IQVIA Holdings - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 revenue was $3.829B (+2.5% reported, +3.5% CC), Adjusted EPS was $2.70 (+6.3% YoY), and Adjusted EBITDA was $883M (+2.4% YoY), with TAS strength offsetting slower R&DS bookings conversion.
• Management raised FY 2025 revenue guidance by $275M to $16.0–$16.4B on FX tailwinds and reaffirmed Adjusted EBITDA ($3.765–$3.885B) and Adjusted EPS ($11.70–$12.10) guidance; Q2 2025 guidance: revenue $3.925–$4.000B, Adjusted EBITDA $895–$915M, Adjusted EPS $2.72–$2.83.
• R&DS quarterly bookings were $2.1B (book-to-bill 1.02x) and TTM bookings $9.7B (TTM book-to-bill 1.14x); backlog reached a record $31.5B with $7.9B expected to convert in the next 12 months.
• Key narrative: robust TAS demand (double-digit RWE), FX tailwind, and AI execution momentum, versus decision delays in clinical programs (especially EBP funding) and adverse mix pressures on margins—setting catalysts around FX-driven top-line raise, TAS recovery durability, and timing of mega-trial ramps.

What Went Well and What Went Wrong

• What Went Well

  • TAS delivered above-target growth: $1.546B (+6.4% reported, +7.6% CC) led by strong double-digit Real-World Evidence demand; pent-up demand and required work returned.
  • Robust cash generation: operating cash flow $568M and free cash flow $426M (89% of adjusted net income).
  • Strategic progress in AI: >20 agents in production across commercial, RWE, and R&DS, with tangible productivity gains (e.g., delivery time cut from 12 to 4 weeks, ~30% cost reduction).

• What Went Wrong

  • Bookings softness in R&DS: quarterly book-to-bill 1.02x amid delayed customer decision-making and lower EBP funding; contracted EBP awards not booked pending funding certainty.
  • Margin pressures from mix and FX: shift toward FSP and labs and FX effects weighed on gross/EBITDA margins; margin expansion expectations moderated.
  • Mega trial timing: one mega trial reconfirmed for late 2025; the other further delayed out of the period, contributing to R&DS skew toward lower end of guidance.

Transcript

Operator (participant)

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. 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 Kerri Joseph, Senior Vice President of Investor Relations and Treasury. Mr. Joseph, please begin your conference.

Kerri Joseph (SVP of Investor Relations and Treasury)

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 Scherber, Executive Vice President and General Counsel; Mike Fedock, Senior Vice President of Financial Planning and Analysis; and Gustavo Peroni, 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 Presentations section of our IQVIA Investor Relations website at ira.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 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 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.

Ari Bousbib (Chairman and CEO)

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. 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&D Solutions. 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.

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 we're seeing for each segment. Starting with GAAP, 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 IQVIA's portfolio of offerings. It's great that TAS is contributing over 40% of our revenue.

TAS's 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 biotechs, especially for early stage, has deteriorated. While the R&D Solutions 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 have been signaled by the new U.S. administration. The White House's initiatives 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, 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 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. To date, we have no evidence of any trial or approval delays. Whatever anecdotal disruptions there may be in non-approval-related interactions with FDA staff, we expect this to normalize.

FDA Commissioner McKerry 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 McKerry 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 two and phase three trials, plays to IQVIA's strengths. Ultimately, this is positive news for EVP 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. 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 50% of the drug's value is realized in years nine to thirteen. Second, the focus on drug pricing, treatment value, and comparative effectiveness drives the need for earlier clinical results and more real-world evidence. In summary, some of our customers have slowed down their decision-making processes, as you would expect, and we experience delays in RFPs moving to contracts in the first quarter.

An unusually high number of EVP 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 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. 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, the last project for an important EVP 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 EVP, 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 mid-size 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, displaces the incumbent at an EVP 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&D Solutions. 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 client that had 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 best-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 provisioning offerings to achieve a significant reduction in case processing time, enable efficiency, and manage the increasing volume. We secured a contract with an EVP client to run a phase two 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 three use cases in each of the commercial, real-world, and R&D Solutions segments. 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 4 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. Now to Ron for more details on our financial performance.

