Charles River Laboratories International (CRL) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-28 10-K against the 2023-12-30 one, compared heading by heading and sentence by sentence.
Item 1A79 rewritten50 added23 removed434 unchanged
All filing items1,102 rewritten662 added453 removed2,290 unchanged
Summary
counted, not written
- Item 1A lists 61 risk factor headings: 1 new, 5 reworded and 55 unchanged since FY2023. 0 headings from FY2023 no longer appear.
- Sentence by sentence, 662 added, 453 removed, 1,102 rewritten and 2,290 unchanged across 18 items that differ.
New Item 1A headings (1)
- Failure to successfully realize cost savings from our restructuring initiatives would adversely impact our growth and profitability.
Removed Item 1A headings (0)
Every FY2023 risk factor heading is still here, word for word or reworded.
Reworded Item 1A headings (5)
- If we are not successful in selecting and integrating the businesses and technologies we acquire or partner with, or
[removed: in managing][added: if we do not manage] our current and future [added: site closures and] divestitures, our business may be adversely impacted. - The outsourcing trend in non-clinical
[removed: (discovery]and[removed: safety assessment)][added: clinical] stages of drug discovery and development may decrease, which could impair our growth. - Failure to comply with U.S., state, local or international environmental,
[removed: health and][added: health,] safety [added: and sustainability] laws and regulations, including regulations issued by the Occupational Safety and Health Administration, Environmental Protection Agency, Nuclear Regulatory Agency and Department of Transportation, could result in fines and penalties and loss of licensure, and have a material adverse effect upon the Company’s business. - Non-clinical [added: and clinical] contract research services create a risk of liability.
- If we are unable to attract, hire or retain key team members or a highly skilled
[removed: and diverse]global[removed: workforce,][added: workforce with various backgrounds and experiences,] it could have a negative impact on our business, financial condition or results of operations.
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
79 rewritten, 50 added, 23 removed, 434 unchanged
[removed: Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties] and the risks described below should be carefully considered together with the other information set forth in this report and in future documents we file with the SEC.
The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors" [added: section.]
- If we are not successful in executing our business strategy, including our failure in selecting and integrating the businesses and technologies we acquire, or in managing our current and future [added: site closures and] divestitures, our business may be adversely impacted.
- The outsourcing trend in non-clinical [added: and clinical] stages of drug discovery and development may decrease, which could impair our growth.
- Failure to comply with U.S., state, local or international environmental, [removed: health and] [added: health,] safety [added: and sustainability] laws and regulations could result in fines and penalties and loss of licensure and have a material adverse effect upon the Company’s business.
- Non-clinical [added: and clinical] contract research services create a risk of liability.
- The failure to successfully obtain, maintain and enforce intellectual property rights and defend against assertions of [removed: third-parties] [added: third parties] to intellectual property rights could adversely affect us.
- If we are unable to attract, hire or retain key team members or a highly skilled [removed: and diverse] global workforce, it could have a negative impact on our business, financial condition or results of operations.
[removed: The] [added: Continued] expansion and ongoing implementation of operational systems may occur at a future date based on value to the business.
In general, the process of planning and preparing for these types of integrated, wide-scale implementations is extremely complex and we are required to address a number of challenges, including information security assessment and remediation, regulatory requirements, data conversion, associated regulatory compliance, network and system cutover, user training, [added: data residency, high availability, disaster recovery, latency, backups, archiving, cloud offerings,] and integration with existing [added: processes or systems.]
Incongruities in any of these areas could cause operational problems during implementation including inconsistent practices, delayed report and/or data shipments, missed sales, animal management/welfare issues, [added: data loss] issues that require re-doing certain studies, personally identifiable information and data privacy issues, billing errors and accounting errors.
Like other companies, we have on occasion experienced, and will continue to experience, threats and incursions to our data and systems, including malicious software and viruses, phishing, business email compromise and social engineering [removed: attacks] [added: attacks, network intrusions,] or other cyber-attacks.
As of the date of this filing, to our knowledge, we have not experienced an information security breach or material cybersecurity incident since [removed: that event.][added: an event in 2019.]
If we are not successful in selecting and integrating the businesses and technologies we acquire or partner with, or [removed: in managing] [added: if we do not manage] our current and future [added: site closures and] divestitures, our business may be adversely impacted.
- difficulties in achieving business and financial success (due to unplanned events such as [removed: the long-term economic impact of the COVID-19 pandemic and] ongoing geopolitical conflicts, such as between the Russian Federation and Ukraine, and between Israel and [removed: Hamas);][added: Hamas, as well as the US-China relationship which could potentially influence sourcing patterns and tariff costs);]
Some of the same risks exist when we decide to [added: close or] sell a business, site, product line or service [removed: offering or decide to close a site.][added: offering.]
We continually evaluate the performance and strategic fit of our business [added: and the sites in which they operate] to determine whether [removed: any divestitures are] [added: a site closure or divestiture is] appropriate.
Such [removed: divestitures] [added: actions] could involve additional risks, other than those listed above, including: difficulties in the separation of operations, services, products, and personnel, the need to agree to retain or assume certain current or future liabilities in order to complete the [removed: divestitures, and] [added: divestitures or site closures, as well as] write-offs, including those related to goodwill and other intangible assets and which could have an adverse effect on our results of operations and financial condition.
In addition, we may encounter [added: in closing or] difficulty in finding buyers or alternative exit strategies at acceptable prices and terms, and in a timely manner.
To address this [removed: issue,] [added: issue generally,] we typically pursue a number of strategies designed to improve our internal growth, including strengthening our presence in selected geographic markets through organic growth and strategic acquisitions and expanding our service [removed: offerings, including our expansion into the CDMO business.][added: offerings.]
We may not be able to successfully implement these strategies, and these strategies may not result in the expected growth [added: or improved profitability] of our business.
[removed: Factors such as insufficient capital, inflation, supply chain interruptions, inadequate forecasting, increases in construction material costs, or labor shortages] could interfere with the successful execution of our strategy and our ability to timely build infrastructure to satisfy capacity needs and support business growth.
While our financial results are reported in U.S. Dollars, the financial statements of many of our subsidiaries outside the U.S. are prepared using the [added: local currency as the functional currency.]
Despite any precautions we take for natural disasters or other catastrophic events, these events, including terrorist attack, a pandemic, epidemic or outbreak of a disease, [added: geopolitical conflict, information system disruption,] hurricanes, tornadoes, fire, [added: wildfire,] floods and ice and snow storms, could result in damage to and closure of our or our customers’ facilities or the infrastructure on which such facilities rely.
Although we carry business interruption insurance [removed: policies] and typically have provisions in our contracts that protect us in certain events, our coverage might not be adequate to compensate us for all losses that may occur.
Notwithstanding, certain special interest groups categorically object [added: to the use of animals for valid research purposes.]
Any negative attention, threats, acts of vandalism or legal action directed against our animal research or procurement [removed: activities,] [added: activities (including species] or [added: research models), or] our third-party service providers, such as our airline carriers or suppliers, or that restrict our or their ability to access protected or conservation areas, could impair our ability to operate our business efficiently.
We depend on a limited international source of supply for certain products, such as large research models, including [removed: non-human primates.][added: NHPs.]
While the Company was not named or referenced in the November 2022 proceedings, the Company shortly thereafter announced that Cambodia was the primary country of origin for non-human primates imports to Charles River, and that it had begun to operate under the expectation that for some time period supply of Cambodia-sourced non-human primates (which according to CDC statistics, [removed: account] [added: at that time accounted] for approximately 60% of supply to the United States) would be difficult to obtain in the United States.
“Legal Proceedings” in this Annual Report on Form 10-K, in February 2023 the Company [removed: was informed by the DOJ that in conjunction with the U.S. Fish and Wildlife Service (USFWS), they had commenced] [added: received] a grand jury [added: subpoena requesting certain documents related to an] investigation [added: by the DOJ and the USFWS] into the Company’s conduct regarding several shipments of non-human [removed: primates,] [added: primates from Cambodia,] which is occurring in parallel to a civil investigation being undertaken by the DOJ and USFWS.
Accordingly, the Company believes that for some undetermined period of time it will not be able to import Cambodia-sourced non-human primates into the United States, and overall supply of non-human primates from Cambodia on a world-wide basis is more limited than [added: it was] previously.
Limited global supply or regional restrictions on [added: importation, exportation, and/or] transportation for certain products may require us to source products from non-preferred vendors, which may not be successful.
[removed: Finally, we] [added: We also] may be unable to obtain supply due to governmental restrictions or limitations, including (as noted above) non-human [removed: primates.][added: primates, such as prohibitions on the importation, exportation and/or transportation of non-human primates from certain geographies entirely.]
Due to any pandemic, epidemic or outbreak in one or more regions in which our Cell Solutions business operates, the portion of the donor pool that typically donates may be unable, or unwilling to donate, thereby [removed: significantly reducing the availability of research products upon which we rely.]
If donor participation declines, we may not be able to reduce [removed: costs sufficiently to maintain profitability] [added: costs, which in turn may negatively impact the operating margin] of the Cell Solutions business.
Additionally, changes in global or regional economic conditions may affect the overall credit environment and impact our [removed: customers'] [added: clients’] ability to fulfill their payment obligations.
Additionally, we have [removed: business] [added: businesses] that [removed: depends] [added: depend] on our supply of large research models to clients.
We also operate businesses which depend upon the regulatory approval of the products they [removed: manufactures] [added: manufacture] for their [removed: contract development and manufacturing organization (CDMO)] [added: CDMO] clients.
As such, if these clients experience a [added: suspension,] delay in, or failure to receive, approval for any of their product candidates or fail to maintain regulatory approval of their products that we develop or manufacture, our revenue and profitability could be materially adversely affected.
Additionally, if the FDA or a comparable foreign regulatory authority does not approve of our facilities for the manufacture of a client product, observes significant deficiencies or violations at its facilities or withdraws such approval in the future, our clients may choose to identify alternative manufacturing facilities and/or relationships, which could significantly impact our CDMO capacity and capabilities and results of operations [removed: therefrom.][added: therefrom and could have a negative impact on our reputation and financial results.]
Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties
- If we are not successful in realizing cost savings from our restructuring initiatives, our business may be adversely impacted.
These threats also may be further enhanced in frequency or effectiveness through threat actors’ use of artificial intelligence technologies, which are becoming more widely adopted and increasingly sophisticated.
Additionally, the rapid ongoing evolution and increased adoption of emerging technologies such as artificial intelligence and machine learning may make it more difficult to anticipate and implement protective measures to recognize, detect, and prevent the occurrence of any of the cyber events described above.
- loss of key customers;
Acquisitions or alliances realizing these risks could increase the likelihood of our results of operations being adversely affected.
In 2024, we experienced such a lower-than-expected demand growth in a number of businesses, including the businesses that comprise our DSA reporting segment.
In addition, we have implemented a number of restructuring actions, including to optimize our global operational footprint and reduce staffing levels, and other initiatives to drive operating efficiencies to help offset the lower-than-expected demand growth and protect the operating margin.
Factors such as insufficient capital, inflation, supply chain interruptions, inadequate forecasting, increases in construction material costs, or labor shortages
Failure to successfully realize cost savings from our restructuring initiatives would adversely impact our growth and profitability.
As discussed in the section above entitled “Our Strategy,” we are taking decisive action to manage the Company through the current demand environment, including appropriately right-sizing our infrastructure, optimizing operations, and driving efficiency with a goal to protect operating margin.
We are committed to initiatives to generate more revenue, contain costs, and protect shareholder value through enhanced commercial initiatives, restructuring and efficiency actions to drive cost savings, as well as a balanced approach to capital deployment; these initiatives include reducing staffing levels to align with the pace of demand and site closures.
While we drive these initiatives to result in significant profit opportunities and savings throughout our organization, our estimated profits and savings are based on assumptions that may prove to be inaccurate, and as a result, there can be no assurance that we will realize these profits and cost savings or that, if realized, these profits and cost savings will be sustained.
Failure to achieve or delays in achieving projected levels of efficiencies and cost savings from such measures, or unanticipated inefficiencies resulting from manufacturing and administrative reorganization actions in progress or contemplated, could adversely affect our business, financial condition, results of operations and cash flows and harm our reputation.
- tariff regulations;
In addition, these groups have on occasion petitioned to have certain species of research models (specifically NHPs) declared endangered by governmental and non-governmental organizations and have advocated for the governing bodies to the Convention on International Trade in Endangered Species of Wild Fauna and Flora to restrict the exportation of certain NHP species from specific countries.
Additionally, in May 2023, the Company received an inquiry from the Enforcement Division of the SEC requesting it to voluntarily provide information, subsequently augmented with a document subpoena and additional inquiries, primarily related to the sourcing of non-human primates and related disclosures.
For instance, on February 4, 2025, the standing committee of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) decided to postpone review of proposed restrictions on the exportation of NHPs from Cambodia until a future CITES meeting, which is expected to occur in late 2025.
Finally, from time to time, special interest groups may attempt to list certain large research models, including certain categories of NHPs, as “endangered” under the Endangered Species Act in the United States or similar statutes in other countries.
In the event that certain NHPs are classified as endangered, our business could be negatively impacted.
significantly reducing the availability of research products upon which we rely.
Certain provisions of the Inflation Reduction Act passed in 2022 impact the U.S. federal income taxation of corporations.
This may impact the profitability for our clients.
Reduced profitability for our clients could in turn negatively impact the overall demand environment for our services from those clients.
For example, the NIH announced on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect overhead.
While, as of the date of this filing, the order has been temporarily stayed, there can be no assurance that it will not take effect or that other adverse actions will not be taken.
For example, in December 2022, the FDA Modernization Act 2.0 was passed, which clarifies methods manufacturers and sponsors can use to investigate the safety and efficacy of a drug.
when interrupted, adversely affects our business”, and “Item 3.
Similarly, if the FDA or other regulators develop concerns over regulatory compliance in connection with our manufacturing activities of clinical trial products, including with respect to the safety of a product, such authorities can delay or suspend a client’s clinical trial by placing it on a full or partial "clinical hold" pending receipt of additional data to satisfy such concerns.
A clinical hold on a client’s trial may require us to spend significant resources to address the underlying causes of the client’s clinical hold.
In addition, if we are not able to successfully address such underlying causes or our response is not deemed adequate to lift the client’s clinical hold, the clinical program may have to be terminated.
The same or similar regulatory issues can occur in connection with the manufacture of commercial products in the event of compliance concerns, whereby FDA or other regulators may prevent the distribution of products manufactured at our facilities and require corrective actions to address such concerns, which can be substantial and time consuming.
In the event of material compliance issues, FDA or other regulators may also refuse to approve our clients’ applications to market products manufactured at our facilities, which may also adversely affect our business.
In January 2025, a CDMO client disclosed that, as a result of observations made during pre-license inspections at a Company facility, (1) one biologics license application for a specific therapeutic treatment had received a complete response letter from the FDA, and (2) the FDA had placed clinical holds on that client’s Investigational New Drug applications.
In addition, subsequently the FDA conducted an inspection at the same Company facility resulting in the Company receiving a Form FDA 483 Notice of Inspectional Observations which the Company is in process of responding to, and which will include commitments to mitigate identified observations.
These types of events, including manufacturing disruptions, delays in clients’ clinical programs, and/or failures to obtain marketing approvals may adversely affect our business and/or results of operations.
