Earnings call transcript: ICON PLC beats Q3 2025 earnings expectations

ICON PLC (NASDAQ:ICLR) reported its Q3 2025 earnings, surpassing analysts’ expectations with an EPS of $3.31, slightly above the forecast of $3.30. Revenue also exceeded projections, reaching $2.043 billion compared to the expected $1.98 billion. According to InvestingPro analysis, ICON maintains a "GREAT" overall financial health score of 3.18/5, though current trading levels suggest the stock is overvalued relative to its Fair Value. Despite this positive performance, ICON’s stock declined by 0.89% in the regular session and fell further in premarket trading, dropping 2.99% to $186.84.

Key Takeaways

• ICON PLC’s Q3 revenue and EPS both surpassed analyst expectations.
• The stock price declined despite strong earnings, reflecting investor concerns.
• The company is focusing on AI technologies and process automation.
• ICON plans to continue penetrating the biotech market amid regulatory improvements.
• Elevated cancellations remain a challenge, though normalization is expected in 2026.

Company Performance

ICON PLC demonstrated strong financial performance in Q3 2025, with revenue increasing by 0.6% year-over-year. The company’s focus on technological innovation and cost efficiency has been pivotal in maintaining its competitive edge. Despite a challenging market environment, ICON’s strategic investments in AI-enabled technologies and partnerships have bolstered its market position, particularly in the biotech sector.

Financial Highlights

• Revenue: $2.043 billion, up 0.6% year-over-year
• Adjusted EPS: $3.31, a 1.5% increase quarter-over-quarter
• Adjusted EBITDA: $396.7 million
• Adjusted EBITDA Margin: 19.4%
• Free Cash Flow: $333.9 million
• Share Repurchases: $250 million in Q3, $750 million year-to-date

Earnings vs. Forecast

ICON PLC’s Q3 EPS was $3.31, slightly above the forecast of $3.30, resulting in a 0.3% surprise. Revenue also surpassed expectations by $60 million, marking a 3.03% surprise. This performance indicates ICON’s ability to consistently meet or exceed market expectations.

Market Reaction

Despite the positive earnings report, ICON’s stock price fell 0.89% during the regular trading session and continued to decline by 2.99% in premarket trading, reaching $186.84. This movement may reflect investor concerns over elevated cancellations and competitive pressures. The stock has shown strong momentum with a 29.3% gain over the past six months, though it trades at a high P/E ratio relative to near-term earnings growth. The stock remains within its 52-week range, with a high of $301.45 and a low of $125.10.

Outlook & Guidance

ICON has set its full-year 2025 revenue guidance between $8.05 billion and $8.1 billion, with adjusted EPS expected to range from $13 to $13.20. The company anticipates a normalization of cancellations in 2026 and continues to prioritize its expansion in the biotech market.

Executive Commentary

Barry Balfe, CEO of ICON, emphasized the company’s resilience and strategic focus. He noted, "We are closer to the end of the cancellation process than the beginning," highlighting optimism for future stability. Balfe also stated, "Good companies have great competitors," underscoring ICON’s commitment to maintaining its competitive advantage through innovation.

Risks and Challenges

• Elevated cancellations in pre-enrollment studies pose a risk to revenue stability.
• Pricing pressures and competitive dynamics may impact margins.
• Market saturation in certain segments could limit growth opportunities.
• Regulatory changes, although improving, continue to create uncertainty.
• Dependence on a few large customers for a significant portion of revenue.

Q&A

During the earnings call, analysts raised concerns about pricing pressures and the competitive landscape. ICON addressed these by highlighting its technological investments as a strategy for margin optimization. The company also discussed challenges related to pass-through revenue mix and its impact on financial performance.

Full transcript - ICON PLC (ICLR) Q3 2025:

Conference Operator: Stay, and thank you for standing by. Welcome to the ICON plc Q3 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there’ll be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to our first speaker today, Kate Haven, VP of Investor Relations. Please go ahead.

Kate Haven, VP of Investor Relations, ICON plc: Hello, and thank you for joining us on this call covering the quarter ended September 30, 2025. Also on the call today, we have our CEO, Barry Balfe, our CFO, Nigel Clerkin, and our former CEO and non-executive board member, Dr. Steve Cutler. 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 statement, 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 SEC reports filed by the company, including the Form 20-F filed on February 21, 2025. 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 press release section titled "Condensed 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 earnings slides, you will note a reconciliation of non-GAAP measures. Adjusted EBITDA, adjusted net income, and adjusted diluted earnings per share exclude stock compensation expense, restructuring costs, foreign currency exchange, amortization, transaction-related and integration-related costs, goodwill impairment, and their related tax effect. We will be limiting the call today to one hour and would therefore ask participants to keep their questions to one each in the interest of time. I would now like to hand over the call to our former CEO and non-executive director, Dr. Steve Cutler, for opening remarks.

Dr. Steve Cutler, Former CEO, Non-Executive Board Member, ICON plc: Thank you, Kate, and good day, everyone. As I reflect back on the last 14 years I’ve spent at ICON plc, I feel a strong sense of pride for what we’ve accomplished over that time, growing from a company of 8,500 employees that was number six in the industry to 40,000 people worldwide and a ranking in the top tier of global CROs. It’s been an honor to lead this organization, and I have no doubt that the future opportunity for ICON plc is robust and the leadership team in place is the right one to move it forward. I want to sincerely thank all my colleagues and friends at ICON plc for their partnership and dedicated efforts that have fueled our success over the years.

