Good morning, ladies and gentlemen, and welcome to the Ergomed plc Interim results 2021 webcast and conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a live question and answer session through the phone lines. To ask a question during the session, you will need to press star one on your telephone. Participants can also submit questions through the webcast platform, which will be answered by the company at a later date. As a reminder, listeners should join the call through either the webcast or the phone lines for the best viewing experience. I will now hand the call over to Dr. Miroslav Reljanović, Executive Chairman. Please go ahead. Thank you very much. Good morning, ladies and gentlemen. I would like to welcome you to Ergomed half-year presentation, which will be delivered by myself as well as Richard Barfield, our Chief Financial Officer. Thank you. Can we move to the next slide four? On this slide, we present our vision, which is building the company towards a global specialized leadership in a very specialized clinical development research area, so orphan drug development and oncology. We can call them also unmet medical needs, as well as patient safety under the system of pharmacovigilance. On the next slide, five, basically, we present two divisions. We operate business in two divisions, one dealing with clinical research, called Ergomed Clinical Research, where we manage clinical trials in all phases from phase I to phase IV, including the most complex clinical trials, which are very complex in oncology and rare diseases, where we specialize. The other division, under the brand name PrimeVigilance, manages monitoring of drug safety, meaning products which are in drug development or the drugs which are on the market. We process adverse events, analyze the data, in order to identify new and potential risks associated with drugs which are in development or on the market. Obviously, we report it to regulatory authorities. I would like to stress that we have the largest global network of QPPVs, which means basically Qualified Person for Pharmacovigilance. We have one of the most sophisticated services in the market, as well as some very basic services like processing adverse event reports in monitoring of drug safety. On the next slide, six, we present our global platform, which is really, truly global with particular growth of Northern America over the last two years with two acquisitions in the area of pharmacovigilance and CRO business. We employ over 200 full-time people now. We experienced a growth of 71% in H1 this year in the U.S. Europe obviously has a very robust infrastructure with about 20 offices throughout Europe, with all services represented. I would really like to stress that we started to grow our Asia-PAC presence, opening a Japanese office early this year, which is fully functional by now, as well as expanding our operations in India. Asia PAC region is one of the fastest-growing regions in the CRO industry. We really want to play an important role in that growth in the coming years. We generated GBP 56 million revenue in the first half of this year, which is 39% up from last year. I mentioned already over 70% growth in the U.S., which is very important to be stressed. We experienced over 20% growth since 2016. With 25 offices worldwide with over 60 countries where we manage clinical trials currently and report safety analysis in 140 countries, as well as with over 1,200 employees, we are really, truly a global company with a very good position for further growth. Next slide, please. seven, presenting a simple format growth of Ergomed over the last 20 years, the foundation in 1997. Then PrimeVigilance has been founded almost 10 years after it. At IPO 2014 in London, we merged these two businesses under Ergomed plc brand. Since then, we've done several acquisitions from smaller one up to bigger one in the area of pharmacovigilance and CRO business. I would like to stress two most recent acquisitions, which happened in 2020 in U.S., pharmacovigilance one, and the MedSource specialized CRO. On the next slide, eight, we present in the numbers the growth since 2016, where you see that particularly since 2018, when we focused fully on development of service business model, we experienced particularly strong growth. As part of that growth, we acquired also these two businesses in States in 2020. I would like to say that we've done it with our own resources, without fundraising, which is obviously very attractive from a patient point of view. We are very confident that we are going to grow further the business with attractive organic growth as well as with M&A, which is the core of our strategy, and that should augment our very attractive organic growth for business going forward. The next slide, nine, we present basically the market. CRO market is over GBP 40 billion now, growing about 6% per annum. While we operate on the right-hand side, you can see oncology and rare diseases, which represents about half of the market, and this part of the market is growing with very attractive 10% per annum. Pharmacovigilance has extremely attractive growth of about 16%, and its value is over GBP 5 billion now, and it will obviously grow very significantly over the next five years with this dynamic. Most of clinical trials is in the U.S. About half of the market is there. Therefore, we need to grow further our U.S. CRO presence and also most of [cleanical] clients and biotech development is also in the U.S., so it is extremely important area of our further growth. On the next slide, we present market opportunity, where the