IQVIA Holdings Inc. (IQV) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the IQVIA First Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Kerri Joseph, Senior Vice President, Investor Relations and Treasury. Mr. Joseph, please begin your conference.

Thank you, operator. Good morning, everyone. Thank you for joining our first quarter 2025 earnings call. With me today are Ari Bousbib, Chairman and Chief Executive Officer; Ron Bruehlman, Executive Vice President and Chief Financial Officer; Eric Sherbet, Executive Vice President and General Counsel; Mike Fedock, Senior Vice President, Financial Planning and Analysis; and Gustavo Perrone, Senior Director of Investor Relations. Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation also will be available following this call in the Events & Presentations section of our IQVIA Investor Relations website at ir.iqvia.com. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the Securities and Exchange Commission, including our annual report on Form 10-K and subsequent SEC filings. In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the press release and conference call presentation. I would now like to turn the call over to our Chairman and CEO, Ari Bousbib.

Thank you, Kerri, and good morning, everyone. Thank you for joining us today to discuss our first quarter results. I'm going to start with the usual update on financial performance for the quarter. I'll then provide perspectives on the market, including our understanding of the possible effects of recent U.S. government initiatives, how we are well positioned to navigate these near-term challenges and finally, why we remain confident about the industry's resilience and prospects. I'll close by highlighting a few important wins in the first quarter. So let's get started. We delivered strong revenue and profit results at the high end of our expectations despite a continued challenging environment in R&DS. Total revenue for the first quarter came in above the high end of our guidance range, representing year-over-year growth of 2.5% on a reported basis and 3.5% at constant currency. And compared to last year and excluding COVID-related work from both periods, we grew the top line about 4.5% on a constant currency basis, including about a couple of points of contribution from acquisitions. First quarter adjusted EBITDA increased 2.4%. First quarter adjusted diluted EPS of $2.70 increased 6.3% year-over-year. Let me share some details on the market landscape and the demand metrics received for each segment. Starting with TAS. The business continued the strong recovery trend we saw exiting last year as our clients are launching new drugs and are executing on their commercial road maps. It is in times like these where there is some uncertainty in the biopharmaceutical sector that we clearly see the value of the scale, diversification and differentiation of IQVIA's portfolio of offerings. It's great that TAS is contributing over 40% of our revenue. TAS revenue growth actually came in above our expectations at 6.4% reported and 7.6% at constant currency, led by double-digit growth in real-world evidence. On the clinical side, as we expected, the near-term market environment continues to be bumpy. We experienced delayed decision-making by customers on new programs, reflecting the heightened macroeconomic and industry sector caution. In fact, our average time from RFP issuance to award in the quarter increased by approximately 10%, both year-over-year and sequentially. We believe that this is the result of the sector uncertainty caused by the pronouncements of the new administration, the precise effects of which are unknowable at this point. Several of our clients are slowing or reevaluating programmatic decisions until there is better visibility. Also reflecting these same concerns, the funding environment for EBPs, especially for early stage, has deteriorated. While the R&DS business is experiencing some turbulence, our demand metrics remain positive. Our backlog reached a new record of $31.5 billion at the end of the quarter, growing 4.8% compared to the prior year. Our first quarter RFP flow improved mid-single digits year-over-year and high single digits sequentially. Our qualified pipeline is up low single digits year-over-year, driven mostly by good growth in large pharma. Now obviously, the demand environment is impacted by the proposed changes that has been signaled by the new U.S. administration. The White House's initiatives relative to our industry sector can be grouped into 3 categories: tariffs; agency actions, particularly HHS and FDA related; and drug pricing. Starting with tariffs. When the President announced plans to initiate the reciprocal tariff program, the pharmaceutical industry received certain exemptions. However, following the announcement, the Department of Commerce began a national security investigation of the life sciences industry, which may result in tariffs specific to the pharma sector. Now IQVIA's direct exposure to tariffs is limited primarily to certain supplies in our laboratory business and is immaterial financially. We understand that industry-specific tariffs, if implemented, may have a more direct impact on our customers. However, it is too early to assess what that impact may be. With respect to agency actions, HHS announced a number of initiatives, including NIH delays and cancellations of government contracts, along with establishing a 15% cap on indirect costs. Now to be clear, IQVIA has no clinical trial contracts with BARDA and no COVID-19 contract sponsored by the government. So our exposure there is zero. That said, we have excellent relationships with these agencies, including BARDA. TAS does have a minimal amount of business with the government, and we do not expect any of this to have any impact at all. The NIH funding cap relates to indirect administrative and overhead costs. It aims at aligning those indirect costs to the same levels as private foundations. This has no impact on direct costs for research funding and, therefore, zero impact on us. Regarding the FDA, there have been numerous restructuring actions announced, which has impacted a significant portion of the workforce. These reductions in force primarily targeted overhead and support functions such as planning, training, travel, communications and records management. Importantly, core products review teams responsible for evaluating new drugs, vaccines and medical devices, which are primarily funded by the industry, were largely preserved to maintain the FDA's essential regulatory functions. To date, we have no evidence of any trial or approval