Fortrea Holdings Inc.

Ladies and gentlemen, thank you for standing by. Welcome to Fortria third quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Hema Nguva, Head of Investor Relations and Corporate Development. Please go ahead.

Good morning. Thank you for joining Fortria's third quarter 2024 earnings conference call. I am Hema Nguva, Head of Investor Relations and Corporate Development at Fortria. On the call with me today are our CEO, Tom Pike, and CFO, Jill McConnell. The call is being webcasted, and the slides accompanying today's presentation have been posted to the investor relations page of our website, fortier.com. During this call, we'll make certain forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995. These statements are subject to significant risks and uncertainties that could cause actual results to differ materially from our current expectations. We strongly encourage you to review this report we filed with the SEC regarding these risks and uncertainties. In particular, those that are described in the cautionary statement concerning forward-looking statements and risk factors in our press release and presentation that we posted to the website. Please note that any forward-looking statements represent our views as of today, November 8, 2024, and that we assume no obligation to update the forward-looking statements even if estimates change. During this call, we'll also be referring to certain non-GAAP financial measures. These non-GAAP measures are not superior to or replacement for the comparable GAAP measures, but we believe these measures help investors gain a complete understanding of results. A reconciliation of such non-GAAP financial measures to the most directly comparable GAAP measures is available in the earnings press release and earnings call presentation slides provided in connection with today's call. With that, I'd like to turn it over to our CEO, Tom Pike. Tom?

Good morning, everyone. Welcome to the call. Let me start by saying that Fortria had a solid quarter of execution and progress on our strategic objectives. Our bookings landed well, and we delivered on other key metrics as anticipated. Fortria, as you probably know, is a pure play CRO serving phases one through four. We're a leading global provider of clinical pharmacology or phase one development, functional service provision, which we call FSP, and full service outsourcing. Fortria is broad and deep in how we address the market. We have preferred relationships with some large pharmaceutical firms and have broad exposure to biotech. Our business overall is about 50-50 between large pharma and biotechs. Our large pharma partners appreciate that we have sufficient scale to conduct clinical services almost anywhere in the world. The biotech customers value that we're small enough to give our customers the personal attention they need to drive agile solutions. Both types of customers value our 30 years of experience and expertise. Since Fortria spun out of our parent, our customer and net promoter scores have improved, especially recently. We're getting external recognition too. This quarter, Pharma Times recognized a number of Fortrians for their great work, including an in-house CRA, global project manager, and other roles. In addition, Fortria has just been named a finalist in Fierce Healthcare's Excellence in Data-Driven DEI Award for our DEI Dashboard. We're also a finalist in the CRO of the Year category in the annual Scripp Awards. Both awards will be announced in early December. All that is pretty incredible, given we've only been independent for 16 months. Now here are some highlights of our execution and progress during the quarter. We achieved a book-to-bill of 1.23 for the quarter. We closed a number of important projects with larger pharmaceutical customers, and we had success with biotechs. Our pipeline of opportunities for the next two quarters is solid. Our exit from our former parent is nearly in sight, with over 90% of the servers and application systems migrated to our independent Portria environment. Our EBITDA and revenue were in line with our expectations. And finally, we continue to uncover why this business is underperformed financially and the people, process, and technology required to fix that. As usual, I'll provide some detail on some of these highlights, and Joe will fill in with others. Last quarter, I discussed a new large farmer relationship and some footholds, as we call them, of work in other larger companies. This quarter, we made progress getting started with these customers, including responding to some early request proposals. For instance, one of the footholds resulted in an attractive full-service engagement. This project is a significant phase three trial that Fortrea won based on our therapeutic expertise in the specific area and our deep investigator relationships. Some other larger projects also came through as planned from longtime larger customers. Biotech companies also featured strongly in our full service wins in the third quarter across a number of therapeutic areas. We had key biotech wins in oncology, diabetes, dermatology, and autoimmune disease. While we're known for our oncology expertise across our customer mix, We continue building a strong position in other areas such as ophthalmology, where expertise in wet AMD and gene therapy skills are seen as a strong differentiator. Fortria's real-world evidence consultants and scientists won several virtually designed observational studies in the Asia-Pac region for different pharma customers. Our consulting and science help us differentiate. Our clinical pharmacology business continues to have strong bookings, with attractive book-to-bills customers and indications. As we've discussed in the past and with analysts, our lead executive for CPS saw some softness in biotech around the time of the spin and has successfully transformed the mix to ensure a strong pipeline of attractive opportunities. That team has been particularly successful with larger pharmaceutical firms who are spending. Our CPS business also continues to have a solid pipeline of qualified new business biotech customers. For instance, this quarter, we secured an important contract with a new biotech customer for a phase one study supporting its Alzheimer's program. What was significant about this award is that we were initially not selected for the program, but were able to unseat the incumbent CRO because of our solutions focus and expertise in the area. Our experience with complex programs in CPS helps us transition our strong relationships in phase one into phase 1B and 2. As we discussed last time, we're making progress there with an increasing win rate. We also continue to press ahead with some productivity and innovative technology projects. We have a nice tool that's used by Fortria and a couple of pharmaceutical firms for study oversight and optimization. We showed our roadmap to customers and several prospects this quarter and generated a lot of excitement. AI and ML is being added to try to improve predictability and utility to that tool. We're also looking at some other interesting applications of technology and AI tools in practical complex areas, such as protocols and amendments, SOPs, a CRA co-pilot tool, and continuous data cleaning. Now let me address the questions I anticipate you will ask about our second half bookings. As we told you, going into the third quarter, our pipeline was higher than the average of the prior three quarters with a nice mix of large pharma and biotech. Coming into the fourth quarter, the same metric held and the pipeline was greater than the average of the prior three quarters. Consistent with our Q2 commentary, we continue to target a 1.2 book to bill for the second half. We know that we need to execute through the quarter. Regarding revenue and adjusted EBITDA, in light of the backdrop of spin-related complexity, I'm pleased with our execution. In addition to a strong quarter for new business, we delivered on expectations of revenues. We also continue to expand our margin, delivering EBITDA as we expected. We know that we have continued work to do, but we're making progress. Let me hand over to Jill, then I'll wrap up with some comments about the remainder of the year. Jill?