I also want to thank our customers for their partnership and loyalty in working with us to deliver their projects through some external challenges, including COVID and several geopolitical conflicts. Finally, I want to thank the analyst community and our many loyal shareholders that I’ve come to know well and who have supported our company and its evolution in my time here, particularly as the CEO. I look forward to continuing to support Barry and the rest of the ICON plc team in my role as a non-executive director, and I remain confident in the continuing success of ICON plc over the longer term. Barry, I’ll now hand it over to you.

Barry Balfe, CEO, ICON plc: Thank you, Steve, and I’d like to start by expressing my gratitude to you for your partnership in ensuring such a smooth transition period and for your leadership and support over many years. On behalf of the whole ICON team, I wish you the very best in retirement and look forward to your continued engagement and contributions as a valued member of our board. Turning to our results for the third quarter, our performance was broadly in line with expectations as we successfully navigated a mixed market characterized by known challenges and emerging opportunities. We executed well on the encouraging level of RFPs that went to decision in the quarter. Similar to quarter two, overall gross business awards were strong, totaling $3 billion and were up mid-single digits on a year-over-year basis.

Encouragingly, these awards were broad-based across large, mid-sized, and biotech customers with notable strength in the areas of oncology, cardiometabolic disease, and FFP. Revenue increased on both a sequential and year-over-year basis in the quarter, with therapeutic mix driving strong pass-through revenues. Our overall burn rate was flat sequentially in quarter three at 8.2%, in line with our previously communicated expectations. While quarter three results reflect continued strong cost control across the business, our overall margin profile was negatively impacted by the higher pass-through revenue mix. Adjusted EBITDA margin was 19.4%, a 20 basis point sequential decline. During quarter three, we bought back $250 million in shares, bringing our total share repurchases to $750 million year to date. This all translated into adjusted earnings per share of $3.31, a 1.5% increase over quarter two.

Additionally, we generated strong free cash flow, totaling $334 million in the quarter and $687 million on a year-to-date basis. While I’m particularly pleased with gross business awards in the quarter, our net book-to-bill of 1.02 times was negatively impacted by elevated cancellations of $900 million, broadly flat with quarter two levels, with a bias towards previously awarded studies that were canceled prior to commencing enrollment. Looking to the remainder of the year, we expect largely similar conditions to persist in the market and have assumed this in our updated guidance. I am particularly encouraged by our strong pipeline of actionable opportunities, reflecting our continued focus on commercial excellence and broader and deeper market penetration across customer groups. A notable area of strength in quarter three was in the biotech sector, with a significant increase of RFP flow on a year-over-year and sequential basis.

However, despite recent improvements in biotech funding, the environment remains mixed regarding the timelines for conversion of opportunities to awards and contracts. We have amended our full-year guidance range to reflect the nature and phasing of business wins and cancellations, as well as stronger pass-through revenue activity. We now expect full-year revenue to be in the range of $8.05 billion to $8.1 billion, and full-year adjusted earnings per share to be in the range of $13 to $13.20. While we’re not providing 2026 guidance at this stage, our outlook for the year will in part be influenced by the extent to which we can sustain the positive trends of the last two quarters regarding RFP flow and gross booking, transition to more normalized levels of cancellations in 2026, and optimize the burn rate of studies that are actively enrolling.

Accordingly, we remain focused on executing our strategy with an emphasis on accelerating top-line growth, rigorous cost management, the deployment of novel technologies to enhance our offering, and a balanced approach to capital allocation. Regarding revenue, our plans prioritize expansion of opportunity flow and win rates in biotech, diversification of our revenue streams in large pharma, increased share of market in the important mid-sized segment, and further acceleration of strong growth in our labs, early-phase, and FFP businesses. ICON continues to manage costs effectively, and our investments in enhanced resource demand management and allocation technologies continue to play a key role in our ability to scale our workforce rapidly and effectively in line with business needs.

While revenue mix and pricing pressure are expected to weigh on gross margins in the near term, we continue to differentiate primarily based on capability, expertise, solution design, and technological disruption of the clinical trials process. This enables us to take time and cost out of the development cycle while creating and capturing value. A key priority for me is the deployment of innovative technologies that allow for greater speed and predictability, as well as enhanced efficiency. We’re building on the significant progress that we’ve made in the area of process automation and will accelerate investments in AI-enabled technologies and external partnerships that enhance our capabilities and provide for seamless analysis and interpretation of clinical trial data.

We continue to see value in returning capital to shareholders, while our strong financial position also gives us latitude to invest organically in our capabilities and to consider opportunities for inorganic growth in the right circumstances. In summary, while recent cancellation levels are a headwind to revenue growth in the immediate term, ICON’s global scale, industry-leading capabilities, and financial strength provide us with an excellent platform for growth. The recent demand dynamics provide significant grounds for optimism regarding the midterm trajectory as we move beyond a period of volatility and return to normalized levels of growth. I’m excited by the path ahead, given the strong market position we’ve established and how we can continue to evolve our offering to better serve our customers and patients around the world. I’ll now hand it over to Nigel for a more detailed review of our financial results. Nigel.

