Ladies and gentlemen, thank you for standing by, and welcome to the Charles River Laboratories fourth quarter and full year 2022 earnings conference call. This call is being recorded. 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 this period, you will need to press star one on your telephone. If you want to remove yourself from the queue, please press star two. Lastly, if you should need operator assistance, please press star zero. I would now like to turn the conference over to our host, Todd Spencer, Vice President of Investor Relations. Please go ahead, sir. Thank you. Good morning, welcome to Charles River Laboratories' fourth quarter and full year 2022 earnings and 2023 guidance conference call and webcast. This morning I am joined by Jim Foster, Chairman, 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 2022, as well as our financial guidance for 2023. Following the presentation, they will respond to questions. There is a slide presentation associated with today's remarks, which will be 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 be also accessed on our investor relations website. The replay will be available through the 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 the core operating results and guidance. 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 the comparable GAAP measures and re-reconciliations on the investor relations section of our website. I will now turn the call over to Jim Foster. Good morning. Before I speak about our strong fourth quarter results, I want to provide an update on the non-human primate, or NHP, supply situation. As many of you are aware, there has been an ongoing industry-wide investigation into NHP imports from Cambodia. On February 17th, we received a subpoena from the U.S. Department of Justice relating to an investigation into the Cambodian NHP supply chain. We've been informed that this investigation relates specifically to shipments of NHPs received by Charles River from our Cambodian supplier. We intend to fully cooperate with the U.S. government. Once the Department of Justice concludes its investigation, we believe it will find that any concerns with respect to Charles River are without merit. As we have stated before, we are committed to ensuring our operations are fully compliant with all U.S. and international laws and regulations, and we maintain risk-based supplier due diligence, audit, and management practices to help ensure the quality of our supplier relationships and compliance of applicable laws, including the status of the NHPs we import. Based on ongoing investigations and the heightened focus on the Cambodia NHP supply chain in recent months, we have voluntarily suspended planned future shipments of Cambodian NHPs until such time that we and the U.S. Fish and Wildlife Service can develop and implement new procedures to reinforce confidence that the NHPs we import from Cambodia are purpose-bred. This will take time to implement and the duration of which is unknown. The investigation and current NHP supply situation will result in study delays in our Safety Assessment business. By way of background, NHPs are the most scientifically relevant large model for the regulatory required safety testing of biologics drugs as mandated by the FDA and other international regulatory agencies. Biologic drugs cannot be approved for commercial use without NHPs, and given the proliferation of biologic drug development activity in recent years, NHPs have been in high demand. As an example, all of the COVID-19 vaccines developed in the United States and Europe utilized NHPs. In recent years, NHPs sourced from Cambodia have been responsible for approximately 60% of the NHP supplied to the United States and to Charles River for drug research and development. While there is no other near-term global source to replace the supply, we are continuing to actively work to diversify our NHP supply chain. It's critical that we work diligently to resolve the NHP supply situation and collaborate with all agencies of the U.S. government, including the U.S. Fish and Wildlife Service, to restore this important supply chain because the U.S. pharmaceutical industry and the patients who need new life-saving treatments are counting on us. The current Cambodian NHP supply constraints and the corresponding impact to our Safety Assessment business are expected to reduce our consolidated revenue growth forecast by approximately 200-400 basis points this year, resulting in organic revenue growth guidance of 4.5%-7.5% for the total company. The non-GAAP earnings per share are expected to be in a range of $9.70-$10.90 in 2023, with the wider ranges encompassing a number of scenarios related to the timing of the resumption of Cambodian NHP imports this year. The top end of our guidance ranges anticipate that we will have Cambodian NHPs available for studies in the fourth quarter, whereas the bottom end of our guidance assumes that we will have no Cambodian NHP imports for the remainder of 2023. In either case, we expect to begin to experience a more meaningful impact from NHP supply constraints in the second quarter. In addition to NHP supply, several non-operating items are significantly affecting the year-over-year earnings per share comparison in 2023, including higher interest expense, a higher tax rate, and the divestiture of our Avian Vaccine business, which was completed in December. These items will generate a combined earnings per share headwind of $1.20-$1.40 in 2023, partially offset by up to a $0.25 benefit from foreign exchange. Flavia will discuss these items in more detail shortly. I'll speak with you about an outstanding finish to another strong year for Charles River. We reported robust operating performance in 2022, highlighted by 13.4% organic revenue growth against the backdrop of escalating macroeconomic pressures. 2022 performance does demonstrates the continued execution of our strategy, which enables us to enhance our position as a scientific partner of choice to accelerate biomedical research and therapeutic innovation. Let me give you the highlights of our fourth quarter and full year performance. We reported record quarterly revenue of $1.1 billion in the fourth quarter of 2022, exceeding the $1 billion mark for the first time and representing an increase of 21.5% on a reported basis. Organic revenue growth of 18.8% was driven by increases from all three business segments, with the most significant contribution from the DSA segment due to another robust performance in the Safety Assessment business. In the second half, DSA organic growth rate rose to 23.6% as we exceeded the second half growth acceleration that we had forecast since the beginning of last year. For 2022, revenue was $3.98 billion, with a reported growth rate of 12.3% and an organic growth rate of 13.4%. The revenue growth rates exceeded the top end of our guidance range by 140 basis points, driven primarily by outperformance in both the Discovery Services and Safety Assessment businesses. The operating margin was 20.4% in the fourth quarter, a decrease of 50 basis points year-over-year, driven primarily by the manufacturing and RMS segments. For the full year, the operating margin was unchang ed at 21%. We are pleased to have held the operating margin steady in a year with substantial cost inflation and the CDMO business generating significant margin pressure. Earnings per share were $2.98 in the fourth quarter, an increase of 19.7% from $2.49 in the fourth quarter of 2021. For the full year, earnings per share were $11.12, a 7.8% increase over the prior year. We exceeded our last guidance range of $10.80 and $10.95, due primarily to the robust fourth quarter revenue growth, particularly in the DSA segment. We believe our 2022 performance thoroughly demonstrated the successful execution of our strategy to position Charles River as the non-clinical drug development partner of choice for our valued clients, as well as the sustained pace of demand from these clients despite macroeconomic headwinds. Our exceptional market position, unique early-stage focus, and our large diversified client base give us confidence that many of the underlying business trends will remain intact in 2023. I'd like to provide you with additional details on our 4th quarter segment performance and our expectations for 2023, beginning with the DSA segment's results. DSA revenue in the 4th quarter was $691.7 million, on a substantial 26.5% increase on an organic basis. The Safety Assessment business continued to be the principal driver of DSA revenue growth, with significant contributions from study volume, pricing, and NHP pass-throughs in order of magnitude. As we have often mentioned, our business is non-linear. In this case, the record fourth quarter DSA revenue growth was driven by a combination of the current robust demand and pricing environment, as well as the comparison to the fourth quarter of 2021, when the business experienced some resource constraints, including staffing. The Discovery Services business services growth rate also improved in the quarter. For the full year, DSA organic revenue growth was also a record 17.5%, exceeding our midterms outlook. As of year-end, the DSA backlog had increased 32% year-over-year to $3.15 billion. The backlog remained robust