Okay. Hi, everybody. Welcome to our Analyst Day. Great to have some of you here with us in person in our office in Blue Bell. Thanks for those of you joining on the webcast as well. Happy St. Patrick's Day. We wanted to provide a really authentic Irish experience to those of you here, and thankfully, the weather is cooperating with us today by giving us a nice Dublin feel here in Pennsylvania with rain and a little bit of fog here today. I just wanna start off with a reminder on our forward-looking statements that our speakers today will be making forward-looking statements. Please reference the slide that's in the adjoining presentation. Just in terms of a quick agenda flow, Steve's going to kick us off today, followed by George McMillan, our head of commercial. Each of our business unit presidents. A quick overview on innovation and technology, and finishing up with Brendan Brennan for a financial overview. We will have a Q&A session at the end of this for about 30 minutes. We'll take questions here in the room as well as via the webcast. When we get to the Q&A session, we will give a quick instruction, but you'll be able to basically submit questions online, which I'll then be able to filter here in the room. Without further ado, I'll hand it over to Steve Cutler. Okay, thanks. Thanks, Kate, and welcome to all of you. I know some of you have come from a fair way away and got early flights, so thank you for attending. Nice to have you all here. Happy St. Patrick's Day as well. It's always nice to get together on the Irish national holiday. This is an opportunity, I think. We do our quarterly calls, as you all know, but this is an opportunity, I think, today to dig a little deeper into the new ICON and what we're doing as a combined organization. We'll talk a lot about that as we go through the day today. I will introduce you to the management team in a moment. Really you'll have an opportunity to get into what we're doing and where we want to go, as an organization, as a healthcare intelligence organization. We'll talk more about that and about what that entails as we go through the course of the day. You'll hear about our strategies, you'll hear about our opportunities, and then we'll give you a sense of where we feel the market is and what those opportunities are in the market. We also have a number of demonstrations as we finish the formal presentations and the Q&A. I think that'll hopefully give you a sense of where we're going as an organization that's moving towards that healthcare intelligence, that's using technology, and that's using data, to make sure that we make good decisions and better decisions around clinical development programs. Then, of course, we'll have some opportunity for some informal discussions, both in the break time and, of course, I think there's some Guinness to be served, later on, which I hope you're all looking forward to. Let me just introduce our management team, the management team of new ICON. First of all, to my left and on the left of the screen, Barry Balfe, who will present a little bit. He's Barry looks after our large pharma group. He's based in Dublin and been with ICON for a number of years now. He's an ICON veteran. Tammy Clerc on Barry's left comes to us from Legacy PRA, looks after our biotech small and mid-size group. Tammy's doing a great job as we drive forward that business, and she will present on that part of the market as well as we go forward. To Tammy's left is Samir Shah. Samir looks after our global strategic services group, our functional group, and that combines nicely with both of our full services group. George McMillan, who's on the far left over there, who'll talk about the commercial. Our Chief Commercial Officer has responsibility for all of our business development activities right across the company. I've got... Who have I got? Nuala Murphy. Yes, Nuala Murphy is out looking after our specialty services. Nuala is an Irish woman who's based in Paris. I'm an Australian who's based in Pennsylvania and works in Dublin. Nuala is the Irish woman based in Paris, but also works in Dublin. We're a very multinational group. To Nuala's left is Tom O'Leary. Tom is our Chief Information Officer, and he'll give you a sense of where we're going, not just from an integration point of view, which is obviously very important, but also from a data analytics point of view. Tom is responsible for a number of the demonstrations that you'll see later on today. On Tom's left over there is Joe Cronin. Joe is our Chief HR Officer. He's had a very quiet time over the last six months or so with the integration. He'll give you a sense, and you can certainly talk to him about the progress we're making on the integration and the opportunities and challenges we have in that space as well. Then finally on, sorry, not finally, but on Joe's left is Diarmaid Cunningham. Diarmaid is our Chief Administrative Officer, our Legal Officer. He has a large part of that global business services group, so he's one of the key people responsible for some of the cost synergies that we're driving, and we'll talk about that specifically as well. I think you all know Brendan Brennan, who's sitting at the back of the room, and Simon Holmes, who is our, who's leading our integration efforts. Simon's part of our senior leadership team, leading the integration effort and can speak in the Q&A sessions certainly about some of the opportunities and work we're doing around integrating the two companies that we have. Let me start a little bit with the end in mind, I guess, in terms of our messages, our key messages that we wanna get across to you. I hope you'll get a sense of this as we go through the presentations from the management team and also the demonstrations going forward this afternoon. We are moving to be that healthcare intelligence organization. I recognize that's a new term in the industry, but it's something we're very serious about as we bring sources, key sources of data together, as we evaluate that data, as we analyze that data and we make better decisions, more informed, more intelligent decisions on that data around clinical development programs. It's a term you'll hear throughout this afternoon and onwards in terms of where our strategy is. I would say very honestly to you all, it's an aspiration. We're not where we ultimately wanna be in that space, but we are moving very much towards that. Again, you'll see through the demonstrations this afternoon more of that. We wanna give you a sense of the market. The market fundamentals we believe are strong, and we'll be more specific about that through George's presentation. The market we're in is operating at a very strong rate, and I think, you know, I want to sort of reiterate the strong fundamentals that we have in biopharma spending, both in the biotech area and in the large pharma space as well, and we'll give you more detail on that going forward. We do have, as an organization, a commitment to invest. Clearly, decentralized clinical trials are the issue du jour, so to speak, but it's more than that. I think as we come out of the pandemic, the technology that's been deployed during the pandemic to the benefit of the trials we've had going has really shown the industry that we can do this on a much more sustained basis. I think we have an opportunity as an industry to move that forward. I was at an industry meeting yesterday, an ACRO meeting. We were talking about the 20-year anniversary of ACRO, the Association of CROs, and there was a real sense, I think, of the opportunity that we have as an industry to move forward with some of the technology and with some of the changes that we saw through the pandemic, and what they can bring on a sustainable basis to our business. We also will talk a bit more about the integration, the progress we've made on the integration, the progress we're making, not just in terms of customer partnerships, and the synergies, but in terms of our employees and how we're building that career map with them and those career opportunities with them. There's certainly significant progress. I'm very, very pleased with the progress that that's making, but we'll give you a little bit more specifics and a little more detail on that as we go through. Finally, to give you, Brendan will certainly talk about the financials, the solid and expected revenue growth in this year, but also in the out years, and the leverage we're gonna get in terms of EBITDA, and EPS growth as well. That's the, they're the messages for this afternoon. I think you'll see those reiterated as we go through the presentations. I won't spend too much time on this. This is the CRO market dynamics. I think you all see that this is a growing market. We see it at around about 6.5% per annum on an overall compounded annual growth basis. That's made up of modest growth in the R&D budgets, but also increasing penetration or continued increasing penetration of CRO and outsourcing services across those R&D budgets. It's a good market to be in. We feel it's in a good place. There are some obviously some near-term challenges, perhaps in terms of biotech funding and how that's going. Overall, we feel this market is moving along very nicely, and we believe we can overplay our role in it. In other words, we can take market share in this space. The biotech funding environment. Again, it's a hot topic, and I think we all know over the last couple of quarters, it's come down a little bit. It's still at historically very high levels. We haven't seen any impact on our business in terms of the numbers of RFPs or opportunities that have come in. We certainly do recognize that, you know, and certainly in the IPO market more recently, there's been some challenges in the follow-on market. Really the information we have, and as we talk to customers and we talk to investors as well, is that privately, there's a lot of money around for this sort of work. The science out there is very exciting. If I move to the next slide, you can see there's real opportunity here in things like cell and gene therapy, in the monoclonal antibodies, in the mRNA world, in things like drug conjugates, the checkpoint inhibitors. Really, as one sort of private investor said to me the other day, the science is 20 times what it used to be, and there is funding for good science. There really is funding for good science. We feel that with that, the FDA playing their part in terms of approving new drugs at a continually solid level. The FDA, I heard from Janet Woodcock yesterday, this meeting that I was at, her inclusion or her involvement and her willingness to play a part in that deployment of the new technology. They certainly have responded very quickly during the pandemic. There is a real willingness at FDA, as we see it, to continue that. That's going not just to FDA, but to EMA, MHRA, all of the European type authorities as well. There's a number of tailwinds, I believe, in our industry, be it regulators, be it the science, and be it the availability of capital. It really puts us, I believe, in a very good spot. Our mission and our vision as new ICON, you can see our mission is, to improve the lives of patients, by accelerating the development, of customers' drugs and devices. Our vision to be that healthcare intelligence, to use the data that we have, and we'll talk a bit more about how we're getting and gaining access to data. We've never believed we had to own all the data, but we do believe we need to continue to invest and continue to bring data and data to inform those decisions around development programs. Those four key strategic imperatives you'll see there. Patient access and engagement continues to be a real focus for us. We are focused in the clinical space. We're not in preclinical. We're not gonna get into preclinical. We're not in marketing. We're not in sales. We're focused in that phase I to phase IV and preclinical services. That's where we wanna be. We're bringing more technology and more data to that space, and we're laser focused in that space. Getting patients into clinical trials, engaging those patients, retaining those patients, is a critical element of any sort of strategy that we put together. Of course, our people are key and career development and being an employer of choice is also a focus for us. We have to be very focused in that area. We've all heard of the Great Resignation. We know what's going on in the industry with people working from home and those sorts of things. That continues to be an opportunity for us as well as a challenge at times. You can see this is our main office here in the U.S. now. We have a number of people now starting to return to the office. Building that culture and bringing new people into our organization, be it through our bridging programs, is a very important part of what we do. Offering career development, giving them a sense of belonging and engagement with an organization like ours, we believe is critical and very important. While we are always gonna have some flexibility, of course, in where they work, it's important that we give them that sense of vision in terms of what they can do with their careers. Customer partnerships, George will talk more about this in terms of the progress we've made. We've made very good progress, I believe, since the union of our two companies has come together. We have a lot of engagement from very key customers who we haven't been working with as either organization in the past. That's something I'm particularly pleased about because it was one of the key rationale for the union that we have, PRA and ICON. Finally, being that healthcare intelligence and applied innovation. Greg and Tom will talk more today about how we're applying innovation. There's a lot of innovation around, as you all know. There's a lot of sexy stuff that's happening. How does it help our business? How does it drive patients into clinical trials? How does it help us deliver development programs to us? That's the question we constantly ask ourselves. What's the value? What's the applicability of that innovation? That's where we're very much focused, and Greg will talk more about that tomorrow. Sorry, to this afternoon. In terms of our culture and our values, this is the new ICON. This is our combined, the best of both. You know, we look our values there surrounded by the owner at ICON. The need as a service organization to own the challenges that our customers have. You all know we work in a challenging environment, doing clinical research with people and investigators whose it's not their main job. It's not their we don't, in most cases, employ those people. They have their own businesses. We ask them, and we pay them, but we ask them to bring patients into clinical trials. That's something that always causes us challenges and always raises problems when you think of some of the geopolitical things that are going on in the world right now. Our focus is really to own those challenges. To not worry about whose fault it is or who's to blame or what, but to own those challenges. That's something that we really wrap our culture and our values around, along with the values of integrity, inclusion, collaboration, and of course, agility, which is a very important value that our legacy PRA folks brought to us in that acquisition. The need to be fast, and Tammy will talk a bit more about that in relation to our biotech business later on. I thought this was useful for you all to understand how we structure our business as a healthcare intelligence organization across the four service areas. You'll hear from each of the presidents of those four service areas today. Large pharma, biotech, development and commercialization. That's Nuala, and of course, Samir with our strategic solutions group. The global business services group is also a fundamental part of our, you know, the way we operate. The business group successfully leveraged right across our organization the HR, the IT, the finance, and we've been able to use that model extremely successfully really over the last 10-15 years. That's a model we believe we can now apply to a much larger organization and continue to get that benefit in terms of growing margins going forward. Underpinned, of course, by innovation. We apply innovation, of course, as we bring patients to clinical trials. It's not just in that space. It's how we retain people, how we focus on career development. It's how we look at our own internal operations. It's how we're deploying machine learning and robots. Again, Tom will talk a bit more about that later on. Innovation is not just in one area of our business. We try to bring it into the whole culture of our business, and it's something that we feel very strongly about. As the new ICON, we're, you know, we're stronger together. We're a bigger organization. We really have the scale in key areas. Again, one of the key rationale for bringing together the two organizations. Scale geographically, functionally, therapeutically. We have 38,000 or so people around the organization. You can see in the various parts of the world. Predominantly, of course, in North America and in Europe. We have scale across our business, and that, you know, that's an important part of what we bring to any development program. The ability to work and to bring resources to bear where they need to be brought to bear in an agile and a focused manner. Our differentiated solutions, particularly around decentralized trials, but not just around decentralized trials. Around the technology, around risk-based monitoring, around the wearables, around our home healthcare. The way we can bring those solutions to customers in a way that and deploy it in a way that makes the impact effective and really adds that value. Customer partnerships, as I say, we've talked about making progress there. Of course, ultimately, shareholder value is something that we believe we've been able to bring to the new ICON. In terms of customer profile, you know, one of the key areas that, as we looked at the union of the two organizations, was our customer partnerships, and we were able to bring a number of customer partnerships together, but also improve our customer concentration. You've seen this data, I think, at length, and you know where we're going on this and what we've done on this. Our largest customers now are around 8% of our business. I think three or four years ago, that was probably three or four times that. We have, as a combined organization, really minimized or limited our risk from a customer concentration point of view. Our top 20 customers, almost every one of them, provide us with, at least $100 million in revenues, on an annual basis. You know, we have a substantial footprint across the industry, and that's something that, we wanna build and we wanna develop, and we wanna move into partnership mode with, any of those who we're not. As you can see on the left there, as we said publicly last, at our call last time. We're about 15% of our revenue with the what we call capital market-dependent companies. That's an area that we haven't seen any issues with at the moment. Our bad debts are very low. We have a good process where we vet those customers as they come into our business, as we bid for them. We look at how much they pay us up front. We look at their credit ratings, et cetera, et cetera. So there's a rigorous financial process that goes into that. So we feel our risk in that space is minimal. They're organizations that spend a lot of money with us. I was looking at our data this morning in terms of new wins in the Q4. Our top two wins, the largest two wins we had in Q4 were from biotech customers. Very substantial wins. These are customers that have significant ambition now in the clinical development space. They're not here to do a phase II and then out-license to partner. They wanna bring products to market. Tammy can talk more about that in her session. In terms of integration, a number of key achievements. As I said, I'm really pleased with the way we've moved forward. Our philosophy is to get the best of both, and we're working very hard to make sure that we're