Good day, ladies and gentlemen. Thank you for joining us on this call covering the quarter ended September 30, 2021. Also on the call today, we have our CEO, Dr. Steve Cutler; and our CFO, Mr. Brendan Brennan. I would like to note that this call is webcast and that there are slides available to download on our website to accompany today's call. Certain statements in today's call will be forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. Actual results may differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, and listeners are cautioned that forward-looking statements are not guarantees of future performance. Forward-looking statements are only as of the date they are made, and we do not undertake any obligation to update publicly any forward-looking statements, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in the SEC reports filed by the company. This presentation includes selected non-GAAP financial measures, which Steve and Brendan will be referencing in their prepared remarks. For a presentation of the most directly comparable GAAP financial measures, please refer to the press release statement headed condensed consolidated statements of operations. Please refer to the appendix of the earnings presentation for reconciliations of non-GAAP financial measures to the most directly comparable GAAP measures. To assist investors and analysts with year-over-year comparability for the merged business, we have included combined company information. These measures include financial information that combines the stand-alone ICON Plc and PRA Health Sciences information for revenue and adjusted EBITDA and other metrics as if the merger had taken place on January 1, 2020, with conforming adjustments to the current year presentation. Specifically, these financials represent a simple addition of the historical adjusted financials of each company. These combined financials are not intended to represent pro forma financial statements prepared in accordance with GAAP or Regulation S-X. While non-GAAP financial measures are not superior to or a substitute for the comparable GAAP measures, we believe certain non-GAAP information is more useful to investors for historical comparison purposes. [Technical difficulty] the call today to one hour [Operator Instructions]. I would now like to hand over the call to our CFO, Mr. Brendan Brennan.

Thank you, Kate. In quarter three, ICON achieved gross business wins of $2.72 billion and recorded $346 million worth of cancellations. Consequently, net awards in the quarter were a record $2.37 billion, resulting in a net book-to-bill of 1.27x, and a trading 12-month met book-to-bill of 1.3x. At the beginning of the third quarter, consolidated backlog on a 606 basis was $18.1 billion. This backlog figure accounts for legacy ICON backlog at the end of quarter 2, along with total backlog from PRA adjusted to include [path trues] in keeping on ICON's reported backlog and methodology. With the addition of the new awards in quarter 3, our backlog grew to a record $18.6 billion, representing an increase of 3% from closing of the acquisition. Included in the press release and the earnings slides, you will note that we included a reconciliation of non-GAAP measures. Adjusted EBITDA excludes stock compensation expense, restructuring costs, foreign currency gains and losses, amortization and transaction and integration rated costs and their respective tax benefits. Adjusted revenue in the quarter 3 was $1.870 billion. This represents a year-on-year increase of 167% or 165% on a constant currency basis. On a combined company basis, adjusted revenue increased 25% from the comparable period last year. One of the key strengths of the new ICON is our increased customer diversification and balanced representation across customer segments. In the third quarter, our top customer represented 8.3% of revenue, and our top 5 customers represented 28.2% of revenue. Our top 10 represented 43.3%, while our top 25 represented 64.7%. Adjusted gross margin for quarter 3 was 27.9%, and adjusted SG&A expense was 10.5% of revenue in the quarter. On a combined company basis, adjusted EBITDA was $325 million in the quarter or 17.4% of revenue. In the comparable period last year,…

