Q4 2024 Earnings Call Transcript

Ladies and gentlemen, thank you for standing by and welcome to the Charles River Laboratories Fourth Quarter and Full Year 2024 Earnings Conference Call. This call is being recorded. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session.

If you want to remove yourself from the queue, simply press star and two. Lastly, if you should require operator assistance, please press star and zero. I would now like to turn the conference over to our host, Todd Spencer, Vice President of Investor Relations. Please go ahead, sir.

Good morning, and welcome to Charles River Laboratories Fourth Quarter and Full Year 2024 Earnings and 2025 Guidance Conference Call and Webcast. This morning, I am joined by James Foster, Chair, President, and Chief Executive Officer, and Flavia Pease, Executive Vice President and Chief Financial Officer. They will comment on our results for the fourth quarter of 2024 as well as our financial guidance for 2025. Following the presentation, they will respond to questions. There's a slide presentation associated with today's call, which is posted on the Investor Relations section of our website, at ir.criver.com.

A webcast replay of this call will be available beginning approximately two hours after the call today and can also be accessed on our Investor Relations website. The replay will be available through next quarter's conference call. I'd like to remind you of our safe harbor. All remarks that we make about future expectations, plans, and prospects for the company constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated.

During this call, we will primarily discuss non-GAAP financial measures, which we believe help investors gain a meaningful understanding of our core operating results. The non-GAAP financial measures are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. In accordance with Regulation G, you can find comparable GAAP measures and reconciliations on the Investor Relations section of our website. I will now turn the call over to James Foster.

Thank you, Todd, and good morning. We are pleased to end the year with a fourth-quarter performance that was slightly better than expected, yielding annual revenue and non-GAAP earnings per share higher than the guidance that we issued in November. Before I provide more details on our fourth-quarter results, I will provide an update on the market trends and our 2025 financial guidance. Beginning with an update on the market environment, I can say that our view of biopharmaceutical demand remains consistent with our last update.

Overall, DSA demand KPIs, including the net book-to-bill ratio, were stable compared to the third quarter, and we expect similar trends throughout 2025. Many of our global biopharmaceutical clients continue to move forward with their restructuring and pipeline reprioritization activities, which are expected to constrain early-stage spending by many of these clients again in 2025. Small and midsize biotechnology clients continue to benefit from a more favorable funding environment through the end of 2024 compared to the previous two years. We expect biotech demand trends will be stable to slightly improved in 2025 versus last year.

These combined trends are expected to result in flattish DSA demand sequentially within 2025. However, we expect steady volume to be at a lower level than in 2024 because many global biopharmaceutical clients reset their budgets in the middle of last year. We are closely monitoring our clients' R&D spending patterns, the funding environment, and interest rates, as well as new biotech company formations, which have slowed over the past couple of years, and believe our expectations for 2025 are appropriately measured. As discussed at a recent investor conference, the primary factors influencing our 2025 outlook are as follows: The first relates to our expectation for a stabilizing DSA demand environment in 2025, as well as an anticipated headwind from lower DSA pricing throughout the year.

The second item is lower commercial revenue in the CDMO business, which will reduce consolidated revenue by approximately 1% in 2025. Finally, our site consolidation actions are expected to reduce revenue by an additional 50 basis points this year. The cumulative effect of these factors is expected to result in a revenue decline of 3.5% to 5.5% on an organic basis this year. When including a foreign exchange headwind of over 1%, a reported revenue decline of 4.5% to 7% is expected. We have taken significant action to protect the operating margin and shareholder value, including restructuring initiatives that are expected to yield annualized savings of approximately $225 million in 2026, of which over $175 million will be realized this year.

However, we will not be able to fully offset the revenue decline in 2025, particularly in the DSA segment, which is expected to result in a modestly lower consolidated operating margin and non-GAAP earnings per share in a range of $9.10 to $9.60. Now, I'd like to quickly recap our fourth-quarter and full-year consolidated performance. We reported revenue of $1 billion in the fourth quarter of 2024, a 1.8% decline on an organic basis from the previous year. For the year, we reported revenue of $4.05 billion with an organic revenue decrease of 2.8%, driven primarily by lower DSA revenue. Our full-year revenue slightly outperformed the ranges that we provided in November, led by a better-than-expected fourth-quarter performance in the RMS segment and a robust year-end for microbial solutions.

Sales to both the global biopharmaceutical and small and midsized biotech client segments declined for the full year, but in the fourth quarter, we were pleased to see revenue from biotech clients return to growth for the first time since the third quarter of 2023. The operating margin increased 80 basis points year over year to 19.9% in the fourth quarter, principally driven by lower unallocated corporate costs and margin expansion in the manufacturing segment. The cost-saving initiatives also helped to limit the margin declines in the DSA and RMS segments. For the full year, the operating margin declined by 40 basis points to 19.9%.

The decrease was primarily driven by the DSA segment, as well as higher unallocated corporate costs. Earnings per share were $2.66 in the fourth quarter, an increase of 8.1% from $2.46 in the fourth quarter of 2023. The fourth-quarter operating margin expansion, as well as favorable below-the-line items, including reductions in interest expense, the tax rate, and share count, led to the earnings improvement. For 2024, earnings per share declined by 3.3% to $10.32, due primarily to the lower revenue and operating margin, partially offset by the benefit of cost-saving initiatives. Turning to segment performance, I'll now provide you with additional details on the fourth quarter and each segment's outlook for 2025. DSA revenue in the fourth quarter was $603.3 million, a decrease of 3.5% on an organic basis.

The decline reflected lower study volume as well as slightly lower pricing. As anticipated, safety assessment pricing turned negative in the fourth quarter as the moderating pricing environment during 2024 started to work from backlog into the revenue stream. In the current demand environment, pricing has become a point of discussion with clients, particularly small and midsize biotechs. We have strategically and selectively utilized pricing and other commercial enhancements, including better integration of our DSA sales force, with the goal to gain additional market share and believe the strategy has been successful, as demonstrated by an improved DSA capture rate during 2024. DSA demand KPIs were also stable in the fourth quarter, including the net book-to-bill ratio and cancellation rate.

