ICON plc

Good day and thank you for joining us on this call covering the quarter ended June 30th, 2024. Also on the call today, we have our CEO, Dr. Steve Cutler, our CFO, Brendan Brennan, and Senior Vice President of Corporate and Commercial Finance, Emer Lyons. 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 23, 2024. This presentation includes selected non-GAAP financial measures, which Steve and Brendan will be referencing in their prepared remarks. For a presentation of the most directly comparable GAAP financial measures, please refer to the press release section titled Condensed Consolidated Statements of Operations. While non-GAAP financial measures are not superior to or substitute for the comparable GAAP measures, we believe certain non-GAAP information is more useful to investors for historical comparison purposes. Included in the press release and the earnings slides, you will note a reconciliation of non-GAAP measures. Adjusted EBITDA, adjusted net income, and adjusted diluted earnings per share exclude stock compensation expense restructuring costs, foreign currency gains and losses, amortization and transaction-related and integration-related costs, and their respective tax benefits. 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 CEO, Dr. Steve Cutler.

Thank you, Kate, and good day, everyone. Icon's results in quarter two continued our positive year-to-date trajectory of growth marked by solid financial performance and further success in securing new business across our segments. Net business wins and backlog grew by 7% and 10% respectively year-over-year as our leading scaled offering continues to resonate with our customers, uniquely positioning Icon to meet increasing demand for innovative, and flexible solutions in clinical development. We remain encouraged by the leading indicators in our market that support a solid demand environment, including continued growth in RFP flow and the overall consistent level of opportunities we are seeing across our customer segments. While biotech funding levels attenuated slightly in quarter two from a robust start in quarter one, we see this market continuing to stabilize and have seen a modest uptick in RFPs on a trailing 12-month and sequential basis within this segment. Importantly, customer sentiment appears to be improving and we remain optimistic around the contribution to mid-term growth this important customer segment represents. In the large pharma segment, we see continued opportunity to win and expand our support of the many customers seeking novel solutions. While macro challenges and budget uncertainties remain a factor at the forefront in their overall spending decisions, we have seen continued prioritization around the development of late stage clinical pipeline assets to advance drugs to market. We believe this provides a certain degree of stabilization to the demand patterns in this area of the market that have largely been steady through more volatile macroeconomic periods in recent years. Our offering in large pharma is particularly well placed to serve customers seeking flexible blended solutions encompassing both full service and functional elements of delivery with our proven agility and scalability in both service areas. One of the key strategic initiatives we laid out at our investor day in May was extending our leadership in the large pharma market through our blended solutions offering. and our differentiated ability to customize a model for customers. This increasingly important approach was critical to our success in securing another new strategic partnership with a rapidly growing top 30 pharma company for full service solutions in quarter two. We were selected for this partnership due to our ability to partner with this customer in creating a tailored operational solution that was optimized to fit their evolving needs. Our deep understanding of various outsourcing models and the ability to pivot between them was a key differentiating point for ICON, as well as our portfolio of integrated peri-clinical services that will create value in areas such as site and patient solutions and laboratory services. This reinforces our recent success in building partnerships outside of our top-tier customers, creating a well-diversified and balanced portfolio that is not overly concentrated to a particular customer or therapeutic area. Specifically, in the first half of this year, we were able to grow revenue outside our top five customers by over 8%, illustrating the success we are having in executing our portfolio and developing our top tier customers of the future. As we continue to grow and scale our company, we remain focused on leveraging the unique blend of experience and capability we have in not only winning, but executing and expanding large-scale strategic partnerships that create strong value for both our customers and ICOM. While our perspective on this year's demand environment has remained consistent, we did receive an update late in the quarter pertaining specifically to next-generation COVID vaccine trials that will cause an impact to our full-year revenue in 2024 due to the delayed start of these studies. There were two primary but separate issues that affected the start of these trials. One was a delay in sponsors receiving regulatory guidance that was required before commencing trial enrolment pertaining to new variant specifications, and the second was investigational product related issues that caused a delay in enrolment. We are working closely with our development partners to ensure efficient and timely execution of these high priority studies that continue to be of critical importance to our customers and the safety and health of our communities. To be clear, these studies have not been cancelled and our expectation is that these trials will enrol the majority of patients in 2025 with startup-related activities having already commenced in some instances. With these anticipated changes, we now expect our COVID-related revenue to be approximately 1.5% to 2% of total revenue for the full year in 2024, representing a year-over-year headwind of approximately 200 basis points to total revenue. While we're disappointed by these unanticipated one-off project delays, these do happen in our industry, and they are limited to one specific area within our business. We remain confident in the strength and delivery of our underlying service offering, as well as the benefits of a diversified mix of customers and therapeutic areas that constitute our entire portfolio. Our business performance excluding COVID has been very solid, with revenue growing 8% year-to-date, over the first half of 2023 and is helping to offset some of the negative headwind we are now expecting from both foreign exchange and the COVID-specific study delays. To that end, given the excellent margin delivery year-to-date through strong project execution and cost control across the business, as well as further leverage of our global business services model, we are increasing our full-year adjusted EBITDA margin expectation to 21.7%. at the midpoint of our range, an increase of 80 basis points on a year-over-year basis. This outperformance, coupled with expected savings on full-year interest expense, is supporting the increase of our full-year adjusted earnings per share guidance, which we now expect to be in the range of $15 to $15.20, an increase of 17.3% to 18.8% over the full year 2023. With the consistent trends in our broader demand environment, our expectation on book-to-bill remain in the range of 1.2 to 1.3 times on a quarterly basis, maintaining our previous target range. Turning to financial performance in quarter two, net bookings grew 7% on a year-over-year basis, resulting in a book-to-bill of 1.2 times in the quarter and sustaining our trailing 12-month book-to-bill ratio of 1.24 times. We again saw a strong performance in our large pharma business, particularly in full service solutions, as well as for operational delivery services in data sciences, which notably secured a new sole provider award in the quarter. Total revenue increased 5.3% on a constant currency year-over-year basis in the quarter. Gross margin of 29.9% increased 30 basis points over quarter two 2023, and total SG&A expense decreased 40 basis points on a year-over-year basis to 8.7% of total revenue, driving another quarter of strong adjusted EBITDA growth of 9% over Q2 2023. This resulted in an adjusted EBITDA margin of 21.2% in the quarter, up 70 basis points year-on-year. With strong margin delivery through our P&L, in addition to the benefits of our debt refinancing, we saw excellent year-over-year growth in adjusted earnings per share of approximately 21%. Following the successful repricing of our existing term loan B facility earlier this year, we continued our strategy of further refinancing our variable debt in quarter two. We completed our inaugural SEC bond offering total $2 billion in early May, which was met with very strong investor interest and initial order book of circa $15 billion. The proceeds of this offering were allocated to the repayment of our fixed-term loan B debt, resulting in a current capital structure which has approximately 72% of our debt subject to fixed rates. As we noted at our investor day in May, this now provides us visibility to a reduction of approximately $110 million in interest expense over 2023, resulting in expected total full year interest expense in the range of $200 to $210 million for 2024. Importantly, this was a great milestone for our company in completing our first investment grade bond offering. and providing increased balance sheet flexibility as we look to continue to optimally deploy capital on a go-forward basis. As we have previously stated, we remain focused on M&A as the priority use of capital in the near term, with a focus on strategic assets that continue to differentiate our clinical offering and drive value for our customers. However, as communicated previously, we have authorization from our board of directors for a share repurchase program of up to $500 million to be deployed opportunistically on an ongoing basis if the appropriate assets cannot be secured at the right price. We are updating our full year 2024 guidance range to account for the delayed COVID-related projects as well as foreign exchange headwinds due to the strengthening US dollar since our quarter one report. We now expect revenue to be in the range of $8.45 billion to $8.55 billion, an increase of 4.1% to 5.3% over full year 2023. As I noted earlier, we are increasing our full year adjusted earnings per share guidance to a range of $15 to $15.20, an increase of 17.3% to 18.8% on a year-over-year basis, reflecting our strong margin delivery and continued cost management. Before I close out my prepared remarks, I want to provide a brief update on our CFO transition. We continue to make good progress on our search for a new CFO, and we now have a small number of very strong candidates remaining in the process. We expect to make a more detailed announcement regarding this transition later in the current quarter. Finally, I want to extend my sincere thanks to all of our colleagues at ICON for their many efforts in the quarter and the first half of this year in supporting our customers and helping to accelerate their development programs to bring new therapies to patients around the world. Brendan, I'll now hand it over to you to review our financial performance in more detail.