Nigel Clerkin, CFO, ICON plc: Thanks, Barry. Revenue in quarter three was $2.043 billion, representing a year-on-year increase of 0.6%. Revenue was up approximately 1.3% sequentially on quarter two, 2025. Overall, customer concentration in our top 25 customers was broadly aligned with quarter two, 2025. Our top five customers represented 24.6% of revenue in the quarter, our top 10 represented 39.8%, and our top 25 represented 66.6%. Adjusted gross margin for the quarter was 28.2% compared to 29.5% in quarter three, 2024, and down 10 basis points on quarter two, 2025. Adjusted FG&A expense was $179.2 million in quarter three, or 8.8% of revenue. Relative to the comparative period last year, adjusted FG&A was down by $1.2 million in quarter three. Adjusted EBITDA was $396.7 million for the quarter, an increase of $0.7 million sequentially. Adjusted EBITDA margin decreased 20 basis points over quarter two, 2025, to 19.4% of revenue.

Adjusted operating income for quarter three was $356.9 million, while adjusted net interest expense was $47 million. The effective tax rate was 16.5% for the quarter. We continue to expect the full-year 2025 adjusted effective tax rate to be approximately 16.5%. Adjusted net income for the quarter was $258.8 million, equating to adjusted EPS of $3.31, a decrease of 1.2% year over year, or an increase of 1.5% on quarter two, 2025. U.S. GAAP income from operations amounted to $86.6 million, or 4.2% of quarter three revenue. U.S. GAAP net income in quarter three was $2.4 million, or $0.03 per diluted share, compared to $2.36 per share for the equivalent prior year period. From a cash perspective, quarter three had cash from operating activities coming in at $387.6 million. This resulted in free cash flow in the quarter of $333.9 million, bringing our total year to date to $687.2 million.

Overall, cash collections were solid in quarter three, with our free cash flow higher than quarter two, reflecting the timing of interest and tax payments, as well as restructuring expenses. At September 30, 2025, cash totaled $468.9 million and debt totaled $3.4 billion, leaving a net debt position of $2.9 billion. This was broadly in line with net debt at June 30, 2025, of $3 billion. We ended the quarter with a leverage ratio of 1.8 times net debt to adjusted trailing 12 months EBITDA. Our balance sheet position remains very strong, which affords us the flexibility to continue to strategically deploy capital. We are focused on an approach that balances further investment in our business as well as future growth, while also returning capital to shareholders.

We made significant share repurchases in quarter three, totaling $250 million at an average price of $175 per share, bringing our total share repurchases year to date to $750 million. With that, we’ll now open it up for questions.

Conference Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. Your first question today comes from the line of Elizabeth Anderson from Evercore. Please go ahead.

Good morning, guys. Thanks so much for the question. Congrats, Steve, and congrats, Barry. Excited for the next steps for both of you. Maybe turning to the question, could you maybe dive a little bit more into the cancellation dynamics? I appreciate that the cancellations in the quarter came spot on with what Steve previewed on the 2Q call. You know, how do you kind of think about those trends going forward? Are you sort of saying maybe we’ll see elevated levels in the fourth quarter, and then you kind of, you know, that should taper down? Is there something, other kinds of dynamics that are sort of driving some of that? Just a little bit more color there would be helpful. Thanks, guys.

Barry Balfe, CEO, ICON plc: Elizabeth, it’s Barry here. I’ll take that. I think, as you say, cancellations came in broadly in line with where we projected. There was a balance on cancels across group. Some significant activity in pharma, it has to be said, within the quarter. As I mentioned in my prepared remarks, there was a bias in those cancellations towards studies that had been awarded prior to quarter three and were canceled prior to commencing enrollment. I suppose that addresses your question in the context of the profile of cancels. These were not, by and large, studies that were in flight and burning at a good clip, so perhaps moderately preferable in that regard. I still think that, as we reflected in our guidance, we expect conditions to remain broadly similar throughout the rest of the year.

I also think we will see this moderate as we move into 2026, certainly over the course of the year. I’m not quite sure where the high watermark and the low watermark is, but I do think we’re certainly closer to the end of a period of elevated cancels than to the beginning.

Conference Operator: Thank you. We’ll now take the next question. The question comes from the line of Michael Turney from Leiring Partners. Please go ahead.

Good morning, and thanks for taking the question. Maybe if I can dive in a little bit on some of the gross margin commentary you had. I think the dynamics on mix and pass-through clearly were in place. Is there anything that you’re working on proactively from a gross margin side to try and offset some of those dynamics? Especially on the pricing side, you know, how you think about firming up price in certain markets, areas where you’ll compete, where you won’t compete. Anything more to give on that front would be great.

Barry Balfe, CEO, ICON plc: Michael, why don’t I start? Barry, obviously, feel free to chime in. You are right in terms of the gross margin picture. Earlier in the year, we had hoped to exit the year at a margin closer to where we exited last year in terms of adjusted EBITDA margin. Clearly, as we’ve gone through this year, we have seen an increase in the proportion of pass-throughs. We’ve talked about that as we’ve gone through the year. That is certainly weighing on the margin outlook for the balance of this year and, frankly, into next year as well. We’ve also, of course, talked about the increasing pricing competitiveness that we’re seeing in the market generally. I’m sure Barry can touch more on that, which again, is not so much of an impact for this year, but is a factor that might weigh on margin outlook for next year.

Having said all of that, you’re absolutely right. ICON, of course, always has had a very long track record of managing its cost base appropriately, and we’ve continued to do that through the course of this year. That is partly through adjusting our resourcing to the demand environment that we see out there. You can see that, for example, in our staffing numbers, which are about 5% lower now than they were at the end of last year, just as an example of that. Also, Barry touched on how we are leveraging technology as well, for sure, in terms of efficiency and how that can help in terms of margin profile, but also in terms of effectiveness and how we deliver to our customers as well for all the reasons you mentioned.

Barry, I don’t know if you want to add in terms of how we can use that to help deliver for our customers and ultimately improve our own margins over time, too.

