Labcorp Holdings Inc. (LH) Earnings Call Transcript & Summary

June 6, 2023

New York Stock Exchange US Health Care Health Care Providers and Services investor_day 179 min

Earnings Call Speaker Segments

Hima Inguva

executive
#1

Good morning, everyone. I am Hima Inguva, Head of Investor Relations, Corporate Development and Competitive Intelligence at Fortrea. Thank you for joining us for Fortrea's inaugural Investor Day in New York City and for those of us who are joining us on the webcast. We are extremely excited to welcome you and have a great agenda plan for you. It's a pleasure to see many of whom I've worked with in the past from my time in Wall Street, and I look forward to working with everyone else. Before we start, I'd like to note that we'll be making forward-looking statements, which include but are not limited to statements with respect to the proposed spinoff and the impact of various factors on Fortrea's businesses, operating and financial results, general economic and market conditions, future business strategies and opportunities for growth. Each of the forward-looking statements are subject to change based on a number of factors, many of which are beyond our control. More information is included in our most recent Form 10 filed with the SEC. We have no obligation to provide any updates to these forward-looking statements even if our expectations change. Please review the cautionary statements and the reconciliations of the non-GAAP financial measures included in today's presentation and materials for more information. With that, I'd like to take this opportunity to introduce the members of the Fortrea management team who are presenting today. The team has extensive combined experience of over 200 years in the CRO industry and have a strong track record of delivering results. First, it's my pleasure to introduce our CEO, Tom Pike. Tom really doesn't need an introduction, especially with this audience. Many of you know Tom from his time at Quintiles, where he was the CEO and member of the Board prior to its merger with IMS and rebranding as IQVIA. Tom has led Quintiles through a successful IPO ranked in the top 10 offerings of the year and implemented transformative initiatives to grow revenues and improve margins at Quintiles. Under Tom's leadership, Quintiles was named as world's one of the most ethical and admired companies by the Fortune magazine. Tom brings more than 30 years of consulting and industry experience, including McKinsey, Accenture and Quintiles. Notably, as the Head of Strategy, Tom was instrumental at taking Accenture public. Tom joined Fortrea in January of this year, and we are delighted to have Tom Pike lead Fortrea on its transformative journey. Next, I'd like to introduce our CFO, Jill McConnell. Jill has over 25 years of broad finance experience across the Board and both in the CRO and pharmaceutical sponsor industries. Jill joined Labcorp in 2018 as CFO of Labcorp Drug Development business and spearheaded initiatives for a successful spin-off of Fortrea. Jill held leadership roles across the entire financial -- finance spectrum both in the U.S. and Europe during her 19-year tenure at GSK. Jill was recently recognized by Healthcare Businesswomen's Association as luminary. Next, Mark Morais. Mark is our Chief Operating Officer and the leader of Clinical Development business. Mark joined Labcorp in 2017 and has more than 20 years of CRO, operational and commercial experience, both at Labcorp and previously at Quintiles, where he served alongside Tom in a series of leadership roles focusing on growth, customer relationships, margin improvement, organizational operation improvements. Throughout his career, Mark has held leadership roles in virtually every critical position in the CRO. Mark was named the Chief Operating Officer of Labcorp's Clinical Services business about 2 years ago. Next, Drayton Virkler, President and Commercial Officer -- Chief Commercial Officer. Drayton has deep and broad global experience, having spent over 20 years leading commercial organizations in the life sciences industry in various marketing and commercial leadership roles, both in pharmaceutical sponsors like GSK and outsource service providers like IQVIA and Certara. Drayton holds an MBA from Duke University. Next up, Sam Osman, President of Enabling Services. Sam has over 15 years of industry experience as a CEO and a leader within clinical -- e-clinical services, building and deploying both site and patient-facing technologies. He led technology-enabled service businesses in the CRO space. Previously, he also worked as an investment banker with Citibank. Tom (sic) [ Sam ] attended London School of Economics, holds an MBA from Carnegie Mellon and further education from Wharton. Next, Oren Cohen, our Chief Medical Officer and President of Clinical Pharmacology Services. Oren has been with Labcorp since 2017 and has over 30 years of industry experience, including his time at Viamet and Quintiles. Oren has -- Oren is a consulting professor at medicine -- Oren is a consulting Professor of Medicine at the Duke University Medical Center and Fellow of Infectious Diseases Society of America. Now let's proceed to the agenda. Joining us today is our -- is Labcorp's CFO, Glenn Eisenberg, whom you all know very well. Glenn will initiate the presentation, followed by an overview of our CEO, Tom Pike. Subsequently, our leaders will provide detailed insights into their respective business lines. CFO Jill McConnell will present a financial overview, and finally, we'll transition to the Q&A session, and expect to conclude the Investor Day at noon. Without further ado, it's my pleasure to welcome Glenn Eisenberg to the stage. Glenn?

Glenn Eisenberg

executive
#2

Good morning, everybody. I appreciate everybody coming out for a pretty special day in the history, if you will, of Labcorp and the future history, if there is such a thing, in the history of Fortrea. So a very excited time and we really appreciate everybody coming out. As you know, Labcorp announced its intention to spin on a tax-free basis its clinical development business, which is now called Fortrea. Again, Fortrea represents roughly around $3 billion of annual global revenue for the company or roughly 20% of Labcorp today. And again, we'll be looking forward to forming -- will become 2 publicly traded companies. The good news is while this has been a journey, we are on track. Right now, the expectation has been that we will effectuate the spin in the middle of the year, which we are still on track. And given we're now in June, we're approaching on a fairly fast level in the middle of the year. So very excited. All the things that we need to do to put the spin in place have really gone very well, from effectively the physical separation, obviously, of the company that will take place, to all the regulatory approvals that are required, to all the financings that need to be done. Everything is kind of hitting the marks of where we would expect it to be at this point in time. So obviously, one of the reasons why we're looking forward to today of really having the Fortrea management team talk about the business in advance of it ultimately becoming this public company. It's interesting to put in perspective Fortrea and the part of Labcorp that it's been. So back in 2015, Labcorp looking to continue to grow into the global life sciences space, acquired a company called Covance. And we like the space of moving into, call it, an adjacency space from where we were on the laboratory services side. And within that, as we looked at the CRO or contract research outsourcing industry, we felt it was really a very close -- a nice fit within Labcorp. As we evaluated all the companies that were there that comprised the CRO space, the #1 target by far for Labcorp was Covance. And it was in part because it had a large central laboratories business that competed directly with Labcorp. So we knew through that acquisition, we would be able to glean significant synergies, consolidate the central labs that we had, promote great value-add and become a global leader in the central laboratory space. But in addition, Covance had 2 other outstanding businesses that had a long and demonstrated track record of profitable growth: its early development research lab business and its clinical development business or Fortrea. So we are very excited about the prospects of having the entire company being part of the Labcorp company. Fast forward the 8 years that we've owned Covance, if you will, all 3 of the businesses performing well, profitably growing and obviously, the focus more specifically on Fortrea, not only has it grown profitably and seen nice margin appreciation over the years of ownership organically, but we've also been able to put in strategic tuck-in acquisitions to really even enhance it. Companies like Chiltern, Sciformix, Global Care, SnapIoT, acquisitions that made the company even more global, more therapeutic expertise, got us into the FSP part of the business, and also additional capabilities to pursue decentralized clinical trials. So over that 8 years, we really created an outstanding company that for today, we're very excited about its ability to ultimately become the standup public company on its own. So again, very excited, when we look at the company and the prospects for Fortrea that we looked as a company, probably around a couple of years ago now, that -- to look at a strategic review. So we like the fact that our businesses were growing profitably. So we are creating shareholder value through that earnings growth and cash generation and capital deployment. But we've always felt, especially within the CRO side of our business, that the market was never valuing us or we were never attaining the full valuation as we look at how CROs trade in the marketplace versus laboratory services companies. So the Board undertook the strategic review. And coming from that, we brought in outside advisers. We looked at the whole portfolio and other actions that we could take. And the Board came up with several actions that it felt was wise in order to continue to promote and unlock this value. So the company, for the first time in its history, initiated a dividend. It increased the amount of share repurchases that it was doing, including an accelerated share repurchase. Listening to investors, we promoted more disclosures, enhanced disclosures for our businesses, as well as promoting a long-term outlook for the company, setting longer-term target objectives so you know what we were expecting to achieve. And then from a structural standpoint, the Board decided to effectuate the spin of the clinical development business, or Fortrea, again, creating 2 publicly traded companies that would both be much more focused in its areas, if you will, of expertise. In the case of Labcorp, becoming a global leader, which it is within the laboratory services. And then on Fortrea, becoming a global leader on the CRO side, Phase I through IV clinical trials. So we're very excited about where we've come to the process of effectuating the spin and getting close to it. As we think about Fortrea as a stand-alone company, right now, Fortrea has the size, scale, therapeutic expertise that can compete with anyone, anywhere in the world. That's unquestionable. The opportunity to become its own public company and really control its destiny is what's really exciting, because now it decides its strategic initiatives, its operating focus, how it's going to allocate its capital versus having to compete with other companies, if you will, for that capital. And frankly, from an investor standpoint, an opportunity, a unique one, to set up a pretty pure play company in a very attractive part of the healthcare industry. So we believe, very attractive to investors. And again, hopefully, with the value -- higher valuation that comes with it as well. And while we love the idea that we're setting up this public company, we also don't want to give up the benefits that the company has realized by being part of Labcorp. So we've entered into multiple strategic partnership agreements in order to continue to leverage the synergies even though we would be 2 separately traded public companies, such as the data that Labcorp has to be able to use in Fortrea to help accelerate the speed of clinical trials for patient recruitment, site selections as well as leveraging the company's central lab businesses and services to perform the trials, as well as the data that comes with it. And frankly, even going from end-to-end with all the different services that we can come in jointly to customers that they would see value. So we view this as a win-win of an independent public company that can create significant shareholder value, at the same time, leveraging the synergies that we had as being part of Labcorp. And then finally, from Labcorp standpoint. Again, Labcorp remains a global leader in innovative and advanced laboratory services. We have a very demonstrated track record of profitable growth, strong free cash flow generation and a capital allocation plan that continues to invest in strategic tuck-in acquisitions as we continue to consolidate in a fragmented industry, as well as returning capital to our shareholders in the forms of our dividends now as well as the share repurchases that we have. And today, obviously, it's all about Fortrea, to see the management team, hear about what's going on. Labcorp as well will have an Investor Day in September, where we will have the leadership team of Labcorp out for the same reasons of kind of going through all the specifics and details, vision and outlook for our business as well. So with this, one last comment before introducing Tom and the team. I always said that the -- obviously, the most important decision the Board made, one of the most important was deciding to effectuate the spin of Fortrea. The next most important decision the Board had to make was who was going to lead it. And we feel extremely fortunate that we were able to attract Tom Pike to become Fortrea's Chairman and Chief Executive Officer. Hima already went through the extensive background of Tom, but I can tell you his experience, obviously extremely relevant for what we wanted for the leader of Fortrea, especially the public company CEO experience, tied with leading one of the largest CROs, so intimately knowing the industry, the business, the customers. So we're very fortunate to have Tom with us. And I can tell you, after the last 5 months of working very closely with Tom, the good news is we're still talking to each other. And I couldn't be more pleased or more confident in his leadership capabilities, bringing together an outstanding team, how he leads the business and how we've progressed over the past 5 months to be where we are today on the verge of establishing this new public company. So again, appreciate everyone's interest in being here. Excited to be with you today. And with that, I would invite Tom to come up and lead today's discussions.