in 2022. Also normalized during the year as expected, because the backlog duration stabilized after substantially elongating in prior years. We are continuing to see broad-based and sustained client demand across the Safety Assessment business as we have the staffing and capacity to accommodate this client demand. The current NHP supply situation may restrict the revenue growth rate and margin expansion in 2023, but the underlying strength and resilience of demand environment and pricing should afford us with healthy DSO growth opportunities once the NHP supply situation is resolved and we have an adequate supply of these large models. The Discovery Services business had a good quarter with improvement in the revenue growth rate from the third quarter level. Many of our clients who previously lengthened the time frames to start new projects moved forward with their programs in the fourth quarter. Discovery booking and proposal activity also support a healthy growth profile as we begin 2023. In order to strengthen our position as a single source partner to support our clients' early-stage research needs, we continue to expand our discovery capabilities through our technology partnership strategy and through M&A. We achieved both with SAMDI Tech, which we acquired in January. We established an initial partnership with SAMDI Tech in 2018, and we were able to validate their proprietary mass spectrometry technology for label-free high throughput screening with our clients. During the partnership, we determined that SAMDI Tech's cutting-edge technology was increasingly favored by clients to accelerate their timelines and reduce the costs required to identify a lead drug candidate and make critical go, no-go decisions earlier. As a result of the successful partnership, we mutually agreed to have SAMDI Tech join Charles River. Partnerships and acquisitions like this advance our ongoing efforts to build our scientific expertise for the discovery of novel therapeutics and strengthen our discovery toolkit by adding cutting-edge capabilities to enable clients to work with us for a single project or on an integrated program in a flexible manner tailored to their specific outsourcing needs. The DSA operating margin was 26.3% in the fourth quarter, a 320 basis point increase from the fourth quarter of 2021. For the year, the DSA operating margin increased by 160 basis points to 25.3%. Both increases were driven primarily by operating leverage associated with the meaningfully higher revenue in the Safety Assessment business. RMS revenue in the fourth quarter was $196.1 million, an increase of 10.8% on an organic basis. For the year, RMS organic revenue growth was 9%, squarely in line with our outlook of high single-digit growth in 2022. Accelerated growth for research model services, particularly our CRADL initiative and research models in North America and China, drove the exceptional RMS revenue growth rates for the fourth quarter and full year. We also continued to benefit from meaningful price increases, which were implemented in part to offset inflationary cost pressures. We expect similar trends will drive high single-digit organic growth again in 2023. In the research model business, North America continued to generate strong revenue growth in China, although reporting a double-digit increase experienced a modest impact from an increase in COVID-19 cases during the fourth quarter. The expansions of the central, southern, and western regions of China are progressing well, and each of those new site is operational with 2 sites already shipping research models. This will enable us to continue to generate robust double-digit growth in China and gain additional market share. Research model services also continued to perform well with broad-based growth across Insourcing Solutions and GEMS in the fourth quarter and for the year. Growth was primarily driven by Insourcing Solutions, CRADL operations or Charles River Accelerator and Development Lab, including last year's Explora BioLabs acquisition. Clients are increasingly adopting this flexible model to access vivarium space without having to invest in internal infrastructure. Explora BioLabs continued to perform very well, and the combined CRADL footprint now encompasses 28 vivarium facilities, totaling over 380,000 sq ft of turnkey rental capacity. CRADL and Explora BioLabs provide us with a new and unique pathway to connect with clients at earlier stages, enabling these clients to invest in their research and not in infrastructure, preferring to leverage Charles River's broader capabilities to continue to advance their research. The RMS operating margin declined by 420 basis points year-over-year to 22.7% in the fourth quarter, and by 210 basis points to 25.2% in 2022. The declines were primarily attributable to the 53rd week, which has a greater impact on the RMS segment, headwinds from expansions of our CRADL and Explora BioLabs operations and new RMS sites in China, and also a modest COVID-19 impact in Ch ina. We anticipate that each of these factors will either be eliminated or will generate less of an impact in 2023, resulting in improvement in the RMS operating margin. Manufacturing Solutions revenue was $212.1 million in the fourth quarter, a growth rate of 5.3% on an organic basis. The full year organic growth rate was also 5.3%, in line with our mid-single digit outlook for 2022. The segment growth rate in 2022 was compressed by lower revenue in the CDMO business. The initiatives that we have implemented to improve the performance of our CDMO business continue to gain traction and earn positive feedback from clients. Our creation of centers of excellence for cell therapies, viral vectors, and plasmids has been well received. Coupled with our focus on CDMO business development efforts and investing in the commercial readiness of our operations, we are generating new client interest. We have won over $100 million of new CDMO projects over the past 12 months, and more than two-thirds of which are for our world-class cell therapy operations in Memphis. We believe that a stronger sales funnel will result in a gradual improvement in the CDMO performance during 2023 as the business returns to its targeted growth rates. We expect the CDMO business will drive a rebound in the manufacturing segment organic growth rate to the low double digits in 2023. The Biologics Testing Solutions and Microbial Solutions businesses both performed very well in the fourth quarter, benefiting from robust client demand as the growth prospects for these legacy manufacturing quality control businesses remain strong. These businesses and the manufacturing segment in total will continue to be principally driven by demand for biologic drugs, including cell and gene therapies and other complex biologics. Microbial Solutions had a strong quarter and full year, benefiting from broad-based growth across its Endosafe endotoxin testing and Accugenix microbial identification testing platforms. We are continuing to convert the marketplace to our more efficient and reliable quality control testing platform. The continued expansion of the installed base of instruments drives demand for the consumable cartridges and reagents, which provides a healthy recurring revenue stream. We believe Microbial Solutions' long-term growth potential continues to be approximately 10%, including in 2023. The Biologics Testing business reported an excellent fourth quarter and full year. Robust demand for cell and gene therapy testing services continued to be the primary growth factor, as well as traditional biologics. The business had an excellent year despite the moderation of COVID vaccine testing revenue during 2022. We have been successful at gaining business because of our extensive portfolio of services to support the safe manufacture of biologics. We believe cell and gene therapies will continue to be significant growth drivers over the longer term. The manufacturing segment's operating growth declined meaningfully in both the fourth quarter and full year to 25.3% and 28.8% respectively. As has been the case all year, the decline was driven almost entirely by the underperformance of the CDMO business. Based on our expectations for the CDMO business, we believe the manufacturing operating margin will improve meaningfully in 2023 to above the 30% level. As you know, there is inherent operating leverage in our businesses, as project volumes improve in the CDMO business, we expect the margin profile will follow. In 2022, we celebrated our Charles River's 75th anniversary. We're delighted to have evolved from a small revolutionary research model company overlooking the Charles River to a leading global drug discovery and development partner, generating nearly $4 billion in annual revenue and helping to lead the biopharmaceutical industry's essential non-clinical drug development efforts. As we look to 2023, we continue to see a resilient funding environment, the continued renaissance in the golden age of scientific innovation, our clients' increasing use of strategic outsourcing, and their need for enhanced efficiency and speed to market. Our core competencies, including our extensive scientific knowledge and our focus on preclinical R&D, are precisely tailored to these trends and make us an even