Thanks, Steve. In quarter two, ICON achieved gross business wins of $3.07 billion, an increase of 7.4% on a year-over-year basis. In addition, we recorded 493 million worth of cancellations, resulting in net awards in the quarter of 2.58 billion, and then booked a bill of 1.22 times. With the addition of the new awards in quarter two, our backlog grew to a record 23.8 billion, representing an increase of 2% on quarter one of 2024, or an increase of 9.9% year over year. Our backlog burn was 9.1% in the quarter slightly down from quarter one levels. Revenue in quarter two was $2.120 billion. This represented a year-on-year increase of 4.9% or 5.3% on a constant currency basis. Overall customer concentration in our top 25 customers decreased from quarter one, 2024. Our top five customers represented 24.7% of revenue in quarter two. Our top 10 represented 39.3%. while our top 25 represented 60.9%. Gross margin for the quarter was 29.9% consistent with quarter one 2024 as expected. Gross margin increased 30 basis points over gross margin of 29.6% in quarter two 2023. Total SG&A expense was $183.5 million in quarter two or 8.7% of revenue. This was in line with the prior quarter on total percent of revenue basis. In the comparable period last year, total SG&A expense was $182.9 million, or 9.1% of revenue. Adjusted EBITDA was $450.4 million for the quarter, or 21.2% of revenue. In the comparable period last year, adjusted EBITDA was $414.2 million, or 20.5% of revenue, representing a very solid year-on-year increase of 8.7%, and expansion of 70 basis points in margin. Adjusted operating income for the quarter two was $417.3 million, a margin of 19.7%. This was an increase of 8.7%, adjusted operating income of $383.8 million, a margin of 19% in quarter two of 2023. Net interest expense was $42.9 million for quarter two. We're continuing to fix the full year interest expense to total approximately $210 million in 2024 with a roughly even split in total remaining interest expense for the remaining two quarters of the year. The effective tax rate was 16.5% for the quarter. We continue to expect the full year 2024 adjusted effective tax rate to be approximately 16.5%. Adjusted net income attributable to the group For the quarter, it was $312.6 million, a margin of 14.7%, equating to adjusted earnings per share of $3.75, an increase of 20.6% year over year. In the second quarter, the company recorded $6.8 million of transaction integration-related costs and $45.8 million of restructuring costs. U.S. GAAP income from operations meant it's $229.9 million, or 10.8% of revenue during quarter two. U.S. GAAP net income in Quarter 2 was $146.9 million, or $1.76 per diluted share, compared to $1.40 per share for the equivalent prior year period, an increase of 25.7%. Net accounts receivable was $1.198 billion at 30 June 2024. This compares with the net accounts receivable balance of $1.146 billion at the end of Quarter 1, 2024. DSO was 51 days of June 30, 2024, a decrease of one day from quarter two, 2023, and an increase of two days from March 31, 2024. Cash from operating activities in the quarter was $218.6 million, and free cash flow was $182.4 million in the quarter, an increase of 6% on a year-over-year basis. We continue to see customers seeking more competitive contracted credit terms as well as a desire to hold on to cash longer given the higher interest rate environment we're currently in. This dynamic is primarily focused in our large pharma customer group, which has been growing faster at ICON and is thus driving greater impact on our overall DSO profile. At June 30, 2024, cash totaled $506.6 million and debt totaled $3.4 billion, leaving a net debt position of $2.9 billion. This compared to net debt of 3.1 billion at March 31st, 2024, and net debt of 4 billion at June 30th, 2023. Capital expenditure during the quarter was $36.3 million. From a capital deployment perspective, 2 billion of cash from the successful investment-grade bond was used to repay 2 billion and 14 million of our terminal B facility. Additionally, our revolving credit facility was undrawn at the end of quarter two. From a capital deployment perspective, Steve indicated our priorities for capital to be centred on M&A, where we can acquire assets that further strengthen our portfolio of services and value proposition for customers. Our pipeline of opportunities is healthy, yet we remain disciplined in our approach to evaluating acquisitions that will meet our criteria from a strategic and financial perspective. We also continue to consider opportunistic share repurchase given our strong balance sheet position. Our key assumptions behind the full year guidance remain in place. An effective tax rate of 16.5%, free cash flow target of circa $1.1 billion, capex spend in the range of 150 to 200 million, and interest expense in the range of 200 to 210 million. All for the full year 2024. Finally, I would like to also thank our ICON employees for their dedicated efforts in quarter two. Operator, we are now ready for questions.