objective and open-minded enough to bring the best of both. The ideas, the people, the structures, the processes. We've essentially left our biotech group as the legacy PRA product registration group, and our large pharma group. Our large pharma group is the legacy ICON phase II, phase III group. We haven't really brought those together because the center of gravity of those two groups was on the PRA side, very much in the biotech and small, and on the legacy ICON, very much in the large pharma. We're moving those organizations forward. There's no major integration problems. There's no major challenges with customer projects because we've kept them separate at the moment. Ultimately, we'll move to some of the back-end services. But we've Our focus really in the first 6-8 months of the integration has really been around our strategic services group, and Samir can talk a little bit about what progress we've made in that. Of course, around our global business services group, that continues to be work in progress, but we've made a lot of progress there. The specialty group has come together. Our early phase group has come together. That's been relatively straightforward. We've made a lot of progress in those areas. Our large pharma and our biotech group have continued to work forward, continued to deliver on projects, and I think we've certainly seen that through our business development results and the feedback that we've had from customers over the last 12 months or so now. In terms of our ESG strategy, a very important part of what we do now, we acknowledge. We now have been putting out an ESG report. We have set ourselves targets in terms of environmental, social, and governance, and we're making progress towards those. We're not, of course, a company that has large manufacturing facilities, but there are areas we can certainly look at, certainly around travel, around our office footprint, and that's certainly an area that we've been working on very hard, not just to reduce cost, but to reduce some of the greenhouse or the environmental issues that are associated with large footprints, et cetera. There are areas that we're focused on and we're working on. Dermot is responsible for that and can talk more about that in the breaks if you wanna know, if you wanna hear more detail. We feel that we're making solid progress in that respect, and we look to continue to do that. We wanted to give an update on the very tough subject at the moment. We all feel extremely sad around what's going on in the Ukraine and Russia. We wanted to provide you with an update on that. Of course, as you'd expect, our focus is very much on our employees, the safety of those people and making sure that they remain safe. We're helping them to you know to move out of the country if that's what they wish to do. We also have, of course, obligations to patients in both these countries, in Russia and in Ukraine. Ukraine being particularly important at the moment because of the disruption that's happening there. We have significant disruption to our customer studies there. We have around 2% of our people in both those countries. It's not a huge part of our business, but it's a very significant part of our business in terms of our patient recruitment. It's, of course, from a humanitarian point of view, we're most anxious to make sure that our employees are kept safe. We've been able to help them in a number of ways, whether it be through accommodation, early payment of salaries. We have set up a fund to... that we made available to help with relocation and those sort of incidental costs. You know, we've had a number of employees be redeployed because there's not much work going on in Ukraine at the moment. We've been able to redeploy some of those people. We continue to do that. We continue to be open-minded on that. We haven't made any long-term decisions about what we're doing in Russia. We have obviously obligations on clinical trials, which will tend to go out for several years in many cases. We absolutely have to fulfill those. We have paused any recruitment of new patients. We stopped any initiation of new sites or any placing of new work in either country at the moment. It's on pause. We're in maintenance mode. We're trying to move forward in a way that keeps patients safe, that tries to get drug to those patients. As you can appreciate, we have some significant challenges, particularly in the Ukraine at the moment with what's going on. Again, happy to take questions on that in the Q&A session. Just to focus in a little bit on where we're going in the longer term and what we wanna be and where we wanna go. You know, I certainly see an increased opportunity for us to connect the patient. I mean that as an industry, but I particularly mean it as ICON. Our ability and our need to connect to patients directly, as a way of getting ourselves very sticky with pharma customers is an important aspect of what we're doing. We're building collaborations. Our site network, of course, continues to grow. Our partnerships continue to grow with those sites and with patient groups. It's an area that fundamentally, you know, we believe is critical to our business, and there is significant, as I say, opportunity there. We wanna bring in new technologies. We want to invest in those new technologies. You'll hear a lot about that today, new and expanded uses of data. We don't have to own it, but we do need access to it, and we wanna get the benefits of that data. However we do it, whether we partner, whether we acquire, whether we look at other ways of getting access to that data, it is a fundamental part of our strategy going forward. Patient tokenization is an area we believe has significant opportunity for us. Greg will talk about that in his session today. But the ability to follow patients up on a long-term basis for a very, very reasonable and efficient price is something that I think we think we can have a real advantage in the marketplace. Can you imagine if, with all this controversy around the vaccines, if we'd been able to tokenize all those several hundred thousand patients who went into those trials? The ability to answer questions on adverse events, on efficacy, on the need for boosters, on relapse, and all of those sorts of things would have been priceless. Unfortunately, we weren't quite there in time to do that. You know, as we think about you know, subsequent pandemics, perish the thought, or even just normal programs. Of course, with regulatory authorities these days approving drugs early in the process before there's a lot of follow-up, particularly in the sort of rare disease space, the ability and the opportunity to tokenize these patients and follow them up on a very regular basis through the data sources that we have, we believe is a significant opportunity, as I say. Then finally, in terms of investing in enhanced capabilities, we continue to expand our Accellacare sites and the services around that. Obviously, the DCT strategy is fundamental. The Accellacare sites are fundamental to our DCT strategy. Our data-driven insights, again, to do feasibility and allow us to, you know, to move forward in a way that allows us to better deliver those projects in the longer term. We also see opportunities to develop things like mega sites as well. The site, the patient, the technology, and the data, those are all areas that we're active about investing in and focusing on to deliver ultimately long-term shareholder value as we move from an $8-ish billion organization in 2022 up to circa $10 billion in revenue in three years' time through those strategies. That's something that we feel we can do. We feel the market is there to allow us to deliver that. We have the management team. I think we have the strategy to be able to do that. I hope we'll be able to convince you that that's the case as we go through the afternoon. Finally, if you say, you know, "Why would we trust you to do that? Why do we think you have a chance to do that?" I think I can point to a pretty solid track record of revenue growth and adjusted EPS growth really over the last 20 years or so. That's something that I think investors and our shareholders and analysts should feel comfortable and should feel confident that we have a track record of that delivery that I think can continue on for another 20 years, which will certainly see me out. It'll be a great opportunity for us and for our whole industry to continue to deliver and to continue to provide strong shareholder value. With that, I will hand the baton to George, and he will talk about ICON and our commercial success. Thank you, Steve. There you go. I will try in the next nine or 10 slides to give people a commercial context for the environment that we're in right now. Hopefully, I'll pick up on some of the themes that Steve has touched on, but also in some measure set up the environment in each of our divisional areas. If you will, give you a sense of some of the things that ultimately my colleagues who follow me will talk more about. Let me start with the key takeaways, okay? I think there are five from a commercial perspective. I think the first is significant importance in ICON on focusing on partnership expansion and new relationship development, formal partnerships and de facto partnerships in our distinct markets, which includes, but is not limited to, large pharma and biotech, and the service capabilities that can span all of those. I'll spend time in a couple of slides talking at greater length about this because people think of partnerships traditionally in a large pharma sense, but it's far from the truth, that the concept of partnership extends across all four of our major service areas. The second, which Steve touched on briefly here, and we'll talk more about it later in the presentation, particularly in Greg's, is ICON's positioning as a healthcare intelligence organization. We are evolving in line with what Steve suggested in terms of who we are and what it means to be a CRO in a competitive environment going forward. Moreover, I think the size and breadth of the new ICON when we are out there now as the market leader is resonating with them. Although the focus continues to be on innovation. I'll talk a bit about that in terms of what they're asking about. It's been well received, but at the same time, the question they're asking now is with that kind of breadth and depth globally. Talk to me about innovation as it's applied to my business. The third is that sponsors have been favorable to the new ICON and to its breadth and depth of capabilities, and we'll talk a little bit more about that as well. I must say, beyond that, the core focus of sponsors as well as competitors in our space is in two areas. Resourcing as an industry and as a CRO is of paramount importance to them. For someone like us who has increased significantly in size, the continued capacity to be flexible in the way we address customer needs, even at our size, something for which ICON has always been well known, as very flexible in the way it shapes its solutions around customers. They're gonna ask the question now with 40,000 people, "Are you still as flexible as you once were?" We'll spend more time on this in my presentation later. The DCT and RWE as well as healthcare intelligence are areas of significant interest by sponsors, small, medium, and large. But my view, and I think that's shared by my colleagues and our experience in the field commercially, is that you can expect that adoption of any and all of these will be deliberate, it will be gradual, and it tends to be very trial-specific. We'll talk a bit more about that. Trial-specific as it relates to finding patients, shaping protocols, finding patients, and enrolling them. We'll talk more about this. It's particularly relevant in Greg's section, where we're talking about how you apply that. The fifth of these is that our unparalleled breadth of service offerings, the widest in the industry, does produce cross-selling opportunities between and among the four divisions across our clinical models and across our service lines. We in commercial are intensely focused on working with the division presidents and their teams to make those capabilities available to existing and future partners. It also enables us to deepen our footprint of services to existing partners and to new partners. We'll talk a bit more about that. Those are the takeaways. Let me spend a few slides to touch on each of those points, if we will, for a second. In this slide and the next slide, I have attempted to put on one slide each for large pharma and biopharma in particular, the commercial environment all on one slide. Let me take a moment and walk you through that. In the case of the large pharma environment that Barry will talk more about in a few minutes, I think these are the most important salient points. From a market growth perspective, large pharma R&D spend is growing in the low single digits. That probably understates the opportunity, and that is as our industry has consolidated into fewer, very large CROs, certainly in the 12 years I have been in this industry as well. Those CROs, including ICON, are being given more opportunities to talk with, and Steve mentioned this, to talk with, engage with, and capture market share, all right, that otherwise might have gone to intermediate-sized CROs that no longer exist, as the market has bifurcated between very large and smaller as well. We think that the opportunity for us at ICON is greater than that represented by the average of the industry overall, and we intend to deliver on that. I think it's reflected in the number that Steve put up there a few minutes ago. When you peel back the covers in terms of what's going on in that industry and the trials that are being done there are several interesting things to bear in mind. I think you will see in large pharma increasing trial complexity in those trials that they have continued to retain on their own, okay? There are new modalities in the way it's being done, new regulatory requirements which require new capabilities, global coverage, because most of these trials are global in scale and more integrated solutions to attack them. That requires, as mentioned before, capabilities such as Steve touched on a little while ago and that Barry will touch on in terms of areas of expertise that might not have existed before that now must exist in order for us to service their needs. Okay. Part and parcel of delivering on that increasing complexity is the importance of technology and the disruption it's creating in the space. There's rapid changes to the way in which clinical data is being captured. It's being collated, it's being integrated, and ultimately, in some cases, cross-referenced against non-clinical data as well. The core infrastructure that supports the use, transmission, and availability of that data becomes key and a source of investment. Finally, in many ways, most importantly, the single most important issue in these spaces right now, in an area that will be touched on in the next presentation, has to do with patient access and engagement. It's the need and the primacy of rapidly and predictably connecting patients and physicians, investigators with clinical trials in very patient-centric designs and support in order to conduct these major trials globally on a timely basis. That very theme of patient-centricity, but also patient identification ripples through the rest of this presentation. That's the environment we're talking about in large pharma. Let me shift for just a moment to the biotech market as well. A little different picture, but some commonalities as well. From a market growth perspective, the biotech R&D spend on trend has been growing in double digits overall, which is being driven by a strong funding environment, particularly for the trials and the maturity of the trials that we are engaged in as a global CRO. In fact, there are a myriad of very large opportunities there and good science, as Steve suggested as well. For many of the clients we're working with them now, liquidity on the balance sheets of these companies that sustain them, not only through good times, but through quiet times that are taking place in the marketplace. From a market dynamics point of view, here too, you see increasing trial complexity with an acceleration in such areas as cell and gene therapy-mRNA technologies and checkpoint inhibitors. Even in this particular space, the complexity of the disciplines associated with the portfolio of trials in the biotech space is getting more and more complicated. It's incumbent upon us and upon Tammy's organization to be able to have the expertise to address these new areas to satisfactorily meet this market. Intensive focus on a consultative model. These are customers who typically want a higher degree of value added scientifically and clinically from ICON overall. We have to have the scientific, the therapeutic, and the medical expertise in-house that is critical to support those development programs, whether a conventional development program or a more complicated state-of-the-art program. That expertise must exist because on average, they don't have it. Then from a molecule ownership point of view, biotech companies are lengthening the cycle of ownership later in development and seeking global support. As Steve said, these were not one and done, step up your basis, move it out at one, stage one, stage two. There's much more money, and that means they're gonna hold those assets longer, which means the relationships we develop are longer and the spend is greater as well. An interesting, slightly different, slightly faster growth market, but with its own share of complexities and nuance. Okay, a moment on branding. If you were to study the branding of us since the merger, as many of you know, we spent really the six months from July first until mid Q4 focused on the notion of stronger together. Really communicating the message to the street that the company combined together had gone smoothly, as Steve suggested as well, and the work would go on smoothly and not disrupted. That played well. We have made a shift from a branding perspective. Focus away from that is behind us, and frankly, I rarely get questions on that topic anymore. People are much more focused on the going forward state. Now our focus, as Steve said, is on the new ICON as a healthcare intelligence organization. Aspirational, but we're rapidly pursuing it as well. I thought it was worth taking a moment to define what we consider to be healthcare intelligence, which is an organization that collects and analyzes healthcare data from various key sources, clinical and non-clinical, that allow people to make intelligent, informed decisions and drive actions that accelerate the development of drugs and devices. I wanna emphasize, if anything, the concept of people here, because while technology is an important component of that, in the end, the technology is really in support of making that data available and aggregated for people at ICON or at the sponsor to make decisions. It's the people that are the most important and training our people to use that data in a way that's intelligent and make decisions with our sponsors that create better, smarter, faster trials, better, smarter, faster recruitment of patients. Next slide. For a second here. We, in commercial, align precisely with what Steve outlined is the way in which our company is organized. We have the four divisions represented by my four president colleagues who are next to me right now. ICON Pharma Solutions, which is the heart of our large pharma business. ICON Biotech Solutions, which addresses itself to biotech. ICON Strategic Solutions, Sabrina will talk about that. That is, in broad terms, our FSP business, a world leader. And then ICON Development & Commercialisation Solutions, which is early phase labs, imaging, commercialization, site and patient solutions, and the Symphony Health data businesses overall. Not unlike our corporation, we have put common areas like proposals, global communications, and marketing in one