ICON at Jefferies London Healthcare Conference: Strategic Shifts in Focus

On Wednesday, 19 November 2025, ICON PLC (NASDAQ:ICLR) presented at the Jefferies London Healthcare Conference 2025. The company discussed its strategic initiatives amid evolving market conditions, highlighting both opportunities and challenges. CEO Barry Balfe emphasized a shift towards value-based economics in clinical trials, while CFO Nigel Clerkin addressed pricing pressures and their impact on margins.

Key Takeaways

• ICON is experiencing an uptick in demand, with RFP flows up mid-single digits and stronger growth in biotech.
• The company plans to invest $300 million in digital innovation, particularly in AI, over the next three years.
• Pricing pressure from renewed strategic partnerships is expected to impact margins negatively next year.
• ICON is transitioning from unit-based to milestone-based contracts, aiming for efficiency and cost reduction.
• The company is broadening partnerships with top pharma companies and aiming to improve its win rate in the biotech sector.

Financial Results

• ICON reported a 5% reduction in headcount year-over-year, contributing to cost discipline.
• Last year's EBITDA margin was 21%, with an anticipated 1% drop this year, further impacted by a 50 basis point decline due to pass-through mix.
• Operating leverage was a drag on margins due to decreased revenue, but cost-cutting measures helped mitigate the impact.

Operational Updates

• Demand trends show a mid-single-digit increase in RFP flows, with biotech seeing opportunity flow up 25%-26% over the past year.
• ICON maintains partnerships with 17 or 18 of the top 20 pharma companies and aims to extend its success strategies to mid-tier companies.
• The company is focusing on value-based solutions and efficiency gains beyond traditional FTE-driven models.

Future Outlook

• ICON is preparing for margin pressures due to pricing from renewed partnerships and the increasing proportion of pass-through revenue.
• The company is optimistic about improving demand, which may lead to positive operating leverage in the future.
• Strategic goals include deepening partnerships with top pharma companies and enhancing collaboration with mid-sized firms.

Q&A Highlights

• Pricing pressures in the CRO domain are influenced by constraints in the pharma sector, with ICON focusing on reducing overall development costs.
• The company aims to provide strategic value in FSP arrangements by emphasizing efficiency and cost savings.
• Competitors like IQVIA and Thermo Fisher Scientific are redefining the clinical CRO landscape, prompting ICON to diversify into lab services and real-world evidence.

Readers are encouraged to refer to the full transcript for a detailed understanding of ICON's strategic discussions and future plans.

Full transcript - Jefferies London Healthcare Conference 2025:

Dave Wendley, Equity Research, Jefferies: Okay. All right. Good morning, everybody. Hope you're well. Hope you got a good night's sleep. Maybe go out, drink a few glasses of wine, hit the pillow. Appreciate your attendance here at Jefferies London Healthcare Conference. I'm Dave Wendley. I'm based in the States in equity research. I'll tell this tired joke again, but I've covered CROs for a long time and ICONs since way back in the 1900s. The management team has heard me say that too many times. I'll have to come up with something new next year. Very gratified to have the ICON management team here with us. Barry Balfe, who's recently assumed the CEO role in the late summer, early fall. And Nigel Clerkin, the CFO, who also is relatively new to the management team, but comparatively long in the seat to Barry's CEO role for just a few months.

Thanks so much for having us or for being here with us, I mean to say. Let me just get you started off with questions on demand. We've talked about in our breakfast this morning and kind of an improving RFP flow environment and gross bookings progression through the year. Maybe you can comment on what you see as the drivers of that, the sources of that, and the kind of sustainability of that.

Barry Balfe, CEO, ICON: Thanks, Dave. Thanks for hosting us. Thank you all for joining. I suppose the first thing to say is that had we been having this conversation a year ago, we would have been talking about whether a demand uptick was on the wind. Were we having it in quarter one, we perhaps had some suspicions that a demand uptick was in the wind. Thankfully, the quarter two and quarter three data, and certainly, we haven't called quarter four, or what I've seen quarter to date in quarter four, would suggest that we are in a period of inflection. RFP flows are up across the book, at least mid-single digits, stronger than that in biotech, for sure. Of course, there are questions about sustainability, et cetera.