Thank you, Tom, and thank you to everyone for joining us today. As a reminder, all my remarks relate to continuing operations of Fortria, following the divestiture of our enabling services businesses, unless I note otherwise. I'll start by saying that this quarter has delivered as we expected. Revenues of $674.9 million declined 5.4% year-on-year. The reduction versus the prior year was driven by lower service fee and pass-through revenues. Our service fee revenue continues to be impacted by a combination of factors, primarily lower new business awards in the pre-spin period, along with the mix of later stage and longer duration studies in our portfolio. The pass-through decline is driven by lower pass-throughs on the biomarker study we have previously called out, which is continuing to normalize given its stage in the project lifecycle. On a GAAP basis, direct costs in the quarter decreased 6.6% year-over-year, primarily due to lower personnel costs as well as lower pass-through costs, partially offset by an increase in stock compensation and professional fees. SG&A in the quarter was higher year-over-year by 27.6%, primarily due to an increase in professional fees and incremental one-time costs incurred for exiting the TSA, along with the yield costs related to the receivable securitization program we initiated in the second quarter. The company reclassified $39 million from direct costs to SG&A expense in the prior year comparison period, primarily related to information technology costs and certain non-clinic facility charges. For the third quarter, you will see SG&A as a percent of revenue on a GAAP basis at 20.2%. However, if you exclude the impact of approximately $27 million of one-time costs related to the continued separation from our former parent and the incremental impact of a full quarter's worth of expense related to the yield cost, underlying SG&A as a percent of revenue was consistent with the last two quarters. Net interest expense for the quarter was $22.4 million a decrease of $12.2 million versus the prior year, benefiting from the repayments we made on the Term Loan A and Term Loan B during the second quarter. When looking at annualized interest expense using outstanding debt, securitization usage, and rates in effect during the third quarter 2024, annual total cash interest and securitization costs are estimated to be approximately 18% lower compared to the annualized costs we were incurring at the start of 2024. Turning to our tax rate, the effective tax rate for continuing operations for the quarter was a benefit of 48.3%, reflecting an updated split of domestic versus foreign earnings relative to our latest forecast. During the third quarter, we recognized a tax benefit of $17.3 million in continuing operations, primarily due to this update in forecasted pre-tax loss, partially offset by evaluation allowance on our deferred tax asset related to the carry forward of disallowed interest expense. We continue to consider initiatives that we expect could improve our overall tax position over time. Our book to bill for the quarter was 1.23 times and for this trailing 12 months is 1.15 times. Our backlog at around $7.6 billion has grown 6.2% over the past 12 months. Adjusted EBITDA for the quarter of $64.2 million decreased 5.9% year-over-year compared to adjusted EBITDA of $68.2 million in the prior year period. Note that adjusted EBITDA increased 16.3% on a sequential basis in line with our expectations. Adjusted EBITDA margin for the third quarter was 9.5% compared to 9.6% in the prior year period. Adjusted EBITDA margin in the quarter was negatively impacted by the lower service fee revenues in the quarter, along with higher SG&A costs post-spin to support operations as a public company. These were partially offset by the benefit from the restructuring program we initiated in the third quarter of 2023, which has continued into 2024. In the third quarter of 2024, adjusted net income of $20.7 million increased 3% compared to adjusted net income of $20.1 million in the prior year period. Adjusted and net income for both basic and diluted share for the current quarter and the prior year period was 23 cents. Turning to customer concentration, our top 10 customers represented 51% of third quarter 2024 revenues. One customer accounted for 15.1% of revenues. As I comment on cash flows, Note these relate to Fortria in total, as we have not segregated cash flows from discontinued operations. For the nine months ended September 30, 2024, we reported $245.7 million in cash flow from operating activities compared to $150 million generated in the prior year. Cash flow benefited from the sale of receivables under the securitization facility and an increase in unearned revenue, partially offset by the decrease in net income. Free cash flow was $217 million compared to $119.1 million in the first nine months of 2023. Net accounts receivable and unbilled services for continuing operations were $689.1 million as of September 30, 2024, compared to $988.5 million as of December 31, 2023. Days sales outstanding from continuing operations was 50 days as of September 30, 2024, four days lower than June 30, 2024. The reduction versus the second quarter is primarily due to reductions in our unbilled services balance as we continue to enhance our contracting terms and processes. We continue to make changes to our contracting and order to cash processes to enable further improvement to our DSO profile over time. We are fully compliant with the financial maintenance covenants of our credit agreement as of the end of the quarter. We ended the quarter with more than a half billion dollars of liquidity. Our capital allocation priorities are unchanged, focusing in the near term on infrastructure investments for timely exit of the transition services agreement with our former parents, targeted investments to drive organic growth and improve productivity, and then debt repayment. Now I will provide an update on our transformation program. We continue to make progress on our journey towards improving the longer-term growth and profitability of Fortria. Our competitive approach to winning new business awards is a primary objective of our entire leadership team, and we regularly leverage their relationships and experiences to enhance our partnerships with our customers. On operational execution, our first priority is delivering high-quality work for our customers. We continue to execute on productivity improvements and actions that speed our time to study startups and milestone delivery. At the same time, there are specific areas that we believe require measured investments to ensure revenue growth and enhanced operational effectiveness. For example, we are making select investments in our commercial organization, certain operational areas, and parts of SG&A. We know that given our current margins, we need to deliver savings elsewhere to fund these investments. We expect to exit the vast majority of the TSA services by year end. with a limited number being exited early in 2025 to ensure business continuity through 2024 year end. We are continuing with targeted programs to reduce costs, including programs intended to better align our resources with the needs of specific projects while reducing pockets of lower productivity. The improvement in overall adjusted EBITDA this quarter is attributable largely to these programs. We are continuing with our plans to reduce SG&A costs across our supporting functions. We expect the benefit from these to ramp up during 2025, as we believe that full independence from our former parent will enable us to deliver these functions in more efficient ways versus how they were historically delivered. Regarding 2024 guidance, we have updated our revenue guidance range to $2.7 billion to $2.725 billion. The reduction in the top end of the range is primarily driven by lower trends and pass-throughs consistent with what I discussed earlier. Our adjusted EBITDA guidance range of $220 million to $240 million remains unchanged. There are a number of moving parts that we are navigating and managing closely, such as the transition of key internal IT systems and devices in and around the fourth quarter. These technology transitions do not impact customer-facing systems. We expect to provide 2025 guidance in the first quarter of 2025. Building our backlog, along with efforts to drive margin expansion, continue to be the primary focus of our leadership team. I'm not commenting specifically on 2025 targets, as they will be informed by the exact timing of exiting the TSA services from our former parents, along with having more certainty on fourth quarter net new business awards and a better sense of the pipeline of opportunities heading into 2025. Before I conclude, I want to take a moment to acknowledge the significant progress our teams are making towards fully exiting the transition services agreement, as well as to build the new infrastructure that will enable us to operate more efficiently and effectively. As Tom mentioned, more than 90% of our IT applications and servers have been transitioned, and the teams leading our HCM and ERP implementations are on track for their respective December and January go-live dates. It's easy to think, okay, what's next? but this demonstrates that our teams have the determination and agility to execute difficult tasks under challenging circumstances. This effort, combined with the work we've done to strengthen our capital position, is laying the foundation for the long-term growth and profitability of Fortria. There is still work to be done, but we are putting building blocks in place to create long-term value for all of our stakeholders. With the solid foundation we have laid in the past year, attractive backlog of nearly $7.6 billion, and a talented global team of more than 15,500 professionals, we are committed to longer-term growth and margin expansion. Our commitment to execution, along with our focus on innovation and customer satisfaction, as shown by our improving NPS scores, are unlocking new opportunities, enhancing our position in the market. We are confident in our ability to improve margins and deliver significant value for our customers, employees, and shareholders over time. Now, I'll turn it back to Tom for the remainder of his remarks.