Ron Bruehlman (EVP and CFO)

Thanks, Ari, and good morning, everyone. Let's start by revealing revenue. First quarter revenue of $3,829 million 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%. As Ari mentioned, acquisitions contributed approximately two points of this growth, the majority of this in the TAS segment.

Technology and Analytics Solutions revenue for the first quarter was $1,546 million. That was up 6.4% reported and 7.6% constant currency. R&D Solutions first quarter revenue was $2,102 million, up 0.3% reported and 1.1% constant currency. Excluding COVID-related work, R&D Solutions revenue grew approximately 3% at 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 at 2.4% year over year. First quarter 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&D Solutions 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 million, and gross debt was $14,330 million, resulting in a net debt of $12,590 million. Our net leverage ratio ended the quarter at 3.40 times 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. 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 $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 million-$3,885 million 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 million 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. 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. 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 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&D Solutions bookings were affected by delayed decision-making by customers on new programs and lower EVP funding, reflecting incremental macroeconomic and industry sector uncertainty.

That said, forward-looking indicators for R&D Solutions offerings, such as qualified pipeline, RFP flow, and backlog, continue to grow. We're progressing as planned to deploy new highly specialized industry AI agents, and we've identified over 40 use cases to scale up deployment across our portfolio in 2025. In the quarter, we repurchased $425 million of our shares. Lastly, we raised our full-year revenue guidance by $275 million to reflect changes in FX. Of course, we reaffirmed our profit guidance. With that, let me hand it back over to the operator to open the session for questions and answers. Hello, operator.

Operator (participant)

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. We'll take our first question from Justin Bowers at Deutsche Bank.

Justin Bowers (Equity Research Analyst)

Thank you. Good morning, everyone. 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?

Ari Bousbib (Chairman and CEO)

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, 7.6% at constant currency. As I mentioned, this was driven largely by the strong growth in real world, which was strong double digits. You will recall that real world had declined.

The part of real world that's discretionary had essentially shut down in the end of 2023, beginning of 2024 timeframe. 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. Both the discretionary piece and the required work that's necessary to support safety or pricing, demonstrating the effectiveness of treatments, etc., 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.

Justin Bowers (Equity Research Analyst)

Thank you.

Operator (participant)

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

Matthew Skyes (Managing Director and Research analyst)

Thanks for taking my question. Ron, just maybe on the margin side, I know you guys had called out in Q4 a 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?

Ron Bruehlman (EVP and CFO)

Yeah. One thing I would point out, Matt, when you're looking at the margin first, our previous guide is obviously the impact of FX because FX affects our top line, but does not have much impact on our bottom line. If you're looking at Gross margins or EBITDA margins, as the dollar is weak and revenue has gone up, profit has not followed. 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. 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. Net net, the margin picture really hasn't changed that much. What you're seeing is mostly just the impact of FX, almost entirely.

Matthew Skyes (Managing Director and Research analyst)

Got it. Thank you. 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. In this environment, given sort of lower levels of demand, how do you feel about your position? Do you think that vendor consolidation trend, which has already been in place, will accelerate in this environment?

Ari Bousbib (Chairman and CEO)

Are you looking about the RDS business and RFP flow?

Matthew Skyes (Managing Director and Research analyst)

Yeah. RDS specifically, yep, and vendor consolidation.

Ari Bousbib (Chairman and CEO)

Yeah. Yeah. Look, the RFP flow is actually pretty good given the environment. 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 2024, maybe 50% higher cancellation levels in 2024 than the historic norm. In the quarter, just I might mention, we had cancellations that were just in the normal historic range. What happened in the course we expect 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. Separately, as you might have noted, there was a deterioration in the funding for EVPs. We had an unusually high number of EVP awards in the first quarter that were actually not only awards, but they were also contracted.