Yeah. I think it’s a fair question, Mike. I mean, the first and obvious thing you do is you try and win more opportunities with heavy direct fee on them. I don’t want to give back any of the opportunities that have high pass-through mix. I just want to augment them with even more direct fee awards. That’s our focus in terms of driving commercial excellence, making sure we can see more of this market and convert more of it into wins. That’s important to us. We’ll continue to do that, and I’m certainly pleased with our progress in quarter three in that regard. In terms of technology, Nigel’s point is well made. You know, we are looking to enhance the technological ecosystem here at ICON plc. We’ll continue to do that.

The deployment of agents to whom we can delegate workflows rather than simply ask questions is really important to us. Of course, in parallel, we do manage the processes that underline those workflows, manage our geographical footprint, and as I mentioned in my remarks, utilizing some of our existing technology to resource just in time and appropriately, identifying those projects that will burn faster and they benefit from some additional resources, or, frankly, areas of the organization where we might have a surplus of resource, migrating those resources where they can be more impactful. On your last point about pricing, I suppose there’s a degree to which that will always bleed into the gross margin line, but we remain really focused on how we win. We’re not going to cut our way to victory in terms of pricing. We’ve never done that. We’re not going to do it now.

We do tend to differentiate. When we win, we win by virtue of superior capabilities, greater expertise, scientific and operational, and, frankly, better solution design. Being able to bring a study in faster and more cost-effectively is a function of those things more than it is of pricing. They’re all factors, but they’re some of the top-level thoughts.

Conference Operator: Thank you. Your next question comes from the line of Justin Bowers from Deutsche Bank. Please go ahead.

Thank you. Good morning, everyone. I also echo Liz’s sentiment, Steven Barry. Barry, can you maybe discuss the industry environment a little bit and bifurcate between pharma and biotech, and maybe more specifically around the tenor of those conversations in light of what seems to be a regulatory and trade environment of increasing clarity?

Barry Balfe, CEO, ICON plc: Yeah. It’s a good question, Justin. There’s a lot in there. I’ll certainly do my best. I think the first thing to say is I understand why people have been looking very carefully at biotech funding and taking some heart from the Q3 numbers, albeit it is a single quarter. Likewise, in pharma, I think we’re pretty clear on why the markets reacted positively to some of the news over the course of the quarter and Trump RX and the interactions with pharma in that regard. There is certainly a sense that we may be getting closer to a point of some consistency. I think we’ve said this before on the call. Good policy or bad, consistent policy, certainty, dealing with some of the uncertainty that our customers have been facing is certainly net good for the sector.

Whether or not that’s what has driven the significant double-digit increases in RFP flow, whether that’s what’s trickling down into the successes we’ve had over the last couple of quarters in terms of gross bookings, it’s a little early to see, but we’re certainly glad to see it. What I would say, just in terms of balancing that, though, is we’ve said for a while we would expect to see improvement on those leading indicators like RFP flow and gross bookings being trailed somewhat by follow-through onto the revenue and earnings line. Some positive indicators in terms of the environment, you know, some interesting signs that perhaps deal flow is starting to tick up around large pharma as well. They’re encouraging signs, of course, we’re still untangling the consequences of the last couple of years of volatility. I think we should characterize the environment as encouraging but still somewhat mixed.

Conference Operator: Thank you. Your next question comes from the line of Jalandra Singh from Truist Securities. Please go ahead.

Thank you, and thanks for taking my questions. I want to get more color around the comparative pricing environment. You gave some flavor of that. Has this got worse than what you guys have talked about in the past? Is it across the board? Are there any particular market segments you’re seeing it? Based on your observation, are you seeing pricing pressure more driven by clients looking to squeeze extra dollar, or is it more driven by your competitors trying to win more business?

Barry Balfe, CEO, ICON plc: It’s a good question, Jalandra. I don’t think it’s gotten worse, for sure. I think what we’ve talked about over the last couple of quarters is that the prevailing environment in 2025 is more competitive than in certain prior years, but I don’t think that’s something that we’ve seen continue to deteriorate by any means over the course of the year. I think that’s fair to say. I think it’s also fair to say that just given the structure of the relationships we have in large pharma, that’s where a lot of the pressure comes from, which is not to say that our biotech customers don’t require significant support, not just getting to the right price, but getting to really good predictability about that price. This is a significant priority for us at ICON plc.

We invest not just in being cost-effective, high quality, and speedy, but we also invest carefully to make sure we can be predictable. Our biotech customers really need to know when their studies are going to start, when their patients are going to be enrolled, and when they’re likely to be completed. That’s certainly something we’ve focused on. I don’t think it’s something that’s gotten worse over the course of the year, but I would characterize it as a particularly competitive environment. To the last part of your question, I think when the bowl is smaller, the dogs are hungrier to a certain degree. I think one feeds the other. We certainly see a heightened level of competitive activity among our competitors, but I think that’s driven by the upstream dynamics that are impacting our customers.

Conference Operator: Thank you. Your next question comes from the line of Patrick Donnelly from Citi. Please go ahead.

Hey, guys. Thank you. Thank you for taking the question. Maybe you want to, you know, kind of follow up with some earlier ones in terms of the pricing and pass-through environment. You know, I know you guys don’t want to talk ’26 too much, but just in terms of, you know, what those impacts could look like on the moving pieces on margins into next year, it seems like higher pass-throughs will continue a little bit on the pricing that you’ve talked about. Can you just talk about the levers on margins as we get into next year, just high level in terms of the moving pieces? Again, obviously, pricing and pass-throughs are an impact, but, you know, just trying to think about potential offsets and the opportunity to keep those flat to potentially up. Is that on the table? Thank you, guys.