The net book-to-bill remained below one times in the fourth quarter, with global biopharmaceutical and small and midsize biotech client segments in a similar range. This was consistent with the third quarter following the divergence in trends during the second quarter that resulted in revenue to global biopharmaceutical clients taking a step down in the second half of 2024, which will continue to impact 2025. Cancellations also remained at lower levels in the fourth quarter, as they have for most of the past year, and closer to targeted levels. We believe the clients have largely completed the process of canceling lower-priority programs that remained in our backlog, so the key for the DSA segment to return to revenue growth will be a sustained improvement in booking activity, which is not yet evident.

For the full year, DSA revenue decreased 6.2% on an organic basis, which was consistent with our expectation in November that DSA revenue would be favorable to our previous outlook of a high single-digit decline. At year-end, the DSA backlog modestly declined to $1.97 billion from $2.12 billion at the end of the third quarter. In 2025, we expect DSA revenue will decline at a mid to high single-digit rate on an organic basis, which will be slightly less favorable than in 2024. We expect that both lower pricing and steady volume will have a similar impact on the 2025 decline. As I mentioned earlier, we expect study volume will be relatively stable sequentially throughout 2025 for the global biopharmaceutical and biotech client segments, but at a lower level than in 2024, due primarily to the softer demand from global biopharmaceutical clients that emerged in the second half of last year.

In addition, lower realized DSA pricing will add an incremental headwind in 2025 that was not present in 2024 when realized pricing was essentially flat for the full year. We have not assumed any meaningful improvement in the DSA demand environment during 2025 at this time, so the quarterly gating of DSA revenue dollars should be relatively consistent over the course of the year, aside from a modest seasonal impact in the first quarter. In recent weeks, NHP supply has once again made headlines as a result of a recent proposal at the standing committee meeting of CITES, an international body that oversees the trade of animals, including NHPs, used in biomedical research, to potentially suspend the trade of NHPs from Cambodia.

We were very pleased that CITES did not enact a trade suspension at their meeting in early February and postponed the agenda item on this matter until the end of the year. This decision underscores the international community's strong support for a fair, accurate, and science-based review process, providing the necessary time to review the facts and counteract the misinformation being disseminated by other groups. Let me be clear: Charles River firmly believes that any action to restrict the availability of purpose-bred NHPs from Cambodia could have significant and unintended consequences that will impact biomedical research globally.

Legally sourced NHPs are critical, regulatory-required models to help ensure human patient safety and advance biologics drug development for the global biopharmaceutical industry. Charles River will continue to work collaboratively with regulatory agencies, government officials, industry trade associations, and our biopharmaceutical clients to promote patient safety and educate our partners about the scientific importance of NHPs, particularly when viable alternatives do not currently exist. With regard to our NHP supply, we will continue to diligently work to diversify and secure our supply chain by procuring NHPs under various supply arrangements outside of Cambodia, including through our controlling interest in NovoPrim in Mauritius.

As a reminder, we will be able to utilize an increasing number of Mauritius NHPs in our DSA segment after 2026. In the appendix of our slide presentation today, we have also updated certain key statistics for 2024 that were included in our NHP report last year. DSA operating margin was 24.7% in the fourth quarter, or a 130 basis point decrease from the fourth quarter of 2023, and was 25.7% for the full year of 2024, representing a 180 basis point decline year over year. Both the fourth quarter and full-year declines were primarily driven by lower revenue, which was partially offset by the benefit from cost savings.

RMS revenue in the fourth quarter was $204.3 million, a decrease of 0.4% on an organic basis. For the year, RMS revenue was essentially flat, with just a 0.1% decline on an organic basis. For both the quarter and the year, lower revenue for research model services, including Cradle, NHP sales in China, and the sales solutions business, was mostly offset by higher sales of small research models in all geographic regions, principally driven by higher pricing. Sales Solutions' 2024 growth rate was impacted by the consolidation of its operations to its largest California site.

In 2025, RMS revenue is expected to increase at a low single-digit rate, driven primarily by higher pricing in the North American and European models businesses, improved growth prospects for research model services, including Cradle, and from higher NHP sales to NovoPrim third-party clients. Unit volume for small research models continued to be lower in 2024 due in large part to the softer biopharmaceutical spending environment. However, higher pricing and higher revenue from academic institutions more than offset these unit volume declines. We expect similar trends in 2025, with higher pricing in North America and Europe more than offsetting lower unit volumes.

We also expect small models revenue in China to be flattish as the life sciences environment continues to be somewhat challenged. Given the recent news around NIH funding, we will closely monitor the health of our academic and government client base. Our direct exposure to the NIH represents less than 2% of our total revenue, largely related to insourcing solutions contracts. For academia, small research models are critical components to academic research projects and considered direct research costs, but we will monitor what, if any, impact the NIH's new directive to cap indirect costs will have on these clients.

Overall, large models are not expected to be a significant contributor to RMS revenue growth this year, as anticipated increases in NovoPrim's third-party NHP revenue will be partially offset by lower NHP revenue in China. Demand for research model services is expected to rebound and become a notable contributor to RMS revenue growth in 2025. Our Cradle business is expected to get back on track as clients increasingly utilize these services to support their complex research efforts and maintenance of genetically modified model colonies. Minor growth of Cradle operations is expected to deliver an improved top-line performance in 2025, primarily driven by new Cradle sites.

To limit risk in this tighter budgetary environment, the new sites will either have dedicated or anchor clients. Clients are continuing to view Cradle as an attractive model to access flexible vivarium space without having to invest in internal infrastructure, which provides a powerful value proposition for clients who are looking to reduce costs and preserve capital. The RMS operating margin decreased by 30 basis points year over year to 22.8% in the fourth quarter but increased by 70 basis points to 23.7% in 2024. For the year, the operating margin improvement was primarily due to higher pricing for small research models, cost savings related to our restructuring initiatives, and the favorable revenue mix related to higher sales of NHPs due to the NovoPrim acquisition.