If you put up there sustained increase in RFP flow, outstanding win rates in pharma, flattish win rates in biotech, which I think we can build on, it certainly feels like we are at that point of inflection, or at least going through a point of inflection, which is positive, as you say. As to why, I think the same factors we talked about a year ago in hypothesizing around a recovery, I don't know what the cure is for loss of exclusivity other than timely, efficient development. If you're pharma, yes, there were external pressures, macroeconomic, geopolitical pressures, which have all abated to a certain degree, I think. We joked, I think, a year ago about the four stages of grief around panic, pause, a little bit of pondering, and then some positive action.

I think we've started to see balance sheets put to work in large pharma. I think we've started to see deal flow tick up, which is certainly positive. We've started to see what I believe is a normalizing of this environment that was characterized by unusually high levels of pipeline reprioritization. That's broadly where we see it in pharma. In biotech, we talked not only about the relative constraint of the funding environment over the last number of years, but also a lag between raising funds such as they were raised and actually deploying them. I think on both of those metrics, we've also seen a softening of the environment in recent quarters. Yes, the last couple of months of funding data are encouraging, but we do see biotechs putting the capital they've raised to work more assertively.

I think that's interesting and broadly positive for the sector, for the industry, and for patients. Of course, the forgotten sibling in the middle, those sort of mid-sized companies, there's been quite a lot of activity in there, both in terms of licensing and in terms of trial starts. There's certainly a real bolus of attractive opportunity to be shot at in that mid-tier as well, Dave.

Dave Wendley, Equity Research, Jefferies: Maybe while we're on that demand trend, we talked a little bit about pricing. There's an element of, well, first of all, I should allow you to level set on when we talk about price, it's perhaps not as direct as labor unit rates, but rather design of trial and how do we create more efficiency and perhaps brevity in the protocol and things like that. You've been through a cycle of pricing in the 2023, 2024 timeframe that may be rolling through revenue today. I'd ask you to comment on that a little bit. Also, as demand is improving, is that price pressure abating? Is the pricing environment firming a little bit?

Barry Balfe, CEO, ICON: I'm grateful for the clarification, actually. I think I've been giving that lecture for a couple of years, so it's nice to hear it come back.

Dave Wendley, Equity Research, Jefferies: I learn. It takes me a while, but I learn.

Barry Balfe, CEO, ICON: We'll come back to that. If I may, though, I might start upstream on pricing. I mean, any pricing pressure in the CRO domain is derived from pricing pressure to one degree or another in the pharma domain. I think it's been interesting that the politics around drug pricing have started to clarify and perhaps depoliticize to a degree in recent months. I think that's a positive. I said this morning over breakfast, the sooner we get drug development off the front pages and back into the business pages, the better, both for us as an industry and for patients in need of new therapeutics. I think that's a positive. Certainly in the U.S., that's something that we see as having at least reached something more normal in terms of the environment. Hopefully, that is something we'll see trickle through.

As regards pricing in the CRO domain, you're right. I do always say that the cost of a clinical trial, the over/under on the cost of a development program is far more related to design, to strategy, to clinical development now than it is to the rate per hour, rate per unit that a CRO is charging. It is also true that there has been pricing pressure in the sector. No surprise. Biotechs in a funding-constrained environment, pharma in an environment where top and bottom lines were under pressure. We certainly saw a period of extensive, in fact, unprecedented, renewing, refreshing, and rebidding of preferred provider ships in large pharma. I can't name you off the top of my head a top 20 pharma that didn't renew relationships over the course of 2023 and into 2024.

When you think about these largely as five-year partnerships, some of those partnerships were one year into a five-year term when they sought to re-up exactly to address the kind of pricing dynamics you're talking about. The reason I like your intro is that takes time to bleed in. If you renew a partnership in 2024, that's setting the terms or renewing or refreshing the terms for a five-year alliance. That will obviously start to bleed into awards in that partnership over time. We did see some increased competitiveness around pricing, for sure. Ultimately, we're all aligned, I think, across the sector that drug development is too expensive. It takes too long. It has too much risk and too little certainty associated with it. I'm fine with the challenge of taking time, cost, and risk out of drug development. That's, frankly, the only reason we exist.

