ICON Public Limited Company (ICLR) Earnings Call Transcript & Summary

June 24, 2026

NASDAQ US Health Care Life Sciences Tools and Services earnings

Earnings Call Speaker Segments

Operator

operator
#1

Good day, and thank you for standing by. Welcome to the ICON plc Q1 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Kate Haven, VP of Investor Relations. Please go ahead.

Kate Haven

executive
#2

Hello, and thank you for joining us today. I'm joined on the call by our CEO, Barry Balfe and our CFO, Nigel Clerkin. 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 most recently filed annual report on Form 20-F. This presentation includes selected non-GAAP financial measures, which Barry and Nigel will be referencing in their prepared remarks. For a presentation of the most directly comparable GAAP financial measures, please refer to the section of the press release dated June 23, 2026 titled Consolidated Statements of Operations. 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. Included in the press release and the earnings slides, you will note a reconciliation of non-GAAP measures. Adjusted EBITDA, adjusted net income and adjusted diluted earnings per share exclude amortization, stock-based compensation, foreign currency gains and losses, restructuring transaction, integration related and other adjustments, transaction-related financing costs, fair value movement on investments in equity, goodwill impairment, impairment of nonfinancial assets and the related taxation effect. In the interest of time, we ask participants to keep their questions to one each. I would now like to hand over the call to our CEO, Barry Balfe.

Justin Bowers

analyst
#3

Thank you, Kate. ICON's results in quarter 1 were in line with our expectations and reflected sustained progress in commercial performance. Alongside the expected impacts of previous demand and conversion dynamics on financial results for the quarter. Commercial excellence has been a central priority for me and for the team. So I'm encouraged by the progress that we've seen over multiple quarters now. We prioritized diversification of sales channels in large pharma and expanding our footprint in the midsize segment and increasing RFP flow and win rate in biotech. So it's gratifying to see significant progress in these areas, reflecting our strategy in action and its resonance with our customers. Quarter 1 gross bookings were $3.3 billion, matching the strong performance in quarter 4 2025 and up 22% year-over-year. Cancellations were also in line with the improved level seen in quarter 4, a total of $383 million for the quarter. For transparency, we have also provided cancellations under our old methodology, although notably, there was very little impact of the methodology change on reported cancels in the quarter. With that being said, cancellations are inherently volatile on a quarterly basis. And we consider it likely that the future cancellation run rate may be somewhat higher than these levels as intra-quarter cancellations in quarter 4 and quarter 1 were lower than historical averages. Strength of gross bookings and cancels resulted in net business wins of $2.88 billion in the quarter, an increase of 42% year-over-year and a net book-to-bill of 1.42x. Encouragingly, we again saw a solid contribution of direct fee versus pass-through awards with our book-to-bill on a direct fee basis in excess of 1.3x for the quarter. This strong bookings performance was broad-based and supported by particularly strong RFP flow in both our Pharma full service and our Development Solutions businesses. RFP flow also increased low double digits sequentially in the biotech full service business. Win rates remain strong in both large pharma and biotech full service, sustaining the step-up seen in quarter 4. We Therapeutic mix continues to favor oncology and cardiometabolic areas of the portfolio. Importantly, within cardiometabolic, we've seen good diversification in awards in the last 2 quarters. in terms both of the number of customers that we're supporting and the distribution of indications, including areas such as [ MASH ], obesity and kidney disease. In large pharma, ICON is positioned as a scaled, integrated partner with leading capabilities across full service and FSP models as well as a broad range of adjacent functions. Our capacity to hybridize FSL and FSP models remains central to our value proposition as customers increasingly require the best of both solutions while ensuring seamless interoperability with their internal functions. As I mentioned earlier, we continue to see meaningful opportunity to deepen established partnerships by increasing the range of services we provide to large pharma customers. One strong example of this in quarter 1 was the award of a Central Labs partnership from a top 5 pharma customer, where we had limited Labs business in the past. Flexibility, strong project management, our kit operation strategy and long-standing delivery in other functions were cited by the sponsor as key factors in that award. Moving on to midsize pharma. I previously emphasized the importance of increasing our relatively low level of penetration in this important market. While win rates remained flat in that sector in the quarter, opportunity flow is improving, up high teens on a year-over-year basis, with several strategic partnership discussions underway. In quarter 1, ICON's global execution capabilities, commitment to strategic collaboration and focus on digital innovation were central to securing a new midsized partnership and displacing the incumbent large CRO provider. In biotech, the market environment remained generally positive. ICON sustained the improved win rate seen in quarter 4 with a good balance of repeat business and new customers contributing to awards in the period. Commercial performance continues to be aided by our evolved biotech strategy with consulting engagements and early development projects continuing to drive demand into Phase II and III supported by enhanced therapeutic and medical expertise. Now turning to our financial results for the first quarter. Performance in the quarter was in line with the expectations we detailed on our most recent earnings call in May. Revenue of $2 billion was up approximately 1% year-over-year on a reported basis but down 1.9% on a constant currency basis. Reflecting challenging prior demand dynamics, including elevated cancellations in earlier periods. Quarter 1 adjusted EBITDA margin of 15.6% and increased 10 basis points sequentially, consistent with our prior indications. While margin performance was primarily impacted by organic revenue decline, we also saw pressure from mix shifts in favor of functional versus full service revenue, foreign exchange and to a lesser degree, the flow-through of pricing dynamics from previous periods. We continue to anticipate that we will see modest sequential margin improvement throughout the year as our commercial strategy delivers increased full-service direct fee revenue as a proportion of the overall mix and as we continue to drive disciplined cost management in the business with incremental benefits throughout the year. Importantly, this margin trajectory is driven by actions that are already in flight, not by future assumptions. As such, our financial guidance for the full year 2026 remains unchanged, with revenue expected in the range of $7.85 billion to $8.15 billion and adjusted diluted earnings per share in the range of $10 to $11. In terms of the macro demand environment, we continue to see things broadly as we outlined on our May call. Biotech funding remains constructive with ongoing activity and larger follow-on capital raises supporting late-stage clinical programs. In large pharma customers continue to invest in their clinical pipelines with encouraging deal flows suggestive of incremental opportunity for ICON. We remain encouraged by the quality of opportunities in our pipeline in key areas we've identified for further expansion as we focus on converting demand into high-quality, profitable revenue. Against this backdrop, we continue to make targeted investments that support our growth ambitions, including talent and capabilities in key functional and therapeutic areas. We are expanding our central laboratory facility in Singapore to support two strategic objectives: a focused effort to expand our laboratory offering in addition to accelerating our growth in Asia. In addition, oncology remains a core therapeutic area and our innovative solutions are strengthened by ICON's growing [ Accelicare ] site network. We recently expanded its oncology research capabilities through our partnership with the [ Brian-Miran ] Cancer Institute in the U.S. By establishing this flagship oncology side, we're working to address persistent industry challenges, particularly in patient recruitment. Historical industry data suggests that the overall number of clinical trial sites conducting oncology research in the U.S. is declining with access to trials highly concentrated as nearly 70% of U.S. counties lack active oncology trials for patients. At the same time, regulators and sponsors continue to target 20% of global patient enrollment from U.S. sites. Our expanded [ Accelicare ] footprint across the U.S., including community-based cancer centers, along with our partnership with [ Avira ] support research naive sites helped to expand patient access to cancer therapies, ensuring that more individuals benefit from innovative treatment options. Separately, we continue to execute on our innovation strategy as we evolve ICON's digital architecture to an intelligence-led platform. Through our recently announced partnership with Microsoft, we are building on the strong foundations already in place, to deliver on three key strategic priorities in this area. Firstly, we are developing the intelligence layer that powers [ Argus ]. This is ICON's Agentic AI platform connecting our expertise, data and AI across the trial life cycle to enable seamless navigation and facilitate teams to make better decisions faster for our customers. Secondly, our focus on driving incremental efficiency is supported by an enterprise-wide deployment of Copilot embedded in key workflows, allowing our employees to automate repetitive activity and shift their focus to higher value work. And finally, perhaps most importantly, by combining Microsoft tools with access to frontier models from other leading providers, ICON will continue to develop and deploy best-in-class domain-specific agents embedded directly into clinical development workflows powered by our deep expertise of execution capabilities. In summary, while 2026 will require us to navigate the near-term headwinds we've discussed, we are executing well on our strategy and the underlying momentum in our business gives me confidence in our trajectory. Before I close out my comments, I want to extend my thanks to our dedicated team at Icon for their continued efforts in delivering for our company, for our customers and for patients in need. Now I'll hand you over to Nigel to take you through our results in further detail.