We expect similar drivers to contribute to the RMS operating margin in 2025. Manufacturing solutions revenue was $194.9 million in the fourth quarter, a growth rate of 2.1% on an organic basis, and the full-year organic growth rate was 6.8%. The slower fourth-quarter growth rate was primarily driven by lower commercial revenue in the CDMO business, offset by a robust year-end performance for the microbial solutions business. These same drivers will likely result in essentially flat manufacturing revenue in 2025 on an organic basis. Biologics testing benefited in 2024 from certain client projects that will not repeat, which will result in a moderated growth rate in 2025. As mentioned at a recent investor conference, we expect lower revenue from two commercial CDMO clients will reduce consolidated revenue by approximately 1% in 2025 and the manufacturing segment's growth rate by more than 5%.

Despite the commercial setbacks, we believe our efforts over the past two years to enhance the CDMO operations have established a solid foundation for this business through investments in facilities, leadership, and scientific expertise. Although demand in the cell and gene sector is not as robust as it was when we acquired the business in 2021, we believe attractive long-term growth opportunities exist, and we have a healthy pipeline of biotech clients with early-stage clinical candidates ready to help move the CDMO business forward. The microbial solutions business reported a strong year-end performance, with solid growth across all three testing platforms: EndoSafe, Celsis, and Accugenix.

EndoSafe continued to lead the way with robust growth for testing consumables as well as another strong quarter for instrument placements. We believe that 2024 performance thoroughly demonstrated that demand for microbial products has rebounded and that clients are increasingly utilizing our comprehensive rapid manufacturing quality control testing solutions to enhance their product release testing speed and efficiency. The manufacturing segment's operating margin increased by 330 basis points to 28.7% in the fourth quarter and by 560 basis points to 27.4% for the full year. We were pleased by the operating margin expansion, which was driven by operating leverage from improved demand in the microbial solutions and biologics testing businesses, and our continued focus on generating greater efficiencies across all of our businesses, including CDMO.

We believe the manufacturing segment remains on track to reach its goal to return to an operating margin above the 30% level within a couple of years. To conclude, we are currently operating in a challenging biopharmaceutical demand environment with continued constrained client spending, but we believe that demand trends are stabilizing. On the positive side, biotech is trending favorably, and we have not seen signs of further deterioration from our global biopharmaceutical clients. However, we are not forecasting a recovery in 2025. We are taking decisive action to manage the company through the current environment, including appropriately rightsizing our infrastructure and eliminating over 5% of our cost structure.

We remain committed to initiatives to generate more revenue, contain costs, and protect shareholder value. To ensure our future success, we continue to make progress on strategic actions in these three main areas: restructuring and other initiatives to manage costs and generate greater efficiency by reducing staffing levels to align with the pace of demand, optimizing our global footprint, and streamlining processes and operations. We have made meaningful progress on this front and continue to selectively evaluate additional opportunities to cut costs and drive efficiency, and now expect to generate approximately $225 million of annualized cost savings from these initiatives.

The second area is concentrating on commercial enhancements to promote a client-centric focus and gain additional market share. Our goal is to enhance the client experience and reinforce our role as a flexible and responsive partner to our clients, including through leveraging technologies such as our Apollo platform and our RMS e-commerce initiatives. As I mentioned earlier, our enhancements to our DSA sales force and dynamic pricing strategy have enabled us to gain market share over the past year. Finally, we are taking a balanced approach to capital allocation and regularly revisiting our best uses for capital.

We are very pleased that our leverage remains low in the low two times range, and as we have routinely done, we continue to evaluate select M&A candidates. Based on our anticipated capital needs this year, and coupled with our belief that we are currently undervalued, it is an opportune time to allocate most of our free cash flow to stock repurchases in 2025 under a $1 billion authorization. We intend to repurchase approximately $350 million in stock over the next month or two, which exceeds our initial goal of $100 million last year to offset annual dilution from equity awards. We have navigated challenges before, and we believe our strategic actions will enable us to emerge from this paradigm as a stronger, leaner, and more profitable company, and an even more responsive partner for our clients.

We have always distinguished ourselves through our exquisite science and preclinical focus, extending our leading position as our client's preferred global nonclinical drug development partner. I'd like to thank our employees for their exceptional work and commitment, and our clients and shareholders for their continued support. Now, Flavia will provide additional details on our financial performance and 2025 guidance.

Thank you, James, and good morning. Before I begin, may I remind you that I'll be speaking primarily to non-GAAP results, which exclude a goodwill impairment in the fourth quarter of 2024, amortization and other acquisition-related adjustments, costs related primarily to restructuring actions, gains or losses from certain venture capital and other strategic investments, and certain other items. Many of my comments will also refer to organic revenue growth, which excludes the impact of acquisitions, divestitures, and foreign currency translation. We are pleased with our fourth-quarter financial results, with revenue and non-GAAP earnings per share slightly exceeding our annual outlook.

In the face of a challenging demand environment, we have taken decisive actions to navigate these headwinds. Our efforts include aggressive actions to rationalize costs and align our infrastructure with the current demand. As James noted, the restructuring initiatives we implemented are expected to result in approximately $225 million in annualized cost savings in 2026, including over $175 million realized this year, slightly ahead of our prior target as we selectively implemented smaller additional initiatives. The multiyear cost savings program is expected to reduce our cost structure by over 5% through headcount reductions and network rationalization efforts, the majority of which are underway and are on track.

To further balance our capital structure, we leveraged our strong cash flow generation to repurchase $100 million in stock in the third quarter of 2024, achieving our goal to offset the annual share count dilution from equity awards. As James mentioned, under the $1 billion board authorization, we intend to increase the level of stock repurchases in 2025 to approximately $350 million. We believe allocating free cash flow to stock repurchases this year will be prudent in light of our low leverage levels and our current valuation, which is certainly depressed because of the current industry headwinds, but also does not ascribe enough value to the favorable long-term growth fundamentals that we expect to again reemerge once the biopharmaceutical industry refocuses on investing in their pipelines.