Thank you, Brendan, and good day, everybody. Today, we're delighted to recognize another milestone in ICON's acquisition of PRA Health Sciences by reporting our first quarter as a combined organization. The overall environment in clinical development continues to be robust with strong demand seen across large pharma, small and midsized companies, biotech and medical device companies throughout the quarter. RFP growth has been solid, and we continue to be encouraged by the healthy level of biotech funding year-to-date. I'm proud to highlight that our team at ICON has continued to aid in the advancement of several new drug approvals this quarter, which now total 27 year-to-date. As seen by our strong performance in the quarter, our customers are continuing to turn to ICON as their trusted partner in clinical development. The response from customers to the merger has been excellent, leading to increased engagement with new and existing customers across all segments and delivery models. Customers are eager to understand our enhanced offering that features increased scale, innovative solutions and broader service capabilities. We are particularly encouraged by the increased number of strategic partnership discussions that are currently ongoing across our service areas, which we expect will drive continued long-term growth for ICON. During the quarter, ICON increased net business wins to a record $2.37 billion, delivering a quarterly book-to-bill of 1.27 and growing our backlog to $18.6 billion, an increase of approximately 3% since the close of the acquisition at the start of the third quarter. The overall activity was strong across all of our operating segments. Revenues also increased 25% on a combined company basis, and our backlog burn for the quarter increased to over 10%. In addition, diversity of our customer base. One of our key strategic merits of our combination was improved in the quarter with…

[Operator Instructions] And your first request today is from the line of Patrick Donnelly of Citi.

Steve, maybe just on kind of 1 of the final points you had there in terms of the synergies. can You talk about the revenue synergies opportunities? And how the deal has been closed for a few months? You certainly sound confident in that opportunity. But as you've been out talking to customers and you kind of had the companies together, can you just talk about that opportunity set? And again, the confidence level in that number continue to move higher, I guess?

I think we've been public in saying about $100 million over approximately 4 years is our expectation. I believe we're well on track for that. We've made some early inroads. Our business development group has been out selling areas, I mean the obvious areas are our lab, central and specialty lab, legacy PRA didn't have a lab. So there's a very obvious one there. And we've been able to secure a number of new awards for our lab through our legacy PRA group. Imaging group is also -- they didn't have that. We've been able to move that along. Language services, Accellacare, the site network and the home health network. So all of those areas really where there's no overlap at all. We've been able to secure some early wins. And we feel like we're well on track for that $100 million annual sort of revenue synergy number. That's not to say we haven't got continued to work to do, but I think our business development group and our operational folks have been have been strong in being able to get those out and those offerings to customers, particularly in the biotech space and any customers that we haven't as legacy ICON hadn't been able to access through some of those services. So I feel good about where we're at.

And then maybe just -- you touched briefly on staff retention. That's always a risk with mergers, particularly in this labor market, I'm sure it's even higher. But can you just talk about any metrics you have there to kind of talk us through? And then maybe on the back of that, Brendan just in terms of the labor costs themselves, inflationary pressures? Can you just talk about the moving pieces on the margin side? And how you're managing through that as we go into '22?

I'll let Brendan comment on the margin side of things. I think there's no question. It's not necessarily merger related, but the labor market really across the globe, but particularly in North America is challenging at the moment is very tight. And I think it's -- as we come out of the pandemic and unemployment rates go up or down depending on the perspective, there's a little bit of a new paradigm around the whole working opportunity, working people working from home, how much they work in the office. We're working through our challenges on that front. Overall, retention has been a little more elevated than I would have liked. But it's not out of WACC. And it's, I think, in line with our competitors and indeed our customers. And our customers certainly understand the challenges of the labor market that we have at the moment. As with any business, and at any time, there are certain parts of the organization that you see retention being a little lower than you'd like it to be. North America is probably our biggest challenge at the moment. But on the other hand, Europe is in a good place. Asia Pacific is in a good place. A number of our functions are really settled down very nicely and very well. India is in a good place. So it's patchy, as always, then there always things we can do to improve it, and we're working hard to make sure we continue to improve that number. Brendan, do you want to talk about the margin.

So I think as we go through the course of this year, and you saw in my prepared comments, the gross margin in the quarter coming up close to 27.9%. A lot of the dynamics at play are obviously some of the vaccine work that we've been working on. And certainly, the cost base as a result of -- to Steve's point that the dynamics at play in terms of staff retention are probably impacting more as we go into Q4. I think overall, the trend in our gross margin profile will still be solid as we go from Q3 to Q4. So we still expect to see as the mix of pass-throughs continue to come down on vaccine work, good progress from a gross margin perspective quarter-over-quarter. I think it will be interesting then I think that's -- that will be a good jumping off point and a good marker in terms of gross margin profile at maybe more of a tone for 2022. So we continue to see, as I said, good margin progression quarter-over-quarter in Q3 to Q4. And then that will probably be a good number to think about how we're thinking about some of those cost pressures as we go into 2022.