delays. Whatever anecdotal disruptions there may be in nonapproval-related interactions with FDA staff, we expect this to normalize. FDA Commissioner Makary has announced his intention to reduce animal testing in favor of AI-based models and enhanced usage of real-world evidence in the approval process. We applaud this, and we see these actions proposed by Commissioner Makary as benefiting our industry. They will enable clients to move prospects faster into clinical trials. The increased use of real-world evidence, not only in preclinical work, but also in Phase II and Phase III trials, plays to IQVIA's strength. Ultimately, this is positive news for EBP companies, which develop over 50% of the drugs in clinical trials. Finally, on drug pricing. The U.S. administration recently issued an executive order regarding the role of PBMs, pricing transparency and Medicare costs. These initiatives are still in their early stages, and some provisions may require congressional approval. The impact of these potential actions is difficult to ascertain at this point because the specifics have not been determined. But there are 2 aspects that could actually be very positive for the industry. First, the proposal to do away with the so-called pill penalty provision in the IRA, which subject small molecule drugs to CMS pricing review after only 9 years versus 13 years for large molecule drugs. This is key for pharma clients as 50%, 50% of the drug's value is realized in years 9 to 13. Second, the focus on drug pricing, treatment value and comparative effectiveness drives the need for earlier clinical results and more real-world evidence. So in summary, some of our customers have slowed down their decision-making processes, as you would expect, and we experienced delays in RFPs moving to contracts in the first quarter. An unusually high number of EBP awards that were contracted in the quarter were not included in our bookings because funding has not been secured yet. Now we are confident that our industry will successfully manage this period of uncertainty and will find ways to adapt. The life sciences industry has consistently demonstrated its resilience, overcoming macroeconomic obstacles and thriving in changing environments, and IQVIA is particularly well positioned to navigate this marketplace. We believe when everything is said and done, key decision-makers will recognize the industry is a strategic sector for the U.S. that deserves to be strongly supported. U.S. companies in the biopharmaceutical sector have maintained strong global leadership in biomedical discovery and clinical research. Our sector serves as an extraordinary engine of innovation. It was responsible for 46% of the 634 novel drugs approved globally over the past decade, confirming strong U.S. leadership. The U.S. is responsible for 61% of global pharmaceutical sales of branded drugs, which is up from 56% a decade ago. The sector invests almost $200 billion annually in research and development and drives economic growth, contributing $1.65 trillion of economic output annually. It supports direct and indirect employment of highly skilled, highly educated workers, employing nearly 5 million people at an average of $157,000 annually, which is double the national average. In fact, many non-U.S. large pharma companies have moved their primary R&D centers to the U.S. to take advantage of the talent pool. And of course, the biopharmaceutical industry provides substantial societal benefits by improving health outcomes and extending life expectancy. Now before I turn it over to Ron, let me give you a little bit of color on business activity in the quarter, and I'll be brief here and just mention a few salient examples. As the revenue numbers show, TAS did quite well in the quarter. We won a number of partnerships with clients that are launching new products. For example, a large project for an important EBP client that's launching their first product and the first-ever treatment for low-grade serous ovarian carcinoma. We also won a launch partnership with another EBP, leveraging our AI-powered patient relationship manager platform for a groundbreaking treatment for a rare condition in an underserved patient community. We were selected to support a midsized pharma client with an omnichannel campaign that includes KPIs designed to improve patient engagement. Our commercial technology suite continues to be successful in the marketplace. Our award-winning SmartSolve offering, which is a proprietary quality management system, displaced the incumbent as an EBP client. In the medtech space, we secured a significant contract to deploy an integrated information solution to help our clients streamline operations and decision-making. Let me skip a few more of these and move to R&DS. We achieved notable wins across customer segments. As you recall, last year, we renewed all 22 of our strategic partnerships with large pharma clients, and we expect to scope in half a dozen of them. We are being awarded significant contracts from these partnerships. For example, in the quarter, a top 5 pharma client that has selected IQVIA as a preferred partner awarded us 4 early-stage studies under the new model. IQVIA was selected by a top 20 pharma client to support a Phase III obesity program across 8 studies. Our best-in-class clinical trial technology solutions and industry-leading expertise were key factors in securing this deal. A top 10 pharma client selected IQVIA's pharmacovigilance offerings to achieve a significant reduction in case processing time, enable efficiency and manage the increasing volume. We secured a contract with EBP client to run a Phase II trial for an innovative treatment for patients with pulmonary hypertension associated with interstitial lung disease. The customer selected IQVIA due to our deep technology expertise, delivery model and partnership-focused approach. Lastly, Mike mentioned our progress with AI. You may recall, we announced our collaboration with NVIDIA earlier in the quarter. We are progressing as planned to deploy highly specialized industry AI agents. So far, we moved over 20 agents into production, covering 3 use cases in each of the commercial, real world and R&DS tenants. We are seeing positive results and productivity gains in areas where these AI agents have been deployed. For example, 1 agentic system in commercial allows us to reduce delivery time by 2/3, from 12 weeks to 4 weeks with a net 30% cost reduction. We plan to scale up from these 3 use cases to 12 by the end of the second quarter and 4 use cases by the end of the year. And now to Ron for more details on our financial performance.

