IQVIA Holdings, Inc.

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the IQV of first quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. As a reminder, this call is being recorded. I would now like to turn the call over to Kerry Joseph, senior vice president of 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 Boosby, chairman and chief executive officer, Ron Broman, executive vice president and chief financial officer, Eric Sherbert, executive vice president and general counsel, Mike Fedop, senior vice president, financial planning and analysis, and Gustavo Torrone, 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 webcasts. This presentation also will be available following this call in the events and presentation section of our IQVIA investor relations website at .IQVIA.com. Before we begin, I'd like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. After results could differ materially, those data are implied by forward-looking statements due to risk 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 10K 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 Duffy. Thank you, Gary, and good morning, everyone.

Thank

you for joining

us today to discuss our first quarter results. I'm going to start with a 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 -over-year growth of .5% on a reported basis, and .5% at constant currency. And compared to last year and excluding COVID-related work from both periods, we grew the top line about .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 di-utility PS of $2.70 increased .3% -over-year. Let me share some details on the market landscape and the demand metrics we're seeing for each segment. Starting with us, 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 roadmaps. 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 IQVS portfolio of offerings. It's great that TAAS is contributing over 40% of our revenue. TAAS revenue growth actually came in above our expectations at .4% reported and .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 RSP issuance to award in the quarter increased by approximately 10% both year over year and sequential. 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 the 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 .8% compared to the prior year. Our first quarter RSP flow improved mid-single digits year over year and high single digits sequential. 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 have been signaled by the new US administration. The White House's initiative relative to our industry sector can be grouped into three 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 IQVL's direct exposure to tariffs is limited primarily to certain supplies in our laboratory business and is immaterial financial. 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. TARs does have a minimal amount of business with the government, and we do not expect any of these 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 have 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 product 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. Today, we have no evidence of any trial or approval delays. Whatever anecdotal disruptions there may be in -approval-related interactions with FDA staff, we expect this to normalize. FDA Commissioner McCary has announced his intention to reduce animal testing in favor of AI-based models and enhance usage of real-world evidence in the approval process. We applaud this, and we see these actions proposed by Commissioner McCary 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 pre-clinical work, but also in phase two and phase three trials plays to IQVF strengths. Ultimately, this is positive news for EVP companies, which develop over 50% of the drugs in clinical trials. Finally, on drug pricing, the US administration recently issued an executive order regarding the role of PVMs, 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 two 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 subjects small molecule drugs to CMS pricing review after only nine years, versus 13 years for large molecule drugs. This is key for pharma clients as 60%. 50% of the drug's value is realized in years nine 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 had not been secured yet. Now we are confident that our industry will successfully manage this period of uncertainty, and we'll 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 market place. We believe when everything is said and done, key decision-makers will recognize the industry is a strategic sector for the US that deserves to be strongly supported. US 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 US leadership. The US 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 five million people at an average of $157,000 annually, which is double the national average. In fact, many non-US large pharma companies have moved their primary R&D centers to the US 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 last 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 long partnership with another EBP, leveraging our AI-powered Patient Relationship Manager platform for groundbreaking treatment for rare condition in an underserved patient community. We were selected to support a mid-size pharma client with an omnichannel campaign that includes KPI 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, displays the incumbent at an EBP client. In the medtech space, we secured a significant contract to deploy an integrated information solution to help our clients stream our operations and decision-making. Let me skip a few more of these and move to R&DF. 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 expanded the scope in half a dozen of them. We are being awarded significant contracts from these partnerships. For example, in the quarter, a top five pharma clients that have selected IQVIA as a preferred partner awarded us four early stage studies under the new model. IQVIA was selected by a top 20 pharma client to support a phase three obesity program across eight studies. Our -in-class clinical trial technology solutions and industry leading expertise were key factors in securing this deal. The top 10 pharma clients selected IQVIA's pharma co-visioning offerings to achieve a significant reduction in case processing time, enable efficiency, and manage the increasing volume. We secured a contract with an EBP client to run a phase two trial for an innovative treatment for patients with pulmonary hypertension associated with interstitial lung disease. The customers 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 three use cases in each of the commercial, real world, and R&DS trends. We are seeing positive results and productivity gains in areas where these AI agents have been deployed. For example, one agentic system in commercial allows us to reduce delivery time by two thirds, from 12 weeks to four weeks, with a net 30% cost reduction. We plan to scale up from these three use cases to 12 by the end of the second quarter, and 40 use cases by the end of the year. And now to Ron for more details on our financial performance.