more indispensable partner to advance our clients' life-saving therapies. I assure you that we will continue to proactively manage the NHP supply and reinforce our firm commitment to conducting ethical, regulatory compliant business practices and to the humane treatment of the research models under our care. To conclude, I'd like to thank our employees for their exceptional work and commitment and our clients and shareholders for their support. I'd like Flavia to give you additional details on our financial performance and 2023 guidance. Thank you, Jim, and good morning. Before I begin, may I remind you that I'll be speaking primarily to non-GAAP results, which exclude amortization and other acquisition-related adjustments, costs related primarily to our global efficiency initiatives, gains or losses from our venture capital and other strategic investments, a gain on the sale of the Avian Vaccine business, and certain other items. Many of my comments will also refer to organic revenue growth, which excludes the impact of acquisitions, divestitures, foreign currency translation, and the 53rd week in 2022. My discussion this morning will focus primarily on our financial guidance for 2023. We're very pleased with our fourth quarter results, which included revenue and earnings per share that outperform our previous guidance, including quarterly revenue exceeding the $1 billion level for the first ti me. Our 2023 guidance ranges reflect multiple scenarios with regards to the estimated impact from the NHP supply constraints, as Jim outlined. The impact of which is expected to result in reported revenue growth of 1.5%-4.5% and organic revenue growth of 4.5%-7.5% in 2023. Notwithstanding the NHP supply situation, our outlook reflects sustained underlying trends in most of our businesses and a resilient funding environment. We expect non-GAAP earnings per share between $9.70 and $10.90, reflecting meaningful headwinds associated with both NHP supply and non-operating items. I will not provide too many more comments on the NHP supply impact since Jim covered it, so I'll focus my comments on the other headwinds, which include the impact of the Avian Vaccine divestiture, a higher tax rate, and increased interest expense. In combination, these non-operating headwinds will reduce earnings per share by approximately $1.20-$1.40 for the year, partially offset by an FX benefit to earnings per share of up to $0.25 in 2023. These items will reduce earnings per share growth by nearly 10% at midpoint. I'd like to provide some additional details on the three non-operating items that we expect will generate headwinds for our financial performance in 2023. First, we completed the Avian Vaccine divestiture in December as expected. The transaction will reduce 2023 revenue by approximately $80 million and non-GAAP earnings per share by approximately $0.25, net of the interest expense benefit since we used the proceeds to repay debt. Second, the non-GAAP tax rate is expected to move to the top of our long-term low 20% range to 22.5%-23.5% in 2023, representing a nearly 400 basis point increase at midpoint compared to the 2022 tax rate of 19.2%. The increase will be primarily driven by a year-over-year reduction in the excess tax benefit related to stock compensation, as a lower stock price will generate less of a benefit in 2023 compared to the prior year, as well as discrete tax benefits in 2022 that are not expected to reoccur this year. The higher tax rate is expected to reduce 2023 earnings per share by $0.50-$0.65 and the earnings growth rate by over 500 basis points at midpoint. Finally, total adjusted net interest expense in 2023 is expected to increase to a range of $133 million-$137 million compared to $105 million last year. We expect year-over-year increase will be driven by higher variable interest rates, primarily as a result of the Federal Reserve's actions, partially offset by repayment of debt. We anticipate the higher interest expense will create an earnings per share headwind of $0.45-$0.50 and reduce the earnings growth rate by at least 400 basis points. As we mentioned last quarter, we entered into an interest rate swap agreement, effectively locking in a fixed rate for 2 years on $500 million of our revolving credit facility. At year-end, approximately three-quarters of our $2.7 billion debt was at a fixed rate. We believe the Federal Reserve will increase rates in the near term, and our outlook accommodates an additional 100 basis point increase in rates in 2023 beyond the recently announced February increase. At the end of the fourth quarter, our growth and net leverage ratios were approximately 2.2x and 2.1x respectively. This is a meaningful decline from the third quarter due in part to a cash gain on the avian divestiture. We continuously evaluate our capital priorities and, as always, intend to deploy capital to the areas that we believe will generate the greatest returns. Our outlook assumes an average diluted share count of approximately 51.5 to 52 million shares outstanding in 2023. From a segment perspective, our 2023 revenue growth outlook reflects sustained client demand trends offset by the NHP supply impact in the DSA segment. Similar to the prior year, the RMS segment is expected to achieve high single-digit organic revenue growth, the result of continued robust demand for research models and associated services. As a reminder, the Cambodian NHP supply situation does not have an impact on our RMS segment, as these large models are sourced and used to support our Safety Assessment operations. For the DSA segment, we expect the organic growth rate will be between low to mid-single digits based on our NHP supply assumptions around the timing of the resumption of imports. The manufacturing segment is expected to generate low double-digit organic revenue growth, with the increase from the 2022 growth rate principally driven by the expected rebound in the CDMO performance during the year. While foreign exchange was a 350 basis point headwind in 2022, the weakening of the U.S. dollar since November is expected to result in a slight FX benefit of up to 50 basis points to revenue growth in 2023, assuming near current foreign exchange rates. This will drop down to a more meaningful contribution to the bottom line and is projected to generate up to a $0.25 earnings per share benefit due largely to movements in the Canadian dollar. You may recall in Canada, we invoice most of our revenue in U.S. dollars, but essentially all of our costs are in current Canadian dollars. We have provided information on our 2022 revenue by currency and the foreign exchange rates that we are assuming for 2023 in our slide presentation. For the operating margin, we would have expected to generate moderate margin improvement in 2023 without an NHP supply impact. Given this meaningful headwind, we expect the 2023 operating margin to be flat to down 150 basis points, depending on the timing of the resumption of Cambodia NHP shipments. Longer term, we still believe there is operating margin improvement that is inherent in our business from a combination of leverage from higher volume, pricing, and continuing to drive efficiency. We will not provide free cash flow or CapEx outlooks at this time because these metrics could vary based on the level of NHP supply impact that is incurred. For 2022, free cash flow totaled $330.3 million, compared to $532 million for the pr ior year. The decrease was due to higher CapEx as we added capacity to accommodate the robust demand as well as unfavorable working capital movement, the timing of which contributed to our free cash flow being below our prior outlook. Capital expenditures for 2022 increased by $96 million - $324.7 million, with most of the increase driven by the continued capacity needs of the Safety Assessment business. Given the current NHP supply situation, we will reassess our capital needs for this year. Longer term, the targeted level for CapEx remains at approximately 9% of revenue as we expect to continue to invest in capacity in order to keep pace with the sustained underlying demand environment and support our long-term growth forecast. The next slide shows a summary of our 2023 financial guidance. Looking at the 1st quarter of 2023, we expect that year-over-year revenue growth will be in the high single-digit range on a reported basis and at or above the 10% level on an organic basis. We're expecting stronger revenue growth in the 1st half of 2023, both due to the comparisons to last year when growth accelerated throughout the year, as well as the gating of the NHP supply impact. We expect only a small impact related to NHP supply in the 1st quarter because these large models are already in place to start the scheduled studies. We expect earnings per share will decline at a mid-single-digit rate in the 1st quarter compared to $2.75 in the 1st quarter of last year. In addition to the impact of the Avian divestiture, the non-operating headwinds will have a greater impact to earnings per share in the first quarter, specifically the higher tax rate and increased interest expense. As previously mentioned, the tax benefit from stock compensation is expected to be lower in 2023, with the greatest impact in the first quarter. We also will not have anniversary last