Thank you, Jill. In closing, let me provide a few thoughts about the remainder of the year. Regarding the fourth quarter of 2024, as I mentioned, our pipeline of opportunities has grown and has sufficient large pharma, which should be more predictable. We're targeting a 1.2 book to fill in the second half. We have looked at qualified opportunities for Q1 and feel it is solid at this point. Our customer systems, such as VIVA and MediData, are already transitioning in production in Fortria's environment. I'll be excited to see our new ERP system implemented this quarter. Next year, our hardworking teams will turn their attention to making improvements for Fortria. Moving to customers, I had a number of senior level meetings with our larger pharma customers this quarter and got consistent reports of the strong job our teams are doing. While the environment is uncertain for some larger pharma organizations causing companies to increase or decrease their spend on R&D, we're doing our best to help them through whatever they need to do. I've also met with many biotech prospects and customers and the Fortria teams are delivering their well as well. They're bullish on their therapeutic assets and know Fortria can provide top quality data packages for regulators. We provide multiple executive touch points to help them achieve their goals. often complex goals with clinical research. In Q3, we published our inaugural corporate social responsibility report, underscoring our commitment to safety, environmental stewardship, fairness, and ethical governance in everything that we do. In summary, Fortria had a solid quarter of execution progress. We're well positioned for growth and value creation in the future. I would like to recognize our Fortria team around the world. It can be challenging to balance the competing demands of working at a 30-year-old company with the needs and energy of a startup. Our team is committed to customers and the important work of developing solutions that bring treatments to patients sooner. I'm proud of what we've achieved so far and remain excited about what we can deliver in the years ahead. Operator, can you please open the lineup for questions? Thank you.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 1 1 again. And our first question will come from Eric Coldwell with Bayard. Your line is open.

Thanks very much. Good morning. Good job to pull in 3Q as you did. I wanted to ask about ClinPharm in particular. You have quite a few studies going in your various units. They're not all diabetes and weight loss, but there are quite a few of them. I'm curious if you could talk about what the nature of studies of, you know, how that's transitioned this year. Is ClinPharm really getting a lift because of the GLP-1 type category or is Are you seeing strength in other therapeutic categories as well? What's your overall read on how strong the overall phase one market is?