I think what we're starting to see is a reversion to value-based economics. Rather than haggling over the last 10 cents per hour on the cost of a project manager, let's go and talk about whether or not we can take 20% out of a $1 billion development program. This is where CROs like ICON exist. It's why we exist. Actually, when you think about it, traditionally, people say that's more in the full service, the project outsourcing space. If I say FSO, that's what I mean. Truthfully, in the FSP space, it's exactly the same. I was with some bankers yesterday morning, and they were talking about 10 of the top 20 CEOs in pharma, giving them feedback that their management teams wanted to double down on internal development augmented by FSP, but they couldn't see the ROI.

Now, as someone who's been in the FSP business for 25 years, I think that's actually a really healthy conversation. Because the best FSP partnerships are those where we partner with a company to say, "What are you good at? Can we help you optimize it? Can we augment you with headcount? What are you not good at? Can you devolve some responsibility to us in a functional outsourcing model rather than a, quote, staffing model where we can actually make a difference?" Dave, I think you and I spoke before about an example where a top 5, top 10 pharma who was already in an FSP model, we could look at them and say, "Your clinical development group is about 30% less efficient than it should be.

I will underwrite the first 20. I think sometimes there's a myth out there that FSP opportunities don't give the CROs the opportunity to drive efficiency. I reject that totally. I think there's a real opportunity across the spectrum, FSO and FSP, to move beyond cents on the dollar in terms of the rate you're charging and really start underwriting value-based gains, whether that's time, whether that's efficiency, whether that's overarching spend. The over/under on that is orders of magnitude greater than any margin-based or pricing-based conversation we're going to have.

Dave Wendley, Equity Research, Jefferies: It's very interesting because you abbreviated a question I was going to ask, and I'm glad you did. Can we double-click on that FSP comment to understand better? I mean, it is my understanding that a lot of FSP arrangements are FTE-driven and therefore an FTE times a rate driven. I'm also aware that there are delivery-based, be it data tables, biostats, things like that. How would you frame our thinking about an FSP arrangement that would still allow you to bring, as you kind of alluded, but still allow you to bring value proposition from more of a strategic sense to the client?

Barry Balfe, CEO, ICON: At the risk of geeking out operationally too much, I'll try and simplify. If you think about, I mean, let's go back to the example I mentioned. There's a pharma that's running a largely in-house clinical development model augmented by a couple of thousand people in an FSP model. And I'm talking about clinical monitoring and project management at the moment. Out in the world, in the countries, running and monitoring the sites with the investigators. If you just layer more people on top of bad process, it doesn't really matter if they're your people or my people. It's bad process. When we took a look at it, it was one of those great opportunities where there was no RFP, actually.

There was just an outreach to say, "We think you're spending too much money on the wrong roles in the wrong places doing the wrong things." We made an offer. We actually started one region at a time, right? We started with North and South America. We went in and said, "We are willing to underwrite that we can do that quantum of clinical oversight and monitoring for at least 20% less than you can in the aggregate. Don't ask me to do one study. Functional resourcing is function by function, not trial by trial." We could separate and stratify the roles. If you've got senior people doing junior things, that's inefficient. If you've got people doing things in Los Angeles that could be done in a lower-cost market, that's inefficient. If you've got people doing things manually that could be done on a more automated basis, that's inefficient.

The key to answering your question, Dave, is saying we require some delegation of responsibility in order to underwrite the savings. If we go to you and say, "We can take 20% out, so it's not about me earning less, it's about you spending less, but I want control over the resourcing algorithms. I want to be able to stratify the roles that these guys do study startup all the time. They're specialized, they're standardized, they're centralized, and they're good at it.

Now let's free up the clinical monitors in the field to work with these investigators to help monitor what's going on at sites. Ultimately, you're getting to a place where you're saying, "I'll underwrite the first X %, but I want a share of the remaining Y % of the savings." True to form, two or three years later, they come back and you're talking to a procurement person who wants to erode your share of those gains, right? That's the game. Our job is to continually reinvent the clinical trial paradigm. Increasingly, that's about technological disruption. There's not a single pharma company out there who can afford to dip their toe in all of the pools of digital disruption and innovation. Part of our job, and we'll deploy perhaps $300 million over the next three years around disruptive digital innovation, mostly in the AI space.