place so we can get as much scale and efficiency in commercial, as is a central part of our GBS strategy for overheads in general right now. I might add, not only does this align with our divisional lineup, interestingly enough, it resonates well with the street. People get it. They understand why we did what we did, right? They understand it, why we have a difference between these two divisions as well. Not only why we did it from the point of view of merging, but how it addresses two distinct markets. Generally, that goes down really well with people. People understand why we're organized this way and have the ability to select where they wanna be. From a customer reaction to ICON in the marketplace point of view, I would summarize it as follows. I think there's been a favorable customer response to the organizational alignment I just showed you, to our integrated offerings, and to the flexible delivery models, and in many ways, the distinctions between and among the different divisions and the different models we have. The scale and breadth of capabilities in terms of opening new customer opportunities is increasing. I think our size and scale and breadth is helping us get there. Our success in retaining existing customers has increased by virtue of our size, but also across segments and the renewing of our partnerships. Barry will talk a bit about that. Our customer-first focus continues, right, as integration focuses on study management. Our innovation offering is resonating well with current customer needs, particularly as it relates to specific trials and specific needs. From the point of view of what customers are focused on now, I touched on it before, so I won't spend a long time on this, but I think their focus is not on innovation as a concept, but it's on applied innovation. I sort of summarized here the five areas that are of greatest importance to them. Speed, we haven't touched much upon it yet, but we will. Diversity, equity, inclusion in clinical research is important. I think Steve touched on it briefly. It is very important from the point of view about attracting people to trials. DCT. We'll spend time on driving data to make decisions and generating and using digital endpoints. There are many topics, but I think this is a good encapsulation of most of what they are interested in. Then just a word on partnerships as well. As I said before, people think of partnerships traditionally in a large pharma sense, but in fact, the way to think about the world we live in as a CRO is that partnerships exist in various forms across our four divisions. The way we think about growing the company overall basically can be defined as winning partnerships, which is very, very important to us, but also retaining and expanding relationships that we have. Starting in one location and expanding across our different business units to get there. For large pharma, it's just that. It is renewing existing multi-year partnerships, okay, and winning new ones. Similarly, in the biotech space, the partnership looks a little bit different, but the notion is expanding multi-study, multi-year, large biopharma relationships, as well as bringing on board new ones. In ICON Strategic Solutions, it involves really both winning, extending, and expanding relationships. In their case, not just in large pharma, but also in midsize pharma, where there's a large presence, and across our Development & Commercialization Solutions, a whole array of partnerships that range from central laboratory across all of our offerings. When we talk about it, bear in mind that there are partnerships is an important concept to us everywhere in our portfolio. Last and finally, cross-selling opportunities as well. As I said, the beautiful blend together the capabilities of the companies under the new ICON has given us opportunities to sell things that are either new or at global scale that might not have existed before. We're trying to take maximum advantage, so that is a very high priority of our executive team. Over $30 million in new awards took place in Q4 of 2021 alone from those cross-selling activities. That includes cross-selling bilaterally or multilaterally across our businesses and across these service offerings to bring these capabilities to existing and new customers where we might not have had them before. We might have had a credible offering before that is now at scale. That was a very quick flyby. With that, I will now turn it over to my colleagues representing the four divisions, starting with Barry Balfe, President of Pharma Solutions. Thank you, George. Good afternoon, those of you in the room, those of you online. My name is Barry Balfe. As George said, I head up our ICON Pharma Solutions business. Gonna take the next 10 minutes or so to recap on how we've decided to segment our approach to full service or project outsourcing between the biotech and larger pharma markets, why we've done that, what was the rationale, how we've been going about addressing that strategy, and I won't say a deep dive, but a slight look into some of the points of difference that we believe are driving our growth, and we'll touch on some of the early successes and some of the positive feedback we've had in that regard. Pre-deal, ICON and PRA, addressing the totality of the market, both companies. We know, as Steve said, that the center of gravity of the legacy ICON organization a little further to the right, more nested traditionally in that large pharma space. PRA, although distributed across the market, again, center of gravity, more directed towards those biotech customers. We felt there was an opportunity to synergize, to target, and to become both more efficient and more effective in how we targeted these sectors. ICON Pharma Solutions is now addressed specifically at about the largest 50 or so companies in the world as ranked by R&D spend. Tammy's gonna speak in a few moments about our strategy for addressing the rest of the market. It's important to note, as has been pointed out already, that across the totality of this spectrum, we are supported by our colleagues, not only in our global business services groups, but also in our FSP businesses, and particularly in our commercialization and development groups, which are helping us deploy capability into these alliance partnerships. We'll talk about DCT. We'll talk about tokenization. We'll talk about site networks. We'll talk a lot about what we're doing in the AI and machine learning spaces. These are not separate businesses. These are incredibly fundamental to how we address the largest and most complex pharmaceutical companies' challenges, as is our mission. What was the rationale for doing this? I hate to oversimplify, but it is our belief that greater focus on these sectors will drive better alignment with these companies and ultimately better success. We believe that when addressing the challenges of large pharmaceutical companies, it is important to align with their corporate outlook. It is important that they're working with the same people who are specialists in addressing the challenges that they face. The challenges of virtual and emerging biopharma are not the same as the priorities set by the largest, more complex pharmaceutical companies in our space. That cultural fit is very important. We also see an element here around employee pathways within the organization. There are those who are better suited and who have ambitions to work in different parts of the market, and we endeavor to reward and to engage with that. Ultimately, we're trying to see by virtue of greater focus, can we drive greater win rate? I'm happy to say that the signs in the first two quarters post-deal are very encouraging. Not only have we managed to increase our win rate to build on growing our RFP flow in this space, but we've had some notable successes. I'll talk in a while about some of the new alliances we've launched, also being able to successfully renew all of the existing alliances that came up in that time and to continue to grow business in those. We've managed to win business on a full service basis for the first time in a number of years with three top ten pharmas since we closed this transaction. There remain a number, as you may be aware, of preferred providership selection processes ongoing. These early signs are very encouraging and something we hope to build on in the quarters and indeed the years ahead. That specialization we talked about extends across a number of dimensions. Of course, we need to be experts across a range of therapeutic areas and modalities, but it's also true that the way these customers choose to work with us varies from customer to customer. It is most unusual that a large biopharma customer will ask us to provide 100% the ICON way. We will incorporate elements of the sponsor's infrastructure and ways of working, potentially partner with third parties and deploy a customized range of ICON solutions from within our systems and process ecosystem. Delivering that from a technology perspective, from a therapeutic perspective, leveraging our global centers of excellence, be that around TAs or different ways of working. George McMillan mentioned cell and gene therapy, for example. The ability to deliver out of a center of excellence familiar with the unique challenges associated with these types of studies is critical to these partnerships. This concept of partners and partnerships is very important in this space. This is not a transactional space where we bid individually on one project or another. This is an arena characterized by major complex sales, long-term strategic relationships, where we are one of one or two or perhaps three partners of these organizations, which sustain for the long term and evolve, focused very much on year-over-year gains, whether that's in terms of timeliness, cost, or other vehicles of progress. I mentioned therapeutic area distribution. These larger companies tend, almost unerringly, to work across a range of therapeutic areas. We don't get to be experts in one corner of the market or another. Our combined strength as the new ICON, bringing together the expertise and the experience of prior trials across ICON and PRA, we believe is market leading. It also leaves us with a well-distributed range of experience across the full spectrum of therapeutic areas. That's something that's very, very important to our customers. So yes, we're global leaders in heme onc, and yes, we're global leaders in vaccines and infectious diseases, but it's also important that we can bring market-leading solutions to cardiometabolic, to neurology, and to other areas. My colleagues are gonna speak in some more detail later this afternoon about some of the applied innovation that characterizes the work that we do at ICON. I certainly don't want to duplicate that conversation. before we look at just a brief case study, I did want to focus on one area that perhaps brings this concept of healthcare intelligence, and indeed data and applied innovation to life. If there is a chief among equals in terms of the problems faced by large pharma, it is the very first pillar that Steve talked about in terms of access to and engagement with patients. You can see on the slide some of the critical metrics that simply make the point that most trials or close to most trials don't meet the expectations that were set for them in terms of the timeliness, rate, and extent of recruitment on those trials. The cost of setting up clinical trial sites that do not perform is very significant. Perhaps even more so, the delay in terms of getting those drugs to market by virtue of having to go back and initiate more sites later in the process, has been a challenge the industry has faced for very many years. Also, the level of experience of sites we consider to be a very important variable. 90% of the sites that we work with have conducted fewer than 10 clinical trials, and there are implications for the predictability of the work done at those sites, for the quality, for the appetite, the experience, et cetera. At ICON, we have invested in the development of a proprietary technology called One Search. We'll be offering a demonstration later on. Travis Caudle and a number of my colleagues will be here to assist. Ultimately, what this is, this is a searchable repository where we bring together data on patients, on investigators, and on sites to enable us to better predict how and where and how quickly we can find sites and patients that are well suited to a particular clinical trial. Gone are the days where we survey physicians around the world, take that number down by a percentage, and hope that that is an accurate number. This is an algorithmic process. This is backed up extensively by machine learning so that the machine can learn based on prior performance, internal, proprietary, and external data sources, which sites are best suited to a particular trial and what rate of enrollment we can best expect. That predictability factor is critical. For these larger companies, it's not just about executing on a single asset, but it's understanding the time and costs involved so they can better engage in portfolio balancing and other important planning activities. The results are on the slide. We've reduced the percentage of non-enrolling sites to an industry leading 12%-13%. That's versus an average in the mid-30s. We've reduced significantly the median time for site identification. Long before we can activate sites, we must make a decision on which ones we're fishing in, which pools we're fishing in order to select the very best sites. Unsurprisingly, this has yielded a positive response from customers. We can trend clearly and improve customer satisfaction in conjunction with the rollout of this and other important innovations. Of course, it also helps us with our investigator relationships. We are enrolling fewer investigators who are poorly suited to a particular trial. We're treating their time more valuably, and we're able to engage them in research in which they can be more successful. I'll close with just one more slide, and I mentioned at the beginning that we've had some positive experience in the first couple of quarters post-integration of our companies. This is an example of a top ten pharma company where we began a new relationship in 2020. It was a series of disparate engagements. It was by no means a one-stop shop. We worked across a range of some regional monitoring FSPs built into the customer's systems and processes. We offered some support in the DCT arena, some home health work, our FIRECREST Investigator Portal, and a modest amount of data management work. Over the course of the first 12 or 18 months or so, we were able to make progress in a number of key areas. We were able to partner with that customer to increase the efficiency of their clinical trial monitoring work, to leverage our data and applied analytics platform, and to externalize it into the customer's portfolio. This enabled them not only to identify problems they didn't know they had, but also to assess better whether the solutions they were bringing to bear were likely to be effective and to make more timely, impactful interventions. I'm pleased to say that after 18 months or so, the customer made 2 important decisions. One, they decided to move from a multi-party model to a sole source global alliance partnership with ICON, a very significant advance for us, and I hope for them. Just as importantly, while we were able to demonstrate a certain degree of progress working within the constraints of the customer's environment, we were also able to demonstrate to them how additional progress could be made by leveraging our applications, our ways of working, our best practices, such as OneSearch, such as our DCT and site networks, among others. We're now in the process of migrating this clinical infrastructure into an ICON managed model. We will, of course, incorporate elements of the customer infrastructure, but much more so skewing from that customer systems and process platform into the ICON model. It's something we look forward to rolling out across the rest of 2022, and we have very clear line of sight on how this model and approach will yield further progress for the customer in terms of timely interventions, in terms of efficiency, and in terms of efficacy. Something we look forward to speaking about a little later in the day, but for now, I'm going to hand over to my colleague, Tammy Clerc, to discuss ICON Biotech Solutions. Thank you. Thanks, Barry. Hi, I'm Tammy Clerc. I'm President of Global Operations for Biotech. I'm also one of the legacy PRA executives, so I'm very familiar with this model. I think George and Barry both have set up nicely that we are purpose-built two divisions. Why is biotech unique? Biotech needs consultative expertise across all development areas. Our model's been built to be able to serve the expertise that they need. They need access to partnerships and large companies, and they also need access to funding. Lot of times that funding is tied to milestones. Our Biotech's team very much understands how important the milestones are, what we have to meet, how we have to get there, and working around that with our clients. Large pharma tends to have more of a directive approach. They know what they're doing right when they come in. They don't need the expertise of medical and therapeutics because they already have designed the protocol. They're looking for more robust systems and processes and governance models, as Barry indicated. They have a much more predictable budget spend than what the biotech does. The rationale for our dedicated business unit. What Steve said was so important. At the beginning of this, everyone was very concerned about integration. We've seen a lot of consolidation in our market, and what has happened in that consolidation when it doesn't go smoothly. A dedicated business unit for biotech and for pharma allowed us to maintain our focus and to keep business continuity, which was our number one priority for our clients. We've set up the biotech division in three different segments. Delivery, so it allows the global reach of a company the size of the new ICON while still having a very consultative and team approach. Specialization, again, Barry spoke to this, George spoke to this. The biotech clients need that therapeutic expertise. We have a very significant therapeutic expertise in Medical and Scientific Affairs department that spans across all therapeutic areas, as well as having the experience of applying innovation for medical informatics, for protocol optimization, and for country site selection. Equally as important, our customer management and general partner model. We have a senior executive signed to most of our biotech clients because on the biotech side, we have a lot of C-suite involvement, and that C-suite involvement starts at the very beginning based on the prioritization. A lot of these clients may only have one or two molecules that can turn into a large partnership, but there's a lot at stake early on. The general partner provides them a senior level of contact, clear escalation pathway, and flexible governance structures. I think one of the two true differentiators in our model that's been purpose-built over the years is we've got 8,000 employees that are pointed directly at full service biotech. That's all they do is service biotech customers, and it's a very well-established proven model that we've built over a number of years. The consultative engagement and delivery model. The model has always been built this way, and it's evolved over time based on what the needs of our smaller clients are. We've talked a lot about the very beginning, the medical scientific expertise that's needed. You couple that with early engagement by a general partner. These clients need to understand they're not going to get lost in the huge company, especially after the merger, right, and that they're still gonna be important. There's this theory that the resources go to the largest customers and large pharma, and they're not gonna get the A