Yeah, I think I'd start, by the way, good morning, Eric. I think I'd start by saying that one of the things we think about here at Portrea is given our size and given our breadth, we do have a different kind of exposure than the largest CROs to the marketplace. And the exposure we have is to some attractive large pharmaceutical firms in phase one in particular, as well as to biotechs around the world. And so the combination of those two, we've kind of re-spliced that business in terms of how we target ourselves in the market, and we're really trying to target those organizations that are spending well. Interestingly, Eric, we do do some work on GLP-1s, but we also have broad exposure across the business. As I mentioned, and actually I had another point that I didn't add in, an interesting autoimmune compound that we have in the U.K. that we're working on. We have a wide variety of things that we work through. So it's actually less GLP-1 oriented, and it's more oriented across a wide array of sophisticated scientific therapies.

That's good to hear. And, Tom, you mentioned the win rate was up. is up, the net promoter score is up. Are there any stats or metrics you could give us around those, put in comparison to that path?

Yeah, I'd rather not give specifics, because then you'll ask me next time, and it won't be as good. But yeah, we basically have win rates that are up since the spin year. Our CPS win rates are quite good, and in particular, as we were talking about it. And the net promoter scores have also taken turns for the better since we spun. So we're pretty proud of those things as we move forward. Great.

If I could squeeze one last one in with Jill, just a technical one. A lot of moving pieces with the TSAs, the facility and the rates changing, just a lot moving on here with your interest expense. You gave some metrics on the improvements year over year. I'm curious if you could give us a sense on where you see sort of normalized interest expense quarterly, what's the exit rate on that as we go into 25?

Yeah, I think what you saw this quarter, Eric, is pretty consistent, because you'll remember Q2 was a little bit unusual in that we had, well, the debt pay down happened during the quarter, but we also had the yield cost from the original debt that we were amortizing, and we had to take a portion of that as a write-off in the quarter, which impacted interest expense. So what you saw this quarter is generally representative it will depend on how rates move and it also would depend on you know what we might do if we need to be in and out of the revolver a bit in the quarter but I think somewhere in this range you know plus or minus 10 15 percent is a decent approximation going forward hopefully minus hopefully minus but we'll see thanks very much guys sure thank you and the next question comes from Patrick Donnelly with Citi your line is open

Hey, guys. Thank you for taking the questions. Tom, maybe just on the bookings environment, it was really nice to see the book to build come in at the 1-2-3 level. I think the prior commentary was 1-2 in the back half. It's kind of a build, right, with 3Q lower building into a higher 4Q. Can you just talk about, I guess, what changed that, what you saw in the quarter that was that much better? And then it sounds like still 1-2 for the second half. Maybe just frame up 4Q for us, what you've seen so far this quarter would be helpful.

Yeah, thanks, Patrick. Good morning. We feel good about back half. I think, you know, given what the uncertainty we saw in Q1 and Q2, we've decided to stick with our prior commentary that we're looking for a 1-2 average in the second half. But as I mentioned in the prepared remarks, we do have a nice mix of large and biotech, which gives us a little bit more predictability in Q4. But as you know, with Q4, given the holiday schedule that many large pharmaceutical firms have, You know, you really have to get a lot done given that holiday period we have there. But I think overall we feel pretty comfortable with Q4. And I'll also add that we've looked at Q1 and we feel pretty comfortable with Q1 as well. So as we look out, you know, I stick with my prior remarks, but we feel pretty comfortable that, you know, if we execute, we can deliver at 1.2 average.

Okay, that's helpful. And then, Jill, maybe just on the margin front, you know, I know the prior commentary was around kind of this 11% to 12% EBITDA margin for next year, very much contingent on the 1.2 book to bill in the second half, which obviously we're just going to talk through. You guys feel good about that. Would it be helpful just to, at least at a high level, to talk through the confidence level in that EBITDA? Again, I know it was Patrick O' The bookings were the big piece, at least one quarter through the second half looking pretty good. So maybe just talk through the moving pieces. And again, just the confidence level in the prior EBITDA commentary.

Sure, Patrick. We specifically are saying we're going to not give 2025 guidance right now. I think it's important. Yes, we're very pleased, obviously, with the 1.23 that we achieved in the third quarter. But we have to deliver in Q4 again, and it will depend very much on the mix and also what we see going into the first quarter. Because you'll recall from earlier this year, we have had to change our guidance based on the fact of where we landed in the first half. So I think it's important for us also to understand what that pipeline really looks like. It looks good at the moment, but the mix is also important. And the timing of those TSA exits is really critical because they're essential. We believe we're on track for year end. But there's still a lot of work. And obviously, as I mentioned, two big systems getting ready to go live. And those are absolutely essential for us in terms of moving into the next generation of SG&A improvement. So we would rather wait and have more clarity on what things look like rather than say something now that, you know, still has a lot of moving parts in it. So I'm going to refrain from answering that one directly, but explain a little bit of why we're going to take the pause and give you that feedback or update in the first quarter.

Understood. Okay, we'll stay tuned on that. Thanks, Joel.

Sure. And our next question comes from Justin Bowers with DB. Your line is open.

Hi, good morning, everyone. Tom, just one for you. You've been in the industry just as long as anyone, and could you help characterize the environment, especially with what we're seeing in large pharma now, and Do you have a sense of maybe where we are in terms of some of the restructurings and reprioritizations? Are we closer to the finish line here, or is this something that we think endures for the next year or two?