Barry Balfe, CEO, ICON plc: Hey, Patrick. It’s Nigel. I think you’ve touched on the key major moving pieces there. Just as Mike went asked through earlier, you’re absolutely right. Pass-throughs and the increasing component of, or composition of pass-throughs within the overall revenue mix is certainly going to be a weighing factor for next year. The pricing environment, to Barry’s point, it has been tougher through the course of this year than perhaps previously. That’s not so much going to impact us really too much this year, but it certainly would be more of a weighing factor as you go through next year. Countering that, all of the stuff that ICON has always had a long track record of doing, managing the business efficiently, investing in technologies that allow us to be more efficient as well as being more effective for our customers, all of the above.

Exactly what that means in terms of margin outlook for next year, Patrick, you’ll understand we’re not going to walk through today. We will provide that when we provide our guidance for next year in January or February when we get to there. Appreciate your patience as we work through that ourselves.

Conference Operator: Thank you. Your next question, Steve, comes from the line of Jack Meehan from Nephron Research. Please go ahead.

Thank you. Good morning and good afternoon, everyone. I wanted to follow up on kind of the margin question. I was wondering if you could provide more color on the level of pass-throughs. I’m not sure if there’s any metrics you can share, like as a percentage of gross revenue, where it was in 2024, where it’s tracking in 2025, and based on what you look at the backlog now, how much that could shift in 2026. I think just trying to get a sense for where gross margins can start to bottom out. Do you think 27% is close to a floor?

Barry Balfe, CEO, ICON plc: Yes, Nigel, again, I’ll take that. We report revenue in aggregate, so we don’t obviously break that out between pass-throughs and direct fee. All we can do is give you qualitative commentary around that as we have done in terms of that increasing proportion of pass-throughs. Likewise, in terms of margins, I think we’ve touched on the various factors that are weighing on margins next year and also how we can hopefully help mitigate some of that challenge. Again, it’s premature for us to give you any guidance on margin outlook for next year. We’ll do that when we get to there. I don’t know if you wanted to add anything else to that.

Nigel Clerkin, CFO, ICON plc: Yeah, I think you covered it really well. I mean, there’s multiple different puts and calls, but one of the big ones is business mix and the degree at which awards in different therapeutic areas manifest into revenue. It’s not always linear, and it’s not always obvious. As an indicator, over the last year, our level of RFP activity and indeed our level of awards in an area like cardiometabolic, which carries a very significant pass-through load, have increased by more than an order of magnitude. When you see significant shifts in pass-through heavy TAs, this is good news. These are gross bookings that will drive direct fees, that will drive margins in time, but they do also make us consider what the pass-through load will be.

It takes time to work how that works through the flow, and we’ll certainly be taking that into account when we set guidance early in the new year.

Conference Operator: Thank you. Your next question comes from the line of Eric Caldwell from Baird. Please go ahead.

Thanks. Good morning. I am curious. When looking at backlog and bookings, you’ve always had an approach of taking written confirmations as opposed to formally contracted awards, which is a bit unique versus the rest of the group, but you’ve been clear about that. How have those ratios changed over time? When you parse the higher cancels that you’re facing today, what percent of those cancels are coming from the non-contracted bookings, the ones that don’t have formally legally bound terms and conditions in them? I’m just curious what that, again, the ratio of non-contracted in bookings and backlog, and then how that ratio has changed, and then where the cancels are coming from.

Barry Balfe, CEO, ICON plc: Eric, maybe I’ll take that, and Barry, obviously, feel free to add. I can’t really comment on what others do, frankly, in terms of how they book awards. I’ll leave you to assess that on what they do. You are right. Our practice has been to take bookings on award, rather than on contract, and the logic for that is that is closer to now, if you will, in terms of what’s happening on the ground commercially. Obviously, there is a lag from awards to signing a contract. That can be, you know, several months. It is a more real-time measure, if you will, of what’s happening in terms of commercial demand.

On your question on the trending of that over time or the pattern of awards and cancels, I think Barry touched on the point that the predominance of the cancels that we’ve seen have been in awards that haven’t yet moved to enrollment. That is a mixture of both. Frankly, I don’t have at my fingertips the mix of that between the two, but it is reflective of, again, the factors that we’ve seen and touched on over the last few quarters around cancels being elevated because of reprioritization decisions, because of, for example, in the biotech arena, funding environment and companies hoping to raise money or haven’t raised money or have been delayed and so on and reprioritizing where they spend, and likewise in large pharma. It is a mixture, frankly, and that’s what we’ve seen so far.

Conference Operator: Thank you. Your next question comes from the line of Charles Rhyee from TD Cowen. Please go ahead.

Yeah. Thanks for taking the questions. Maybe if I could follow up to Eric’s question. When you look at the backlog, and I’m sure you’ve done sort of analysis of the backlog itself, do you feel comfortable that maybe we’ve gotten through most of the potential projects that you think could get canceled? Or do you have a better sense of what the quality of the remaining backlog that you’re looking at today is? A follow-up, Barry. At the beginning, you kind of talked about good RFP flow in biotech. Any kind of additional information you can give us in terms of win rates in biotech and how your market share has changed in biotech? Has that increased here in the third quarter or in 2025 versus 2024? Maybe what you’re seeing there. Thanks.