It's our job not just to deploy new capabilities, but to co-develop new capabilities, to share risk across development portfolios worth billions of dollars in pharma so that we can co-develop and share in the upside, spread the risk. Consequently, for our biotech customers, we've got best-in-class capabilities that have been developed elsewhere that can then be deployed on a bespoke basis. These are the kind of synergies you see between the FSO and FSP and also between the biotech and the pharma landscape. I think what we're talking about is a higher bar to playing at the cutting edge of drug development, and it's somewhere where we're very pleased to invest.

Dave Wendley, Equity Research, Jefferies: This is just a we could just peel and peel and peel. In these FSP relationships, I guess the first question I would ask as follow-up to that is, you've given us this very interesting, compelling example. To what extent have you been able to proliferate that?

Barry Balfe, CEO, ICON: You know, I think one of the problems someone said to me years ago that A Brief History of Time, the Stephen Hawking book, was the book that everybody had on their shelf, but few had read and no one had understood. I think there's a bit of that around FSP. Too much of this market has been based on, "It's fashionable. Let's internalize. Let's rent bodies on a capacity management basis rather than truly on a functional outsourcing basis." So FSP is not a controlled term. And I could give you the good, the bad, and the ugly of the market.

I think the people who are winning in FSP models, the people whose successes have driven others to experiment with the model, are those companies who have partnered well to understand where they have core competency internally, the systems, the process, the people, the oversight, to say, "You know what? We're going to do 60% of the clinical or whatever function biostats may be. We're going to do 60% ourselves and then augment with an FSP partner for flexing with demand," versus those who say, "They did that and it worked. Let's insource all these people, but we're not sure how to develop them well." The short answer to your question is, I think there's too much poorly informed capacity management model out there where we're haggling over the price per FTE without really having value-based discussions.

If you ask me what's the biggest change between the last two years and the last six months, I think it's that people have seen there's been limited ROI on penny pinching on the rate. Now we're starting to get back to, "Okay, my CFO wants to know why that didn't work. Can you move the needle at least double digits in the near term and orders of magnitude of that over time when we think about some of these disruptive technologies?" All of a sudden, we're back to a little more like 2015 through 2019, where we're talking about innovative, customized, hybrid sourcing, where pharma are doing something in-house, something insourced, and something outsourced, and we optimize at the interface. That's sort of how I'd characterize it.

Dave Wendley, Equity Research, Jefferies: I want to another question on this is, you're describing a, say, a 30% in this example, a 30% spread on their inefficiency and your willingness to essentially take some risk on the first 20, underwrite the first 20. I want to give you the opportunity to explain that a little bit and, one, ensure that people understand, like, you're not taking equity risk in the molecule, things like that. But from an operational standpoint, it does sound like you are effectively taking a little bit of margin risk. We talked about pricing pressure. In thinking about the cadence of taking that, like, for example, you underwrite that 20%, can you take that cost out pretty quickly?

As you ramp up that relationship with the client, you're driving that efficiency over time, and therefore there is a little pressure in the early part of the assumption of that relationship?

Barry Balfe, CEO, ICON: I think it's a really good question. I mean, the example I gave you went from zero to $350 million-$370 million in two years, right? That's not a room you walk into blindly. You don't take on a deal like that walking into a room you don't know how to walk out of. The reality is we're able to look at the metrics and say, "Why are you getting two to three, three and a half units of output per clinical monitor per month, and I'm getting nine and a half?" It's because of how you're structured. It's because of how you're managing. It's because of your data flow. It's because of role stratification. The terms and conditions that go with underwriting a deal like that are pretty explicit. They're simple, but they're pretty explicit. We're talking largely in the large pharma space now.

We can talk differently about how it manifests in biotech. One of the challenges in companies as large and as complex as these pharma companies is that they have traditionally, at least in my 25 years of doing this, really struggled to measure true internal cost allocation, where it went, and what the cost per output was. Everybody knows the cost per input, but what was the cost per unit monitoring, per unit stats deliverable, per unit medical writing? I think when you look from the outside in, we're better able to do that and to support that. One of the corollaries of that, though, is that where, frankly, for a long time, but certainly three years ago, we were still seeing a lot of these bonus penalty clauses in these contracts. If you overperform, we will give you 5% more.