Nigel Clerkin

executive
#4

Thanks, Barry. Revenue in quarter 1 was $2.0 billion, representing a year-on-year increase of 0.9% or a decrease of 1.9% on a constant currency basis. Overall, customer concentration in our top 25 customers was aligned with quarter 4 2025. Our top 5 customers represented 25% of revenue in the quarter. Our top 10 represented 40.3% while our top 25 represented 63.4%. Adjusted gross margin for the quarter was 24.4% compared to 28.4% in quarter 1, 2025. Adjusted SG&A expense was $178.5 million in quarter 1 or 8.8% of revenue compared to $173.4 million in quarter 1 2025 or 8.6% of revenue. Adjusted EBITDA was $317.7 million for the quarter or 15.6% of revenue. This compares to $398 million Q1 2025 or 19.8% of revenue. Adjusted net interest expense was $44.7 million for quarter 1. In the comparable period last year, net interest expense was $44.3 million. The effective tax rate was 17.2% for the quarter. We continue to expect the full year 2026 adjusted effective tax rate to be approximately 17%. Adjusted net income for the quarter was $192.9 million, equating to adjusted earnings per share of $2.50. U.S. GAAP income from operations amounted to $173.8 million or 9% of quarter 1 revenue. U.S. GAAP net income in quarter 1 was $104.8 million or $1.36 per diluted share. From a cash perspective, quarter 1 had cash from operating activities of $167 million. Capital expenditure was $30.8 million resulting in free cash flow in the quarter of $136.2 million. At March 31, 2026, cash totaled $765.2 million and debt totaled $3.4 billion, leaving a net debt position of $2.6 billion. This was a decrease on net debt of $2.8 billion at December 31, 2025, and $2.9 billion net debt at March 31, 2025. We ended the quarter with a leverage ratio of 1.8x net debt to adjusted trailing 12-month EBITDA. Our balance sheet position remains strong, reflecting our disciplined approach to capital deployment and solid cash generation in our business. While returning capital to shareholders through share repurchases remains our top capital deployment priority, we will also continue to invest in expanding our capabilities and solutions to support future growth and strengthen our leading market position. And with that, I believe we're ready to open up for questions.