market consists of large top-tier companies, and there are less than 10 of these companies with over GBP 1 billion revenue. Most of them are public companies with 10,000 or more employees. They operate mainly with big pharma, where they have preferred providerships and stuff like that. The consolidation is happening in that area, and particularly the important one was acquisition of PRA Health Sciences by ICON plc relatively recently. The mid-tier market is the area where we operate, and particularly as we specialize in certain areas of research like oncology, rare, as well as pharmacovigilance. We compete really successfully with large and mid-tier companies due to that specialization. This market is very vivid from consolidation point of view. Over the last less than 12 months, two companies have been acquired. Synteract has been acquired by Syneos, Clinipace by dMed, Chinese company, and further consolidation is happening as we are talking now. We believe that Ergomed is really well-positioned due to its public positioning as well as market cap and its own resources to play very significant role in further consolidation of mid-tier market. We have a very strong and clear ambition to become definitely the lead mid-tier player by being specialized. With that approach, we believe we can compete very successfully even with large top-tier organizations. Next slide, 11, presents some key headline numbers for H1 where we experienced service revenue growth of 29%. Northern America, or to be more specific, U.S. revenue growth, 71%, adjusted EBITDA over 30%. We also employ now 29% more colleagues. Some of these colleagues came to company through MedSource acquisition. Over 100 colleagues have been employed during this period. We now employ approximately 1,250 people. We have more than 300 contractors who work more or less continuously for us. Thank you very much. Hand over to Richard now. Hello? Excuse me. It looks like Richard Barfield is disconnected. Should we wait for him? Hopefully Richard will dial back in again. Operator, is it possible to dial out to Richard? I can do. He didn't give me a contact telephone number because he said he was on a landline, and he felt that everything would be okay. Okay. We'll wait for him to call back in. Thank you. Okay. Richard is back with us. Thank you. Hello, Richard. Yes. Hello. Sorry, I was kicked out of the call. I don't know why. Okay, fine. Yeah, Richard, now it's your turn. Yeah, slide itself, yeah? Yeah. Okay. Thanks very much. Thank you, Miro. Well, good morning, everybody. Apologies for that. For some reason, I was thrown out. I don't know why. Thank you all for joining the call this morning. We are pleased to be able to report a solid set of numbers for Ergomed for the first half of 2021. This combines ongoing strong organic growth with the addition of growth from our recent acquisitions. I'll start with the total revenue. We're on slide 12 here. I'll start with the total revenue. You can see that the revenue for the first half is up 38.8%. In constant currency terms, the revenue was up 48.1%. I'll say more about the revenue and the impact of FX over the next few slides. The gross profit is up 24.2%. The gross margin on the face of it has declined. Some of that is due to a higher proportion of pass-through revenue in MedSource than in the legacy parts of the business. There's also a significant impact from FX in constant currency. Our legacy business service fee gross margin% was actually strong. Again, I'll move on to that on the next couple of slides. Having said that, the adjusted EBITDA rose strongly by 33%. With good cost control, effective integration of acquisitions, we managed to absorb the FX impact and still report an improved EBITDA margin up to 25.4% of revenues. Our net cash at 30th of June was up GBP 10.5 million at GBP 24.6 million compared to the first half of 2020. The EBITDA conversion to operating cash was again very strong at 91%. Our order book of contracted future revenue was up 50.5% since the end of the first half of 2020, and over the first half of 2021 was up 18%. A very significant turnaround in our retained earnings at the end of the first half of 2020, a GBP 800,000 deficit. That's now positive GBP 51.9 million. Some of that obviously is due to profits, but the larger element of that is due to the capital reduction that we did in the second half of 2020. The basic adjusted earnings per share are up 48.7%. Moving on to the next slide. To say a few words now about the service fee revenue in the CRO and PV businesses, where we've seen strong growth of service fee revenues and a solid gross margin performance. I'm going to talk about the impact of FX on these numbers. You can see on the left-hand side the Ergomed Clinical Research, the legacy business, excluding MedSource, where on a reported basis, the revenue was up 11.7%, on a constant currency basis, up 20.7%. Similarly, with PrimeVigilance, the reported revenue increase was 10.9%, the constant currency increase, 17%. PV continuing its strong growth in constant currency terms. The reason why the constant currency has such an impact, you can see at the bottom of the page, the average rate over the first half of 2020 being 1.28. The dollar average rate over the first half of 2021 being 1.38. If we move on to the next slide. This talks about the impact of FX on our reported service fee gross margin, where there was also a significant impact. This is because, as we just saw, the revenue is depressed in reported terms in the first half of 2021 versus the first half of 2020, with around 60% of our revenue now being billed