Thank you. As a reminder to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. Please note, we ask you to limit your questions to one only. To withdraw your question, please press star one and one again. We will take our first question and your first question comes from the line of Justin Bowers from Deutsche Bank. Please go ahead, your line is open.

Hi, good morning everyone. In terms of what you're seeing with large pharma, what inning are we in in terms of some of the announcements that we've seen, let's say over the last six months, and how they're approaching IRA and what opportunities does that present for you outside of the core clinical business?

You mean inning in terms of budget discussions or budget cuts, Justin? Is that where you're coming from?

Yeah, that's right, Steve.

Yeah, that's always hard to tell. But I suspect we're into the middle inning, I guess. I'm thinking fourth, fifth, even sixth. I think we've seen a number of companies make fairly public announcements. Certainly some of our top customers have been in that in that cohort. I think we're seeing that starting to get through. We're pretty optimistic about large pharma growth in terms of R&D spending, in terms of outsourcing growth going forward. That's what we see in our RFP numbers. Certainly on the trailing 12-month basis from large pharma, we're in the low double digits, even pushing up a little bit higher than that. We're pretty optimistic around where large farmers are going. Sometimes, as I think I've said before on these calls, the cost cuts and the budgets, while they do have an immediate impact long-term, they think more about how they spend their money. And we can benefit from that. And I think that applies to the second part of your question around the IRA. They are thinking about how best to deploy their capital. I've been to one or two... strategic partnership meetings recently where they've been very open saying that they're not where they want to be and they think outsourcing and strategic partnerships is one of the ways they're going to improve their efficiency, their speed, their cost competitiveness. And so I'm encouraged by that attitude, by that open attitude that many of our larger pharma customers are taking and the opportunities that they're presenting to us, even as they go through considerations around IRA and even even budget cuts. It does, I think, present us with opportunity in the long term.

Thank you. We will take our next question. Your next question comes from the line of David Widley from Jefferies. Please go ahead. Your line is open.

Thank you. Good morning. Thanks for taking the question. Steve, I guess I'm interested. I appreciate your comments on large pharma. If I could sneak in kind of a two-parter. Biotech, you had both at our conference in June and then again on the call, talked about attenuation in funding. I wanted to understand, is that just a funding comment or did you also see that flow through to your activity? And then thinking about your, you know, kind of the pace of business flowing not only into backlog but through backlog, burn rate kind of just very moderately declining as has been the case for the industry for a long time. Just wanted to understand if that's kind of what we should set as our expectation going forward or do some of the global business services and your new functional center of excellence approach have the ability to stem that tide? Thanks.