Hey, Justin. Good morning. I guess a few things I'd say. We mentioned last time that we've started to categorize the top 20, and they are so much of the spend of the industry into three groups. There are those who are very successful and growing rapidly, and frankly, spending rapidly on R&D. And you even heard some of our competitors talk about it, that it's spilling out into new full-service outsourcing projects and opportunities for the industry. And then we have two other groups that are kind of easily described. the really flat to declining group and the other ones have slower growth or they're flat and both of those other groups are doing some level of restructuring so a huge amount depends who you're exposed to if you're one of the largest CROs you're probably exposed to most of that mix so you have a fairly complex puzzle if you're somebody like us we're exposed to some of it and you know we're we've been able to manage it to date, I think would be a way to say it. So, and I'd also, Justin, I saw your report associated with the market growth and comments, and I generally agree with what you said in there, I think. I think there are certain pharmaceutical firms where R&D is accelerating, and the general backdrop, you know, it seems solid on the biotech front. We said that in prior quarters. I think the recent September funding numbers, for instance, have indicated that as well. So it seems solid, not spectacular, but solid. And so I think that firms can execute against this if their commercial organizations manage well.

Got it. And then maybe one for Jill. Appreciate the EBITDA bridge that you guys provide in the deck. With respect to the bridge from 3Q to 4Q, You have two buckets, one for service fee revenue growth and one for cost savings. Which one has the greatest variability, and what's the interrelationship between the two, if any?

Yeah, let me start. I think the two buckets, when you look at the SG&A bucket and, well, margin optimization generally, I think, as you saw in this quarter, that was a big contributor, really, to the improvement quarter on quarter. There's a piece of really related to variable comp and where we end up landing for the year that's still on the table and that kind of will drive how big we are in that range. But the margin improvements that you saw this quarter, you'll probably also note I called out 15,500 people. That's come down a little bit from where we were in the past quarter or two. And so it's a combination of the work that we've been doing in a very thoughtful way to manage the business and set ourselves up for future success, all while making sure that we prioritize our customers' needs and think about the needs of the projects. On the revenue side, as I had mentioned at Q2, some of this step up in the second half was going to be related to a large suite of projects that we had won in the clinical pharmacology business, as we've been talking about earlier, and we did see that step up as we headed into Q3. And we're expecting that to continue into Q4, although sometimes with the volunteers and things around the holidays, things can be a little bit variable. So we wanted to just provide that little bit of range there because I do think there could be a little bit of movement just depending on where we land. We feel good about it at the moment, but it will very much depend on how things play out over the next couple of months. So those are some of the big drivers in terms of what's driving those two buckets and the range that we provided.

Understood. Thank you so much.

And the next question comes from Luke Serget with Barclays. Your line is now open.

Great. Thanks, guys. I guess can we talk about some of the pricing dynamics here? And, you know, for the recently won award that you guys have, you know, the fear is that, you know, the feedback has been, like, pricing has been extremely competitive. And so... You know, how much of this your wins are associated with coming in as one of the lower cost providers?

Yeah, good morning, Luke. You know, as we said on prior calls, we recognize the situation that this organization needs to improve its margins. And in general, our belief is that we can price it market and based on our capabilities and experience, we can win projects. And so I know there's been some noise out there about different organizations, but in general for us, we're trying to price that market because we don't believe our customers make a decision based solely on price. They base it on, if you think about it, the strategy we have, how long the duration is that we propose, the probability that we can deliver patients in the timeframe that are required for the study. So they're looking at quite a number of things and And our customers really aren't short-sighted enough to make choices on that. Now, I will say FSP continues to be competitive. You'll hear this everywhere. There's less differentiation there. But again, the size of our business at this moment in those most competitive top pharma FSP clinical situations, we're that's not a focus for us right now. So I think you'll hear from people who are in that area, you'll hear an intense focus on price.

So, okay. And then just follow up here. Um, I mean the, just talk about, you guys talked about biotech strength and, and the, you know, larger strategic strength that you guys saw and that's driving the bookings. Um, Can you talk about, like, from a biotech perspective, is this mostly, like, from the recent or the public raises that we've seen this year, or is it mostly broad-based? We're just trying to figure out, like, you know, the rest of the CROs have been really choppy, and then you guys kind of have really avoided a lot of the bookings and other issues that others have seen. So you could talk about, like, how you're positioned in the market differently than the others that you guys aren't. really seeing this pressure exposure.

I think I acknowledge that with the biotechs, and you saw this for us in quarters one and two, there is some uncertainty around their decision-making process. That is the nature of the beast over there. And the question is really how well can the commercial organizations manage that? You heard us talk last time, Luke, that that we've put a lot of intense effort around our commercial organization trying to understand those decision processes better. We actually created a new process for forecasting. So we had a prior process, but in terms of forecasting book to bill, we added a new process after really late in the second quarter, starting in the third quarter. And so I think that that's helping us manage those expectations and make sure we point our resources at the most likely situations and really try to manage the decision process. You know, one of the things you get with Fortria is you get the entire management team involved where we need to be involved with customers, not just, you know, in the back offices administering the business. So we're trying to put, you know, not only the sales teams, but the operations team and the leadership, uh, when necessary and get them directly involved with customers. And frankly, I think that makes a difference. That being said, again, what we've seen at our size, given our exposure, is a solid biotech environment. We've been saying this for several quarters, and it really is how does your commercial organization execute against that that can help you create some consistency there. Does that help, Luke, then?

Yeah, it does. Thank you.

Thanks. And the next question comes from David Windley with Jefferies. Your line is open.