in US dollars. On the other hand, less than 20% of cost of sales is incurred in US dollars, it doesn't mitigate the FX impact on reported revenue. When you look at both the legacy CRO and PrimeVigilance in constant currency terms, a robust picture emerges where the CRO is actually increasing its gross margin percentage to 47.7%. Pharmacovigilance is maintaining a strong gross margin percentage of almost 52%. In both cases, 48% for CRO, 52% for PrimeVigilance. These are robust levels of gross margin for these types of businesses. Moving on to the next slide. Slide 15. We've already talked about the total revenue being up around 39% and North America being up 71% from GBP 20.7 million to GBP 35.5 million. You can see in the chart on the right-hand side that North America now represents 63% of our total revenue. Continuing strong growth in the key U.S. market. On the next slide, focusing on the sales and order book, these obviously underpin our forward visibility to future revenues. The net sales awards up 50.8% compared to the first half of 2020, with a healthy overall book-to-bill ratio of around 1.6. The contracted order book up 50.5% and up 18% during the first half of 2021. This gives us a high degree of visibility and dare I say, confidence about our outlook over the second half of 2021. Finally, to focus on cash flow, strong operating cash flow over the first half of 2021. We started the period at GBP 19 million. We finished at GBP 24.6 million. With an EBITDA of GBP 12.1 million, the conversion to operating cash flow of GBP 11 million represents a 91% conversion rate, which is quite strong. As a reminder, we continue to be debt-free, and we have an unutilized facility of GBP 30 million. That completes the snapshot of the strong financial performance and our continuing robust financial position. I'll now hand back to Miro. Thank you. Thank you, Richard. Can we go to slide 18? This slide presents basically our initiative toward technology-driven trial execution. As we all know, particularly COVID crisis, pushed the business very strongly, as well as regulators toward virtual clinical trials. We back quite strongly on these initiatives regarding the achievements in the first half of this year. We enhanced our risk-based quality management with Cyntegrity platform. Also, the important development was the development of feasibility from site perspective as well as country selection through Citeline informatics on the global basis. We fully implemented our clinical trial management system using the platform of Flex Databases. Regarding upcoming initiatives and milestones in front of us, we are further developing our strategic partnership to accelerate our digital capabilities. There is a lot of options on the market and really the key is to evaluate them and integrate them in our Clinical Trial Management System. Also, integrating technology for solutions to deliver electronic consent, electronic patient-reported outcomes, that's absolutely clear target, which is delivering now. Consolidate quality and learning management system, which is very important due to all these technology solutions which are coming in the business and to drive efficiency and compliance. Please, next slide. This is our basically CRO therapeutic area focus toward oncology and rare. This pie chart shows very clearly that in H1 our sales has happened really mainly in the area of oncology and oncology rare, including rare diseases. Basically, really a completely insignificant part of the business has been outside of this area, which basically shows very clearly that business is going very strongly in this strategic direction. Also, acquisition of MedSource. It is important to be stressed helped there because MedSource has been operating mainly in the area of oncology in the U.S., so it helped us further to position from sales perspective and in these directions. We acquired a very rich track record of oncology trials in the U.S. On the next slide, we present slide 20. We present the development of integration of MedSource, which we acquired in December last year. In spring, we worked very hard and very fast in integrating the brand within Ergomed. It suited the commercial colleagues very much. In April, we fully implemented brand and business development of MedSource within Ergomed. We decided during summer that we are going to accelerate earn-out and fully integrate the company because the market dynamic and the dynamic of the CRO business, which is very strong as you can see this year, helped us to move in this direction. We basically accelerated earn-out with paying out GBP 3.8 million. The total consideration, including earn-out, is GBP 21.8 million for this business, which is about 10x EBITDA, what we believe is a really great deal, particularly taking account that this is a U.S.