team or the prioritization. When you can walk in and say, we have 8,000 people that are pointed directly at biotech, they have all biotech experience. That speaks volumes, and I'll show you a little bit of data on that in a few slides. Innovation, we had to continue to try to innovate, to make sure that we are being as efficient as possible, and delivering bespoke solutions because not all the solutions are the same for biotech. We have found over the years they've been more willing to adopt innovation earlier than pharma has. I'll show you a case study where we used that to accelerate timelines. All of this has been integrated into the sales process, which is really important. George talked about how the commercial divisions have been set up to mirror the operational divisions. The business development team for biotech is the legacy business development team. They're very familiar with how to sell this model. It starts at the beginning, like I said, with that early engagement. When we look at a protocol, and we go in for a meeting, we talk to them right then about what the data supports, what the enrollment rate supports, what countries they should be going to. We get them very involved and hooked, if you will, at the beginning with that expertise and kinda lay out the plan from proposal all the way through to bid defense, and then that's the project plan that we're gonna execute. The greatest part of this is through the merger now, we've completed all the pieces. Now we have additional services that we started cross-selling right away. Barry mentioned One Search for site selection. The biotech group has already transitioned to using One Search, which we're very excited about. We have examples where we've already been able to cross-sell across all the new services that we now have access to. For a biotech company, based on this model, they can come get all the breadth and depth of full service, but still have the feel of the attention and the small CRO that that general partner model provides. Why is this important? Because this is exactly what our clients want. We went out, and we talked to a series of customers or sorry, a series of clients, customers and non-customers, and all of them initially said that therapeutic expertise was the most important aspect in partnering. After we talked to them about the model, we told them the differences between the model and that we were truly set up as a biotech division. Everyone changed their answer to having a biotech experienced team as the number one characteristic. They said that they note the difference between having people come to the table that understand biotech versus doesn't is night and day. I think what's really important about our model, like I said, it's been purpose-built this way over the years and evolved, and they know that this model really does support biotech. They're savvy enough to tell the difference between when you just create a division that's called biotech that doesn't really have the same expertise and the model beginning to end the way we've set it up. This really validated the approach that we've taken. We've seen it continue. I mean, we're seeing more work in small and emerging biotech, along with partnership expansion in some of the larger biotechs, and it's all based on the very different elements that I went through with the model. I too will end with a case study. 2015, seven years ago, we started a relationship with this client with an oncology compound and a phase II study, and it was all that they had. We started out with heavy therapeutic expertise with them. We applied innovation where we needed to accelerate timelines. We pivoted when we had to pivot. The agility is really important with these clients. As time went on and the trust and the collaboration and the success continued, they ended up making us a sole provider. Over the course of that time, this relationship has grown from one phase II study to a sole provider with three assets across 16 different studies, with hundreds and hundreds of employees in the biotech division assigned to this particular client. We have a number of examples that are very similar of where we started out that way, built the trust, showed we could do this across multiple therapeutic areas, multiple assets, building teams that are dedicated to those clients, somewhat like a workforce, but full service, that often ends up in a preferred provider model, as opposed to just, you know, the one-off type of thing. What Barry was talking about large pharma being the long process, the preferred provider for partnerships. Biotech, we have an evolving customer mix. It changes, right? You have these examples where we have long-term partnerships, and we build on it, but we also have ones where we have very large studies, and they might have one or two molecules. You know, the change in the customer mix, you know, over the quarters or over the years, changes. I think that we have shown historically that we are able to do that. We have been able to pivot and replace clients, replace customers, focus on the right therapeutic areas. Our therapeutic expertise lines up very nicely with where the market development's being done. I think that again, the 8,000 people and how we deploy technology, DCT innovation going forward is what's gonna continue to differentiate us from our competitors. Now Samir Shah. Thanks, Tammy. Mm-hmm. Good afternoon, everyone. Just wanted to start by telling you that I'm the president of the Global Strategic Solutions division. I too joined Steve and the ICON team as part of the legacy PRA organization, along with Greg Licholai and Tammy. Let me start for those of you who are less familiar with the FSP business and just to ground you on it. Tammy and Barry both spoke about the external programmatic outsourcing or the full service business. The model as they've described is really outsourcing on projects and leveraging the expertise of the organizations, the systems, and processes. Certainly, it is a different business than what I'll describe. It is a higher gross margin business, and it really is based on capturing the infrastructure and the risk associated with doing full service work. The business that I'm in is what we call the FSP business, and that's the internal product development. We're leveraging the customer's SOPs, process, systems, and we're doing that in an efficient manner. We don't really do it on a trial-by-trial basis, but across the pipeline, and usually in particular functions, and I'll describe that in a few minutes. This is attractive to large pharma who wanna have strategic control of their portfolio and certainly gives them more of a direct connection to the processes, the systems, and also the investigators or their sites. It is a lower gross margin business, lower risk, and therefore it is one, you know, that has minimal infrastructure for the most part, and it's where we utilize full FTEs. Although that business is evolving, and Barry and I will talk about that further. I'm gonna start a little bit with my background for those of you who are familiar with the space. I joined the industry actually coming out of basic research, made no money and had to join the industry and that was about 26 years ago. Spent time in bio and pharma tech and CROs, and then 22 years ago joined an organization called RPS. That organization was the first in the FSP space. It was a staffing-type company. One of the first FSPs out there was the Wyeth- RPS relationship. I see a lot of heads nodding up and down. That business continued to grow, was bought by Warburg Pincus, and we continued to grow that business. That business was eventually bought by KKR along with PRA and that the business continued to grow. Through that, as Steve has already mentioned and as all of you know, PRA was bought by ICON and I have now the pleasure of leading that FSP business. My fiercest competitor was actually ICON, the DOCS business. Having now the combined business of both the Strategic Solutions business and the FSP business called DOCS all under one umbrella has made us the market leader in this business with over 14,000 employees. We have a partnership with 11 out of the 15 top pharma. One of them, as Barry mentioned, just came online right after the partnership. We're continuing to build the business not only with large pharma but with midsize pharma in what I call blended solutions, and I'll describe that in a few minutes. Very quickly, large pharma. For large pharma, we do FSP and embedded solutions. We also have done workforce transformations. Many of you have been familiar potentially with deals like Takeda, where we did an entire workforce transformation, and I'll describe that a little bit further in terms of our continued space. We're leveraging pharma's infrastructure, SOPs, process, and systems for the most part. In mid-size, it's slightly different. There we're consulting with them. They are in those build or buy stages, and those organizations are not only needing FSP solutions, but they need some of the infrastructure that sits around that inserted within their environment. We believe that's new to the mid-size pharma market. It's something that we're innovating on and continuing to build off the market. Now in terms of our customers, I wanted to give you a sense of them. First, you'll see it's aggregated with customers with staff around 200 to 500,000 plus to give you a sense of the scale of these relationships. But one of the more interesting aspect is the years of partnership that we have with them. As you'll see across the spectrum, we usually get in within an organization, start within one function and proliferate within that function and then adjacent spaces as Steve referred to as white space. You'll see those relationships over time have matured, have grown, and that's where we have continued to gain momentum within our large and mid-size pharmaceutical organizations. They are mature in size and in terms of dimension, but also multifunctional, but also in terms of years experience. Some of our relationships span 15, 20 years as you see towards the right. They're multiyear contracts, as many of you know, stable, predictable revenue, and generally it's one that's working across the pipeline. As Steve stated, though, that this is a great foundation for us to accelerate partnerships. We're able to, in some cases, upsell or bring in other solutions through what George described. This gives you a bit of the geographic cut, but more importantly, I wanted to focus on the functional areas. Traditionally, you may have thought of this business, those of you that are more familiar with it, as a monitoring business, a monitoring house, a CRA house. Monitoring is only 30% of what we do, and you'll see all the other functions that we're involved in. I did note the non-traditional areas in that as we continue to move in the spectrum and get more comfortable with pharmaceutical organizations, we're able to take on some of the more higher intellect functional activities such as regulatory or medical and scientific affairs. That's a key area of growth within these companies to not only start out in some of the areas that are rote in activity like monitoring and data management, but also the more higher level functions. Now being in the space over the last 22 years, the business has evolved. When I first was in the business, that's when the patent cliffs were coming, large pharma wasn't really growing, so they had to do layoffs or had to look at ways to variable-ize the workforce because they couldn't manage that, right? That's not happening anymore, right? Pharma's growing, single digits, but it is growing. The value proposition in the FSP model changes. What we're moving the business towards is more of a productivity-based organization, what I call a KPO. Those of you familiar with that, it's like a BPO, but more in the specialized area. As we do that, as Barry alluded to, you start to change the operating model. Absolutely, the premises that you use, the customer's SOPs, processing systems, but you adapt, you evolve from there. Within the new ICON, we have a lot of opportunity to leverage those capabilities and make those internal organizations within the pharmaceutical organizations more productive and more efficient in how they operate. That means changing the model slightly to not just traditional FTE modeling, but value-based operating models. Again, I think that's a great opportunity for us to continue to build in our FSP space and also to evolve them in what I call the FSP 2.0. That gives you a sense of what I said so far as we're in 11 out of the 15 top 15 biopharmaceutical organizations. We'll continue to expand with them. We're gonna go after the other 4, and so we'll have all 15 under our belt. In addition to that, how are we gonna continue to expand? One area is in the mid-size pharma space. I'll spend a few minutes to talk about that. We think that's a great opportunity that will continue to expand outside of the top 15. The other is in more nontraditional ways in terms of workforce transformations. Both legacy organizations have a lot of experience in rebadging pharmaceutical staff, and that, I think, we think is a key element of our continued expansion strategy. Finally, the blue ocean strategy in terms of continuing to expand in nontraditional areas and working with other nontraditional healthcare providers that Greg Licholai and others will talk about throughout the presentation. Let me spend some time on the mid-size pharma market. We are first in this area in terms of expanding outside of the large pharma space into the mid-size pharma space. Mid-size pharma is very different than large pharma in that they don't have all the systems, processes, and SOPs. What you have to do is you have to help build that for them within their organization. They are, again, in those build or buy stages. In terms of assets, they generally have 3 or 4 assets. Their pipeline has some perturbation, somewhere around 10%-20%. They generally are doing about $75 million-$100 million in R&D spend. Those are the ripe organizations by which you can leverage a strategy like this. What you're doing is it's not only about establishing and providing them the people, but in some cases, it's helping them establish a footprint in certain geographies and markets where they're not in today. In others, it's about providing more agile and blended solutions. The distance between the work that traditionally was in FSP and full service is getting a lot closer, and the work that Barry and I do together is to find solutions that make sense for those customers, agnostic to whether or not it's in a traditional FSP environment or a full service environment. Obviously, in some cases, we'll have to leverage ICON systems, processes, or help them with that selection. This is proven in a number of customers. One that I'll highlight as a case study is one in which we worked with an organization that primarily did full service outsourcing. It was in the rare disease space, and they had a lot of challenges because they needed to have a lot of control and a lot of connection with their investigators. Frankly, they didn't have a lot of success with full service outsourcing. What we did was we put together a model, and it required a lot of consultation with them to help them set up what the right processes and systems and operating models would be and insert that within their organization. It's what I call blended solution. When we have now delivered that solution, it's been in place for the last three years. That the organization has moved from 100% outsourced to now this blended model, where about 85% of that comes through the delivery from us. In terms of cost efficiencies, they've seen that, and they've also seen it in terms of timelines and efficiencies in terms of their cycle times. This is just one of several customers that we have evolved in the mid-size pharma space. I'll conclude by saying that it's a pleasure, obviously, to be leading the FSP business and being the market leader. Being a market leader is not just about size, but it's also about being the best and bringing new innovation to the market. You'll see that in our white papers, our talks, but more importantly, in our connection with customers. On the right side, you'll see last week we held a meeting with all of our key partners that are in our FSP space. About 30 partners came together, and we brought them together, operation procurement leader, and we're able to share data and insights and how we're operating and what's really competitive versus not competitive, ways where we can collaborate and become more efficient and more innovative. It was a pleasure to have Steve and the rest of the leadership team there and leverage the analytics of the ICON organization, where we're able to give them that insight into how they operate and working very closely with Tom O'Leary and his organization. With that, I wanna thank you, and I'll turn it over to Nuala. Nuala? Green, is it? Thank you, Samir. Good afternoon, everybody. My colleagues have spent some time talking about how we serve the various different market sectors, whether that's from a delivery perspective or indeed from a tailored resourcing perspective. In the next few minutes, I'm gonna touch a little bit about how we ensure that we can support development across all phases of drug development while commercializing products and while really focusing on how we can transform the way we actually conduct clinical research. In doing so, I feel that it's a good place to start in terms of really talking through the key areas of focus. The first is on how we can transform clinical trials. The second, you've heard a little bit about healthcare intelligence, and I'll talk a little bit about how we're using data to support both commercialization and also how we conduct clinical trials. I'll talk a little bit about our site and patient focus, which really is a strategic area of focus for us as an organization. It's also about how you bring it all together across phases of development and how you bring it together across all pharmaceutical or biotech sectors. It is a given that you need to start a clinical trial in an early clinic. It is a given that if you're running interventional trials, you need laboratory data. It's a given that you need sites, you need patients to really run through the process, and data can help you to inform that process. It's also important to think about the end in mind, which is why we have a commercialization group that is also focusing on real world intelligence, while supporting also pricing and market access. What I'm now gonna do is drill down to each of the five areas that are sitting in the development and commercialization organization. I will be brief, but I think it's important that you know what is available today to our customers, and what is available to really drive long-term transformation. It is a given I will start with the patient. It's a given that we always need to think about what's important for a patient, how they can be part of the equation, and how we can really make it easy for them to be part of a clinical trial. Our Accellacare site, or Accellacare, group, I should say, is composed of four key areas. The first being our site networks or our physician network. The second being our home health services, essentially our nursing capabilities. The third is how we actually access patients, what our digital outreach is. The fourth is really how we engage in a digital fashion with patients and with investigators, allowing us to train them and to ensure compliance. First, our site network is present across the U.S. and the EMEA region. The network is composed of over 100 physicians who are fully dedicated to clinical research, and they focus across therapeutic areas, albeit it's fair to say in the last couple of years, we've certainly had a strong focus on COVID development and have been involved in over 60 trials. I think you're probably also familiar that we played a predominant role in the first vaccine that did ensure emergency use approval. Why