Thanks, Ari, and good morning, everyone. Let's start by reviewing revenue. First quarter revenue of $3.829 billion grew 2.5% on a reported basis and 3.5% at constant currency. In the quarter, we had virtually no COVID-related revenue versus over $40 million in last year's first quarter. Adjusting for this COVID step-down, constant currency growth was about 4.5%. So as Ari mentioned, acquisitions contributed approximately 2 points of this growth the majority of this in the TAS segment. Technology & Analytics Solutions revenue for the first quarter was $1.546 billion. That was up 6.4% reported and 7.6% constant currency. R&D Solutions first quarter revenue was $2.102 billion, up 0.3% reported and 1.1% constant currency. Excluding COVID-related work, R&DS revenue grew approximately 3% constant currency. Finally, Contract Sales & Medical Solutions first quarter revenue of $181 million declined 4.2% reported and 2.1% at constant currency. Moving down the P&L. Adjusted EBITDA was $883 million for the quarter. That was growth of 2.4% year-over-year. First quarter GAAP net income was $249 million and GAAP diluted earnings per share was $1.40. Adjusted net income was $479 million for the first quarter, up 2.4% year-over-year, and adjusted diluted earnings per share grew 6.3% to $2.70. R&DS backlog at March 31 was $31.5 billion, an increase of 4.8% year-over-year and 4.6% at constant currency. Next 12 months revenue from this backlog is $7.9 billion. Reviewing the balance sheet. As of March 31, cash and cash equivalents totaled $1.740 billion and gross debt was $14.330 billion, resulting in net debt of $12.590 billion. Our net leverage ratio ended the quarter at 3.40x trailing 12-month adjusted EBITDA. First quarter cash flow from operations was $568 million and CapEx was $142 million, resulting in strong free cash flow of $426 million. In the quarter, we repurchased $425 million of our shares. This leaves us with approximately $2.6 billion remaining under the current program. So let's turn to guidance now. You saw we're raising our full year revenue guidance by $275 million. This to reflect more favorable foreign currency exchange rates since we last guided. We now expect revenue to be between $16 billion and $16.4 billion, which represents year-over-year growth of 3.9% to 6.5% on a reported basis or 5.2% growth at the midpoint. This guidance now includes a year-over-year FX tailwind of approximately 50 basis points compared to about 150 basis points of headwind in our previous guidance. We continue to assume approximately $100 million of step-down in COVID-related work and about 150 basis points of contribution from M&A activity for the full year. We are reaffirming our adjusted EBITDA guidance of $3.765 billion to $3.885 billion as FX changes had a negligible impact on EBITDA. This represents year-over-year growth of 2.2% to 5.5%. We're also reaffirming our adjusted diluted EPS guidance, which continues to be $11.70 to $12.10. That's up 5.1% to 8.7% versus the prior year or 6.9% growth at the midpoint. Now let's go through the second quarter guidance. For the second quarter, we expect revenue to be between $3.925 billion and $4 billion, adjusted EBITDA is expected to be between $895 million and $915 million and adjusted diluted EPS to be between $2.72 and $2.83. Both this guidance for the second quarter and our full year guidance assume that foreign currency rates as of May 5 continue for the balance of the year. So to summarize, in Q1, we delivered strong revenue and profit results at the high end of our expectations. We had a very solid free cash flow, up 89% -- at 89% of adjusted net income. The TAS business continued to achieve above-target performance with revenue growth of 7.6% at constant currency, and R&DS bookings were affected by delayed decision-making by customers on new programs and lower EBP funding, reflecting incremental macroeconomic and industry sector uncertainty. That said, forward-looking indicators for our R&DS offerings such as qualified pipeline, RFP flow and backlog continue to grow. We're progressing as planned to deploy a new highly specialized industry AI agents, and we've identified over 40 use cases and scaled up deployment across the portfolio in 2025. In the quarter, we repurchased $425 million of our shares. And lastly, we raised our full year revenue guidance by $275 million to reflect changes in FX. And of course, we reaffirmed our cost guidance. So with that, let me hand it back over to the operator to open the session for questions and answers. Hello? Operator?