If you underperform, we will give you 5% less. Now, I'm happy to do those. The truth is, if we get punished a 5% penalty for being late, I think I said it yesterday in a meeting here, that's the worst money pharma will ever save, right? There is absolutely no incentive or upside to them in me earning 5% less on a trial that's now delayed two years and it's going to cost them orders of magnitude of that cost. So much more of what we see now is, "Let's take those dollars that we were willing to put at risk and let's go invest them in something that might bring this thing in early." Another interesting trend in the full-service outsourcing space is that even two and a half years ago, we were probably 60% unit-based contracts.

You got paid X for every unit of work you did. That 60/40 has completely flipped towards milestone-based contracts. You get paid when the work is done. If you did it more efficiently, we're happy for you to share in that benefit. If you undercalled the amount of work that was required, that's going to cost you money, CRO. It's not going to cost me money in pharma. I'm really happy to play in that space because if we can get away from a sort of procurement-led model that's about value destruction and get back towards a co-invested model that's about value creation, I think there's real incentives for partnerships. Actually, it's really interesting. A lot of the biotechs are leading the way.

A biotech CEO or head of R&D does not care if we manage to bring their trial in six months early and share in the upside. There is no natural large corporate function whose job it is to eliminate profitability in the sector. They are just delighted that we are able to do it faster, more cost-effectively, and with a higher probability of success. A lot of pharma talk about moving back towards biotech-type thinking and agility. This is one of the areas where we have seen some traction. We are certainly not declaring victory there.

Dave Wendley, Equity Research, Jefferies: We've explored a lot of this as more large pharma. I think one of your other goals is to try to extend your success, your strategies in top 20 or top 25 into the next, pick a number, 20, 40, 60 in what we might call the mid-tier. Maybe talk about the traction, the conversations that you're having and where you think the opportunity is.

Barry Balfe, CEO, ICON: Sure, happy to. I mean, maybe to put it in some context, we've gone from partnerships with 13 of the top 20 to 17 or 18 of the top 20. I think we're working with all of them, but strategic alliance partnerships with 17 or 18 of the top 20, that's good. We need to broaden and deepen in that space. We've said we need to partner with more of the biotechs, and we've probably seen opportunity flow up 25%-26% over the last year or so. That's positive. We just need to work on our win rate in that space, which is broadly flat, I think, over the last four or five quarters. That's an opportunity.

The data I look at, and it's all dirty data, actually says that ICON's share of wallet is lower in companies 20-60 by R&D spend than it is either in the top 20 or in biotech. I've been saying for some time that a priority for me and a priority for the company is to partner better in that space. These are really interesting companies. I mean, the upper reaches of that 20-60 bracket, these are companies of real scale, really innovative science in the space, a lot of licensing activity going on. We, frankly, need to do better as an organization. We've had a number of really interesting wins there, but two or three incremental partnerships in that space, they're obviously not as large as the top 20. I want to see 12 and 13.

I'd certainly like to see four to six over the next 18 months. We are pretty pleased with the progress we're making in that space, but I would call it out as an area where we can and must do better.

Dave Wendley, Equity Research, Jefferies: I'm going to try to incorporate a Nigel question here so he doesn't fall asleep. We've talked about pricing pressure, the cycle of reprocurements in 2023 and 2024, and then the lag of that to awards, to study starts. The revenue and the P&L feels it at a lag. We talked a little bit over breakfast at some of the factors that have, I think, prompted you guys to begin to message a little bit of margin trajectory out into next year. Talk us through those factors, please.

Nigel Clerkin, CFO, ICON: Yeah, sure, Dave. Look, let me start with this year, actually. If you think about the factors that impact our margins at a higher level, first of all, you have operating leverage. Obviously, that's been a drag on margins this year, given our revenues decreased versus last year, expected to decrease versus last year. Second is pricing, to your point. We obviously have seen a lot of those large strategic partnerships be renewed over the last couple of years, as Mari touched on. We're starting to see the awards under those partnerships now flow into revenue next year. That will obviously be a negative impact on our margins going through into next year.

Probably a bigger factor, and we've touched on this in our Q3 call commentary in particular, is we obviously, and we're not alone in this, but we have seen an increasing proportion of pass-throughs as a composition of the overall mix of our revenue. That's driven in part by, obviously, the increased complexity of studies more generally, and then therapeutic area mix as well, as we've seen that sort of further strengthen that mix shift impact. That certainly also will be a factor as we move into next year as well. Now, going the other direction, we have and will continue to mitigate those issues with continued cost discipline, frankly, and continued focus on efficiency. You've seen that, for example, in this year. When you look at our headcount at the end of Q3 versus year-end last year, it's about 5% lower.