Sure. Let me take the biotech First, we continue to see a constructive improvement in the biotech market. I think we're all aware of the first quarter was pretty strong from an overall funding. Second quarter, perhaps not so strong. And so my comment was related to some attenuation in the funding side of things on the biotech in the second quarter, although I think year to date we see a very positive constructive progress in that biotech funding area. In terms of the activity in our group, we're still seeing opportunities. Something like 50% to 60% of the opportunities that we have in the pending pipeline, and I'm talking about significant, these are the top 25, are in the biotech space. And these are very substantial opportunities. So we feel there's plenty of opportunity and plenty of projects coming through. Interestingly, as we look at cancellations in the biotech And the RFP area, we typically talk about biotech dollars coming through and not so much what actually gets decided on. So we've seen actually in quarter two a reduction in the number of cancels in the pending side of things. In other words, proposals that come to us and we bid on A proportion of those always get cancelled, never actually come to decision. We've seen a reduction in that, and that I think gives me some encouragement in terms of the rigour and the robustness of our pending pipeline. And as I said, of the top 25 opportunities, about half of them are in the biotech segment. So it really shows, I think, that the biotech are coming through. They're serious about offering us opportunities. and they are substantial opportunities. We're talking about very significant multi-million dollar, tens of millions of dollars of opportunities. So I'm pretty optimistic around where the biotech market is going and around the opportunities that we're gonna have to execute on those opportunities. In terms of backlog burn, it did tick down a little bit and I think that's a consequence of the makeup of our backlog. As you know, a lot of it is oncology and that will continue to be the case. Our centers of excellence will, I think, help to mitigate that downturn, but I don't think it's necessarily going to change the overall challenge there or the overall trend. We'll still see, I think, a push perhaps down. We're down at around the 9%. We may push under that a little bit in the more medium term. I think what will give us an opportunity is as we get into some of these other therapeutic areas in cardiovascular and metabolic, these COVID trials will help us as well. And so as we improve the mix of the, or at least change the mix of our portfolio, I think that's the opportunity from a burn point of view. The other thing is, as we said at our investor day as well, we have a very clear and strong initiative around our study startup program, which I think is starting to pay some dividends and starting to improve. So I do think that will be a mitigating factor as well, and we'll be able to get studies started and get patients in and burn revenue a little bit more faster, which is also a good thing, of course, for customers as we complete those projects on time or even ahead of time. So there's a number of things we're doing, and I think we see on the horizon as an opportunity to improve our backbone burn. But that oncology and rare disease portfolio composition is always going to be a continued challenge.

Thank you. We will take our next question. Your next question comes from the line of Max Smock from William Blair. Please go ahead. Your line is open.

Hi, good morning. Thanks for taking our questions. I wanted to follow up on the small biotech and get an update around some of the traction that you're making with your revamped small biotech offering that you've been talking about over the last couple of quarters here and just how that revamped offering has translated into your win right here in the second quarter of this year. Thank you.

Yeah, I think it's still early days, Max, in that. We have, as we said at the investor day, rebranded our biotech offering. I think we said at the investor day, we're known as a large pharma CRO. So this is a process and this is something that's going to take a little bit of time. We are seeing some progress. As I said, we've got a lot of opportunity to prosecute in that pending pipeline. And I think the next couple of quarters, probably the next 12 months, will determine how successful that refocus and rebranding So I think it's a little early to call, to declare victory in that space. We're seeing certain, certainly we're seeing some progress in terms of opportunities to bid on. And we've won our share of those. But I'd like to perhaps give that question another quarter or two before we really give you a definitive answer.

Thank you. We will take our next question. Your next question comes from the line of Elizabeth Anderson from Evercore ISI. Please go ahead. Your line is open.

Elizabeth Anderson Hi. Maybe sticking on the biotech theme, like obviously earlier this year we saw a massive increase in funding come through and sort of moderating but still positive trends in the second quarter. Have you seen, where are we in sort of that bolus that we saw in the first quarter coming through? I'm sure the answer is that it varies somewhat, but, you know, are those, you know, still coming in the RFP stage? Are they sort of starting to convert? Like, how do we think about that in terms of the opportunity that that presents?

Yeah, it's a good question, Elizabeth. You know, I think it's fair to say that we're starting to see that early year funding can flow through. And as I said, the cancellations in the funding area, in the proposal, seem to be down in the second quarter. So I'm really encouraged by that opportunity. It seems to be a much more robust pipeline of pending opportunities, which I think is good news for us. We are seeing that sort of push up in the mid-single digits. Even sequentially, we've seen a progress on that Q1 to Q2. And so, again, I'm encouraged there. You know, in terms of awards and then converting to revenue, I think we're probably still a couple of quarters away. I think maybe Q4 early next year is going to be when that starts to play through. But I think overall, we're starting to see that, but we're at the sort of early part of that sort of progress, if that makes sense.

Thank you. We will take our next question. Your next question comes from the line of Patrick Donnelly from Citi. Please go ahead. Your line is open.

Hey, guys. Thanks for taking the questions. Steve, maybe one for you just on the bookings trends. Pretty solid first half here. is it still right to think about kind of that mid one, two range, you know, any changes to your level of confidence, obviously the RFP flow and things like that support it, but just curious, obviously last quarter sounded really good coming off that one, two, seven, just want to take your temperature on, on the book to build trends. And then just a quick housekeeping one for Brendan on the revenue guide. It seems like if you back out the COVID piece, the core actually moved up over 50 million. I just want to make sure I'm doing the math on that correctly. I appreciate it guys.