[Operator Instructions] And we'll take our first question from Justin Bowers at Deutsche Bank.

Ari, could you discuss some of the drivers behind the strength in RWE in the quarter, how the order book looks for the balance of the year and whether or not this outperformance is durable?

Thank you, Justin. Look, TAS delivered better-than-expected revenue growth, which is what helped the company deliver above the high end of our guidance with 7.6% at constant currency. And as I mentioned, this was driven largely by the strong growth in real world, which was strong double digits. This basically -- you will recall that real world had declined. The part of real world that's discretionary has essentially shut down and in the end of '23, beginning of '24 time frame. And the rest of the real-world business, which is more mission-critical, have been delayed and pushed to the right in terms of when to do it and so on. So both the discretionary piece and the required work that's necessary to support safety or pricing demonstrating the effectiveness of treatments, et cetera, both have returned. There's pent-up demand, and we expect this based on the book of business to continue. The rest of TAS was also good, basically low to mid-single digits for the different other aspects of the business.

We'll move next to Matt Sykes at Goldman Sachs.

Ron, just maybe on the margin side. I mean you guys have called out in Q4 a 20 basis point potential margin expansion. It looks like as you kind of rearrange the guide, might be not expecting that. Could you just maybe talk about the opportunities for any potential margin expansion and kind of what you could do on the cost side to help achieve that?

Yes. Well, one thing I would point out, Matt, when you're looking at the margin versus our previous guide is obviously the impact of FX because FX affects our top line, but doesn't have much impact on the bottom line. And if you're looking at gross margins or EBITDA margins as the dollar has weakened and revenue has gone up, profit hasn't followed. So that really explains all the change in our implied margins versus what we guided to previously. Now if you're looking towards what can help drive margins going forward, it's always cost reduction, where AI would be one example that we're looking at. We're always looking at taking cost out across the organization. That's an ongoing effort. You'll see that in our restructuring expense. Of course, against that, we do have pressures on things like not just FX, but mix has gone against us to a certain extent. You'll see that in the gross margin. And that mix includes, for instance, the shift towards FSP, which hurts margins a little bit. But net-net, the margin picture really hasn't changed that much. What you're seeing is mostly just the impact of FX, almost entirely.

Got it. And just for a follow-up, Ari, could you just maybe talk a little bit about on a longer-term basis? You made a comment in Q3 regarding sort of the competitiveness of RFPs going from sort of 1 of 13 to 1 of 4, if I've got the numbers correctly. And just in this environment, given sort of lower levels of demand, how do you feel about your position? And do you think that vendor consolidation trend, which has already been in place, will accelerate in this environment?

Are you talking about the RDS business and RFP flow?

Yes, RDS specifically, yes, and vendor consolidation.