Thomas Pike

executive
#3

It's been fun working with Glenn in the last few months. He's a hard-nosed CFO and a great guy and still plays a good game of basketball by the way, which is kind of nice. Good morning, everybody. I do know a number of you in the room. It's great to see you again. And I hope on the AudioCast, we're able to see the slides. We're working on trying to make sure the AudioCast is effective for everybody who's decided to join that way today. I will tell you, I'm very excited about this company. I've been looking at this company since 2014. So when Labcorp bought the company, Quintiles was the other bidder for the company, at a nice dinner with Joe Herring, the then-CEO over in New Jersey, we talked about the company, talked about the fit, and I was excited about it then. I've been watching it closely and excited about it now. The last few years, just to pick up where Hima was talking about, I've been working in the innovation space mostly in this industry. So I've cofounded a couple of companies in the site management area. I've also worked in the technology services part of our industry. So been continuing on. And I'm really excited about the opportunity, as Glenn described, to take a pure-play clinical services company in this great industry back into the public domain. Let me just talk a little bit about our mission. We're going to talk a lot about shareholder value today. And it's easy to forget that this company has a deep and important mission. And that mission is bringing medicines faster to patients. We've added something else so important here when we talk about our mission, and that's solutions, because we're not just a service provider. We're not just a company that is bringing people to this. We're bringing solutions, this mixture of data, technology, people, globality, deep expertise. That's what we're bringing to try to bring medicines to patients faster. So we're excited by this mission. We're not going to talk about it too much today because we're going to talk to you about Fortrea as an investment, but we're very excited as a team to bring medicines to patients faster. This is my organizing framework for today. It's a little bit about why we're a great investment. I'm going to talk to you about the decades of experience and this wonderful marketplace that we participate in, this global clinical research marketplace. We're a long-term organization. We have long-term customer relationships. They're deep and they're diversified around the world. We've made some investments in differentiation we're going to talk to you about today. We went back-and-forth a little bit, to be honest, because of the webcast, about how far we should go, but we're going to share with you some of the things that we were working on that really differentiate the company in addition to its base business. Not only are we about growth in this business -- and you want to be about growth when you're in clinical research, because in clinical research, with the underlying market growing, you want to capture that growth. But we're also business operators. And we're going to improve the margins of this business over time, and we're going to create a great company on both the top line and the bottom line. Finally, you see our attractive financial profile. I think we've done some good things over the year, and I'm going to -- over the years, and I'm going to introduce you to the management team. Let me start with this discussion about the industry. I'm proud to report, after reporting to a decade ago when we brought Quintiles public, that we had a healthy R&D environment. That it's, if anything, healthier than it's been in the past. We've had incredible advances in molecular biology that help us understand what's happening in the body and help us understand mechanisms of action better, help us understand the biology of disease in ways we haven't before. You only have to pick up The New York Times to see at ASCO last week, reports of therapies that are reducing brain tumors in areas that really haven't taken place before. Or look at what's happening with Alzheimer's. And this amyloid plaque hypothesis being confirmed associated with a therapy there that looks like it could help millions. So all you have to do is pick up the Times, and you can see that we're in this tremendous period of innovation for moving forward. This has led to growth in research and development. It comes in 2 ways. Large pharmaceutical firms are continuing to invest in R&D. They continue to get the value to their company. They're valued largely based on their R&D spending, what's in their pipeline. And then we've seen continued interest by smaller companies and by investors in very targeted therapeutics take place in the biotech. Sometimes it's platforms, sometimes it's very specific therapies. But all of that is creating a continued growth estimated here at about 3.5% of the R&D spending for the coming years. In addition to that, we have this outsourcing situation. This industry that we participate in is about 35 years old now. So over the last 30, 35 years, what's happened is pharmaceutical firms have gone from in-house development, in-house R&D to using groups of third parties and technology organizations to do R&D. It only makes sense. The average clinical trial probably takes place in 25 or 30 countries around the world. May involve thousands of patients, may involve hundreds of investigators spread around the world. It might be in a therapeutic area that's different than the last drug that was developed by a pharmaceutical firm. Or you might be a biotech without the resources. And what we do is we provide that global infrastructure to be able to conduct the clinical trial. We all saw very closely during COVID, it had to be executed with incredible speed, going out to investigator sites, getting thousands of patients to prove that the drug was safe and that it worked. That's what we're about, is putting that infrastructure in place, and it's created a big outsourcing environment. The combination of these 2 creates an addressable market that's at least $35 billion for us. We were arguing internally, it actually could be quite a bit more. But we decided to settle on a conservative $35 billion for our clinical services. So it's a big marketplace that we're going after. And as it says on the right of the slide, we continue to have tailwinds. So some of them I talked about, these new platforms, new technologies associated with mechanisms of action and our understanding of the biology of disease. But also, it's getting more complex. So the more products that are out there, the greater the need to show the distinction between drugs. And with that greater need, it actually makes the trials more complex. That benefits us. We're also changing geographies a bit. So you've seen what's happened with Ukraine and Russia. These were major clinical research sites around the world. Russia had a big initiative to develop novel therapeutic drugs. And so when they come off the market, we have to respond and respond quickly. This, again, helps us as a service provider, actually with our nimble way of operating. And again, it makes pharmaceutical firms want to outsource. Finally, expanding scope of novel therapeutic platforms. I think we've talked about that quite a bit. So it's a big, attractive market that we chase. In addition, since coming on board, we've been meeting with leaders in pharmaceutical firms. I think you expect this of me, being in the industry for a long time. And we've been saying, what do you need? And the things that we're hearing from them are changes in how we deal with patients and sites. You look at the sites, and especially coming after COVID, I think everyone in this room has personally experienced the fact that access to hospitals and access to doctors was difficult during this period. We've all seen healthcare wages. We've seen issues with turnover and nursing, in certain parts of the country in the United States, the turnover has been over 40% in certain nursing categories. So you've seen issues going on there. And our sponsors, that's the pharmaceutical firms, want us to get better at dealing with sites and help make the sites more successful. At the same time, you saw, especially during COVID, this need for diverse representation. That's had a little bit of a ripple into our site network as well all around the world. So we need to respond to that. The sponsors themselves, it's interesting, being 30 years into outsourcing. They're not happy. They -- you can just look at the cost of developing a drug and the time that it takes, and we still aren't really solving the problem. They're looking for organizations that are going to be innovative and really take clinical research development to the next level. And so it creates a great opportunity for Fortrea to do that, and I'll tell you why. Ceros themselves, where there's been a lot of innovation in this business. We're going to talk about it. There's been a lot of innovation around tech, a lot of innovation around data in the last few years. And so again, there's opportunities for us to create a little bit of a different model, a model that has competitive advantage that the other firms don't have. I think it's the next phase of industry transformation. Doing clinical research in 2025 is very different than doing it in 2015. We've seen a sea change in the technology, the data, the way sites work, the novel therapeutic areas. And so you look at it and there's a great opportunity for us to bring around industry transformation. Glenn alluded to this, this company that you're looking at, this is not an assembly of a few companies that have been pieced together over 5 years, slapped together. This is a company with over 30 years of heritage. And you could argue that it started well before this. But Covance, kind of our root company here, was spun out of Corning in the '90s and has been a pioneer in this business forever. If you walk through our halls, if you go to Maidenhead and walk through the halls, you'll meet Michael George, one of our chief medical doctors. Michael has been with the organization over 20 years. He's renowned. And so this organization has deep roots. It's well known, and that's important in clinical research, in a regulated industry, that you have deep knowledge. As Glenn was describing, once Labcorp took over, a series of acquisitions took place. Importantly, Chiltern, importantly, Sciformix adding more capability. A number of other acquisitions took place that really created the company that you see today that's a $3 billion company, just in clinical services. And so it's been carefully assembled. Interestingly, this management team, people that you're going to meet today, Joe McConnell, Morais, other people in the room, have improved this business significantly over the last few years, adding 540 basis points of margin. And then this business overall has been growing for a long time. Now it's 15% revenue growth over the last 12 years. So it's -- this is a substantial business. It's been here, it's important to the industry, and it's going to stay a leader. We're big. I mean we -- over 20 therapeutic areas. I'm not -- it's funny, the numbers moved around even since the Form 10, but we were at 19,000 staff just a little while ago. There's 20,000 people here. When I talk to some of the leaders in pharmaceutical firms, they say, "I didn't know you were that big. I didn't know you had that kind of reach in your clinical services organization." So we can handle just about anything. And in this industry, just about anything comes at us. We operate in 90 countries. I mean that's a big organization. That's what it takes to do clinical research. $3 billion of revenue. Last year, over $400 million of EBITDA, and you've seen some pretty significant growth in the last couple of years, in addition to that long-term growth that I was describing before. So we're going to talk about it in a little bit as we go through each of the pieces here. But this is a scale organization that we're bringing to market. This is one of those pictures you probably have to have. It shows us all around the globe. And basically, everything in green is where we operate. I'm not sure we do a lot in Siberia, but historically, the organization has operated all over the world, and this is where clinical research happens. And so we are a participant in that way. Dr. Oren Cohen will talk to you a little bit about our clinical pharmacology or Phase I. You'll see a few dots on here about the Phase I facilities. One of the things that's always been interesting about Covance was it had built-for-purpose Phase I facilities that are very important in our clinical development process. They're very effective, very important. And Dr. Cohen has continued that and expanded that network. And I think we have the leading innovative Phase I set of facilities in the world: Madison, Daytona, Dallas and Leeds in the U.K. Now this slide was put together just to show you a bit about the scope and the breadth of what we do. Our solutions are global. So if you look at clinical pharmacology, our customers are global, our solutions are global, associated with that very important Phase I. Again, Phase I is where you test that it's safe, and it works. It tends to be an in-facility type analysis where patients come and stay, they become subjects and they stay in the facility. So Phase I global solution, very important. Clinical development is the core of our business. Again, that's a global solution. I will talk a little bit about the pieces of it, but we really go all the way from Phase Ib, as it's called, that's that important phase where you see whether you're going to get accelerated approval or not. It's a very important phase, all the way through Phase IV. We offer all the models. We'll talk about that a little bit. And then we have a new segment that we're going to introduce to you called enabling services, where we've collected some of the different things that Labcorp has assembled over time, and we put them into this area that we call enabling services. Essentially, these are services that enable clinical research and commercialization to be more effective. So we'll talk to you about that. Two of them are mentioned here. Therapeutic specializations were actually across the board. You'll see today we have a big focus in oncology, which is where most of the clinical research and a huge amount of innovation takes place. But we do work across the board associated with exciting areas like cell and gene and the central nervous system and all across the board. Our customers -- the big guys, Big Pharma, we have many, many long-term relationships with Big Pharma. We also work extensively with biotech, which is exciting, and we want to do -- some of the greatest innovations come out of biotech, and we want to be on that leading edge. But we're also a leader in medical device as well. It's been an investment area, and it's an opportunity for continued growth. And as I said, we really work across the clinical development continuum. With regard to our business segments, we'll talk about this a little bit today. Whenever you take a company public, you have to think very carefully about what your segments are and what you're going to represent to the public marketplace. What we've chosen to do is put our clinical businesses together, it's about 91% of the business. And these are clinical pharmacology, clinical development primarily, and all the supporting services associated with that. And then enabling services. You'll see that we're about 91% of revenues in those clinical services at about 9% in enabling. And then you'll see that there's a little less operating income coming out of enabling services at the moment. Over time, we actually expect these both to grow that 9%, 10%, it comes and goes and moves around a little bit. It happens to be a bit of an investment time for enabling services right now. And so that's why you're seeing that performance. But again, the main segment, and we talked about it a little bit, this is a very pure-play shot at going after that very attractive clinical services market. See if we can get this moved. Hima, I might be stuck. Here we go. All right, studies. This is just another one of those slides to show you, we're big and we do a lot of this stuff. I think 5,400 total studies, it's more than this now, obviously, because you do these over a period of time. We're showing you across different phases. We're showing you sites, studies, participants. We're pushing 1 million over the last 5 years, pushing toward 1 million patients or subjects who have been involved in our trials. We're pushing toward 100,000 sites that we've worked with over time, and the studies themselves, well over 5,000 studies across the spectrum. This is a scale organization that knows how to get it done. This organization wins awards, too. So it wins general awards, International Clinical Researcher of the Year, but it also wins awards for other things. The training, the technology. Again, this is a real scale organization that wins awards. Now I'm going to switch a little bit. So we talked about that it's a great industry. We talked a little bit about that this is a company that's big, has deep roots, has the skills to compete in this industry, skills to grab share for sure. Now let's talk a little bit about the customers, and then we'll get into this in a little bit more detail, in particular, when Drayton talks to you. But we are diverse in a number of ways. We're globally diverse. We're therapeutically diverse. One of the issues with investing in this sector is you don't want to be in a class of drugs where they all fail at once or one wins and the other ones lose. We're diverse therapeutically. And our customers are diverse. So 60% of our revenue is across 20 customers. I'd say that's fairly normal for a big -- for an organization our size with diversity. There's no major revenue concentration in a therapeutic area or in a customer. And then finally, we have many customers with multiyear contracts. The average contract in this business tends to be 3 to 4 years. So when you look at our backlog, you're looking at a company that has revenue in years to come, and it has multiyear arrangements with pharmaceutical firms big and small. You can see on the left side of this that we're somewhere around 50-50 large pharma biotech. We actually like that right now. We're a little more large pharma. But we like that ratio, because we're of a size that for a biotech, we're very attractive because we can do global, sophisticated studies and reduce their risk associated with them. But for Big Pharma, we can work with them very closely on their strategies and be nimble. So for Big Pharma, we're attractive. And frankly, I'd love to keep this ratio around 50-50 as we grow. Now what this discussion is, is we're going to talk a little bit about our competitive advantages and how we win. We're not going to get into it too much because this is a big webcast, and I'm sure some competitors are looking at it. But what I want to show you here is on the left side of this, you see that any given day in a clinical research opportunity, we can win it. We can put together a great design of the project. So typically, what will happen is the pharmaceutical sponsor will come to you with their design, and then we'll take a look at it. We'll look at it for implementability, we'll look at it for time frames, for cost. They'll come to you and then you'll give your response. And typically, what we do is we give an alternative proposal about how we might think about it in addition to the way they think about it. We're great at that. I'll show you why in a minute. But we have a tremendous strategic and medical team who helps develop and design clinical trials. We have a great team, as you can imagine, with 20,000 people around the world. We have fantastic resources that we can draw. We have strong MDs and experts. So I'll show you that in just a minute. It's very impressive. And then we have global operations and a great quality management structure. One of the things that has to happen in research, we're a regulated industry. We work with patients, we're with novel therapeutics, and we have to be great at quality. I'm really pleased Sandy Kennedy is sitting over there. She's known in the industry as one of the leaders around quality, quality management, making sure this stuff is safe and it works. And I'm so pleased she's on the team to help lead us there. Now on the right side of this, while all this goes on every day, we know we need to differentiate. We know that there's still pain points in the industry. As I said, we've been interviewing leading players, developing our strategy side-by-side with getting the spin accomplished as we go forward. And we're selecting areas and areas of investment that they agree are great for the industry. So in addition to that, you'll see a little bit later that we're focusing on partnering strategies with them that I think are next generation and unique. Now here's a slide that just talks a little bit about some of the areas we're differentiating. We are going to continue to invest in what I call magnet expertise. So what is that? That is really the area where we hire people who are so impressive that they're a magnet for our sponsors to work with. We have a number of people in the pipeline right now we're talking to. We're going to continue to focus on that over the coming years. I'm going to talk to you about this thing that we call ideal scale. We're the perfect size. We call it the goldilocks size: Not too big, not too small. The opportunity is right in front of us at our size to be very effective for both biotechs and for Big Pharma. Culture is a competitive advantage. One of the unique things that we get to do is we get to rebuild the culture. And as good as the Labcorp culture is, we're going to pull some of the good stuff, the ethics, the integrity, the focus on science out of the Labcorp culture. We are going to develop a world-class services culture to be able to serve biopharma. 