do we go to the site? It's because we've access to EMR. We've access to patient data. We're able to direct patients into trials. Patients consent to be part of a database, and they consent to actually being informed if a particular trial is in development. We've access to patients. We also have the ability to ask patients to provide data or indeed input on protocol design. Given that the world is shifting far more towards decentralization, being very prominent in home and health is really important to us. Being able to deploy our nurses to homes across the globe is really an important part of the solution. Moving on, I will touch on the second key area of focus for us, early development. We have clinics across North America and also across Europe. We have bioanalytical capabilities across the globe, and we also have presence in the Asia-Pacific region. I will not drill down into these various different locations, but you have a feel for the breadth of expertise and the geographic coverage. Given today is St. Patrick's Day, I should also call out that Ireland is at the center of the universe, and Happy St. Patrick's Day to you. I am Irish, of course. We also have laboratory and indeed imaging solutions that are available. These are again across the globe. Our central laboratory is a key component of all our trials, whether it's in the biotech or the pharmaceutical sector. Of course, those of you who are interested in imaging, it is a given that when you're working in an oncology trial, the majority of them actually do require imaging endpoints. This gives you a flavor for the breadth of the kind of central laboratory and imaging capabilities that we have, whether it's in kit building, logistical management, biomarker development, site support, and data services. That is the third key area of focus of this group. The fourth is really around commercialization. How do we help our customers bring their products to market? It's really a focus in four key areas. The first being in real world solutions, so we're very involved obviously in phase III-B, phase IV, long-term follow-up and extension studies, expanded access programs. We're very involved in registries, particularly in the field of rare diseases. This is actually coupled with a focus on patient-centered services. We also have a group called The Mapi Trust that provides a library of outcome assessments for patients. We have over 100 outcome assessments that are available. We are also able to develop and validate whether it's backwards, forwards translations to actually bring more tools to the marketplace. Decentralized trials, I think we're all talking an awful lot about, but certainly in the field of late phase research, being able to do observational trials or interventional trials in a far more decentralized fashion has really been the theme of this group as well. Medical device and diagnostics, we've been in this space for over 30 years, and we've certainly seen a strong growth in this area. We're certainly seeing now that there's a particular focus on cardiovascular development, whether that's with, you know, artificial heart stents and components. That remains to be an area of focus for us as we move forward. The last asset in, I suppose, the development and commercialization equation is really around the Symphony Health data. For those of you who are familiar with Symphony Health, it is a group that allows us to access data, whether it's in a clinical outcome setting, whether it's wearables data, registries, social media data, prescription data, et cetera. Really what this team does, they focus on bringing all this data together, and we actually have our own technology, Synoma, in-house that really allows us to analyze, consolidate, and provide the data back to our customers to help them be informed or indeed think about where they're actually commercializing their products. But also what we're striving to achieve with this group is how can this data be brought together to help inform protocol design. How can it help us understand where the patients are, in which city, how are they linked to the various different physicians, and in turn, how can we actually inform these patients that they can actually be part of a clinical trial. All of these groups are very unique in their own rights. They all provide certain capabilities. It's fair to say that as we shift from being traditional in how we deliver clinical trials to being decentralized, you need to have a mega site. You need to have nurses. You need to have the ability to go direct to patients to capture laboratory data. You need to be able to capture the data and bring it all in-house and this is facilitated by a digital platform. The reasons we have these groups, and we're working with these groups is to really drive faster site selection, to improve the volume of patients that are coming into trials. Ultimately, it's about ensuring that patients who are in trials are actually staying in the trials as well. This is where we see that the home health capabilities really play an important role. You know, it's kinda difficult if you're becoming more disabled, whether it's from a mental or a physical perspective, to really stay engaged in long-term trials. Being able to facilitate the patient being in a trial via home health is really an important area of focus. My colleague, Tom, will talk a little bit more about our digital focus. Suffice it to say, we do have a platform that allows us to run decentralized trials. I touched a little bit on FIRECREST that allows us to engage with investigators. We have an e-consent capability. We're able to communicate with patients in a telemedicine fashion. As I said, we're also able to bring the data together. We also have a roadmap that allows us to think about this in the long run. We've a dedicated team focused on decentralized trials that really allow us to think about how we can redesign protocols, how we can advise our customers as to what is possible and indeed capable if you wanna really try and speed up your trial or indeed ensure a better patient access. I will stop on that note, and I think at this moment in time, we take a break. Correct me if I'm wrong, Kate. Thank you very much. Okay. Thanks. We'll start the presentation back up, and I'll turn it over to Tom O'Leary to start with technology and innovation. Thanks, Tom. Many thanks, Kate. Welcome, everybody. I'm Tom O'Leary. I'm the Chief Information Officer here with ICON. I've been with ICON now just over 21 years and worked across the various parts of the organization. Delighted to be telling you about some of the capabilities that we have been developing within our organization and how this ultimately feeds into our healthcare intelligence strategy. I'll show you here the data that we're talking about when we talk about healthcare intelligence. You can see here on the left it is the patient data, the claims data, the EMR data, the imaging data, the lab data that we have got access to within ICON that we bring together in real time now every day, and we provide insights and informatics on that data to our own internal project teams as well as to our sponsors. That allows them to make informed decisions about the drug development pathways that they are considering. That's a really powerful set of insights that we give them in that data. We also look at the operational data. That is as important to them as well. They want to know what is happening. What is it taking to get the activities done and completed, and where do we see we're going to be as we look out in the week ahead, the month ahead, and ultimately to the end of the trial? To be able to deliver that in real time, to be able to deliver that into their hands on a real-time basis is a very powerful capability, and we leverage all of the latest analytic capabilities that are available in the marketplace to be able to provide that to them. You can see here all of the platforms that we leverage. The quantities of data are vast here, so we're exploiting the capabilities that are available in the cloud with Azure and with Amazon. We use those to be able to burst out into the environments that they provide to be able to provide that information very quickly and very easily. It's a highly modern, highly intuitive platform capability that we offer both internally and externally. We mentioned previously about the integration effort. It is going really well. Simon has guided us all along the way. He had us prepped right from the day in which the announcement was made as to what the expectation was. Delighted to be able to tell you that the Tier One systems, those systems are those enterprise systems, be it working with Brendan, with Oracle Financials, working with Joe on Workday, those Tier One systems are now rolling out. We knew exactly from the point at which we closed the deal, what systems we were going to be moving forward with from a Tier One basis. Right throughout Q3, Q4, We were into the delivery mode. We're doing it in a very controlled way in terms of the sunsetting of the system that is not going to be taken forward, and how we're bringing the data and the information across into the enterprise systems that we're going to be using into the future. We're not doing it in a big bang approach at any point in time. We're also enabling the communication and collaboration capabilities within the organization, so everybody is quickly and easily now able to communicate with each other on a day-to-day basis. Right from the start, we created a bridge between the two organizations, is probably the best way to think about it. Now we're bringing that together, everybody on the one integrated platform. Now, we're at a point where we're talking to Barry Balfe and Tammy Clerc and Nuala Murphy about the Tier Two systems. The operational systems that they employ on a day-to-day basis, and how we bring those together and how we can leverage those at an enterprise capacity within the organization, and again, sunset those systems that we don't think we're going to need going forward. That'll increase the efficiency, that'll increase the way in which the organization can leverage our resources, because we won't have to have people trained on three, four, five different sets of platforms. We'll be able to have people using the one platform to serve all of the areas of the business. Huge efficiencies to be achieved there, and that's something that we're advancing with every single day now in the organization. We touched on this, OneSearch, and a capability that we're immensely proud of, and a capability that you'll get the opportunity to see in a few moments' time. I can't overstate the amount of data that this brings together in the organization. You get a sense of it in terms of, you know, the 300 million patient lives. You get a sense of it in terms of the 180,000 institutions, the 371,000 studies that we've in there. That creates trillions of data points. The OneSearch capability is able to take that and answer the queries that our Site ID people are trying to answer for where do we go for the sites and the patients, on any one or a number of studies that we are bidding on a day-to-day basis. The AI capability there is also being leveraged. I guess maybe the best way to think about that, when you go onto Amazon and you buy a book, the next time you're on Amazon, it will suggest a similar book to you. The AI capabilities here with OneSearch are operating in a very same way. So it goes on and says, "Others have searched what you're searching for now, and this is what they selected," or it comes up with an alternative choice to what you have considered. People are able to bring that together. We talk about human being in the loop. It's ultimately the human is the one who makes that decision, but they are getting vast quantities of data assimilated down in a matter of seconds as to what choices they have from all of the data sources that we're leveraging within the ICON organization. The AI and machine learning capabilities are also being introduced right across the organization to increase the speed and efficiency with which we are cleaning our data across our data management organization, across our pharmacovigilance organization, across our laboratory, and all the areas that we are providing service. So it's really speeding up the cleansing of data processes. We're also leveraging RPA, robotic process automation. We use a platform called UiPath, and the beauty of what we've done is we've been able to take that and leverage it into the other side of the organization. Either the automation that legacy PRA was using, we're able to bring that into legacy ICON, and the automation that legacy ICON has been using, we're able to introduce that into legacy PRA. We're getting a real bang for our buck there at the moment in terms of the amount of automation that we're able to leverage, and we've a well-funded path forward in terms of the RPA opportunity that we have ultimately to be able to bring to the organization. It's becoming a critical dependency now. The speed at which we can get more of the data cleaned and more of the data available is really being significantly helped by our RPA capabilities. Our ICON Digital Platform, and again, you'll have the opportunity to see this as part of the demo. We have Jeff Bieler and Matt Harrington who are going to take you through this. Very important to point out here, the way in which we have designed the platform now is different to other competitors in the marketplace. We have taken an approach whereby the studies can be set up much faster, much more efficiently than what others have. We're bringing together the knowledge and experience that we have in legacy ICON, as well as the platform and capabilities that they had in legacy PRA. It is reducing the time very, very significantly in terms of what can be done and how quickly the studies can be deployed. You'll hear about capabilities such as planner and builder and the way in which we're able to take a protocol, the key information points in a protocol, and build the study in real time. That reduces the amount of technical knowledge that it takes to get studies up and available. It also increases the amount of study builds that you can do concurrently that we saw through COVID. There was a huge run to what the DCT could solve for through COVID. The thing that became the choke point there was there wasn't enough technical resources available to build out all of those studies with the expectation and the timeframe that was needed. We wanted to solve for that, and we have found a way to be able to solve for that in how we have designed our new DCT platform. Very much look forward to showing you that in anger. Maybe some of you will be brave enough to put on a blood pressure cuff, and we can see how excited you are about what we have developed here today. It's something that we're immensely proud of. Maybe to the point that Nuala and Barry were drawing upon as well, we've built this with the benefit of the knowledge and experience of the study teams that we have internally. This isn't guys off doing a tech fest to build out a capability and seeing does it have an application? This is study teams saying, "This is what needs to be done. This is the real-world setting in which the technology is being used, and this is what you need to be able to solve for." We very much sought to incorporate that into the design of what we have here today. As I say, in a few moments, we'll take you through how that works on a day-to-day basis. With that, I'll hand over to Greg Licholai. Greg will talk to you about some more of the capabilities that we have from an innovation perspective. Greg. Excellent. Thank you so much, Tom. That's a great background and a great lead into what I want to talk about. I am the Chief Medical and Innovation Officer, and I wanna wrap up some of the themes that you've been hearing around applied innovation, and what does that mean. I wanna talk to you about some specific examples of what we mean when we say we are becoming a healthcare intelligence organization. As you've heard, we have tremendous upside. We have a tremendous opportunity. We're an organization that now operates on a global scale to make a difference. How are we gonna make that difference is in the mission statement that you've heard, by creating better drugs faster for patients and for our sponsors. We have the ability to do that. You've heard some of the challenges earlier today. Despite the fact that over 75% of people say they would be willing to be in a clinical trial, however, somewhere only 3%-5% actually get offered the chance to be in a clinical trial. That means tremendous upside for us to be able to improve drug development, improve the speed of recruiting, improve diversity in drug development, and to bring trials closer to people. Those are kind of the concepts that we're focusing on when we talk about innovation, healthcare intelligence. Well, we step back. How are we gonna deliver this? How are we gonna deliver these missions now that we've got this opportunity and we've got this scale in front of us? The way we do this is by having a culture of innovation. As they say, you know, it takes a team, it takes a village. As has been mentioned before, you know, our innovation. Sure, we've got great technology. You've heard about that. Sure, we've got access to networks. Sure, we've got, you know, great, you know, apps and technology. Really what makes the huge difference is our people, our expertise. It's very important for us, and it's very important for our culture, for our people to be part of this engagement process around a culture of innovation, and I'll give you some specific examples around that. You know, one of the conversations that we have with our clients, whether it's big clients or small clients, we say, "Look, we're probably not gonna know your molecule better than you, but we've done thousands of trials in this space. We get dozens of drugs approved in this space. We get a perspective that you probably don't have. So we can help you, we can engage with you, we can think about how to do things better, how to do things different. I'm delighted to see that at all levels, our culture of innovation, our people are engaging with clients in a better and better way. Ultimately, it's for the patients. It's for the patient benefits. If we can do drug development better, everyone wins. Our areas of focus, very simply, are better diversity and health equity. Why? Well, it certainly is the right thing to do. It's the ethical thing to do, but it also means better drugs that reflect the patient journey and genetically what's going on with the patient, just a better reflection of a solution from a drug and pharmaceutical point of view. Our other focus is on networks. We talk about data networks, patient networks, site networks, and leveraging the networks that exist. Some are our own, but many are out there that we need to partner with, work with in order to speed drug development so that we can get to bringing the trial closer to the patient. Ultimately, that's the goal of decentralization, taking it from the center, the medical center, decentralizing it, and bringing it out to the patient themselves, making it easier for them to have a much better patient experience in order to be part of clinical trials. Let me get specific here. A couple of years ago, we sat down with one of the top global pharma companies with the cardiovascular leadership there who are looking at doing things differently. How were they going to achieve some of these goals in a really terrible disease, in congestive heart failure? They were working with academia, they were also working with regulators, and they were talking to a number of commercial partners. They quickly realized that there essentially was one CRO partner that they could work with to deliver an end-to-end digital solution, just like Tom was just talking about. An end-to-end digital solution to deliver a fully decentralized clinical trial. That led to. Well, you know, talk about culture of innovation. That led to us building