A contamination event could also have a negative impact on our reputation and financial results.
develop and commercialize their inventions.
actions), government investigation or inquiries, enforcement actions, claims, proceedings, judgements, awards, penalties, sanctions or other adverse impacts that could have a material adverse effect on our business.
or the Company’s by-laws (in each case, as they may be amended from time to time), or (4) any action asserting a claim governed by the internal affairs doctrine shall be a state court located within the state of Delaware (or, if no state court located within the State of Delaware has jurisdiction, the federal district court for the District of Delaware).
section.
processes or systems.
In March 2019, we detected evidence that an unauthorized third party, who we believe was well resourced and highly sophisticated, accessed certain of our information systems and copied data.
We worked with a leading cyber security firm to assist in our investigation and coordinated with law enforcement authorities.
Our investigation indicated that the affected information included client information.
By the end of 2019, we disclosed that we had completed our remediation of the identified incident.
If an acquired business, technology or an alliance does not meet our expectations, our results of operations may be adversely affected.
local currency as the functional currency.
to the use of animals for valid research purposes.
Increasing demand could harm relationships with customers if we are unable to alter production capacity, or purchase products from other suppliers, to fill orders adequately.
Furthermore, our Cell Solutions operations are structured to produce research materials, such as blood products based on clients’ existing demand, and perceived potential changes in demand, for these products.
Sudden or unexpected changes in demand for these products could have an adverse impact on our profitability.
This could result in a decrease in overall revenue and profits.
Lack of access to sufficient capital, or lack of adequate time to properly (or the failure to adequately) respond to changes in demand, could result in declining revenue and profits, as clients transfer to other suppliers.
For example, in December 2022, the FDA Modernization Act 2.0 was passed, which requires the FDA to develop and implement a strategy to reduce the use of animals in testing while maintaining the safety and effectiveness of medical products and to explore the use of non-animal alternatives to animal testing.
Transport Association, the Convention on International Trade in Endangered Species of Wild Fauna and Flora, USFWS, The Centers for Disease Control, the Department of Transportation, the Department of State, the office of Laboratory Animal Welfare of NIH, the Drug Enforcement Agency, as well as numerous other oversight agencies in the jurisdictions in which we operate), failure to comply could subject us to denial of the right to conduct business, fines, criminal penalties and other enforcement actions.
Any such incident could, among other things, lead to increased costs, lost revenue, reimbursement to customers for lost drug substances, damage to and possibly termination of customer relationships, time and expense spent investigating and remediating the cause and, depending on the cause, similar losses with respect to other manufacturing runs.
In addition, such issues could subject us to litigation, the cost of which could be significant.
sustain periods of marginally profitable or unprofitable sales.
The EU GDPR imposes stringent obligations regarding the collection, control, use, sharing, disclosure and other processing of personal data of individuals within the EU and European Economic Area (EEA).
The EU-US DPF was adopted in July 2023 and provides US-based organizations who self-certify with a reliable mechanism for personal data transfers from the EU, United Kingdom, and Switzerland.
provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.
result in liability to us.
An excerpt. Shown here: 40 of 79 rewritten, 40 of 50 added and all 23 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2024 filing and the FY2023 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
134 rewritten, 141 added, 103 removed, 222 unchanged
A discussion of our results of operations for the fiscal year ended December [removed: 31, 2022] [added: 30, 2023] and a comparison of our results for the fiscal years ended December [removed: 31, 2022] [added: 30, 2023] and December [removed: 25, 2021] [added: 31, 2022] was included in Item 7.
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the fiscal year ended December [removed: 31, 2022,] [added: 30, 2023,] filed with the SEC on February [removed: 22, 2023.][added: 14, 2024.]
We also provide a suite of products and services to support our clients’ manufacturing [removed: activities, including our contract development and manufacturing organization (CDMO) business.][added: activities.]
We currently operate in [removed: 155] [added: over 130] sites and in over 20 countries worldwide, which numbers exclude certain Insourcing Solutions (IS) sites.
Our RMS reportable segment includes the [added: products and services offered within] Research Models, Research Model Services, and Cell [removed: Solutions businesses.][added: Solutions.]
Research Model Services includes: [added: Insourcing Solutions (IS), which provides colony management of our clients’ research operations (including recruitment, training, staffing, and management services) within our clients’ facilities as well as our own vivarium space, utilizing our Charles River Accelerator and Development Lab (CRADL™) offerings,] Genetically Engineered Models and Services (GEMS), which performs contract breeding and other services associated with genetically engineered models; [added: and] Research Animal Diagnostic Services (RADS), which provides health monitoring and diagnostics services related to research models; and [removed: Insourcing] [added: Cell] Solutions [removed: (IS), which] provides [removed: colony management of our clients’ research operations (including recruitment, training, staffing,] [added: controlled, consistent, customized primary cells] and [removed: management services) within our clients’ facilities] [added: blood components derived from normal and mobilized peripheral blood and bone marrow] as well as [removed: our own vivarium space, utilizing our Charles River Accelerator and Development Lab (CRADL) option.][added: cells from disease state donors.]
Our DSA segment is comprised of [removed: two businesses:] Discovery Services and Safety [removed: Assessment.][added: Assessment services.]
We provide regulated and non-regulated DSA services to support the [removed: research,] [added: discovery,] development, and regulatory-required safety testing of potential new drugs, including [removed: therapeutic discovery and optimization plus in vitro] [added: *in vitro* (non-animal)] and [removed: in vivo] [added: *in vivo* (in research models)] studies, laboratory support services, [added: including bioanalytical] and strategic non-clinical consulting and program management to support product development.
Our Manufacturing reportable segment includes Microbial Solutions, which provides *in vitro* [removed: (non-animal)] lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO).
Despite the [removed: near-term] [added: current, challenging] market [removed: pressures,] [added: environment,] many of our pharmaceutical and biotechnology clients continued to benefit from the long-term value of strategic outsourcing to improve their operating efficiency and to access capabilities that they do not maintain internally.
Many of our large biopharmaceutical clients have continued to [removed: increase investments in] [added: rely on relationships with outsourced partners like Charles River to enhance] their drug discovery and early-stage development [removed: efforts and have strengthened their relationships with outsourced partners, like Charles River,] [added: efforts,] and biotechnology companies to assist them in bringing new drugs to market.
[removed: Our] [added: However, our] ability to continue to deliver our leading suite of [removed: research and] [added: research,] non-clinical [removed: development] [added: development, and clinical bioanalytical] solutions has endeavored our clients to continue to choose to partner with us for our flexible and efficient outsourcing solutions, broad scientific capabilities, and global scale.
[removed: Clients are increasingly adopting CRADL™’s flexible model] [added: However, CRADLTM continues] to [added: be an attractive business model as a cost-effective and flexible solution for clients allowing] access [added: to] vivarium space without having to invest in internal infrastructure.
DSA backlog decreased to [removed: $2.45] [added: $2.0] billion as of December [removed: 30, 2023] [added: 28, 2024] from [removed: $3.15] [added: $2.5] billion as of December [removed: 31, 2022.][added: 30, 2023.]
Revenue for [removed: our] products and services that support [removed: our] [added: biopharmaceutical] clients’ manufacturing activities increased across [removed: most of our] [added: the] Manufacturing Solutions [removed: businesses in fiscal year 2023 however, demand in this reportable] segment [removed: was impacted by clients’ more cautious spending trends] in fiscal year [removed: 2023, as well as destocking activities and other challenges associated with CDMO and biopharmaceutical clients.][added: 2024.]
In response to recent trends [removed: described above,] [added: observed across each of our businesses,] we have undertaken [added: and will continue to implement] restructuring actions [removed: within all reportable segments] at various locations across North America, [removed: Europe] [added: Europe,] and Asia.
[removed: This includes workforce right-sizing actions,] resulting in severance and transition costs; and costs related to the consolidation of [removed: facilities,] [added: facilities to optimize our global footprint and drive greater operating efficiency across the Company,] resulting in asset [removed: impairment and] [added: impairment,] accelerated [removed: depreciation][added: depreciation, and other site consolidation charges.]
We expect that these effectuated [removed: actions] [added: actions,] as well as other upcoming planned actions [added: designed to optimize our global footprint to drive greater operating efficiency,] will result in approximately [removed: $60 million to $70] [added: $225] million of cost savings on an annualized [removed: basis.][added: basis, of which approximately $100 million impacted fiscal 2024.]
[removed: Our] [added: We maintain an acquisition] strategy [removed: is to augment] [added: that focuses on augmenting] internal growth of existing businesses with complementary acquisitions.
We [removed: continue to] make strategic acquisitions designed to expand our portfolio of products and services to support the drug discovery and development continuum.
Our recent [removed: acquisitions] [added: transactions] are described below.
On November 30, 2023, we completed our acquisition of an additional 41% equity interest of Noveprim Group [removed: (“Noveprim”),] [added: (Noveprim),] a leading [removed: provider] [added: supplier] of non-human primates [removed: (“NHPs”) used for biomedical, pharmaceutical and toxicological research purposes,] [added: (NHPs) located in Mauritius,] resulting in a 90% controlling interest.
We had previously acquired a 49% equity [removed: stake] [added: interest] in 2022 for $90.0 million [removed: up-front and] [added: plus] additional [removed: future] contingent payments up to $5.0 million based on future performance.
The total [removed: preliminary purchase price for] [added: consideration allocable to] the Noveprim acquisition is [removed: $374.8] [added: $392.4] million, which includes $144.6 million additional cash paid for the 41% equity interest, elimination of historical activity and intercompany balances of [removed: $198.8] [added: $209.5] million which includes a remeasurement gain on the 49% equity investment of [removed: $103.2] [added: $113.0] million, contingent consideration of $33.3 million, deferred purchase price of $12.0 million payable from 2024 through 2027, offset by estimated post-closing adjustments for working capital of [removed: $13.8] [added: $7.0] million.
This business is reported as part of our DSA reportable segment for NHPs vertically integrated into [removed: our Safety Assessment] [added: the DSA] supply chain and the RMS reportable segment for [added: those] NHPs sold to third party customers.
On January [removed: 30,] [added: 27,] 2023, we acquired SAMDI Tech, Inc., (SAMDI), a leading provider of high-quality, label-free high-throughput screening (HTS) solutions for drug discovery research.
On February [removed: 16,] [added: 17,] 2023, [removed: the Company was informed] [added: we received a grand jury subpoena requesting certain documents related to an investigation] by the U.S. Department of Justice (DOJ) [removed: that in conjunction with] [added: and] the U.S. Fish and Wildlife Service [removed: (USFWS), it had commenced an investigation] [added: (USFWS)] into [removed: the Company’s] [added: our] conduct regarding several shipments of non-human primates from Cambodia.
[removed: The Company is aware of] [added: As also previously disclosed,] a parallel civil investigation [added: is] being undertaken by the DOJ and USFWS.
[removed: The Company maintains] [added: Although we maintain] a global supplier onboarding and oversight program incorporating risk-based due diligence, auditing, and monitoring practices to help ensure the quality of our supplier relationships and compliance with applicable U.S. and international laws and regulations, [removed: and has operated under the belief that all shipments of non-human primates it received satisfied the material requirements, documentation and related processes and procedures of] [added: including] the Convention on International Trade in Endangered Species of Wild Fauna and Flora [removed: (CITES) documentation and related processes and procedures, which guides] [added: (CITES), in connection with] the [removed: release] [added: civil investigation, we have voluntarily suspended future shipments] of [removed: each import by USFWS.][added: non-human primates from Cambodia to the United States until such time that we and USFWS can agree upon and implement additional procedures to reasonably ensure that non-human primates imported from Cambodia are purpose-bred.]
[removed: The Company continues] [added: We continue] to care for the Cambodia-sourced non-human primates from certain [removed: recent] shipments in the United States.
On May 16, 2023, [removed: the Company] [added: we] received an inquiry from the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) requesting [removed: it] [added: us] to voluntarily provide information, subsequently augmented with a document [removed: subpoena,] [added: subpoena and additional inquiries,] primarily related to the sourcing of non-human [removed: primates,] [added: primates] and [removed: the Company is] [added: related disclosures, and we are] cooperating with the [removed: request.][added: requests.]
We are not able to predict what action, if any, might be taken in the future by the DOJ, USFWS, SEC or other governmental [removed: authorities as a result of the investigations.][added: authorities.]
None of the DOJ, USFWS or SEC has provided [removed: the Company] [added: us] with any specific timeline or indication as to when these investigations or, specific to the DOJ and USFWS, discussions regarding [added: resolution and] future processes and procedures, will be concluded or resolved.
[removed: The Company] [added: We] cannot predict the timing, outcome or possible impact of the investigations, including without limitation any potential fines, penalties or liabilities.
[removed: Applying the practical expedient, we do not assess whether a significant financing] component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less.
During fiscal year [removed: 2023, $2.6] [added: 2024, $2.4] billion, or approximately 60%, of our total revenue recognized [removed: ($4.1] [added: ($4.0] billion) is DSA service [added: and product] revenue transferred over time.
The value of the client relationship acquired was $23 million [removed: for fiscal year 2023] and [removed: $64] [added: the value of the biological assets acquired was $168] million for fiscal year [removed: 2022.][added: 2023.]
Events or circumstances that might require an interim evaluation [removed: include] [added: include, but are not limited to,] unexpected adverse business conditions, economic factors, unanticipated technological changes or competitive activities, loss of key [removed: personnel] [added: customers or personnel,] and acts by governments and courts.
In fiscal years [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] we performed the quantitative goodwill impairment test for our reporting units.
Our [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] impairment tests indicated that goodwill was not [removed: impaired.][added: impaired for any other reporting units.]
In fiscal year 2024, biopharmaceutical clients intensified their actions around restructuring initiatives and reprioritized their drug development programs, leading to constrained budgetary spending.
The uncertainty from a combination of a macroeconomic slowdown, pending patent expirations, and the impact of the Inflation Reduction Act (IRA) on drug pricing had led to significant cost-cutting measures by our large biopharmaceutical clients, including significant restructuring initiatives aimed at improving efficiency and reprioritization of spending shifting to late-stage clinical pipelines.
In addition, while biotechnology companies benefited from a more favorable funding environment in fiscal year 2024, recovery for this client base has occurred at a more gradual pace than anticipated due in part to uncertainty around future funding levels and the broader interest rate environment.
However, because of their more cautious view with regard to early-stage R&D spending, revenue due to both large biopharmaceutical clients and small and mid-sized biotechnology client declined in fiscal year 2024.
Within the DSA segment, these demand trends led to lower study volumes in both Safety Assessment and Discovery businesses, principally driven by softer demand from both large biopharmaceutical clients and small and mid-sized biotechnology clients.
Demand trends for large biopharmaceutical clients stabilized at a lower level during the second half of 2024; however, many of these clients are still in a period of tighter budgetary spending, continuing to reprioritize pipelines or eliminate some programs, which influences our cautious outlook for the near-term biopharmaceutical demand environment.
In addition, while biotechnology companies benefited from a more favorable funding environment and a slight improvement in demand trends during fiscal year 2024, recovery for this client base occurred at a more gradual pace than anticipated.
To enhance operational efficiency within the segment, the global Discovery and Safety Assessment businesses will implement a “One DSA” integrated operating structure.