Maybe I'll take the first one and I'll leave the second one to Brendan, Patrick. We feel pretty good about where we are on the book to build, 1.2.2 this quarter, 1.2.7 last quarter. 1.2 to 1.3 is where we think we'll be and what we need to do to continue the growth trajectory of the company. So there's certainly nothing that's happened in the last couple of months that would change our view on that. So I'll leave it at that. We're optimistic, as I said. The RFP cancellation seemed to be down. I'm encouraged by that. The RFP opportunities seem to be continuing to move forward across the segments, not just in large pharma where we're doing well, but across the mid-sized companies and the biotechs as well. So, you know, overall, we're pretty constructive, pretty optimistic on where we think the market will be and what we think we can deliver the back end of the year in terms of a book to bill. Brendan, you want to take the call question?

Sure. Yeah. The, uh, I think, you know, Patrick, it's well observed, you know, we've, you know, and Steve called it out when he was talking through his points, we've seen, you know, good, good elements of growth in our core, you know, ex COVID where we talked about being up for the first half of the year, 8%, uh, and also out of our, outside of our top five, you know, there's, there's good growth and diversification of our customer base. And outside that top five, we're, we're, we're in additional 8%. So absolutely. I think when you look at the component parts of the guidance, What you see is that, you know, circa $150 million of headwind from COVID. And also we talked to the fact that there was another bit of a headwind on FX there of 20 million. So I think that the revised 100 million decrease does show good strength outside of those elements and certainly good elements of growth there as I listed at the start.

Thank you. We will take our next question. Your next question comes from the line of Michael Reiskin from Bank of America. Please go ahead. Your line is open.

Great. Thanks for taking the question, guys. I want to focus on the margin. You know, like you said, solid progress in 2Q and you're raising the guys for the year. Looks like you're guiding to roughly 22% EBITDA margin in the second half just to get to that full year number. So I just want to dig into that a little bit further. You know, you called out project execution, cost controls, efficiencies, things like that. But just curious if you could go into that a little bit deeper. You know, do you expect those to continue going forward? And I'm just asking that in the context of, you know, your analyst day just a couple months ago, you talked about 22.5% for 2027. So you're already, you know, hitting 22 in the second half of the year. Just curious about the sustainability of that and how we should think about that as a jumping off point. Thanks.

Yeah, Michael, let me give you some high-level thoughts on that, and then Brendan might jump in on a little more of the detail. You know, overall, I'm really pleased with the way the margins, you know, continue to progress and expand. We've done a number of, you know, and it's not just in the sort of SG&A area, you know, it's across the gross margins as well. I think we're up 30 bps on the year in gross margin due to good, strong execution. from our team and I'm really proud of the way the team's delivered on the work we have. They're very efficient and it enables us to be very aggressive and on the money when we bid on these more strategic partnerships. The pricing environment is getting challenging in some of those areas, but we have a lot of confidence in our ability to deliver margins or deliver work above the theoretical margins that we bid on. We have a good, strong execution team that's helping us on the gross margin line. On the SG&A side, as I said before, we have a very, very good global business services team that continues to challenge itself with respect to where they're located. The automation, AI, our IT team have done a great job in moving that forward. As you can see on the headcount, we're pretty much flat over the year, and yet we've been able to grow the business. You know, I think that shows you that we're focused on cost, but we're focused on getting more efficient, and that's important because of some of the challenges that we get as we, as I say, compete for these strategic partnerships. So overall, you know, we're up, I think, 80 bps on the EBITDA number, and that's a combination of both. And I certainly see us, you know, being able to, you know, you can't keep doing that. Obviously, there's some limits to that, But we're challenging those limits. I think as my former boss used to say, every ceiling becomes a floor. And that's the way we're approaching it. Brendan, maybe on a more specific basis, you can give us a few thoughts.

Yeah, no, I think maybe that's all correct. I think, Michael, to your question, circa 22% in the second half, just to give a guide on that piece, is broadly incorrect as well. Obviously, we're looking for good margin expansion. As Steve said, it's going to come from all elements of the business. It's cross-controlled right across the organization. So we expect to see gross margin expansion in the second half and continued really, really good cost control in our SG&A. And that should help us drive up to that overall position for 21-7 for the full year, but certainly in the range of 22s in the second half.

Thank you. We will take our next question. And your next question comes from the line of Eric Coldwell from Baird. Please go ahead. Your line is open.

Thank you. Good afternoon. So first one, it's probably a bit of a nuanced question, but these COVID delays, is that part of the equation on the EBITDA margin increase? Because those programs, at least historically, typically came with higher pass-throughs. So you'll have perhaps a less negative mix from that revenue headwind?

Eric, it's Brendan here. Yeah, I think that's absolutely correct. Obviously, as we went into the second half of the year and as we were thinking about our forecasting and our guidance, for the start of the year, we were expecting those programs to hit in the second half predominantly. They're obviously, as we talked about, majoritively going to be delayed out into the very end of this year, into 2025. Still good work, still get done, but, you know, just delayed. That certainly will have a positive gross margin impact as we continue to ramp up other parts of our business that we were expecting and as we talked about are coming through well as we go into the second half of the year. So yes, I do think that'll have a positive gross margin mixed impact.