up the teams, building up a new knowledge base to create a new type of solution. Well, unbeknownst to us, as we did this, we launched right at the beginning of the pandemic. I mean, this was an experiment that had to be done. We didn't know that it was gonna be done in such a dramatic way, that we're gonna launch a decentralized trial away from the medical centers right at the time when medical centers were closing their doors to bring patients in for non-acute work and clinical trials. This launched in spring of 2020, and thrilled to now come to this conclusion that the results now have been published in a number of places, including Nature Medicine, one of the most prestigious academic peer-reviewed journals in the world. It was published here, not because of the class of medication, which is important, but those publications had already been done, not because of the disease category. Those publications had already been done. Because of the methodology. This is a method paper that came out in Circulation. This is the first successful, fully decentralized clinical trial results that have been published. That's why it shows up in Nature Medicine, and a 400% improvement in diversity. This is a disease where we have to be very conscious of the patient mix and are we getting the right patient mix. You know, our healthcare system isn't so great about health equity and diversity. This is a huge step in the right direction to get clinical trials closer to patients so that we have better diversity reflected, and we can have these solutions, not just during pandemics, but overall. We're also. That's one example. We're also trying to build the bridge to the last mile to get to the patients. Now, how do we think about that? We think about these data networks, patient networks, and site networks. You know, these are. You know, I can tell you about these partnerships, but it's not so much the specific partnerships, but the concept that we're working with a number of partners who have extensive data and extensive site relationships. You know, here's an example where they've got hundreds of oncologists, oncology sites. They're using AI technology, machine learning and artificial intelligence to focus in, to find patients for very difficult to recruit clinical trials, oncology clinical trials, combining genetics as well as the phenotype of the patients, et cetera, to take things where you know, examples where we hadn't had any recruitment, and now we're able to recruit patients based on this. You know, this is another example where we're working with a much broader network, one of the top EMR companies, Veradigm, Allscripts, to bring, in this case, millions of patient records for their EMR to do machine learning, artificial intelligence to do better recruitment, bringing the clinical trial to the patient, closer to the patient, so we can increase the speed of enrollment, increase diversity, and do better drug development. Let me end on this. How do we think about data? What is one terrific example of being able to use data? As Steve had mentioned before, one of the dreams of being able to use healthcare data is to follow patients silently in the background in a longitudinal way so that you can monitor what's going on with their safety, with adverse events, with efficacy. Just imagine if we were able to do this when the thousands of patients were being enrolled in COVID. Everyone's very concerned about long COVID. We didn't even have that phrase when these trials were starting. Now everyone's concerned about long COVID. This gives us the opportunity to track that. How? It's a completely compliant algorithm that links clinical trials, clinical trial data to real-world data. So once patients are in a clinical trial, after that clinical trial ends, well, that's kind of when the data set ends. Yeah, you can do some things and open it up, but that's kind of where the data set ends. Obviously, that's not where the patient experience ends. That's not where the disease ends. How do we continue to monitor those patients? Well, this gives us a method to link that clinical data to the vast real-world data sets that we have, that we're partnering with, that we're expanding, that we're building, so that we can follow these patients in a longitudinal way. Think of this as a virtual registries that allow us to perpetually monitor. Again, fully compliant, everyone's permission. It's monitored by an outside organization, fully compliant. We can monitor these patients perpetually to track disease. Think of what we could do with oncology. Sure, it's incredibly important to see the short-term results, and many drugs are approved based on relatively short-term survival results. Incredibly important. Now we get to track them over a longitudinal basis, see how they've switched from drug to drug, see what other effects they're having, see what's happening in the real world. I hope that gives you some perspective of why we're excited, why we think we're really at the precipice of a terrific opportunity and wanna continue this work. With that, I will introduce the person we've been waiting for. Our Chief Financial Officer, who will answer all our questions. Thank you. answer questions. As most of the analysts know, answering questions is not something I do terribly well. We'll have a look at some financial information, and then we'll get on to the question and answer session, and spend some time with that. All right. I suppose we wanted to start off by saying, to an extent, even though we've come through a big transaction in the last little while, fundamentally, we haven't changed our spots, right? We still are the same organization from a financial mindset we always were, and that centers around these pivotal pieces of how we think about our P&L account and how we run our organization from a financial perspective. Long-term sustainable growth rates, margin optimization leading to EPS growth, disciplined capital deployment, high levels of cash generation. Delighted to see that continuing, obviously, in the combined organization over the first six months and really seeing great cash generation and leading to obvious return for shareholders. That's what we're about as we go forward, as it has been what we have been about over the last number of years, as a standalone entity. The market has been good. We have had solid business wins, as you guys know, and you've tracked this data as closely as we do. We've seen a really strong response. All of the presidents spoke to that in terms of their business presentations today. You saw some of the specific case studies today as well. They give you a real feeling for how we're developing this marketplace. We see it being strong. We've seen that in Q3, Q4. As we come into this year, we continue to see a really solid marketplace. Well supported marketplace, leading us to that ability to really continue to drive that new target or the target we're kind of renewing today of 7%-9% in terms of top-line annual growth rates and our expectation for that over the next number of years. I suppose turning to revenue, obviously, this slide is an apples and oranges slide, okay? You've got the combined organization moving from Q3 to Q4 and the standalone ICON legacy organization prior to that. I think that one of the points that becomes apparent when you look at this slide, it bumps up and down. We have Q2 2020 there dropping. What you really see is that step in between Q4 and Q1, where you saw that big uplift. That has really continued, and I think that's the point to make in Q3, Q4. If we had this slide that was the back through time for the combined organization over the full two-year periods, you'd see a 25% lift in revenue from 2020 into 2021. That strength of the combined organization is one of the reasons we came together in the first place. We knew we were two really strong organizations moving in the right direction. That overall strength really driving the revenue, as I said, into the back half of 2021, and the expectations are certainly that that will continue as we go forward. The margin profile, again, it's a little bit of an apples and oranges slide. You do have, obviously, we were coming through an odd year here. As we all know, the world stopped in Q2 2020, and then we got to using our technology advantage to be able to deliver something that looked more like normality as we got into Q3 and Q4 of 2020. Then we saw some of the pass-through pieces that we've all been tearing our hair out about over the last year and a half, right? How that's muddled the numbers, how it's impacted upon the margin profiles. You can see that impacting in Q1, Q2. Well, obviously then we're into Q3, Q4, we've got our combined organization. I suppose the news that really we've made the point in the past, I wanted to reiterate it here today, is that 17.7 is a pretty decent jumping off point in terms of that pass-through mix that we saw in Q4. We do expect, obviously, that's creating a headwind in terms of the ASC 606 revenue from year, 2021 into 2022. But from a margin perspective, in terms of how you think about your margin profiles as you go forward for the next couple of quarters, 17.7 is not a bad way to think about as we jump off into Q1 and as we're going through that at the moment. I think one of the things that I did really wanna point out on this particular slide is the EBITDA story. One of the things that was really impressive, I felt, in the combined organization was how strong the EBITDA profile was as we came through the course of 2021, particularly. Again, we have an apples and oranges slide, right? We have the first section of time that reflects the ICON standalone business, and then obviously it's amazing what you do when you buy a company that's equals your size. It's how you can increase those bars. The point here is that if we were comparing the like-for-like organizations, just like revenue increasing 25% year-over-year from 2020 to 2021, EBITDA did exactly the same thing. 25% increase year-over-year. That gets back to the point that while we did have those pass-throughs muddying the numbers, we did an excellent job on making sure the top-line growth got down to the bottom line and back into our cash flows and all of those pieces that are so important in terms of delivery. Really good job in managing margin profile as we came through those big COVID vaccine studies. Earnings per share. Again, it speaks to exactly what I was talking about in the previous slide. We were able to continue to leverage our organization. There's obviously, you know, we've come now to a position where we in the back half of 2021, we had a tax rate of about 17%. That's dropped to 16.5% as we've modeled out for 2022. We saw obviously that good growth rate of the 25% EBITDA that I was talking to really dropping through, and you can see 21% year-over-year growth in 2021 from an earnings per share perspective. That's obviously even with the level of debt that we now have on board as a result of the transaction that we completed back in the July 1, 2021. Good progress made there, and obviously it sets up the map in terms of how we think we're going to go forward in terms of our continued EPS expansion. How do we wanna think about our capital deployment, and how we use our balance sheet and those pieces over the next number of years really, but certainly in the short term, our leverage position, as you guys know, our priority is still pay down of debt. That is with something we've said and is clear. We wanna get back to where we've been over time, which is the 2.5% level. We do think that's important psychologically, but also from an investment attractiveness point of view. We want to be back in that investment grade territory, as you can see there as well. We think that 2.5 times leverage point is the right way to think about it. We also think that's probably the right way to think about our future debt levels. We're not going back to big cash balances. We're not going back to zero multiples of EBITDA debt. We certainly think 2.5 times is the right rate as we go forward. Likewise, we have a more short-term ambition of being under 3, certainly by the end of the year, 2022, with the, I suppose, hope and ambition of maybe even getting down to 2.5 times before the end of this year, and that's certainly what we're working towards. As you'll recall, we did authorize $100 million of buyback in the last time we had a call, our earnings call, for Q4. We'll update you on the progress of that buyback by the end of the quarter. It was, as you know, $100 million probably doesn't move the dial that much in terms of capital deployment or even our overall share count. It was to give a signal to the market at that point that we feel there's a lot of value in the share price at the moment with the way markets have performed in the first chunk of 2022. Our M&A, we haven't really changed focus here. We've talked a lot today, and you've heard a lot of information from all of my colleagues around how we're thinking about the future. It's around technology. It's around developing the organization. It's around moving the dial in terms of clinical research. That's certainly what you can see when we look at the focus areas from our M&A perspective. We're still thinking about, as Nuala spoke about, the site and patient solution. That has to be core to what we're doing, the site, the doctor, and the patient. The DCT platforms that we will talk about and which you'll see in a moment in terms of the technology platforms. Continuing to develop our lab services, which have been very successful over the last number of years in developing new business, but also now reaching a whole new marketplace from a biotech perspective with the addition of Themis group. Of course, data and analytics being key to how we think about evolving clinical research as we go forward and really being a healthcare intelligence organization. $150 million of CapEx on an annual basis is our expectation for 2022. It's in around 2% of revenues. That's how we think about that. We'll be continuing on that basis, and obviously looking at all of the areas really in M&A to the same extent. When we talk about where do we spend our money, it's on IT, it's on the infrastructure, it's on the laboratory early phase businesses. It's on building those things that we think will give us the most advantage as we go forward as an organization. A quick update on integration in terms of the synergies piece, where we stand on this. As you guys know, we set out our synergies targets from a cost perspective and from a revenue perspective. The cost perspective was $150 million of synergies. We said we would attack those over a number of years, and you can see from our starting point in mid-2021 out through 2024, we're still targeting $150 million at this point. We've made good progress. We are now realizing $75 million or half of those synergies in 2022. Actions have been taken in 2021 to deliver those savings in 2022. Likewise, we feel that by 2023, we will deliver $113 million of incremental savings from the legacy organizations, and then delivering $150 million of those additional synergies in the full year 2024. That's how we've talked about it and think about it. These are the areas that we've tackled so far. You know, Jim is in the room here. I'm sure at the breakout and Q&A, we'll talk about what we're doing from a facilities perspective. If you had visited us a little while ago, and some of you who have will know that we were in the ICON old legacy business was about 15 minutes away by car from here. We're now consolidating our office footprint. And all of the other elements that are probably the easier chewing stuff that we've done at the early stage, the stuff we need to do in the 2023 and 2024 periods, and that's why it takes a bit more time, is around IT infrastructure, right team, right location, and getting the organization more integrated from that perspective. The piece George made reference to it in terms of the cross-sell, we see a lot of traction on that. You can see even in Q4 of 2021, we did in excess of $30 million that we would not have done had it not been for the transaction. I think I just wanna be super clear on what we say when we mean cross-sell. It is not the advantage of the combination of both businesses being brought together in terms of the scale and geographic footprint, right? When a pharma company comes in to us and says, "You guys are number one in the marketplace. We think you're amazing. We want to do business with you," that is not what we're talking about when we're doing cross-sell. This is existing customers using a broader spectrum of our existing services. It's our biotech partners using the lab. It's our existing pharma customers using early phase that they wouldn't have had in the Legacy ICON organization. That's what we're talking about there, and our ambition is really to make sure that by 2024, by the end of 2024, leaving 2024, that we have set up a revenue of additional $100 million coming in. Of course, the business wins number will take a bit of time to churn through, and that's why we have a slightly longer trajectory on that one. I wanted to spend a moment to talk about some of the pieces that we use in terms of our global business service model. This is something that you guys would be familiar with, speaking with me and over time over the last number of years in terms of how we structure our cost services and how we deliver services, whether it be IT or finance or admin, facilities and all those other pieces, HR, that we deliver to our business units and business services. We have a very centralized process. We standardize. We centralize. We do not have a distributed model, so we have most of our people in the world being centralized into time zone hubs. You've got the EMEA region predominantly out of Ireland. You've got India supporting a lot of our APAC regions, as well as the Philippines. Of course, you've got probably an element here in North America but also a very large hub in Mexico supporting our western territories. It's very much around centralizing, so we don't have hubs of people scattered around the place from a back office support perspective, which is about standardizing and using similar processes and similar systems. Tom made reference to the fact that we're moving towards those systems. We're not picking new systems. We're not trying to integrate the world, so half the organization is already up. What we need to do is bring the other half up, or as appropriate in terms of the system that we're using. That's gonna really have a significant impact in terms of our ability to bring consistent service and delivery to our operations partners and obviously to make sure that we're optimizing from a cost perspective. You know, we've used technology, and we continue to use technology. You've heard me talk about in the past about RPA process automation. That effectively brings some of the more basic work back to being completed by machines or being completed by robotics. During the Q1 of this year, we saw the equivalent of about 200 people, their time being taken off and being able to be RPA'd, okay? So that's a significant step from where we were a couple years ago. You would have heard me talking about this being pilot projects into getting it up and running. Myself and Tom have been working on this for many years, and Center of Excellence has been established, and we are now really making significant progress. I said 200 people who would've otherwise been doing stuff that they can now focus on more higher value tasks and be more efficient with their time now is being taken off their hands and being done by bots, which is excellent to see. I suppose the last thing as well comes back to our culture as an organization. We are a zero-based philosophy culture in terms of costing. We question everything, and we look at everything, and we do have that diligence about it. I'm sure I drive my presidents around the bend, and they can talk to you about that after over a drink possibly later on. It is something that is absolutely integral