Your next question is from the line of John Kreger of William Blair.

Steve, just to follow up on a couple of your comments. I think you indicated good uptake from larger, smaller and even device clients. Can you give us a sense about kind of the relative growth you're seeing across those 3 buckets?

I mean, Device is still relatively a small part of our portfolio. I'd say a growing part, but it's still relatively small. Large pharma customers, we had a very strong quarter in terms of wins in that front. And then certainly on the RFP front, we're seeing good, solid growth in that area. The Biotech also -- we had a good quarter, significantly up revenue-wise year-to-date. They had a good quarter in terms of new awards and RSPs. And so, I think, I said in my comments, it's really across the board. We're seeing a very strong, robust environment. It's hard to pull out any one particular area. It's across the board, and we're seeing a lot of positivity in the environment in terms of RFPs, in terms of awards and ultimately, that's flowing through into revenues.

And maybe another way to kind of cut that same question. If you think about your awards in the quarter, maybe your new trial starts, can you give us a sense about the uptake of some of these newer tools that you've got good capabilities and now like DCT or home-based or site networks? Just curious how broadly those are being adopted in your newer wins.

Yes, it's interesting. I don't think there are many trials that we start these days that don't have component of a decentralized trial. Now there are very few that are completely decentralized. I don't want to overstate that. But there are very few that don't have some sort of component, whether it be a risk-based monitoring component, a wearables component, a home health component. So the customers are increasingly asking us to include these sorts of the decentralized type component. You can sense another one that's proven very helpful in the vaccine trial where you have many thousands of patients and many protocol amendments that all need to be approved by the patients. And so having an electronic copy an electronic version has been extremely helpful in that respect. So the uptake is, I would say, very good in terms of individual components. But I don't want to overstate it in terms of the completely decentralized trial. They're still relatively rare animals. We do some of them. And we have some of them and we're working well with some of them. But they're not, I wouldn't say anywhere near as common as perhaps as I say, the normal approach, which is a more hybrid version, I guess.

Your next question is from the line of Elizabeth Anderson from Evercore.

Could you just -- I know you obviously talked about the COVID projects being 5% to 7% of backlog. So we should think -- how should we think about that sort of transition from maybe more vaccine-based trials to more therapy-based trials as we sort of think about the backlog burning into revenue?

Well, I think we've been public in our comments in terms of the awards from a COVID point of view in the past. Those have certainly come down this quarter. I think they're around about 11% of our revenue this quarter. Going forward, we would expect cover related work. And a lot of that's been vaccine. But a lot of -- that will come down. No question about it. Luckily or fortunately or thanks to our good work, we're seeing a good uptick in non-COVID-related work. But I wouldn't -- I would caution, there's no cliff here. I mean we're going to see coded work continue to be an important part of our backlog, albeit decreasing part of our revenue burden backlog for some time yet. I certainly see COVID becoming more endemic in the community going forward. And those treatment type trials are going to become more common. Certainly that's been an increasing part of our wins in the recent quarter. The big vaccine trials, the days of the big vaccine trials are probably limited, if not over, there may be others coming forward. So in terms of second-generation vaccines. And who knows in terms of new variants, what might happen. But at the moment, the way we see it is it will be more around treatment work. That's the way our backlog is evolving, and our revenue will obviously follow what's in the backlog. So there's no question that the COVID-related work is decreasing. But it will still be an important part, I would say, of our revenue, I would think, for another at least 12 to 24 months.