We are particularly pleased with our strong free cash flow generation of $501.6 million in 2024. This achievement reflects the effectiveness of our tightly managed capital expenditures, disciplined working capital management, and the early success of our cost savings initiatives. By maintaining a balanced approach to capital deployment, we continue to demonstrate our commitment to enhancing long-term shareholder value. I will now provide additional details on our 2025 outlook. As James discussed, 2024 reflected a constrained biopharmaceutical spending environment, which is expected to persist into 2025. Therefore, we expect a reported revenue decline of 4.5% to 7%, including the foreign exchange headwind, and 3.5% to 5.5% on an organic basis.

FX has become more of a headwind in recent months as the US dollar has strengthened and is now expected to reduce reported revenue by 1% to 1.5%. We have provided additional information on FX rates and our currency exposure in the appendix to our slide presentation. Non-GAAP earnings per share are expected to be in a range of $9.10 to $9.60. On a segment basis, we have also provided the reported and organic revenue outlook for 2025 on slide 31. In 2025, we expect the consolidated operating margin will be modestly lower from 19.9% in 2024, as the cost savings associated with restructuring initiatives will not fully offset the lower revenue this year.

This is particularly true in the DSA segment, for which we expect an operating margin decline. However, there are opportunities for margin expansion in the RMS and manufacturing segments. Unallocated corporate costs in 2025 are expected to be 5% of total revenue. These expenses normalized in the fourth quarter of 2024 to 5.2% of revenue, primarily driven by performance-based bonuses.

However, the 40 basis point increase to 5.7% for the full year 2024 was primarily attributable to higher health and fringe-related costs throughout the year. We expect corporate costs to decrease in 2025 because of benefits from cost-saving actions. The non-GAAP tax rate for 2025 is expected to be in the range of 22.5% to 23.5%, an increase from 21.3% in 2024. The anticipated increase in the tax rate is principally due to an increase in the global minimum tax, as well as a modest impact related to stock-based compensation. In addition, we have not assumed that discrete tax items which benefited 2024 will repeat.

As is typically the case, due to the timing of equity award vesting, the headwind from stock-based compensation will be more pronounced in the first half of the year, including an expected first-quarter tax rate in the mid-twenty percent range. Total adjusted net interest expense in 2025 is expected to be in a range of $112 million to $117 million, compared to $117.7 million last year. The slight decrease will be primarily driven by lower interest rates on floating rate debt. We do expect to borrow during the year to balance the timing of the stock repurchases earlier in the year with the free cash flow that we will generate, but overall, expect debt balances will be similar at the end of 2025. In 2024, we lowered our net interest expense by repaying approximately $400 million in debt, the highest repayment in recent years, bringing our gross and net leverage ratios to 2.2 times at year-end.

Additionally, in December, we amended our existing credit agreement to establish a revolver with borrowing capacity of up to $2 billion, reduced from our previous $3 billion facility, due to our lower current leverage and anticipated capital needs. Importantly, we were able to obtain competitive pricing on this new agreement. At the end of the fourth quarter, we had outstanding debt of $2.2 billion, with approximately two-thirds at a fixed interest rate, compared to $2.3 billion at the end of the third quarter. For 2025, we expect free cash flow will be in the range of $350 million, representing a decrease from $501.6 million in 2024. The decrease will be driven by lower earnings and higher working capital to build inventories, particularly for NHPs, and stabilization of receivables after favorable collections in 2024. Capital expenditures for 2025 are expected to be essentially flat from 2024 levels, at approximately 6% of total revenue or about $230 million, with projects primarily related to a mix of maintenance capital and the completion of ongoing projects.

This outlook reflects our disciplined approach to aligning capacity and capital investments with client demand and is well below our peak CapEx in recent years of 8.2% of revenue. A summary of our 2025 financial guidance can be found on slide 37. With regard to the first quarter of 2025, we expect revenue will decline at a mid-single-digit rate on an organic basis and at a mid to high single-digit decline on a reported basis, due to several factors, including first-quarter seasonality in the DSA and Biologics Testing businesses, as well as a modest headwind from the timing of NHP shipments. From an earnings perspective, we expect non-GAAP earnings per share of at least $2 in the first quarter.

The decline from the fourth quarter will be primarily driven by lower operating margin due in part to the seasonal business trends and the timing of NHP shipments. As I mentioned, we expect a meaningfully higher tax rate in the mid-twenty percent range, reflecting a headwind from stock-based compensation. Unallocated corporate costs will also remain slightly above 5% of revenue in the first quarter. We expect revenue and operating margin will improve after the first quarter, principally as we move beyond the seasonal trends at the beginning of the year.

In conclusion, we are confident in our ability to emerge from this period of softer demand as a stronger, more agile organization. Our decisive actions, including aggressive cost optimization initiatives, stock repurchases, and a disciplined approach to capital management, demonstrate our commitment to enhancing shareholder value. We believe our leaner infrastructure will position us well to capitalize on new business opportunities when they emerge and drive sustainable, profitable growth in the future. Thank you.

That concludes our conference. We will now take questions.

And now to our phone audience. If you would like to ask a question, please press the star key followed by the number one on your telephone keypad. If you would like to remove yourself from the queue, press the pound key. Please go ahead.

Hi, guys. Excuse me. Good morning, and thank you so much for the question. I just had a question about your bookings.

Given the backlog number that you guys had in the fourth quarter, it seems like maybe the book-to-bill, at least on my math, has taken a bit of a step down sequentially. I just wanted to understand, like, if you look at it on the current quarter basis, so I just want to understand if there's timing. Obviously, on a TTM basis, it's more stable. So one, could you confirm my math?

And then, how are you seeing things in the first quarter and sort of can you talk a little bit more about your sort of trending expectations in that regard as we move through 2025? Thank you so much.

Elizabeth, I can maybe start just with your question on the net book-to-bill. Actually, the fourth quarter, both gross and net book-to-bill was sequentially, essentially, stable. There was no deterioration or improvement either. So we were pleased that after the second quarter decline that we saw, especially with our global accounts, we had a bounce back in the third quarter and then stayed flat in the fourth quarter.

Okay. Thank you.

Yeah. So, Elizabeth, for the first quarter, which is typically softer for us, we anticipate some seasonality in DSA and Biologics. And that half of the year will see stronger sales for NovoPrim for NHPs. We feel that biopharmaceutical client demand has stabilized and that biotech demand has stabilized to be slightly up.