2 very important things. I've mentioned this before, there's been a sea change in what's happened in technology and what's happened in data over the last decade. And so we're not going to try to do our own thing there. We're going to surf the wave with the leaders, and we'll talk to you about that. I'm not going to talk about it in this part of the presentation, but Mark will talk about it in a little bit. We're also looking at this last mile problem. So if you remember the telecommunications industry, they always talk about the last mile is kind of between your curb and your house. And it's the most expensive, most difficult part of telecommunications, getting fiber into your household and actually enabling your Internet services. Well we have the same problem in this industry, that the most difficult part we have is actually working with investigator sites and getting them to effectively recruit patients and keep the patients in the studies. So Mark has done a lot of work around that. He'll share some of that thinking with you. Sam Osman is going to talk to you a little bit about enabling services, which we think is really a catalyst for being even better in this business. And then Drayton will talk to you about world-class customer relationship management. So first -- so this is a company that's been around for a while. This is a 30-year-old company. 700 physicians, 1,500 PhDs in this organization. This organization is broad and deep when it comes to the expertise required to do clinical trials. We publish over 100 peer-reviewed publications per year. Ebbs and flows a little bit, as you might expect, but very interesting stuff. We just produced one around the implications of COVID on the pharmaceutical research environment. And really great stuff coming out, some of it quite technical, some a bit broader. You look at what we do here. We look at digital biomarkers, improved management of specimens. We work across a realm in terms of innovations that are important to our sponsors. We pulled out a couple of examples of our experts here. Just to give you a sense, a couple of these folks were with the FDA, and they were reviewers. That's very important to our customers. But in addition, we have these really nichey deep expertises. Pediatric neuro-oncology. Gene therapy with expert who focuses in rare disease of the brain. So these are the kinds of resources that we bring to the table. Now even with that, we think there's more. We think we can go deeper. When I look at this business, I don't think we're getting our fair share in certain areas. I think we're doing a great job in oncology. So if you look, this number is about 46% of our current business right now is in oncology. Again, this is -- if you're just going to be in 1 segment in clinical research, that's where you want to be. You want to be in oncology. But -- and we've been very successful grabbing more than our share there. We're very good at these complex studies that have a nice, long duration to them and great client customer reviews, but we also think there's opportunities for more. When I look at our share associated with CNS, I think we could do more in the central nervous system area. We've actually been quite good in cell and gene, and we leveraged some of the Labcorp expertise there as well on the science side, but we could do more. There's some very interesting ways to leverage the supply chain needs associated with cell and gene that we can lean into more that will differentiate us. Rare disease, medical device, we think, is a growth area. And on the other areas at the bottom, we just think we'll continue to build out our skills in these areas. Because as good as we are, there's more opportunity for us to grab more share of wallet with more therapeutic expertise. Now this ideal scale, so you say, is 20,000 people. Is that the right number? I think it's exactly the right number. 90 countries, we're -- I know this sounds funny to people, but that scale of organization is small enough that Mark Morais and I can reach right down through our organization if we need to get some focus on something. We can represent 2 customers what's going on in our business. We can have more personal relationships, which is very important in biotech and very important at the top of large biopharma, because we don't have as many layers as the competition. So on the other hand, though, we're much bigger than the small, focused nichey CROs. So we really are at this ideal size. Now in addition to that, what we've been talking to sponsors about is the potential of co-investing where we need to because the world is changing a little bit. For about the last 30 years, you've seen this move from West to East associated with clinical research. So we've had more and more clinical research taking place in Asia. Actually, we've had a lot of novel therapeutics coming out of China. So we've seen this push to the East. What we're seeing now is a pull back to the West. And that does include South America and other places. So what we're talking to our sponsors about is using our ability to invest our perfect size network and really figuring out what's right for the industry and investing there. So I think we're at the perfect size that we can reach in and have an impact, we can have less layers, we can support our customers well, but we can do anything with our scale. Culture is a competitive advantage. I hope some of our employees are listening to this today, because I can tell you, we are going to evolve, and we are going to be the best place to work in this industry. I was talking to one of the ex-heads of R&D who now is working with a consulting firm, and he's saying, "Tom, it's great that you have these relationships. But the reality is that it's the people that I met with every day on my projects that really is where I formed an impression of a CRO." So we know that, and we've been doing work on our culture, and we've been doing work on how do we have a world-class culture. We're going to take some of that and we're going to continue to push it forward. Because again, the wonderful thing about a spin is we get the opportunity to get our employees to participate in the redevelopment of a culture. There's been an opportunity in this industry for a long time for a world-class professional services culture, and that stands in front of us, and we're going to do it. Now we've already got a lot to build on. Clinical team lead accelerated development program, project management academy. You see there are a lot of assets here. We actually have a number of employee resource groups that work very, very well. So we're active in terms of the engagement, but we're going to do even more. Now an important area. I don't know if you're familiar with this S-curve concept. Came out of some of the consulting firms years ago, and it's generally used around technology to talk about what happens with technology, that there's kind of a -- when innovation is taking place, there's a relatively slow adoption, and then it goes up this rapid adoption curve. And sometimes they call it the tornado, but it's essentially rapid adoption curve. And then it tops out a little bit and it becomes more mature. I think whether you're talking about our phones or you're talking about computers, it's easy to think about this example. And we've had it happen here in the clinical research business. Since I've been involved in this business, in 2010, if you were a CRO, you really had to build it yourself. There was not much here. There was a little bit of Oracle, a few other vendors. But in general, if you wanted to be effective with capturing information about the trial, you really needed to build it yourself. Since about 2015, we've had a huge amount of innovation taking place. This slide happens to show the tech side of it. I could show the same thing with Concert AI and Komodo and some of the data companies that you all know about. But we've had this enormous investment in this industry because there's been a recognition by tech companies and data companies that, that clinical research pie is very attractive and growing. And so the world has changed. It's not time for us to build our own technologies and core systems associated with research. It's time for us to leverage relationships with the leaders like the Veevas, the Advarras. So if you know Advarra, they're focused more in the site space. They were an IRB, as we call it, so they were review board, and they used that data that they have about so many trials taking place and they've assembled a lot of technical capabilities and are now trying to simplify the world for sites and get some consistent technology. They could be the next Medidata in our industry. And I'm not saying others aren't, but just to give you an example, the investment that's taking place in Advarra associated with the sites is something that we leverage. So Mark and I have been on the phone with the CEO, Gadi. We're working on some innovative areas, because we bring this functional expertise to them and they bring this technical expertise and investment level. So we look at ways that we, together, can help disrupt and push this industry forward. Same thing with Veeva, I was on the phone with the CEO, Peter. We're figuring out ways that we can partner together. Certainly, Medidata, been close to them for many years. They continue to be a leader in this industry, but there are many more, too. So again, organizations like Concert AI, Komodo, I was on the phone with the CEO last week. He's an ex-McKinsey colleague of mine. And we're figuring out ways that we can work together to bring really, a force multiplier of investment to clinical research. So our vision is a complementary strategy where we integrate with leading tech and data players. And then we develop our IP -- and Sam will talk a little bit about this, but we develop our IP where it adds value for our business and for our sponsors based on our deep expertise. We think the time is right. Our sponsors are very excited about this, somebody who can help integrate all of this stuff together. And so that's how we're thinking about data and technology. And just to give you a couple of quotes, I talked a little bit about Veeva and Advarra and I really don't mean to leave some of our other partners out, so if anybody is listening, we actually have a number of partners that we've targeted, but it just happens that these 2 are top-of-mind and gave us great quotes. But essentially, we've been working with Veeva since they started to put that Vault Suite together. And again, under this leadership, we have been one of the most comprehensive users of the suite, being able to get the most benefits. And now, as you can see here, early adopter, first CRO partner, thought leader, influencer to create efficiencies across the industries, how Veeva thinks of us. And then at Advarra, I'd say the same. We're working together to -- they're offering a pretty unique set of capabilities, and we're working together to bring those innovations to the site world and to our sponsors. Data. So the data world has changed. Used to be a decade ago, there was 1 or 2 providers that had claims data. And that has really evolved. I mean if you look, you now have organizations that have ophthalmology data, oncology data. And you can go by therapeutic area or you can go broad, organizations that use claims data and put EMR data. One of our board members is on the board of a company that has 30 hospitals putting their data together associated with trying to help the clinical research enterprise to be more effective at finding patients. And so that world has really changed. There's a tremendous access to that data. So we have this fantastic Labcorp data. And as Glenn alluded to, the idea of the spin is we're going to take the best of working together and continue to use that. It was funny, Glenn. I was on a plane, and I sat next to a woman who was coming from the ASCO conference. And she said to me, "Oh, yes, I've used the Labcorp data. It helped us find 15 patients that were really difficult to find." And so we still have access to that data. And it will be a key to what we do. But in addition to that, we actually have quite a bit of data in Fortrea not always leveraged in the past. So we do have our own country start-up. When we talk to you a little bit about enabling services, there are data repositories in there that have never really been fully leveraged that we'll talk to you about in a few minutes. Patient access data as well. And then we have these other stores of data where we're working closely with them. What's happened over the last 5,7 years here is using the Labcorp data, we've developed tremendous know-how in terms of how to pull the data, how to look at the data, how to get our medical experts to be able to use the data effectively. And what we're going to do is take that proprietary intelligence and know-how and put it against a system of data lakes as we drive forward. We think this is the most effective way. We think those who are stuck with their own proprietary data source are going to be left in the dust with this. Now again, so we talked a little bit about the business. It's got deep roots. We talked a little bit about the diverse customer base and diverse therapeutic base that we have. We talked a little bit about how we compete. But I will tell you, we are business operators. And anybody who knows me, I cut my teeth in McKinsey and Accenture on cost reduction programs, and this is -- it's very important for us to not only run a growing business but to run a profitable business. And Jill and I know that our benchmarks are not as good as others in the industry in terms of our margins. We're going to work on that. Jill is going to talk about it a little bit more later, but I can tell you it's on my agenda too, to take some of the optimization programs we've done in the past, look at the savings initiatives, look at our cost structure as we come into Q3 and the cost structure on the spin becomes real, and then we're going to develop a series of executable programs to improve this business over coming years. What we see is a multipart program. And that's growing the business, managing it more effectively, in particular, getting through this spin, unlocking ourselves from Labcorp, putting in place long-term margin improvement programs, and then over time, having that disciplined strategy to drive shareholder value. Now again, our mission: Bring medicines to patients faster, solutions for that. But we are about our stakeholders, and we're going to deliver value. Again, you'll see this. You've seen it in the Form 10. It's an impressive organization, a large backlog, strong EBITDA. We demonstrated great growth, if you look across the last 3 years. We've demonstrated that we can improve margins with this team. And so, again, Jill will cover this in more detail, but this is an organization with a track record. I'm going to briefly talk about the management team, and then I'm really running out of time here. You know when your timer goes the other way that you're running out of time. So it's now in the -- it's no longer going down. It's going up. So I've really been pleased to get to know Jill. I think Hima gave a great introduction. What you'll find with Jill is she both manages the details. She's done an incredible job with the spin office, keeping it on time at the same time as preparing what you see today, and essentially helping run the business. Just an incredible leader with great followership. Dr. Cohen and Mark Morais, these are 2 guys are part -- the reason I'm here, if you really cut through it. As attractive as it was to work with Glenn, I knew Oren Cohen and I knew Mark from before. I knew they were top-quality people. And when I heard about this opportunity, I called them up and I said, "What's life really like over there? Is this something that we can turn into a world-class organization?" And we believe we can. And so, so pleased, it's kind of like a soccer team or something of a football team. You have some of your athletes who've been there for a while, some who are new, and these are core folks who've been here for a while. I couldn't be more pleased to have Drayton Virkler, who's going to talk to you about our commercial side. He was my #1 -- I didn't tell you this, by the way, Drayton, but he was my #1 pick to run our commercial organization because he's got that balance of leadership. He's an excellent communicator. He's great with partnerships, and then he knows this business really well from both sides as both a sponsor, as well as on the clinical services side. Sam Osman, I don't think we could have anybody better there. He has literally created the #1 business in the past in one of the major businesses in our enabling services segment. And he's an innovative leader who's run multiple companies, turned around multiple businesses. He has the Wall Street background. He's as smart as they come, he was an ex-pro tennis player, which I always like in people, an ex-athlete, but he has -- he brings us tremendous quality. Alejandro Martinez, so pleased to bring him in as CTO. This is so important in our industry because we need somebody who's up with the time. And he has this wonderful mix of experience where he was at GM. So he's had the big tough company stuff and that kind of heritage you need when you're pulling systems out of a Labcorp and you're transitioning to yours. So you need that kind of knuckle-dragging toughness of an IT person. But he also has done really interesting things in the digital space and in the whole analytical space, data analytics space. He brings to us, I mean, Capri shoes, Jimmy Choo shoes, Walgreens, organizations like that, plus he understands our business. So he's a tremendous acquisition for us and I couldn't be more pleased. We actually had our first meeting at a hotel right up the street a couple of months ago. Sandy Kennedy, I mentioned, Sandy, is just a tremendous asset to the team. She's not only going to work on quality, but she's also going to work on the whole ESG area for us because we are -- we intend to be around for a while, and we want to do things right. So she brings us tremendous leadership experience, which our customers appreciate. Georgina Strickland actually helped pull all this together. She's our Head of Strategy, my Chief of Staff. She's worked across multiple organizations in the industry and in some innovative companies and just probably understands these businesses better than nearly anybody else in clinical research. Dave Cooper, I'm proud is our Head of HR. Dave has actually done a spin before. We did one within Quintiles. We spun this thing called Q2 Solutions, which was our lab business out. And Dave led that spin. He's got a long track record associated with HR and CAO type activities. And so he's come in as our CAO and he's going to help us drive this spin. And Stillman Hanson is another guy who's been here before. He's got 20 years in the industry, comes to us from a pharmaceutical firm where he was General Counsel. So I couldn't be more pleased with the leadership team. And I'm going to tell you just for a moment that leadership matters, given the situation that we're in, this is a team, as Hima said, with over 200 years of experience in this industry, but importantly, experience outside of this industry, too. And they're all successful, they could be successful anywhere. I'm so pleased they're with us. Now just as a final notion here. We are building a long-term franchise. This organization has been around for 30 years. We expect it to be around a lot longer. So we are focused on great governance. We are focused on our stakeholders. We're aware of our impact [ on climate ]. We're aware that we work with patients and safety is job one. So we're going to achieve value creation with a mind toward the future. Now I'm going to switch gears here. So that's the end of my prepared remarks. Just to talk a little bit about the businesses here. So the next segments here, you're going to hear Mark Morais talking about our clinical development business. Then we're going to take a deeper dive into a portion of our clinical development business, which is the clinical pharmacology business. And then finally, we're going to have Sam talk about patient access and solutions and our enabling services business. I'm looking at the slide and just reading it, but our enabling services business that has patient access and technology solutions within it. And then we'll have Jill or Drayton Virkler talk about our commercial side and then Jill will act clean up. Now we don't have a break scheduled, Hima, right? Just so people know. So if you're in the room and you need to use the restroom, why don't you just quietly slip out. We don't have a break schedule just to tell you. And what we will do, there'll be a little bit of time before Q&A, after Jill's done, that you probably get reorganized if you need to a bit. So I think with that, Mark, let me leave it to you and give you the reins here, and you'll see our strong Chief Operating Officer, Mark Morais, punches above his weight.