Our policy is not to include those in bookings if we're not confident in the funding, or as long as we're not 100% sure that the funding has been secured. Respecting the RFP flow, though, it's still very, very good. I mean, we've seen consistent numbers in terms of whether it's dollar value or volume, and our win rates and hit rates are stable. We're not seeing any changes really in the flow of RFPs. The large pharma RFPs are up stronger than EVPs at this point. It's pretty good, actually. Sequentially, it's rising the digits higher. From that standpoint, I feel better at this point in the quarter than I did at the same point last quarter. Yeah.

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

Matthew Skyes (Managing Director and Research analyst)

Thank you.

Operator (participant)

We'll go next to Shlomo Rosenbaum at Stifel.

Shlomo Rosenbaum (Managing Director)

Hi. Thank you for taking my question. Hey, Ari, I wanted to ask a little bit more, just probing on the operating environment. Given the uncertainty of what you saw in R&D Solutions, I'm just surprised that you didn't see that in more of the short-cycle business in TAS. You kept the guidance, and I guess the assumption is things are going to continue.

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? Could it potentially result in further reprioritizations even in the R&D Solutions business? If you give us your thoughts on those things. Y

Ari Bousbib (Chairman and CEO)

eah. I mean, you're kind of somewhere you're asking the question. There's considerable uncertainty out there. Whenever you have uncertainty, then obviously people are hesitant to spend money. That's just a general rule. That's the concern out there. 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 pent-up demands.

We had already gone through a period of holding back on spend in TAS, starting from the middle of 2023 through the middle of 2024. At that point, drugs that had been approved needed to be launched. That is what is happening now. What we do in TAS is support the launch of the drugs, market access, pricing of drugs, supporting commercialization efforts, etc. That is the day-in and day-out day-to-day business of our clients. They have not stopped doing that. We have not seen that. I understand the question, but in the TAS business, we are seeing continued good growth as expected. I believe that the spend has been held back for a while, and there is pent-up demand and necessary things to do. Now, the discretionary stuff, the absolute discretionary stuff, consulting, and so on, yeah. I mean, it is not spectacular.

It's just like flat to mid single digit kind of level. It is not that we are looking at the spectacular things. 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. That was driving TAS. I do not see the environment influencing this much. On the R&D Solutions side, yeah. Again, because of uncertainty, you hold back on decisions. The type of reprioritizations we saw before were due to the IRA. I think, as we mentioned 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. I remind you, the IRA was, I guess, at least 2022, and this process started in 2023.

We are now a couple of good two years after that process started. We believe that that reprioritization process of R&D pipelines at large pharma due to the IRA is largely complete. Now, could there be other cancellations? We have not seen that yet due to new developments. We do not 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.

That's an indication, if you will, a high-level metric, but we know this directly from clients who've told us, "Well, we were planning on making a 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 the decision on large capital investments.

Shlomo Rosenbaum (Managing Director)

Thank you.

Operator (participant)

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

Great. Thanks for taking the question, guys. Just going to follow up on, I think, Matt Flik's earlier question. You 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 like talking about this number quarterly, but just 1.02 in the quarter.

Last year, you called out a few major cancellations that caused the req to be lower. This year, this quarter does not seem to be the case. What do you attribute that number to? Is it really the emerging bias that you talked about, how some of the RFPs are not quite in bookings yet because the funding is not there? Is that the major swing in there? Do you expect to be closer to that 1.15 - 1.2 number for the rest of the year?

Ari Bousbib (Chairman and CEO)

Okay. I love this question on the quarter, to be honest. I mentioned before that awards that should have been contracted in the quarter, the contract was not signed and was delayed. That happened at large pharma a number of times in the quarter, and that is due to this uncertainty, general uncertainty in the biopharmaceutical sector. That is one reason for software bookings.

The second reason, as you mentioned, is the EVP funding. I think you noticed that there are many different sources for what was the EVP funding in a given quarter, but we follow consistently BioWorld stats. 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. That's an indication, I think, whatever source you look at, you'll see that EVP funding declined. Again, it's due to the same reasons people are hesitant to commit the funds. It does happen that an EVP signs a contract with us, and we decide not to include it in the bookings because we're not sure about the funding. That happens like once or twice in a given quarter. Here, we had a much larger number of such cases in the quarter.