So we do not anticipate any further deterioration in demand from a volume point of view. We will have a little bit of a step down on price in DSA though. And that first-quarter trend that I just talked about is embedded in our guidance.

Okay. That's super helpful. Thank you.

Our next question will come from Matt Sykes at Goldman Sachs.

Hi. Good morning. Thanks for taking my questions. Maybe just in RMS, I know you quantified the direct NIH exposure at less than 2%.

Could you just talk about academic as a whole, including NIH, what that is in terms of percentage of RMS? And what are you seeing in real-time from that customer base in terms of the metrics that you're observing or feedback that you're getting, just given all the uncertainty in that segment?

Yeah. So I do not think we are seeing much or hearing much yet. It is fair enough to speculate about what such an indirect cost recovery support there will actually be. Assuming that things are as anticipated, as you say, it's about 2% of total revenue.

Academic and government are about 40% of RMS. A lot of that is related to government contracts with the academic impact of that will be much less. Let's say over the entire company, even though most of it's in RMS, academic and government are about 10%, and if you peel that back, a bunch of it's outside of the US, a bunch of that is in academic institutions, and a relatively small amount is government-related. So we'll have to see what impact, if any, that will have, particularly with long-term contracts for things like producing animals for certain institutes at NIH.

Anything's possible, but that would be pretty disruptive to the researchers. So we feel that given the relatively small percentage of revenue that's associated with that, we should be fine.

Got it. And then just on sort of large pharma demand, I mean, you've been calling that out as an area of weakness. As you think about sort of the reprioritization cost-cutting cycle that we've been through, you kinda mentioned we're maybe towards the end, but no view on terms of recovery. But are you expecting any sort of improvement to that dynamic in the second half of 2025, or should we be thinking more about 2026 in terms of recovery from that customer segment?

Yeah. So in 2024, we just assumed that things get better in the back half of the year, you know, for a whole bunch of reasons. We talked about capital markets opening up and this reprioritization stuff being over, and assuming that things are gonna get better is not a great strategy. So all we can do is have guidance based on conversations with clients.

Now we're dealing with every big pharmaceutical company in the world. They're reprioritizing their pipelines and restructuring their infrastructures to deal with the patent pending patent cliffs, etc. And, you know, depending on who you talk to, much of that has been done, and there's still a fair amount still to be done. And, you know, it's impossible for us to predict what that will be and when that will be concluded, except for what the clients tell us.

So we would anticipate that while things have stabilized and while we do not anticipate things would get worse or deteriorate further, pharma would be pretty much consistent for the balance of the year. And the biotech is more stable and would be slightly improving throughout the year. That depends very much on capital markets. They have some several IPOs that have gotten and priced well, so that's encouraging.

There's been some really good inflows into venture capital firms. That's encouraging as well. While there definitely has been some reprioritization for the biotech companies, they do not have the same sort of large infrastructures to reduce. And they do not do anything internally, so they very much need us and other companies like us.

So we anticipate kind of consistent revenue throughout the year. A little bit of a step down in DSA over 2024 because of the pricing headwinds. And if it's better than that, that will be terrific, but we do not have any indications now that would cause us to guide differently.

Thank you very much.

Our next question will come from Tejas Savant at Morgan Stanley.

Hey, guys. Good morning. And thanks for the time here. Maybe one for you, Flavia.

On the CDMO business, just a couple of housekeeping items for me. Any cancellation payment benefit in the fourth quarter? Do you expect one to come through in 2025? And then what can you do to cushion the margin impact on the segment from underutilization?

I think I heard you mention that there are opportunities for operating margin and manufacturing to actually grow year over year in 2025.

Yeah. Hi, Tejas. Thanks for the question. And I'll take the latter part first.

You're correct. We are forecasting margin expansion for the manufacturing segment. Margins will be challenged in the CDMO business, as you pointed out, given the loss of those commercial clients, but we're taking actions there to right-size our infrastructure and staffing to the lower sales. And then in addition to that, the other two businesses within manufacturing are gonna continue to do well and perform well.

We saw, as James mentioned in his prepared remarks, a very strong finish for the microbial business, which will continue to help with margin expansion. Going back to your first question, there are some contractual obligations that we will benefit from. Those are embedded in the 2025 guidance that we provided for the segment.

Got it. That's helpful. And then one for you, James, on the CITES decision to defer the decision on the Cambodian NHP trade. I was just curious as to whether there's any step you can take proactively over the next twelve months to further de-risk your supply chain there, perhaps increasing sourcing from other countries in Southeast Asia.

Or is it basically NovoPrim ramping in that 2026 plus time frame that's the real meaningful offset for any Cambodian supply disruptions here?

We will do everything we can as we always have, by the way, even without potential disruption. We might have to decide if it's to source NHPs from multiple geographies and multiple providers, some of which we have long-term contracts, some of which we buy on markets, some of which we have an ownership position like in Mauritius. So we will do everything we can to protect ourselves in the eventuality that that doesn't go well. Obviously, we and the rest of the scientific community will provide valid and valuable scientific input to the CITES folks to make the decision, to underscore the criticality of these animals for drug development, particularly for large molecules around the world, given the fact that there are no general alternatives.

So we're cautiously optimistic that that will go well. If it doesn't, we will use multiple sources of supply to satisfy the needs of our clients.

Got it. Thanks for the color, guys. Appreciate it.

Our next question today will come from Dave Windley at Jefferies.

Hi. James, you've commented in your remarks about your expectations for demand throughout 2025 and then also commented about pharma continuing its restructuring. You may have seen in a couple of surveys we've done recently where a number of large pharma respondents talk about expecting kind of a second round of restructuring. And so my question to you is how much visibility are clients able to give you on that type of thing?

For example, if there's another restructuring coming, and the internal people seem to know about it, are they sharing that with you such that you're able to incorporate that in your expectations? And then kind of relatedly, your thoughts about 2025 as far out as the end of the year, is that based on this type of conversation, or are you just having to take a conservative posture given limited visibility? Thanks.