Unknown Executive

executive
#4

Thanks, Tom.

Thomas Pike

executive
#5

Thank you.

Mark Morais

executive
#6

Good morning, everyone. Tough act to follow. In the clock, there's a glare on it, apparently, you just can't see it. It's -- I'm going to go a little bit deeper into our clinical services business. Tom touched on quite a bit of it this morning, but I do want to go into the areas that I see truly differentiating. Going to talk a little bit about the work that we've done to date as a business and then a little bit about where we're going. In terms of our scope, it is a big business. Tom said it many times. It's quite large when you look at it, almost $3 billion in revenues, but this clinical segment that we're talking about, roughly 91%, give or take, with the flow of our business. Dr. Oren Cohen, I'm going to turn over to in a few minutes, a few 20-ish so he can work on that joke, really represents the other portion of our clinical segment as well, within that 94% of our operating income comes within that as well. So the part we're going to start talking about I'm particularly proud of is this really this margin improvement. When we started on this journey, we really looked at as core operators, how do we run the business? How did we need to look at improving the business as a business? And that's the journey we're on, so we're going to talk about that now. When you looked at the elements that we've put in place really over the last several years of my tenure in this role, we wanted to think about how we operationalize the business. And so we broke it apart into some key elements that really factored into the way we ran the business. We looked at those elements that were going to drive delivery, that we're going to expand our margins and then differentiate us to our potential customers that we're going to work with. COVID gave us a good opportunity to think about our footprint as we rationalized our footprint, gave us 2 opportunities. One, we recruited talent from within the industry really from any core of the world. We have the ability to attract talent in a virtual setting. But with that attraction, we were able to rationalize our footprint. So we were able to scale down without exiting countries, we could scale down our footprint and really saved about 50 basis points worth of margin expansion by doing so. We then started to look at as we globalized our talent, how could we then start to look at our spans and layers. Tom has talked about that quite a bit. We've started on that journey. We're going to do a lot more. But our current rationalization, our billable to nonbillable ratios, our span of controls really took off probably about another 80 bps or so. Finally, we started to think about how did we want to centralize delivery. Part of the attractiveness of working with the CRO is how do you capture that global scale? And then how do you have that scale work in terms of delivery? We actually looked at creating a centralized delivery model, some of this captured through labor arbitrage, but a lot of it through driving high throughput volume of repeatable tasks that captured about another 110 basis points. very successful. And I actually would like to say, and Tom can back us up on this, when I look across the industry, I think our centralized delivery model is truly differentiating. I think we've built not only a scale of an operating model there, but a model that's high quality, repeatable, scalable and it's actually customer-facing. The final part that we really focused on in this journey to get to the 450 basis points was truly productivity. It's not just how you deliver for a customer, but we have to make sure that the business within the business was driving to the right speed as well. And we looked at grabbing those high revenue elements and what could we do to put the right metrics around it, the performance metrics, the cadence. It helps to develop staff. It helps to set expectations, but it also helps financially to create that margin expansion. So by driving productivity, we're able to capture about 220 bps on the back end of it all in, that's the 450. Now that, like I said, is I think the first step of our journey. I do think we have a lot more room to go. As we go forward, we're going to go from those billable, non-billable ratios to spans and layers. We're going to look deeper into the organization. We're going to continue to scrutinize where we can drive centralized delivery. I think we can do more in that space in terms of how we interact in a centralized fashion with the customers we serve. Additionally, we're going to continue to look at how do we apply automation. I'll talk to that in a few minutes and we're going to think about how do we continue to drive productivity. Now not at the individual elements any longer, but we're going to turn it around. We're going to think about milestone achievement, very important in our industry. You're going to be measured on how you achieve those milestones. We're going to look at the more granular elements of delivery, how do you get there in terms of patient recruitment, data cleaning. I think those elements [indiscernible] could easily add the same scale of margin expansion that we saw over the last couple of years. So as Tom has said, plenty of opportunity as we go forward. Let's talk a little bit about the services within it. So just like how Tom put up some slides with the map, you can't have an operational slide without the bullets of the services that you offer. We're in every space that we need to be. We really span the scope of delivery from regulatory on the front end, a regulatory consulting, all of the functional elements through delivery through the conduct of it and then through the back-end services, not only how do you bring the data in with the patients, how do you clean the data, how do you extract the insights out of it, how do you package it for approval or scale. I mean, I think the goldilocks size, Tom, spot on. It's the right way to think about it. We're not going to be the biggest. We want to be that perfect size. You have to be the agile scale that sits in the middle of it. And when you think about 4,800 studies over this period of 5 years, it's inspiring. We've really touched everything, every therapeutic, every phase, every modality of delivery over this period of time. 2,600 CRAs, that's what you're measured by in our industries, all of the resources are important. But when you want to talk about scale, this is the resources that are deployed to the sites to partner with those sites, 2,600-plus, that number grows every single day. Now we want to talk about how do we partner. I think really in our industry, partnering comes down to truly how do you combine not only the right team, as Tom said, but the right strategy. Strategy is unique to each individual player. I do think with our mix of therapeutic expertise and our scientific background, we have an ability to put forward a scientific approach of what we refer to as an alternative strategy that differentiates us. I truly feel at any given day, we've got more than our fair share of opportunity to win on those opportunities. I do think we have a unique opportunity in front of us being Fortrea in terms of how do you create an agile partnering model. And so there's a term that I use quite often when I talk to customers. I talked to them that we strive to be more than a partner. And I think it's a bit of a cliche term, but when you look in our industry, there are certain terms that have become commoditized, governance, partnership. Partnership for me has just become synonymous with almost a transactional engagement. And I think with Fortrea, we have the ability to be more than a partner. And so what does that mean in terms for us going forward? Agility is how you bring that magnet expertise on any given opportunity. We're going to go forward. We're going to extract the right technology for any particular opportunity. we're going to extract the right leadership for any opportunity. And then we're going to overlay our rich scientific and therapeutic expertise. Agility, when you talk about an organization our size, means that we're not formed fitting biotech into a large organization, and forcing them to comply. We actually work around them, giving them the expertise and the scale that they desire to deliver their trial. We give them that agility of the upfront scientific expertise for consulting as well as the back-end expertise for submission. For leading pharma, we have the ability to then create a model that's bespoke to their solution. We can take our delivery model, craft something akin to what Tom described as their extension of their own delivery. Part of that outsourcing paradigm is how do you partner with sponsors in a repeatable way where they get the benefits of our scale, our repeatability, our quality in a way that's not foreign to the way that they operate and we can set up partnerships in that way. At the top, when you think about how CROs have evolved, really, there's been 2 classic models that sit at the top, full-service, FSP. FSP is where we really provide a service in terms of resources that go deep across one specific function, be it monitoring, data management cleaning. Full-service being where we take over the protocol and deliver the full aspects of it. I think as we go forward at Fortrea, what we're seeing is there's actually a solution that sits in the middle. It's called hybrid. Hybrid is becoming a bit of an overused term, but we think that there's going to be a new solution that's going to emerge. That's truly portions of FSP embedded within full-service for large portfolios. And we've actually been pioneering those delivery models with many of our customers. And we've got some really rich partnerships that are founded on the basis of this hybrid delivery with a large FSP embodied and embedded within full-service. This allows our customers to benefit from such things as the centralized delivery that we've put in place. Scale. So just like we talked about the map here, this is who we are, 700-plus physicians in this clinical segment, very important. Patient safety is at the heart of what we do. So we've got to make sure at any given point that we have the right physicians, but not only to drive patient safety, but to bring that medical expertise that allow us to be nimble in terms of how we deliver. So these 700-plus physicians that operate, not just in medical roles, but they operate in CRA roles, consultative roles, partnering roles, are there to bring solutions, these agile solutions into the customers that we partner with. What you're going to see on the screen behind is actually what I think is a very unique case study and what Tom referred to as really in the history of our development. We've seen research go from east to west -- or sorry, west to east. Now we're going to see the exact opposite. And so we're working with a customer who is really looking at kind of a uro-oncology opportunity in China, very complex, and they need to help navigating that regulatory market, and we were able to bring forward regulatory experts in China, familiar with Chinese regulatory obligations, then combine them with medical experts and also combine them with Fortrea's own delivery experts in country to talk about how did you operationalize the trial in China in this indication following the very complex regulatory guidance. This really, to me, embodies that agile delivery because it's fit for purpose in the region at the regulatory expertise needed. So just like the circles that you see on the functions that we offer. Here's a little bit of the time line of the scale of what we offer. Tom alluded to early on in the slides that we go from first-in-human, [ Oren ] with our clinical pharmacology group. But when we get into the interventional phase where we're actually giving study medication to subjects, that's our Ib space, all the way to Phase 4 real-world evidence. We see there's some challenges in this space, and this is where I see Fortrea is uniquely positioned through initiatives currently underway and those that we're going to continue to build forward near term and long term. Each of the boxes on the bottom represent an area that we're going to go a bit deeper into in a few minutes. The first really embodies that last mile that Tom referred to, the site challenge. Post-COVID, sites globally have really struggled in terms of how they recover, and we're going to talk about how we're creating unique opportunities, not just to partner with sites, but to bring those important solutions to them in a way that our sponsors can see true benefit. The second is really that data stacking. Gone is the day of proprietary data that you hold close to your vest and you only get access to if you decide to partner. And the new world is really going to be Fortrea's model, where you can buy multiple data sources, stacked in an appropriate way. Then you're going to use technology that's proprietary to us to extract out the relevant details and then you apply that to your design. We're going to talk about that in a minute on how it moves us from a reactive position to a proactive position. I think that's critical. The third, digitization in our industry, DCT has been a hot topic for years. And in fact, what's interesting, I think most of you in this room, as you hear that, you're probably even wondering what does DCT mean anymore. I think what you're going to hear from us is the notion of DCT really is going to fall away and it's going to move into the fabric of how we deliver every day in terms of how do you augment proposals and protocols to embrace digitization. How do we bring that to sites in terms of reducing the complexity of how they deliver. And then how do we use that to design protocols that not only execute quicker, derisk through decomplexifying them, but also ensuring that we're identifying the right subjects and moving it into the fabric of delivery instead of a bolt-on. And then finally, innovation, automation. Tom showed the paradigm, the S curve that talked about how you partner. We're going to partner, we're going to leverage expertise here, but we're also going to bring our own AI to the table that talks about how do we take that technology and move it across the way we deliver that actually differentiates us. So let's go into each of these in greater detail. The last mile with sites, the paradigm. So I've been very vocal over the last 2 years talking about post-COVID, post-pandemic, the sites have really struggled as the world variabilized for talent acquisition. It hit the sites hard. They've really struggled in terms of continuing to maintain talent, develop that talent. On top of it, protocols continue to become ever more complex. We're not over -- not just overlaying digital and technology. We're looking at multiple protocol amendments. We're looking at granularity in terms of how we're recruiting subjects. And we're thinking globally how do we attract in a very crowded space, many protocols competing for the same subjects. How do you really differentiate? Sites needed a solution. In our industry, over 20-plus years, I've watched all of us try to create solutions for sites. And most of those solutions were very inwardly focused. We solve for sites by solving for ourselves. We solve by placing resources on that are dedicated to sites. So when they call, they talk to one singular person, but that doesn't take away their problems. And so Fortrea actually came out in a very different way, and we've spent a tremendous amount of time not just focusing on contacts, but how did you take the technology that exists in the industry, deploy it to a side in a consistent fashion. So if you think about 10-plus major global CROs all running at any given time, 500 to 1,500 studies, all rushing to the same sites with disparate technology searching for disparate patients, the complexity fell in the shoulder of the sites. We're actually partnering with likes of companies like Advera to think about how do you take their technology, deploy it across a large portfolio to then enable that site to run not just our protocols in a more consistent fashion, but all the work that they do, allowing them to become more successful as an industry. We see that as the paradigm that needs to be solved and we're leading that charge today. And so we're at the forefront of that. I think it's not only differentiating in terms of a customer partnering way. But it's actually differentiating when you can talk to sites and you're becoming their CRO of choice because we understand and listen to their needs. The data stack. So Tom talked about this data stack, and I'm going to give it to you in a slightly different view. At the top, it's very important. Glenn mentioned it, Tom mentioned it and you're going to hear it repeatedly through our presentation. The data assets that sit at Labcorp are unique in 2 fashions. The U.S. diagnostic data represents at any given point, nearly 50% of the U.S. population in terms of diagnostic codes. In terms of finding rare patients and understanding patient flows, prevalence, particularly for diversity and inclusion, this data is key. Secondly, the central data, the central lab data that comes from what was historically Covance Central Labs, now Labcorp Labs, represents how sites are performing globally at any given point in the research space. We can understand through how kits were ordered and resupplied through protocol deviations through cleaning, how sites are performing against protocols. And we know how saturation impacts the site in terms of their own delivery. And so we're using that data combined with our own data around site performance, that from endpoint in terms of randomization data, our own start-up time lines in terms of how quickly we can start up and then stacked on top of partnership data. All this together through a proprietary tool that we've created years ago, allows us to move from the paradigm of what sponsors felt was a very reactive CRO landscape to the ability to be a proactive CRO because we can model not only at start-up, but this tool sits in the hands of our project managers. And they can reforecast on the fly to see how we're performing against benchmarks, how we're performing against the industry and what are the mitigations we need to navigate around potential challenges. Diversity and inclusion has not become just a hot topic in our industry. Recently, the FDA has actually mandated this. And so we were ahead of the game in terms of the development of our own software that sits at the top of it. And it's really more of an AI machine learning than it is a software. We've partnered with sponsors to really look at 2 types of inclusion of diversity and inclusion in our industry. Number one, how do you find diverse sites? Diverse sites are going to find diverse patients. It's also going to help solve the challenge of volume within our sites. Two, we needed a model. How did you attract diverse subjects into it? Now the reason diversity in subjects is important, we have to ensure that the population tested represents the intended [ treat ] at the point of approval. That's how the sponsors get approval for their drugs. And so what we do is we use our data upfront, the model out where the sites are, what the patient powering needs to look at and then we monitor during the conduct of the trial, the important elements that influence this. We look at number one, race, sex ethnic background. We look at all of the diversity elements as subjects screen, who screens successfully? What were the reasons for screen failure? We then look at who enrolled, what subjects enrolled, what subjects failed. We look at dropout rates, who stayed in the trial, who dropped out. We take that data and we provide it back to sites in real time to help them augment their own screening practices, their own retention practices, but we also work with statisticians to look at the powering of the trial to ensure that we're moving forward in a way that's going to satisfy the objectives of the trial. We are the only CRO that's able to do this right now and it's impressive. And so what you're looking at on the screen is a dashboard that we use, we track this throughout the course of a trial to ensure that we're driving the appropriate elements critical for our own submission. Digitization in our industry, you hear a term for me that it's in the fabric of what we do. It can't just be a bolt-on and a function. I'm not going to go through this slide in the interest of time. The way I would break out these 3 elements, to the left is about how do you augment the design. How do you weave in the digital elements in terms of protocol amendments, not just add digital elements to traditionally design protocols. It's very important that you augment. Two, how do you bring that to the site and to the subject. A lot of digitization is how you influence that to the subject, either in terms of e-consents, telemedicine, wearables, those elements. And we're seeing as complexity goes up, the amount of vendors in the space continues to increase exponentially. So it's of critical importance that we can decomplexify this and pull this data together in a centralized fashion. And then the third element is what do you do with the data? How do you take this data and put it into a usable dashboard so we can understand the impact of the point of delivery. And so that's what we're doing. And so for Fortrea, DCT digitization is really about taking those elements and weaving it into delivery to where it becomes business as usual. Finally, automation, AI. So as we leverage our existing partners and new partners to look at how do we bring in automation and what we do, it's critical for margin expansion. It's critical for quality. It's also critical for the evolution of delivery. There's a few examples that we've noted here on the slide that we've had in place for many years that I actually think are differentiating. So I'll go through a few of them. At the top, we have a bot that actually scans through a trip report. So when a CRA goes on site, one of the outputs is they write a report. What data do they review? What findings did they have at the site? What did they uncover in terms of IP usage, challenges around protocols? All of that goes into a comprehensive report. We have a bot that stands through all of those reports for a given trial. It extracts elements out for various reasons. Number one, what are those elements that have to go into the trial master file, that a company's submission of that data. So that is able to then make sure nothing is lost. We skim through that in a very quick way. Number two, it takes that data and then it fires it out to the appropriate team members. Multiple CRAs were able to track for trends. Medical doctors were able to check for safety signals. We're then able to look at, are we seeing any challenges in the way that we're operationalizing a trial that need to be adjusted in a real-time fashion? Allows us to be productive or proactive. One more, we look at how do we prepare a visit. So part of creating those visits is how do you create a pack, we call it a prep pack for a CRA to show up on site. When I entered this industry 20-plus years ago, you'd show up on site, you say, give me the binder. They hand you this giant stack of pink and blue sheets, and you would just sit there and review through it. But those days are over. Now you show up on site, and I want to see specific subjects that have had specific visits, and I want to see how the data has progressed for them. So I have to have the monitor show up with that pack in place that gives them a road map, a blueprint of who they need to monitor, what they need to look for, what signals may be presenting and we're able to then start extracting the appropriate data. This is going to continue forward, and we've invested greatly in this space. All of this means nothing if you can't manifest it into a case study. So what stands behind me is actually a poster that was presented at a recent conference with a leading pharma where we conducted a trial with them. It wasn't just any trial. It's pediatric RSV on a global scale. So you could argue that this is not only one of the most complex trials to run, but in a very complex population. And as parent that had a son who had RSV when he was 8 weeks old and was intubated for nearly 2 weeks, I know consenting to a trial is the least thing on my mind at that state. But we were able to actually create a protocol with this sponsor that overlaid the digital elements, e-consent, many different devices, pull those devices together in a singular way to wear for a site. It was simple for them. If you think about when these babies are entering the trial, most of them are having some episode. They're struggling to breathe, parents are upset. They want to know what's going on. We consented them in a very clear way. We're able to track the protocols they were on. We were able to drive that through a solution. Why this is important? At the end of it, the sponsor actually published into their poster that this became their new operating model. It's the new standard in which the way they're going to conduct trials and we pioneered this with them. So very proud of that. Fortrea is on the -- not only the cusp of adopting technology, but we're bringing it to the reality of how we're delivering that for trials. So with that, I have the pleasure of introducing you to my esteemed colleague, Dr. Oren Cohen. He may weave in a joke or 2 for Tom. I was right on time. I went positive just a few minutes.