Hi. Thanks for taking my questions. Impressive progress in the quarter. What we've heard in addition to what some of the other folks have asked already, one of the key things we've heard in the quarter has been cancellations. So, topping this in the environment, you know, difficulty to predict. decision-making timelines, things like that, but predominantly cancellations. Can you talk about what you are seeing or maybe not seeing from the standpoint of clients changing their mind about intention to move forward on projects?

Yeah, thanks, David. I can take that one. We've looked at this really closely because we obviously hear what our peers are saying, and we have not seen any increase in cancellations. We had called out the one. You remember that late in the first quarter that kind of impacted the first quarter book to bill, but we have not had any uptick. We looked across the portfolio very carefully. We've seen it be kind of our normal rates. So obviously it can be situational from customer to customer, but fortunately for us, this doesn't seem to be an issue.

Yeah, Dave, I'd add, just because, you know, sort of in full disclosure, and Jill and I have talked about it, in our clinical pharmacology business, there's almost what I'd call a churn, where there are cancellations, but it's usually just pulling back a project to re-strategize how to deal with it, and then it's going to come back later. And so we've seen that, and I think the industry talks about, you know, what happened with CRL and what's happening in the early development stuff and whether it spills into clinical pharmacology. But for us, I'd almost call it a churn. It's not really a cancellation rate. It's things moving in and out based on different strategies that customers are taking. But overall, Jill's absolutely right. When you look at our numbers overall, they're at sort of historical norms.

Tom, while I have you, on this concept of qualified pipeline, I appreciate you've talked about your comfort there. I think to Justin's question, you talked about kind of the triage of top 20 and how you think about it. I'm going to assume, but I'm going to let you confirm that when you think about what's in your qualified pipeline and what's moving forward, that more of that, maybe not all of it, but more of that leans toward these folks that are spending more, moving more, maybe less mired in restructuring and things like that, maybe flesh out a little bit more of what gives you the comfort that you expressed in the qualified pipeline that you're looking at internally. Yeah.

I'd say, interestingly, Dave, we do have a mix. So I'd love to say that our exposures Tad Piper- Highly to that top segment, but we do have a mix, but given the exposure that we have. Tad Piper- We they are moving ahead with projects, you know everybody in the industry is moving ahead with projects, even the folks who. Tad Piper- talked about restructuring have important projects that they're driving so right now, you know what we're involved in how we're delivering I got some excellent feedback this quarter from some of our large pharma customers. with some terms like you know that we are doing excellent work and phrases like that that that are helping us um so we may not be as large but what we are doing in larger pharma we're getting some accolades for got it if i could i if i could sneak one more in jill on the on the tsa exits appreciate that you said the the timing is critical i just want to make sure i understand

as you've kind of emphasized to me, that the TSA, the kind of removal of the check that you're writing to LabCorp for the TSA support services they are providing, that in and of itself is not what drives your margin expansion, but rather your ability to manage the business on your own systems and identify areas to take SG&A costs out. Is that correct? Is my understanding correct if you flesh that out a little bit?

Yeah, no, your understanding is correct, David. And I do think that's important. I know we have talked about it before. So getting out of those TSA exits is really critical. Obviously, there's additional costs associated there and the one-time costs. And you will see, I've shared this before, but for everyone's benefit, the way those things are paid and billed, you're going to see one-time costs through the first quarter just by the nature of how things go. But we still believe that we're on track to exit the vast majority of it all by the end of this year, right around the end of this year, certainly by the time we're coming out talking about Q4 results with all of you. And that is then really important. We'll go live on the new systems, and then that allows us to bring in different processes, new structures and ways of working, be able to do more volume of transactions in a more efficient, effective way. So that is really critical. It's not an immediate switch that you exit a TSA and we get massively reduced SG&A. There are some places, as we've talked about, particularly with our IT infrastructure, where because of the work that we're doing with Cognizant, we've talked about that before, there will be some improvements, but you'll see more of those come out over the course of next year. And we'll provide a lot more detail about that journey when we give our guidance for 2025.

Fantastic. Thanks for taking my questions and the extra one. Appreciate it.

Sure.

Thanks, Dave.

And the next question comes from Elizabeth Anderson with Evercore. Your line is open.

Hi, guys. Congrats on the nice quarter and thanks for the question. Maybe just to start out with a shorter-term question on the cost side. Traditionally, you've seen, at least in the last two years, a nice dip down in SG&A in the fourth quarter. Could you talk a little bit, Ryan, as to why that happens and sort of your expectations? Obviously, it's in your embedded guidance, so I just want to kind of structurally understand what that is and then have a follow-up.

Yeah, sure, Elizabeth. Thanks for the question. We typically do, and oftentimes, over the course of the year, you're managing things, right? Most folks would understand that in an organization, you get to the end of the year, you tend to get a little bit tighter on things. So you see some of that that comes through. I do think for us, as I mentioned, one of the drivers there is around some variable comp and where the year lands in terms of how that plays out. But I also highlight the changes we've been making over the course of this year. And I called out the change in headcount. That's not just operations. That's also parts of SG&A as well, where we can do it a bit more thoughtfully. So it's the cumulative impact of those as they've been happening over the course of the year. You get the full quarter of benefit in the fourth quarter, and then some of the other things that we mentioned. But I think there is a bit of a, most organizations over the course of the year, you get closer to the end, you tighten up a bit, and you see that. But that is generally what's driving the improvements as we go into the fourth quarter. Having said that, I think as a percent of revenue, it's not going to be, it'll be broadly in line with what we've seen over the course of this year, because we really do need to exit those TSAs and SG&A to start to be able to drive the really different model. Got it. That's very helpful.