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 EVPs not confirming that the funding is secure for a contract they've already signed. As a result, we do not include that in our bookings. That's what caused the software 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 board. I typically react to mentions of quarterly book-to-bills. Look, we are projecting for our company 5% growth or thereabouts, 5.2% for this year. If you focus on the CRO business, our guide for the year was 4% -6% for the year, but we see that we have software bookings.

Even if it's at the lower end of that range, in the 4% kind of range for R&D Solutions. That's excluding the step down of COVID business, which is about $100 million year over year, and effects, it's still somewhere around 4%. 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. I looked at the numbers this morning, and it happens to be coincidentally the exact same book-to-bill ratios, quarterly or trailing 12 months. Yet, they are projecting negative growth. On a comparable basis, I think that negative growth is 5%. You have 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. If there ever was a proof point that this quarterly book-to-bill ratio does not mean anything with respect to predicting growth and performance, I think that is a very strong one. This. Very. It is an interesting snapshot picture of what is going on at one given point in time, given circumstances in the world. It is like you are taking a picture of a particular horse in the Kentucky Derby in the mud running, and you took a picture, and it looks like all its muscles extended and doing extremely well. When you see the full movie, you see that the horse lost the race. It really does not mean very much. It is a snapshot. It is interesting, but it does not tell you the whole story. Sorry for backing once again.

No, not at all. Very fair point, Ari. Thank you for that color. Appreciate the context. If I could squeeze in a quick follow-up, just any commentary on pricing environment? Just wondering if there's any change in the quarter given all the macro uncertainty. Again, this is more specific to R&D Solutions. Thanks

. No, no change. Look, I mean, pricing is not a level. It has not been a level for some time. The pricing negotiations always are tough. 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. I think we are comfortable operating in the current environment. No changes. Thank you.

Thank you so much. Thank you.

Operator (participant)

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

Jailendra Singh (Managing Director)

Yeah, thank you. And thanks for taking my question.

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? One other follow-up quickly, if I can ask, what's the latest on two mega trials that were delayed? Are they expected to resume in the second half? Sorry for two-parter.

Ari Bousbib (Chairman and CEO)

Those three questions? It's a binder. Thank you very much for the questions. Number one, I think you're talking about the mix, full service versus FSP. Look, we had signals over the course of the prior year that large pharma was sort of doing a little bit more FSP. I think we saw this reflected in the RFP flow and in the awards and in the bookings, where FSP as a percentage of total was increasing.

We said that in our bookings in the year, it was reaching 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, FSP represented in 2024 more about 15%-16%. Obviously, we're trying to do 20%. However, 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 insource more of the activity, but then they swing back. You might find it interesting to know that in the quarter, we actually started seeing some signs of this reversal. Actually, in the quarter, FSP bookings represented less than 10% of the total. We look at our qualified pipeline. It's in the mid single digits, low single digits.

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. 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. 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. Invariably, they revert back for any of these reasons to full service. 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 have another question about the two mega trials. Yes. 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. 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. Again, all of that was contemplated in our guidance, and nothing's changed with respect to our numbers.

Jailendra Singh (Managing Director)

Okay. Thanks, Ari.

Ari Bousbib (Chairman and CEO)

We'll cover on that. Yeah, just to add a little bit more color on that. 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 booking requirements and the balance in the year, you can conceivably see sort of RDS probably shading more towards the lower end of our guidance range. We'll have to see. Our BD teams are out there actively working to secure your business, and that's kind of the current view.

Jailendra Singh (Managing Director)

Got it. Thanks, guys.

Operator (participant)

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

Eric Coldwell (Managing Director)

Thanks. I have two, if you don't mind. You might have just partially answered the first one. 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 run, 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. 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? You have a question.