Thank you. And then on the DSO, you made really nice progress through 2023 with sequential improvements. Now it's ticked back up into the last year average range here over the last couple of quarters. You mentioned it was either a more competitive environment or a continuation of a more competitive environment. And then I just want to clarify which is it. Is it that the competitive environment continues but you're getting more mix from larger pharma that are traditionally more competitive or asking for more, I should say, or has has it actually, has the pressure to delay payments actually increased?

Let me, I'll try that one from a high level, and then, again, Brendan can jump in. Eric, certainly on the pricing environment, you know, I do think it has ramped up a little bit in the last, I want to say, few months even. And maybe that's, you know, you tend to get involved in some of these more strategic meetings, and I'm aware of some of the requests and the asks that, you know, Our larger farmer partners are looking for, particularly for these more strategic relationships. When they're going to commit themselves to a three to five year type of relationship, they're looking for the best possible rates they can get, and it gets pretty hairy at times. And there are one or two of our competitors who are willing to entertain some, dare I say it, fairly unconventional sort of rates. We're not going there, and I think that's not the whole market, but there are one or two out there who are moving in that direction. And I think our customers can see through a lot of that. But it does present something of a challenge. And as I said before to the previous question, I feel confident that our delivery and our execution can manage any challenges we have on that top line, because we are able to typically deliver a couple hundred to 400 bps ahead of what we usually propose. I'll leave Brendan to talk a little bit more on the DSO side of things.

Thanks, Steve. Yeah, Eric, I think there's two really salient points to note here. First off, obviously, we've been very successful in our large pharma group, and we've seen probably more expansion in our business. So certainly the mix of our customer base, that is that larger proportion, certainly the revenues that come from them, and consequently the billing and the DSO. is probably push more towards customers who do push us on credit terms. There's no question about that. So the mix is one piece. I would say in terms of the competitiveness, in terms of DSO and credit terms, I would say that internally, really more internally, is from the pharma companies themselves. As we know, the very first question was about the implications of IRA and the mix of costs. Pharma companies are very focused on maintaining their cash balances. And some of them have specific issues where they really need to do that in 24 and into 25. So I think the push on this from a credit terms perspective has been much more driven rather than by competition between CROs, but actually from the actual pharma company base themselves and the folks that they're working with to manage their cost base and their R&D spends as well as their cash balances over the next couple of years.

If I could go back to Steve's response on the pricing competitiveness, we heard earlier in the week from your competitor that is much more biotech-focused that they felt like perhaps, if anything, maybe the pricing competitiveness got a little easier in recent months, that it was worse a couple of quarters ago and before. Your mix is obviously a bit more skewed or balanced, but skewed more to big pharma than that competitor. Is this a nuance on pricing? Big pharmas are, you're seeing big pharmas get a bit more competitive, particularly in strategic deals. Are you seeing the same thing in your smallest biotech base, or could perhaps you align with your competitors' comments that maybe that cohort, given the funding and the better mood, is a little less focused on price today than it was a few quarters ago? Yeah.

Eric, I think you've characterized it very well. That's exactly the way we see it. We're not seeing the sort of pricing discussions and pricing pressure that we see in the biotech space as we do in the large pharma space. But it's kind of the way it's always been. When you have these large strategic partnerships, three to five years, hundreds of millions of dollars annually, they're looking and they tend to negotiate these up front and we all line up and negotiate. and do the beauty parade, you know, as you'd expect, they're looking for optimal terms. Brendan referenced it in terms of credit terms, pricing, you know, and all of that sort of stuff. And so it is a very competitive process because once you're in there, you know, you're competing with one other or maybe two others. So that's typically the way it goes. And expect that. On the other hand, as you sort of quite rightly said, and the biotech space and our... Our competitors said it pretty well as well. I think the pricing, while it's always competitive and we compete with them and others, it's not quite as intense because you tend to be one-off projects. One program, one trial, maybe there's some follow-on if you've got other indications to develop, but it's a different type of environment and I think one that lends itself to a slightly different outcome in terms of pricing, although, of course, the volume is not there in the end.

Thank you. We will take our next question. Your next question comes from the line of Luke Sergot from Barclays. Please go ahead. Your line is open.

Great. Thanks, guys. I just kind of want to dig in on the enrollment delays. And you're talking about how they're not canceled and they're coming back. So can you give us a sense of the timing of how we should think about those kind of rolling back on? And then more high level is like, the delays, were they caused more from you lacking those functions and having to subcontract out or partner with somebody else? And then, you know, would those issues have been rectified if you guys had those functions internally?

No, let me take the second part of your question first, Luke. No, no, the advice we were looking for, the regulatory advice, was really from the agencies. in terms of the variants that needed to be in the comparator. So it was very specifically with the agency. It wasn't something that we were able to provide. We could have obviously had our opinion, but the customer was looking for the agency advice. So it wasn't anything that we didn't have that would have mitigated it. We needed that advice. And the other part of it was the investigational product as well. There were very specific issues, nothing that we could have actually done. Of course, we jumped in and tried wherever possible to help, but it wasn't anything we didn't have. In terms of the delays, we got the news in June, and so it was pretty clear that there was going to be a delay. It's not that the work has stopped. We're actually going to be enrolling around 400 patients in one of the trials. this year, and that'll be starting in sort of late August, September. So the work is moving along, certainly on one of the trials. The bulk of the enrolment will not really be until early next year, and so that's because of the delays we've had, but the initial part of one of the studies will happen, the start-up work will start, but it's not going to be material enough to impact, and obviously the bulk of the enrolment with the investigator fees and our direct fees around monitoring and management are where the bulk of the revenue is recognised as that work gets done. So that won't happen until next year.