This unification will focus on a combined salesforce and leadership approach, with integrated scientific programming in order to facilitate a more seamless client experience and enhance the Company’s client relationships.
Revenue for RMS increased in fiscal year 2024 due largely to revenue contributions from the acquisition of a controlling interest in Noveprim, as well as increased pricing for small research models.
Offsetting this growth, the challenging biopharmaceutical demand environment led to lower revenue for research model services, including Insourcing Solution’s CRADLTM operations.
This flexibility is particularly valuable in the current environment, where organizations are seeking to optimize their research budgets and minimize operational costs.
The Microbial Solutions business experienced robust growth as client destocking activity by large biopharmaceutical and CDMO clients was largely completed in the prior year.
The growth was further driven by higher revenue of our rapid microbial testing solutions, primarily for Endosafe® testing consumables and instruments.
Our Biologics business benefited from improved volumes for biologics quality-control testing services, as well as increased demand for our cell and gene therapy CDMO services during the year.
Since the strategic acquisition of the CDMO businesses in 2021, Cognate and Vigene, significant steps have been taken, such as establishing Centers of Excellence for cell therapy, viral vectors, and plasmids, to support the emerging modalities and technologies enhanced operations and capabilities.
However, in December 2024, our Biologics business experienced the loss of certain key customers, ultimately resulting in a reduction in its long range financial outlook.
As a result, the Company expects lower revenue from commercial clients to impact its CDMO business in 2025.
This includes workforce right-sizing actions,
During fiscal 2023, the Company began to take restructuring actions as a result of these emerging business trends.
The Company incurred restructuring charges of $107.0 million and $29.7 million during the fiscal years 2024 and 2023, respectively.
Despite the near-term market pressures, we believe clients will continue to benefit from the long-term value of strategic outsourcing to improve their operating efficiency and to access capabilities that they do not maintain internally.
As the scientific partner of choice to accelerate biomedical research, we are committed to driving greater efficiency and speed while providing exceptional service to our clients.
The purchase price reflected an agreement with the seller on working capital and debt, which was adjusted from $13.8 million to $7.0 million during fiscal year 2024.
As a result of measurement period adjustments to the purchase price, goodwill and remeasurement gains on the previous 49% equity investment during fiscal year 2024, were increased by $17.6 million and $9.8 million, respectively.
Remeasurement gains are recorded in Other income (expense), net, within the consolidated statements of income.
The contingent consideration fair value is estimated using a Monte Carlo Simulation model and the maximum contingent contractual payments are up to $55.0 million based on future performance and milestone achievements from fiscal years 2023 through 2025.
The Company has the call option right to purchase the remaining 10% equity interest up until one month after the sixth anniversary of closing the 41% equity interest.
On the first anniversary of the expiration of the call option, a 12-month put option will be triggered giving the seller the right to require us to acquire the remaining shares of the seller.
The redemption price for the call/put is fixed and ranges from $47.0 million to $54.0 million depending on when exercised.
The noncontrolling interest is classified as a redeemable noncontrolling interest in the mezzanine section of the consolidated balance sheets.
That investigation remains ongoing and we are continuing to cooperate with the investigation.
We are also cooperating with that investigation, and although we continue to dispute the merits of certain positions taken by the DOJ and USFWS in the civil investigation, we have discussed a potential resolution of that matter with the DOJ and USFWS.
Those discussions are ongoing.
Due to a number of factors, including the age of these NHP’s, during the fourth quarter of fiscal year 2024, we recorded a charge of $27 million to costs of products sold within the accompanying consolidated statements of income to reflect the reduction in carrying value of this inventory to zero.
Our Audit Committee has retained counsel to conduct an independent investigation into certain issues raised in the investigations, and that work is ongoing.
Applying the practical expedient, we do not assess whether a significant financing
Business Combinations
During fiscal year 2024, we did not enter into any acquisitions.
Goodwill
Cell Solutions provides controlled, consistent, customized primary cells and blood components derived from normal and mobilized peripheral blood and bone marrow.
In fiscal year 2023, biopharmaceutical clients reprioritized their drug development programs and were more cautious with their budgetary spending amidst the uncertainty in the broader market environment, including a slowdown in biotechnology funding activities, as well as macroeconomic challenges, including higher interest rates.
The demand and pricing for our products and services continued to increase in fiscal year 2023, but at a slower pace than in recent years.
While these clients were more cautious with their early-stage R&D spending in fiscal year 2023, these large biopharmaceutical clients were the principal driver of revenue growth.
A reduction in the biotechnology funding environment from peak levels in 2021 resulted in a moderation of demand from small and mid-size biotechnology clients.
We have recently experienced an increase in our allowance for credit losses, which increased to $25.7 million as of December 30, 2023 from $11.3 million as of December 31, 2022 and may expect this trend to continue if the biotechnology funding environment remains consistent or further softens.
Revenue for RMS increased, principally driven by pricing.
China reported healthy growth rates despite pressure from more cautious spending on biomedical research activity from clients within China.
Demand for research model services continued to perform well, led by our Insourcing Solutions business, particularly our CRADL™ operations.
To support client demand, we have expanded CRADL™’s footprint both organically and through the acquisition of Explora BioLabs in April 2022.
DSA continued to benefit from sustained trends in fiscal year 2023.
The Safety Assessment revenue growth rate moderated due to our clients’ budgetary spending constraints but continued to report a solid growth rate for the fiscal year due to a combination of price increases and study volume.
Safety Assessment growth was supported by the meaningful scale of the backlog for this business, although it has recently decreased.
Biotechnology clients continue to move their programs forward and utilize outsourcing to achieve their goal of more efficient and effective drug research to bring innovative new therapies to market.
We continued to enhance our Discovery Services capabilities to provide clients with a comprehensive portfolio that enables them to start working with us at the earliest stages of the discovery process.
We have accomplished this in recent years through acquisitions and by adding cutting-edge capabilities to our discovery toolkit through technology partnerships.
In fiscal year 2023, demand in our Discovery Services business declined, as clients reprioritize their program and conserve their early-stage spending, which resulted in lower proposal activity and a longer lead time to commence new projects.
Demand for our cell and gene therapy CDMO services improved meaningfully in fiscal year 2023 as the initiatives that we have implemented to improve the performance of our CDMO business gained traction and generated a healthy pipeline of new business opportunities including working on two commercial products.
Charles River remains a premier scientific partner for development, testing, and manufacturing of advanced drug modalities and the acquisition of the CDMO businesses in 2021, Cognate and Vigene, further enhanced our presence in the high-growth cell and gene therapy sector.
charges.
Restructuring charges recognized during fiscal year 2023 were approximately $30 million, of which $18 million related to asset impairment and accelerated depreciation charges and $12 million related to severance charges.
The acquisition strengthens and diversifies the supply chain for our DSA segment.
On April 5, 2022, we acquired Explora BioLabs Holdings, Inc. (Explora BioLabs), a provider of contract vivarium research services, providing biopharmaceutical clients with turnkey *in vivo* vivarium facilities, management and related services to efficiently conduct their early-stage research activities.
The acquisition of Explora BioLabs complements our existing Insourcing Solutions business, specifically our CRADL™ footprint, and offers incremental opportunities to partner with an emerging client base, many of which are engaged in cell and gene therapy development.
The purchase price of Explora BioLabs was $284.5 million, net of $6.6 million in cash acquired.
The acquisition was funded through proceeds from our Credit Facility.
This business is reported as part of our RMS reportable segment.
Recent Divestiture
We routinely evaluate strategic fit and fundamental performance of our global infrastructure and divest operations that do not meet key business criteria or where capital could be better deployed in other long-term growth opportunities.
On December 20, 2022, we completed the sale of our Avian Vaccine Services (Avian) business to a private investor group for a preliminary purchase price of $167 million in cash, subject to certain customary closing adjustments, and future contingent payments up to an additional $30 million.
Prior to divestiture, this business was reported in our Manufacturing reportable segment.
On February 17, 2023 the Company received a grand jury subpoena requesting certain documents related to such investigation.
The Company is cooperating with the DOJ and the USFWS and believes that the concerns raised with respect to the Company’s conduct are without merit.
Notwithstanding our efforts and good-faith belief, in connection with the civil investigation, the Company has voluntarily suspended future shipments of non-human primates from Cambodia to the United States until such time that the Company and USFWS can agree upon and implement additional procedures to reasonably ensure that non-human primates imported from Cambodia are
purpose-bred.
The carrying value of the inventory related to these shipments is approximately $27 million as of December 30, 2023, which reflects the value of the shipments in accordance with our inventory accounting policy.
Refer to Item 1A, “Risk Factors” disclosed herein for our assessment of risk factors surrounding this matter.
Intangible Assets (including Goodwill) and certain Biological Assets
The value of the biological assets acquired was $168 million for fiscal year 2023.
We review definite-lived intangible assets for impairment when indication of potential impairment exists, such as a significant reduction in cash flows associated with the assets.
An excerpt. Shown here: 40 of 134 rewritten, 40 of 141 added and 40 of 103 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the FY2024 filing and the FY2023 filing.
Item 1. Business
137 rewritten, 49 added, 58 removed, 379 unchanged
For example, we may use forward-looking statements when addressing topics such as: our expectations regarding the availability of non-human primates and our ability to diversify our non-human primate [added: (NHP)] supply chain; the outcome of (1) the U.S. government investigations and inquiries related to the [removed: non-human primate] [added: NHP] supply chain (including shipments of [removed: non-human primates] [added: NHPs] from Cambodia received by the Company), (2) the putative securities class action lawsuit filed against us and certain current/former officers on May 19, 2023, [removed: and] (3) the derivative lawsuit filed against members of the Board of Directors and certain current/former officers on November 8, 2023; [added: and (4)] the [added: derivative lawsuit filed against certain current/former members of the Board of Directors and certain current/former officers on August 2, 2024; the] timing and impact of the development and implementation of enhanced procedures to reasonably ensure that non-human primates we [removed: source] [added: import] are [removed: purpose-bred;] [added: legally sourced;] changes and uncertainties in the global economy and financial markets, including any changes in business, political, or economic conditions due to the November 16, 2022 announcement by the U.S. Department of Justice through the U.S. Attorney’s Office for the Southern District of Florida that a Cambodian non-human primate supplier and two Cambodian officials had been criminally charged in connection with illegally importing non-human primates into the United States; client demand, particularly future demand for drug discovery and development products and services, including the outsourcing of these services; our expectations with respect to our ability to meet financial targets; our expectations regarding stock repurchases, including the number of shares to be repurchased, expected timing and duration, the amount of capital that may be expended and the treatment of repurchased shares; our ability to successfully execute our business strategy; our ability to timely build infrastructure to satisfy capacity needs and support business [removed: growth,] [added: growth;] our ability to fund our operations for the foreseeable [removed: future,] [added: future;] the impact of unauthorized access into our information systems, including the timing and effectiveness of any enhanced security and monitoring present spending trends and other cost reduction activities by our clients; future actions by our management; the outcome of contingencies; changes in our business strategy, business practices and methods of generating revenue; the development and performance of our services and products; market and industry conditions, including competitive and pricing trends and the impact of those conditions, including on our allowances for credit losses; our strategic relationships with leading pharmaceutical and biotechnology companies, venture capital investments, and opportunities for future similar arrangements; our cost structure; our expectations regarding our acquisitions and divestitures, including their impact and projected timing; our expectations with respect to revenue growth and operating synergies (including the impact of specific actions intended to cause related [removed: improvements, particularly with respect to our CDMO business);] [added: improvements);] the [added: nature, timing and] impact of specific actions intended to improve overall operating efficiencies and profitability (and our ability to accommodate future demand with our infrastructure), including [added: actions to optimize our global footprint, and] gains and losses attributable to businesses we plan to close, consolidate, divest or repurpose and the impact of operations and [removed: cost structure alignment efforts] [added: restructuring actions] (including as estimated on an annualized basis); our expectations with respect to study cancellation rates and the impact of such cancellations; [added: our expectations with respect to tax rates and benefits;] changes in our expectations regarding future stock option, restricted stock, performance share units and other equity grants to employees and directors; expectations with respect to foreign currency exchange; assessing (or changing our assessment of) our tax positions for financial statement purposes; our liquidity; and the impact of litigation, including our ability to successfully defend litigation against us.
In addition, these statements include the impact of economic and market conditions on us and our clients, the effects of our cost-saving [removed: actions] [added: actions, including on an annualized basis,] and the steps to optimize returns to shareholders on an effective and timely basis; and our ability to withstand the current market conditions.
We currently operate in [removed: 155] [added: over 130] sites and in over 20 countries worldwide (excluding certain Insourcing Solutions sites).
In [removed: 2023,] [added: 2024,] our total revenue was [removed: $4.1] [added: $4.0] billion.
[added: We continue to maintain our position as a global leader in the production] and sale of the most widely used research models, including over 140 different stocks and strains of purpose-bred rodents.
In [removed: 2023,] [added: 2024,] RMS accounted for [removed: 19.2%] [added: 20.5%] of our total revenue and approximately [removed: 4,300] [added: 4,100] of our employees, including approximately 200 science professionals with advanced degrees.
Our DSA segment provides services that enable our clients to outsource their innovative drug discovery research, their related [removed: nonclinical] [added: non-clinical] and [removed: some] clinical [removed: drug development] [added: bioanalytical] activities, and regulatory-required safety testing of potential new drugs, vaccines, industrial and agricultural chemicals, consumer products, veterinary medicines and medical devices.
The demand for these services is driven by the needs of large global pharmaceutical companies [removed: that continue to transition to an outsourced drug development model,] [added: where outsourcing may complement internal activities,] in addition to mid-size and emerging [removed: biotechnology] [added: biotechnology/biopharma pharmaceutical] companies, [added: hospitals, academic institutions, contract research organizations, and] industrial and agrochemical companies and non-governmental organizations that rely [added: more heavily] on [removed: outsourcing.][added: outsourcing partners.]
[removed: These] [added: Many of these] entities [removed: may] choose to outsource their discovery, [removed: development and] [added: development, bioanalytical and/or] safety [added: assessment] activities to reduce fixed costs and to gain access to [removed: additional] scientific [removed: expertise] [added: expertise, robust capabilities,] and [removed: capabilities.][added: regulatory experience.]
We have extensive expertise in the discovery of [removed: nonclinical] [added: clinical] candidates and in the design, execution and reporting of safety assessment studies for numerous types of [removed: compounds] [added: therapeutic modalities,] including cell and gene therapies, small and large molecule pharmaceuticals, industrial and agricultural chemicals, vaccines, consumer products, veterinary medicines, biocides and medical devices.
In [removed: 2023,] [added: 2024,] our DSA segment represented [removed: 63.3%] [added: 60.5%] of our total revenue and employed approximately [removed: 13,400] [added: 12,100] of our employees including approximately [removed: 1,800] [added: 1,500] science professionals with advanced degrees.
Biologics Solutions is comprised of both our Biologics Testing Solutions business, which provides specialized testing of biologics frequently outsourced by global pharmaceutical and biotechnology companies, and our [removed: CDMO] [added: contract development and manufacturing products and services (“CDMO”)] business, which provides comprehensive contract development and manufacturing solutions for cell and gene therapies.
In [removed: 2023,] [added: 2024,] Manufacturing accounted for [removed: 17.4%] [added: 19.0%] of our total revenue from continuing operations and approximately [removed: 3,000] [added: 2,800] of our employees, including approximately [removed: 400] [added: 380] science professionals with advanced degrees.