year's Federal Reserve more aggressive interest rate increases in the first quarter. These two items are expected to result in a combined earnings headwind of approximately $0.40 per share. In addition, the manufacturing segment faces a difficult comparison versus the first quarter of last year with regards to commercial readiness milestones in the CDMO business and COVID testing revenue in the biologics testing business. This will result in a lower growth rate for the manufacturing segment in the first quarter. Each of these headwinds will improve throughout the year, beginning in the second quarter. In conclusion, we're very pleased with our 2022 financial performance and will proactively manage the challenges in 2023. We're confident in our ability to generate value for our shareholders by consistently growing revenue, earnings, and cash flow. Over the last five years, we have achieved compound annual growth of 16% for revenue and 17% for earnings per share, generating robust operating and free cash flow while continuing to make necessary investments to support the growth of our business. We're focused on continuing to drive growth, executing our strategy, and enhancing our position as the leading global non-clinical drug development partner, working with our clients from discovery and preclinical development through the safe manufacture of their life-saving therapies. Thank you. That concludes our comments. We will now take your questions. At this time, if you would like to ask a question, please press the star and one keys on your touch-tone phone. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. Our first question will come from Derik De Bruin with Bank of America. Your line is open. Hi, good morning. Thanks for taking my question. Jim, I'm just curious, what are your customers doing, then, in the biotech space and elsewhere in terms of their studies? I mean, are other vendors having similar delays or similar issues? Basically, are you at risk of losing business because other vendors have better access to some of the model systems? Tough to comment on the competition, Derik. I guess my overarching comment would be number 1, we are a much larger scale. Number 2, we have, you know, different supply sources and different capabilities. I would say that with regard to Cambodia, where 60% of the animals come from, we are all at least temporarily foreclosed from bringing new animals in and utilizing them on studies in the United States. If you wanna extrapolate this and say this is an industry issue, a relatively profound one because drugs aren't gonna move through preclinical and into the clinic. Biologics aren't gonna move unless they're tested on large animals and it's gonna have to be NHP. We are, you know, our focus now is to work with Fish and Wildlife to come up with a collaborative methodology that they're in agreement with and we can execute to show parentage, which is sort of the underlying issue here. It's gonna be some sort of laboratory assay that we're developing, but we have to be able to do that quickly and across a large population of animals. You know, Just to reset the table for you know, the irony of is that demand is really significant for us. I can't comment on the competition, but I assume similarly. Demand is exceptional. We're well-staffed. Capacity is in a good place. We actually have enough animal supply in terms of our relationships with the various suppliers that we have, where we either own a piece or have a long-term contract. We've, you know, we've hit this unanticipated speed bump where the Fish and Wildlife are saying that, you know, they're concerned about parentage. I don't, you know, I can't guarantee anything. I don't think this is a situation of that we'd be concerned about losing share. It's a situation of how do we, and that's both Charles River and the competition to some extent, move past this so we can support the clients to get drugs through preclinical and to patients. That's, that'll be pretty much 100% of our focus going forward. We're optimistic that we will be able... That's been the request. We're optimistic that we'll be able to meet that request. It's a little bit difficult to determine exactly when it will be resolved and exactly when we'll get the animals into the U.S. We've sized our guide, as we say in the prepared remarks, to either have animals kind of late in the third quarter for utilization in Q4. That would be sort of the best case. Worst case would be that Cambodia doesn't open up at all for fiscal 2023. Of course, it's about 60% of the supply source, both for Charles River and the industry at large. I don't know how else to say this. It's not really optional that we fix it. Have to fix it for our clients and for patients and for ourselves. I think the U.S. government authorities understand the criticality of the work that we do and the role that NHPs play, and we're hoping they'll work closely with us, as we work through the resolution. Great. That was sort of my next follow-up on this one is like, how closely are FDA and Fish and Wildlife, working together? I mean, do they clearly understand the importance of what this is? Did you get any sort of suggestion on timing on when this would be resolved, or what the milestones they need to see? I mean, the time is hard only because they're pretty much insistent that we prove parentage. By the same token, Fish and Wildlife absolutely understands how these animals are used and the critical nature of them. I know that the various government agencies have been in conversation with one another. You know, they all look at the world through a different lens. It's gonna be essential to move drug development forward for hundreds of clients and drugs that we have a resolution. We're off working on that. We're off with an open dialogue with Fish and Wildlife about what exactly they need. We'll have to explain to them that the reality of, you know, it's gonna take some time to get this up and running. We're well-intentioned that we have deep science on our own. We'll collaborate with some others to get this up and running, and, you know, we'll provide these tests, which, yeah, that's, and that's the basis of this whole situation to prevent wild animals being used in biomedical research. Thank you. Sure. Thank you. Our next question will come from Eric Coldwell with Baird. Your line is open. Thanks very much. On the subpoena, are there any additional details you can provide on the timing of the receipt? What DOJ perhaps might think they have come across that would drive this. Can you confirm that the decremental margin on the rough $80 million-$160 million revenue headwind is about 50%-60%, that's what's embedded in the guidance? Third, could you talk about the supply expansion you've to what extent you've been able to achieve supply expansion beyond Cambodia? Is there any additional detail you would be willing to provide on countries of origin, new suppliers, increases with existing non-Cambodian suppliers? Is there anything you can share to let us know, you know, what might be the ultimate outcome if, let's say, worst case scenario, Cambodia doesn't reopen? Sure. Subpoena's relatively recent, Eric, and, you know, we're a subject here, meaning that they wanna get information from us. Just to back up, you know that another Cambodian supplier was indicted in November, not somebody that we work with. We think a couple of our competitors we work with, and that started the whole questioning and to prove the methodology. They're now looking at all of the suppliers in Cambodia, one of whom we get our monkeys from. We were just there and audited them, I guess I should say, without sort of weighing in on what the government thinks. It doesn't think that, you know, we believe it's a professionally run operation from a veterinary point of view, from a nutritional point of view, from a housing point of view, from a shipment point of view. It's a big farm, and, you know, they take our advice and counsel really well. You know, we feel that we have some input and some auditing capability with them. We believe that, as this DOJ investigation continues, you know, we're confident that they'll conclude that any concerns they have with regard to Charles River are without merit. We don't believe we did anything wrong. To the contrary, we, you know, we always fully comply with U.S. and international laws. We'll, you know, we'll work closely with them. We'll be collaborative, we'll be transparent, we will take the high road in terms of coming up with a solution that works for them, works for us, and probably will work for other providers and competition, which is great. The supply thing is, I mean, it is what it is, Eric. You know, it's frustrating. We worked really hard over the last, I'd say, COVID years, so probably 3 years now, maybe 4, particularly after China closed up in 2018 to have a multiplicity of suppliers, and I won't go through where they are and what their names are, but you know, we have multiple supply sources. We were starting this year with more than a sufficient number of monkeys to do the work for the... You know, we had orders last year way into the back half of 2023 and some into 2024, and hopefully some incrementing on top of that. As I said earlier, we had staff and space. You know, we're