Thanks, Dari, and good morning, everyone. Let's start by reviewing revenue. First quarter revenue of ,000,000 grew .5% on a reported basis, and .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%. As Dari mentioned, acquisitions contributed approximately two points of this growth than majority of this in the TAS segment. Technology and analytics solutions revenue for the first quarter was ,000,000, that was up .4% reported, and .6% constant currency. R&D solutions first quarter revenue was ,000,000, up .3% reported, and .1% constant currency. Excluding COVID-related work, R&D's revenue grew approximately 3% constant currency. Finally, contract sales and medical solutions first quarter revenue of ,000,000, declined .2% reported, and .1% at constant currency. Moving down the P&L, adjusted EBITDAO was ,000,000 for the quarter, that was growth at .4% year over year. First quarter net income was ,000,000, and gap diluted earnings per share was $1.40. Adjusted net income was ,000,000, for the first quarter, up .4% year over year, and adjusted diluted earnings per share grew 6.3%, to $2.70. R&D's backlog at March 31 was $31.5 billion, an increase of .8% year over year, and .6% of constant currency. Next 12 months revenue from this backlog is $7.9 billion. Reviewing the balance sheet, as of March 31, cash and cash equivalence totaled ,000,000, and gross debt was ,000,000, resulting in net debt of ,000,000. Our net leverage ratio ended the quarter at 3.40 times 12 month adjusted EBITDAO. First quarter cash flow from operations was ,000,000, and capex was ,000,000, resulting in strong free cash flow of ,000,000. In the quarter, we repurchased ,000,000 of our shares. This leaves us with approximately $2.6 billion remaining under the current program. Okay, 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 ,000,000, which represents -over-year growth to 3.9 to .5% on a reported basis, or .2% growth at the midpoint. This guidance now includes a -over-year FX tailwind of approximately 50 basis points, compared to about 150 basis points at 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 ,000,000 to ,000,000, as FX changes had a negligible impact on EBITDA. This represents -over-year growth of 2.2 to 5.5%. We're also reaffirming our adjusted deleted EPS guidance, which continues to be $11.70 to $12.10, that's up 5.1 to .7% versus the prior year, or .9% growth at midpoint. Now let's go through the second quarter guidance. For the second quarter, we expect revenue to be between ,000,000 and ,000,000. Adjusted EBITDA is expected to be between ,000,000 and ,000,000, and adjusted deleted 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 5th continue for the balance of the year. So to summarize, in Q1, we delivered strong revenue and profits results at the high end of our expectations. We had a very solid free task flow of 89% of adjusted net income. The task business continued to achieve above target performance with revenue growth at .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 set forward looking indicators for R&DS offerings, such as qualified pipeline, RFP flow, and backlog continue to grow. We're progressing as planned, deploying new highly specialized industry AI agents, and we've identified over 40 use cases and scaled up, deploying it 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 FFAC, 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?

I apologize, I was muted, yes. At this time, I would like to remind everyone in order to ask a question, press star then the number one on your telephone keypad. We request that you please limit yourself to just one question so that others in the queue may participate as well. And we'll take our first question from Justin Bowers at Deutsche Bank.

Thank you, and good morning, everyone. Ari, could you discuss some of the drivers behind the strengths 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 delivers better than expected revenue growth, which is what helps the company deliver above the high end of our guidance, with .6% of cost on currency. Now they 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 had essentially shut down, and in the end of 23, beginning of 24 timeframe, and the rest of the real world business, which is more mission critical, had 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. Thank you, Justin. Thank you.

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

Thanks for taking my question. Ron, just maybe on the margin side, I know you guys had called out Q4, 20 basis point potential margin expansion. Looks like as you kind of rearranged the guide, maybe 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?

Yeah, well, one thing I would point out, Matt, when you're looking at the margin first or 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 first margins, or either top margins, as the dollar is weak and revenue is going 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. AI would be one example that we're looking at. We're always looking at taking costs out across the organization. That's an ongoing effort. You'll see that in our restructuring expense. You know, of course, against that, we do have pressures on things like not just FX, but MIPS has gone against us to a certain extent. You'll see that in the gross margin. And that next includes, for instance, the shift towards FSP, which hurts margins a little bit. But in that 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, thank you. 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 one of 13 to one of four, 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? Yeah, RDS specifically, yep. And vendor consolidation.