And maybe just to jump on the back of John's question. when you talked about some of the elements of decentralized trials, I mean can you generalize and to say sort of like do people kind of dip their toes in with what you said like e-consent or some of those things and then generally expand? Is that kind of the general momentum is? I guess I'm just trying to figure out like how to think about that ramping opportunity maybe within clients overall?

They don't usually expand within the trial. Once you've planned the trial, it has a component of a sort of a wearable consent component or a risk-based monitoring or the home health that would tend to be set. I mean obviously, that was not the case as we pivoted during the pandemic, everything became. And so there was some pivot. But I think as we get into a more steady state now, the new starts, we're seeing, have that component or one or more, it can sometimes be more e-consent plus a wearable plus a risk, but it varies. But it usually is set for the trial. So I'm not -- it doesn't expand. But we're seeing, I think, increasing interest in those components because we're -- I think we're increasingly able to provide evidence that it is a more efficient way of doing these trials. And with the pressure on resources, hiring and getting people is challenging for us. We have a lot of work to do and prosecuting that work requires a side. And the ability to be more risk-based and remote with our monitoring is allowing us to be much more efficient with those monitoring resources. And so there's a big incentive for us to drive forward with this. And we're seeing customers increasingly interested in doing that sort of work. But -- so I would say it will increase. There will be more components of more trials become decentralize. But I think we're -- I would hesitate to say that in 2 years' time, everything is going to be fully decentralized. This is going to be a marathon, not a sprint. It's going to take, I'd say, many, many years for us to move to be, and we'll probably never be fully decentralized. But I think at the moment, there's probably, I don't know, 1% or 2% of trials are fully decentralized. I'd say certainly in starts, probably 75% to 80% of our trials have some component of decentralization. And I think going forward, the number of components involved in those trials is only going to increase as we prove the model and we show how efficient it can be. And of course, as regulators audit and approve.

Your next question is from the line of [Noah Bernard] of JPMorgan.

It's Tycho, actually. A couple of questions. Congrats. It sounds like the integration is going fine so far. Can you give us any color on the PRA numbers? Obviously, they had a blowout second quarter. And I'm really just curious if the guidance increase is more tied to the PRA side versus ICON or just how it's been performing overall.

Tycho, I hate to disappoint what I'm going to say we're the new icon and we're going to present our numbers on that basis on a go forward. I will say, though, that there was good growth across both organizations. I think if you look at the year-over-year growth that we talked to, it wasn't dissimilar in both organizations. So we were really -- I mean, we always said we were 2 organizations coming from a point of strength and the combination would be a great one. and that's what we've seen. So yes, we're really happy with how that's progressed so far.

And the step up in backlog burn, I mean, sequentially, 8.7% to 10.4%. Is that just a function of the blended combination or the COVID work rolling off? Or can you maybe just touch on the backlog burn?

Yes, Mark, I'll take that 1 as well. I mean, yes, it is. I mean it is more to do with the blended blending of the organizations, and we're happy to see it in excess of 10%. We were very happy with the combined backlog as we talked to 18.1 at the start of the quarter, 18.6% at the end of the quarter. And that, of course, reflects as we have always done, the pass-through elements coming into the historical PRA backlog and that entire piece being added to the historic icon backlog. So we're -- yes, that's certainly the range that we're thinking about.

And the last one for Steve. It sounds like you're flagging some early wins here, which is great to see. Are there particular things that your customers are honing in on? I mean one of the things you've talked about in the past is accelerating patient recruitment with Accella, the care network and maybe that can even step up a little bit with the combined combination. So can you maybe just touch on that aspect in particular around patient recruitment?