Barry Balfe, CEO, ICON plc: An expertly managed two-parter, Charles. I’ll do my best to address both. I think on the backlog, look, as we said, there are a mix of reasons why studies cancel, whether it’s emerging clinical data from an ongoing study, whether it’s reprioritization of the portfolio, or other reasons. There are a mix of contracted and ongoing, ongoing, pre-contract, etc. There are really a mix. What I would say is that to the degree that the turmoil of the last couple of years did result in some delays and some disruption in terms of awards proceeding to contract and contract proceeding to study start, I am confident we are closer to the end of that process than the beginning. Now, who knows what normal looks like in this business?

As I said earlier, I do anticipate that we will return to more normalized levels of cancels, which I think is germane to the question that you’re asking about backlog. I’m also encouraged by the profile of the awards that are going into backlog of late. I do think there’s a much healthier association between the awards that are coming in now and in the last number of quarters than perhaps those that are coming out of backlog, or at least those that are driving us above historical norms for cancels. I’m encouraged by that for sure. In terms of biotech RFP flow, retrospective rationalization is a dangerous thing. We know biotech funding has improved somewhat. We’ve spoken repeatedly that that’s sort of a two-sided coin. There’s the level of funding, but there’s also the amount of the allocated funding that gets deployed.

I think that’s probably the under-discussed side of the argument. We do see a number of our biotech customers not just moving forward to deploy capital, but to deploy it in indications where they’re running larger studies relatively deep into the development cycle. Now, is that good for us? Yes, I think it is. Does it mean occasionally you see some larger cancels come out of that biotech organization or that biotech field? Yes, it does. I think in the main, I am optimistic and encouraged. We made a strategic priority out of seeing more of the biotech market. We are being successful in that regard. We’re looking at very significant increases in RFP flow, quarter over quarter, year over year, trailing 12 months. That’s a good thing.

We also, in balance, said that we wanted to see a significantly higher win rate in biotech, and that’s materially flat on a quarter over quarter basis. There is work to do for ICON there. In all honesty, there are areas of the biotech market where ICON was not historically as present or as focused as I want us to be and as I believe we are now. If that means we show up on other people’s radar more than we did in the past, I think that is a really good thing, and the focus of the teams will be converting that elevated RFP flow into sustained higher booking.

Conference Operator: Thank you. Your next question comes from the line of Mikhail Uiskin from Bank of America. Please go ahead.

Great. Thanks for taking the question. I love the, when the ball is small or dogs are hungry metaphor. That’s a great way of putting it. I want to sort of go back to that and maybe come at the pricing and the pass-through component from another angle. Just curious, you know, there’s obviously fluctuation from therapeutic mix, customer mix, pricing dynamics, pass-through. This all happens on a regular quarter-to-quarter basis. Anything you could say in terms of what you’re seeing now? Is it how short-term is it? Is it a little bit more cyclical, a little bit more structural? As you look forward longer term, any visibility or any comments you can make on the duration of this dynamic and when you think things could sort of normalize a little bit. Thanks.

Barry Balfe, CEO, ICON plc: I think I said on our last call, Mike, that history makes fools of us all. I’m going to be careful of prognosticating around what the pricing environment might be like a year or two or five from now. I think the important thing to note is that it’s stable, right? It is an elevated competitive market. I’ve always said, you know, good companies have great competitors, and that’s a good thing. There’s an onus on all of us to realize that drug development is too expensive and it takes too long. The over-under on more cost-effective drug development skews substantially towards better process, more effective interaction with regulators to reduce the on-risk burden on patients and on drug developers, and on the deployment of technologies to move this whole industry in the right direction. I think that will drive up net spend in the sector, actually.

I don’t think it’ll drive it down. I just think we’ll get more research done per dollar spent. I don’t want to overstate the impact of pricing per se on the cost pressures that are actually creating those pricing dynamics in the first place. It’s stable. Is it competitive? Yes. Do I think that’s a function of the upstream dynamics, be they regulatory, geopolitical, or LOE-related for our customers? I absolutely do in pharma, and likewise, funding for our biotech customers. I’ve said a few times now, we didn’t get to where we are in a heartbeat, and I don’t think we’ll get back in a heartbeat. As things begin to normalize in terms of funding, in terms of deployment of capital, in terms of a clearer regulatory and political picture, I imagine we will see things graduate back towards more normalized levels right across the sector.

I’m afraid I’m not going to throw out a number and a date for you. I think that would be a little previous.

Conference Operator: Thank you. Your next question, Steve, comes from the line of David Windley from Jefferies. Please go ahead.

Hi. Thanks for taking my questions. Best wishes to Steve and Barry for your next phases. I wanted to try to combine two of the major themes here, margins and bookings together, and ask the question, how do you balance labor force stability and the benefits of that in both productivity and also perceptions of clients of stability of their project teams and things like that with the defense of margin? I figure over multiple years, ICON has had several risks, both synergy-driven by PRA and in the market environment demand-driven. How do you balance that stability of workforce and the external perceptions that that can create? Thanks.

Barry Balfe, CEO, ICON plc: It’s a pretty broad question, David, and I think I appreciate where you’re coming from, albeit I’m not entirely sure how to answer you, to be candid. Maybe the easiest way is to say that our headcount moved by about 100 FTE over the course of the quarter, which in a 40,000-person organization isn’t substantial. I think our trailing attrition remains near historic lows, and that’s been a good number for us, pretty much in a straight line since the COVID peaks, where the whole industry saw a bit of a peak. We focus on really driving efficiency, making sure we have the right resources in the right roles, in the right locations, at the right times. That’s not so much a function of bookings, actually, as it is a function of what is required to move these studies forward.