Yeah. Yeah, Luke, you know, 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. You know, we went through a period of reviews and re-prioritization 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 the normal historic range. So what happened in the course of respect to our building 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 EVPs. So we had an unusually high number of EVP awards in the first quarter that were actually not only awards, 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. Respect the RFP flow, though, it's still very, very good. I mean, whether we've seen consistent numbers in terms of whether it's dollar value or volume, and our wind rates and heat 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 EVPs at this point. But it's pretty good actually, and sequentially it's high, so even which it's higher. So from that standpoint, I feel better at this point in the quarter than I did at the same point last year.

Yeah, and as we 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 and those relationships coming through.

Thank you. We'll go next to Shlomo Rosenbaum at Steeple.

Hi, thank you for taking my question. Hey, Ari, I want to ask a little bit more just probing on the operating environment. Given the uncertainty, what you saw in RDS, 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 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 RDS business? If you give us your thoughts on those things.

Yeah, I mean, you guys, that way 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, you know, 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 timelines and so on continue to be strong. I believe that the reason we haven't seen that is because there were 10-type demand. We had already gone through the 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 had been approved needed to be launched and that's what's happening now. So what we do in TAS is support the launch of the 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 haven't stopped doing that. So we haven't seen that. I understand the question, but in the TAS business, we're seeing continued good growth as expected. And again, I believe that the spend has been held back for a while and there is a 10-type demand and necessary things to do. Now the discretionary staff, the absolute discretionary staff, consulting and so on. Yeah, I mean, it's not spectacular. It's just like, you know, flat to mid-single digits kind of current level. So it's not that we are looking at the spectacular things. So what is being done now is the stuff that was necessary to operate. I mentioned the real world before, as well as the fact that demand on other things. And then that's what's driving TAS. So I don't see the environment influencing this much. On the R&D side, yeah, again, because of uncertainty, so you hold back on decisions. The type of re-practice stations we saw before were due to the IRA. And I think as we mentioned prior calls, we see that to be largely over. The re-prioritization of pipelines, which led to elevated levels of cancellations that were triggered by certain provisions of the IRA. And I remind you, the IRA was, I guess, at late 22. And this process started in 23. So we are now a couple of good two years after that process started. And we believe that that re-prioritization process of R&D pipelines at large format, 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 seen or 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 -over-year and sequential. So that's an indication, if you will, a high-level metric, but we know this directly from clients of Tula as well. We're planning on making a decision this quarter, but we just kind of wait a little bit to understand the implications. No one has signaled that they are not gonna do the program, but it's just natural that in an environment of uncertainty, you hold off on making the decision on large capital investments.

Thank you.

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

Great, thanks for taking the question, guys. I'm gonna follow up on Matt's earlier question. He talked about cancellations in the quarter already being kind of normal. Maybe I could hone in on -to-bill trends. I know you don't want me talking about this number quarterly, but 1.02 in the quarter, last year you called out a few major cancellations across the country. 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 set that you talked about, how some of the RFPs aren't quite in bookings yet because the funding's not there? Is that the major swing there? And 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. 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 bio-pharmaceutical sector. That's one reason for softer bookings. The second reason, as you mentioned, is the EDP funding. I think you noticed that there are many sources for what was the EDP funding in the given quarter, but we follow consistently by world stats. And I think the funding in the first quarter went down to $13 billion. Now, $13 million 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 that EDP funding is fine. Again, it's due to the same reasons people are hesitant to commit the funds. It does happen that the EDP 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 two 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 EDP 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 start of the bookings in this particular quarter, not the cancellations. Now, again, I want to, since you bring it up, and it's my kind of, it's like agitating the red flag in front of a bull. I typically react to mentions of quarterly book to bills. Look, we are projecting for our company 5% growth or thereabouts .2% for this year. If you focus on the CRO business, we have guide for the year was 4 to 6% for the year, but we see that we have softer bookings. Even if it's in at the lower end of that range, the 4% kind of range for RMDS. 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, you look at our sector, there aren't that many benchmarks out there, but we do have a large competitor that's published, which is published in numbers. And I looked at the numbers this morning, and it happens to be coincidentally to the exact same book to bill ratios, or trading for a month. 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. Are we projecting about mid-single digit growth, positive growth for that segment, and they're projecting mid-single digit decline, it's an eight or nine 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 is an interesting snapshot picture of what's going on at one given point in time, given circumstances in the world. It's like, you know, 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 affect the whole story. Sorry for that, once again.