Yes. Yes. Look, the RFP flow is actually pretty good given the environment. So the underlying demand is still there. We're not seeing customers decide to no longer do certain programs. We went through a period of reviews and reprioritization of pipelines, which led to very elevated cancellations during the course of '24, maybe 50% higher cancellation levels in '24 than the historic norm. In the quarter, just I might mention, we had cancellations that were just in a normal historic range. So what happened in the quarter with respect to our booking is mostly, again, programs that clients decided to pause and wait to see what the actual consequences are of some of the administration's pronouncements before they decide to go ahead. And separately, as you might have noted, there was a deterioration in the funding for EBPs. So we had an unusually high number of EBP awards in the first quarter that were actually not only won, but they were also contracted. But our policy is not to include those in bookings if we're not confident in the fund, or as long as we're not 100% sure that the funding has been secured. With respect to the RFP flow though, it's still very, very good. I mean whether in -- we've seen consistent numbers in terms of whether it's dollar value or volume and our win rates and hit rates are stable. So we're not seeing any changes really in the flow of RFPs, whether -- the large pharma RFPs are up, stronger than EBPs at this point. But it's good -- it's pretty good actually and sequentially, it's high single digits higher. So from that standpoint, I feel better at this point in the quarter than I did at the same point last quarter.

Yes. And as we've mentioned previously, we did very well last year with renewing and expanding all the large pharma providerships that they went through. And we're starting to see the benefits of those new RFPs from those relationships coming through.

We'll go next to Shlomo Rosenbaum at Stifel.

Yes, Ari, I wanted to ask a little bit more just probing on the operating environment. Given the uncertainty of what you saw in R&DS, I'm just surprised that you didn't see that in more of the short-cycle business in TAS. Like you kept the guidance, and I guess the assumption is things are going to continue. But do you think that there's risk that, that could spill over into some of the -- the uncertainty into some of those areas in TAS like consulting or some of the analytics or some of the areas like that? And could it potentially result in further reprioritizations even in the R&DS business? If you could give us sort of your thoughts on those things.

Yes. I mean you guys, when you're asking the question, there's considerable uncertainty out there. And whenever you have uncertainty, then obviously, people are hesitant to spend money. That's just -- that's a general rule. And that's the concern out there. But so far, we haven't seen that in TAS. All of our indicators -- leading indicators, pipeline, decision time lines and so on continue to be strong. I believe that the reason we haven't seen that is because there were pent-up demand. We had already gone through a period of holding back on spend in TAS, starting from the middle of '23 through the middle of '24. And so at that point, drugs that have been approved needed to be launched. And that's what's happening now. So what we do in TAS is support the launch of new drugs, market access, pricing of drugs, supporting commercialization efforts, et cetera. And that's the day in and day out day-to-day business of our clients. And they're not going to stop doing that. So we haven't seen that. I understand the question, but in the TAS business, we are seeing continued good growth as expected. And again, I believe that the spend has been held back for a while, and there is pent-up demand and necessary things to do. In our discretionary stuff, the absolute discretionary stuff, consulting and so on, yes, I mean, it's not spectacular. It is just like flat to mid-single-digit kind of level. So it's not that we are looking at a spectacular thing. So what is being done now is the stuff that was necessary to operate. I mentioned real world before as well as the pent-up demand on other things, and that's what's driving TAS. So I don't see the environment influencing this much. On the R&DS side, yes, again, because of uncertainty, so you hold back on decisions. The type of reprioritizations we saw before were due to the IRA. And I think as we mentioned in prior calls, we see that to be largely over. The reprioritization of pipelines, which led to elevated levels of cancellations that were triggered by certain provisions of the IRA. And I'll remind you, the IRA was, I guess, at late '22, and this process started in '23. So we are now a couple, a good 2 years after that process started. And we believe that, that reprioritization process of R&D pipeline at large pharma due to the IRA is largely complete. Now could there be other cancellations? We haven't seen that yet. Due to new developments, we don't know. Again, no one really knows the exact impact of what has been signaled by the new administration. The uncertainty has caused delays in decision-making. I mentioned in my introductory remarks that the time from receiving the RFP to the actual award has expanded by about 10%, in some cases, more than that, both year-over-year and sequentially. So that's an indication, if you will, a high-level metric, but we know this directly from clients who told us, "Well, we're planning on making the decision this quarter, but we're just going to wait a little bit to understand the implications." No one has signaled that they are not going to do the program. But it's just natural that in an environment of uncertainty, you hold off on making a decision on large capital investments.

We'll take our next question from Michael Ryskin at Bank of America.