Operator

operator
#5

[Operator Instructions] And your first question today comes from the line of Eric Coldwell well from Baird.

Eric Coldwell

analyst
#6

Thanks very much. Good morning. I just wanted to check on the spread between backlog and performance obligations. It did widen this period. I just wanted to confirm that, that was due to growth in new awards that are not yet contracted as opposed to any adjustments to the realizable value of contracted awards or for some other reason?

Barry Balfe

executive
#7

Eric, it's Barry here. It's two things. As you rightly say, it's strong book-to-bill right back to back. So you're going to see some drag there. The other side of it is seasonality-wise, Q1 is not always the strongest quarter for signings. I will tell you that Q2 is looking like a very strong quarter for signings. So I'd expect a significant shift in that number in the Q2 print.

Operator

operator
#8

And the next question today comes from the line of Michael Ryskin from Bank of America.

Michael Ryskin

analyst
#9

You had a comment earlier in your prepared remarks on cancellations and just something along the lines that you wouldn't be surprised to have higher cancellations going forward because intra-quarter cancellations in 4Q 1Q were lower. Could you expand on that a little bit, sort of what drove that order cancellation, not just noise? And is that indicative of what you've seen in 2Q so far because you are 2/3 the way through the quarter? Just maybe give us an update on that? .

Barry Balfe

executive
#10

Yes. Mike, it's two things, honestly. If you look at Q4 and Q1, we gave it to you both ways, right? So if you look at Q4, there was some benefit to the methodology change at the end of Q3, albeit the underlying cancels were significantly down. . In Q1, there's not really any material benefit from the methodology change, but it is a notably low canceled quarter. My comment really is only intended to reflect that. I don't think anyone should take an exceptionally low canceled quarter and call at par by default. Regarding your question about Q2, Q2 will take up a bit. certainly nothing like the concerning levels of cancellations we saw in the past. But as I've been saying for a while, it cancels bands around between, I don't know, $500 million and $600 million, I don't think that's going to be out of the ordinary for a business of our size. But my comment was really more broad based than that. It was simply looking at, I think it was 3.83% in the quarter, looks conspicuously low, and I certainly wouldn't want to anchor off that as guaranteed for go-forward quarters.

Operator

operator
#11

Your next question today comes from the line of David Windley from Jefferies.

David Windley

analyst
#12

I wondered, Barry, if you could expound on the quality of pipeline that you're referring to on -- it sounds like diversity is reasonably good, but I'd be interested in a little more color on how much are labs contributing? How much are you pushing Phase 1? And within that, is quality also reflected in the pricing that you're seeing in the awards that you're chasing and winning?

Barry Balfe

executive
#13

A lot in there, Dave. I'll do my best. I think the point about qualitative pipeline flowing into quality of opportunities, quality of awards and quality of backlog is exactly the point. I mean the way we think about demand is not simply volume of demand. We're focused on convertibility of the pipeline we see quality opportunities, we can turn into significant revenue that drive significant profitability. We're reasonably encouraged to be candid. I mean, adding a new midsized partnership in the quarter, labs partnership in large pharma the quarter, albeit they didn't particularly contribute to awards in the quarter, I think, is encouraging. We continue to see good opportunities to grow our labs business. That's no surprise. You have called it out in the past. I would also say the skew towards Phase III in recent quarters is interesting. So I think the number of Phase III trials in the Q2 awards were up around 38%, 39%, average SKUs from 29% to 45%. In Q2, that's going to be substantially higher, as I understand it. Obviously, we haven't closed that just yet, but that's encouraging. The area where caliber of pipeline would have been a question 12 or 18 months ago was in biotech, and that's where I'm perhaps most encouraged. We've talked about getting the RFP flow up in certain quarters. We've talked about getting the winds up at the win rates up that's sustaining on those. So that's pretty encouraging, to be honest. So we feel pretty good about it. These things are inherently volatile, right? I mean pharma had a particularly strong quarter in Q1 for a flow that probably drops a little in Q2 and then biotech has a notably strong input in Q2 RFP flow. So these things will bounce up and down. One of the metrics I look at is the percentage of RFPs that are ballparks. So for example, in quarter 1, that bounced from about 12% in quarter 4 up to about 17%. But interestingly, those ballparks skew heavily towards our development solutions business. Now I think that's actually expected and welcome. What we're looking at there is a stated objective to bid on development solutions businesses, whether it's early day, whether it's specialty labs, central labs, bioanalytical, whatever, maybe that we weren't bidding on before. And sometimes, you got to jump through hoops before you get to really productive work there. So that's not unexpected. Likewise, in biotech, I think we'll see a tick up in the proportion of biotech or flow that's ballpark in quarter 2 with very significant increases in RFP volumes there. So these things bounce around, but I would characterize the pipeline environment as positive and really focusing on taking a qualitative approach. We're looking to drive volume where we want to drive volume and we're looking to convert wins where we need to convert lens. And so far, the teams have been doing a good job with that. On pricing, I mean, I would say you it's a separate question. I'm not sure if you intended to link them my views on pricing haven't really changed. There's never been a quarter where we weren't wrangling with pricing dynamics. There's never been a quarter where pricing expectations -- sometimes we're pricing expectations, we didn't want to meet. Our business really is to try and understand what problem customers are trying to solve. And where we can meet them in a place where our ways of working our strategy, our technology, our teams, our superior expertise and particular functions and indications can drive cost out of their business with their customers that we think we can create significant value for. And when they meet us there, they tend to profit from us. There will always be quarters and this quarter is no different where people want to get all the way home in terms of rate negotiations or discounts and whatever else you have. And while I respect the needs of our customers, my consistent feedback to them and to my own team, is that you can't cut your way to victory. The way to do it is to work smarter, to work with better teams who've done the work before and know how to execute in a superior way. So that's where we are, no underlying change in the pricing environment, Dave, I would say. It's the same knife side it is every quarter.