Thank you. We will take our next question. Your next question comes from the line of Jalandhra Singh from Truest Securities. Please go ahead, your line is open.

Thank you, and thanks for taking my questions. I actually want to follow up on comment around guidance excluding COVID and effects stable to improving. As you think about the business over the past six months compared to expectations heading into the year, what are some of the key areas will you highlight that trends either macro front or from the company specific have been coming in better than your expectations? And what are the areas you will see that they didn't play out as well as you expected? Again, I'm focused on core trends, excluding COVID and NFX.

Fernando, I might take that one. It's Brendan here. Obviously, when we looked at the modeling for the organization as it came into this year, obviously, we were talking about different quantums of COVID work. And obviously, we've spoken to that extensively on this call. I think the positive signs, as we've talked about a little bit already, is kind of some of our growth customers actually have done very well during the course of this year. And that's really customers that are outside that top five. We've seen really very strong, pleasing growth coming from them. There's some developing relationships there that we, as Steve referenced in his prepared remarks, you know, we see as the big customers of the future. That, and added to that, the fact that we, you know, we continue to do well on signing new major relationships. All of these things are very significant positives in that core business. So that continues at good price. As we said, out of our top five, we grew year over year at 8%. And that's been driven by some of the good growth, probably even maybe even a little bit ahead of our expectations as we came into the year. But as I said, probably more importantly, Those new customer relationships that we continue to win are going to obviously be what really keeps us going as we go forward into the more medium term. So still very much believe in our medium term growth outlook as we talked about in our New York conference.

Thank you. We will take our next question. Your next question comes from the line of Jack Meehan from Nefron Research. Please go ahead. Your line is open.

Thank you. Hello, everyone. I wanted to talk a little bit about just expectations around the burn rate. So, you know, step down a little bit sequentially here, you know, just based on the business that's coming in the door and some of the adjustments you made. Can you just talk about, like, how you think it trends, you know, through the remainder of the year? And, you know, do you think we're kind of at a bottoming point here as we enter 2025?

Jack, hi. It's Brendan here again. Obviously, we did step down a little bit in the current quarter. We were 9-1 in Q2. As we look at Q3 and Q4 and you look at our guidance, obviously, it's not terribly hard to do the math to see that it will be kind of stepping down a little, probably into the high eights as we think about the back half of the year. That's really still very solid when we look at our mix of backlog that we have. The trend in the longer term here has been one that has seen it decreasing and that's as much to do with the mix of you know the business that we have obviously a lot of that is oncology uh you know longer term in nature uh in the business it just takes longer to burn through it's all solid business wins we've obviously talked about the fact that we we have some you know fast burn vaccine work which we think will kick in in 2025 so there is opportunity to push back on that a little bit but the way i would look at it is it's more about um from from from our perspective it's more about trying to lessen the impact of the backlog burn rate dropping over time. So really what we're always trying to do and will continue to do in 2025 is to really have that impact as little as possible. Could we see some uptick maybe with different vaccine mixes as we go into 2025? Well, that will very much depend on obviously business wins performance between now and the end of the year. But certainly you can absolutely be guaranteed that we will continue to make sure that we convert as much as we can in each quarter and that will remain a significant focus for the company.

Thank you. We will take our next question. Your next question comes from the line of Dan Leonard from UBS. Please go ahead. Your line is open.

Thank you. Can you discuss whether or not your view on the long-term durability of COVID vaccine work has changed?

I don't know that it's changed much. We see the percentages of revenue from our COVID vaccine work is sort of moderately dropping, but we do feel there's going to be opportunities such as we're talking about today for the new next generation vaccines and even other vaccines that are coming through for similar type diseases, COVID-20, dare I say it. So I think this is going to be an ongoing part, albeit fairly modest part of our work in the long term, but it will be fairly volatile as well. These trials are typically, as you would expect, very large trials, very material trials. And so when they hit and when they happen, they'll have quite a significant impact as it did during the pandemic. It's hard to predict the future in terms of what's going to happen pandemic-wise, but I think certainly the regulators, the agencies, the governments around the world are very conscious about the potential for a future pandemic and are wanting to be well prepared for that, much better prepared than they were for the recent one. And I do think that will mean there'll be opportunities for us, next gen or whatever that may be. But it won't be, it'll be hard to predict. It'll be inconsistent. It'll be volatile. That's all I can say. And it's, I don't have a crystal ball in front of me, Dan. So it's difficult to sort of put too many, you know, specifics on it.

Yeah, I mean, the way that we talked about it, Dan, was that it wouldn't be, it would be somewhat similar to, you know, other, you know, infectious disease areas like flu that we see on an annual basis being, you know, call it one to sometimes 2% of revenue for us. that it could be, you know, somewhere in that range on an ongoing basis. Obviously, our expectation based on the work that we had won was higher than that this year, but certainly something like that on a longer-term basis we don't think would be, you know, out of the realm of possibility, but of course will depend on, you know, obviously the size of those trials and what we see come in ultimately.

Thank you. We will take our next question. Your next question comes from the line of Jack Wallace from Guggenheim Securities. Please go ahead. Your line is open.