Dave, we're staying as we always do, as close to our clients as possible. We have long-term, very senior relationships with folks at pretty much every drug company. They depend heavily on us for a whole range of things. Many of them buy across our entire portfolio.

Is there another shoe to drop? We're not hearing that. I suppose anything is possible. Some of them have told us that they're dying to move away from this and will be spending more.

Some of them have announced that in terms of their overall R&D expenditures, but we do anticipate that some of that is not over yet. So, I think we have as good visibility as we possibly can have. They're very much dependent on us doing the work for them, so they need to get out ahead of that in terms of communicating with us in terms of how much work they anticipate having us do or not do. And when they get done with their infrastructure reductions, it's likely that they want to crank things up meaningfully.

We're looking for getting back to IND filings or maybe discovery spending. So I do think it's incumbent upon them to keep us well informed. As I said earlier, we're just not gonna make any overall assumptions on what's gonna happen aside from what they tell us is going to happen. And so all we can do is stay in very close communication with them, which we do constantly.

And so we anticipate that things won't deteriorate further. Things will be stable there. Even if some have a second round, some of them will be out of that and will be moving forward. So it should be a decent offset.

If I could ask a quick follow-up. In the deck, around DSA and pricing, you highlighted that in the current environment, pricing has become a topic of discussion. I wanted to clarify whether that was, you know, in the current environment part of that is, is that kind of an extension of what you have been telling us, or is this a signal that pricing is, you know, the kind of the pricing demands from clients are intensive? Thanks.

Yeah. No. It's a continuation. With the biotech guys that have, you know, where access to capital is difficult and even a big fund with companies who have been reducing their infrastructure, they have been more price-sensitive.

And, of course, as we've reported, multiple particularly in the safety assessment business that compete with us primarily on price. So price becomes both an issue and an opportunity for our clients. As we've also said, we both strategically and selectively will utilize reduction in our own prices to either preserve or garner new share. We don't go to the point of matching our competition because those price points, we feel, would be too low given the complexity of the studies and the cost of the studies that we're doing.

So it's an issue. The work that we've done to continue to lean out our infrastructure, which I think we've done a really good job at, allows us to be slightly more aggressive with our pricing if our cost structure is lower and still be able to protect margins as well as possible. So a continuation of kind of the dialogue that we saw last year. I don't think that's a new intensive now with regard to price.

Got it. Appreciate the clarification. Thank you.

Our next question will come from Ann Hynes at Mizuho.

Hi, good morning. Thank you for the question. What do you think is different about this downturn versus other downturns? And do you think the recovery from this downturn would be different?

I guess what I'm trying to get at is you gave long-term growth rates, you know, right before the industry sort of declined. Do you think those growth rates will be intact post a recovery from this downturn, or do you think there's a structural shift in the growth of any of your business lines? Thanks.

Yeah. So I don't think this downturn is like the last time we had a situation like this, it was after the economic meltdown in '08. So we had a tough time in '09, '10, '11, and '12. During that period, things were fundamentally different from a marketplace point of view. Number one, many of our competitors we now own, so I think we have a bigger infrastructure. I'm talking principally about safety assessment.

There were a modest amount of biotech companies. Now there are hundreds, if not thousands. So many more companies need our capability. And in those days, the big pharma companies were doing a lot more work internally, and that's changed fundamentally.

We also, we and all of our competitors have built a lot of space, and we were really swimming in excess capacity, which I think allows the clients to really push pricing way down and margins down as well. So the situation isn't, I mean, everything that I just said is different. There are thousands of biotech companies. Pharma is much leaner.

We have, I would say our capacity utilization isn't optimal and isn't where we would like it to be, but it's not nearly in the position that we were in previously. So the thing that's similar is these clients are approaching a patent cliff, and that's somewhat circular. I mean, that's probably, you know, every decade or so we see patent cliffs happening. This one's pretty profound because there's a lot of very expensive drugs out there.

But we do think that there's a necessity for all of our clients, both large and small, to get back to work as soon as they feel comfortable doing that from an affordability point of view. The host of drug modalities right now that treat really tough diseases is the best maybe it's ever been. And there's definitely a lot of drugs that have not been pursued. So they're either parked somewhere or they may be parked before the IND phase.

So we're not seeing that as well. So, you know, we can't predict exactly what the recovery will be, but it feels like a fundamentally different situation than the last time. And it feels like there's a significant amount of pent-up demand and need on our client's part to develop these drugs, as I said, which are very powerful and meeting unmet medical needs.

Great. And just as a follow-up, I believe you said in 2025, you're assuming some growth in biotech. Can you just elaborate how much growth? And what gives you confidence in that growth?

I mean, just so we're being, we began to see it tick up a little bit in the fourth quarter, and it feels more stable than the big pharma folks. And as I said, everything that they do is outsourced. So given the both current and anticipated inflows from the capital market, and into the venture firms, you know, we anticipate an improvement, but modest. You know, a modest improvement.

So, you know, that's embedded in our guidance. And the modest improvement will not be sufficient to offset the situation from the big pharma companies who will be pretty much stable, but definitely not increasing.

Great. Thank you.

Our next question will come from Justin Bowers at Deutsche Bank.

Hi, good morning, everyone. Just pivoting back to DSA. One clarification on Liz's question. With the bookings being stable sequentially, is that in terms of, like, the nominal bookings and net bookings or just on the book-to-bill?

And then part two of this is can you just help us understand some of the underlying dynamics in DSA? You've discussed a fairly stable demand environment from the second half of the year. Stability in global, modest improvement in biotech. But it looks like, you know, organic is down mid-single to high single in 2025. So is that delta price or mix or discovery?

Just sort of help us peel the onion back a little bit there.

Let me just take the back half of the question, and then Flavia can take the beginning of it. So it will be down similar range to last year, slightly more. Last year, the decline was principally volume. And this year, it's gonna be sort of half price and half volume.

So the price is coming through the backlog as work comes out of the backlog, and we actually do it. We have prices that were lower than previously. The good news about that is that we anticipated the volume decline to be lower than it was the prior year, so that's a good thing. But we do have a pricing headwind, which we should move through for the balance of the year.

I'll let Flavia answer the book-to-bill questions.