A significant portion of our Research Models business involves the commercial production and sale of small research models, principally purpose-bred rats and mice for use by [removed: researchers.][added: researchers in fundamental biology through to drug discovery and development.]
Our research models are bred and maintained in controlled environments, which are designed to ensure that the models are free of specific viral and [removed: bacterial agents and other contaminants that can disrupt research operations and distort scientific results.]
Our small research models include inbred, outbred, and hybrid strains, as well as mutant [removed: strains and] [added: strains,] genetically engineered models [added: and humanized models] with biological features, which enable research aims.
[added: While we provide some non-human primates directly to clients who utilize] them primarily for safety testing of new therapies, most of the non-human primates associated with our business are utilized in connection with our [removed: customers’] [added: clients’] studies conducted by our Safety Assessment [added: services in our DSA] business.
In both cases - non-human primates we provide directly to [removed: customers] [added: clients] and non-human primates which are utilized [removed: in] [added: through] our Safety Assessment [removed: business] [added: services] – these large research models are sourced from Charles River audited and approved suppliers, some of which we have an ownership and/or operational involvement.
[removed: See Note 2, “Acquisitions] [added: Segment] and [removed: Divestitures”,] [added: Geographic Information,] included in the [removed: notes] [added: Notes] to [removed: our consolidated financial statements] [added: Consolidated Financial Statements] included elsewhere in this Form [removed: 10-K for a description of the recent acquisition of Noveprim Group.][added: 10-K.]
The business supplies controlled, consistent, customized primary cells and blood components derived from normal and mobilized peripheral blood and bone [removed: marrow.][added: marrow, as well as cells from disease state donors.]
We currently offer regulated and non-regulated DSA services to support the [removed: research,] [added: discovery,] development, and regulatory-required safety testing of potential new drugs, including [removed: therapeutic discovery and optimization plus] *in vitro* and *in vivo* studies, laboratory support services, [added: including bioanalytical] and strategic non-clinical consulting and program [removed: management to support product development.][added: management.]
[added: Discovery Services.] We offer a [added: single source of services for discovering and characterizing novel drug candidates for preclinical development by providing a] full spectrum of discovery services [added: —] from identification and validation of novel targets, [removed: chemical compounds] [added: low molecular weight small molecule compounds, oligonucleotides,] and [removed: antibodies] [added: biotherapeutics] with actual or potential intellectual property [removed: value] [added: value,] through to delivery of preclinical drug and [removed: therapeutic] [added: biotherapeutic] candidates ready for safety [removed: assessment.][added: assessment and progression toward the clinic.]
[removed: Our Discovery Services business] [added: This] includes services to streamline and enhance drug discovery programs for our clients, including expertise and capabilities in all stages of [removed: Discovery] [added: discovery] and all major modalities including small molecules, [removed: antibodies] [added: biologics (antibodies), oligonucleotides,] and cell and gene therapies.
[removed: This] [added: Our] seamless [removed: discovery organization,] [added: offering portfolio,] along with [removed: its] [added: our] broad [added: expertise and] capabilities [removed: allows] [added: allow] us to better engage with clients at any stage of their drug discovery programs and support their complex scientific needs.
[removed: Our Discovery Services business focuses] [added: We focus] on [removed: all of the] major therapeutic areas, with a strategic [removed: focus] [added: emphasis] on [added: neuroscience,] oncology, [removed: immunology] and [removed: neuroscience.][added: immunology.]
[added: We believe there are growing opportunities to assist] our clients in a variety of drug discovery applications and [removed: platforms] [added: platforms,] from target discovery to candidate selection and across the full range of modalities.
Our full suite of service offerings, together with our knowledge and expertise, allows us to engage and support our clients at any stage of their discovery or early-stage development programs, including the design and [removed: implementations] [added: implementation] of their research programs, and to stay with them through the entire drug discovery [removed: process.][added: process, providing a seamless end-to-end offering.]
- target deconvolution through [removed: proteomics;][added: proteomics and cell microarray technology;]
- hit [removed: identification] [added: identification, hit-to-lead progression] and [added: lead] optimization to deliver candidate molecules [added: and biotherapeutics] across modalities, [removed: including] [added: making use of state-of-the-art techniques such as] computer-aided drug [removed: design;][added: design, structural biology and machine learning/artificial intelligence;]
- early [removed: nonclinical] [added: non-clinical] pharmacokinetic and pharmacodynamic studies, transporter-mediated drug-drug interaction, and *in vitro* and *in vivo* assays to assess mechanism, bioavailability and metabolism as required for regulatory [removed: approval of new drugs;][added: approval;]
- target engagement [added: and safety] biomarker development to support non-clinical and potentially downstream clinical studies.
[added: Safety Assessment.] We offer a full range of safety assessment studies required for regulatory submission on a global basis across all therapeutic areas in the pharmaceutical, biotechnology, industrial chemical, agrochemicals, consumer products, veterinary medicines and medical devices industries.
[removed: Our Safety Assessment business is] [added: We are] a global leader in both non-regulated and regulated [removed: (GLP)] [added: GLP] outsourced safety assessment [removed: services.][added: services and provide expertise in a variety of therapeutic areas and modalities.]
*Toxicology.* [removed: We] [added: In addition to offering standard toxicology services, we also] provide a broad [added: range of] specialty toxicology offering from inhalation and infusion to developmental and reproductive toxicology.
Our services include [removed: a broad] [added: an extensive] offering of [removed: *in vitro* and *in vivo*] capabilities and study types designed to identify possible safety risks as well as a [removed: broad] [added: comprehensive] offering of *in vitro* and *in vivo* studies in support of general toxicology (acute, sub-acute and chronic studies), genetic toxicology, safety pharmacology, off-target screening, receptor identification profiling, reproductive and developmental toxicology, juvenile toxicology, and carcinogenicity bioassays that are required for regulatory submissions supporting “first-in-human” to “first-to-the-market” strategies for potential human therapeutics.
Additionally, we support safety studies in numerous specialty areas including [removed: abuse] [added: cell] and [removed: seizure liability,] [added: gene therapies,] ecotoxicology, environmental risk, musculoskeletal toxicology, neurotoxicology, ocular toxicology, ototoxicology, and phototoxicology.
For new chemicals, industrial chemicals, agrochemicals, veterinary medicines, consumer products and medical devices, safety studies are performed to identify potential hazards to [removed: humans and the environment and are required for regulatory registration.]
Toxicology studies performed for any of these compounds are typically performed using *in vitro* and *in vivo* research models to identify any potential adverse effects that a compound has on an organism [added: or tissue] over a variety of doses and over various time periods of exposure.
*Pathology Services.* The ability to identify and characterize clinical and anatomic pathologic changes is critical in determining the safety and efficacy of potential new therapeutics, industrial and agricultural chemicals, veterinary medicines, and medical [added: devices.]
In addition to all standard anatomic and clinical pathology techniques, we provide specialized evaluations such as [added: digital primary and peer review histopathology options,] cytology, platelet function, assay development, immunohistochemistry, in situ hybridization, [removed: electron microscopy,] image analysis, tissue morphometry and spatial analysis services.
As part of our efforts to manage the Company through the current demand environment, we have undertaken a comprehensive review of our global footprint.
Through these optimization initiatives, we expect to close or consolidate approximately 15 additional sites over the next two years, principally focused on the DSA and RMS segments.
These footprint optimization efforts will enhance the efficiency and economies of scale in our global infrastructure, leading to a more disciplined operating model.
bacterial agents and other contaminants that can disrupt research operations and distort scientific results.
In 2025, we initiated the integration of our Discovery Services and Safety Assessment businesses into one overarching DSA organization.
This unification focuses on a combined sales force and leadership approach, with integrated scientific expertise to facilitate a more seamless client experience and make us a stronger and even more responsive partner for our clients.
In the discovery phase, we leverage our capabilities in non-GLP toxicity assessment and predictive models to enable identification and mitigation of safety issues to ensure a smooth progression into regulatory safety assessment.
We have in depth capabilities in formulation and pharmaceutics to provide seamless transfer of optimized drug substance from the discovery phase into pre-clinical development and safety assessment.
Our Safety Assessment teams can flag unexpected issues observed in regulatory toxicology to our Discovery Services team that might be resolved by further optimization within Discovery Services, enabling clients to potentially regain momentum in pre-clinical programs after resolution of the issues.
Our offerings include:
- disease biology;
*•*appropriate *in vivo* Discovery Services evaluation, which is essential to generate confidence in the initial safety of a novel therapeutic agent, its fate in an intact mammalian system and its potential to translate into an efficacious treatment in humans;
humans and the environment and are required for regulatory registration.
Our Accugenix® business provides state-of-the-art microbial
Our laboratories in the U.S., Germany, Ireland
We are taking decisive action to manage the Company through the current demand environment, including appropriately right-sizing our infrastructure, optimizing operations, and driving efficiency with a goal to protect operating margin.
We are committed to initiatives to generate more revenue, contain costs, and protect shareholder value through enhanced commercial initiatives, restructuring and efficiency actions to drive cost savings, as well as a balanced approach to capital deployment, including:
- Restructuring initiatives to manage costs and generate efficiency by reducing staffing levels to align with the level of demand, as well as evaluating our global footprint to optimize, consolidate, and simplify operations.
We are also engaging in global footprint optimization efforts to maximize capacity and enhance our capabilities.
We have taken a client-centric approach to these actions with a goal of serving our clients more efficiently and seamlessly in order to capture synergies and savings that extend beyond the facility costs.
These footprint optimization efforts are intended to enhance the efficiency and economies of scale in our global infrastructure, leading to a more disciplined operating model.
In addition, Charles River’s culture of continuous improvement strives to implement initiatives to drive greater operating efficiencies.
In the current demand environment, we are focused on achieving this goal through streamlining global business services, driving enhanced procurement savings, and leveraging our digital platform.
- Focusing 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 technology such as our Apollo™ cloud-based platform to provide real-time access to scientific data and self-service tools for clients.
- Continuing to evaluate additional strategies to enhance the business.
We are working on initiatives to further transform how we operate, including harmonization and centralization of processes, tools and tasks, continuing to better leverage technology, adoption of a global businesses service model to streamline our operations, as well as other projects such as generating greater procurement savings.
Over the past decade, we have expanded our capabilities by adding high-science services with the goal to deliver fast and high quality end-to-end integrated, non-clinical solution to accelerate drug development.
Segment and Geographic Information, included in the Notes to Consolidated Financial Statements included elsewhere in this Form 10-K.
tailored solutions across our entire portfolio.
Microbial Solutions has four main competitors, of which three are public companies in Europe and one is part of a public company in Japan.
As part of the HCI, we also have quarterly recognition and celebration of employees that go above and beyond to promote animal welfare and safety, In 2024, we published on our website an extensive and comprehensive Corporate Citizenship Report, which includes information on our Global Animal Welfare and Training, Responsible Animal Use and New Alternative Methodologies (NAMs) work, including investments in NAMs through our recently launched Alternative Methods Advancement Project (AMAP) initiative that is dedicated to investing in and developing alternatives to reduce animal testing.
Part of the decisive action we have and continue to implement to manage the Company through the current demand environment includes restructuring initiatives to manage costs and generate efficiency by reducing staffing levels to align with the pace of demand.
We have reduced our total headcount by approximately 8% since the end of 2023.
It is imperative in this environment to keep our staff well utilized in order to protect operating income margin, which is our goal.
As a global organization, our growth and development depend on hiring, engaging, and retaining a skilled and global workforce in a highly competitive marketplace.
In order to attract the best candidate for each position, we prioritize widescale recruitment efforts to attract a larger pool of applicants from a variety of backgrounds.
Our hiring process is designed to ensure fair and objective decisions lead to the most qualified candidate being hired.
We strive to make our hiring practices accessible, including offering reasonable accommodations as appropriate.
It is critical that our people feel valued, supported, and that we provide opportunities for all.
We continue to maintain our position as a global leader in the production
While we provide some non-human primates directly to customers who utilize
Our DSA segment is comprised of two businesses: Discovery Services and Safety Assessment.
Discovery Services.
Our Discovery Services business operates as a single source of services for discovering and characterizing novel drug candidates for preclinical development.
We believe there are growing opportunities to assist
Our Discovery service capabilities include:
*•In vivo* Discovery Services, which are essential in early stage, non-clinical discovery research, and are directed at the identification, screening, optimization and selection of effective therapeutics agents in pharmacology models.
These *in vivo* activities typically extend anywhere from 1 to 2 years in conventional pharmaceutical R&D timelines; and
Additionally, we offer ion channel and drug transporter testing for both discovery and non-clinical purposes.
We also provide these services at our clients’ laboratories with Charles River scientists as part of an insourcing service model.
Through comprehensive *in vivo* and *in vitro* offerings, Discovery Services helps to reduce the time needed to research, develop, and assess the efficacy of new therapeutics under development.
Our offerings include businesses that provide critical data to advance novel therapeutics, as well as drug transporter assays and kits.
We offer R&D expertise, capabilities and services globally to accelerate our clients’ drug discovery pipelines from lead generation to candidate selection.
We complement and extend clients’ capabilities and expertise to improve their decision-making, increase their flexibility, and reduce their internal costs and product development timelines.
Through strategic partnerships, we also offer an artificial intelligence drug design platform, a human stem cell model platform, and 3D *in vitro* oncology models.
Safety Assessment.
Our safety assessment business also provides expertise in a variety of therapeutic areas and modalities.
devices.
Generally, the
Our Biologics Testing Services business encompasses process development and quality-control testing to support the manufacture of biologics.
In the last 4 years, we have
invested approximately $200 million in alternative methodologies, including technologies and digital platforms that reduce/modify animal use via strategic acquisitions, partnerships, and internal investments.
*Digital Enhancements.* We believe the healthcare industry is at a unique inflection point post COVID, where vaccines and treatments were developed in record time, and there is increasing focus on personalized medicine and rare diseases.
and manufacturing processes they will choose to outsource.
In recent years, we have expanded our service capabilities into the high-growth, high-science sector of cell and gene therapy.
Our goal is to deliver the fastest and highest quality end-to-end integrated solution to accelerate cell and gene therapy development and manufacturing globally by leveraging our comprehensive portfolio of cell and gene therapy capabilities with a consistent, easy-to-use, and customizable, high-science approach, while offering the flexibility to adapt and innovate to meet our client’s changing needs.
In the cell and gene therapy sector, we aim to accelerate our clients’ path to market, to expand capabilities and geographic reach to complement our leading non-clinical portfolio, and to collaborate with our clients and partners to enable and commercialize the next generation of cell and gene therapy innovations.
Our CDMO capabilities, combined with our comprehensive portfolio, most notably our Biologics Testing Solutions business, industry experience, and established infrastructure, helped solidify Charles River as a premier scientific partner for cell and gene therapy development, testing, and manufacturing.
In particular, our focus has been to drive differentiation through technologies that enhance the speed to develop a clinical candidate and allow biopharmaceutical companies to make earlier go/no-go decisions.
Among other arrangements, these relationships may include entering into license agreements, strategic technology partnerships or joint ventures that will allow us to access innovative capabilities and cutting-edge or nascent technologies with a modest investment component.
Our ability to thoroughly assess these technologies and market opportunities may later result in an acquisition.
cutting-edge capabilities.