I talked earlier on about a more algorithmic approach to resource management. Part of that is being able to spread your risk over your portfolio. You remember earlier in the year when we talked about some very large studies coming in, then going on hold, some canceling, some renewing, and then stopping. We didn’t see massive swings in the labor force. We didn’t see massive swings in the margin dynamics, and we didn’t see massive disruption of the customers on the other studies that were in the book. I think the answer is we pull all the levers that any professional service company does. We continue to invest in the best talent. I believe we have the best expertise in the industry. It’s absolutely vital to me that we sustain and improve that position. I don’t really see it as a trade-off of margin and bookings.

It’s more about making sure that we give our customers the best people and we give our people the best environment in which to be successful.

Conference Operator: Thank you. Your next question comes from the line of Dan Leonard from UBS. Please go ahead.

Hi. Thank you for taking the questions. This is Kyle on for Dan. It sounds like you expect cancellations to moderate in 2026, given your current view on the backlog. Is there a risk that elevated cancellations related to older, not yet started studies will persist throughout 2026? Separately, could you provide an update on BARDA-funded COVID-related trials that you continue to service? Thank you.

Barry Balfe, CEO, ICON plc: I’ll take the second one, Dan. I mean, I think we’ve talked about 1% to 2% COVID revenue. There’s not much of a cliff to fall off there, more of a curb.

On a full-year basis.

Yeah, I think any change there is to the upside, very honestly. In terms of cancels, I mean, no one can ever say there’s not a risk of anything happening probabilistically. I think it’s unlikely. What we think we’re seeing, at least my sense of it is, we are seeing the consequences of the last couple of years. You’ve got the confluence of a couple of issues, funding pressures, LOE driving reprioritizations, perhaps some of the science that got funded when money was cheap and abundant, not perhaps being followed through. That has, you know, put a different light on some of the studies that were planned, awarded, and in some cases, started. Am I confident that we will see a return to more normalized level of cancels in 2026? Yes, I am.

Am I willing to sign on the dotted line and say that will be linear from January 1? No, I’m not. I do think we’re closer to the ninth inning than the first, on the basis of how we interpret the backlog, on the basis of how we speak with our customers, and on the basis of the broad demand dynamics across the industry. I think that’s a reasonable assumption. How far, how fast, and how soon, I think it’s a little early to say. As we’ve said, we do consider them likely to remain elevated in quarter four.

Conference Operator: Thank you. Your next question comes from the line of Luke Sagot from Barclays. Please go ahead.

Great. Thanks for the question. I just want to talk a little bit about the burn rate and, you know, it’s been relatively stable here. Your 4Q, basically the midpoint kind of implies like a little bit of a step down there. You know, talk about the recent bookings that you’re getting, what’s coming out of the backlog, and just the visibility that these burn rates will stick around this like 8 to 8.2 level as we think about kind of modeling in the toggles for 2026.

Barry Balfe, CEO, ICON plc: Luke, it’s Barry here. I’ll start, and Nigel might want to elaborate a little bit. I would point you first to my remark that the cancels that we took during the quarter, not entirely, but they did skew disproportionately towards studies that had not yet started that were sitting in the backlog effectively at a 0% burn rate. I’d also point you to the increase in gross bookings, which in the immediate term actually are a drag on burn rate as studies take time to ramp up. I think there are some of the primary dynamics, but Nigel, you might want to expand.

Nigel Clerkin, CFO, ICON plc: Yeah. Look, I think you combat, look, again, you’re right. Obviously, we had, you know, expected burn to be approximately stable at approximately 8% through the course of the year, and that is what we have seen. In fact, it’s come in a little better than that, as you’ve noted, year to date. Let’s see exactly where we land in Q4, but in around 8% was what we anticipated and what we are seeing. Going into next year, absolutely, it’ll be a function of, you know, of course, what happens in terms of cancels as Barry Balfe touched on, and importantly, gross wins as well. Also, all the initiatives that we are driving, frankly, to enhance and improve that burn rate over time.

Look, again, that’s also, of course, one of the important components of how we frame our guidance for next year, which we will provide you more color on when we get to there.

Conference Operator: Thank you. Your next question comes from the line of Max Smart from William Blair. Please go ahead.

Good morning. It’s Christine Reinsohn from Max. Wanted to echo the congratulations to both Steve and Barry. In terms of our question, hoping you can discuss if you’re still seeing strength in early-phase work that you called out previously or if there’s been more of a shift towards late-phase work. Thanks.

Barry Balfe, CEO, ICON plc: Thanks, Christine. Appreciate your good wishes. The answer is yeah. We continue to see good activity in our early-phase business with strong growth both on a year-over-year and a sequential basis. That’s a business that’s grown at double digits on a year-over-year basis, and that’s growth that we intend to sustain and improve on.

Conference Operator: Thank you. Your next question comes from the line of Casey Woodring from JPMorgan. Please go ahead.

Great. Yeah, Steve, Barry, congratulations. Yeah. Just quickly, two quick ones. First one, any more granularity on the trial mix that drove the higher pass-throughs this quarter? Was it all cardiometabolic? Just one on the cost management side, automation has been a theme you’ve called out in the past as a margin driver. Going back to your last analyst day, you talked a lot about the advancements you’ve made there on taking man-hours out. Just curious on the progress you’ve made on that front and how much you can offset pricing pressure there via automation and AI. Thank you.