Oren Cohen, MD

executive
#7

Thank you man. I will wipe it down, I'm an [ ID ] guy. I don't know where your hands have been. All right. Good morning, everybody. It's great to be here in New York. I did my internship and residency about 30 blocks that way at the New York Hospital, when it was part of Cornell, before they built that new cantilevered thing that's over the river that makes me very nervous. At the time, actually, we had rotary phones. It was a little while ago. And many brushes with greatness, a lot of celebrities came to New York Hospital. And I remember one day I was in the emergency room, and this ex-Secretary of State asked me if he could use the telephone. He had come in with some minor injury that needed to be attended to. Yes, and I said, of course, and you have to dial 9 to get out and he did, and he said, hello, Nancy, I'm going to be a little late. Anyway. So let's talk about clinical pharmacology. And if I could get the next slide, it's a super exciting time to be in drug development. It's -- I cut my teeth professionally in the early years in HIV medicine and drug development. And when I was at New York Hospital, it was really at the height of the HIV pandemic and we were losing a tremendous number of patients on a regular basis. And the life expectancy at that time of someone with an HIV diagnosis was less than a year. And now with combination antiretroviral therapy, I mean back then, ribavirin was about the only antiviral in existence, and acyclovir. And now the life expectancy of someone diagnosed with HIV on highly effective antiretroviral therapy, their lifespan is essentially normal, which is just an unbelieve -- it's not in the news very much anymore, but it's pretty unbelievable. And Tom mentioned some of the other advances that we're seeing in real time. So it's super exciting in clinical pharmacologies. To me, the most exciting place to be. We're really seeing that leading edge of people's pipelines with very novel innovative compounds, and we get to do the first-in-human trials. We get to hand it off into Mark shop . And then Mark shop hands it back to us in later phases of drug development when we do the pre-submission studies, drug-drug interaction studies, hepatic impaired, renal impaired, what have you. I was just in Japan last week with customers and sat with a Japanese customer who had awarded us their Phase I trial, which we're doing very successfully, and they've just awarded us the Phase II trial into Mark shop. So that sort of virtuous circle in drug development starts with clinical pharmacology in Phase I. And over the past several years, we've really driven strong growth in the business through strong and enduring customer partnerships, increasing our bed capacity and utilization of those beds and developing an external site network to supplement our offerings within our own clinics. We've consistently grown revenue and then we've consistently grown operating margin at an even greater rate and we steadily driven that margin improvement through increased productivity, higher utilization and some targeted increases in pricing. And just as an example, over the last about 3 years, we've sequentially reduced our labor cost as a percent of revenue by more than 15%. We've increased our average bed occupancy by more than 30% and we've increased pricing by about 20%. We haven't really seen any decrement in our win rate. So the business is doing very well. I think we're a recognized leader in clinical pharmacology for a number of reasons. We've got some great strategic partnerships with some really A-list pharmaceutical companies. But as Tom mentioned, we also serve a very broad customer base and our ratio in clinical pharmacology is right around 50-50 pharma to biotech. Over the last 5 years, we've done more than 600 studies really across the whole gamut of the different types of clinical pharmacology studies, including first-in-human, single and multiple ascending dose studies, exploratory studies. And then the more sort of standard food effect, drug-drug interaction, in addition to some niche capabilities like radio-labeled human absorption, metabolism and excretion studies. Our staffing, importantly, we have expertise that's dedicated to clinical pharmacology. So whether it's our physicians, our clinical scientists, our project managers, our data people, they're all dedicated to clinical pharmacology, and I think our customers really appreciate that. Top therapeutic areas, really interesting that oncology turns out to be our #1 area. Oncology traditionally has been very separate in clinical pharmacology because of the need to do these studies in cancer patients, in cancer centers with cytotoxic drugs. But these days because of the number of compounds that are not cytotoxic and can be studied in normal healthy volunteers, this has become our #1 therapeutic area in normal healthy volunteer population. So it really speaks to that strength of the oncology pipeline. And otherwise, I think our study mix really reflects pipelines generally. So we see a lot of neurodegenerative space, in the endocrinology space, immunology and inflammation, cardiovascular, it otherwise looks pretty much like our customers' pipelines. The figure on the right-hand side of the slide is super important. And when I came to the company about 6, 7 years ago, we had 4 clinics. They weren't terribly interconnected in any meaningful way. And we've built what I call an integrated platform around clinical pharmacology that I think is a great value proposition. And it really speaks to managing complexity in the space. Protocols have become so much more complex in this space over time. As our customers seek to gain early insights into not only whether the drug is safe, which used to be really the only thing you did in Phase 1. But now trying to glean some insights into possible early signals of effectiveness. And this platform really delivers holistic solutions. So the 4 walls of a clinical pharmacology unit used to be sufficient to really deliver those holistic solutions. It's not anymore. And this is why I think we've gained so much market share because we have that ability to solve for complexity in the space. I'd point out project management is probably the best example of this. When I joined, project managers were strictly assigned to the individual clinics and we had about 25 full-time staff in the project management department. We've totally changed the operating model. They operate in a totally site-agnostic way now, and we've grown that group to over 150 full-timers in the project management department. Our differentiators, we have tremendous first-in-human experience and expertise. Our cGMP pharmacy, so clinical good manufacturing practice pharmacies allow us to do small-scale manufacturing on site for our customers, and that includes pressing tablets, filling capsules, preparing intravenous sterile formulations. We have -- I mentioned our fully dedicated experts, including 23 dedicated pharmacokinetics and a whole team of physicians and clinical scientists. We're really the world's leader in those radio-labeled human absorption metabolism and excretion studies in our Madison clinic alone. We do them in Madison and over in the U.K. in Leeds. Just in Madison, over the history of that clinic, we've done over 400 of these studies. And I don't believe that anyone has nearly that expertise. And it makes a difference when you don't just dabble in these kinds of studies, when you have regular ongoing experience, makes a huge difference in terms of the outcome. Special populations, we've built this experience initially on renal impaired and hepatic impaired populations, but we really expanded into patient populations in that Phase Ib space where we start in normal healthy volunteers, but then we end up in cohorts in patients. So my group and Mark's group collaborate on this, figure out the overall complexity, does it belong in the global shop where this is 50 patients in 8 countries, whereas if it's a smaller number of patients in a couple of countries, it's probably done in my shop. So that's an area, I think, that we're also mastering increasingly. We have terrific partnerships. We have students, residents, fellows rotating through all of our clinics from -- in the U.K., we've got a partnership with NHS Health. We have partnerships with the University of Leeds, University of Liverpool, St. George's University in London. And then University of Wisconsin, Madison, University of Texas, Texas A&M and Lake Erie College of Osteopathic Medicine, LECOM. Yes. So all 4 of our clinics have these partnerships that I think are win-win. And we continue to grow that external site network to really accommodate more of these niche and patient populations to supplement our in-clinic offerings. And quality is super important to us. We operate a tried and true methodology, failure modes and effects analysis to derisk studies that we undertake before we undertake them. We've implemented bedside data capture system, which is also a tremendous advantage from a quality standpoint. So our footprint, Tom mentioned the 4 clinics that we have, they're all pretty good size, 72 to 100 beds. The clinic in Leeds. You see a couple of photos there and a couple of snapshots. We've built a brand-new purpose-built clinic there in Leeds. We took an existing core and shell of an old building south of the river. There's been tremendous economic development there going on. And we're at the leading edge of that. We have a tremendous ally in Sir Roger Marsh and really fantastic things are happening in Leeds. That clinic is absolutely magnificent. It is the crown jewel. I do believe, and I may be slightly biased, but I've seen a lot of Phase I units. This is the finest Phase I unit in the known universe. I'll go out on a limb and say that. And you're all invited. June 21, if you want to come over to Leeds, we're having a ribbon-cutting ceremony I will take you to dinner. It will be worth the trip. So please hit me up if you want to come on the 21st to see the Leeds clinic. It's absolutely fabulous. We invest -- we're investing in clinical pharmacology. We think that's good for the business, good for patients, good for our customers. I mentioned, of course, the new Leeds clinic. We've also expanded our clinics in Madison and Daytona. Operational excellence, project management, I think, is a good model there and the use of failure modes and effects analysis. Our medical and scientific capabilities are very deep. We've got dedicated investigators, pharmacokineticists, our cGMP pharmacies and some device technologies. And then also in the technology and AI space, really excited, is sort of my holy grail. I've been on a mission for about a decade and finally realized it. And that was the way that all clinical pharmacology businesses book their beds is old school. It's a big piece of paper and a pencil and a giant eraser and I thought that's kind of shameful because it's really the key driver of the productivity of the business side of it. And so we worked with our AI team. We developed an AI model that predicts very well whether a study that's scheduled will stick or whether it will change. And that helps us overbook to just the right extent, and that's part of the big story of increasing utilization of our beds. And I think that's a great story. And then my timer is counting up. So I have not saved us any time, I apologize. A super quick case study. The beginning of the pandemic, I got a phone call on a Sunday from a CEO of a tiny company that I never heard of, Ridgeback Biotherapeutics. They had a compound that they thought had good activity against SARS-CoV-2. We put a team together. We helped them write their protocol. We helped them write their regulatory submission. We did the first in-human dose of this in Leeds, 5 days after receiving regulatory approval in the U.K., we went on to complete 8 single [indiscernible] dose, 7 multiple [indiscernible] dose and 1 food effect cohort in 16 weeks from the time that protocol was submitted for regulatory approval. Working to standard time lines that would have taken -- normally, it would have taken 46 weeks, it was done, delivered pristine data. That compound was sold to Merck and is it maybe not the greatest antiviral history. At the time, it was the only one that we knew of, and I think a tremendous story of accelerated drug development and happy to talk all day about that one. But it is time to move on, and it is my pleasure to introduce Sam Osman to talk about enabling services.

Sam Osman

executive
#8

So I'm not going to bore anybody today with a bad dad joke. I'm also not going to invite you to our locations, but that's only because they're not as interesting as a Phase I facility. So thank you for the opportunity. I'm really excited to be here. I'm excited to work with this world-class management team. I'm really excited about some of my assets and I'm even more excited about the potential. So I'll be discussing enabling services as a segment. You've all seen these numbers before, but enabling services comprises roughly 9% of 2022 overall revenue and roughly 6% of overall operating income. This is a new business segment for Fortrea. We're bringing together existing solutions with a new focus. As you heard from Glenn, both Covance and Labcorp have assembled a number of commercial and technology assets over the years. Our commercial services organization has been with us for a number of years, and some of the technology assets were acquired through acquisition more recently. So we're bringing together disparate but truly best-in-class services to create a comprehensive solution for the industry. My team has the opportunity to leverage the right components of each of these offerings to develop innovative and impactful solutions that span the clinical as well as the commercial spheres. My focus is optimizing for growth and margin creation, both as a stand-alone but also working with Mark and Oren's organizations to provide differentiation for our clinical segments. There are some opportunities to improve operating income through productivity and automation in the midterm. There's also opportunities for better leverage of our infrastructure as we bring these business units together. So there are 2 parts to our enabling services segment. And as I mentioned, they truly span the continuum of clinical and commercial. I'm going to start with our technology solutions and there's 3 of them. So patient randomization and trial supply management, the term RTSM. It's provided by our endpoint brand. We have patient and site-facing technologies that support virtual and hybrid trials through a DCT model. This platform also supports telemedicine and remote patient management. And then thirdly, we have a suite of analytics and automation dashboards. These support internal teams, Mark's teams, but also external teams to better and more effectively run clinical trial operations and collect high-quality data. On the right-hand side of the page, are patient access solutions. These focus on supporting patient access and adherence on commercialized drug products in the U.S. market. I'm going to double-click on some of our technologies within the clinical space, starting with endpoint clinical. Endpoint is a global leader in interactive response technology for clinical trials. And this team has operations in the U.S., in Europe as well as APAC. The team has deployed over 1,700 studies that ensure clinical trials are correctly randomized. This is important to achieve accurate and unbiased results. So what does this team do? In a nutshell, we make sure the right drug is at the right site at the right time, but it's more complicated than that. We also ensure that each dose is dispensed at the correct amount and the correct cadence per the business schedule. The core product is used by the majority of top 10 pharma and enables deployment of the most complex of studies, including oncology and radiotherapy. In 2017, inventory management was added to help manage the complex distribution of drug for manufacturing through patient dosing or through destruction. Moving drug management from a protocol level to a portfolio level is really important as it enables cost savings by advanced functionality such as drug [indiscernible]. This is really important in the world of large molecule development where active is costly and limited supply and comparator is tough to get a hold of, okay? So oncology, radiotherapy, cell and gene studies are all prime for this. As we look at the future, our future offerings will look to consolidate many of these multiple individual platforms into a single instance so we can better enable efficiency. Okay. As you've heard from Mark and Tom and you'll hear from Drayton and others, decentralized trials have become far more common in recent years. And there is an increased focus, as we've all heard by all stakeholders to ensure that patients, sites and all clinical trial participants have an improved study experience. What's important on this is how we exchange data frictionlessly between patients, their caregivers and all trial participants. Now both the decentralized clinical trial and the clinical outcome assessment markets are large markets and they're forecasted to grow through the end of the decade. As Mark alluded to, there is no standard DCT study, either technology or service. And what we have here is a technology enablement that allows the clinical sites to be transformed and transferred into the living room of the patients. So patients can perform informed consents. They can have a telemedicine visit with their healthcare providers. They can complete study diaries, all within an easy-to-use app interface. The technology can integrate with a multitude of connected sensors and wearables. And during the pebdemic, this platform was used for 3 emergency use authorizations and also provided a portfolio of dozens of studies, the ability to engage and retain with patients when they couldn't go to their sites. A couple of slides ago, Mark shared an example of a recent large pharma study where many of these features were deployed. As I move over to the right-hand side of the page, our analytics dashboards, these are a suite of dashboards and automations that have been built to provide a risk-based approach to quality management and study delivery. What does that mean? These platforms provide dynamic insights that provide actionable and timely information to both internal as well as external study teams. And this is truly one of the many advantages of having an enabling services segment alongside of CRO. Now we've deployed this platform internally on Fortrea studies. It's also deployed externally to pharma customers on a stand-alone software as a service basis. As you can see from the 28,000 users and the over 2,000 studies that are on this platform, it's secure, it's scalable and it's fit for enterprise-wide use. All right. Switching to patient access solutions. And in a nutshell, this team supports product access and product adherence in the commercialization of products in the U.S. market. The team's roughly 1,800 professionals supporting this business. So we help patients get access to drug, and we support education and adherence programs by working directly with patients, caregivers, HCPs and also health insurance companies. Patients are at the center of everything that we do. If we take a step back, patients on drug sooner and for longer, is critical to pharma's revenue model. There are 3 main components for how we perform this. Hub services, which is provided by our call centers, where we work to help patients get access to drugs quicker. A noncommercial specialty pharmacy, where we support the free drug programs that have been offered by pharma. We've made selective investments in the space that allow us to support the fulfillment of cold chain products. Cold chain includes all your large molecules for oncology, cell and gene and other studies. And then lastly, we have field services. These are trained professionals that provide health care providers in-person training and education. We also have a team of clinical educators that conduct product training to various stakeholders and to patients. So there's tremendous opportunity to bring together some of these disparate technology pieces and sell a suite of solutions direct to pharma, but also to work better with Mark and Oren's team. When I think about synergies and opportunities, I think about it in 3 areas. I think about patient support, site support and data support. Specifically, for site support, what are the tools that enable sites to more effectively and efficiently operate clinical trials? For patient support, what are the suite of technologies that reduce frictions in collecting patient data and promoting patient retention? And then thirdly, around data support. How do we ensure timely and high-quality data to our pharma customers and to the regulators? So I'm running short on time, but I'll be quick on some of these. So there's a lot of opportunities. We've talked about mining data across some of these platforms. We've also talked about the digital platform that supports DCT and hybrid studies. That's really well positioned to support the next evolution of trial designs and studies that both Tom and Mark have mentioned. And I wanted to talk about drug accountability. We've all seen it. The pandemic continues to have an impact on supply chains. Optimization of supply is a nascent but a growing area of focus for pharma, especially where drugs are costly or especially where drugs are personalized and have a relatively low shelf-life stability. So in summary, me and my team are really focused on building a durable foundation for today, but I'm optimistic that there's a really strong story for expansion over the next few years. And that story around expansion, that's where Drayton Virkler comes in, and I'm really excited to announce him on the stage as our Chief Commercial Officer.