In part, that's reflecting, obviously, our response to the current lower demand environment, but also as well, the efficiency gains that we've been making through good use of technology, as Barry touched on. Obviously, we're a little bit early in terms of guiding for next year, Dave, but we did feel it was important to sort of frame out for people the puts and pulls that are there. There is, as we talked about as well, obviously, a lag effect too between when you start to see an uptick in the commercial demand environment and when that starts to flow into the P&L. It is encouraging for us, obviously, that we've seen two quarters now of good gross wins, and we've seen a good uptick in RFP flow in Q3. We've talked about that as well. Obviously, it's too early to talk about Q4.

We'll report on Q4 when we do. Look, if we continue to see that demand environment be supportive and getting to a sustained pattern of gross wins continuing, there is obviously a lag from wins, from awards through to starting activity. As you know, if that starts to flow through, you should, somewhere down the line from here, get back to a place of, obviously, operating leverage has been negative to us in this current year. As that demand environment continues to improve, you should get back to a place where operating leverage turns to be a tailwind rather than a headwind. Yeah, 2026, there are certainly, there will be a bit of an uptick in the pricing dynamic for the reasons we talked about, and pass-through mix continues to evolve. We will continue to mitigate that as best we can.

If we see the demand environment come back longer term, that should be supportive to ultimately margins expanding again.

Dave Wendley, Equity Research, Jefferies: Nigel, you talked us through over breakfast, the start of the year anticipated about 100 basis points of margin pressure, I think largely on revenue being down and the deleveraging effect of that. Then over the course of the year, pass-throughs have outpaced the expectations. The mix issue of pass-throughs added another 50 basis points or so to the margin delta.

Nigel Clerkin, CFO, ICON: In this current year, Dave.

Dave Wendley, Equity Research, Jefferies: In the current year.

Nigel Clerkin, CFO, ICON: Yeah, exactly. Look, last year, obviously, our EBITDA margin was 21%. At the start of the year, we anticipated that would be about 1% lower, reflecting negative operating leverage offset by this sort of efficiency actions we were taking. That has evolved as we've gone through the years. Now, when you look at our updated guidance, we would expect it to be about another 50 basis points roughly lower again, mainly driven by the pass-through mix impact.

Dave Wendley, Equity Research, Jefferies: Is that, given the continuation of factors and the lag that you talked about, the uptick in demand, but that will take a little bit of time to get to the P&L, is that order of magnitude of margin pressure something that we should be thinking repeats itself?

Nigel Clerkin, CFO, ICON: I think it's too early, Dave. I mean, we're obviously not guiding today. Look, it's a useful framework in terms of what we saw as we went through this year and just to give some sense of magnitude. That said, it is too early. We'll obviously give you a better perspective on that when we get to guide for next year.

Dave Wendley, Equity Research, Jefferies: All right. I'm going to cheat. My 25 years of tenure gives me this latitude, I believe. So I'm going to ask you one more.

Nigel Clerkin, CFO, ICON: Sure.

Dave Wendley, Equity Research, Jefferies: Competitively, strategically, your top peers in the space are looking a little different. I'm thinking about IQVIA has competed in the commercial space as well as CRO, Thermo PPD goes to market with a DMO CRO, now acquiring Clario. Is the definition of a clinical CRO changing?

Barry Balfe, CEO, ICON: I think it's always been changing. I mean, when I look at ICON and how diversified a business it is compared to the business I joined 20 plus years ago, you've clearly said something really exciting, Dave. We're getting a lot of extra people in the room. I think it's massively different. When I think about the opportunities for us to continue to expand in the lab space, which is doing really well in the early development phase one and bioanalytical space, which is growing very nicely. When I think about real-world evidence, the co-work that we do, I think the definition of clinical partners and CROs in the main has broadened to the point where we're really looking at relatively diversified life sciences companies. I think that's a trend we may see continue.

Dave Wendley, Equity Research, Jefferies: All right. I think we better yield the floor to our friends at GSK. So thank you.

Barry Balfe, CEO, ICON: Thank you.

Nigel Clerkin, CFO, ICON: Thank you.

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