Tycho, I mean we are seeing a lot of interest in the patient crime, particularly around the Accellacare site network. That business has been moving nicely for us. It played a major role in our vaccine work. And I think on the back of that, we're getting some good publicity, good verification validation of that model. A number of aspects in I talked about the revenue synergies, the labs and the imaging and patient, as I say, the home health is also stepping up. There's a lot of interest in that around, particularly around the decentralized trial basis. So the early wins are really in those areas. They do tend to be focused around the efficiency aspect of the trials of home health of an ability to do risk-based monitoring. We're talking to a big customer around taking over a large region around their monitoring area and applying some of our data analytics to their monitoring process and an ability to identify how to monitor more effectively, more efficiently, quite frankly. So the scale that the organization now brings to our customers is really starting to play out nicely in terms of the discussions we have for new business. We really are able to deploy a depth and a breadth of scaled resources that allows us to provide a very efficient or much more efficient and effective service. So that's where I'm encouraged on the business wins.

And last one, are you finding any more doors opening with all the kind of consolidation in the background? Are you starting to kind of see some of your customers shift away from some of the combined combinations?

I didn't quite get the question.

A question on all the consolidation in the background in the CRO space. And is that starting to kind of drive more discussions to your way?

I hesitate to say that, Tycho, to be honest with you. I think we're certainly not being hurt by the consolidation that we're putting together. We've seen you saw the backlog increase since the closing of the acquisition. We've seen RFPs are up double digits over the year. We had a very good quarter, not just in terms of new business wins, but our RFP numbers coming in. So I think your customers haven't necessarily expressed to me any concerns about the industry and the consolidation going on in the industry. But -- so I don't get too worried about that. I think we're focusing on what we're doing and we're not hearing any concerns. I think the evidence in terms of the data suggests that our customers are not concerned either.

Your next question is from the line of Eric Coldwell from Baird.

I appreciate it. So my question is maybe a bit of a -- I'm not sure if postmortem is the right word, but a review of how -- what you've seen in terms of patient identification, enrollment and retention over the last, call it, what, 18, 20 months, at least in the U.S. since we had our national emergency declared, but I'm really globally -- I'm just curious, have you with the waves of lockdowns and out reopenings, how have you seen patient enrollment and retention more over this time frame? And the reason I ask is because there seems to be to conflicting views in the market right now. One view is that as the world opens up, patients will be harder to identify. They'll be back at work. They'll be getting back to daily activities. And the other view is that mean sites will be open and people will feel and be able to more freely move around. So I'm just curious how you're seeing these trends evolve as COVID opens and closes markets.

So I think it's almost a little early to fully answer that question as we come out of the pandemic or hopefully, we're coming out of out of the pandemic, and we're not going to go back into a sort of lockdown situation. I will say very clearly that when the pandemic happened, the enrollment in our non-COVID trials dropped off substantially. That's not news to anybody. And then fortunately, of course, we were able to enroll some very large COVID studies, which really helped to make up that shortfall. In fact, overcompensated on a patient basis for that [Indiscernible]. I think as we truly come through it, I'm more a subscriber to your second explanation in that as the economy -- as our society opens up again, that patients and people will be more able to move around at sites. We said -- we talked about 15% of sites still impacted. I think that's probably a number that might not change dramatically in the next year or so. There's still going to be a component as we get through this, as I say, COVID becomes more endemic. So I think there will be a sort of hangover there. But I do think that we're starting to see enrollment in our non-COVID trials go up, improve fairly substantially as those sites have opened, and as at least in certain parts of the world, the economy is opened up again. So I'm a fully paid-up subscriber to your second component rather than the first one. I think that will happen. I think as we combine that with some of the new technology, some of the new data opportunities that we have, we'll be able to accelerate that. Obviously, our tokenization component is something that we're -- we've seen a lot of…

And Brendan, I know there is a reluctance to give too much detail on pass-throughs, but it is -- they are hard to project, and they're very lumpy in terms of revenue and then the impact on gross margin. I'm just curious if you can give us any sense, even if it's more qualitative on how pass-through bookings are coming in or what you see happening? I know you made a comment that the COVID pass-throughs will wind down a bit here as we progress through the year. But when you look at the total mix of work or the total pipeline, are you seeing any big shifts in pass-through versus, say, pre-COVID era periods? And if you could give us any more color on those statistics or what you're looking for as we move into '22 or beyond, that would be, I think, very helpful.

