathal involved in the business? He is very involved. He sits in the office next to me three days a week. We talk on a regular basis. The day-to-day running of Open Orphan is left to me, but we talk on a strategic level to see what we're going to do forward with the company. He is especially focused on the spin-outs, as I mentioned. Yeah, he is still very heavily involved. I take responsibility for the day-to-day running of Open Orphan. When will Mo buy shares in Open Orphan? Very soon. I'm talking to Cathal and NOMAD to see when I have an open window to be able to buy those shares. How has the roadshow going or gone? Any new investors coming on board? We have one today, we met a number of brokers and analysts and potential investors, and we'll continue that for the rest of the week. I think the message is much stronger now that we are in a profitable situation and able to show a positive trajectory. I'm not saying we are where we should be, but I think we're showing a good trend, and I think this is what is attracting potential new institutions as future investors. How much is a weighted pipeline now? We're not currently disclosing that, but I will say it's higher than what we disclosed previously. Is Mo buying shares? I think I've answered that question. Why did it take so long to issue the final results? Really good question. This is something we'll fix for next year. We'll give our interim results in September of this year for the first half. But going forward, we'll be looking to publish our annual report in April and then do a first half in July and interims in September. You're absolutely right for your comment. As a professional organization, we should be able to report our annual finances in early April, and that will be the aim going forward. Very impressed with the range and depth of your answers to questions. Oh, thank you. Okay. I think we have taken enough of your time. I appreciate your time here. I know I'm new to this, and most of you don't know me. I did meet some of you at a recent conference. I'm here to drive the company forward and continue to increase on the revenue. I appreciate that the EBITDA itself isn't as much as it should be, but look, year-on-year, the turnaround is GBP 9 million, which I think is significant. As we move forward, I'm sure we'll do bigger and better things. Thank you for your time. Thank you. Fantastic. Mo, Leo, thank you indeed for updating investors today. I think you have covered off a number of those questions that came from investors, of course. The company reviews all questions submitted to them. We publish those responses on the Investor Meet Company platform. Could I please ask investors not to close this session? You should be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete and is greatly valued by the company. On behalf of the management team, Open Orphan plc, we'd like to thank you very much for attending today's presentation. That concludes today's session. Thank you and good evening to you all. Thank you. Bye.