Ari Bousbib (Chairman and CEO)

No, 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 two reduced our implied margin guidance. Yeah, that's yeah. No notable impact on EPS then for the year from FX.

Eric Coldwell (Managing Director)

Okay. Good. If I can have one more quickly, and apologize toggling like everyone, I get to 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. If you addressed this, I'm sorry, but I am getting some questions on it. I thought I'd throw it out there.

Ari Bousbib (Chairman and CEO)

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.

Eric Coldwell (Managing Director)

The question, Ron, was if TAS was the majority, and I do not know if that is 60% or 90%, but if it was the majority, then mathematically, I believe you could have picked up as much as five percentage points of growth in TAS.

Ron Bruehlman (EVP and CFO)

No, no. There was not that much. Organic growth in TAS was sort of mid single digits.

Eric Coldwell (Managing Director)

Okay. Perfect. Thanks very much.

Ari Bousbib (Chairman and CEO)

Low mid single digits. Yeah.

Operator (participant)

We will move next to David Windley at Jefferies.

David Windley (Managing Director)

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. 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.

Ari Bousbib (Chairman and CEO)

Yeah. Yeah. Look, what we're doing in terms of margins is essentially to work on our cost structure the same way we've been working on it forever, that is, address 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&D Solutions side. We continue to shift work different places where it's optimal. Finally, we use technology, automation, and now AI agents to bring more efficiencies to our processes. Those activities result in the restructuring of headcount literally all over the world and in all segments.

That's what you see reflected in the quarter and the structural numbers, but that's the do we talk about margins by segments? I mean, we have a disclosure of we disclose. We have a disclosure, segment disclosure on a GAAP basis. Look, there's a little bit more pressure on overall margins in the R&D Solutions segment than there is in the Technology & Analytics Solutions segment. Both have good FG&A performance, a little bit more gross margin pressure in the R&D Solutions segment. Some of that mix relating to FSP and also increases, higher growth in the lab business. It tends to be a little bit lower margin. The mix influences margins in the segments, right? Real-world, for example, is somewhat lower margin than the rest of the business, than the analytics or the data or the technology.

As a result, when real-world grows faster, you do have a mixed impact on margins. That is for the commercial side. Then on the R&D Solutions, as Ron mentioned, FSP and lab do have lower margin profile than full service. As I mentioned, in our revenues, FSP is a little bit higher, maybe a point in the quarter. On 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. On the revenue side, FSP was a little larger in the quarter, and lab was also a little bit larger. Those two have somewhat lower margin profiles than full service. Yes, we did have the quarter adverse mixed impact on margins. Again, that can fluctuate quarter to quarter. All right. Quickly, David.

David Windley (Managing Director)

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?

Ari Bousbib (Chairman and CEO)

Nothing significant. Nothing significant. No.

David Windley (Managing Director)

Okay. Great. Thank you.

Ari Bousbib (Chairman and CEO)

All right. We have time for one more operator.

Operator (participant)

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

Tejas Savant (Executive Director)

Hey, guys. Thank you for the time here. 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 2026? Is there any risk that the second trial, which you just got confirmation on, could slip again in that sort of forecast timeframe into 2026 as well? 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?

Ari Bousbib (Chairman and CEO)

I'll start, Tejas, with the stranded cost. 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 resources and use them for other purposes. We're not going to keep them there indefinitely. For the one that's going forward, there is a little bit of impact, not terribly significant. We can only react to what our customer tells us on the trial that was further delayed, and we're assuming that it'll go forward. The customer still wants to do it, and we'll see. Yeah.

The one that's starting 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. That's for that. What was the other question? Real world, yeah. Real world, I think 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. I think, again, we are very well positioned here to navigate these 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 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&D Solutions side and based on our conversation with clients. With that.

Tejas Savant (Executive Director)

Okay

Ari Bousbib (Chairman and CEO)

yeah. Okay. Thank you, everyone, for taking the time to join us today in our Second Quarter 2025 Earnings Call. The team will be available the rest of the day to take any follow-up questions that you might have. Thank you very much, and have a good day.

Operator (participant)

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