I think, Eric, as you say, the complex question. Certainly, the vaccine studies that we've had in the business have significantly put a larger -- a much larger proportional element of the pass-through through the business in the first half of this year, certainly, and to some extent at the back end of last year. I do think we're tapering down those on those [Indiscernible] now. So we are starting to see probably backlog and pass-through elements of backlog, going back to kind of where they were prior to the pandemic, prior to those vaccines. And as we get into Q4, I think the revenue run rate and how it ticks along from Q3 to Q4, will be good an indicator of what kind of post the big vaccine studies our revenue is starting to look like. So again, to the same margin point I made earlier on about the margin point being much more reflective of causes call it, normalized levels of pass-through in Q4. I think that's true of revenue as well. Obviously, we'll give you more color as we go into our 2022 guidance. And obviously, Steve spoke about the fact that we're still ambitious about the high single-digit revenue growth that we talked to when we did the transaction as we go out into next year. But I think the lumpiness to your point, will hopefully be predominantly done by Q4, and hopefully, we can see a more normal pattern on a quarterly basis there afterwards.

Last one for me, should be pretty easy. Do you have or have you provided a long-term DSO goal on a combined basis? And just a quick reminder to save us from having to track it down. What is the term loan interest rate drop in Q4 if you maintain this leverage below 4x post-synergy?

On the DSO, no, we haven't got a target there yet. We'll have to think about it. I'm just really pleased with the fact that how good our -- my colleagues in legacy PRA are doing their cash collections. So that's been an education to me and something that we're looking to pursue across the organization. So certainly, we want to bring their skill sets and our best of both mentality to the whole company, and hopefully, we continue to see that DSO target fall from where we are, but I'm delighted obviously with the number we have in the quarter. On the interest rate, it will be about 25 bps, Eric, on that interest rate as we go into Q1. I think we're coming into an inflationary environment. So you might see interest rates tick up on the bottom line. But certainly in the immediate term, it's about [4%].

Your next question is from the line of Dave Windley from Jefferies.

But I believe, Steve, at the end of your prepared remarks, you made a comment about kind of enthusiastic about your long-term guidance construct. And Brendan, the answer you just gave, Eric. You kind of touched on this, but I'm wondering if you believe that, that long-term construct specifically applies to '22.

I mean, yes, I think so, Dave, we've given -- I think we've talked about high single digits -- mid- to high single digits for revenue for '22. And I think that goes on beyond that in the teens on the EBITDA and EPS a bit higher. So we feel that '22 is going to be a good year. We feel like we're setting ourselves up to be in a good position to really move nicely, whether it be burn rate, whether it be new wins is shaping up as a good year for us.

A separate topic and following up on the decentralized trial commentary. I guess I'm wondering, as you move into that and you see, as you mentioned, a high percentage of new trial starts that includes something. I'm curious on two points. One, is there a common theme in that something? Or is it kind of all across the board? And then two, as you are pricing projects or maybe more appropriately the RFPs that come through that ask for maybe some blend of traditional and DCT type approaches, is that revenue enhancing? Does the value of that project grow versus just a traditional approach? Or do the DCT elements actually drive an efficiency into that, that shrinks the value of a project like-for-like?