Operator

operator
#14

Your next question comes from the line of Michael Cherny from Leering Partners.

Michael Cherny

analyst
#15

Maybe if I can go back, I think there was a comment you made, Barry, regarding margins and the in-flight opportunities. As you think about the embedded ramp in guidance over the course of the year, how do we think about the confidence intervals and the split between direct costs versus SG&A and the biggest proactive opportunities you're taking versus areas where it could be a mix-related contribution?

Nigel Clerkin

executive
#16

Mike, it's Nigel. Why don't I take that. So look, obviously, we reported 15.6% EBITDA margin in Q1. And right in line, slightly above actually what we had flagged 4 weeks ago as to where we thought that would land, nothing has fundamentally changed, Mike, in terms of our outlook for margin through the course of the rest of the year. And just as a reminder, what we talked about then was obviously when you look at our guidance range for the year, it is a range, but just taking the midpoint for modeling purposes for a moment, that implies an EBITDA margin for the year of 16.5%, approximately. So looking at where we see that evolving, we are very much focused on EBITDA margin dollars, much more than EBITDA margin percentage. We've talked about that before or pass-through volatility, frankly, can impact the margin percent, so we're much more focused on margin dollar gradual improvement as we go through the year. Having said that, looking at Q2, particularly where we are now, at this stage in the quarter, we would anticipate some continued margin progression in the second quarter, some somewhere in the order of about 0.5% or so. So EBITDA margin for Q2 of somewhere and around 16%. Then from there through the balance of the year, we will continue to focus on executing. And as we said before, the drivers for that margin expansion through the course of the year will be on that mix impacts mitigating somewhat as we go through the year as we see further progression in direct fee growth through the back end of the year and the mix of that between full service and FSP, continues to be the expectation. And then secondly, on cost actions and managing the P&L efficiency, that we would also expect to contribute more heavily in the second half, as we mentioned, just given that the actions that Barry mentioned that are already in flight coming to fruition and flow into the P&L. So it will be a mixture of both, Mike. But nothing changed in our fundamental expectations from a month ago.

Operator

operator
#17

Your next question comes from the line of Charles Rhyee from TD Cowen.

Charles Rhyee

analyst
#18

Barry, I just wanted to go back to, I think, your comment earlier, you mentioned that in 1Q demand, pharma was particularly strong. I think you're saying in 2Q, biotech has been stronger. If we think about the balance between those, now that we're basically at the end of the quarter. So can you give us a sense on how to think about 2Q demand in the sense that if I think about from a gross bookings dollar or -- yes, maybe from a gross awards perspective, and our understanding is 1Q is maybe more seasonal, like a step down from 4Q and 2Q tends to be a step up as people kind of ramp up, but you kind of suggested that in terms of contracting. But maybe can you give us a sense how to think about where 2Q demand is shaking out a little bit and more relative to what we saw in 1Q?

Barry Balfe

executive
#19

Yes. Demand is broadly comparable. It's always dangerous to do quarter-over-quarter comparisons on numbers like our flow, Charles, there's an inherent volatility in it. So I tend to look at it over multiple quarters. But quarter-over-quarter, not much to say in terms of broad demand dynamics, as I said in my prepared remarks, we see the world broadly as we did 3.5 weeks ago when we came and spoke to you guys, in terms of outlook, I'm always a little bit reticent to call quarters before they are closed, but very reticent. But I see no reason why performance shouldn't be broadly in line. That's certainly what we're shooting for. And if you think about the things that matter to us, and I've spoken about what we want to do in large and mid and biotech, I want to continue to lead and diversify ourselves in large pharma and want to continue to add partnerships in midsize I want to continue to sustain a good win rate in biotech. These are the things we've got to do. I also -- in terms of that demand environment, we've had two notably strong quarters in terms of the direct fee contribution as part of that overarching book-to-bill. I wouldn't necessarily expect it to stay that high. But if the direct fee book-to-bill stay open the 1.2x territory, that's indicative of good potential for future growth. And I haven't seen anything in the quarter that suggests that isn't achievable for us in Q2. And honestly, then thoughts turn immediately to Q3 and the incredibly condensed quarter, it always is. It tends to be much more back ended into Q3. So while the teams are busily locking out Q2, we're planning for next quarter and the back end of the year. And that's frankly, business as usual on our side, Charles.

Nigel Clerkin

executive
#20

The one thing, Charles, I might just add into that would be just coming back to the guidance and the financial outlook for the balance of the year. We've obviously just reiterated the financial guidance for the full year with an EPS range of $10 to $11. So again, nothing has fundamentally changed in our outlook for the balance of the year in terms of the P&L performance. It's great to see that commercial traction. The Q1 book-to-bill print that we've seen, we obviously had already factored into the guidance for the year. The outlook for the balance of the year, we talked about before, the guidance is based off a book-to-bill assumption for the balance of the year of somewhere around 1.0 actually. That said, if we continue to see commercial traction flowing in stronger, that's more of a, hopefully, a tailwind as we head into 2027. And wouldn't change materially our outlook for the balance of this year. So we continue to feel that range of $10 to $11 is appropriate, and nothing has massively changed our view on that since a month ago.