to how we run our organization and the mindset we have around just questioning and making sure that we are really delivering value. All of those things added together gives us a brilliant opportunity to leverage our cost base and to drive what I think is a really important point here is the last point in the page, a strong working capital management, which leads to good really solid cash flow and cash generation. When we talk about our P&L account, when we talk about EBITDA, we're really getting that as cash in bank and making sure we can utilize that to continue to build the company but also to return value to shareholders. No change here. This is not, I suppose, the slide du jour in terms of our big ambition for 2025. We'll get to that in a second. I just wanted to reiterate some of the targets we set out at the beginning of the year, and of course, that's revenue in the same range of 42%-47% of an increase year-over-year, $770-$805. EPS in the 11.55-11.95 proportional range, 20%-24% up year-over-year. You'll see probably the only adjustment we've made here is obviously to say that this does include the share repurchase. As I said earlier, the $100 million doesn't move the dial that much, and certainly we'll talk to that a little bit more, but it's a couple of pennies there from an additional EPS perspective. That's included in that existing range. The other point maybe to point out as well is, of course, when we model this and we put it together, we had an exchange rate of the euros, US dollar to the euro of $1.15. Obviously you'll all know that that's now moved down to $1.10. That has a couple of different pieces and impact. We'll update you on that as we go through the course of the year. For now, we're very happy that our guidance, as set out today, is as it stands. Now, I suppose coming to this as my second to last slide before we have a chance to get you guys up and have some Q&A, which I'm sure you'll find much more beneficial than listening to me. Steve said it at the beginning of the meeting. We have our ambition of getting to $10 billion by 2025. That means high single-digit growth off our current base. We feel that the market is well supported to do that. We feel that we're in a position where we can take share, and we can really drive the engine of the organization to make sure we deliver on that on an annual basis over the next number of years. A very realistic goal from our perspective. We're talking about getting from 18%-21% EBITDA. This is slightly new because we're talking about getting 14%-15%, there or thereabouts, in terms of annual CAGR on our growth rates on EBITDA. That's an ambition, obviously, of 100 basis points a year. Again, we think that's something where we've got experience at delivering that kind of margin expansion. We'll do that both through the development of our gross margin, which, as you guys know, exiting Q4, we were in the ballpark of 28%, so we need to continue to move on that direction, but also through further leverage of our SG&A, and it was on my previous slide. Indeed, it's one of the things we're talking about in terms of how do we get that to 9% and indeed below 9% as we think about our operational makeup of our EBITDA over time. We do feel 1% increase year-over-year as we go through the next number of years, up to 21% is very doable, and that obviously will deliver mid-teens growth on an annual basis as we go through the next 3 years as well from an EPS perspective. I should say mid-teens plus, of course, because our EBITDA is growing at mid-teens. Mid-teens plus growth, which is obviously, very, very attractive. Okay. Finally, I'm gonna end on this, and then I'll hand back over to Steve to do a quick summation. We just, again, wanted to set out the principles of how we get to the targets that we've set out today. Then we've talked about this, so I won't insult your intelligence by going through it too much. We do feel we've got a market that supports the growth. We do feel that we have the ability to take market share as we go through the next number of years, that we're gonna see those $100 million of revenue synergies, and we're gonna drive past them if we can indeed. We've got a well-supported environment from a book-to-bill perspective that should be able to deliver us in that 1.2-1.3 range. Certainly, we've seen that in the first six months of our combination. In terms of our EBITDA margin expansions, I spoke to it a moment ago. We still wanna develop up that gross margin, push back towards those 29%-30% levels that we've seen in the past. We need to make sure that, as you guys know, in an inflationary environment, that our pricing is reflected in how we do this and make sure that that is well managed. That's something that we have been able to do over the last number of quarters, so happy with that and the progress we're making there. Gives us confidence about being able to continue to work with our gross margin and drive it in the right direction over the next number of years. Of course, the fact that we're going to and I think we've got very good visibility to delivering our SG&A down to the levels we talked about. Certainly sub 9% is something that we think is very, very realistic and doable over the next number of years. With all of that said, I'll hand back to Steve for just one quick summation slide before we go to our Q&A session. Great. Thanks, Brendan. I hope over the course of the last couple of hours, you've got a sense of where ICON, the new ICON is going as an organization and what we want to do within our industry. You've had a chance to meet the management team. I believe a very strong management team, very competent in all of their areas. We bring together that technical expertise, that drug development expertise, that therapeutic functional with a very strong global business services group. Just to reiterate the messages that I started out with, we want to become, and it's an aspirational message, but we want to become a healthcare intelligence organization. We believe that's the way to change the industry. We're past the arms and legs. I've been in the industry now for, well, way too long, 25 years. I know when I first came in, actually, when I worked with pharma prior to being in the CRO industry, CROs were muscles. They were arms and legs. You know, you brought them in to help, you know, get your NDA done or help finish your clinical trial. It was a very tactical sort of approach. Over the last 20 years, and particularly, I think, over the last 5 to 10, it's moved. We wanna take that next step to really become that healthcare intelligence partner of choice. The data, the analytics, the decisions, and then the implementation of those decisions to bring drugs and devices to market faster. We think the market fundamentals are strong. You've got a sense of that as we've gone through. Large pharma growing, biotech's strong. We believe we're in a good environment to continue to grow our business over the longer term and the medium term. We have that commitment in terms of technology, in terms of investment. We have plans specifically to invest in data, to invest in our organization such that we can become that healthcare intelligence organization. The integration is going well. You heard a little bit more from that. Joe, and Diaramid and Simon are available to you if you have specific questions on that area. It generally is going very, very well. We're really pleased with the way. As I say to my board, if someone had said to me, you know, a year ago as we kind of announced the merger of the two companies, that we'd be in the position we're in now, I'd have taken it with both hands and grabbed it. We really are very pleased with the way things have moved forward, the way the team's coming together, not just at the senior management level, but at all levels within the organization. Then as Brendan has eloquently pointed out to you and shown you, we've got good plans, strong plans for driving the organization forward, for leveraging our global business services, for improving our gross margins as we go forward, and ultimately improving our value to shareholders. With that, I'll wrap up, and we'll have, I think, 30 minutes or so for questions. Kate, is that Yeah. With you. That's the plan. We'll start with questions in the audience here. If you do have questions via the webcast, you can submit them. We'll take the questions in the room first, and then as time allows, we'll take questions from the webcast as well. Patrick's right on it. He's going to kick us off here. Great. Thank you. Yeah, it's Patrick Donnelly from Citi. I guess maybe on the revenue synergy side. I know you guys talked about $100 million. It seems like good progress already in terms of some of the cross-sell. Can you just talk about the traction you've seen to date? It seems like that number is conservative in terms of the amount of deals you're already in on- Right in the conversations that you weren't before. Can you maybe just talk about that opportunity and again, what you've seen in the couple quarters here since close? Sure. Let me take that and then Brendan might jump in. I think as Brendan said, we're kind of pretty focused on what those revenue synergies are. It's revenue that's coming to us that wouldn't otherwise come unless we'd come together. It's really around the labs, our imaging, home healthcare. We're very specific in terms of how we're tracking that. There'll be other more peripheral type of revenues that come together because we've got the scale, because we're a bigger partner in the marketplace. You know, so you're right, Patrick. It's a relatively conservative number, but it's one that we think is very doable. We may well update as we go forward, but we believe it's something that we can deliver on. Absolutely. It does take a bit of time. This, you know, what you've seen, we delivered $30 million in new awards. We have targets, you know, going forward on an annual basis that will drive that $100 million and possibly plus, but at this stage, we're sticking with that relatively conservative sort of formula. Do you wanna jump in? Yeah, no. I was joking with George this morning to remind him that unfortunately in our business business wins don't turn exactly one for one to revenue over time. We were saying that $30 million was a good start, but we're ambitious about doing more and in order to get to that $100 million over time, we'll certainly need to continue at that rate and actually probably go beyond it as well. I think that's the opportunity, right? As we develop, I mean, it was a really good start. As we develop as a company, can we do more than that? Yeah, we're ambitious to do more than that, but like you've heard from us down through the years, we'll, we don't really tend to set goals if we don't feel like we can hit them. We will be at that $100 million and then we'll talk from there. Okay. That's helpful. Steve, maybe just on the biotech side, the early stage, obviously a big focus for everyone. I guess when you think about that 7%-9% growth, obviously I expect you're not thinking that we're gonna bounce back to where the funding was a year ago. I mean, what's the sufficient level that you need to see for to kind of execute on that? Again, I think you've talked about it being 15% of revenue, so it's not the biggest piece, but again, to your point, there's cash out there now. I guess when do we need to see funding come back for you to be comfortable, or do you feel again, the landscape's healthy, at some point we get back to, you know, levels that we saw a few years ago, and that's sufficient for you to execute on? Yeah, I think if you look at that trend, that pattern of biotech funding, there is a kind of a three-year, you know, up and down on that. We possibly are on a little bit of a downturn now that'll probably, I think, start coming back up again in, you know, a couple of years, 2024, 2025. As that pattern, it is up and down, but it's kind of up and down up. If that pattern continues as we've seen, we feel very confident that that will sustain our ambitions in those capital market dependent companies and the broader biotech space. Okay, perfect. Last one, probably for Brendan, just on the margin outlook. Should we think of that kind of linear, 100 bps a year? Just again, visibility into that. Obviously, the cost synergies stay the same, but clearly, you know, some good internal improvements. Maybe just talk through kind of the visibility into that and how we should expect it to track over the three years. Yeah, no. I mean, the way we're modeling it certainly is in terms of 100 basis points on an annual basis. You know, you've got 2018, 2019, 2020, and 2021 as you go through the next three to four years, you know, including 2022. We do think that that is an ambitious but attainable goal as we go through those years. I think it comes back to how we get there is very much around the synergies will play into that model certainly. I've always been, and I've said it to you guys in the past, synergies are something we talk about when we do deals, but cost management goes way beyond synergies. In order to get to that kind of ambitious goal, you have to be, have that mindset of always kind of resetting the dial on the year as you come into it. We'll, you know, in order to get there, yeah, we'll need the $150 million synergies. We'll need more than that from our cost efficiency perspective. I think the way we'll think and talk to that is really around our ambition around margin and margin expansion. Certainly at the moment, we would certainly see it as about 100 basis points on an annual basis in terms of additional expansion. Thank you, guys. Next question. Hi, guys. Thanks so much for the question. Elizabeth Anderson from Evercore. As we think about particularly in pharma, the additional opportunities and sort of the share gains that you guys are seeing there, where do you see sort of the most, you know, resonance with clients on that side? Is it really like the additional scale? Is it sort of new geographies? Is it different capabilities than you'd traditionally been offering? Thanks. I think the answer to that, Elizabeth, is yes. It's all of those things. I'll ask Barry to comment in a moment, but you know, there's no one magic bullet or magic formula for any particular customer. They all need those sorts of things. Some need some things more than others. Some of it's more scale. Other it's more therapeutic expertise. Others, it's a more innovative model. Others, go down the FSP route and then transfer or move into other areas. You know, we don't necessarily need to be all things to all people, but we have a suite of services and a scale in those suite of services that we can pick off the shelf and bring to bear in a compelling and an integrated fashion that really customizes the solution for our customers, particularly the larger pharma customers. Do you wanna comment? Yeah. It's hard to disagree. I think certainly scale is a factor. We talked about these large global complex portfolios and having the scale but also the range of expertise to deliver on them, I would say, is point one of three. You mentioned in your question, and Steve acknowledged differentiated capabilities. We've talked about the sum of our parts being greater, and I think that's important. The third one, quite honestly, is about being able to nimbly- Customize those solutions to deploy, particularly in our pharma landscape, where their existing infrastructure and their existing partnerships may vary which elements of the ICON ecosystem they want to interact with and how. There is this notion of becoming more agile as we get larger to ensure we can customize and really tailor those solutions. That's the third one I would add. All right. Maybe a quick definitional question for Brendan. The cost synergies, is that like a run rate number for the full year? Yes. It is. Okay. When you see on that slide, when we talk about the 75, so that's actioned in 2021, will be realized in 2022. Likewise, it's cumulative as you get to the next number and cumulative as you get to the next. There will be realized savings in those years cumulatively. Thanks. We'll just keep it in the middle row here. Hey, it's Eric Coldwell at Baird. I have a smattering of questions across different people. First, no particular order. The commentary on the big pharma MSAs preferred partnership deals being available in the market, I'm curious what the main drivers are. Is it disruptions from past M&A in the group? Is it needing to change in a world that changed dramatically with COVID? Is it the notion that a number of three, four, five-year deals didn't get renewed because of COVID for two years and now we are playing catch-up on pharma's going through a natural cycle? Just maybe a little bit more on the landscape of what is going on with the big pharma rules? Sure. I mean, I'll start. George can jump in, Eric. I mean, you know, with those big pharma deals, they typically do have a 3-5-year kinda run rate. You know, customers work with a CRO for that period of time and then decide that, I mean, they want to do a renewal process. They even if it's going reasonably well, they wanna do that because they wanna see what's out there pricing-wise, capability-wise, technology-wise. I would say that, you know, that sort of force of regular assessment is probably the main driver. Most of our competitors do a pretty competent job in that. As you come in and compete in those deals when you're not, incumbency is an advantage. We certainly find incumbency is an advantage. Where you can be really creative and where you can change it up and where you can be really, you know, aggressive, not, you know, not in pricing is always an issue, but in terms of innovation, you really can, you can really turn their heads a little bit. I think we now have that ability and that opportunity to turn their heads a little bit in terms of what we're doing on the innovation front. Do you wanna talk? Yeah, I would agree with that. There's sort of a natural pace and cycle in which people do it. If you wait for them to call and say, "We're gonna go through that process again," right? You stand a one in two, one in three, one in four chance of getting it. I do think what we have seen more of, I've seen it, he has seen it, given our size now, is inclination for people to wanna talk and then, you know. Our job is to get in front of that, to try and engage in those conversations. As things evolve, certain needs aren't getting met in the context of who they have. They'll ask you to take a little something on and then a little something else, and they're really trying to get a sense of that. Then by the time a preferred providership process starts, or they just decide to add one, you're really well-positioned. There's been a lot of that going on in the last 6-12 months, as people are kinda curious what's going on, and they have some needs, and they're really looking around in advance of any reconsideration of their current base at whether or not, at our scale now, we might be an attractive addition or replacement or supplement to that. We need to take advantage of that. My next one's for Samir. You went through a number of categories that could drive FSP Strategic Solutions growth. Getting into the remainder of the big pharma you're not working with, one example. I am curious, you talked about mid-tier expansion. What is the smallest client you work with today? What's the smallest you've seen? And what I'm getting to is, are we talking about clients number 25 to 100 on earth, or is it 25 to 1,000 that could be a potential client? Thanks for the question, Eric. Traditionally, when I define mid-tier, it's after 15, so 16 through 40. Because FSP, by nature, is going to be heavily skewed towards only. That. The largest clients. That's right. That's right. Now, that being the case, we do have strategic deals within Tammy's organization, for example, whereby she is with very small companies that are beholden to her organization, but they need some FSP complementary services. That's, I think, you know, a uniqueness that we have in the new ICON, is that we can do that even for small biotech companies. Is it my bread and butter? Is it what I do every day? No. It's something that we will do strategically. To answer your question specifically, for mid-size, we have shown you that it's after in the slide that Steve showed you, after number 20. But I think of it as from 16 onwards. Those are organizations that have multiple assets. They do at least $75 million-$100 million in development, and they're in that build or buy stage, whereby they want some infrastructure, but they are not sure how they're gonna do it, and they were beholden fully to full services in the past. Is that helpful? Yes. Thank you. Last one for now. Brendan, I personally thought it was a great update today. Loved the long-term numbers. 