Let me take the first one in terms of common themes. I don't have the data in front of me, Dave, in terms of the specifics there. But my impression is that there are certain areas of a decentralized trial that we would commonly apply as a product. So things like the risk-based monitoring approach and remote monitoring, I think, would be 1 that would be -- we -- in pretty much every trial we propose now we have a component. It may not be everything and it might not be in every region because certain regions have certain restrictions in terms of access to electronic health records, et cetera, et cetera, more difficult in Europe, of course. And so that but that component in some safe way say performance is probably the most common. Then you have things like wearables, probably a little less common, but still regularly -- pretty regularly included. E-consent, we're very passionate about given our experience, particularly with the vaccine trial. So it is a little variable. And as I say, there's very few trials that have everything in there. But I would say it's probably the remote monitoring, the risk-based monitoring that's doing that. And in terms of how that's impacting our pricing, I would say it's probably having a fairly minimal impact on our pricing and overall price at the moment. But it is helping. it is driving us to be more efficient. And so I would say it's margin enhancing. And there may be a modest impact on revenue. It's pretty small, though, at the moment, really, because of the sort of hybrid approach and because of the fact that, as I said, even we do risk-based. It's rare that the whole trial is risk-based and it's rare that the whole trial is remote. So I would say margin enhancing, modestly margin enhancing probably not driving up our revenues, but that's okay as well. We feel that our customers then can do more trials with the dollars that they have. So I would say overall, a benefit for us and certainly a benefit for our customers and offering it. It gives us an ability to be more effective and efficient for them and help them do -- ultimately, let's be honest to get more shots on goal in terms of the trials they need to do. That's where we want to be. So we don't get worried about any sort of impact on revenue from being more efficient and more effective at all.

Your next question is from the line of Luke Sergott from Barclays.

I'm just going to go back to Dave's first question on '22. I know you're not going to give the guide, but -- you talk about growing at -- comfortable in the high single-digit growth. IQVIA is out there talking about a 2% to 3% COVID headwind, resulting in a soft landing. When you guys are talking about that high single digit, are you talking about that ex the COVID, sorry, COVID headwind? Or is that inclusive of it, implying a slightly 4% to 5% growth? Just any type of context and framework because this is the only question we're getting from investors right now?

I'll let Brendan can have a go on that one as well. But I think we're talking mid- to high single digits, I think is what we said. And I think -- so we'd stick with that. And to me, that includes everything. That does include something of a ramp down with the COVID work, particularly the large vaccine work. As Brendan said, the change in component with pass-throughs. It's probably going to be revenue -- sorry, margin enhancing even if the revenues -- there is a little bit of a headwind. So I wouldn't disagree with revenue headwind, if that's what you want to call it, but the sort of qualitative guidance we're doing -- we're giving there in terms of mid- to high includes any sort of headwind that we have expected from lower amounts of covered well. We do expect there's going to be a continued amount of work. The treatment sort of protocols are coming in. They're not as large, they're not as impactful in terms of your overall revenues, but there's a significant amount of work there. And as I say, it will be an important component of what we do for me, at least the next 2 years as we go forward at the moment.

Yes, I wouldn't disagree with that, Luke, to your question there. I mean, you're quite right. There's obviously an outsized pass-through element in 2021. We won't see that. And as I said, I think we'll be more like a normalized pre-pandemic pass-through element as we go into '22. That will have some impact certainly on the year-over-year comparisons. I think the direct fee and margin revenue generating revenue that we always talk about and focus on in -- certainly in terms of our EBITDA profile. It's still going to be very strong as we go through year-over-year. And that's where our focus is in terms of making sure that we can drive those numbers we have talked to earlier on in terms of the double-digit growth.

And then I guess just one here, one last one on FSP. PRA, you -- they had a -- they're a large business. You guys also had another large business. Can you give an update on appetite here demand? How that's been progressing pricing and any ability to pass on some of the wage inflation?

It continues to be a significant part of our business. It's growing nicely on the top line as are the other more full service components of our business, Luke. So we're happy with the progress that business is making. In terms of passing on, we've been in significant negotiations with a number of customers around some of those challenges. And let's be honest, customers have been accommodating, I would say, generally, customers don't always like to hear about labor challenges and wage inflation that's beyond what we expect in terms of normal inflation, but they've been, I would say, a receptive to those sorts of discussions. And we've made progress on a number of fronts in that. So I'm encouraged by our customers' understanding of those sort of challenges and our ability mitigate any margin pressure that we have in that business. But there's other ways, lots of work to do in that space, and it remains 1 that we continue to need to work harder.

Your next question is from the line of Jack Meehan from Nephron Research.