In 2023, we added a fourth “R” to the longstanding 3Rs framework - Responsibility.
In 2023, we established the management Office for Responsible Animal Usage to oversee responsible animal utilization and reduction practices, and operating standards of care.
employees, while approximately 1,400 are considered part-time employees.
Recently, we developed a unique employer brand that is infused in other aspects of our employee experience and in the past year, we have trained 1,400 managers on our inclusive hiring approach utilizing behavioral based interviewing that is aligned to our Charles River DNA.
In order to attract, onboard, support, and retain such great talent, we provide our employees with opportunities for skill building and career advancement.
While we perform pay equity audits in countries where they are legally required, we also perform a larger pay equity analysis on a global scale and take corrective action where appropriate as part of our continuing efforts to be competitive in the marketplace.
We maintain a Global Policy on Safety & Sustainability and, as part of our efforts to promote our goals of working safely and sustainably, in early 2020 we implemented a management systems approach to improve our safety performance, which involves both employee and management engagement in and ownership of our site-level environment, health, safety, and sustainability programs globally.
An excerpt. Shown here: 40 of 137 rewritten, 40 of 49 added and 40 of 58 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2024 filing and the FY2023 filing.
Item 3. Legal Proceedings
11 rewritten, 10 added, 7 removed, 11 unchanged
On February [removed: 16,] [added: 17,] 2023, the Company [removed: was informed] [added: received a grand jury subpoena requesting certain documents related to an investigation] by the U.S. Department of Justice (DOJ) [removed: that in conjunction with] [added: and] the U.S. Fish and Wildlife Service [removed: (USFWS), it had commenced an investigation] [added: (USFWS)] into the Company’s conduct regarding several shipments of non-human primates from Cambodia.
[removed: The Company is aware of] [added: As also previously disclosed,] a parallel civil investigation [added: is] being undertaken by the DOJ and [removed: USFWS.]
[removed: The] [added: Although the] Company maintains a global supplier onboarding and oversight program incorporating risk-based due diligence, auditing, and monitoring practices to help ensure the quality of our supplier relationships and compliance with applicable U.S. and international laws and regulations, [removed: and has operated under the belief that all shipments of non-human primates it received satisfied the material requirements, documentation and related processes and procedures of] [added: including] the Convention on International Trade in Endangered Species of Wild Fauna and Flora [removed: (CITES) documentation and related processes and procedures, which guides] [added: (CITES), in connection with] the [removed: release] [added: civil investigation, the Company has voluntarily suspended future shipments] of [removed: each import by USFWS.][added: non-human primates from Cambodia to the United States until such time that the Company and USFWS can agree upon and implement additional procedures to reasonably ensure that non-human primates imported from Cambodia are purpose-bred.]
The Company continues to care for the Cambodia-sourced non-human primates from certain [removed: recent] shipments in the United States.
On May 16, 2023, the Company received an inquiry from the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) requesting it to voluntarily provide information, subsequently augmented with a document [removed: subpoena,] [added: subpoena and additional inquiries,] primarily related to the sourcing of non-human [removed: primates,] [added: primates] and [added: related disclosures, and] the Company is cooperating with the [removed: request.][added: requests.]
We are not able to predict what action, if any, might be taken in the future by the DOJ, USFWS, SEC or other governmental [removed: authorities as a result of the investigations.][added: authorities.]
None of the DOJ, USFWS or SEC has provided the Company with any specific timeline or indication as to when these investigations or, specific to the DOJ and USFWS, discussions regarding [added: resolution and] future processes and procedures, will be concluded or [added: resolved.]
A putative securities class action [added: (Securities Class Action)] was filed on May 19, 2023 against the Company and a number of its current/former officers in the United States District Court for the District of Massachusetts.
While the Company cannot predict the [added: final] outcome of this matter, it believes the class action to be without merit and plans to vigorously defend against it.
The Company cannot reasonably estimate the maximum potential exposure or the range of possible loss in association with [removed: this matter.][added: these matters.]
While the Company cannot predict the outcome of [removed: this matter,] [added: these matters,] it believes the derivative [removed: lawsuit] [added: lawsuits] to be without merit and plans to vigorously defend against [removed: it.][added: them.]
That investigation remains ongoing and we are continuing to cooperate with the investigation.
USFWS.
We are also cooperating with that investigation, and although we continue to dispute the merits of certain positions taken by the DOJ and USFWS in the civil investigation, we have discussed a potential resolution of that matter with the DOJ and USFWS.
Those discussions are ongoing.
Due to a number of factors, including the age of these NHP’s during the fourth quarter of fiscal year 2024, the Company recorded a charge of $27 million to costs of products sold within the accompanying consolidated statements of income to reflect the reduction in carrying value of this inventory to zero.
The Company’s Audit Committee has retained counsel to conduct an independent investigation into certain issues raised in the investigations, and that work is ongoing.
On July 1, 2024, the court dismissed the complaint, denied the plaintiff’s informal request for leave to amend, and entered judgment for defendants.
On July 30, the plaintiff filed a notice of appeal in the United States Court of Appeals for the First Circuit.
On August 2, 2024, a different stockholder filed a lawsuit in the U.S. District Court of Delaware asserting similar derivative claims on the Company’s behalf against members of the Company’s current and former Board of Directors and the same current/former officers based on similar allegations of purportedly misleading disclosures and non-compliance with legal rules and ethics standards in respect of the importation of non-human primates, as well as insider-trading claims against certain of the defendants.
Both of these lawsuits are currently stayed by agreement of the parties pending further developments in the Securities Class Action pending in the United States Court of Appeals for the First Circuit.
On February 17, 2023 the Company received a grand jury subpoena requesting certain documents related to such investigation.
The Company is cooperating with the DOJ and the USFWS and believes that the concerns raised with respect to the Company’s conduct are without merit.
Notwithstanding our efforts and good-faith belief, in connection with the civil investigation, the Company has voluntarily suspended future shipments of non-human primates from Cambodia to the United States until such time that the Company and USFWS can agree upon and implement additional procedures to reasonably ensure that non-human primates imported from Cambodia are purpose-bred.
The carrying value of the inventory related to these shipments is approximately $27 million as of December 30, 2023, which reflects the value of the shipments in accordance with the Company’s inventory accounting policy.
resolved.
The Company filed a motion to dismiss.
The Company intends to file a motion to dismiss.
Cover and table of contents
25 rewritten, 6 added, 6 removed, 63 unchanged
FOR THE FISCAL YEAR ENDED December [removed: 30, 2023][added: 28, 2024]
[removed: ][added: ]
On June 30, [removed: 2023,] [added: 2024,] the aggregate market value of the registrant’s voting common stock held by non-affiliates of the registrant was approximately [removed: $10,686,736,278.][added: $10,563,584,605.]
As of January [removed: 27, 2024,] [added: 25, 2025,] there were [removed: 51,349,770] [added: 51,141,607] shares of the registrant’s common stock outstanding, $0.01 par value per share.
Portions of the registrant’s definitive Proxy Statement for its [removed: 2024] [added: 2025] Annual Meeting of Shareholders currently scheduled to be held on May [removed: 8, 2024,] [added: 20, 2025,] which will be filed with the Securities and Exchange Commission (SEC) not later than 120 days after December [removed: 30, 2023,] [added: 28, 2024,] are incorporated by reference into Part III of this Annual Report on Form 10-K.
With the exception of the portions of the [removed: 2024] [added: 2025] Proxy Statement expressly incorporated into this Annual Report on Form 10-K by reference, such document shall not be deemed filed as part of this Form 10-K.
FOR FISCAL YEAR [removed: 2023][added: 2024]
| 1A | | | [Risk [removed: Factors](#ic6467edc77a545dbbaf755b735281537_16)] [added: Factors](#i156301b78a764c0383b3e8ebe09c492b_16)] | | | [removed: [17](#ic6467edc77a545dbbaf755b735281537_16)] [added: [17](#i156301b78a764c0383b3e8ebe09c492b_16)] | | |
| 1B | | | [Unresolved Staff [removed: Comments](#ic6467edc77a545dbbaf755b735281537_19)] [added: Comments](#i156301b78a764c0383b3e8ebe09c492b_19)] | | | [removed: [35](#ic6467edc77a545dbbaf755b735281537_19)] [added: [36](#i156301b78a764c0383b3e8ebe09c492b_19)] | | |
| 3 | | | [Legal [removed: Proceedings](#ic6467edc77a545dbbaf755b735281537_25)] [added: Proceedings](#i156301b78a764c0383b3e8ebe09c492b_28)] | | | [removed: [36](#ic6467edc77a545dbbaf755b735281537_25)] [added: [37](#i156301b78a764c0383b3e8ebe09c492b_28)] | | |
| 4 | | | [Mine Safety [removed: Disclosures](#ic6467edc77a545dbbaf755b735281537_28)] [added: Disclosures](#i156301b78a764c0383b3e8ebe09c492b_31)] | | | [removed: [37](#ic6467edc77a545dbbaf755b735281537_28)] [added: [38](#i156301b78a764c0383b3e8ebe09c492b_31)] | | |
| 5 | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#ic6467edc77a545dbbaf755b735281537_34)] [added: Securities](#i156301b78a764c0383b3e8ebe09c492b_37)] | | | [removed: [38](#ic6467edc77a545dbbaf755b735281537_34)] [added: [39](#i156301b78a764c0383b3e8ebe09c492b_37)] | | |
| 7 | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ic6467edc77a545dbbaf755b735281537_40)] [added: Operations](#i156301b78a764c0383b3e8ebe09c492b_43)] | | | [removed: [40](#ic6467edc77a545dbbaf755b735281537_40)] [added: [41](#i156301b78a764c0383b3e8ebe09c492b_43)] | | |
| 7A | | | [Quantitative and Qualitative [removed: Disclosures](#ic6467edc77a545dbbaf755b735281537_58)] [added: Disclosures](#i156301b78a764c0383b3e8ebe09c492b_64)] about Market Risk | | | [removed: [53](#ic6467edc77a545dbbaf755b735281537_58)] [added: [54](#i156301b78a764c0383b3e8ebe09c492b_64)] | | |
| 8 | | | [Financial Statements and Supplementary [removed: Data](#ic6467edc77a545dbbaf755b735281537_61)] [added: Data](#i156301b78a764c0383b3e8ebe09c492b_67)] | | | [removed: [54](#ic6467edc77a545dbbaf755b735281537_61)] [added: [55](#i156301b78a764c0383b3e8ebe09c492b_67)] | | |
| 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#ic6467edc77a545dbbaf755b735281537_160)] [added: Disclosure](#i156301b78a764c0383b3e8ebe09c492b_181)] | | | [removed: [103](#ic6467edc77a545dbbaf755b735281537_160)] [added: [104](#i156301b78a764c0383b3e8ebe09c492b_181)] | | |
| 9B | | | [Other [removed: Information](#ic6467edc77a545dbbaf755b735281537_166)] [added: Information](#i156301b78a764c0383b3e8ebe09c492b_187)] | | | [removed: [104](#ic6467edc77a545dbbaf755b735281537_166)] [added: [104](#i156301b78a764c0383b3e8ebe09c492b_187)] | | |
| 9C | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#ic6467edc77a545dbbaf755b735281537_169)] [added: Inspections](#i156301b78a764c0383b3e8ebe09c492b_190)] | | | [removed: [104](#ic6467edc77a545dbbaf755b735281537_169)] [added: [104](#i156301b78a764c0383b3e8ebe09c492b_190)] | | |
| 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#ic6467edc77a545dbbaf755b735281537_175)] [added: Governance](#i156301b78a764c0383b3e8ebe09c492b_196)] | | | [removed: [105](#ic6467edc77a545dbbaf755b735281537_175)] [added: [105](#i156301b78a764c0383b3e8ebe09c492b_196)] | | |
| 11 | | | [Executive [removed: Compensation](#ic6467edc77a545dbbaf755b735281537_178)] [added: Compensation](#i156301b78a764c0383b3e8ebe09c492b_199)] | | | [removed: [105](#ic6467edc77a545dbbaf755b735281537_178)] [added: [105](#i156301b78a764c0383b3e8ebe09c492b_199)] | | |
| 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related [removed: Stockholder](#ic6467edc77a545dbbaf755b735281537_181)] [added: Stockholder](#i156301b78a764c0383b3e8ebe09c492b_202)] Matters | | | [removed: [106](#ic6467edc77a545dbbaf755b735281537_181)] [added: [106](#i156301b78a764c0383b3e8ebe09c492b_202)] | | |
| 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#ic6467edc77a545dbbaf755b735281537_184)] [added: Independence](#i156301b78a764c0383b3e8ebe09c492b_205)] | | | [removed: [106](#ic6467edc77a545dbbaf755b735281537_184)] [added: [106](#i156301b78a764c0383b3e8ebe09c492b_205)] | | |
| 14 | | | [Principal Accountant Fees and [removed: Services](#ic6467edc77a545dbbaf755b735281537_187)] [added: Services](#i156301b78a764c0383b3e8ebe09c492b_208)] | | | [removed: [106](#ic6467edc77a545dbbaf755b735281537_187)] [added: [106](#i156301b78a764c0383b3e8ebe09c492b_208)] | | |
| 15 | | | [Exhibits and Financial Statement [removed: Schedules](#ic6467edc77a545dbbaf755b735281537_193)] [added: Schedules](#i156301b78a764c0383b3e8ebe09c492b_214)] | | | [removed: [107](#ic6467edc77a545dbbaf755b735281537_193)] [added: [107](#i156301b78a764c0383b3e8ebe09c492b_214)] | | |
| 16 | | | [Form 10-K [removed: Summary](#ic6467edc77a545dbbaf755b735281537_196)] [added: Summary](#i156301b78a764c0383b3e8ebe09c492b_217)] | | | [removed: [108](#ic6467edc77a545dbbaf755b735281537_196)] [added: [108](#i156301b78a764c0383b3e8ebe09c492b_217)] | | |
| 1 | | | [Business](#i156301b78a764c0383b3e8ebe09c492b_13) | | | [1](#i156301b78a764c0383b3e8ebe09c492b_13) | | |
| 1C | | | [Cybersecurity](#i156301b78a764c0383b3e8ebe09c492b_22) | | | [36](#i156301b78a764c0383b3e8ebe09c492b_22) | | |
| 2 | | | [Properties](#i156301b78a764c0383b3e8ebe09c492b_25) | | | [37](#i156301b78a764c0383b3e8ebe09c492b_25) | | |
| 6 | | | [Reserved](#i156301b78a764c0383b3e8ebe09c492b_40) | | | [40](#i156301b78a764c0383b3e8ebe09c492b_40) | | |
| 9A | | | [Controls and Procedures](#i156301b78a764c0383b3e8ebe09c492b_184) | | | [104](#i156301b78a764c0383b3e8ebe09c492b_184) | | |
| [Signatures](#i156301b78a764c0383b3e8ebe09c492b_220) | | | | | | [109](#i156301b78a764c0383b3e8ebe09c492b_220) | | |
| 1 | | | [Business](#ic6467edc77a545dbbaf755b735281537_13) | | | [1](#ic6467edc77a545dbbaf755b735281537_13) | | |
| 1C | | | [Cybersecurity](#ic6467edc77a545dbbaf755b735281537_1736) | | | [35](#ic6467edc77a545dbbaf755b735281537_1736) | | |
| 2 | | | [Properties](#ic6467edc77a545dbbaf755b735281537_22) | | | [36](#ic6467edc77a545dbbaf755b735281537_22) | | |
| 6 | | | [Reserved](#ic6467edc77a545dbbaf755b735281537_37) | | | [39](#ic6467edc77a545dbbaf755b735281537_37) | | |
| 9A | | | [Controls and Procedures](#ic6467edc77a545dbbaf755b735281537_163) | | | [103](#ic6467edc77a545dbbaf755b735281537_163) | | |
| [Signatures](#ic6467edc77a545dbbaf755b735281537_199) | | | | | | [109](#ic6467edc77a545dbbaf755b735281537_199) | | |
Item 1C. Cybersecurity
7 rewritten, 1 added, 0 removed, 31 unchanged
Charles River places high importance on identifying and [removed: eliminating] [added: mitigating] potential cybersecurity threats to its employees, customers, IT infrastructure, proprietary technologies and confidential information.