Thank you. And then I know earlier in the year, you know, you talked about some variability in terms of trial starts and sort of maybe sort of pivoting off of Dave's question a little bit, just sort of like slower decision-making in biotech. But it seems like maybe what you're saying, and I just want to make sure we're understanding this correctly, is that you're seeing that as perhaps like stabilizing slash maybe even a little bit better. Is that a fair characterization?

Let me take that one, Elizabeth. Good morning. I think we would say we really tried to manage that hard this quarter. So we had two factors. We talked about this a little bit last time. One is that can you manage the the biotech decision processes better and our commercial team worked really hard to try to do that try to make sure we had the right interactions with executives understood the processes had less stuff at the last minute so so we worked hard on that and then the other thing frankly is that we just had a little bit more large pharma in the mix and and that does add predictability so because they have a tendency to stay on schedule they don't make decisions, you know, they don't have the board intervene or, you know, things that can happen with biotechs. So it's really the combo of those two and the second half that makes us feel better about our second half numbers. But we're, I think, as an industry, we all, as biotech continues to grow as a proportion and continues to be targeted by various CROs beside us, you know, everyone has to get used to and get better at managing those decision cycles.

Thank you very much.

Thank you.

Our next question comes from Max Smock with William Blair. Your line is open.

Hi, Tom. Hi, Jill. Thanks for taking our questions. I wanted to follow up on some of your commentary on the pipeline here. You mentioned the pipeline for the next two quarters is strong, but Just wondering if you think it's healthy enough to support a 1.2 book to bill beyond the next couple of quarters here. I mean, you had those decisions in 2Q that got pushed out to 3Q. On average, the last couple of quarters, book to bill about 1.1. How much of the solid bookings this quarter do you think was a push out of those opportunities from 2Q? Or do you really think the environment is healthy enough to kind of support that 1.2 book to bill moving forward? Thank you.

Yeah, good morning, Max. As I said, we've got a process that we – Tad Piper- have initiated here, where we try to look out and we look at you know essentially what's in a stage where it's been awarded not contracted what still will be awarded and contracted. Tad Piper- We look at the size, we look at the likelihood that there'll be some kind of issue with the process and so we've done that in quite a bit of detail. And so when we look out over the next two quarters, we feel comfortable that if we execute, we can be in that range of that target at 1.2. Now it's frankly, it's a little difficult for us to look out that much further. You know, this is such a funny industry. We do have things in the pipeline for next year, but it's such a funny industry because so many things come in on short term RFPs where there's a 10 day response time. You know, for those who don't know the industry that well, it's the good news is there's so much volume of this and it's fairly well structured that it's consistent. You can manage around it. The bad news is you have these short cycle RFPs that you deal with all the time. And so, so I think we feel comfortable saying the next two quarters are, have a solid pipeline. What Jill was referring to around 2025. I think we'd like to get a little bit further in the quarter. And frankly, because we'd be reporting during the first quarter on Q4 results and providing guidance, we'd like to get further along, finish out the year, understand these TSAs, understand where our systems are at, and then really talk about that full pipeline for next year. So I realize that's probably not what you want to hear, Max. But what I can tell you is we have a very rigorous process. what we see among our large and small customers looks solid for the next two quarters.

Yeah, that was helpful, Tom. Thank you for that, Tyler. Also, I just wanted to follow up on some of your commentary around small biotech. Tom, you mentioned there's still some uncertainty around small biotech decision-making timelines, but just wanted to clarify whether you've actually seen those decision-making timelines get better at all over the last few months, and if so, what do you think were the drivers behind that improvement? I guess my question really is, do we need to see funding get better from here, or do you think the funding environment's actually okay now that we're past the election and just had another rate cut? Does that give these smaller innovators some more confidence to go ahead and start spending again?

Yeah, I think on the second part, I was thinking about, in case we get near this question, Max, and we're still kind of in battlefield fog from this election this week, but there is no question that, in general, biotech funding is correlated with lower rates, and if we have an SEC that's more comfortable with mergers and acquisitions, you know, you could see some tailwinds to the biotech sector. You know, what we, if you, my father-in-law used to talk about, you know, assume the positive, because it is a better way to live, and so if we assume the positive, you know, we did see some good things last time, like a guy like Scott Gottlieb put in his FDA commissioner and Tom Frantz, We did see project warp speed, which I think we were all hoping would give us the same kind of tailwinds for decision making that you saw during. Tom Frantz, You know the HIV crisis so and and we won't see the IRA expansion or we may not see the IRA expansion that was discussed so. Tom Frantz, So I think they're you know, right now we're in battlefield fog it's very early but. But if things continue to progress the way they are, it's possible that we'll see more attractive biotech environment in the coming months here. I actually don't think for Fortria it needs to be increased. I think given our size and our exposure, if we execute well as a commercial team, I think the solid funding we've seen, the numbers that have come out in August, September, are solid enough for us in the beginning of IPOs again. But for the industry overall, certainly more funding is always better.

Does that help? Thanks again for taking us a little longer. No, no, not at all. That was very helpful. Thank you again for taking our question. Thank you.

And the next question comes from Matt Sykes with Goldman Sachs. Your line is open.

Good morning. Thanks for taking our questions. This is Will Ortmeier on for Matt. Just wanted to touch on the burn rate. Given the higher conversion in the quarter and step up that's implied for the fourth quarter, what are your expectations for backlog burn going into 2025?