heading into this, and we had an extraordinary second half of last year. You know, we're heading into this year really optimistic about our supply sources. I would say that we have multiple supply sources, which was great. I would tell you, in specific answer to your question, that if Cambodia never opens up, there will be an insufficient number of monkeys to do the work for the whole industry. And I'm not just saying this with, through Charles River lens, that's not a tolerable situation. That's not an acceptable situation for the health of patients, for drug development, for getting drugs, through preclinical into the clinic. We have to find an accommodation. They, you know, the dialogue with them is quite open, and they've been really clear to say, "You just have to show parentage." By, you know, by that, for anybody who's listening and doesn't know what we mean by that, it's just that you can track the offspring to mothers and that those mothers are part of a purpose-bred operation. We believe that we can do that. We believe that Cambodia will open up at some point. We're hopeful that it will be, sort of our best case would be kind of end-ish of third quarter with the animals in the fourth, because it's a big industry dilemma if that can't happen. I will let Flavia drill down on the financial impact of what we just gave in our guidance. Thanks, Jim, and good morning, Eric. Yes, our EPS guidance obviously assumes different scenarios as we mentioned in our prepared remarks. Obviously, the revenue loss drops down at a fairly high rate initially, but I'll prefer not to comment on the specifics. All right, thank you. Our next question will come from Sandy Draper with Guggenheim. Your line is open. Hey, Sandy, are you on mute? We can't hear you. Yes. Thanks, Todd. Just a quick follow-up on NHP and then my bigger question is on the CDMO business. To make sure I understand it correctly, you've decided, Jim, to stop, but were you ordered to stop taking on primates from the supplier till this resolved? Basically, you know, is this you're waiting from signals from the Fish and Wildlife Service or the FDA, and so your hands are tied? Once you think things are clear, you can make the call. Just wanna make sure I understand that. Then the bigger question is just on clearly encouraging signs on the CDMO in your guidance. Going back to the miss in 2022, is this just a function of time and that you sort of gone through that 12 months of just rebuilding the pipeline that you had that sort of the air pocket, or has demand actually gotten better? Thanks. Yeah. On the Fish and Wildlife situation, you know, there was all sorts of contradictory and probably erroneous information about what Cambodia was doing after this first farm was indicted back in November. The initial rumor was that the Cambodian government just closed down exports, which was, we don't believe was ever true. Cambodia is, from their end, is open for business. We'd like to ship the animals but we'll provide the paperwork. The U.S. government is saying, "You can't bring them in yet. And the ones that you have in country, and we have some in country, you can't use yet until we sort of work out and ensure that they are indeed purpose-bred." No. I don't think we can just do what we want. I mean, there's always permitting. There are these CITES permits that one has to get, and then, once those are canceled, you can go ahead and utilize the animals. Just to use your prominence, I guess our hands are tied, but we're trying to look at that positively that it's within our control to get them untied. They're just gonna sort of wait for us to, you know, make a proposal on how we can prove that they were purpose-bred. As I said, that's like 100% of our focus right now, in our control. And obviously, the faster we do it, the faster they will allow us to utilize the animals. CDMO business is an interesting one. You know, as we've spoken to consistently for a while now, integration's been complicated. The science is quite complicated and new, we really had to restaff the all three of the companies, the major companies that we bought from kinda top to bottom, you know, senior management, sales, regulatory, et cetera. I think the demand has been great across the board. The sales cycle's long, I'm not sure that was totally clear to us or the length wasn't crystal clear to us when we bought the company. Plus some of the clients that we felt we had firm commitments, you know, weren't so firm. You know, I think we've done a great job with the new sales force, with people that understand the science, can explain it well. You know, we have in the period of our commentary, been $100 million of new business come in last year. Our Memphis facility, which is our gene-modified cell therapy manufacturing operation, just feels particularly solid right now just in terms of numbers of clients, scale of clients. By that I mean, you know, there's a bunch of companies that are cell therapy companies that are kind of small and new that you never heard of, but there's a bunch of really big companies, including big biotech and big pharma, who either don't have their own space or don't feel there's sufficient space in the system. We have several clients that we're talking to who have either finished phase 3 or are almost done who are talking to us about commercial quantities. There, there's at least one client that we are confident that we will produce commercial quantities for them this fiscal year, which obviously would be fabulous just in terms of, I don't know, expertise, reputation, capability, and really doing it because there's, you know, there's so few commercial products actually being manufactured. The business feels better, stronger, better demand, better client understanding of who we are, better integration amongst and between the cell and gene therapy companies, and also between cell and gene therapy and our biologics business in particular, and I would say Safety. Secondarily, we have very good facilities that have been all three of the major facilities have been added on to over the past year. We've got new space, incremental space and pretty well staffed. It's a very attractive area. There's lots of people that wanna work in cell and gene therapy. I think there's a little bit of a positive buzz around our capability and potential. We should have nice growth rates in those businesses in fiscal 2023. The margins won't be anywhere near we want them to be, but they will be distinctly better than the prior year. CDMO should be accretive for sure to the manufacturing top and bottom line. Similarly, obviously to a lesser extent, given the denominator, but similarly to CRL's top and bottom line also. Feel good about those businesses as we've entered this fiscal year. Thanks for the update, Jim. Pleasure. Thank you. Our next question will come from Elizabeth Anderson with Evercore. Your line is open. Hi guys. Thanks so much for the question. I was wondering if you could comment. It seems like you, based on the guidance that you gave for this full year on NHPs, that you probably have enough supply domestically to get you to this sort of fourth quarter, at least between the Cambodian, non-Cambodian supply. If that's something you could comment on. Secondarily, can you talk about the impact of potentially follow-on work after NHPs? It seems like maybe is that something that you guys have accounted for in the guidance, or is that something that would maybe impact 2024 more than 2023? Thank you. Yeah. We have some supply for sure, Elizabeth. You know, we have, we do a lot of NHP work in the U.S., but we also do a bunch in Europe, and we have other suppliers for our European operations. We have other suppliers for U.S. We had monkeys in country, some of which our hands are tied at the moment, but some of which our hands aren't tied. And I don't wanna peel it back too finely, but, you know, I think that we have a sufficient supply for a while, and then it begins to dwindle a bit. You know, we're just gonna have to have conversations with our clients about their priorities and what they really need to be done quickly and, you know, try to match their priorities and the cadence of their drug development pipelines with availability of space and NHPs. So yes, to some extent, we'll have sufficient supply, and to some extent we won't. And hopefully, as we've indicated, in our prepared remarks today and in the numbers in our guidance, that we'll be off and running in the back half of the year. We're, you know, we're continuing to take orders and book orders, certainly into 2024. I don't wanna comment on what the impact is in 2024. We're early in the first quarter of 2023 except to say that, you know, our hope would be to resolve this problem because, you know, we have sufficient supply if the U.S. Fish and Wildlife Service and the other regulatory agencies will let us use them. Just given the importance of the work, we have to figure it out. We're confident that they will listen. They understand the importance. We're also confident they don't have a lot of options. You know, very few of our clients have internal toxicology capacity, and even if they did, they can't get the NHPs either. We have perfectly capable competitors, but they have limited infrastructures, and they