Drayton Virkler

executive
#9

Thanks, Sam. A former professional tennis player. I did play in my Member Member Golf Tournament and finished second in the sixth flight. So I have nothing. All right. So hello, everyone. I am honored to be with you today to introduce you to our commercial capabilities. And I'm also honored to be here to lead the evolution of our commercial organization from a divisional sales organization to really a world-class commercial engine. The good news is that as I stand here today, in my -- at the end of my first month of being the Chief Commercial Officer, what I found over my first 30 days is we have a really, really strong foundation that we're going to be building from. As you can see here, we have a diverse customer base made up of a great mix of large pharma customers as well as all sizes of biotech customers. We also have solid capabilities that have been well outlined today by Mark, Oren and Sam. And then as I think about our commercial organization, we actually have a global commercial footprint. We have great sales talent sitting across the world at scale. And then we also have a strong divisional track record of delivering sales results quarter after quarter. Now what are we going to evolve to? We're going to evolve to that commercial engine where we will land and expand more large pharma accounts. We will become the partner of choice of biotech by driving customer centricity and we will focus on making sure that as we drive our customer centricity that we're focused on building the right mix of business that enables us to really optimize our margin profile. And we will do all these things while building the brand of Fortrea with each of our customer interactions. As Tom covered earlier, once the slide advances, you're going to love this next slide. It's great. Okay. As Tom covered earlier, we do have a diverse set of customers with 54% of our revenue represented by large pharma customers, with 46% of our revenue coming from small and other customers. Also, we only -- no one customer represents more than 10% of our revenues. What this slide covers is this shows our level of account penetration within our top 15 customers. And as you can see, the value that we bring our customers is represented by a multitude of our service offerings, but the good news is even with our top customers, we have room for growth, and we can drive cross-selling across white space to really drive more opportunities for our organization. Digging a bit deeper. When I think about Oren's business and I look at the top 10 customers, that Oren's business is serving, only 3 of them are represented within the top 10 of what Mark does. What does that mean? That means these are customers that we have solid senior-level relationships with. Yet, we still have great opportunity and knowledge of their organization to drive greater cross-selling, greater penetration and growth for our organization. It's also interesting to note, as you look at the full service and the FSP business, many of you are probably thinking, well, wait a second, I thought large pharma only did either full service or FSP. The fact of the matter is many of these customers leverage us for both. And then even -- and that's not even take into consideration what Mark was talking about with more of these hybrid FSP approaches that we're also driving with our customers. And the final thing I'd like to drive on this slide is that we have a great set of offerings that enables us to follow the molecule from first in human to Phase II to Phase III to regulatory approval and beyond. These services are very focused. They're at scale and they're global. Now Mark talked to you a lot about our overall service capability. I'd like to dig in a little bit deeper here to one of our key therapeutic areas of oncology. Within oncology, in 2022, 46% of our revenues came from oncology studies. Also in 2022, 65% growth in our new bookings compared to previous year. And then when you think a bit about what is our experience, historically, we've run over 1,200 oncology studies through 2021, enrolling over 210,000 patients in 9 primary indications. On the right side of the slide here, we talk a bit about why customers partner with us in oncology. Starting out with early engagement. With early engagement, we come in well ahead of an RFP, well ahead of a decision process, and we bring our operational and scientific expertise to help our sponsors guide their protocols, their strategies and their clinical approaches. This enables us to really help them build the best programs and also gets us in early so that we can build those relationships. Next, thinking about data-driven site selection. Mark did a great job of explaining the data that we leverage in order to drive the best site selection. I'm a sales guy though, so I'm going to break it down and make it a little bit easier. So what we do is we take the experience that we have with our sites, and we set the recruitment strategies for our customers to enable them to drive recruitment more quickly, specifically in oncology, when you think about what kind of site experience do we have. Over the last 5 years alone, we've worked with 27,000 cancer sites in 91 countries around the world. What this enables us to do is to know what sites are the most productive and which sites kind of stumble a little bit. And so that enables us to do great site selection. The other thing that we're able to do is from that experience, we figured out how best to work with sites to help enable them deliver the protocols while also meeting the needs of patients. And finally, out-of-the-box thinking. Fortrea examines the proposal from both an operation and scientific lens to provide bespoke solutions to optimize our sponsor's end-to-end drug development journey. Now getting a bit more to my team. As I noted in my intro slide, on day 1, Fortrea has an experienced commercial organization with a global footprint. On the left side of the slide here, you can see that we have team members positioned in all the major areas around the globe. The commercial team is also a sufficient size and scale to power our growth going forward. Our sales team has an average tenure of over 18 years of experience in the industry, supported by our global inside sales team. Our proposal managers leverage best practice to assure that each proposal is customized to our unique customer needs. And we have strategic deal teams that help build focused win-win deal structures. And then our contracts team finalizes negotiations and help get contracts across the line. So this is truly a very strong commercial engine. Is everything perfect? Not yet. We're evolving. And so this is the area where we're going to be really evolving over time to build that world-class commercial engine. Within our sales team, we're evolving our focus from focusing on our division to focusing across the business and really driving those cross-sell opportunities with existing customers while we're also driving prospecting to fill the funnel to drive growth for future quarters. We're also building a culture within our organization where everyone sells. So it's not just the salespeople that are going out. It's the medics excuse me, yes, we're not supposed to call them medics, they get insulted. So it's our physicians who go out with our sales organizations. It's our delivery leads. And it's also every executive that you see here today is part of the sales team of Fortrea. And why do we do that? We do that with a goal to provide deep customer stakeholder engagement that matches the right Fortrea team member with the appropriate client peer to really understand what their needs are to drive better solutions and wins for the organization. As we go through the sales process, we also have dedicated customer deals teams to develop delivery offerings that meet and exceed the expectations of our customers. And we also use proven sales methodologies along with AI technology to help us assign the right person to the right problem for the right deliverable. And finally, we're evolving our planning process to our current and future customers to move from the divisional focus to thinking across the company to target customer white space where we can drive growth and optimize mix to improve our margin profile. And we're doing this through our strategic, cross-functional and territory account planning to enable us to really build those strategies to help us achieve those goals. And all of this is held together by our sales culture of winning, collaboration and growth. Now we also talked a bit about the key customers that we work with. What we're doing on this slide is we're looking at some of our current partnerships, current relationships that we have. And we have 3 that are large pharma on one side and then 3 that are agile biotech on the other side. With leading pharma, I'd like to call out a successful partnership in clinical pharmacology that we have with the top 15 biopharma. This partnership has been in place for over 15 years, and we currently have 80 studies ongoing with this customer. From the biotech space, we have a great example of a sole source partnership with a European biotech who leverages for our expertise in oncology. This partnership started with a single engagement and has grown over the years to a sole source relationship that brings great benefit both to the sponsor as well as to Fortrea. And at the bottom of the slide, you'll see some of the key themes of why our customers like to work with us. And you've heard these throughout the course of this morning. One, early engagement; two, deep therapeutic and scientific expertise; and then three, dedicated client teams. Before I hand over to Jill, I want to quickly summarize what the commercial team will be focusing on over the remainder of this year. Number one, we will put the spin behind us and we will focus on building the brand of Fortrea and driving awareness across our customer and future customer base. We will leverage our strong foundation and drive the commercial engine to increase our sales funnel and increase our win rate. To increase the funnel and win rate, we will continue to drive customer intimacy with current customers and increase our share of wallet. And finally, we will ensure we build the right strategies and deal approaches to drive the right mix of services for our customers and for the organization. Thank you for your time. And now I'd like to hand it over to Jill, our Chief Financial Officer.

Jill McConnell

executive
#10

Thank you, Drayton. And let me also add my thanks to everyone who's joined us today. So I am going to just start out before I get into a lot of the details. Just talk a little bit about some of the benefits in the story, and you've heard a lot of this from my colleagues. But being part of Labcorp over the last 7, 8 years has really been a great benefit for Fortrea but the spin is now giving us increased strategic focus and flexibility. As you've heard from many of my colleagues, we are starting our journey with an extensive history as a market leader from Phase I through IV and beyond. The announcement of a significant transaction like a spin-off often creates a period of brief disruption and we've experienced some of this over the last few quarters. It has impacted certain orders, primarily with small and midsized customers who are concerned about the uncertainty, and this has led to some revenue softness in the short term. For the spin itself, we've been very intentional about moving at pace to reduce this period of uncertainty. So we adopted a lift and shift model, taking the existing systems and processes over to Fortrea, rather than taking a longer period of time where we would transform and then move across. So this creates meaningful opportunity for the organization to improve both top and bottom line performance over time. Before I start my commentary on those historic and more recent financials, I do want to reinforce a few key points that my colleagues have called out which give me confidence about the future financial prospects for Fortrea. We have that large and diversified customer base. You've heard them talk about with long-term relationships, many of which have lasted for more than 10 years. We're evenly balanced between large pharma and small and midsized pharma. We have that favorable customer concentration risk profile with no one customer being more than 10% and our top 5 customers are all large pharmaceutical organizations with whom we've worked for more than 10 years across multiple offerings for dozens and dozens of projects. We're experiencing more than 20 therapeutic areas, and we operate in more than 90 countries across the globe. As I know personally, oncology continues to be an area of unmet medical need, and we are strategically positioned to compete there with oncology constituting nearly half of our portfolio. We see opportunities to grow our top line, not only in oncology but in other therapeutic areas like neuroscience, cardiovascular, renal, cell and gene therapy, among others, you saw my colleagues talk about as well, through targeted organic investments. We have a strong history of margin expansion with more than 500 basis points of expansion over the last 4 years. Key members of this leadership team, including myself, have been involved in driving that performance, and we're committing to do that again in the future. Overall, Fortrea has an attractive financial profile with a history of strong delivery, and our new leadership team is committed to conservative financial policy that balances revenue growth and margin expansion with sustained long-term growth in the business. We ended 2022 with $8.6 billion in our backlog, growing at roughly 5% CAGR over the past couple of years and keeping us in that desired range for the CRO industry of 1.2x book-to-bill, which will drive sustained long-term growth for the business. We ended 2022 with over $3 billion in revenue. This was roughly a 10% constant currency revenue CAGR over the last couple of years. Our quarterly backlog continues to grow, and we ended the first quarter at our highest level ever at $8.9 billion. In the first quarter of 2023, we had a renewal with a large pharma customer for a large multiyear FSP contract we've worked with for many, many years. It really demonstrates a vote of confidence with those customers with whom we've had enduring relationships that they are confident in the future of Fortrea. Our orders mix has been a bit unusual over the last few quarters, where we've seen a bit of softness in that small and midsized biotech space being offset by a number of large pharma wins from leading pharma customers that have helped to balance out that overall volume, but it has led to a bit of a mix, which is driving a little bit of the short-term revenue softness. We are confident that with our spin nearing its close and we are getting -- we've had such a smooth transition in our pilot period, we believe we'll be returning to strength and the conversations we're having with customers about this have been very positive. And we believe we'll see that return now of the small to midsize as that period of uncertainty or perception of uncertainty is behind us. In terms of the track record of margin expansion, again, this leadership team has delivered that over many years. You heard a lot of my colleagues talking about specific examples. And we've done that by driving top line growth, which is primarily -- of primary importance, but also by leveraging our capabilities and our global footprint. We have supplemented strong internal talent with hiring experienced leaders from the industry to maintain business continuity, but also to ensure that we are looking for absolutely every opportunity for growth and optimization. In just the last couple of years, we grew adjusted EBITDA by more than 300 basis points. This was also achieved through top line growth, but also reductions in duplicative management structures, increased geographic optimization and facilities rationalization. We reported $405 million in adjusted EBITDA for the full year of 2022 and $387 million on a trailing 12-month basis through the fourth quarter of 2023. As we exit out of the spin and put that perception of uncertainty firmly behind us, we are confident in our ability to drive growth and return to margin expansion. Now I'm going to touch on Q1. Q1 was softer than what we have seen in the past. And we do not expect this to be indicative of our ongoing performance. However, historically, for Fortrea, the first half has been softer than the second half. We are experiencing effects of a separate FSP contract that we lost in the first quarter of 2022, and that has taken a while to wind down due to the nature of that contract. So as that winds through and annualizes, it's disproportionately affecting our first half revenue. We are also experiencing some slowness in our backlog burn rates driven by a changing mix in the backlog, an increase in longer duration studies, continued staffing challenges at investigator sites, as you've heard some of my colleagues talk about that, along with geographic headwinds, primarily driven by the continued conflict in Ukraine. In addition, we took an unusual provision for credit losses in the first quarter related to a small biotech that declared bankruptcy. And we use that trigger as an opportunity to review our overall provisions for that space. Historically, our write-off provisions have been minimal, less than 1% of revenue annually, and we remain in line with that in spite of taking that additional reserve in the first quarter. We anticipate these headwinds to be short term in nature and are confident in the near and longer-term market opportunities for Fortrea in the CRO space. Here, we're providing a reconciliation of historical net income to adjusted EBITDA with a further walk to the management view of adjusted EBITDA, where we replaced historic corporate allocations from Labcorp with our bottoms up build of incremental stand-alone costs. On the walk from historical net income to adjusted EBITDA, more information about each of these line items is available in the Form 10. These adjustments reflect accepted and similar peer-driven adjustments to drive industry comparable adjusted EBITDA. In determining our stand-alone costs, we looked at what had been allocated to the clinical development business from Labcorp historically and looked internally to what we believe we absolutely needed to be able to operate on a stand-alone business as a public company. We worked on this initiative with both internal leaders as well as external advisers who've consulted on numerous spins to ensure that we could account for what worked well and what has worked less well for other spins in the past. By focusing on what was truly needed for our organization versus some of the things that might have been nice to have as part of the larger Labcorp organization, we believe we can operate more efficiently on a stand-alone basis, particularly once we exit the transition service agreements that we have with Labcorp. Work has already begun to further optimize our cost base, and I'll touch on this a bit more in the next slide. Beyond the margin expansion we expect to see through top line growth over time, we see optimization opportunities through process improvement initiatives as we branch out from the processes and systems that existed as part of the larger Labcorp organization that can be streamlined and rightsized for Fortrea. We will separate with a number of TSAs with Labcorp. These were essential to deliver speed of execution of the transaction and to ensure business continuity for both organizations. But when we look at what works for us is a $3 billion revenue organization, with 19,000-plus employees and we exit the TSAs over the next 24 months, stand-up costs will trend down, and we see avenues for improvement not only through building fit-for-purpose infrastructure but also through better leveraging of our external service partners. We will look at opportunities such as additional facility optimization, strategic sourcing, better leverage of shared service capabilities and allocating the right resources to the most effective and efficient locations. On SG&A, we have already started benchmarking as we recognize there is room for improvement for us to be more in line with our peers. We will share initial details about our margin improvement plan. We will provide our Q2 '23 results in early August. From a capital structure and capital allocation perspective, we will be capitalized appropriately to operate as an independent company and to execute our capital allocation priorities. We will have strong liquidity with roughly $120 million on our balance sheet at close and a $450 million revolving credit facility, which we expect to be undrawn at close. We are focused on generating free cash flow and working capital improvements over time. On capital allocation, we will initially prioritize 3 areas: First, select infrastructure investment to enable timely exit of the TSAs with Labcorp. Second, targeted organic investments in capabilities and capacity for key therapeutic areas where we believe we can grow our share. And you heard my colleagues talk about a few of those. In the longer term, we will selectively look at inorganic tuck-in investments to drive growth. Note that we do not plan to issue a dividend in the near to medium term. Our opening net leverage of 3.9x on adjusted EBITDA and 3.7x on stand-alone adjusted EBITDA are in line with where many of our peers have been on their journey, and we will focus on driving strong cash flow, EBITDA expansion and debt paydown to reach our net leverage target of 2.5 to 3x over the medium term. In terms of opportunity to create shareholder value, you've heard Tom and my colleagues give numerous opportunities that we have for value creation at Fortrea. In the near term, we have ideal scale, which many of my colleagues have talked about, offering global reach with leadership focus and approachability. We will selectively invest where it can drive growth, including on data and technology partnerships and to enhance the productivity and experience of our site partners. We are committed to further enhancing our customer relationships through developing an industry-leading sales organization. In the medium term, we have a series of margin expansion initiatives we will deploy to improve the bottom line, all centered around matching our infrastructure and our cost base to best-in-class targets for our industry. We will also better leverage the end-to-end strengths of our clinical pharmacology and enabling services businesses to create seamless customer and journeys that incorporate the best of our service offerings. Longer term, we will continue to invest organically where the payback is tangible. And as we get within our stated net leverage range of 2.5 to 3x, we will consider where targeted inorganic bolt-on acquisitions make sense. Having personally led the setting up of Fortrea as a stand-alone organization over the last 10 months, I can tell you that I have been delighted with our employees as time and again, they have proven that anything is possible. To underscore that point, we were pleased to see that our Net Promoter Score improved in the first quarter, which demonstrates that even in the midst of a significant transaction, our employees were focused on delivering for our customers. I am confident in our teams and their capabilities and the future is bright for Fortrea. With that, I will turn it back to Tom for some brief closing remarks, and we'll move to Q&A.