Operator

operator
#21

Our next question comes from the line of Patrick Donnelly from Citi.

Patrick Donnelly

analyst
#22

Nigel, as a follow-up on the margin piece. Can you just talk a bit -- I know the pass-through pricing dynamic is kind of ongoing. Can you just talk about how that plays out as the year goes and how that plays into the margin bridge? And then a follow-up on that. just on the cash flow front, how we should be thinking about the cadence there throughout the year after the 1Q results?

Barry Balfe

executive
#23

Yes. Sure, Patrick. So firstly, on the margin, so Q1 look come in pretty much buying on what we had flagged a month ago. That in terms of pass-throughs, we did talk about back then, pass-throughs were especially high in the fourth quarter. It did come down by about $100 million roughly in the first quarter versus the fourth quarter. So -- and we talked about a month ago, pass-through has been broadly stable at the midpoint in our guidance year-over-year. So obviously, where we end up in the range, and that guidance depends on both direct fees and pass-throughs. Faster inherently are a bit more difficult to forecast and are a bit more volatile. Our sort of central case planning assumption at that midpoint would be that pass-throughs are broadly stable quarter-to-quarter as we go through the year, so similar to Q1 levels, okay? Clearly, as we go through each quarter, we will absolutely flag to you any deviation to that over down and what impact that had on our central sort of perspective on the midpoint that I walked you through on margin evolution. Again, we're much more focused on margin dollars than margin percent for that reason. And again, I'll refer you back to my comments earlier on margin dollar evaluation during the course of the year. On cash flow, obviously, free cash flow in Q1 was down about $100 million. [Technical Difficulty] So we got an interference on the line. On cash flow, free cash flow, obviously, in Q1 was about $100 million lower than Q1 last year. That's broadly consistent with the EBITDA decrease year-over-year as well, which is about $80 million Q1 to Q2. Our Q1 to Q1, I should say. As we go through the year, I would just -- at a macro level, focus on that EBITDA movement year-over-year. We had an expectation last year of free cash flow in the $700 million to $800 million range. We outperformed that in the end at $862 million. So again, a range is a range, but at the midpoint, our EBITDA is forecasted to be about $200 million lower than last year. So just point to that as a sort of an anchor point, and then we'd obviously talk about where we end up on a plus or minus depending on how we perform. For Q2 specifically, Q2 free cash flow is generally lower than Q1 because we have in terms of the timing of interest and tax payments. So that's likely to be the case in Q2 as well.

Operator

operator
#24

Thank you. We will now go to the next question. And your next question today comes from the line of Elizabeth Anderson from Evercore.

Elizabeth Anderson

analyst
#25

Given the strong book-to-bill performance and you talked about the continued strength in oncology and metabolic, how do you think about the conversion of bookings is primarily maybe in the last 2 quarters, but in terms of conversion into revenues? Is that kind of like a typical like maybe you start to see it in 6 to 12 months? Anything you would call out on that front in terms of the conversion of these bookings.

Barry Balfe

executive
#26

Yes. Elizabeth, it's Barry here. It's kind of in line with the usual story. The burn rate on a study in the quarter, you win it is about and the subsequent quarters might 1, 3, 4 and 6, right? So it's a while before you get to those 9% and 10% burn rates. But this is also a bit of a mix. It depends on whether you're winning FSP, you're running labs, you're bringing stand-alone work. I mean, to your point about oncology and cardio med, they burn at different speeds once they're up and running, but you also have to get them started. Oncology probably skews a little bit further ex U.S. so might burn a little bit slower. So nothing particularly unusual other than to say the increase in the full service book to bills in quarter 4 or quarter 1 and what I hope will be sustaining quarter are much more relevant for 2027 than they are for 2026. I mean it's part of the story of where we'll see some direct fee and some full service direct fee business mix uptick in the back end of this year. But it's not particularly material for 2026. I think the #1 indicator for sustained growth on the top line will be, can we sustain anything like that level of commercial performance. And then we'll see it start to tick up as we get to the back end of '26 into 2027 and beyond. But I'm afraid I don't have a super exciting answer for you. That 1 is just kind of the plumbing. It takes a while to push it all through the pipes.

Operator

operator
#27

Thank you. Your next question comes from the line of Sean Dodge from BMO Capital Markets.

Sean Dodge

analyst
#28

Maybe, Barry, just to kind of clarify one of the last points you made there on the bookings and some of the dynamics? Anything you can share just kind of overall on like FSO versus FSP mix? Are you still seeing the pendulum kind of shift toward FSP in terms of what's going into backlog? And then -- and just like what is the mix now of FSP in backlog and revenue?