have limited access to NHPs as well. Just given our scale and prominence, we have to resolve it. We're hopeful that people will work with us and understand that we're doing everything, you know, in good faith and want to come up with a scientific solution that satisfies everybody's expectations and demands. Thank you. Our next question will come from Jacob Johnson with Stephens. Your line is open. Good morning. This is Max on for Jacob. Just a quick one for me. Are there any areas of your business where the funding environment actually drives additional demand or outsourcing? I think CRADL is perhaps one of these areas. Yeah. CRADL for sure. CRADL is, I don't wanna overstate. I'd say it's a relatively recession-proof business and kind of the pure play outsourcing move for. We thought it was only gonna be small companies. It's a whole range of companies. It's quite interesting. For everyone at the moment who might not want to add, you know, build de novo space, add onto their current space, just hold onto their capital and, you know, lease small amounts of space from us, use our people either in large measure or small measure, I think that business is going really well. Look, our whole thesis, I mean, the whole basis of the bargain with Charles River is that we can be, and are, your outsourcing partner. You use our people in our spaces as if they're your own. We'll invest in technology and capacity, consistently. We'll help you get your drug into the market, or at least tell you that it shouldn't get into the market 'cause of high levels of toxicity or whatever, lack of efficacy. I think that so much of what we do, all of the Research Model Services are pure outsourcing. All of our Discovery and Safety work is pure outsourcing, and so is the biologics work. Everything that we've added through M&A over the last decade or even two decades has been about providing a large cohesive portfolio to, you know, so somebody can literally give us a drug and say, "Please help me file my IND and get this thing to market." Obviously, it's somewhat correlated to the availability of cash. I would say that our biotech clients in particular are very judicious and thoughtful about the way they spend money. you know, they tend not to move forward unless they think they have enough money to at least get their drug minimally into the clinic and maximally to proof of concept. We're still hearing very little from our clients about concern about access to capital and how that would impair or slow down both the demands from us and ability to spend. Yeah, we think our, and if they have those concerns and they're just not articulating it, I think our portfolio is quite helpful for them. Yes, I would agree that CRADL is kind of the top of the list. Thank you for taking my question. Sure. Thank you. Our next question will come from Patrick Donnelly with Citi. Your line is open. Hey, guys. Thank you for taking the questions. Jim, can you maybe just talk through the timeline of how this all played out? I mean, obviously you put out the 8-K, I think it was mid to late this November, sorry. December there were mixed reports Cambodia was shut down, then it wasn't a few days later. Obviously you guys got the subpoena just a few days ago. Can you just talk about when you guys started to realize, hey, this might be a real disruption, and this is gonna shut down? Just try to get a sense in terms of how quickly you could prepare for this and just how it played out internally would be helpful. Thank you. Sure. When the information came public about the indictment in November of a supplier in Cambodia, that was the first time we knew anything about any concern about Cambodia. Just to remind you all, probably around the same percentage of our animals, our NHPs were coming from China up until that point. We had pretty wide-scale supply agreements from China, then the Chinese government closed those exports down in favor of keeping those monkeys in country. We and our competitors pivoted to Cambodia, which has essentially the same type of animals with the same genetic background. We knew that the research community would be fine with them. They also didn't really have a choice. It's similar background. You know, we've been working hard to validate our supply sources by visiting them, by telling them what our kind of requirements were from an operational point of view. We've been quite pleased with them. We've been quite pleased with the quality of the monkeys. As I said earlier, you know, we had probably the best, not probably, we had the best year in the company's history for our Safety Assessment business in fiscal 2022. Really strong demand way out a year or year and a half, and escalating price points and market share gains. We were feeling very good coming into this year as we were locking down our operating plan, then this came literally out of the blue. As you say, and I, you know, I can't put a finer point on it than what you said. All sorts of rumors, tough to verify, you know, Cambodia closed. No, it's not closed. Oh, great, it's not closed. The U.S. government is, "We don't care, but you can't use them until you can determine and prove to us that the animals are purpose-bred." It's just November to now, which is, it feels like decades, but it's a relatively short period of time. We have finally opened up channels to have conversations with both DOJ and Fish and Wildlife. Obviously, not only will we cooperate, but I think it's incumbent upon us, given our scale and who we are, to be the leaders in solving this problem. We have to solve this for the client base. You know, by that I mean we have to come up with the necessary tests that can be done quickly to determine which animals are that the animals are indeed purpose-bred, and we will do that. We'll stay close to all of our suppliers, but particularly the one that we, the principal one that we use, in Cambodia, provide advice and counsel on what we think they need to do additionally on their end, and we'll enhance our own internal testing methodology such that we can just show Fish and Wildlife, the data and hopefully they'll be pleased with it. It's as, it's as straightforward, as frustrating, and as sort of, sudden as that, you know, the information and the kind of severity of what the government was looking for, seemed to come out of nowhere, certainly with no advance notice. It's not something we had spoken to them about previously. As I said, you know, we had an extraordinary fiscal 22, and never even a hint of this kind of concern or investigation or conversation. That's helpful. Thanks, Jim. Sure. Thank you. Our next question will come from Max Smock with William Blair. Your line is open. Hi. Thank you for taking our questions. Maybe one for me on the CDMO business. You mentioned a stronger sales funnel for this part of the company. Just wondering if there's any more detail you can share around how the sales funnel has grown over the last couple of quarters here and what you're seeing in terms of the strength of the cell and gene therapy market more broadly. Then in terms of those potential opportunities that you've won so far, I guess it'd be helpful to hear really what has differentiated you or what you think differentiates you from some of your maybe larger competitors in the space. Thank you. Sure. You know, the market is strong, and as you know, it's strong. You know, there's a plethora of cell and gene therapy drugs that have been, quote, "discovered" and need to be developed, either to success or failure. We're gonna be very, very busy. We've, as I said earlier, retooled the sales organization. We've got people with great expertise in both cell and gene therapy who understand both the science and the processes for manufacturing and the timeframe. As I said earlier, the timeframe is longer than we had anticipated. We're really pleased with the way we've been signing up clients large and small. The openness to share their anticipated plans with us to we know what the market size they think, the drugs might have. As I said earlier, we have several clients, that are on the verge of commercialization. That doesn't mean the drugs will get to market, but I'm just saying that from a regulatory point of view, are on the verge of having finished clinicals and will be filing and one that has moved into a commercial zone. The sales funnel feels solid, consistent, persistent, and pretty varied in terms of the scale of the companies. The market itself, you know, it's probably a number we should update, but, you know, when we quantified it last time, we said there were about 3,000 cell and gene therapy drugs in development, probably two-thirds of which were in a preclinical domain. Obviously some meaningful portion of these, we'll get to work on. The differentiating factor for us and the reason we went into CDMO space having kind of fled from it a few years ago, 'cause it's kind of a crowded space, is that this is kind of an interesting niche. We have a couple of other very good players in the space, which is fine, the market needs them. What the differentiating feature is that we don't just manufacture a drug. We, you know, we have this big Biologics Testing business, which is kind of how we ended up pivoting back into this space because clients were saying, "You know, speed