I was hoping maybe just a little color on what cost synergies may have already been recognized in the first quarter out of the gate. I look at the pro forma cash EBITDA was up 7% sequentially versus the pro forma revenue, which was down 2.5% sequentially. So just maybe talk a little bit through the dynamic there would be helpful.

Yes, we're happy, Jack, with the progress we're making. We're obviously pretty, pretty good cost controllers in the ICON organization, and that's obviously a strength we'll bring forward as we go into this -- into the further into the new ICON as we get into Q4 and certainly into '22. I mean, it was not material. It's a quick answer, Jack, in terms of the first quarter. You're talking about mid-single digits in terms of millions of dollars in terms of the actual synergy benefit in the quarter. We've got good visibility to how we're looking at the $150 million, as we've outlined before, and we're actioning -- a lot of items around that will certainly help the progress of how that comes through into P&L account over the next number of years. For now, I'd still tell people to how to think about that in the same way that we talked about when we did the transaction. I think as we get to the guidance in Q1, we might be able to give a bit more color in terms of when and how we think that timing will impact on the overall cost base.

And then another follow-up for you, Brendan. You referenced some of the changes in tax regulations globally. I know you're going to give us more thoughts in 2022, but just was curious your philosophy, just any high-level thoughts as to what this can mean up, down versus the prior forecast you talked about, any type of magnitude you're thinking?

It's I suppose there are so many moving parts here, Jack, at the moment in terms of both what's going through the Congress in the United States, which obviously will have a big impact. And there's been talk about different tax rates there, our corporation tax rates in the States started off with a higher number but [I believe, it'll] back down. It also impacts on the GILTI rates as you guys know, the amount of work that you had so in the United States. The other big piece that's impacting, of course, is the OECD rules around this new 15% global tax rate -- or minimum global tax rate. The Irish corporation tax rate previously was 12.5%. So quick math, obviously, there's 2.5% of an impact there. If you consider our historic tax rates versus that base Irish rate. So that's a piece of it, obviously. But it's not the whole story. And I think it was one of the reasons we're saying we'll talk more about that in January, hopefully, is that we'll have better visibility as to what's going to happen or shake out a little bit more, at least in terms of U.S. tax legislation. So I think yes, it probably will be increasing a little bit. Albeit, still pretty competitive versus our peer set.

And your last question is from the line of Donald Hooker from KeyBanc Capital Market.

I'll just ask one. I was curious if you all would be willing to elaborate on the comment you made, I think, in the prepared comments around 1 large biopharma company selecting ICON DCT platform as its enterprise solution. So I'm just maybe trying to sort of understand that. Is that -- am I thinking of that as like a technology sale are you providing sort of a set of technologies that they are running clinical trials on? Or is this part of a full-service solution embedded in your full service solution? Or is it some sort of a stand-alone technology sale?

It's not a stand-alone technology sale, Donald. But it does involve services as well. But in a sense, essentially, it's a hybrid. I mean we will be providing the platform and services, but they will be able to use the platform for their own internal trials as well. So that's the way it's working out at the moment. We're very encouraged by that as an endorsement of our platform. And this is a very significant organization. And so having their involvement with it, we think is going to be a real positive for us from a platform and a platform development point of view, but it does involve services as well as technology.

But just to be clear, you mentioned they might use your like e-consent tools, for instance, or monitoring tools for studies that they're not outsourcing to you as well, right?

That option is available to them should they wish to take.

There are no further questions. Please continue.

Okay. Thank you, operator. Well, thank you, everyone, for listening in today. We're pleased to have delivered another strong quarter at our first as the new ICON. So we look forward to further progressing our integration and building the world's leading health care intelligence organization, continuing to help our customers accelerate the development of drugs and devices. And finally, I want to take this opportunity again to recognize our entire 38,000 people around the globe for their commitment and efforts over the past quarter. So thank you all, and have a good rest of the day.

And that concludes presentation today. Thank you for participating. You may disconnect.