Our information security management system is certified to the ISO/IEC 27001:2013 [removed: standard] [added: and 27017:2018 standards] by the British Standards Institution (BSI); [removed: certificate] [added: certificates] IS [removed: 780367.][added: 780367 and CLOUD 806141,respectively.]
For instance, we conduct risk and compliance assessments of third parties that request access to our IT resources and information or who provide technology products [added: or services] to Charles River.
Through these processes, during our fiscal year [removed: 2023] [added: 2024] and through the date of this filing we did not identify risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected, or are reasonably likely to materially affect, our business strategy, results of operations, or financial condition.
However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced an [removed: undetected cybersecurity incident.]
Our Chief Information Security Officer has more than 25 years of experience working in information technology-related roles, of which [added: more than] 10 years has been in information security leadership, and holds degrees in bio-medical engineering and computer science.
Our Chief Information Officer and our Chief Information Security Officer meet [removed: annually] [added: regularly] with the full Board, and periodically, but generally at least quarterly, with the Chief Executive Officer, Chief Operations Officer, and Audit Committee to review the company’s information technology systems and discuss key cybersecurity risks.
undetected cybersecurity incident.
Item 2. Properties
3 rewritten, 0 added, 0 removed, 12 unchanged
Approximately [removed: 60%] [added: 65%] of our real estate portfolio (by area) is owned including all facilities over 200,000 square feet.
Within the DSA business, we own or lease large facilities (greater than 50,000 square feet) in [removed: 9] [added: 7] countries including the U.S., Canada, [removed: Scotland, France,] China, [added: France, Hungary, the] Netherlands, and [removed: Hungary.][added: the United Kingdom.]
We own large RMS facilities in Canada, France, [removed: England] [added: the United Kingdom,] and the U.S with additional large facilities leased in China and the U.S. Manufacturing is supported in over 10 countries with large, owned properties in the U.S., Ireland, and China which are supplemented by additional leased facilities in the U.S., [removed: England,] [added: the United Kingdom,] France, and Germany.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
8 rewritten, 10 added, 9 removed, 18 unchanged
Our common stock began trading on the New York Stock Exchange on June 23, 2000 under the symbol “CRL.” There were no equity securities that were not registered under the Securities Act of 1933, as amended, sold during fiscal year [removed: 2023.][added: 2024.]
As of January [removed: 27, 2024,] [added: 25, 2025,] there were [removed: 67] [added: 63] registered shareholders of the outstanding shares of common stock.
The following table provides information relating to our purchases of shares of our common stock during the fourth quarter of fiscal [removed: 2023:][added: 2024:]
As of December [removed: 30, 2023, we] [added: 28, 2024, the Company] had [removed: $129.1] [added: $899.3] million remaining on the [added: current] authorized stock repurchase program.
The following stock performance graph compares the annual percentage change in the Company’s cumulative total shareholder return on its Common Stock during a period commencing on December [removed: 29, 2018] [added: 28, 2019] and ending on December [removed: 30, 2023] [added: 28, 2024] (as measured by dividing (1) the sum of (A) the cumulative amount of dividends for the measurement period, assuming dividend reinvestment, and (B) the difference between the Company’s share price at the end and the beginning of the measurement period; by (2) the share price at the beginning of the measurement period) with the cumulative total return of the S&P 500 Index and the S&P 500 Health Care Index during such period.
The graph is not “soliciting material,” is not deemed filed with the Securities and Exchange [removed: Commission] [added: Commission,] and is not to be incorporated by reference in any filing of the Company under the Securities Act of 1933 or the Securities Exchange Act of 1934 whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
[removed: ][added: ]
| | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2023] [added: 2024] | | |
| September 29, 2024 to October 26, 2024 | | | 198 | | | | | | $ | 194.96 | | | | | — | | | | | | $ | 899,326 | |
| October 27, 2024 to November 23, 2024 | | | — | | | | | | — | | | | | | — | | | | | | 899,326 | | |
| November 24, 2024 to December 28, 2024 | | | 430 | | | | | | 199.06 | | | | | | — | | | | | | 899,326 | | |
| Total | | | 628 | | | | | | | | | | | | — | | | | | | | | |
On August 2, 2024, the Company’s Board of Directors approved a stock repurchase authorization of $1.0 billion.
This authorization fully replaces a prior stock repurchase authorization of $1.3 billion that had $129.1 million remaining when it was terminated.
In fiscal year 2024, the Company repurchased 0.5 million shares of common stock for $100.7 million under the new stock repurchase program.
| Charles River Laboratories International, Inc. | | | $ | 100 | | | | | $ | 166 | | | | | $ | 243 | | | | | $ | 143 | | | | | $ | 156 | | | | | $ | 123 | |
| S&P 500 | | | 100 | | | | | | 118 | | | | | | 152 | | | | | | 125 | | | | | | 158 | | | | | | 197 | | |
| S&P 500 Health Care | | | 100 | | | | | | 113 | | | | | | 143 | | | | | | 140 | | | | | | 143 | | | | | | 147 | | |
| October 1, 2023 to October 28, 2023 | | | 133 | | | | | | $ | 195.40 | | | | | — | | | | | | $ | 129,105 | |
| October 29, 2023 to November 25, 2023 | | | 17 | | | | | | 167.72 | | | | | | — | | | | | | 129,105 | | |
| November 26, 2023 to December 30, 2023 | | | 440 | | | | | | 197.08 | | | | | | — | | | | | | 129,105 | | |
| Total | | | 590 | | | | | | | | | | | | — | | | | | | | | |
Our Board of Directors has authorized, in aggregate, a stock repurchase program of $1.3 billion.
During the fourth quarter of fiscal year 2023, we did not repurchase any shares of common stock under our stock repurchase program or in open market trading.
| Charles River Laboratories International, Inc. | | | $ | 100 | | | | | $ | 136 | | | | | $ | 225 | | | | | $ | 330 | | | | | $ | 195 | | | | | $ | 212 | |
| S&P 500 | | | 100 | | | | | | 131 | | | | | | 156 | | | | | | 200 | | | | | | 164 | | | | | | 207 | | |
| S&P 500 Health Care | | | 100 | | | | | | 121 | | | | | | 137 | | | | | | 173 | | | | | | 170 | | | | | | 173 | | |
Item 8. Financial Statements and Supplementary Data
644 rewritten, 391 added, 227 removed, 992 unchanged
| [Report of Independent Registered Public Accounting [removed: Firm](#ic6467edc77a545dbbaf755b735281537_64)] [added: Firm](#i156301b78a764c0383b3e8ebe09c492b_70)] (PCAOB ID 238) | | | [removed: [55](#ic6467edc77a545dbbaf755b735281537_64)] [added: [56](#i156301b78a764c0383b3e8ebe09c492b_70)] | | |
| [Consolidated Statements of Income for fiscal [removed: years](#ic6467edc77a545dbbaf755b735281537_67) 2023,] [added: years](#i156301b78a764c0383b3e8ebe09c492b_76) 2024, 2023 [and](#i156301b78a764c0383b3e8ebe09c492b_76)] 2022 [removed: [and](#ic6467edc77a545dbbaf755b735281537_67) 2021] | | | [removed: [58](#ic6467edc77a545dbbaf755b735281537_67)] [added: [59](#i156301b78a764c0383b3e8ebe09c492b_76)] | | |
| [Consolidated Statements of Comprehensive Income [added: (Loss)] for fiscal [removed: years](#ic6467edc77a545dbbaf755b735281537_70) [](#ic6467edc77a545dbbaf755b735281537_67)2023,] [added: years](#i156301b78a764c0383b3e8ebe09c492b_79) [](#i156301b78a764c0383b3e8ebe09c492b_76)2024, 2023 [and](#i156301b78a764c0383b3e8ebe09c492b_79)] 2022 [removed: [and](#ic6467edc77a545dbbaf755b735281537_70) 2021] | | | [removed: [59](#ic6467edc77a545dbbaf755b735281537_70)] [added: [60](#i156301b78a764c0383b3e8ebe09c492b_79)] | | |
| [Consolidated Balance [removed: Sheets](#ic6467edc77a545dbbaf755b735281537_73)] [added: Sheets](#i156301b78a764c0383b3e8ebe09c492b_82)] as of December [added: 28, 2024 [and](#i156301b78a764c0383b3e8ebe09c492b_82) December] 30, 2023 [removed: [and](#ic6467edc77a545dbbaf755b735281537_73) December 31, 2022] | | | [removed: [60](#ic6467edc77a545dbbaf755b735281537_73)] [added: [61](#i156301b78a764c0383b3e8ebe09c492b_82)] | | |
| [Consolidated Statements of Cash Flows for fiscal [removed: years](#ic6467edc77a545dbbaf755b735281537_76) [](#ic6467edc77a545dbbaf755b735281537_67)2023, 2022] [added: years](#i156301b78a764c0383b3e8ebe09c492b_85) [](#i156301b78a764c0383b3e8ebe09c492b_76)2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [61](#ic6467edc77a545dbbaf755b735281537_76)] [added: [62](#i156301b78a764c0383b3e8ebe09c492b_85)] | | |
| [Consolidated Statements of Changes in Equity [added: and Redeemable Noncontrolling Interests] for fiscal [removed: years](#ic6467edc77a545dbbaf755b735281537_79) [](#ic6467edc77a545dbbaf755b735281537_67)2023, 2022] [added: years](#i156301b78a764c0383b3e8ebe09c492b_88) [](#i156301b78a764c0383b3e8ebe09c492b_76)2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [62](#ic6467edc77a545dbbaf755b735281537_79)] [added: [63](#i156301b78a764c0383b3e8ebe09c492b_88)] | | |
| [Notes to Consolidated Financial [removed: Statements](#ic6467edc77a545dbbaf755b735281537_82)] [added: Statements](#i156301b78a764c0383b3e8ebe09c492b_91)] | | | [removed: [63](#ic6467edc77a545dbbaf755b735281537_82)] [added: [64](#i156301b78a764c0383b3e8ebe09c492b_91)] | | |
| [Note 1. Description of Business and Summary of Significant [removed: Accounting](#ic6467edc77a545dbbaf755b735281537_85)] [added: Accounting](#i156301b78a764c0383b3e8ebe09c492b_94) [Policies](#i156301b78a764c0383b3e8ebe09c492b_94)[](#i156301b78a764c0383b3e8ebe09c492b_94)] | | | [removed: [63](#ic6467edc77a545dbbaf755b735281537_85)] [added: [64](#i156301b78a764c0383b3e8ebe09c492b_94)] | | |
| [Note 2. Acquisitions and [removed: Divestitures](#ic6467edc77a545dbbaf755b735281537_88)] [added: Divestitures](#i156301b78a764c0383b3e8ebe09c492b_97)] | | | [removed: [71](#ic6467edc77a545dbbaf755b735281537_88)] [added: [72](#i156301b78a764c0383b3e8ebe09c492b_97)] | | |
| [Note 3. Revenue from Contracts with [removed: Customers](#ic6467edc77a545dbbaf755b735281537_94)] [added: Customers](#i156301b78a764c0383b3e8ebe09c492b_106)] | | | [removed: [77](#ic6467edc77a545dbbaf755b735281537_94)] [added: [75](#i156301b78a764c0383b3e8ebe09c492b_106)] | | |
| [Note 4. Segment and Geographic [removed: Information](#ic6467edc77a545dbbaf755b735281537_100)] [added: Information](#i156301b78a764c0383b3e8ebe09c492b_112)] | | | [removed: [79](#ic6467edc77a545dbbaf755b735281537_100)] [added: [77](#i156301b78a764c0383b3e8ebe09c492b_112)] | | |
| [removed: [Note](#ic6467edc77a545dbbaf755b735281537_154) [5.] [added: [Note 5.] Supplemental Cash Flow [removed: Information](#ic6467edc77a545dbbaf755b735281537_154)] [added: Information](#i156301b78a764c0383b3e8ebe09c492b_118)] | | | [removed: [80](#ic6467edc77a545dbbaf755b735281537_154)] [added: [79](#i156301b78a764c0383b3e8ebe09c492b_118)] | | |
| [Note 7. Property, Plant and Equipment, [removed: Net](#ic6467edc77a545dbbaf755b735281537_1774)] [added: Net](#i156301b78a764c0383b3e8ebe09c492b_124)] | | | [removed: [80](#ic6467edc77a545dbbaf755b735281537_1774)] [added: [80](#i156301b78a764c0383b3e8ebe09c492b_124)] | | |
| [Note 9. Fair [removed: Value](#ic6467edc77a545dbbaf755b735281537_109)] [added: Value](#i156301b78a764c0383b3e8ebe09c492b_133)] | | | [removed: [81](#ic6467edc77a545dbbaf755b735281537_109)] [added: [81](#i156301b78a764c0383b3e8ebe09c492b_133)] | | |
| [Note 10. Goodwill and Intangible [removed: Assets](#ic6467edc77a545dbbaf755b735281537_115)] [added: Assets](#i156301b78a764c0383b3e8ebe09c492b_139)] | | | [removed: [83](#ic6467edc77a545dbbaf755b735281537_115)] [added: [82](#i156301b78a764c0383b3e8ebe09c492b_139)] | | |
| [Note 11. Debt and Other Financing [removed: Arrangements](#ic6467edc77a545dbbaf755b735281537_121)] [added: Arrangements](#i156301b78a764c0383b3e8ebe09c492b_142)] | | | [removed: [84](#ic6467edc77a545dbbaf755b735281537_121)] [added: [84](#i156301b78a764c0383b3e8ebe09c492b_142)] | | |
| [Note 12. Equity and Noncontrolling [removed: Interest](#ic6467edc77a545dbbaf755b735281537_127)] [added: Interest](#i156301b78a764c0383b3e8ebe09c492b_148)] | | | [removed: [86](#ic6467edc77a545dbbaf755b735281537_127)] [added: [86](#i156301b78a764c0383b3e8ebe09c492b_148)] | | |
| [Note 13. Income [removed: Taxes](#ic6467edc77a545dbbaf755b735281537_133)] [added: Taxes](#i156301b78a764c0383b3e8ebe09c492b_154)] | | | [removed: [89](#ic6467edc77a545dbbaf755b735281537_133)] [added: [89](#i156301b78a764c0383b3e8ebe09c492b_154)] | | |
| [Note 14. Employee Benefit [removed: Plans](#ic6467edc77a545dbbaf755b735281537_136)] [added: Plans](#i156301b78a764c0383b3e8ebe09c492b_157)] | | | [removed: [91](#ic6467edc77a545dbbaf755b735281537_136)] [added: [91](#i156301b78a764c0383b3e8ebe09c492b_157)] | | |
| [Note 15. Stock-based [removed: Compensation](#ic6467edc77a545dbbaf755b735281537_139)] [added: Compensation](#i156301b78a764c0383b3e8ebe09c492b_163)] | | | [removed: [95](#ic6467edc77a545dbbaf755b735281537_139)] [added: [95](#i156301b78a764c0383b3e8ebe09c492b_163)] | | |
| [Note 16. Restructuring and Asset [removed: Impairments](#ic6467edc77a545dbbaf755b735281537_142)] [added: Impairments](#i156301b78a764c0383b3e8ebe09c492b_166)] | | | [removed: [97](#ic6467edc77a545dbbaf755b735281537_142)] [added: [97](#i156301b78a764c0383b3e8ebe09c492b_166)] | | |
| [Note 18. Commitments and [removed: Contingencies](#ic6467edc77a545dbbaf755b735281537_157)] [added: Contingencies](#i156301b78a764c0383b3e8ebe09c492b_178)] | | | [removed: [101](#ic6467edc77a545dbbaf755b735281537_157)] [added: [102](#i156301b78a764c0383b3e8ebe09c492b_178)] | | |
We have audited the accompanying consolidated balance sheets of Charles River Laboratories International, Inc. and its subsidiaries (the [removed: “Company”)] [added: "Company")] as of December [removed: 30, 2023] [added: 28, 2024] and December [removed: 31, 2022,] [added: 30, 2023,] and the related consolidated statements of income, [added: of] comprehensive [removed: income,] [added: income (loss), of] changes in equity and [added: redeemable noncontrolling interests and of] cash flows for each of the three years in the period ended December [removed: 30, 2023,] [added: 28, 2024,] including the related notes (collectively referred to as the [removed: “consolidated] [added: "consolidated] financial [removed: statements”).][added: statements").]