is of the essence. We give you our molecule, you develop it for us. We can't tolerate you sending us out to find someone to manufacture and negotiating prices. Maybe it's someone we don't know or trust. We'd like you to be able to do that for us." If you think about it, we can do some of the discovery development, we can do all the toxicology work to say it's safe. We can test that molecule before it goes into the clinic. Sorry, we can now manufacture the molecule, test it before it goes into the clinic, test it as it goes into commercialization. I do think it's the, it holds true not just for the cell and gene therapy, but pretty much everything we do. We just have this broader portfolio than the competition. Even if they're bigger companies, and even if they're bigger and have a larger reputation than us for being a CDMO, they don't have the pull-through that we have, and they don't have the comprehensive portfolio. We think that gives us a significant and distinct competitive advantage. Thank you. Sure. Thank you. Our next question will come from Dan Leonard with Credit Suisse. Your line is open. Thank you for taking the question. I have a couple of follow-ups to Derik's question at the start on what customers are doing with the NHP supply constraints. How actively are they pivoting to different models like mini pigs or dogs? Are clients being more discriminating about NHP use in line with the recent FDA guidance? Then finally, is there any chance, Jim, that the heightened NHP concern reduces long-term demand for NHPs from biopharma as clients reconsider their NHP needs? If that happens, what does that do to Charles River's business opportunity? Thank you. Yeah. Very smart and sophisticated question. Not an easy one to answer. I think that we all, particularly given the complexity of NHP availability, and by the way, it's always been complex. It's just more complex these days because of the sheer numbers. If there was an alternative species that was, you know, so let's start with your pig question. You could produce them domestically, and they have litters as opposed to one offspring, and you could get significant numbers. The problem is. By the way, we do a fair amount of swine work right now, mostly for dermatology and cardiovascular work. It's not a bad model. Several problems and several issues. Number one is there are not enough swine either. Number two is if you use sort of farm-sized swine, they're just too big. By too big, I mean, at that stage, drug companies have made a very small amount of the drug, which costs an extraordinary amount. They like to put it in small animals. If you put it in mice or rats, that's obviously a small amount of drug. And the monkeys that we use are quite small as well. Plus, it's, you know, years and years and years of data, using NHP. I would say that swine is theoretically a long-term solution, but you'd have to have lots of validation work done by our clients, accepted by the FDA, and then a massive breeding operation, which we would undertake that. It just, it's not around the corner. You know, the utilization of NHPs and a small animal model, usually a rat, is required by the FDA and comparable organizations around the world. That's unlikely to change. I think the essence of your question as well, that's really interesting, but what if they're not available? What happens? You know that the FDA is the protector of the public safety, so they won't do anything to impair safety. Biologics are complicated drugs that are made from human proteins or artificial human proteins. You really want something that's as closely allied with a human being as possible. I, I don't see a significant pivot out of that. Would it reduce demand? I mean, if you have a host sold. Let's take the worst case that Cambodia never opens up. That would beg the question of, would the FDA accept smaller numbers of animals per study than they do now? I don't know the answer to that. If they did accept that, would that be significant enough to give them enough data to approve the drug? Maybe. Probably not. They couldn't pivot overnight to another animal model. Again, I just have to go back to where I've been on this whole call. The animals are available. There are enough animals available. The farm that we use, you know, we provide a really good oversight, and we think that they're, you know, we think it's a well-run farm, and we think the animals are of high quality, and we have to get through this logjam. It's not like, think about your qu estion. It's not like there literally aren't enough animals available in the world to satisfy the demand because there aren't. These animals typically are pests in these countries, and then they take the pests, and they use them as initial breed stock, so they're wild. Then, you know, we sell usually the second generation, occasionally the first, but the second generation. The animals are clean, and we've had an opportunity to ensure their viral and bacteriological and genetic profiles are, as it were, as you want it to be. Trust me, we talk daily about alternative models, what our responsibility would be, how we would go at it, how we would support our clients. That may happen over the next, I don't even know what the timeframe is, let's say five years. That doesn't satisfy any of the short-term needs right now. I do think that we're quite hopeful in the final analysis, organizations like NIH and the FDA will weigh in seriously about how important these animals are, support us in the work that we do, and, you know, ensure that on a long-term basis, these animals are available. Thank you for that perspective. If I could ask a quick follow-up. Sure. Can you help me better understand the complexity of showing parentage for NHPs? Presumably, this isn't just a 23andMe test, it's more complicated than that, but I'd love to be able to better understand that. Yeah. It's, I don't think it's all that complicated. You're just, you're proving genetics, and there are all sorts of genetic assays that are available. The issue is actually more trivial. It's just, it's just actual scale, depending on how many of the animals they want tested, and how do you do that on a large enough scale quickly enough so it doesn't impede the, you know, the speed, the velocity of your business. We're hopeful. We're speaking to a few organizations right now. We're hopeful that we can enhance the technology to be able to do it faster. That would be good for us, and that would be good for our clients. I think that's beyond our control. Speed is an issue with the regulatory folks. They just want proof of it. Appreciate that perspective. Thank you. Sure. Thank you. Our next question will come from Casey Woodring with J.P. Morgan. Your line is open. Hi. Thanks for taking my question. Just curious, is this your max impact from NHPs, or do you think there's more downside to that range for 2023? I guess, does that headwind include any pricing offset? You know, is there any way to go back to the table and renegotiate price for work that you maybe had booked last year pre-supply crunch year? Just as a follow-up, how much of your existing supply will you have burned through in 2023? You know, does that downside case, that you laid out assume you would be entering 2024 with only 40% of your NHP supply available? Thank you. I'm gonna stay away from 2024. Just it's too far away, and we don't know how this year is gonna unfold in terms of access to new animals. The supply will be. Yeah, it's hard to call what it'll be going to next year, which of course is more than 10 months away. We believe, based upon everything we know today and based upon our conversations with the Fish and Wildlife and others, that the guidance range that we have out there now accommodates for sort of close to the best case and close to the worst case. We're pretty comfortable with that. you know, we'd like our shareholder base to just s ort of get in that genre. The price points for work, you know, in the kind of the back half of this year and definitely for 2024 continue to escalate. They might not be quite at the escalating point that we had it last year, you know, to really cover our inflationary costs, but meaningful prices. I don't know. It feels unclear as to what we would do from a pricing point of view to accommodate for this lack of demand. You know, I think we need to be paid well for the complexity of the work we do and for the animals that we have. We may have a small amount of pricing power only if the costs go up dramatically. I wouldn't think that we could make up much of this by significantly increasing the cost to our clients. All right, thank you. Our next question will come from Tim Daley with Wells Fargo. Your line is open. Great, thanks. First I wanted to ask on RMS. Within the RMS organic growth guidance for the year, are you assuming any divergence in product versus service above or below the segment average? Secondly, a few quick yes nos for you, Jim, on DSA. Will you be providing inter-quarter updates to investors regarding developments in the NHP dynamics? Does your guidance assume any resumption of China NHP exports to the U.S.? Just a quick follow-on to Dan's first question on the FDA Modernization Act. Where you sit today, is there any meaningful mid to long term risk to the Safety