-based business. Since August this year, operations as well as business development is fully controlled by Ergomed management. On the next slide, we move to Pharmacovigilance, which obviously shows continued momentum and development. On the right-hand side, you have this attractive graph from 2013 when we integrate company ICON plc upto last year with strong momentum in first half of the year. We opened office in Tokyo, Japan, during first half of the year. Established some further strategic partnership with key vendors and experienced some new wins with major pharma accounts, which is extremely important from business going forward. You have seen it from some sales numbers. We also went through some restructuring exercise in this business to increase further cost efficiency and rationalize service delivery. On the next slide, 22, we present the PV digital transformation in this part of the business, where automation is a key focus, we look from different angles how to automate the processes. One of very important element is progress in consolidation of safety databases into Oracle Argus, which is a leading safety database. We will have all our data and the clients in this Oracle Argus system, which would help also with automation of the processes, as well as enhancing signal detection capabilities, which is important part of our business. Regarding upcoming milestones, we want to upgrade or we are upgrading our Oracle Argus and complete cloud migration. As well as we migrate our own automation system, ASaPPV to MS Azure Cloud, to extend to scale up our capabilities. Already we are well-positioned with that system. We are winning some new clients, and we are developing further this in-house automation system. Obviously, we further automate our regulatory submissions, which is very important via xEVMPD and develop a strategic partnership for further digital transformation. Lot of initiatives particularly in automation of this part of the business. The last slide before we start with discussion is investment case. We believe that through market drivers as well as strong market positioning, we are very well positioned for the further growth. Regarding market drivers, you've seen the numbers of rare disease oncology, where we specialize, as well as pharmacovigilance market, which forecast the highest growth in these sectors. It's important to be stressed that regulations are increasing, particularly in the area of pharmacovigilance and in rest of the world. We believe that that would be the very strong driver for further growth. We are positioning ourselves in Japan, and we will expand from there to Asia, and we think that could help us tremendously growing the business in next years. There is acceleration of technology due to COVID-19 crisis, as I mentioned before, in regard to richer clinical trials, where we believe we can play a significant role as well. A robust order book provides really high visibility for the business going forward and leading expertise of the brand and the specialization, what I mentioned a couple of times. This brings us to really strong market positioning. We deliver leadership really in this mid-tier global CRO market now, and positioning us very well for further growth, not only organically but through, I believe, very attractive acquisitions going forward. We have a strong balance sheet and access to capital, which is the best platform for the delivery of the strategy. Thank you very much. Richard and I are open for your questions now. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, please press the hash or the pound key. Please stand by while we compile the Q&A. Your first question comes from the line of Stefan Hamill of Numis. Please ask your question. Morning, folks. A couple of questions from me. Just on the acceleration of the MedSource earn-out. Can you just give us some color on what this enables you to do now, six months earlier than we might have previously expected? Could it drive more cross-selling, for instance? Yes. Thank you, Stefan, for this question. As you've seen on some slides before, we obviously have done multiple acquisitions up to now. We all know that earn out structure is not the most favorite structure in M&A. The sooner we integrate the business, the better. We really base this acceleration on our experience in integration of some former businesses. Really from commercial point of view, we've seen that it's much better to operate as one company. Soon after that, we realized and discussed with the management of MedSource that having operations fully integrated earlier would benefit the business because we just reduced some number of some positions. We had an overlap. We had a legacy Ergomed CRO Business U.S. With accelerated integration, in fact, we hired up some of key colleagues from MedSource and reduced the need for some further employment and duplication of the position. All that brought us to this accelerated position of integration, including earn-out. Got you. Thank you. Just one more from me. The sort of striking some new KPI that you presented was just on the mix of business in terms of therapeutic area, where there's only 2% beyond your therapeutic core cancer/rare disease. Is this a case of focus, just focusing 100% on those core areas? Are you still pitching for work outside that? We clearly focus on these two areas because winning the business in these areas really helps tremendously our colleagues in the clinical research business to develop a resource-based specialist, monitors, project managers with experience in the area of research, more efficient feasibility, everything. We are really asking our sales force and our commercial team to focus in these areas, and you see the results are here. Yeah. That's very clear. Thank you. Thank you. Your next question comes from the line of Jonas Peciulis of Edison. Please ask your question. Hi, good morning, everyone. Can I please focus on the expansion in Japan today with several questions? I was just keen to understand the market, CRO and PV market better there. In terms of the competitors and market structure, is it dominated by the same competitors you face in Europe and the U.S., and whether they have similar market shares there, or is it unique in its way? Yeah. Thank you for the question. The PV market is quite similar in Japan like in Europe and U.S., and we compete really with the largest CROs