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

All right. Good morning, everybody. Hope you're well. Hope you got a good night sleep. Maybe go out and drink a few glasses of wine, hit the pillow. Appreciate your attendance here at Jefferies London Healthcare Conference. I'm Dave Windley. I'm based in the States and equity research. I'll tell this tired joke again, but I've covered CROs for a long time in ICON since way back in the 1900s. So 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.

So thanks so much for having us -- or for being here with us, I mean to say. And 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?

Thanks, Dave, and thanks for hosting us. And 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 1, we perhaps had some suspicions that a demand uptick was in the wind. And thankfully, the quarter 2 and quarter 3 data and certainly, while we haven't called quarter 4, what I've seen quarter-to-date in quarter 4 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. And of course, there are questions about sustainability, et cetera. But 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. So if you're pharma, yes, there were external pressures, macroeconomic, geopolitical pressures, which have all abated to a certain degree, I think. But we joked, I think, a year ago about the 4 stages of grief around panic, pause, a little bit of pondering and then some positive actions. So 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. And we've started to see what I believe is a normalizing of this environment that was characterized by unusually high levels of pipeline reprioritization. So 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. And 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. And again, I think that's interesting and broadly positive for the sector, for the industry and for patients. And of course, the forgotten sibling in the middle, those sort of midsized companies, there's been quite a lot of activity in there, both in terms of licensing and in terms of trial starts. So there's certainly a real bolus of attractive opportunity to be shot at in that mid-tier as well.

Maybe while we're on that demand trend, we've 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. But you've been through a cycle of pricing in the '23, '24 time frame that may be rolling through revenue today. I'd ask you to comment on that a little bit. But then also as demand is improving, is that price pressure abating? Is the pricing environment firming a little bit?

So 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.

I learned. It takes me a while, but I've learned.

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. And 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. So 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. And hopefully, that is something we'll see trickle through. As regards to 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 standardized to the rate per hour or rate per unit that a CRO is charging. But it's 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 are under pressure. We certainly saw a period of extensive, in fact, unprecedented renewing, refreshing and rebidding of preferred providerships 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 '23 and into '24. When you think about these largely as 5-year partnerships, some of those partnerships were 1 year into a 5-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. So if you renew a partnership in 2024, that's setting the terms or renewing or refreshing the terms for a 5-year alliance, that will obviously start to bleed into awards in that partnership over time. So we did see some increased competitiveness around pricing for sure. But ultimately, we're all aligned, I think, across the sector that drug development is too expensive. It takes too long. There's too much risk and too little certainty associated with it. So 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 $0.10 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. And 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. But 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 "staffing model where we can actually make a difference. And 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, and we'll underwrite the first 20. So I think sometimes there's a myth out there that FSP opportunities don't give the CROs the opportunity to drive efficiency, and 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. And the over-under on that is orders of magnitude greater than any margin-based or pricing-based conversation we're going to have.

It's very interesting because you created the question I was going to ask, and I'm glad you did. But 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, but 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?

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. So 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. So when we took a look at it, and 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. And we made an offer, and 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 L.A. 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. And 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 start-up all the time. They're specialized, they're standardized, they're centralized and they're good at it. And 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 percent, but I want a share of the remaining Y percent of the savings. Now true to form, 2 or 3 years later, they come back and you're talking to a procurement person who wants to erode your share of those gains, right? But 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. So part of our job, and we'll deploy perhaps $300 million over the next 3 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 codevelop and share in the upside, spread the risk. And 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.

So this is just -- we could just peel and peel and peel. So in these FSP relationships, I guess the first question I would ask as a follow-up to that is, you've given us this very interesting compelling example. How -- to what extent have you been able to proliferate that?

I think one of the -- 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 biostat may be. We're going to do 60% ourselves and then augment with an FSP partner for flexing with demand versus those who say, well, they did that and it works, let's in-source 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 2 years and the last 6 months, I think it's that people have seen there's been limited ROI on penny pinching on the rate. And 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. And 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 in-sourced and something outsourced, and we optimize at the interface. That's sort of how I'd characterize it.

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 this -- 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, and we talked about pricing pressure. And so in thinking about the cadence of taking that -- like, for example, you underwrite that 20%, can you take that cost out pretty quickly? Or 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.

I think it's a really good question. I mean the example I gave you went from 0 to $350 million, $370 million in 2 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 2 to 3, 3.5 units of output per clinical monitor per month, and I'm getting 9.5. 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. And 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, and 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. And 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 well, frankly, for a long time, but certainly 3 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. But 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's absolutely no incentive or upside to them in me earning 5% less on a trial that's now delayed 2 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 co-invest them in something that might bring this thing in early. Another interesting trend in the full service outsourcing space is that even 2.5 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 undercall 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, then I think there's real incentives for partnerships. And 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 the trial in 6 months early and share in the upside. There's no natural large corporate function whose job it is to eliminate profitability in the sector. They're just delighted that we're able to do it faster, more cost effectively and with a higher probability of success. So a lot of pharma talk about moving back towards biotech type thinking and agility, and this is one of the areas where we've seen some traction. We're certainly not declaring victory there.

We've explored a lot of this is 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?

So 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. So that's positive. And we just need to work on our win rate in that space, which is broadly flat, I think, over the last 4 or 5 quarters. So that's an opportunity. But the data I look at, and it's all dirty data, actually says that ICON's share of wallet is lower in companies 20 through 60 by R&D spend than it is either in the top 20 or in biotech. So 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. And these are really interesting companies. I mean, the upper reaches of that 20 to 60 bracket, these are companies of real scale, really innovative science in the space, a lot of licensing activity going on. And we frankly need to do better as an organization. So we've had a number of really interesting wins there, but 2 or 3 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 4 to 6 over the next 18 months. So we're 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.

So I'm going to try to incorporate, Nigel, a question here so he doesn't fall asleep. We've talked about pricing pressure the cycle of reprocurements in '23 and '24 and then the lag of that to awards to study starts. And so the revenue and the P&L feels it at a lag. So we talked a little bit over breakfast that 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.

Yes. Sure, Dave. So look, let me start with this year, actually. So 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 Barry touched on. And we're starting to see the awards onto those partnerships now flow into revenue next year. So 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. And 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. So 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. So 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, there is 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. So what is encouraging for us, obviously, that we've seen 2 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 in Q4 when we do. But 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. But as you -- if that starts to flow through, well, then you should somewhere down the line from here, get back to a place of -- obviously, operating leverage has been negatives to us in this current year. But 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. So yes, 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. And then longer term, if we see the demand environment come back, that should be supportive to ultimately margins expanding again.

So 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. And then over the course of the year, pass-throughs have outpaced the expectations. So the mix issue of pass-throughs added another 50 basis points or so to the margin delta.

In this current year.

In the current year.

So yes, exactly. So look, last year, obviously, our EBITDA margin was 21%. And at the start of the year, we anticipated that would be about 1% lower, reflecting negative operating leverage offset by the sort of efficiency actions we were taking. That has evolved as we gone through the year. So now when you look at our updated guidance, we would expect it to be about another 50% -- 50 basis points roughly lower again, mainly driven by the pass-through mix impact.

And 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?

I think it's too early, Dave. I mean we're obviously not guiding today. So 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. But that said, it is too early. We'll obviously give you a better perspective on that when we get to guide for next year.

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. Competitively, strategically, your top peers in the space are looking a little different. And 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?

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 going to 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 I and bioanalytical space, which is growing very nicely. When I think about real-world evidence, the [ colo ] 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. And I think that's a trend we may see continue.

All right. I think we better yield the floor to our friends at GSK. So...

Thank you.

Thank you.