Assessment addressable market due to synthetic models? Thank you. Wow. Four parter. I would say that the FDA Modernization Act is well intentioned and is pointing to alternatives to the extent that they are available and viable. We would be the first company to own those technologies were they available and viable. I think that there's very limited technologies right now. We try to invest in them when we see them. We've bought one company in the last 25 years that was clearly in vitro or non-animal based to replace an animal technology that the FDA required. It's done quite well, but I remember when I made the decision to buy it many years ago, I assumed by now there'd be 20 other technologies, and there simply aren't. While the FDA Modernization Act means well, and, you know, it's sort of pointing towards less animals, more sophisticated animal models, earlier assays that are in vitro, I think some of that will happen. I think you're gonna see AI and machine learning and utilization of data to design better trials used, potentially more in the early discovery phase to give you an indication of, I don't know, whether the new drug is likely to work as well as an old one and minimally in toxicology. We hear every month, and I totally ignore it, by the way. We hear every month that China's opening up again for exports. I don't know why we're hearing it. I don't know who's saying it. I don't believe it. You know, China is at odds with the U.S. and probably Europe right now. They have lots of animals that would, you know, potentially give them, I don't know, but an edge, but at least access to more monkeys. It's hard to imagine what the scenario might be that they would open up again. We're certainly assuming for all of our guidance and assumptions and plan that we don't have them available for us. You had another question. I can't imagine that we would give inter-quarter updates on DSA, so I would leave it at that. On the RMS business, you know, this is a business that's really rocking right now. It's kind of, you know, moved up into sort of high single digits. John, or we did 9%. For fiscal 2022, that's the best it's been in a long time. We've got China doing well. We've got North America doing really well. I'm only laughing because it's been years since that's happened. It happened 2022, and I would imagine 2023 as well. The CRADL business with the acquisition that we made last year is doing particularly well. Our genetically engineered model business is also doing particularly well. We, you know, we see really good opportunity to take share. We always get price in those businesses. Our clients are pretty much happily dependent on us. Nobody produces their own animals or provides the level of services that we do. The business feels continually stronger, pretty much in all the geographies in which we participate. Some of our competitors, particularly 'cause of COVID, have had a rough time, I don't know, having enough infrastructure to work through COVID. I think they've been had some financial issues as well. Some of them are only in the research model business, I think they've had a lot of pressure on them. Feel really good about that business, its growth rate, potential, and its operating margin potential. Really feel good about how it ended up in 2022. Great. Thanks, and sorry for the multi-part there. It's all right. It's fine. Thank you. Our next question will come from Dave Windley with Jefferies. Your line is open. Hi, good morning. Thanks for taking my questions. Jim, I wanted to ask one on kind of availability. You touched in one of the earlier answers about the test. I wondered if you could give us a framing as to whether you think this is a test that kind of the assay exists, but you need to repurpose it and validate it in your area, or are you kind of starting from scratch? More broadly, in terms of kind of longer term availability of NHPs, I wonder what consideration you have given to establishing domestic colonies and/or working with U.S. primate research facilities that I think are mostly used for NIH, but is there any opportunity to leverage those for access to primates? Yeah. The domestic colony question's a really good one, Dave. I can't tell you how many times we've discussed it, and I think you know that we did it once. We set up a domestic colony in Southern Florida at extraordinarily significant expense, and had the bad luck of even though we had built hurricane-proof enclosures of having a hurricane which really ruined a bunch of the facility. Actually, a bunch of monkeys got out. At the time, this is a long time ago, Dave, I remember the project was, like, cash flow negative for over a decade. It's just a brutal drop. You have two problems with it. One is it's crazy expensive no w. I think underlying your question was, you know, could you go to the federal government and say, "Can you help us with this? This is critical national resource." They probably would, so that would take some of the financial sting out of it, but it still would take forever. You know, we're talking about what can we do between now and the end of this year, and it just would be forever. It just, it's not a practical, it's not a practical approach. On the tests, you know, I think it's both. The answer to your question is both. There are current tests that can be utilized but are set up not on a very large scale, so we'd have to scale them up or, you know, find a partner to scale them up. We'll minimally do that. What we're really hoping for, particularly with one or two of the collaborators that we've begun to talk to, is that the quality of their science is so sophisticated they can help us refine the tests in a way that we can do more, have more throughput faster with better and unequivocal results and obviously do that in our own labs. As you know, Dave, we have big labs all around the world in our facilities. We have really good capacity and really capable people that would know how to do this work. We just would like to get ahead of it. It's kind of a work in progress, literally, as we speak. We're working on it. I'm confident that we will minimally have kind of something relatively new and not yet standard and potentially something better than even something that's new that would be, I don't care so much about the cost as speed and accuracy. We're all over that, and we'll update you folks on, you know, what our progress is and if the relevance of the partners, assuming we have an appropriate partner, if we think that's meaningful to our shareholder base, we'll share that with you as well. That's great. If I could follow up on kind of the, I guess, the breadth of the effort. Do you see, I mean, you mentioned industry. Understand that, certainly makes sense to kind of be collaborative to solve an industry problem. For your purposes, are you needing to scale this up to kind of validate parentage with your primary supplier in Cambodia? Or is it needs to apply to all of Cambodia and get the U.S. government comfortable with the whole thing as opposed to just KF in your case? I mean, eventually, I think it's good for the industry if you can even call what we do an industry, and certainly for our clients, if you could. Certainly they are an industry. I think it would be good if the whole Cambodian source, and there are, you know, there's a couple of really big players and then some smaller ones. If they could use a similar methodology to show who are the moms and who are the offspring. If we're successful, we won't be selfish about it. I think the way we see the landscape right now, we're unlikely to work with anybody besides our principal supplier because we just know them so well. We like the scale at which they work, they really take our advice and counsel really well, we're quite confident they'll work with us. Maybe that will be the knife's edge. You know, we'll start with our supplier. We'll work with them. We'll show Fish and Wildlife what we've accomplished, then we can offer to share that. I don't care. We could share that with our competition. We don't have a 100% share, we just want the biopharmaceutical industry to be well-resourced here then have access to companies that can do the work well for them. I do think that the U.S. providers will be quite reliant on Cambodia for the foreseeable future, just given the, you know, genetic similarity between the Cambodian monkeys and the Chinese ones, and it's much better for the researchers from a background data point of view. That's how I see it unfolding. You know, it's possible that our competition will do something similar and maybe they get there first. I don't even care. We're not gonna spend a lot of time, I think, working with them because we just have different, I think, viewpoints and capabilities and scale and just the way we deal with our suppliers and the government. While we may talk to them and get each other's support, I think we have to do this all alone. I think we have to do it q uite quickly. Right. Understood. Thanks for the perspective. Good luck with that. Sure, Dave. Thanks. Thank you. Ladies and gentlemen, we have reached our allotted time for questions. This does conclude today's Charles River Laboratories fourth quarter and full year 2022 earnings call. Thank you for your participation. You may now disconnect.