Thomas Pike

executive
#11

Thank you. Dr. Cohen's got me worried about the infectious disease issues here. So sorry if that was a little bit of a soft handshake. I want to thank everybody for their time today. We're going to go into Q&A in a moment, but I just want to emphasize a couple of things. And you've heard and you saw and I forget if I have a slide here or not, I'm afraid to go forward here in case it's not there, but you've heard that we do have a great marketplace here. I think as an investor, you want exposure to that clinical research investment marketplace. We have a team here. I mean, we have an organization here with over 30 years of experience. This organization is important. It's a player. It's really the reason that I'm here. We're diversified globally, customer-wise, therapeutically, so it's attractive from that point. We have a good growth strategy. On any given day, we can win in any therapeutic area for any customer, but we're investing in more differentiation. It's in my background, I know it's important. It's absolutely critical. Finally, you've seen a lot of margin improvement strategies, not lost on us that there's opportunities, I'm actually carrying around, I don't know, I saw Dave Windley a little earlier, Dave, I see you over there. I'm carrying around this little sheet of the benchmarks that some of it comes out of your data just to remind me every day about where we are versus some of the benchmarks of competitors. And so I know we have some work to do in this business. Now I want to talk to you for a minute, though, about why invest in us. So Jill has talked probably predictably in a business-to-business business. We've had a little bit of softness since the spin was announced with certain customer sets. We've really had the support of our ongoing customers and large customers who understand these things, but we've had a little bit of softness that's shown up in our results. I'll just give you 2 reasons that I believe you should stick with us and you should invest with us. One is that focus matters. You see it again and again that when organizations are 100% focused on what was previously a division or a product or whatever that spin is, results happen. Here come the chairs. The -- and focus really matters. The other thing, and I'll go quick because it's a little distracting, but the other thing is this management team. You've got to believe sometimes in a management team. And I think we've assembled between the athletes we had there -- here and the athletes we've added in this core organization, we've got an incredible team that knows how to deliver results. So with that, I think we'll go ahead and go into the Q&A and I think the way we're -- Hima, you're going to come up and talk about how this is going to happen?

Unknown Executive

executive
#12

Yes.

Thomas Pike

executive
#13

So I want to thank you all very much for your time. Thanks to the management team also for all of their great comments. I thought that was a great overview of the company. So go ahead, Hima.

Hima Inguva

executive
#14

Thanks, everyone. So I just wanted to cover a few things. So that concludes our prepared remarks, and we're going to begin our Q&A session. [Operator Instructions] So with that, I think I'd request management team to come up for Q&A.

Thomas Pike

executive
#15

The lunch is though...

Hima Inguva

executive
#16

Yes, right. Lunch is after the Q&A session. The Investor Day will end at noon and then the lunch is going to be arranged over there.

Thomas Pike

executive
#17

Or as soon as you run out of questions because when you run out of questions, then you get lunch. Got to have some benefit to that. I see Mr. Windley raising his hand since I got his stuff in my hand here, too. We'll, Hima will help coordinate the various microphones here.

David Windley

analyst
#18

Dave Windley with Jefferies. So a 2-parter, Covance or now Fortrea, but the Covance business has been an integrated central lab preclinical, clinical business for, as you said, north of 25 years. It's kind of the only one. So I'm wondering on that front, is the extraction of the clinical business from the other 2 businesses -- I think you can get more focus, does that create benefits in terms of winning business? Can you generate more pull-through with that focus from clinical pharmacology into later-stage clinical on the positive side? And then do you lose any selling synergies probably more with the central lab, but do you lose any selling synergies by not being a part of the other 2 pieces of the historical Labcorp or Covance business?

Thomas Pike

executive
#19

Yes. Thanks. I'll start on this, then ask if my colleagues want to comment a little bit who've been here. I actually think it's the perfect time to split it away from the central lab because the central lab -- for those of you who know Covance, I mean they really established the leading central laboratory business that it has greater market share than anyone else. But what happens over some period of time is that, that lab business actually sits at a different point in the clinical development decision process. So lab business is typically done through a separate arrangement. It might be a preferred partnership arrangement across various studies. It's also -- the labs in general, are selected at a later time than the CRO. So when you have a dominant lab business, to some degree, it's not beneficial for clinical services organization that is some of my colleagues described, we need to engage earlier, we engage in the protocol, develop relationships differently. We get selected at a different point in time. So I do think right now, there's -- we don't -- we haven't seen any negative customer reaction to it from a sales standpoint. And we actually feel like the ability to focus on our sales process, which is a little bit different without the distraction of that major lab. I'll just give you a simple thing coming in here, fresh and it came up in the conversation today. The lab is such a big established business, they call new business orders. I don't think about orders. I think about selling, I think about new business, but they actually write orders. It's a different sales cycle, different kind of business than what we do. And that's part of the reason we brought in Drayton and the world class. Drayton, do you want to comment on what you see from a sales standpoint?

Drayton Virkler

executive
#20

Yes, sure. And also in my past, I was with an organization that also had a central lab. And even in that situation, as Tom pointed out, they're not always going to want to work with one lab or the other. And so you have to be adept even as -- even before as Labcorp drug development, we had to be adept at working with other laboratories that the sponsor wanted us to work with because they are a preferred provider or because they just made a different selection process. I think kind of the benefit that we see is that since we have been so close to the central lab through the years, Mark and his team have created just phenomenal ways of working of driving efficiency and working together that don't go away when we spin out as Fortrea. Those relationships are still there, but then that also taught us how to work better with other central labs and other companies. So I think that we'll be able to take the best of those things. And then specifically and thinking about has it impacted RFPs or something like that. And actually, what we saw from going from the fourth quarter to the first quarter, we saw a 20% increase in RFPs, so we haven't seen necessarily a decrease in demand as a result of this. And I think our experience in working with our own lab has taught us to be a better partner with other companies.

David Windley

analyst
#21

[indiscernible]

Drayton Virkler

executive
#22

Yes, actually, I was interested. Oren, do you want to talk a little bit about the pull-through and historically, it used to be there wasn't that much synergy between Phase I and Phase II. And Oren, I think you're starting to evolve that.

Oren Cohen

executive
#23

Yes. I mean I think, Dave, there are some headwinds to pull through that are difficult to address. So some of it is structural. Some of our large pharma partners are just so siloed in those decisions that there's not going to be the opportunity; but I think if you focus on the addressable pull-through market, I think we've been getting better at it. And I think this Phase Ib space that's expanding pretty rapidly is a great laboratory for increasing pull-through. And so I highlighted one of the recent opportunities where we've successfully done it. There are many others. And I think as we move -- as we step forward and really increase the focus on that transition, we've got great teams on my side of the business and Mark's side of the business that are working really hand-in-hand on pulling through these Phase Ib opportunities, which I think are a natural model to increase pull-through. And it's not only the pull-through, again, from my perspective, it's also the what we call the pass back as there are studies in later phase drug development. In order to complete those studies that are necessary for regulatory submission, the drug-drug interaction study, the renal impaired study, whatever, so I think it's really that virtuous cycle pull through and the pass back.

Mark Morais

executive
#24

I think it's a good call out or -- and Dave, we're also seeing protocol design is changing. As you go forward, we're starting to see a different hybrid in this space, what I would say is you're seeing an adaptive design that's bringing into place treatment arms that are moving from healthy volunteers or oncology Phase I into -- from an in-clinic setting into an interventional setting. That's really promoting greater pull-through just by a trial design, adaptive design. And as we see more of that continue to permeate into the clinics, into portfolios, I think naturally, that's going to create an opportunity to tear down what I think was more historical in terms of the buying patterns and more necessitated in terms of how we deliver, but have to be truly a seamless delivery as patients evolve in those treatment arms become adaptive.

Oren Cohen

executive
#25

And did we mention June 21st [indiscernible]

Thomas Pike

executive
#26

He's really trying to get [indiscernible], so you may do, why not? Thank you, Dave.

Patrick Donnelly

analyst
#27

Patrick Donnelly from Citi. Tom, I thought it was interesting you showed kind of the near-term CRO market growth rate of 3.5% and then the long term of 6% to 9%. Can you just talk about, I guess, how you think about are those near-term headwinds all around more kind of the SMID pause, let's say, in terms of the funding environment and then how do you think about Fortrea navigating kind of that near term and then accelerating in the long term? Just in terms of where you fit? I know you on one of the slides talked about above-market growth rates. So just curious how you think about that near term into long-term setup for you guys?

Thomas Pike

executive
#28

Yes. You picked up a nice detail, absolutely. It's absolutely right that there's been a little bit of a swoon in terms of the growth overall, it seems. And I would -- I think the way we generally characterize it, although there are people in this room who analyze it more than we do that it is more some of these biotech headwinds associated with it. Interestingly, for us, what we see, we don't see too many single-asset companies that are affected by those headwinds as Drayton referred to our RFP flow did swoon a little bit late last year when we were kind of at the head of the crisis, if you will, associated with biotechs. But we've seen it come back. So our vantage point into it is that right now, we're not seeing a particular issue with biotech, and we are seeing large pharma after a little bit of portfolio rationalization early in the year, we're seeing them come back into normalcy, if you will. So we think that we use third-party statistics and analysis just like you do. And so we're comfortable that it probably is a little bit of a lower short-term growth rate but a continuation longer term with the growth rates that we've seen over the past several years.

Casey Woodring

analyst
#29

This is Casey Woodring from JPMorgan. Just on EBITDA margins. So the 13% in 2022 is below peers as you noted. But the 320 bps expansion from 2020 was impressive. Can you maybe elaborate on why your margins are inherently lower than peers, the runway you see for expansion? And then maybe just ultimately what your long-term margin targets are or annual margin expansion targets are?

Thomas Pike

executive
#30

Jill usually answers these questions, but since we have Mark here, and he really operates the clinical services business, I'm going to put Mark on the spot first. And then, Jill, you can do any cleanup you want to do. But -- what do you think, Mark?

Mark Morais

executive
#31

Yes. In terms of where we exist according to our peers, there was really a lot of work to be done. If you look at the evolution as the -- Glenn and Tom talked about acquiring Covance bringing it in that we had a lot of inorganic movement with the acquisition of Chiltern. We went hard at buying other assets, bringing them in. Really through that integration, we saw a lot of margin deterioration at that time while we were investing in cleaning up. The opportunities for growth, I think, are actually much better. And I went through a few of those when I went through the slide. So the $450 million that we actually saw on my side of the business, I'll run through the numbers again. We saw about 50 bps from facility rationalization, 80 in terms of, what I would say, non-billable, billable ratio is really rationalizing those management redundancies as Jill put in place. And when you've got inorganic growth to that degree, you do acquire quite a bit of redundancies. We saw about 110 improvement points from really globalizing that footprint, building out a large scale global model in low-cost areas, some of that through labor arbitrage, some of it just through process improvement and then the final was a little over 200, 220 based on productivity. I think if you look at that productivity gain of about 220 bps, I think we can continue to see the same type as we go into the near term as we focus in on patient recruitment, that's going to accelerate your backlog burn. It's going to help you on your revenue growth, but it's also going to allow for milestone achievement as well. We think there's future push you can do on centralization, probably not to the same degree, but you can probably pull another 50 to 100 bps on top of it as well. So I do think when you look at the future layering, productivity increases, additional centralization on top of the fact that we've removed a lot of those redundancies, I think we've got a clear path, Jill, you can keep me honest here, probably at least another 300-ish in the near term.