Just going to follow up on, I think Matt Sykes' earlier question. He talked about cancellations in the quarter already being kind of normal. Maybe I could hone in on book-to-bill trends. I know you don't want to be talking about this number quarterly, but just 1.02 in the quarter. Last year, you called out a few major cancellations that caused 3Q to be lower this year that this quarter doesn't seem to be the case. Is really -- so what do you attribute that number to? Is it really the emerging bio stat that you talked about, how some of the RFPs aren't quite in bookings yet because the funding is not there? Is that the major swing in there? And if so, do you expect to be closer to that 1.15, 1.2 number for the rest of the year?

Okay. So I love this question on the quarterly book-to-bill. We -- I mentioned before that awards that should have been contracted in the quarter, the contract wasn't signed and was delayed. So that happened at large pharma a number of times in the quarter, and that's due to this uncertainty -- general uncertainty in the biopharmaceutical sector. That's one reason for softer bookings. The second reason, as you mentioned, is the EBP funding. I think you noticed that there are many different sources for what was the EBP funding in a given quarter, but we follow consistently BioWorld stats. And I think the funding in the first quarter went down to $13 billion. Now $13 billion is fine, but it's way lower than what we had seen before. And that's an indication, I think, whatever source you look at, you'll see at least decline. Again, it's due to the same reasons, people are hesitant to commit the funds. It does happen that an EBP signs a contract with us and we decide not to include it in the bookings because we're not sure about the funding. But that happens like once or twice in a given quarter. Here, we had a much larger number of such cases in the quarter. So again, the 2 reasons, all deriving from the same underlying factor, which is the macro uncertainty, large pharma ticking down the signature of a contract to a later period and EBPs not confirming that the funding is secure for a contract they've already signed. And as a result, we do not include that in our bookings. That's what caused the softer bookings in this particular quarter, not the cancellations. Now again, I mean, I want to -- since you bring it up and it's my kind of -- it's like agitating a red flag in front of a bull, I typically react to mentions of quarterly book-to-bill. Look, we are projecting for our company 5% growth or thereabouts, 5.2% for this year. If you focus on the CRO business, we -- our guide for the year was 4% to 6% for the year, but we see that we have softer bookings. Even if it's at the lower end of that range, the 4% kind of range for R&DS, and that's excluding the step-down of COVID business, which is about $100 million year-over-year and FX, it's still somewhere around 4%. Now if you look at our sector, there aren't that many benchmarks out there, but we do have a large competitor that's publicly traded and publishes numbers. And I looked at the numbers this morning, and it happens to be coincidentally, it's the exact same book-to-bill ratios quarterly or trailing 12 months. And yet, they are projecting negative growth. On a comparable basis, I think that negative growth is 5%. So you've got the same exact book-to-bill ratio, the same exact. We're projecting about mid-single-digit growth, positive growth for that segment, and they're projecting mid-single-digit decline. It's an 8- or 9-point swing in revenue growth. So if there ever was a proof point that this quarterly book-to-bill ratio doesn't mean anything with respect to predicting growth and performance, I think that's a very strong one. This said, it's an interesting snapshot picture of what's going on at one given point in time given circumstances in the world. It's like you're taking a picture of a particular horse in the Kentucky Derby in the mud running. And you took the picture, and it looks like all its muscles extended and doing extremely well. But then when you see the full movie, you see that the horse lost the race. So it really doesn't mean very much. It's a snapshot. It's interesting, but it doesn't tell you the whole story. Sorry for venting once again.

No, not at all. Very fair point, Ari. I appreciate the context. If I could squeeze in a quick follow-up. Just any commentary on pricing environment? Just wondering if there is any change in the quarter given all the macro uncertainty. And again, this is more specific to R&DS.

No, no change. Look, I mean, pricing is not a lever. It has not been a lever for some time. So we are -- the pricing negotiations always are tough. But again, as Mike mentioned earlier, we've secured the strategic partnerships with our large pharma clients last year. That was the time at which order rates were negotiated and so on. And so I think we are comfortable operating in the current environment. No changes.

We'll move next to Jailendra Singh at Truist Securities.

So just given all the recent macro development and uncertainty you flagged, and thanks for all the color you gave, Ari. Are you guys seeing any change in the RFP or new bookings mix in terms of FSO versus FSP? And one another follow-up quickly, if I can ask. What's the latest on 2 mega trials that were delayed? Are they expected to resume in second half? Sorry for 2-parter.

Those 3 questions?