Barry Balfe

executive
#29

So Sean, the disproportionate presence of FSP, if you like, is a comment on revenue in the quarter. I mean book-to-bill is honestly the opposite. If you think about the Q4 or Q1 and early expectations for Q2, where you're seeing very strong book-to-bill ex-FSP. FSP is a fun one, just in terms of the math insofar as we only take 12-month values into backlogs. You're never going to see especially on a footprint as large as ours, you're never going to see wild oscillations in book-to-bill. So when you see significant uptick performance in book-to-bill, you can assume that not being driven by FSP, that's going to be driven primarily by full service, but also other areas like the lab. So that's where we are. The overarching business mix doesn't change much quarter-to-quarter. We said FSP has been growing a little faster. Full service direct fee revenue has actually declined a little bit. So no change there. But were we to sustain these kind of book-to-bill, obviously, that changes in time, which is part of the math as it relates to the back end of '26 and the longer-term prognostications for direct fee revenue flows and associated margins in 2027 and beyond. But yes, apologies if we confused you that the reference to business mix was in revenue in the quarter, but the book-to-bills that we've been talking about are being driven largely a strong book-to-bill in both pharma and biotech. That's sort of the encouraging piece, right? There's no sponsor in here that's over 10%. The number of bolder deals over $50 million are up again in Q1 on what was already a good Q4. I said a year ago, I wanted to see more repeat business in biotech. But of course, you want to see a lot of new business as well. So we're good to see a mix of new and repeat customers in the quarter. So this was a little bit like what I was talking about with Dave earlier on, where it's not just volume of opportunity, it's growth quality. We're going to drive margin. We're going to drive top line growth. We want to see what the mix is like in that pipeline because pipeline becomes RFP flow becomes awards becomes backlog becomes revenue. So good Phase III presence in the mix is to be welcomed. Good full service presence in the mix is to be welcomed good therapeutic distribution in the mix is going to be welcomed. And obviously, the direct fee component is particularly significant. So we're reasonably pleased with how that panned out over the last couple of quarters.

Operator

operator
#30

Thank you. Your next question comes from the line of Ann Hynes from Mizuho.

Ann Hynes

analyst
#31

I know you don't have any share repurchase in your guidance. Can you remind us just how you view any share repurchase potential in 2026 and 2027?

Nigel Clerkin

executive
#32

Ann, it's Nigel. So you're right, the guidance excludes any benefit from buybacks. So as a reminder, we currently are not able to do buybacks because of the delay in publishing our year-end results has meant we have not actually been able to enter into an open period yet, and we're still in a close period until we publish our Q2 results. But we would anticipate being in a position of being able to go back to start buybacks again in the third quarter. To the point on magnitude or order of magnitude, I would just point you back to what our track record has been. So last year, we spent pretty much all of our free cash flow dollars on buybacks. And we continue to see share buybacks as a very strong desire from a capital allocation perspective. in the current environment and of the current share price. So hopefully, that gives you some sense of what we're thinking.

Operator

operator
#33

Your next question today comes from the line of Justin Bowers from Deutsche Bank.

Justin Bowers

analyst
#34

So 2-parter maybe just following up on the prior question. Is there any -- are you still constrained by free cash flow in the period given the sort of like the moratory in the last few quarters and the accrual of cash on the balance sheet? And then is that also -- are you constrained from M&A as well? And then the other part, just going back to your prepared remarks, Barry, on the mix shift in the back half of the year, is that pointing to like a return of growth in service fee revenue of the year or more of the pass-throughs declining as a percentage of mix and/or a shift in favor of more FSO versus FSP? Just directionally, that would be helpful to understand the comments.

Barry Balfe

executive
#35

Yes, Justin, I'll take the second one first and then hand you back to Nigel. I mean we've said that we anticipate top line revenue to be broadly consistent throughout the year, but the business mix improves as we go through the year. So I guess you can do the math on the directly versus pass-through components there. As I said, the FSP business has been growing very nicely. I mean, I'm very pleased with how that business has been progressing. But because of the relative mix of FSP and FSO revenue, that obviously creates a certain amount of margin pressure. So as we think about incremental margin performance over time, it's not just cost action, it's not just pass-through mix. It's also about making sure we return to sustainable levels of growth in those FSP business. That will take some time, as I was just explaining to a little bit, that takes time to bleed through into the P&L. So perhaps not massively material to 2026, but certainly something that these book-to-bill suggests is on the agenda longer term.

Nigel Clerkin

executive
#36

And just to underpin that point, for sure, part of the margin evolution over the course of the year, the improvement we anticipate seeing as we go through the quarters, is, as we said before, an improvement in that -- those mix dynamics in the later part of the year, which obviously includes the FSP, FSO relativity on the back of, again, some consistent quarters of performance on good gross wins. So that again is a fact with us. We're obviously not getting in 2027 guidance yet, but that should be hopefully a trend that continues to be supportive if we continue to execute on our commercial strategy over the next few quarters. So that's certainly a factor. The range, again, part of the reason for the range is pass-throughs, as I've said before, are inherently a bit more volatile. And so the exact margin percent would be impacted by the pass-through composition. It's a little more difficult to forecast. And best we can do there is we guide you as best we can as we go and give you the granularity when we see it, where it's impacting margin quarter-to-quarter. But fundamentally, FSO, FSP shift should improve a little bit as the year goes on from where it is today. On your first question, Yes, you're right. So there is a bit of pent-up capacity from not being in the market currently for the last -- for the first half of this year. So that's helpful certainly in terms of free cash flow capacity as we come into the third quarter and are able to get back to the market. So it's not -- we're not constrained by free cash flow in the quarter. It's cumulative essentially. And likewise, in M&A, we do have constraints in Irish company law rules around share buybacks from a free cash flow perspective and from a leverage perspective. not so on M&A. We could look at M&A without being constrained by free cash flow. As such, Barry would bring you back to our comments before on strategic priorities and where we would focus. And we do continue to look opportunistically for those areas. So at the moment, again, our priority from a capital allocation perspective is buybacks, but we do continue to look at M&A opportunities as well.