I thought you were going to talk about fourth quarter and you tried to sneak in one on 2025 there, Will, but I will say you did see a little bit of a step up in the in the burn rate from from q2 to q3 we'd expect that to be consistent i did talk at q2 about the fact that some of the improvement we'd see in the back half would be due to the improvement in the clinical pharmacology business which has so far come in generally as we expected and it is a bit faster burning i don't think at this point i can comment on 2025 burn rate except to say that we're continuing to look at ways to improve productivity and get projects started faster and focus on improving the timelines of milestone delivery. So it's a focus for us, but I'm going to hold off on commenting on 25 burn until we give 25 guidance.

That's helpful. I had to try on 2025.

I appreciate it.

You did well there. That was clever, yes.

I guess just one more from our side. When you think about the drivers of the gross margin improvement, how should we be thinking about that between mix and cost efficiencies as you grow that backlog? And are there any mixed dynamics to call out that we should think about moving forward?

Yeah, you know, I do think we've been really clear from the beginning that prior to the spin, the mix wasn't necessarily in the places. We really want to grow the full service clinical business. You know, we all know that that is the strongest from a margin delivery. And so we're still focused on that. We have really seen great strength in ClinPharm, as we talked about earlier. And we still like the FSP business, although as Tom mentioned, it is getting more and more price competitive. We still like it, though. It's very steady revenue, and we've learned to navigate that business really well. So we welcome it all. But I do think that mix is really important. And even within late-stage clinical, the therapeutic mixes, you know, you've heard, we've talked about, some of our peers have talked about the fact that the oncology programs do tend to to burn a little bit slower as they get more and more specialized. Some of them are longer because you have longer-term follow-up requirements. So the mix is critical. We want to be in all of it. We've talked about going into, we've got really strong therapeutic breaths, but we've talked about areas we want to continue to focus on, cardiovascular, neurology, some of these things with the obesity, drugs. And we're making great inroads on all of those, but that mix really does drive. So I think that's also part of why We want to be really thoughtful as we go into 25 because, you know, in a quarter, you can have a great book to bill, but if it's all long duration, slower burning studies, it's going to impact your revenue rates for the next year. So we are looking at all of that, but the focus is clearly broad balance, but we really do want to grow more of that late stage clinical.

That's helpful. Thanks, Jill.

Sure.

And our next question comes from Michael Riskin with Bank of America. Your line is open.

Good morning. This is John Kim on for Michael. So you've talked about the SG&A and the TSA exits seem to be on track. But without giving us the margin details, if you think about the investments and investments you still have to make, the parts of the SG&A that involves IT infrastructure, but you also mentioned commercial organization today. So I wonder what that entails. And earlier you mentioned that SG&A as a percentage of revenues would be consistent, but at least for the next two quarters, I'm wondering what the percentage would be for those one-time costs. It's fairly high as percentage of EBITDA.

Okay, sure. I think two things there, the in terms of the investments, I did call that out, because it is really important to understand, you know, as we've come out of the spin, you know, one of the reasons you did this was so that we could focus and have the right attention on the things we need to do to grow for TRIA. And so the commercial investments are very much about and we've talked about this previously, you know, certain therapeutic areas or locations in our sales organization, where we might feel like we're slightly underrepresented and we want to have more opportunities to go after the, you know, the great portfolio of work that's out there and really focus on the pipeline. So that's the commercial investment we're talking about, particularly in the biotech space. You know, I think the other areas, you know, I mentioned operational investments in SG&A. Operationally, we've talked about really wanting to focus on better resource management tools, which also help with our margin longer term, even though there's a bit of an upfront investment. An SG&A is very small amounts. I'll say personally, within finance, there are a couple of technical expertise areas that we've had to invest in. But generally, with an SG&A, it's not so much significant systems or changes there. It might be around how do you think about places where you can do work and making sure you invest in the best technology to drive that work. So those are the types of investments we're making. in one-time costs we will see those especially the spin related ones come down they you know you we did expect q2 it was the highest it's come down this quarter probably step down a little bit again in q4 and it should it's not going to completely go away in the first quarter because there are still some things that happen but truly as you get through the first half those one-time spin related costs will disappear and we are on track really um and really pleased you know i do There's a lot of focus on this, and it might not be as obvious to the outside, but the effort to stand up in HCM, stand up in ERP, rebuild your entire infrastructure, it's significant. So I do think the teams have done a phenomenal job, and we feel really good about where we are. We have to get a few things over the line, and it's a lot of moving parts in the quarter. Thankfully, they're all internal moving parts, so hopefully it doesn't have any impact on our customers. But, you know, there's a lot to navigate here, but we're excited about the fact that once we turn that corner, it really allows us to focus on how we take Fortria forward in the right way for our organization in 25 and beyond.

Gotcha. And then, sorry if I missed it, but in terms of the pharma versus biotech mix, I think Tom mentioned earlier that it's a 50-50 split there, and the large, it seems like the awards are coming in evenly, but How is the RFP flow trending looking ahead? What's your expectation there?

Good morning, John. I think it's consistent with the prior discussions here. It's solid. We carefully choose our words and we continue to see opportunities that are adequate for us to be able to grow. We just have to sustain our win rate against those and deliver well and what we see is a solid pipeline for the targets that we have. So I think we're out of time, operator. I think I'd just close out by saying that we had a solid quarter of execution and progress, and we thank all of you for your time.

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