Barry Balfe, CEO, ICON plc: Christine, Casey, I’ll start on the trial mix. Certainly, that is a factor, and Barry touched on the strengths we’re seeing there in terms of opportunities and wins. Of course, you touched on the COVID study as well, or the vaccine study that was ongoing that was particularly active in the third quarter. There was a particular impact there. In general, the comments we’ve made before around pass-throughs being an increase in proportion of our revenue over a more sustained period is not so much that. It’s more around a therapeutic mix as we’ve talked about. On automation, you’re absolutely right. That is, of course, one of the levers that we lean into always in terms of driving more efficiency and is something we will continue to do.

Barry, I don’t know if there’s anything you wanted to add to that in terms of, I know you’ve touched on already, our priorities there.

Nigel Clerkin, CFO, ICON plc: I think you’ve dealt with it well. At the end of the day, Casey, our customers depend on us to take time and cost out of the development cycle and create value in that regard. We get to share in some of that value. That’s the basic premise of our partnership. When we think about cost management, there’s puts and calls there in terms of what we save and what we share. Certainly, technology is a huge part of it. I’ve talked before about the importance to me of leaning more assertively into some of these AI-enabled technologies. We just actually progressed a project to roll out an end-to-end project management workflow management system, which is a really important evolution for us to be able to bring all of the data together, put it in the hands of the PMs, and inform more rapid and accurate decision-making.

We’re obviously engaged in a range of external partnerships where these technologies allow us to recruit patients more effectively, more quickly, to manage patients both in terms of their care and the stipends that they’re paid more effectively, our clinical trial management systems with our external partners, and indeed, risk-based quality management. One of the big areas that will drive efficiency is actually in the area of agentic AI. We’ve started deploying over the course of the last year or so agents across our business to help us delegate workflow and process to these agents rather than simply information gathering via large language models, etc. One that I would call out is a proprietary technology we developed by the name of Orbus, which is effectively a multi-agent digital assistant.

If you think about multiple agents across the ICON landscape, this is the front door through which employees can go in and relate to multiple agents at the same time without needing a PhD in the organization’s digital infrastructure to access that information. Effectively, an agent of agents that allows you to run multiple analyses, source multiple different data points from multiple different agents across the system. That’s early days, but that’s exactly the kind of thing that will create and I hope capture value for the company and its customers.

Conference Operator: Thank you. We will now take our final question for today. The final question comes from the line of Rob Cottrell from Cleveland Research. Please go ahead.

Hey, good morning. Good afternoon. Thanks for taking our questions. I guess I want to dig back into the margin and potential benefit from technology investments that both Barry and Nigel, you focused on, to help offset some of the price and pass-through margin pressure. Can you just share how some of these customer conversations are developing as it relates to how you balance sharing the savings with customers versus capturing the savings to help your margins in the near term? When you expect these potential efficiency savings to begin to flow through, for you all into 2026 or 2027?

Barry Balfe, CEO, ICON plc: It’s a good question, Rob, but a multifaceted one. I guess I wouldn’t encourage you to think about it as a single day on which we start managing margin through technologies or otherwise. That’s an organic process. It’s been going on for the 20 years I’ve been here, and it’s continuing. The other thing I would point out before I get to the heart of your question is we are calling out sustained margin pressure in the immediate term. It’s not like we’re calling out massive upside in the immediate term because of a particular technology that’s going to solve all of our problems.

To your question about the customer conversation, one of the interesting things that’s cropped up, as we’re developing and in many instances co-developing these transformational technologies and capabilities with our customers, it forces us to think in the context of long-term relationships about whether our pricing and commercial arrangements now will be reflective of the situation by the time those relationships come to maturity. If you’re signing a five-year partnership 10 years ago, you probably agreed to your terms, plus or minus inflation. Now we’re very much building into those discussions. Hey, guys, here’s how efficient we believe we can be together based on the nature of that relationship. Let’s build into the governance model a forum and a format where we can recognize efficiencies as these new capabilities come on screen. That’s a big part of the attraction of working with a company like ICON.

We’re going to get incrementally more efficient with you, through you, and for you, and we want to be in a creative conversation about how we share the benefits. That co-development piece, it’s actually quite a high bar because there’s a huge level of IT and technological investments between ourselves and probably one or two others and the larger customers in the space. We are very much having conversations with them about how we will revisit commercial terms as the clinical trial paradigm gets disrupted and as we become more efficient as a company. Nigel, I don’t know if there’s anything you wanted to add there.

Nigel Clerkin, CFO, ICON plc: Yeah. No, I thank you for that line as well. Barry, Rob, I guess the only things I would add is that, as Barry just went through, that’s a clear example of the benefits of scale that, frankly, we can bring to those conversations. We are able to, you know, we have the capability of making those investments, providing that sort of longer-term perspective. Secondly, the only other thing I would add is that point of how do we share these benefits together? It’s a great question, but also is fundamental, frankly, to the philosophy and culture that you should have as a service organization, to your customers. In the end, you know, it is about delivering better service to them more effectively and more efficiently and jointly sharing in that. That is how we always have and will continue to approach these topics.

Conference Operator: Thank you. I would now like to hand the call back to Barry Balfe for closing remarks.

Nigel Clerkin, CFO, ICON plc: Thank you. Very briefly, before we close out, I would like to extend my thanks to our 40,000 dedicated employees across ICON for their continued commitment and outstanding delivery for our customers and the patients we all serve. For all of you joining us on the call today, we thank you for your support and look forward to connecting again over the course of the coming quarter. Thank you.

Conference Operator: Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.

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