Operator

operator
#37

Your next question today comes from the line of Luke Sergott from Barclays.

Luke Sergott

analyst
#38

Just on the quarter, with that $100 million sequential reduction in pass-through benefiting 1Q. Is that a function of part of the cleanup that you guys had done prior in 4Q? And like is that kind of the new steady state we should go forward? Or is it more of a function of just kind of how the trials were shaking out at that time?

Nigel Clerkin

executive
#39

Luke, so this is Nigel again. So yes, that decline in pass-throughs, it's roughly $100 million decline in pass-through revenues from Q4 to Q1. So that's the main driver why revenue increased from Q4 to Q1. Just to be clear, and as I said, guidance is a range, but at the midpoint of the guidance, the working assumption is that pass-throughs would be broadly stable at that Q1 level through the course of the rest of the year. That is currently our expectation for Q2 also. So that's really what's driving that. So I think if you refer to the investigation, again, there's no real material impact from the other factor we talked about in Q4, the $50 million decrease in Q4 revenue related to full service cost complete estimate changes Obviously, there's a bounce back effect from that in the first quarter because that decrease isn't there, but there's no material bleed of that into future quarters that will come in gradually.

Operator

operator
#40

Thank you. On next question today comes from the line of Casey Woodring from JPMorgan.

Casey Woodring

analyst
#41

So you said you sustained the improved win rate you saw last quarter here in 1Q. Can you just maybe elaborate on that? Did win rates accelerate from last quarter? And was strength more in Pharma or in biotech from a competitive perspective? And then maybe just comment on any sort of changes that you've made in the commercial strategy here over the last few months that is really driving that step-up in win rates. It sounds like maybe you're focusing a bit more on driving labs work, for example. So maybe just unpack the win rate comments, please.

Barry Balfe

executive
#42

Yes. The win rates were broadly consistent in both pharma and biotech full service, which was notable, I think, within 1% for both of them, maybe up 1% on a down 1% the other. But in very impressive well sustained in IPH and that approved level or a pharma rather and the approved levels sustained in biotech. So that's largely a product of what the teams have been doing over the last 5 or 6 quarters. We talked about making sure that we're mapping the market better, both in terms of old school customer engagement, but also in terms of some of these newer technologies that allow you to better map the molecular landscape, if you like, in early development to make sure you're engaging with these entities as early as possible or at least just in time rather than too early. That's important. I've talked before about needing to be a little bit less efficient sometimes to be more effective in biotech and don't really mean less efficient. But what I do mean is that the way you do business with a very small nascent entity is very different from the way you do business with a very large alliance partner you've been working with for 35 years. So reflecting that in our go-to-market approach, making sure we have the right level of regulatory and scientific consulting available to these potential customers. making sure that we triage all of those biotech opportunities like their gold dose knowing that not all of them are today, by treating them all that way, we'll certainly be more effective at planning for gold when the opportunities arise. That's certainly important. Making sure we break down any silos internally, so that we're selling holistically to our large pharma customers. I talked to you, I think, before about not selling A or B. If you're buying both, I want to be partnering with you for both. So these are all parts of the process. A huge piece of it, though, is about when you meet the customer making sure that you're in a position to advise them well on strategy, whether that's at the level of a development plan at the level of an asset or program or at the level of a particular study. So that means getting your feasibility right, getting your intel right, making sure there's an expert-led sale there, particularly for biotech customers and making sure we put that effort in upfront because that's how we can create value for the sponsor and extract value for ICON in the back in. That's really what we're talking about. It's entirely consistent with what we said back in Q1 of 2025, and we talked about sharpening up that commercial focus setting out specific objectives that were clean and clear for everybody internally in each of those sectors. And really then it's just about the margin, right? It's good disciplined commercial hygiene moving through the process. And I have to say, I give the teams a lot of credit and how they've executed on it.

Operator

operator
#43

Your next question today comes from the line of Ryan Halsted from RBC.

Ryan Halsted

analyst
#44

I just wanted to follow up on the business mix line of questioning. And just go back to your comments about how your -- you've been hybridizing your offering. So I just wanted to maybe kind of reconcile how that strategy has impacted your mix? And why that kind of is leading to your view that you expect a greater proportion of direct fee going forward?