We also have audited the Company's internal control over financial reporting as of December [removed: 30, 2023,] [added: 28, 2024,] based on criteria established in [removed: Internal] [added: *Internal] Control - Integrated [removed: Framework] [added: Framework*] (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December [removed: 30, 2023] [added: 28, 2024] and December [removed: 31, 2022,] [added: 30, 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December [removed: 30, 2023] [added: 28, 2024] in conformity with accounting principles generally accepted in the United States of America.
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December [removed: 30, 2023,] [added: 28, 2024,] based on criteria established in [removed: Internal] [added: *Internal] Control - Integrated [removed: Framework] [added: Framework*] (2013) issued by the COSO.
[added: A company’s internal control over] financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of [removed: unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.]
The determination of the fair value of [removed: biological assets] [added: the Biologics Solutions reporting unit] requires the use of significant judgment using management’s best estimates of inputs and assumptions that a market participant would use.
The principal considerations for our determination that performing procedures relating to the [removed: valuation] [added: interim goodwill impairment assessment] of [removed: biological assets acquired in] the [removed: acquisition of Noveprim] [added: Biologics Solutions reporting unit] is a critical audit matter are (i) the significant judgment by management when developing the fair value estimate of the [removed: biological assets acquired;] [added: Biologics Solutions reporting unit;] (ii) a high degree of auditor judgment, [removed: subjectivity] [added: subjectivity,] and effort in performing procedures and evaluating management’s significant assumptions related to [added: earnings multiples and sales multiples used in] the [removed: cost of] [added: market-based approach and future] revenue, [removed: productivity] [added: long term growth] rates, [added: operating income margins,] and discount [removed: rate;] [added: rate used in the income approach;] and (iii) the audit effort involved [added: in] the use of professionals with specialized skill and knowledge.
These procedures included testing the effectiveness of controls relating to [removed: the acquisition accounting,] [added: management’s goodwill impairment assessments,] including controls over [removed: management’s] [added: the] valuation of the [removed: biological assets acquired.][added: Biologics Solutions reporting unit.]
These procedures also included, among others (i) [removed: reading the purchase agreement; (ii)] testing management’s process for developing the fair value estimate of the [removed: biological assets acquired; (iii)] [added: reporting unit; (ii)] evaluating the appropriateness of the [removed: multiple period excess earnings model; (iv)] [added: market-based approach and the income approach used by management; (iii)] testing the completeness and accuracy of [removed: the] underlying data used in the [removed: multiple period excess earnings model;] [added: market-based approach] and [removed: (v)] [added: the income approach; and (iv)] evaluating the reasonableness of the significant assumptions used by management related to [added: earnings multiples and sales multiples used in] the [removed: cost of] [added: market-based approach and future] revenue, [removed: productivity] [added: long term growth] rates, [added: operating income margins,] and discount [removed: rate.][added: rate used in the income approach.]
[removed: Evaluating management’s assumptions related to the cost of revenue and productivity rates involved considering (i) the past performance of Noveprim;] [added: Biologics reporting unit;] (ii) the consistency with external [removed: research] [added: market and industry] data; and (iii) whether the assumptions were consistent with evidence obtained in other areas of the audit.
Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the [removed: multiple period excess earnings model] [added: market-based approach] and [added: the income approach, as well as the weighted combination of the approaches and] (ii) the reasonableness of the [added: earnings multiples, sales multiples, long term growth rates, and] discount rate [removed: assumption.][added: assumptions.]
[removed: *Discovery] [added: *Revenue Recognition using Cost-to-Cost Method – Discovery] and Safety [removed: Assessment Service Revenue Recognized Over Time Using the Input Method*][added: Assessment*]
As described in Notes 1 and 3 to the consolidated financial statements, the Company recognized Discovery and Safety Assessment (DSA) revenue from services and products transferred over time of [removed: $2,611.6] [added: $2,446.8] million for the year-ended December [removed: 30, 2023,] [added: 28, 2024,] of which [removed: the majority] [added: a significant portion] relates to services that are delivered to the customer based on the extent of progress towards completion of the performance obligation that management [added: measures using the cost-to-cost (input) method.]
[removed: Management] [added: The Company] uses the [removed: input method] [added: cost-to-cost] measure of progress when it best depicts the transfer of value to the customer, which occurs as the Company incurs costs on its contract, generally related to fixed fee service contracts.
Under the [removed: input method] [added: cost-to-cost] measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation.
The principal considerations for our determination that performing procedures relating to DSA [removed: service] revenue recognized [removed: over time] using the [removed: input] [added: cost-to-cost] method is a critical audit matter are a high degree of auditor subjectivity and effort in performing procedures and evaluating audit evidence related to the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation.
These procedures included testing the effectiveness of controls relating to [removed: DSA service revenue recognized over time using] the [removed: input method,] [added: revenue recognition process,] including controls over the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation, review of contracts, testing of budget versus actual costs incurred, and testing of revenue recognition.
These procedures also included, among others (i) reading contracts and reports describing the results of services provided for a sample of DSA service contracts; (ii) testing management’s process for determining the amount of DSA service revenue recognized over time for a sample of DSA service contracts; (iii) evaluating the appropriateness of the [removed: input] [added: cost-to-cost] method used by management; (iv) evaluating the reasonableness of the ratio of costs incurred to date to the total estimated costs at completion of the performance obligations through performing a retrospective comparison of actual costs incurred to historical estimated costs for completed service contracts; and (v) testing actual costs incurred for a sample of in-progress service contracts by examining evidence of costs incurred.
| [Note 6. Inventory](#i156301b78a764c0383b3e8ebe09c492b_121) | | | [79](#i156301b78a764c0383b3e8ebe09c492b_121) | | |
| [Note 8. Venture Capital and Strategic Equity Investments](#i156301b78a764c0383b3e8ebe09c492b_127) | | | [80](#i156301b78a764c0383b3e8ebe09c492b_127) | | |
| [Note 17. Leases](#i156301b78a764c0383b3e8ebe09c492b_172) | | | [100](#i156301b78a764c0383b3e8ebe09c492b_172) | | |
unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
*Interim Goodwill Impairment Assessment – Biologics Solutions Reporting Unit*
As described in Notes 1 and 10 to the consolidated financial statements, the Company’s goodwill balance was $2,846.6 million as of December 28, 2024, and the goodwill associated with the Biologics Solutions reporting unit was $606.0 million.
Goodwill is tested for impairment annually during the fourth quarter or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company's reporting units below their carrying amounts.
In December 2024, subsequent to the annual goodwill impairment test, a triggering event was identified for the Biologics Solutions reporting unit.
This resulted from a loss of key customers, ultimately resulting in a reduction in Biologics Solutions’ long range financial outlook.
Management conducted a quantitative impairment test for goodwill to determine if the goodwill in the Biologics Solutions reporting unit was impaired.
The fair value of the Biologics Solutions reporting unit was determined by using a weighted combination of a market-based approach and an income approach.
Under the market-based approach, the Company utilized entity specific information about the reporting unit as well as publicly available industry information to determine key assumptions including earnings multiples and sales multiples.
Under the income approach, fair value was determined based on the estimated future cash flows of the reporting unit which includes key assumptions for future revenue, long term growth rates, and operating income margins, discounted by an estimated weighted-average cost of capital.
As a result, the Company recognized a goodwill impairment charge of $215.0 million.
Evaluating management’s assumptions related to future revenue and operating income margins involved evaluating whether the assumptions used by management were reasonable considering (i) the current and past performance of the
February 19, 2025
| Goodwill impairment | | | 215,000 | | | | | | — | | | | | | — | | |
| Other income (expense) | | | | | | | | | | | | | | | | | |
| Net income attributable to Charles River Laboratories International Inc. | | | $ | 22,203 | | | | | $ | 474,624 | | | | | $ | 486,226 | |
| Calculation of net income per share attributable to Charles River Laboratories International Inc. common shareholders | | | | | | | | | | | | | | | | | |
| Net income attributable to Charles River Laboratories International Inc. | | | $ | 22,203 | | | | | $ | 474,624 | | | | | $ | 486,226 | |
| Less: Incremental dividends attributed to noncontrolling interest holders | | | 11,906 | | | | | | — | | | | | | — | | |
| Redeemable noncontrolling interests | | | 41,126 | | | | | | 56,722 | | |
| Total Charles River Laboratories International, Inc. equity | | | 3,461,503 | | | | | | 3,596,882 | | |
| Net income | | | $ | 25,291 | | | | | $ | 480,370 | | | | | $ | 492,608 | |
| Goodwill impairment | | | 215,000 | | | | | | — | | | | | | — | | |
| Write down of inventories | | | 46,992 | | | | | | 6,290 | | | | | | 5,973 | | |
| Other, net | | | 33,251 | | | | | | 1,079 | | | | | | 16,118 | | |
| Purchase of remaining equity interest of other redeemable noncontrolling interest | | | (12,000) | | | | | | (4,784) | | | | | | (30,533) | | |
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| Purchase of redeemable noncontrolling interest | | | (15,000) | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
| Purchase of remaining equity interest of Vital River redeemable noncontrolling interest | | | (24,148) | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
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| [Note 6. Inventory](#ic6467edc77a545dbbaf755b735281537_1767) | | | [80](#ic6467edc77a545dbbaf755b735281537_1767) | | |
| [Note 8. Venture Capital Investments and Marketable Securities](#ic6467edc77a545dbbaf755b735281537_106) | | | [81](#ic6467edc77a545dbbaf755b735281537_106) | | |
| [Note 17. Leases](#ic6467edc77a545dbbaf755b735281537_148) | | | [99](#ic6467edc77a545dbbaf755b735281537_148) | | |
As described in Management’s Report on Internal Control Over Financial Reporting, management has excluded Noveprim Group (“Noveprim”) from its assessment of internal control over financial reporting as of December 30, 2023, because it was acquired by the Company in a purchase business combination during 2023.
We have also excluded Noveprim from our audit of internal control over financial reporting.
Noveprim is a subsidiary whose total assets and total revenues excluded from management’s assessment and our audit of internal control over financial reporting represent less than 1%, respectively, of the related consolidated financial statement amounts as of and for the year ended December 30, 2023.
A company’s internal control over
*Acquisition of Noveprim – Valuation of Biological Assets*
As described in Notes 1 and 2 to the consolidated financial statements, on November 30, 2023, the Company completed the acquisition of Noveprim, resulting in a 90% controlling interest.
Of the acquired long-term assets, $167.8 million of biological assets were recorded.
To determine the fair value, management utilized the multiple period excess earnings model, which relies on the following key assumptions: projections of cash flows from the acquired entities, which includes future revenue, cost of revenue, operating income margins, and productivity rates, as well as the discount rate based on market participant’s weighted average cost of capital.
measures using the cost-to-cost (input method).
February 14, 2024
| Net income attributable to common shareholders: | | | | | | | | | | | | | | | | | |
| Total equity attributable to common shareholders | | | 3,596,882 | | | | | | 2,976,293 | | |
| Loss on debt extinguishment and amortization of other financing costs | | | 3,967 | | | | | | 4,118 | | | | | | 29,964 | | |
| Changes in fair value of contingent consideration arrangements | | | 1,810 | | | | | | (3,753) | | | | | | (34,303) | | |
| Other, net | | | 1,592 | | | | | | 21,726 | | | | | | 2,567 | | |
| Payment of debt extinguishment and financing costs | | | — | | | | | | — | | | | | | (38,255) | | |
| Purchases of additional equity interests, net | | | (4,784) | | | | | | (30,533) | | | | | | — | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| December 26, 2020 | | | 49,767 | | | | | | $ | 498 | | | | | $ | 1,627,564 | | | | | $ | 625,414 | | | | | $ | (138,874) | | | | | — | | | | | | $ | — | | | | | $ | 2,114,602 | | | | | $ | 3,567 | | | | | $ | 2,118,169 | |
| Net income | | | — | | | | | | — | | | | | | — | | | | | | 390,982 | | | | | | — | | | | | | — | | | | | | — | | | | | | 390,982 | | | | | | 2,480 | | | | | | 393,462 | | |
| Retirement of treasury shares | | | (148) | | | | | | (1) | | | | | | (5,061) | | | | | | (35,645) | | | | | | — | | | | | | (148) | | | | | | 40,707 | | | | | | — | | | | | | — | | | | | | — | | |
| Other comprehensive (loss) | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (97,317) | | | | | | — | | | | | | — | | | | | | (97,317) | | | | | | — | | | | | | (97,317) | | |
| Retirement of treasury shares | | | (130) | | | | | | (1) | | | | | | (4,574) | | | | | | (34,076) | | | | | | — | | | | | | (130) | | | | | | 38,651 | | | | | | — | | | | | | — | | | | | | — | | |
| Dividends declared to noncontrolling interest | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,645) | | | | | | (1,645) | | |
In September 2022, the FASB issued ASU 2022-04, “Liabilities – Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations.” ASU 2022-04 requires quantitative and qualitative disclosures about the use of supplier finance programs.
The ASU is effective for fiscal years beginning after December 15, 2022, except for the amendment on rollforward information, which is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years for selected disclosures, and will be applied on a prospective basis.
The Company participates in certain supplier finance programs that are immaterial to the consolidated financial statements and related disclosures.
The cost of normal, recurring, or periodic repairs and maintenance activities related to property, plant and equipment is expensed as incurred.
Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software.
Maintenance and training costs related to software obtained for internal use are expensed as incurred.
are fair valued using a probability weighted model.
Goodwill and Intangible Assets
Definite-lived intangible assets, including client relationships, are amortized over the pattern in which the economic benefits of the intangible assets are utilized and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.
In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the definite-lived intangible assets, the definite-lived intangible assets are written-down to their fair values.
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.
Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition.
An excerpt. Shown here: 40 of 644 rewritten, 40 of 391 added and 40 of 227 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2024 filing and the FY2023 filing.
Item 9A. Controls and Procedures
4 rewritten, 0 added, 5 removed, 8 unchanged
Based on their evaluation, required by paragraph (b) of Rules 13a-15 or 15d-15, promulgated by the Securities Exchange Act of 1934, as amended (Exchange Act), the Company’s principal executive officer and principal financial officer have concluded that the Company’s disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, are effective, at a reasonable assurance level, as of December [removed: 30, 2023,] [added: 28, 2024,] to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms.
Based on our assessment and those criteria, management concluded that the Company maintained effective internal control over financial reporting as of December [removed: 30, 2023.][added: 28, 2024.]
The effectiveness of our internal control over financial reporting as of December [removed: 30, 2023,] [added: 28, 2024,] has been audited by PricewaterhouseCoopers LLP, an Independent Registered Public Accounting Firm, as stated in their report which appears in Item 8, “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.
[removed: During fiscal year 2023, there] [added: There] were no material changes in the Company’s internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of the Exchange Act Rules 13a-15 or 15d-15 that occurred during the fourth quarter of [removed: 2023] [added: 2024] that materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our assessment of the effectiveness of our internal control over financial reporting as of December 30, 2023 excluded Noveprim, which was acquired by the Company in 2023.
Noveprim, whose total assets and total revenues were excluded from the Company’s assessment, represented approximately less than 1%, respectively, of the related consolidated amounts as of and for the fiscal year ended December 30, 2023.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Item 9B. Other Information
1 rewritten, 0 added, 7 removed, 0 unchanged
During the quarter ended December [removed: 30, 2023,] [added: 28, 2024,] none of our officers or directors adopted or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act or any “non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation [removed: S-K., except as follows:][added: S-K.]
- On November 14, 2023, James Foster, our Chair, President, and Chief Executive Officer, terminated a Rule 10b5-1 trading arrangement, dated February 23, 2023 for the sale of up to 112,341 shares of common stock.
Mr. Foster did not sell any shares pursuant to such plan, which, absent such termination, would have expired on March 1, 2025.
- On November 15, 2023, Birgit Girshick, our Corporate Executive Vice President & Chief Operating Officer, terminated a Rule 10b5-1 trading arrangement, dated February 24, 2023 for the sale of up to 25,320 shares of common stock.
Ms. Girshick did not sell any shares pursuant to such plan, which, absent such termination, would have expired on February 28, 2024.
- On November 22, 2023, Ms. Girshick entered into a Rule 10b5-1 trading arrangement for the sale of up to 22,362 shares of common stock, subject to certain conditions.
The arrangement’s expiration date is February 28, 2025.
During the quarter ended December 30, 2023, the Company did not adopt or terminate any “Rule 10b5-1 trading arrangement” as defined in Item 408(a) of Regulation S-K.
Item 10. Directors, Executive Officers and Corporate Governance
3 rewritten, 1 added, 2 removed, 22 unchanged
Any information required by this Item regarding our directors and compliance with Section 16(a) of the Exchange Act by our officers and directors will be included in the [removed: 2024] [added: 2025] Proxy Statement under the sections captioned “Nominees for Directors” and “Delinquent Section 16(a) Reports” and is incorporated herein by reference thereto.
The information required by this Item regarding our corporate governance will be included in the [removed: 2024] [added: 2025] Proxy Statement under the section captioned “Corporate Governance” and is incorporated herein by reference thereto.
The information required by this Item regarding the audit committee of the Board of Directors and financial experts will be included in the [removed: 2024] [added: 2025] Proxy Statement under the section captioned “The Board of Directors and its Committees-Audit Committee and Financial Experts” and is incorporated herein by reference thereto.
Since December 2021, there have been no material changes to the procedures by which security holders may recommend nominees to our Board of Directors.
In December 2021, we amended our By-laws to include a proxy access by-law.
Under our proxy access by-law, if a stockholder (or a group of up to 20 stockholders) who has owned at least 3% of our shares for at least three years and has complied with the other requirements set forth in our By-laws wants us to include director nominees (up to the greater of two nominees or 20% of the Board) in our proxy statement for an upcoming Annual Meeting, the nominations must be received in a timely manner, between 120 and 150 days prior to the anniversary of the date our proxy statement was first sent to stockholders in connection with the prior year’ annual meeting.
Item 11. Executive Compensation
2 rewritten, 1 added, 0 removed, 14 unchanged
All grants to executive officers are [removed: made] [added: approved] by the Compensation Committee itself and not pursuant to any delegated authority.
The remainder of the information required by this Item will be included in the [removed: 2024] [added: 2025] Proxy Statement under the sections captioned [removed: “2023] [added: “2024] Director Compensation,” “Compensation Discussion and Analysis,” “Executive Compensation and Related Information,” “Compensation Committee Interlocks and Insider Participation” and “Report of Compensation Committee,” and is incorporated herein by reference thereto.
During fiscal 2024, we did not award options to any named executive officer in the period beginning four business days before and ending one business day after the filing of a Form 10-Q or Form 10-K, or the filing or furnishing of a Form 8-k that discloses material nonpublic information.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item will be included in the [removed: 2024] [added: 2025] Proxy Statement under the sections captioned “Beneficial Ownership of Securities” and “Equity Compensation Plan Information” and is incorporated herein by reference thereto.
Item 13. Certain Relationships and Related Transactions, and Director Independence
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item will be included in the [removed: 2024] [added: 2025] Proxy Statement under the sections captioned “Related Person Transaction Policy” and “Corporate Governance-Director Qualification Standards; Director Independence” and is incorporated herein by reference thereto.
Item 14. Principal Accountant Fees and Services
1 rewritten, 0 added, 0 removed, 7 unchanged
The information required by this Item will be included in the [removed: 2024] [added: 2025] Proxy Statement under the section captioned “Statement of Fees Paid to Independent Registered Public Accounting Firm” and is incorporated herein by reference thereto.
Item 15. (a)(3) and Item 15(b) Exhibits
27 rewritten, 2 added, 3 removed, 27 unchanged
| 3.1 | | | [Second Amended and Restated Certificate of Incorporation of Charles River Laboratories International, Inc. dated June 5, [removed: 2000](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-3_1.txt)] [added: 2000](https://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-3_1.txt)] | | | | | | S-1/A | | | June 23, 2000 | | | 3.1 | | |
| 4.1 | | | [Form of Common Stock certificate, $0.01 par value, of Charles River Laboratories International, [removed: Inc.](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-4_1.txt)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-4_1.txt)] | | | | | | S-1/A | | | June 23, 2000 | | | 4.1 | | |
| 4.4 | | | [Charles River Laboratories International, Inc. Indenture Agreement with MUFG Union Bank, N.A. as Trustee dated April 3, [removed: 2018](http://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0401.htm)] [added: 2018](https://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0401.htm)] | | | | | | 8-K | | | April 3, 2018 | | | 4.1 | | |
| 4.5 | | | [Charles River Laboratories International, Inc. Second Supplemental Indenture, dates as of October 23, 2019, to the Indenture dated as of April 3, [removed: 2018](http://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm)] [added: 2018](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm)] | | | | | | 8-K | | | October 23, 2019 | | | 4.1 | | |
| 4.6 | | | [Form of Note for 4.250% Senior Notes due [removed: 2028](http://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm)] [added: 2028](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm)] | | | | | | 8-K | | | October 23, 2019 | | | 4.2 | | |
| 10.1* | | | [Charles River Laboratories International, Inc. 2016 Incentive [removed: Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068216000013/crl6252016ex101.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068216000013/crl6252016ex101.htm)] | | | | | | 10-Q | | | August 3, 2016 | | | 10.1 | | |
| 10.2* | | | [Charles River Laboratories International, Inc. Amended and Restated 2018 Incentive Plan, dated March 20, 2018, as amended November 21, 2023](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex102.htm) | | | [removed: X] | | | [added: 10-K] | | | [added: February 14, 2024] | | | [added: 10.2] | | |
| 10.3* | | | [Charles River Laboratories International, Inc. Form of Stock Option granted under the 2016 Incentive [removed: Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex104.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex104.htm)] | | | | | | 10-K | | | February 14, 2017 | | | 10.4 | | |
| 10.4* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Unit granted under the 2016 Incentive [removed: Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex107.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex107.htm)] | | | | | | 10-K | | | February 14, 2017 | | | 10.7 | | |
| 10.6* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Unit granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex106.htm) | | | [removed: X] | | | [added: 10-K] | | | [added: February 14, 2024] | | | [added: 10.6] | | |
| 10.8* | | | [Form of Change in Control [removed: Agreement](http://www.sec.gov/Archives/edgar/data/1100682/000104746909001689/a2190829zex-10_7.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1100682/000104746909001689/a2190829zex-10_7.htm)] | | | | | | 10-K | | | February 23, 2009 | | | 10.7 | | |
| 10.9* | | | [Charles River Laboratories International, Inc. Non-Employee Directors Deferral Plan dated April 5, [removed: 2016](http://www.sec.gov/Archives/edgar/data/1100682/000110068216000010/crl3262016ex101.htm)] [added: 2016](https://www.sec.gov/Archives/edgar/data/1100682/000110068216000010/crl3262016ex101.htm)] | | | | | | 10-Q | | | May 4, 2016 | | | 10.1 | | |
| 10.10* | | | [Charles River Laboratories, Inc. Executive Life Insurance/Supplemental Retirement Income [removed: Plan](http://www.sec.gov/Archives/edgar/data/1100682/000104746905005909/a2152761zex-10_23.txt)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1100682/000104746905005909/a2152761zex-10_23.txt)] | | | | | | 10-K | | | March 9, 2005 | | | 10.23 | | |
| [removed: 10.13*] [added: 10.13†] | | | [Charles River Laboratories amended and restated Deferred Compensation Plan, as [removed: amended](https://www.sec.gov/Archives/edgar/data/0001100682/000110068221000010/ex103dcplandocument-amende.htm)] [added: amended](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex1013.htm)] | | | [added: X] | | | [removed: 10-Q] | | | [removed: May 4, 2021] | | | [removed: 10.3] | | |
| 10.14 | | | [removed: [Ninth] [added: [Tenth] Amended and Restated Credit Agreement, dated as of [removed: April 21, 2021,] [added: December 13, 2024,] among Charles River Laboratories International, Inc., the Subsidiary Borrowers party thereto, the lenders party thereto, JPMorgan Chase Bank, N.A., as administrative agent, and the other agents party [removed: thereto](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321005992/dp149793_ex1001.htm)] [added: thereto](https://www.sec.gov/Archives/edgar/data/1100682/000095010324017767/dp222024_ex1001.htm)] | | | | | | 8-K | | | [removed: April 23, 2021] [added: December 13, 2024] | | | 10.1 | | |
| 19 | | | [Insider Trading Policy](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex19.htm) | | | [removed: X] | | | [added: 10-K] | | | [added: February 14, 2024] | | | [added: 19] | | |
| 21.1 | | | [Subsidiaries of Charles River Laboratories International, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex211.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex211.htm)] | | | X | | | | | | | | | | | |
| 23.1 | | | [Consent of PricewaterhouseCoopers [removed: LLP](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex231.htm)] [added: LLP](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex231.htm)] | | | X | | | | | | | | | | | |
| 31.1 | | | [Rule 13a-14(a)/15d-14(a) Certification of Chief Executive [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex311.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex311.htm)] | | | X | | | | | | | | | | | |
| 31.2 | | | [Rule 13a-14(a)/15d-14(a) Certification of Chief Financial [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex312.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex312.htm)] | | | X | | | | | | | | | | | |
| 32.1 | | | [Section 1350 Certification of the Chief Executive Officer and Chief Financial [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex321.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex321.htm)] | | | X | | | | | | | | | | | |
| 97 | | | [Financial Statement Compensation Recoupment Policy](https://www.sec.gov/Archives/edgar/data/1100682/000110068224000007/crl1230202310-kex97.htm) | | | [removed: X] | | | [added: 10-K] | | | [added: February 14, 2024] | | | [added: 97] | | |
| 101.SCH | | | [removed: Inline] XBRL Taxonomy Extension Schema [added: Document] | | | X | | | | | | | | | | | |
| 101.CAL | | | [removed: Inline] XBRL Taxonomy [removed: Extension] Calculation Linkbase [added: Document] | | | X | | | | | | | | | | | |
| 101.DEF | | | [removed: Inline] XBRL Taxonomy [removed: Extension] Definition Linkbase [added: Document] | | | X | | | | | | | | | | | |
| 101.LAB | | | [removed: Inline] XBRL Taxonomy [removed: Extension Labels] [added: Label] Linkbase [added: Document] | | | X | | | | | | | | | | | |
| 101.PRE | | | [removed: Inline] XBRL Taxonomy [removed: Extension] Presentation Linkbase [added: Document] | | | X | | | | | | | | | | | |
| 10.7* | | | [Charles River Executive Separation Plan dated December 05, 2024](https://www.sec.gov/Archives/edgar/data/1100682/000110068225000011/crl1228202410-kex107.htm) | | | X | | | | | | | | | | | |
| 101.INS | | | eXtensible Business Reporting Language (XBRL) Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | | | X | | | | | | | | | | | |
| 10.7* | | | [Charles River Corporate Officer Separation Plan dated April 30, 2010](http://www.sec.gov/Archives/edgar/data/1100682/000104746910006917/a2199599zex-10_1.htm) | | | | | | 10-Q | | | August 3, 2010 | | | 10.1 | | |
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
| 101.INS | | | eXtensible Business Reporting Language (XBRL) Instance Document | | | X | | | | | | | | | | | |
Item 16. Form 10-K Summary
14 rewritten, 0 added, 3 removed, 37 unchanged
| February [removed: 14, 2024] [added: 19, 2025] | | | By: | | | /s/ FLAVIA H. PEASE | | |
| By: | | | /s/ JAMES C. FOSTER | | | *Chairman, President and Chief Executive Officer* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ FLAVIA H. PEASE | | | *Corporate Executive Vice President and* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ MICHAEL G. KNELL | | | *Corporate Senior Vice President and* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ NANCY C. ANDREWS | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ ROBERT J. BERTOLINI | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ RESHEMA KEMPS-POLANCO | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ DEBORAH T. KOCHEVAR | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ GEORGE LLADO | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ MARTIN MACKAY | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ GEORGE E. MASSARO | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ [removed: C.] RICHARD [removed: REESE] [added: F. WALLMAN] | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ CRAIG B. THOMPSON | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| By: | | | /s/ VIRGINIA M. WILSON | | | *Director* | | | February [removed: 14, 2024] [added: 19, 2025] | | |
| | | | | | | | | | | | |
| | | | C. Richard Reese | | | | | | | | |
| By: | | | /s/ RICHARD F. WALLMAN | | | *Director* | | | February 14, 2024 | | |