Yeah, thanks, Dan. I wanted to quickly touch back on the accounts receivables.

Again, it sounds like you're really not willing to bet too much on price, but in terms of you winning some additional share inside of your larger customers, is the strength of your balance sheet an asset for yours to, you know, be able to be a little bit more competitive than maybe some of your competitors on payment terms?

Thanks, Jack. It's Brendan here. Listen, I think this is a competitive piece that goes into those conversations. As I mentioned earlier on in my answering of a different question, it is a big requirement from the pharma companies themselves. That's as much to help them in their own cash flow issues and their own issues that they have generally, speaking at the moment. think everybody is met with the same uh response from large farmers on this uh those are other competitors i think the strength of our balance sheet certainly gives us an ability here yeah and that's something that we've we've looked at in the past as uh you know and we've always thought our balance sheet and the strength of our balance sheet is a competitive advantage in our marketplace and we'll use that wherever and whenever we can be that deployment of capital from an m a perspective or be that in the ability to negotiate deals with our customers. So, yeah, we'll use everything that we have in our arsenal to our advantage to make sure we're continuing to be a winning business and competitive.

Thank you. We will take our next question. Your next question comes from the line of Casey Woodring from JP Morgan. Please go ahead. Your line is open.

Great. Thank you for taking my questions. So just cancellations in the quarter were slightly above 2% of beginning backlog, which has been your quarterly guide over time, but they were up 7% sequentially. So just wondering if there's anything to read into there. Steve, you mentioned earlier in the call that cancellations related to funding were down in the second quarter. And then just on the GLP-1 front, a few larger pharma companies have made some progress in the last couple of months. So curious if the recent updates we've seen in that space has changed your view on the LT1 contribution in the near to medium term. Thanks for fitting me in.

Sure. Casey, you're right. There was a very, very modest uptick on cancels in the court. I don't think we're not reading anything into that really at this stage. We feel the portfolio has been prosecuted pretty well um you know there's cancels can be volatile can be up and down uh in this business that's really why we exist in case things don't don't work so we can't complain too much about that but we don't we don't see any trend any particular trend uh in that space in terms of the glp ones you know we're encouraged by the by the research and the uh the opportunities that are that are coming through in that space particularly more in the in the large farmer area um and and we're also encouraged by some of the strategic partnerships We've won that are also working actively in that area. So there's plenty of, again, opportunity and constructive positivity going forward in the GLP-1. We feel we're well-placed for those very large-scale trials. We're well-known as probably the best of the vaccine CROs in the industry. And these trials in the GLP-1, be they new or be they old, you know, new indications are going to be very large trials. And so, you know, our scale, our infrastructure is well positioned to really be able to put those trials and to execute those trials really well. And our technology in terms of tokenization is going to allow us to do them in a really efficient manner. So, again, I'm very positive about the future around the, whether it be obesity or cardiometabolic areas, diabetes, And these trials will also burn a bit faster than some of the rare disease or the oncology studies we have. So it's a good place, and I'm looking forward to seeing more opportunity in that space, and we're starting to see that.

Thank you. We will take our next question. Your next question comes from the line of Matt Sykes from Goldman Sachs. Please go ahead. Your line is open.

Good morning. Thanks for putting me in. Just on capital deployment, I know you have the buyback authorization. You've talked about wanting to be active in M&A. Is this like an either-or decision for you? Can you do both depending on the potential size of the M&A transaction? How are you thinking about prioritizing those two capital deployment efforts?

I think we've been fairly clear, Matt, that M&A will be our focus. and we do have a number of opportunities in the pipeline at the moment that we feel a good chance of moving forward over the next, realistically, six months or so. We have some targets in terms of the areas we want to prosecute in, and that's around sites and around late stage, around labs. We've talked about those sorts of areas, and that's all starting to move together. These things always take a little longer than we'd like, and, of course, there's... We're not going to overpay in this area, but we do have some good opportunities in that space around how we facilitate the prosecution of our clinical work and improve our offering. That's really where we're focusing on that space. Having said that, I've also said we want to stay in the 1.5 to 2.5 in terms of ratio of adjusted EBITDA. And so as we get towards the end of the year, without any M&A, we'll be getting below that. And so we will be, of course, considering what the opportunities are for buying back, and we won't be shy where we see those opportunities. Again, I would say it very clearly, M&A is the focus, and we do have some opportunities. But we want to use our balance sheet, as Brendan's Already said, we have a very strong balance sheet and we're a good player in that market and so we're going to continue to use it. We're certainly not going back to the days perhaps of five, ten years ago when we really had very little debt at all. We think it's a reasonable place to be and we feel good about our positioning in that space.

There are no further questions. I would like to turn the conference back to Steve Cutler for closing remarks.

Okay, thank you. Thank you, operator. I think we certainly see a very constructive market going forward and certainly plenty of opportunity for ICON. There's no doubt there'll be a little volatility, but with the biotech funding stabilising and our opportunities increasing within large pharma, we feel like this is a good place to be and we feel in a very strong position to be able to benefit from that constructive market. So thank you, For joining the call today, your continued interest and support of Icon, we do appreciate it. We look forward to further updates as we continue our progress in partnering with our customers and accelerating their critical medicines to the patients who need them. Thanks all and have a good day.