Barry Balfe

executive
#45

They're slightly related and slightly different questions, Ryan. Sometimes, I worry that I'm boring you guys on this topic. It's a hot topic for me. I know we've bought a lot of other people that -- look, bottom line, I went with a customer last week who really prioritizes internalized development supported by FSP, but they also have certain criteria when they're going to outsource fully and somewhat counterintuitively, when they outsource fully, they really outsource fully, like completely everything. So we're a customer like that who has a highly internalized model. with whom you're an established FSP customer. But over the last year or so, we started winning significant volumes of either full service or stand-alone things like labs work, it's really important that you can optimize the interfaces and you don't come with a rigid CRO playbook. Honestly, the playbook for customers like that as a white page, every time you go to a governance or every time you go to a pitch meeting and you sit down and say, how can we make this work more seamlessly for you? And sometimes, it's as simple as saying we've just run a large full-service study for you. That team is now available but we're a massive supplier of functional resourcing to you. Isn't there an economic and strategic value to recycle that legacy team into whatever way you're partnering today. So you get that continuity of experience that we keep the experts involved, they know the molecule. They know the ways they're working across both businesses. Other times, you'll get customers who are doing a lot of outsourcing, but want to move a particular function to an FSP platform for standardization purposes. So we might be one or two or even three CROs, each of whom are running full service outsourcing studies, but we might be doing their start-up across the whole portfolio or doing investigator grant negotiations. We're doing data management or doing whatever it may be certain functions that way horizontally across the portfolio rather than vertically at a study level. So for me, it's about not taking anything off the table. Perhaps the most topical way of thinking about this for FSP customers is the CRO industry for far too long, at a nasty habit of saying, you don't get my toys if you're not outsourcing the way I want you to. You don't get anything both the people if you're in an FSP model. And we think that's math. I think I said on our last call that we don't just want to be the best delivery engine in the business. We want to be the best partner in the business. And that's really at the core of how we try and differentiate. Beyond the anatomical differences between CRO and CRO A and CRO B, my way of thinking about this is if you can work out what's important to your customers, if you can deliver it brilliantly in the way in which they wish it to be delivered, you are much more likely to be top of mind when a new piece of work comes to mind. Honestly, that's what happened with the labs provider ship in Q1. This was a customer we've been delivering really, really well for across a range of other functions. They obviously weren't happy or whatever they had other considerations in their labs business. And we were invited in to add that stream to our partnership, [ Boan ] that's traditionally what's underpinned our whole partnership philosophy going back 35 years at this stage.

Operator

operator
#46

Thank you. We will now take our final question for today. And the final question comes from the line of Josh Waldman from Cleveland Research.

Joshua Waldman

analyst
#47

Two-part question. First, I wondered if you could provide more context on where you're seeing the strength in Q2 signings. I think you mentioned Q2 is looking very strong. Is it just biotech? Or is large pharma also improving? And then it sounds like you had assumed that H1 bookings would be stronger than H2 bookings. If so, what was the reason for that assumption and the initial guide? And when do you think you could start to get more confidence that H2 bookings could come in like 1H if that ends up being the case?

Barry Balfe

executive
#48

I'll give you the answer to part 2 first, if that's okay, Josh, I think what we were really saying is when we were guiding, we were already through Q1. So we knew what the Q1 book-to-bill was going to be, and therefore, while we were taking a conservative outlook to full year commercial numbers, it seemed prudent to include the actuals for quarter 1 that we had in hand at the point at which we were guiding. So that's really what was behind that. To your point about commercial for the back end of the year. I'm sitting here on comfortable calling Q2 and it's over in a matter of minutes. I'm certainly not going to call the back half of the year. But if the spirit of your question, is whether or not we feel like there's at least an opportunity to avail ourselves of an opportunity where the overarching demand environment seems relatively more benign than it did a year ago and where the teams are incrementally executing well on our commercial strategy. I mean one of the main pillars of our strategy here is commercial excellence. So if you're asking me if we think there's a shot at putting those two things together and doing better than a 1.0 book to build the back half of the year, I certainly hope so. Really, we were just giving transparency on how the guidance was constructed. The only thing I'll repeat at the risk of being boring, is that we could add basis points or 20 basis points off the book-to-bill in the back half of the year and it won't have much impact on the financials for the balance in 2026. In terms of signings, this one is perhaps not as anomalous as it sounds, quarter 4 tends to be a strong signing quarter whether that's to do with annual purchase order budgets or whatever within pharma. So there was a pretty strong signing quarter in quarter 4, a little less so in quarter 1. And what I suspect will be a notably strong signing quarter in quarter 2. Again, when you think about the way the book-to-bill works, it's often the same with respect to work orders -- FSP work orders often have annual extensions on them, which sometimes disproportionately sometimes they just pop up as they go through the quarters, but there's often an element of seasonality to FSP work orders. So where you see significant movement between Q1 and Q2 signings, as likely to be disproportionately FSP. So think about Q2 signings as being a product of Q3 and Q4, probably Q2 and 3, actually, awards from last year. It's just a function of seasonality of signatures being heavy in Q4 and a little later in Q1, but also you would expect it to tick up based on the increase in gross bookings we saw as we moved through 2025. So there's no particular alarm about it, I guess we're only talking about it because someone asked a smart question, why did unsatisfied obligations only move up about $100 million in a quarter where your non-GAAP backlog moved up much more. Again, it's just a function of the plumbing. There's nothing particularly exciting there.

Operator

operator
#49

Thank you. I will now hand the call back to Barry Balfe for closing remarks.

Barry Balfe

executive
#50

Well, thank you, Sharon, and thank you, everybody, for joining today. We're pleased to have had the time to answer your questions. We're pleased with the print today. It's largely in line with expectations. We were with you only 3.5, 4 weeks ago. So I guess it would be a problem if there were any major surprises. Pleased that they were not pleased with the work the teams have done. And I guess I would just reemphasize the demand environment is what it is, but our job is to understand it qualitatively and to execute on it selectively because that's what drives high-quality growth. That's what will drive top line expansion in the longer term. And as we take the actions we need to take improve the underlying margins, these things are going on in parallel at ICON. So continuing to invest on the strategic side, continuing to execute on the near term, but encouraged by the underlying momentum in the business that gives us confidence in the trajectory. Thank you all very much.

Operator

operator
#51

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.

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