[ I don't mind ]. Thank you very much for the questions. Number one, I think you're talking about the mix, full service versus FSP. And look, we had signaled over the course of the prior year that large pharma was sort of doing a little bit more FSP. And I think we saw this reflected in the RFP flow and in the awards and in the bookings, okay, where FSP as a percentage of total was increasing, okay? We said that in our bookings in the year, it was reaching in '24 close to 20%. Whereas in our revenue, of course, it's lower than that since we're burning revenue related to prior period bookings. In our revenue, FSPs represented in '24 more about 15% to 16%, so obviously will trend to the 20%. However, again, I said before many times that these are pendulum swings. We've seen it before in this industry where large pharma reverts to FSP, decides to in-source more of the activity, but then they swing back. And I might -- you might find it interesting to know that in the quarter, we actually started seeing some signs of this reversal, okay? Actually, in the quarter, FSP bookings represented less than 10% of the total. And we look at our qualified pipeline, it's in the mid-single digits, low single digits. And in the RFP flow, it's about 5%. We actually have a very, very strong and exciting pipeline and RFP flow in full-service work for large pharma. And the reason is -- the reasons are the same as the reasons that have always led our clients to do more outsourcing, which are basically that they cannot possibly have all the expertise in-house. Sometimes, they buy an asset in a different therapeutic indication, and they need resources that they don't have in-house. And thirdly, after they've been doing FSP work and taking more oversight in-house, they realize that it can become prohibitively costly to do so over a large number of studies. And invariably, they revert back for any of these reasons to full service. And we're starting to see some signals of that. It's not just a snapshot in this case. It was true in the bookings, it's true in the RFP flow, and it's true in the qualified pipeline where we see FSP as a percentage of total decline. I think you had another question, oh, the 2 mega trials, yes. So the 2 mega trials we said had been postponed and taken out of the end of last year and pushed back to the back of this year. We received confirmation from one of them, and that's the good news, that it's expected to get started in the -- towards the second half, towards the end of the year as planned. So that's confirmed. The second one though, for reasons that are inherent to the trial itself, the same logistics reasons they were facing before, was pushed out of the period and won't start this year. And again, all of that was contemplated in our guidance, and so nothing has changed with respect to our numbers. Mike, just any more color on that?

Yes. Just to add a little bit more color on that. So we are reaffirming our range with that mega trial like pushed out of the period, as Ari said, plus let's see what happens with the bookings environment for the balance of the year, you can conceivably see sort of R&DS probably shading more towards the lower end of our guidance range. But we'll have to see. Our BD teams are out there actively working to secure new business, but that's kind of the current view.

We'll move to our next question from Eric Coldwell at Baird.

I have 2, if you don't mind. You might have just partially answered the first one. So I was going to ask about the impact on guidance from FX. And the question was, was there any other change to the guidance or directionality of the guidance excluding FX? What I'm getting to is during the prepared remarks or maybe the Q&A, Ron said that the year-over-year gross margin reduction in Q1 was primarily FX, but FX has now turned from a big headwind to a moderate tailwind. So I'm questioning how much EBITDA and EPS were protected by the FX shift, i.e., would you have needed to maybe reduce the range on EBITDA and EPS if it weren't for FX? And then I have a follow-up.

No. No, I mean, EBITDA is -- you can think of it as being largely independent from the FX ranges. The impact of FX on EBITDA is very muted. The impact on revenue, obviously, isn't. You saw a big increase in our guidance for the year on revenue. And the combination of those 2 reduced our margin -- our implied margin guidance, but yes.

So no notable impact on EPS then for the year from that?

No. Correct, no, no.

Okay, good. And then my -- if I can have one more quickly, and I apologize toggling like everyone, I guess, toggling multiple calls today, so I might have missed this. I have received a couple of inbound questions from investors during the call about TAS M&A and the M&A impact overall from the firm. So if you addressed this, I'm sorry, but I am getting some questions on it. I thought I'd throw it out there.

There's about 200 basis points for the quarter, Eric, and about 150 basis points for the year, the majority but not entirely in TAS.

So if TAS -- so the question, Ron, was if TAS was the majority, and I don't know if that's 60% or 90%, but if it was the majority, then mathematically, I believe you could have picked up as much as 5 points of growth in TAS.

No, no. No, it wasn't that much. Organic growth in TAS was sort of mid-single digits -- low mid-single digits, yes.

We'll move next to David Windley at Jefferies.