100 basis points a year is pretty sexy, if I have to say that. [inaudible] I figured. Financial geeks. Here's the question, though. Tactically. You previously talked about. Look, we all know you have COVID comps, right? That's pretty obvious, and big pass-through comps. Yeah. Tactically, you've talked about Q1 being on the lower end of your growth goal for this year. Yeah. Since then, we've seen a stronger dollar and the unfortunate situation in Russia, Ukraine. You wanna help us out a little on where you really feel about 1Q revenue, so when we get there, everybody's in the right place? Yeah, do you just want me to tell you the numbers now and we're gonna go home? Does this feel like Dublin 2016 all over again? Look, I y eah, no. No. You're right. Unfortunately, we are for the first half of the year, we're obviously going through that headwind of those big COVID revenues that we had last year. It's ASC 606 revenue accounting, right? It's a bunch of pass-through. I can tell you, the quality of the revenue this year in Q1, Q2 is gonna be a lot stronger. It's gonna deliver a lot more EBITDA and subsequently EPS, right? This is a revenue story and mix of revenue story for the first half of the year. We've already said that we felt that our direct fee revenues were, you know, in a good, strong growth position as we go through the course of this year, and probably just as good as the numbers that we put up there. If not even a little better, from the longer term growth perspective. That I think is something to bear in mind. You're also right, though, that we've got a couple of other headwinds. We've got the Ukraine-Russia situation. That probably has in the Q1. It's hard to measure for the full year. We've said on the slides that we put up in front of you guys there that it was a 2% of our revenue for as an organization. You would've picked that up. It's not only 2% headcount, but it's also 2% of revenue. For the Q1, there's probably a $4 million-$5 million impact there that we need to manage and work through. That is something that you should be thinking about. The FX elements as we go through the remainder of the year, I think are something that, again, as I said on the slide, we've moved from $1.15 - $1.10. Right now as we think about that, I'm not sure if it has a massive impact on the Q1, but as we get through the quarters, certainly we'll give you an update in terms of how that looks and how that will impact, particularly the second half of the year and as we get into that piece. Now, you know, none of these things are absolutes, right? So we could be. Hopefully, in a couple of months' time we'll be in a better position. The euro/dollar may have recovered a bit, and we'll be in a different position again. I don't wanna get out ahead of my skis on this one at this point. Certainly in the Q1, I think it probably is fair to say the Ukraine-Russia issue is gonna cause a bit of an issue, too. Yeah. Yeah, I think Brendan has characterized it pretty well, Eric. I would also say that as we get to the second part of the year, you know, one of the things that the team's doing very actively at the moment is putting in place mitigation plans for the Russia-Ukraine situation that do have some potential upside, or at least mitigation of the downside in the more medium, I suppose, sort of medium term. Probably not until Q4. You know, these type things take a while. There's a little bit of, I think, potential opportunity to ameliorate some of the challenge in Q1, Q2 with a little bit more in Q3, in Q4 probably, and into 2023. Great. Thank you. I'm Derek Brown from Bank of America. Just wanted to go back to the 100 basis points of operating margin expansion. Just talk a little about the mix, 'cause obviously you've got FSP, you've got technology coming in. Can we talk a little bit about the mix changes and just sort of think about, you know, how those sort of impact the margin? Sort of the first question. Yeah. You know, as we think about it, and we think about how we grow our margin profile over the next number of years, I mean, all of our business units, all the guys who spoke today, and, you know, their growth profiles are not massively dissimilar. We have kind of all of those have high single digit expectations in terms of future growth. Obviously, some of those markets are growing at different paces. Yeah. You got biotech growing at different pace, albeit the larger pharma market is just a bigger marketplace as well. There is more opportunity from a share perspective there. We do kind of as I say, the guys might and they may not feel that this is a fair thing to do, but every year we set out similar levels of growth for all our business units to try to obtain from a budget perspective. I mean, from a mix perspective, we feel like what we need to do to really drive gross margin, for example, is two predominant things. One is around the making sure our pricing is in the right position, and we continue to work with our customers on that, and we continue when we're pricing new business to make sure that the margin profile can continue to deliver the same levels that we've seen in the past. Also in terms of our staff utilization and making sure that we're bringing in the appropriate amount of staff and also making sure that they're well trained and they're ramped up. That obviously has a bit of a suck on, utilization and efficiency that drops into gross margin. We're seeing that a little bit as we go through the course of this year. We're on a good growth trajectory. We're kind of exiting Q4 2021 in and around, as I said, kind of, you know, in the kinda 28% ballpark for gross margin. We do wanna see expansion there, but I think it's more gradual as we go through time, 'cause I think we wanna deliver to our customers, we wanna invest in the business. As we think about, you know, really making sure we are hitting those 1% targets, we're certainly thinking more of that. Yeah coming from SG&A over the next number of years, and continuing to leverage. I mean, that's why I spent a little bit more time talking about the GBS model, talking about the fact that we're gonna roll this out to the entire organization. We're in that process now. We are very fortunate in that we're very experienced at that model, and so what we're doing really is a kind of a big plug-in. Now, it's a very, very big plug-in. It's not as straightforward as some of the pieces we've done in the past by any stretch. I think that piece is as much one of the big drivers of how we can leverage growth. As I see it, you know, and we kind of walk out over the number of years, it's kind of getting back to that 29% or 20%-30% gross margin, and then in the range of 8%-9% on SG&A. It's the combination of those two things. Yeah that we need to do to deliver that. Great. I come at this from more of the life sciences and diagnostic side versus the biopharma services side. And a lot of the companies that we're dealing with, both publicly and privately are, you know, significantly increasing their, you know, patient sequencing, their resources on genomics, bringing in databases, and doing things like this. It's like, how do your sort of like data resources fit in with this idea? It's like, you know, how are you sort of looking to expand and sort of bring in these other sources of information other than what's traditionally thought of in with the Symphony assets? Yeah. Our focus on data is probably less so on the genomic side of things, although that could be one of them. It's more on how we identify patients for clinical trials. I'll ask Tom to kinda jump in on this one as well. There's a number of... I mean, there's a multiple sources of data that we use, and when we're it depends on what you're trying to do. If you're trying to plan a clinical trial, where are these patients? How do we find them? How do we bring them into sites? There's a logistical component. There's some other... There's some sort. If you're trying to actually look at, are they gonna be suitable for this particular protocol, then it's a different type of data. As we think, we look at all of the sources of data. We look at how we wanna partner with those data organizations and how we can bring them into tools like our OneSearch. That OneSearch is very much a sort of site logistical sort of system. There are other things we use in order to find those patients. Tom, do you wanna talk a little bit about that? I think we're going to remain flexible in this regard. We have brought in genomic data in the past when we worked with Yeah Genomics England. Sure. You know, insofar as that data is something that our sponsors want us to utilize and that we can see value in in leveraging, we certainly have the technical ability to be able to bring that in. I think we've got the competence within the operational groups to be able to leverage it also. We're not seeing a huge demand for it at the moment, but we have used it in the past. Great. Then just one final one. I'll give you a softball. So you talked about deliberate and trial specific for decentralized trials in terms of growing that. So what's the aha moment where suddenly that really takes off, or is it just going to be a gradual pickup? Because this is sort of like how I was thinking about it, 'cause we hear it from a lot of companies. It sounds great. Yeah. Yet there's a little bit of hesitation that you don't want us to get too far ahead putting that out there. How should we Yeah think about that? Thank you. Yeah. We hear from customers, "I don't wanna be first on this one. I'm happy to be second or third or even fourth." We get that because there is an element of risk, I suppose, as you think about new drug development coming to market. You know, we know the industry. You know that we're still doing paper trials despite the fact that electronic data capture's been around for, what? 25, 30 years now. We'll probably still be doing non-DCT trials in 20 years as well. However, you know, we do see a convergence of forces, if you like, I think in the landscape at the moment. The regulators, you know, are saying the right things and are moving in the right direction. They're even getting down to the auditors. 'Cause one of the things I hear from customers is, "Oh yeah, Janet Woodcock says it's all great and wonderful, and Rob Califf's all for it. But once we get audited, there's a challenge, there's a problem." Then there's a little bit of that, but it is moving down their organization a bit more. FDA, MHRA, and we're seeing more consistency of approach there. Also customers as well, they've seen what we can do post-pandemic or through the pandemic, and it's leading to, I think, a definite momentum. I told you that meeting I was at yesterday with the Association of CROs. There really is a momentum there. We see it moving forward, and I'm very optimistic that it is gonna move forward faster than some of the previous technologies. It's not gonna be an overnight thing. There will be no sort of light bulb moment when everything switches. As we look at it at the moment, you know, probably 80% of our trials have a DCT component. Now, does that mean we're doing lots of, you know, totally decentralized trials? No, absolutely not. Pretty much all of them have a component of it, whether it be risk-based monitoring or a wearable, home health, you know, using our Accellacare site that we put. We're moving in that direction. Certainly in my experience, the momentum is there and the. I think the willingness is there, both from a regulatory point of view or customer point of view. You know, the science is helping us get there as well. I'm just gonna sneak a quick one in from the webcast from Jack Meehan. If you can comment on how pricing has trended over the last couple of years, and if you're seeing industry consolidation affecting that? Over the how many years? Just. Just the past. past few years. Few years. Interestingly, you know, this is a competitive business. As you all know, this is a competitive business. Pricing is always challenging. I think I've probably seen pricing become a little bit more accommodating over the last 6-12 months. Soft is the wrong word. You know, customers recognize that there's, you know, the workforce, the great resignation, all of the challenges around that is leading to pressures to retain people. We have to be market competitive with our salaries. They're also recognizing that that means there's some pricing adjustments. Those discussions, you know, generally have gone in a more favorable way than they have in many years previously. I'd characterize it in those ways. That's not to say that, you know, that your general customer, they say, "Oh yeah, we'll give you 10% increase." That doesn't happen. Those conversations are much more amenable, I think much more. The outcomes of those conversations in several instances have been pretty positive for us. You know, there was certainly some headwinds in terms of, you know, labor costs, et cetera, as we go forward. We've been and we are mitigating those on the top line as well. I'd say overall, you know, we're in a good place because our customers, who also compete for the same resources and understand the environment, recognize that we need to keep our people. I think I'll just add on the second part of that question, which is, has market consolidation impacted on it? I mean, we haven't, we certainly haven't felt that. To Steve's point, this is a tough industry, and we all sharpen our pencils, and we go to battle all the time with our big competitors. But I don't think that we've really seen a measurable difference over the last number of years as a result of just consolidation in the marketplace. Yeah. Hi, this is Casey Woodring from J.P. Morgan. Retaining and expanding existing large pharma customer relationships was an important piece of the presentation. Do you see any customer concern that they may be over-indexed to one CRO as a percentage of their outsourcing spend from the merger? Wouldn't that sort of hinder the ability to expand existing relationships moving forward? Do you wanna take that one, George or Barry? Go ahead. No, go ahead. One of the attractive components of the deal was how the accounts overlapped or didn't across the two legacy organizations. I think that was certainly an interesting dynamic for us. We know that customers always look at how to leverage their books of business, whether they go multi-partner, few partner, in some cases, sole partner. Short answer to your question is no major concern. Got it. OneSearch was mentioned a bunch today. Just wanted some color around how many customers are using it right now and any sort of competitive advantages that that platform has versus offerings from other CROs. Thank you. Okay. How many customers? I mean, many customers. You know, it's, we use it. It's being used on all of our projects. In terms of, you saw the figures that, was it Tom or was it one of you, presented in terms of our, you know, reduction in the number of zero recruiting sites, the improvement in the, in our startup times. I'll be honest and say, you know, 2, 3 years ago, our startup, our whole startup, you know, was. You know, I would say we were just average. I honestly believe we've moved that up, and credit to these guys over here, that we've moved up our startup process significantly. OneSearch, I think, has been a very important tool in that. We really are getting some great information. It's a good example of becoming that healthcare intelligence organization. You know, we're bringing, as Tom said, data from trillions of data points together to get those recommendations on site. You'll see the demonstration. It's, I think, a very cool toy, a very cool tool that really drives us to get an outcome that's that our customers are very happy with. Yeah, your assessment is correct. I mean, one of the first things we did was deploy that into the legacy PRA organization. It's now on every single trial, we are using OneSearch to inform our decision as to what sites we go to for the patients that we're trying to recruit. Go ahead. Okay. We probably have time for one more. Any last questions in the room? Justin Lin from William Blair. Just one follow-up question on, I guess, decentralized trials. What resources do you think you currently lack to be able to do more decentralized trials? Do you think it's more on the tech side of things, or is it more about sort of expanding your network of, you know, mobile nurses, investigators, things like that? I don't think we lack any resources to do decentralized trials. We have. That's one of the things I think we bring to the market. A really nicely integrated, compelling soup to nuts solution on the integrate. That's probably our biggest differentiator on the decentralized trials. We can do it all, and that's what we wanna do. We don't have to go and get a Medable or a Science 37 or a Home Healthcare and then try to project manage that. We can go to a customer and say, "Here it is." You know, we can go right from the protocol development, the sites, the idea of the sites, the patient connecting with the patients, the wearables, the home healthcare, the platform itself, the e-consent. You know, we're able to bring that whole shooting match to the customer. I think there's nothing we lack. Now, you know, in terms of scale and building those functions and build, that's absolutely where we'll be going. But there's no specific area that I think we lack in that area. We will continue to invest in terms of data sources and those things, and that's gonna help us with that, with those solutions. But nothing out there that I think, "Oh, God, don't have that. There's a big gap." It's you know, we've got that solution there and, we're developing it and, I think we feel very good about it. [inaudible] the Mapi acquisition that we did a number of years ago. Right. That's a good point. brought with it all of those data capture instruments. Yeah that are critical, and we're able to deploy those in a matter of hours into the study. FIRECREST and how that trains the sites and how it trains patients is also critical in terms of how you get that deployed quickly and efficiently. We have all of that wrapped into. Yeah What we are offering in our DCT capability. Yeah. The other thing is the e-consent, which we have available. I mean, you know we did the big Covid trial with Pfizer. That's a matter of public knowledge. On that trial, there was something like 12-15 protocol amendments. Now, we had 45,000 patients odd in that trial. Can you imagine doing those protocol amendments, having patients sign off a piece of paper 12-15, something like 15 times? It's a mind-boggling amount of work. We had e-consent. We were able to provide that to the patient on their device, and they were able to, you know, sign off on it electronically, all complete documented audit trail. Regulators happy, investigators happy, you know, Pfizer happy. You know, those sorts of tools, we really just up the ante in terms of delivery quality of our trial services when you're able to deploy those. Okay, thanks. We're up on our allotted time. If there are more questions in the webcast, we'll be following up with those directly after the call. We want to say thanks to everybody who joined us via webcast and certainly in the room here today. We look forward to talking again soon.