Jill McConnell

executive
#32

Yes. I think when I joined in 2018, we were in single digits. And you have to be responsible with the way you expand margin also, right? It's a service business and it relies on people. And so if you have a lot of people who think they're going to be let go because you're doing a massive restructuring, you will not have a service business. So we've been very responsible about the way we've done the margin expansion, trying to look at multiple avenues but also be really focused on what matters most to our customers, and that is continuity of the people that they work with. So as we go forward, there is still significant -- there's nothing structurally that keeps us from being able to be at peers. We've got to do that journey responsibly. And Mark talked about some of those options, but there are also places where we can just look at how we resource projects. We called out SG&A and some people will look at it and say, oh, if I just look at your numbers, you have to remember that every organization kind of treats parts of SG&A differently, which is why we're working with some outside parties because I think when you get in and look underneath, we know that we have places where we are not in line with peers. Interestingly, when I came in, in 2018, and the business was just about to start on this journey to optimize the global footprint. In many organizations, you start with that in SG&A because you're nervous about operational delivery and then you do it in operations once you get comfortable. This was done the other way around. And so we now have an opportunity to do more globalization with our SG&A footprint. So there are really meaningful opportunities for us to expand margin, and we'll be very focused on that, but we'll do it in a thoughtful way so that we don't disrupt the business.

Albert Rice

analyst
#33

It's A.J. Rice from Crédit Suisse. Maybe 2 quick things. One, just to follow up on that discussion. I guess, in the prepared remarks, you said you're going to be rolling off the TSAs over the next year. How much specific -- does that represent and has an opportunity for margin enhancement? And then in one of the discussions, there was a comment about improving win rates, I wonder if you could flesh that out a little bit more. What's the historical win rate? And what do you think is the opportunity to do better there?

Thomas Pike

executive
#34

Do you want to talk a little bit about TSAs, Jill?

Jill McConnell

executive
#35

Yes, I can, so we have a period of up to 2 years. And we're obviously focused. We already have -- we have a small but dedicated team internally looking at how we can optimize that because we recognize it is an opportunity. I think we'll call that out as we do our earnings announcements in terms of how much of that is TSA overhang, but I believe in the Form 10, it showed like a full year estimate of about $15 million of TSA dissynergies. So important, but there's more that needs to be done in terms of that. But we are very focused on it and not just exiting them, but exiting them with an infrastructure that's more fit for purpose. That's where the real opportunity will come.

Thomas Pike

executive
#36

Yes. And on win rates, we don't really disclose the win rates. But Drayton, do you want to talk a little bit about some of the things you're doing to improve win rates?

Drayton Virkler

executive
#37

Yes. I mean I think that the -- where organizations really hit their stride is when you have that perfect partnership between the physicians, the delivery leads, the operation strategy and planning organization with the sales team where you're looking at each opportunity, you're engaging early with the client and you're crafting that bespoke solution that's really going to help that customer be successful. Clearly, Fortrea, when we're clicking, that -- it's magical. But at this point, we're good, we're going to be great. And so it really will be creating those structural bonds whereby the teams are working together, they're prospecting together. They're leveraging inside sales. They're building that sales funnel. We're getting the senior-level relationships starting early with the clients, so we can really understand what's critical to them in their decision-making. And then that's all going to pull through into how we write our proposals and how we drive wins. So right now, we -- I think we do a good job of pulling it together as a team. And what we're going to focus on is really building those ways of working so that it happens every time, not just on our best day. So those are the different things we're going to be doing in the medium -- short, medium to long term to really increase our win rates and drive better efficiency.

Thomas Pike

executive
#38

And I think this is another area to the prior question, where focus makes a huge difference. If you think about it and you had the central lab, you have the early clinical, which is more the [ animal ] piece of the business, you're working across all of that versus you're 100% focused on the sales cycle that we deal with and that is very much -- it's different. It's very much that early engagement. It's all these pieces working together. It's the strategy because it's hard for a pharmaceutical firm not to go with us when we're on our best day with that with the medical expertise and the depth of talent that we have here. So I think this is one of those areas where you should see a real difference in performance based on focus because this is all we do now. So next question.

Elizabeth Anderson

analyst
#39

Elizabeth Anderson from Evercore. You talked a little bit about some targeted and organic investments. Could you talk about sort of -- or maybe Tom, could you talk about sort of what those are? Like what are you looking to do and sort of how you prioritize those opportunities?

Thomas Pike

executive
#40

I'll say one thing and then Jill will go through that capital structure. It is interesting, and it really fits with the strategy. If you look at the debt, you look at the performance, this organization can grow organically. I mean not every organization can. Many organizations have to acquire certain capabilities. This organization really only needs point to expertise to be able to continue to grow as opposed to acquiring a company that has a certain capability. So we are in a little bit of a unique situation, and that's why that discussion of therapeutic expertise, little bit more growth around clinical pharmacology over time and investment in facilities potentially enabling services, which is a little bit of a different animal but even in the near term, [indiscernible], I think organic investment in enabling services is the focus that it needs. So we're just an interesting because they're -- you come to this organization, there are so many assets here that we can take advantage of. It makes it a little unusual. And do you want to go through capital priorities?

Jill McConnell

executive
#41

Yes. Just to remind, I mean, in the near term, we only have 2 years to accept the TSA. So some of the cash has to go towards building out that infrastructure. Although having said that, we are working with partners already. We've been in that process for a few months now trying to think about what makes sense for us to build versus where someone else whose more expert at this might be a better place.

Thomas Pike

executive
#42

In IT, in particular.

Jill McConnell

executive
#43

In IT in particular, yes. But thinking more about SG&A in general there. And then obviously, there are some targeted internal organic investments that we'd be looking at. We talked about some of those therapeutic areas where we compete, but we need more bench strength. So we'll think about how primarily therapeutic expertise, we add that in. And then it will be debt pay down because we are targeted on getting into that net leverage range that we've committed to. I think in terms of inorganic, Tom talked about it. And I actually think the mindset here, which is great is different that it doesn't have to be or used to buy something to work with someone. I think we are also much more open to partnerships and thinking about how we can use that to leverage and build out some of those capabilities. But Tom talked about enabling services. There could be a few geographic areas. We've talked about Japan, for example, some other places where you may need to do something, but we don't need to do it right now to be able to compete. So that's probably more of a mid- to longer-term type of opportunity.

Kevin Caliendo

analyst
#44

It's Kevin Caliendo from UBS. I want to go back to the $409 million run rate that you had for the last 12 months for EBITDA. Can you take us through, is that a decent baseline of which to think about 2023, sort of what are the pushes and what are the pulls on that number? And I guess the follow-up would be when do you think you'll be comfortable to provide sort of longer-term financial targets?

Thomas Pike

executive
#45

Jill, that's definitely a Jill question.

Jill McConnell

executive
#46

So I will start with the second question because I will tell you a little bit about how I'm going to answer the first. But in terms of -- we will give guidance on 2023 when we do our Q2 earnings announcement in early August, right? We are still part of Labcorp, still getting their allocation. So that will give us a little bit of time to try to really understand -- I mean, in spite of our best efforts to understand, you need to be on your own 2 feet. So we will do that in early August in terms of 2023. And then I think as we get into the later part of the year and have more clarity on exactly the levers for margin expansion, we'll be able to provide more detail around the longer-term guidance, either end of this year or as we do earnings early next year. In terms of 2023, I think it's fair to say that the first quarter was soft. And so I think that, that will be a little bit in terms of how it impacts the year, that FSP contract will impact the first half and then it annualizes in the second half. And as we talked about a little bit of that softness in terms of the orders that came in, it's -- at this point in the year, it will be hard to massively change the trajectory, but we are committed to already starting to make some of the changes that we'll expect to see around margin expansion so that as we go into 2024, you'll start to see more meaningful expansion of that number.

Eric Coldwell

analyst
#47

Eric Coldwell with Baird. I have 2, the first one should be really easy. When you talk about definition of biotech, 46% of your mix, what is the definition? Every company has a different framework for how they define biotech?

Thomas Pike

executive
#48

Do you want to say our official one, Jill?

Jill McConnell

executive
#49

Yes. I mean we can -- I think we think about top pharma as the top. I think it's 40 to 50 sponsors, yes. And then so everyone else would be based on industry rankings of revenue essentially.

Eric Coldwell

analyst
#50

So anything that's not top 50 is in the biotech?

Jill McConnell

executive
#51

Yes.

Eric Coldwell

analyst
#52

Okay. And then this may be coming later, but every company also has a different profile for net bookings, backlog disclosures. I'm curious if you can share in specifics what yours will be or what they are now, things such as -- we only put an award in once it's a written contract. We don't have revenue -- we don't have backlog in if revenue isn't seen burning within 6 months, 12 months, FSPs some put in 5 years, some put in 1 year. There's a lot of nuances that can give us a sense on the integrity and quality of the backlog that we could use, whether it's now or later.

Thomas Pike

executive
#53

I think I gave 2 things, Eric. It's good to see you again, by the way. I think one is -- I think we can follow up with Hima on some details of that. So as you're getting to know Hima, if you have more questions. Jill, why don't you give the quick overview on it, but I definitely would go back for more detail. And I will say, coming here, we're pretty straight down the middle industry standard. But go ahead.

Jill McConnell

executive
#54

Yes. I think we're fairly conservative. So we take -- we have to have a written contract or start-up agreement to be able to take it and the value has to be referenced in there. So we don't go by e-mail or word of mouth. Revenue has -- or the study has to be starting within 12 months. Otherwise, we'll hold it until we get into that period. In terms of FSP, we do take the awards. We've had some conversations about that, but we take the awards as we get them. But if they're large, we'll call that out so that people understand in the quarter if there was some significant impact related to that. We would take the 3 years. Yes. As of right now -- as of now, yes. No, it's consistent.

Thomas Pike

executive
#55

No, we actually decided to keep it consistent [indiscernible] changing it a little bit, but there's pros and cons because if you don't take more of it when you have a new win, then it doesn't show the incremental business that you have. So for the moment, we decided to stay with the Labcorp policy, which we actually thought was consistent with most of the industry.

Unknown Analyst

analyst
#56

It's Christine Raton with William Blair. So I appreciate the discussion in clinical surrounding full service, FSP and hybrid work. I was hoping for a current breakdown of the company's clinical sales as it relates to FSP and full service. And what is the company's ideal target for this mix? And is this part of the company's margin expansion pathway?

Thomas Pike

executive
#57

Yes. As you can imagine, we don't disclose the details of that, but what I can tell you is that the full service is the dominant piece of what we do. And then the other portions are smaller. So the clinical pharmacology is small, the FSP is smaller. The other attendant services like biostatistics are smaller. So it's the predominant piece is the full service. I will say -- I'm not sure this is quite on your question, but when we're talking about mix today and when Drayton is talking about selling the right mix, one of the things that we're keenly aware of after the last, let's say, 3 quarters of a year is just not only having a strong book-to-bill number, but having the right mix within that book-to-bill because one of the things that's happening here is that we've had strong book-to-bills and by all of the normal industry guidelines, but just like everybody else's book-to-bill, strong book-to-bills, but the mix has not been as fast from a revenue burn standpoint, the duration of study or type of work because we do have several subsidiary businesses within this enterprise. So we are very focused to latter part of your question on selling the right mix now, making sure we're generating RFPs and relationships that have the right mix so that we can optimize the business both from a growth and a margin standpoint.

Unknown Analyst

analyst
#58

Tom, this is [ Tejas ] from Morgan Stanley. A quick sort of follow-up there to that question on mix. I mean, is there a -- was there historically a situation that you think you need to address on pricing? You talked about a lot of the other sort of fundamental disconnects versus peers where you can do some of the heavy lifting to get the margins more in line. But is there an element here where you need to be more judicious about which work you take on and which work you walk away from that could perhaps have top line implications? And then as a second follow-up, this is actually one of Dave's questions earlier on synergies and dissynergies. But I was curious as to whether those -- the data synergies on the central lab side, et cetera, with Labcorp, will those be exclusive partnerships or could Labcorp also monetize that with other CROs down the road? And is there a preclinical to sort of clinical handover as well with the early development business that Labcorp is still keeping?

Thomas Pike

executive
#59

Yes. Let me start with the pricing one, and I'll give you an observation, I'll hand it to Mark for a minute. But coming in here, it's definitely one of the areas that I look at. And it's definitely one of the things that we're going to look at, especially when we're dealing with small, mid-biopharma because that has been proven to be an attractive place. So it's definitely something that we're going to look at. But it doesn't jump out at you that were inappropriately pricing. We've actually been pretty disciplined and Mark, do you want to chat about pricing? You've been all over that.

Mark Morais

executive
#60

Yes. I mean I think if you look in terms of discipline, I think we're there, but we need to continue to monitor the complexity of protocols and make sure that we've captured that into it. There have been some unforeseen issues with crisis that's broken out pandemic; but if you look at core, how we're pricing the core protocols, I'd say we're probably right on it. We continue to monitor it. We do adjust on an annual basis. We look at not only how we're delivering, we look at inflationary factors, how we deliver versus what we forecast going forward. So I think in terms of that, we're right where we need to be.

Thomas Pike

executive
#61

It's good. The thing -- Jill, why don't you talk a little bit to the timing of the -- and Mark can get into more detail about the data, I think we actually gave a really good rendition of that earlier about how we use the data. But just the timing, Jill, on what the TSA side.

Jill McConnell

executive
#62

Yes. The strategic partnerships, Glenn alluded to them as well. They are for a period of 2 years, where they will be exclusive that we would be the only CRO that Labcorp would work with. And so at the end of that 2-year period, they will have the opportunity to work with other CROs. We have the ability to renew those. In the meantime, we're going to also be looking for other places to augment our data. We have a good relationship with Labcorp, and we don't really see any reason. The other thing I would say is data is data . You can't -- you have to be able to do something with the data. You have to be able to mine it and get insights from it. And so we obviously will have an advantage over any other CRO that comes in because we've had the last 5, 7 years, well, 30 years in some cases to work on how we use that data in a more effective way for making decisions and someone else is going to come in and have to start from scratch potentially and build that out. So we believe that, that's not a real risk to us in the longer term.

Thomas Pike

executive
#63

Okay. I can't believe it, but we're actually at time already, Hima. So maybe I'll just say a closing comment and then hand it back to Hima for anything else. But first of all, I can't believe we went so fast. It's so great to be out in front of you. It's been worked on for a long time. We've been a little internally focused as we're getting this company ready to fly on its own. And we are very excited about the opportunity to bring Fortrea to the public market over the next few years, but frankly more excited about the opportunity to be an industry leader and an industry innovator that is very focused in that attractive clinical business. I think this all-star team and I, Glenn, we want to thank everybody for the time. I would encourage you, Hima is heavily engaged in our business, understands us very well. So any further questions now that we've done the Investor Day, please do contact Hima and we'll do what we need. We recognize it's very important for you to be well informed about this great company, and we want to do what we need to help you make great investment. So thank you very much.

Hima Inguva

executive
#64

Thanks, everyone, for being here. That concludes our Investor Day. We really appreciate it that you made the effort to come over here and excited that you were able to join us for our debut Investor Day. With that, please make sure to pick up box lunches over there. Thank you very much. Have a great day.

Thomas Pike

executive
#65

Thank you.

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