No, not at all, very fair point, Ari. Thank you for that, Kolar, appreciate the context. If I could squeeze in quick follow-up, just any commentary on pricing environment, just wondering if there was any change in the quarter, given all the macro uncertainty. And again, this is more specific to R&DS.

Thanks. No, no change. Look, I mean, you know, pricing is not, it's not a level, you know, has not been a level for some time. So we are, you know, 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 all the rates were negotiated and so on. And so I think we are comfortable operating in the current environment, no changes.

Thank you. Thanks so much.

Thank

you.

We'll move next to Jaylendra Singh at Trist Securities.

Yeah, thank you, and thanks for taking my questions. 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 two mega trials that were delayed? Are they expected to resume in second half? Sorry for two-parter.

Those three questions. It's a point.

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 signals 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 2024, 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, FSP represented the average in 24 more about 15, 15 to 16%. So obviously we 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 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 very, very strong and exciting pipeline and RFP flow in full service work for our pharma. And 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 customers. 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 through the bookings, it's through the RFP flow, and it's through the qualified pipeline where we see FSP as a percentage of total decline. I think you have another question. Oh, the two mega trials. So the two 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 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 client 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's changed with respect to our numbers. Okay, thanks, Adi.

Can I just

add a little

bit more color on that? Yeah, just add a little bit more color on that. So we are reaffirming our range. With that mega trial pushed out of the period, as Ari said, plus, let's see what happens with the focusing environment and the balancing here, you can conceivably see RDS probably shading more towards the lower end of our guidance range, but we'll have to see. The RDB teams are out there actively working to secure any business, but that's kind of current. Got it, thanks, guys.

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

Thanks, I have two, if you don't mind. You might have just partially answered the first one. So I was gonna 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 -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 we'll move on. 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 to reduce our margin, our required margin guidance, but yeah, but.

Yeah, but. So no, no notable impact on EPS then for the year for FX. No, no. Good. And then if I can have one more quickly and 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 address 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 five points of growth in TAS. No. There wasn't that much.

Organic growth in TAS was for mid-single digits.

Okay, perfect. Thanks very much.

Low mid-single digits, yeah.

We'll move next to David Wendley at Jeffries.

Hi, good morning. Thanks for taking my question. 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 right-sizing headcount 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. Thanks.

Yeah, yeah. Well, look, what we're doing in terms of margins and is essentially to work on our cost structure, the state where 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 have offshore centers all over the world for different centers of excellence, for different types of activities, both on the commercial and the R&GS side, and we continue to shift work different places where it's optimal, and finally, we use technology, automation, and now AI agents to bring more efficiencies to our processes. Those activities result in the restructuring of headcounts, literally all over the world and in all segments. So that's what you see reflected in the whole range of structural numbers, but that's the, do we talk about margins by segments? I mean, we do, we have disclosure of- We disclose that.

We have a disclosure, segment disclosure on that basis. Look, there's a little bit more pressure on overall margins in the R&DS segment than there is in the TAD segment. Both have good SG&A performance, a little bit more gross margin pressure in the R&DS segment. Some of that mix relating to FSP and also increases higher growth in the lab business that tends to be a little bit lower margin.

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 mixed 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 and full service, and as I mentioned, in our revenue, FSP is a little bit higher, maybe a point, in the whole, in the revenue side. And 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 a little bit larger, and those two have somewhat lower margin profiles than for service. So yes, we did have the quarter adverse mix impact on margins, but again, that can fluctuate in the quarter to four. All right, quickly.

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, no,

nothing significant,

no.

Okay, great, thank

you. All right, we have time for one more operator.

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

Hey guys, thank you for the time here. So I'll ask a quick two-parter. Ron, any comments on the stranded costs associated with the mega trial that you said 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 four-queue timeframe 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, okay, this would be the stranded cost. A little bit of impact, but not a huge impact. Obviously on the trial that got further delayed, we're gonna free up those resources and use them for other purposes. We're not gonna keep them there indefinitely, but for the one that's going forward, there is a little bit of impact, not terribly significant. And 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. The customer still wants to do it, and we'll say.

Yeah, 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, yeah. 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 repeat again, I feel better at this point in the order 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&DF side, and based on our conversation with clients. So with that.

Okay, good, okay. Thank you, everyone, David and Clam has joined us today. Our second quarter of 2025 earnings crop, the team will be available the rest of the day to take any follow-up questions that you might have. Thank you very much, have a good day.

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