I wanted to focus on margin and ask if you could talk about margin performance by segment. And then on the restructuring activities, the expense that you took in the quarter, the add-back was a little bigger. I wondered if you could comment related to cost takeout, what some of the targets are? Is it still kind of rightsizing head count or facility consolidation? Or is it something else? And how we should think about those cost takeouts, again, going back to the margin by segment?

Yes. Yes. Well, look, what we're doing in terms of margins and is essentially to work on our cost structure the same way we've been working on it forever, that is address the overhead structure as we continue to scale up our business, address labor arbitrage. We offshore -- we have offshore centers all over the world for different centers of excellence for different types of activities, both on the commercial and the R&DS side. And we continue to shift work in different places where it's optimal. And finally, we use technology, automation and our AI agents to bring more efficiencies to our processes. Those activities result in the restructuring of head count literally all over the world and in both -- in all segments. So that's what you see reflected in the quarter in the structural numbers, but that's the -- do we talk about margins by segment? I mean we do -- we have disclosure on...

We disclose that. We have a disclosure -- segment disclosure on a GAAP basis. So look, there's a little bit more pressure on overall margins in the R&DS segment than there is in the TAS segment. Both had good SG&A performance, a little bit more gross margin pressure in the R&DS segment. Some of that mix related relating to FSP and also increases higher growth in the lab business, it tends to be a lot lower margins, but...

This is the mix, the mix influences margins in the segments, right? So real world, for example, is somewhat lower margin than the rest of the business, than the analytics or the data or the technology. And so as a result, when real world grows faster, you do have a mix impact on margins. That's for the commercial side. And then on the R&DS, as Ron mentioned, FSP and lab do have lower-margin profile than full service. And as I mentioned, in our revenues, FSP is a little bit higher, maybe a point or two in the quarter. In the revenue side, I mentioned earlier that in my commentary on bookings and pipeline and RFPs that it seems to be going the other way now. But on the revenue side, FSP was a little larger in the quarter and lab was also a little bit larger. And those 2 have somewhat lower margin profiles than full service. So yes, we did have the quarter adverse mix impact on margins. But again, that can fluctuate quarter-to-quarter.

All right, quickly, any -- yes. I was just saying, any pass-through movement as part of that conversation that we should be aware of, pass-through change in the revenue composition?

Nothing [ overly significant ].

No, nothing [ really significant ], no.

And we'll go to Tejas Savant at Morgan Stanley.

So I'll ask a quick 2-parter. Ron, any comments on the stranded costs associated with the mega trial that you -- that is now pushed to '26? And is there any risk that the second trial, which you just got confirmation on, could slip again in that sort of 4Q time frame into '26 as well? And then, Ari, one for you on real-world evidence. You called out some of the unique sort of policy-driven opportunities for that business over the medium term. Is there anything you're doing either organically or perhaps from an M&A standpoint that could position you to fully capitalize on some of these opportunities that are coming up?

I'll start, Tejas, with the stranded costs. A little bit of impact, but not a huge impact. Obviously, on the trial that got further delayed, we're going to free up those sources and use them for other purposes. We're not going to keep them there indefinitely. But there is -- for the one that's going forward, there is a little bit of impact, not terribly significant. And look, we can only react to what our customer tells us on the trial that was further delayed. And we're assuming that it will go forward, that the customer still wants to do it and we'll fit.

Yes. And the one that started as planned, we got recent confirmation that, that's the plan. So there's no further news on that or notification of any changes as of today. So that's for that. What was the other question? Real world. Yes. Well, no, look, real world, I think we are -- the industry will tell you that we are recognized as the leader in the area, in this segment. And we intend to fully capitalize on the opportunities that may emerge from any new initiatives from the administration, as I mentioned in my remarks. So I think, again, we are very well positioned here to navigate this sort of turbulent times. I'm very, very confident based on our conversations with clients that the world is not coming to an end, and the industry will find ways to adapt. In fact, there are many reasons to feel very optimistic. As I said before and I'll repeat again, I feel better at this point in the quarter than I did at the same point last quarter when I look at the metrics, whether it's on the commercial side or on the R&DS side and based on our conversation with clients. So with that...

Okay. Good. Thank you, everyone, for taking the time to join us today on our second quarter 2025 earnings call. The team will be available for the rest of the day to take any follow-up questions that you might have. Thank you very much, and have a good day.

And this concludes today's conference call. Thank you for your participation. You may now disconnect.