Yeah. Justin, I was talking about gross and net book-to-bill in my earlier comments about stability sequentially in the fourth quarter versus the third quarter.

Okay. And maybe just one more follow-up on pricing. If we're looking at the environment now, and call it 1Q, is it stable versus 4Q or any changes either direction with respect to price in DSA?

I can take that, James. Yeah. I think prices are stable. I think that's the clarification to Dave Windley's question that James provided additional color when we said the continuation of the environment.

We started seeing some pricing headwinds in terms of the bookings we were taking as early as last year, and we have signaled throughout 2024 about that selective pricing, selective discounting that we were conducting, and that is now materializing in a price headwind in 2025. But we're not seeing a continuation of erosion of pricing of what we are booking in 2025 towards the later part of 2025 or 2026, if that makes sense. So spot prices I'd say, flattish to the end of the year.

Understood. That's helpful. Thanks so much.

We'll hear next from Charles Rhee at TD Cowen.

Hi. This is Lucas on for Charles Rhee. Wanted to dig deeper into the manufacturing segment and the opportunities you see for margin expansion. I understand that you guys are expecting margins to improve in 2025 here, driven by growth in microbial solutions.

You also called out rightsizing actions in the CDMO business and potential received payments from clients who terminated their arrangements. Should we think about those two items as the opportunities to see improved margins, or are there other items that you guys expect to benefit within the segment?

James, I can take that if you want since I was answering the question about the manufacturing solutions margin expansion. So, Lucas, all the items that you relayed. In addition to that, we've been looking at rightsizing our staffing across the entire company all throughout last year. And the $225 million of cost savings that will annualize fully by 2026, but $175 million of that will be in 2025, benefit all segments and all businesses within each of the segments.

Right? So biologics testing, microbial, and CDMO all had actions in the works. And then as I mentioned, we further enhanced the restructurings in CDMO given the loss of those two commercial clients. So the focus on margin protection has been the case throughout all of last year, and it's gonna impact all businesses.

Okay. I appreciate that. And then just as a follow-up, in your guys' 10-K filing, it noted that one of your clients received a complete response letter from the FDA. Can you clarify whether this was one of the clients, the two clients that you discussed at JPMorgan, or if this is a new client, the filing for which took place in January 2025?

It's one of the two clients we talked about at JPMorgan.

Alright. Thanks.

Our next question will come from Michael Ryskin at Bank of America.

Great. Thanks for taking the question. First, I want to just dig in a little bit on margins for next year. I think you generally just said modestly down margins for 2025 versus 2024. Wanna make sure my math is right.

Once I go through the model, sort of add in the share buyback and some of the other non-GAAP items, I'm getting, you know, pretty close to down a hundred bps, something in that ballpark. Is that right, or is it mostly more in there, like, ten, twenty bps year over year?

James, I can take that. I think, Mike, we're gonna let each of you interpret what we mean by modestly below and update your models accordingly. I know you would rather have more quantitative guidance than qualitative. But, at this point, we're gonna stick with how we provided that color.

Okay. Sure. And then a quick follow-up then. You touched on pricing a couple of times.

I appreciate your comments on sort of stable price and the answer you gave just a couple of questions ago in terms of how price works through the backlog impact on 2025. That all makes sense. But I just kinda wanna take a step back and see how you think about pricing relative to just historical levels. There's been a lot of price taken over the last couple of years. Obviously, you're seeing that as a headwind flow through now.

But maybe sort of ignoring the week-to-week, month-to-month trends of is there pricing stability or not. Do you feel like in general for your business and maybe for the market overall, prices are at a healthy level? I guess, put in other words, could we be seeing something where you get some stability for a few quarters and then another reset or at least maybe stability for a few quarters, but you just don't have pricing power for several years because it is still a little bit on the more expensive side relative to historicals. Just kinda wanna take a step back and take a bigger view of the price question.

I mean, it's tough to predict except this is a certainty that this cross that we're in is pulled back. The biotechs relative to finding and the big guys relative to getting their infrastructures in good state is transitory. For sure. And if you look at our safety assessment business, just as an example, given that it's such a large business and so impactful, it's just a classic supply-demand quotient.

And so as the demand rebuilds, as more drugs, more INDs are filed and pipelines get robust again and space gets tight again, which it has for years, most recently in 2021 and 2022, and will again, we think, for a meaningful amount of time, we'll have a meaningful amount of pricing power. Number one, price will be less of an issue for our clients, and getting access to capacity and in a timely fashion will be paramount to them, which, as I said, which we saw for years. So that's inevitable, and that will be coming back. We get price in the research model business every year, so it's seventy-six years, and will again in 2025. And we get price in other businesses with this rate to be in, microbial, in particular.

And so it's a very pure supply-demand quotient.

And, Mike, just to come back to your question, as I said, I'm not gonna provide quantitative additional color, but just if helpful. For 2024, where we just finished the year, we had said that margins were gonna go down modestly, and they ended up going down 40 bps. So if that's helpful as you think about what our modestly moderately means, you know, just to provide some qualitative color.

Okay. Thanks.

Our next question will come from the line of Max Smock at William Blair.

Hey, good morning. Thanks for taking our questions. Let me just a quick one for me here. Was a little bit surprised by the impairment for the biologics test business.

I think over the last couple of quarters, you've talked about seeing a continued rebound in that subsegment. It seems like things are going well. I know you touched on it a bit during the call, but can you just walk through the issues facing that business and how you're thinking about growth there from that subsegment in 2025? And then longer term, whether there's been a material change in how you're thinking about the long-term potential for that business, which I think going back to the analyst day you pointed to as being a high single-digit or maybe even ten percent grower longer term.

Thank you.

Yeah. I can take the question on the goodwill impairment. So we obviously do a goodwill assessment of all of our segments annually. And in this case, the CDMO business is part of the segment where the goodwill charge was recorded.

So as you can imagine, the loss of the two commercial clients in addition to perhaps a lower level of growth in those businesses versus what we had assumed at the time of acquisition were the primary drivers of the impairment. So while there's still good growth potential, especially with cell and gene therapy, once the market rebounds, it is at a lower level versus what we had assumed at the time of acquisition, and the loss of those two commercial clients put additional pressure. Does that help?