there, and few specialized mostly tech companies from India. Basically, they are in Japan as well. It was very important for us to establish our own brand and the Prime vigilance in Japan in order to be able to compete with these players. We operate in Japan for last maybe 5 years with subcontracting to some Japanese companies. On the basis of current clients working with us in Japan and transferring to our own capacities, we quite elegantly established our presence in Japan on the basis of the current business. Really important stuff is that we have to have a Japanese infrastructure in order to be able to compete with the largest players. Okay. Just going back to this idea. Is it primarily pharmacovigilance opportunity or CRO opportunity or a similar mix that you currently have in Western markets? Yeah. We are currently focusing on pharmacovigilance because it's relatively simpler from operational point of view than CRO. We have clinical trials in Asia for a number of years. We subcontract this to some Asian companies from Australia to Thailand and Taiwan and so on. CRO is more complex to be established on an organic basis. We tried it earlier. I believe that CRO expansion in Asia should go through acquisition because of the complexity. Right. Thank you. That's very useful, actually. That was my next question. Yep you plan to achieve more significant sales level organically or via M&A, but I think you just answered it. You're currently operating in planning to use the Ergomed brand, right, to promote the Ergomed brand in Japan, which is- No, this is a PrimeVigilance company in Japan because the company. Okay -is dealing just with pharmacovigilance services, yeah. Okay. We will promote those services currently in Japan. Okay. Thank you. I guess, the next question. Given your status as a CRO company, what's your current impression about the specifically CRO market recovery after the pandemic troubles? Let's say, what do you hear and see, what's different now versus the beginning of this year, let's say? What do you hear about potential effects this upcoming winter? I think that some of the hospitals are preparing again to potentially focus on ICU departments and things like that. So far in the West markets, there are signs of the link has been broken and hospitals are still open. I'm just interested in what's your current views and what do you hear about what's coming this winter, specifically CRO market? Yeah. Generally, CRO market is obviously very mature and very competitive market. The key was really to make an acquisition in the U.S. last year. Obviously it helps us really quite a lot in our commercial positioning in the area of our expertise, as I mentioned earlier. There is always competition. Competition is obviously tough, but the business is very attractive, and it's growing very significantly. Fortunately, the clinical development research market is not affected by COVID. We could even say that maybe there is some boost, yeah, in drug development, which is great, yeah. Very different from crisis 2008, 2009, 2010 and so on. In such a buoyant market, obviously there are a lot of opportunities. Therefore, we are optimistic regarding that part of the business. Regarding the threat of closing the hospital or interrupting clinical trials, I personally think that this is really incomparable, less risk than last year due to all developments happened during this year. There might be some issues, but really, we don't expect some significant one. Not compared to last year. That's my personal opinion, yeah. Okay. Thank you. That's helpful. Thank you. That's it from me. Thank you. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. That's star one on your telephone if you wish to ask a question. You have a question from Stefan Hamill of Numis. Please ask your question. Hi, folks. I thought I'd join for one more question, given it was a bit quiet there. Just the other striking thing about your presentation today is just there's a lot more depth on the technology solutions that you're offering your clients and you're using to manage your business. And in general, it just seems to be across the board, best of breed off-the-shelf solutions. Is that what your customers prefer? Do you ever lose out not having your own tech platforms? Yes, Stefan, particularly in the area of clinical trials, there are a lot of, you can say, on-the-shelf or developed solutions, yeah. It is much more realistic to integrate those solutions in our management than develop our own. There is a lot of opportunities, and our team is very busy to integrate it, to implement it, and things like that. It doesn't mean that we would come across some solutions which might be specifically interesting for us. Currently, we are very busy integrating the solutions which are on the market. Regarding pharmacovigilance, we have our own initiatives in automation, particularly through ASaPPV, as well as our partnership with Automation Anywhere and DataRobot. We partner with them on those solutions, and currently we are working a lot on Oracle Argus platform, where there are some also automation capabilities. In PV, we would embark more on our own solutions going forward. There are some companies who can help us, basically accelerating it through partnership or even through acquisitions and stuff like that, yeah. Great. That's good color. Thank you, Miro. Okay. Thank you. There are no further questions coming through on the line, sir. Please continue. Thank you. This concludes today's conference. Thank you for participating. You may now disconnect. Speakers, please stay on the line.