Yeah. And sorry. Maybe I misunderstood. Was there an impairment related to the sounds like the impairment was entirely related to the CDMO business. I maybe misinterpreted your comments around it being related more towards the testing business itself, which again, I think has been one of the better-performing subsegments in your broader manufacturing business over the last couple of quarters.

Yeah. The goodwill for the CDMO business is combined with biologics testing in terms of how the segment is tested. And so I would say you think about what triggered that is mostly driven by the CDMO adjustment, not the biologics testing.

Got it. Thank you. It's helpful.

Our next question will come from Jacob Johnson at Stephens.

Hey, thanks. Good morning. I've got two on CDMO that I'll just ask in combination. One, just clarification.

Flavia, you mentioned maybe there's some contractual arrangements or around the loss of these commercial customers. Is that something that's contemplated in guidance? Is that something that is contemplated in the 1% headwind from the loss of those customers? And then the second question just has the loss of these commercial customers and you disclosed the 43 in the 10-K, has that impacted business development activities?

You know, I think commercial therapy support is a good selling point. Has the loss of these customers made things more difficult? Thanks.

I just wanted to take a second to quickly, which is that obviously, we're not thrilled with the loss of our largest commercial customer. And the second one, I would say, we would describe that more as reduced revenue rather than a loss. But anyway, yeah. So I do think that having those clients has been helpful and beneficial to our sales effort.

By the same token, we have a fair number of clients that we have and continue to get many who are in the clinical phase and some in the late clinical phase. So we should continue to see significant demand. I think that business is actually very well run right now and very well staffed, and capabilities have been enhanced significantly. And clients are really in need of high-quality providers.

So I don't think it's helpful, but I think that we're gonna continue to get business notwithstanding the loss of those clients.

And, Jacob, just to confirm, the contractual obligations that we have with one of those clients is contemplated in the guidance and embedded and included in the 100 basis points of headwind that we talked about.

Got it. Thanks for taking the questions.

Our next question will come from the line of Patrick Donnelly at Citi. Please go ahead.

Hey, guys. Thank you for taking the questions. Flavia, maybe one more. Just on the book-to-bill, I guess with the $150 million step down in the backlog, I was getting closer to kind of a 0.75 book-to-bill, which would have been down from the low 0.9 range last quarter.

I know you're saying it's flat sequentially. So what am I missing? Is it FX or something in there? I'm just trying to figure out that book-to-bill comment.

If you could provide a little more color.

I won't provide additional quantitative commentary other than to say, you know, the math is, it's like very flat quarter over quarter. So don't know if FX is playing an impact in your model or, you know, remember you have denominator and denominator and you have the bookings, but also the revenue outlook that plays into it. So, you know, it's flat. Both gross and net book-to-bill Q4 versus Q3.

Okay. Alright. Take a look at that. And then, you know, James, maybe one for you.

Just to talk about the DSA margin outlook going forward. You certainly understand this year, you have the pressure on the price and the revenue up to down the high single margin that went down with it. You talked a little bit about the manufacturing long-term margin. Can you talk about DSA as we go forward here?

You think about the margin trajectory, certainly a question we get a lot about where this goes over the next few years. Continue to contract or their past higher years and there's a recovery. Can you just talk about, I guess, the moving pieces inside DSA? And then you talked a little bit about the pricing environment forward.

But curious how you think about that margin trajectory over multiple years in DSA. Thank you, guys.

We definitely don't think it'll continue to contract. So you got two issues. One is three issues, really. One is significant leaning out of the infrastructure there, I think we've done a really good job at this year, both in terms of physical capacity and human capacity as well.

We coupled with, you know, technology digitizing the company had allowing the clients to do self-educated book studies themselves and have things be much less manual than people-oriented. And as I said earlier, as capacity and by the way, we're being very careful in terms of how much capacity we add given what the demand is right now, which is why our CapEx will be down. But in 2025, but as the capacity fills and the backlog elongates, people will be willing to pay more. We've seen that, as I said earlier, for multiple years to long periods of time where pricing suddenly becomes much less of an issue.

I would remind all of you that while the preclinical spend is not insignificant and is obviously very important to get a drug into the clinic, it's 20% to 25% of the cost of developing a drug, and 70% to 75% is in the clinic. So they can and should and will begin to spend more in discovery and early development. So if you combine those three issues, we should see improvement in operating margin. I'm not gonna give you a number or quantify that, but I think they could be meaningfully better than they are now going forward.

Understood. Thank you.

And Casey Woodring at JPMorgan, your line is open.

Great. Thanks for taking my questions. Just have one two-part question on the new administration. The first is on tariffs.

So earlier this morning, President Trump said he would likely impose a 25% tariff on pharmaceutical imports that could come as soon as April 2nd. So just any quick thoughts on how something like that would impact pharma budgets and that customer group's preclinical drug development spending. And then second, on the new administration, just kinda curious to hear your general thoughts around how customers are thinking through any other potential impacts, you know, such as RFK's confirmation, just given in the past you've talked about greater scrutiny of pharmaceutical approvals. Any color you can share there?

Yeah. I mean, it would all be total speculation at this point. So we're really not hearing much from our clients on the RFK situation. And, you know, he's talked a lot about food, and he's talked a lot about vaccine spending, and we'll just have to see how that pans out.

What impact, if any, will we have on both the rate and the quantity of new drugs being developed and what, if anything, will happen to the FDA? Haven't seen the situation this morning relative to the tariffs. That's trying to support US development of drugs, so that could be beneficial to US drug companies. So we'll just have to see how that plays out as well.

Great. I think that concludes the questions for today's call. Thank you for your time.

Yes. That is the final question in our queue. Mr. Spencer, I'm happy to turn it back to you, sir, for any additional or closing remarks.

Oh, sorry. That was me. Yeah. No. That is the conclusion of the call. Thank you, everyone, for joining us this morning.

That does conclude today's Charles River Laboratories Fourth Quarter and Full Year 2024 Earnings Conference Call. Thank you for your participation, and you may now disconnect your lines.