Charles River Laboratories International (CRL) 10-K risk factor changes: FY2021 vs FY2020
The 2021-12-25 10-K against the 2020-12-26 one, compared heading by heading and sentence by sentence.
Item 1A91 rewritten151 added32 removed288 unchanged
All filing items1,123 rewritten835 added622 removed2,186 unchanged
Summary
counted, not written
- Item 1A lists 59 risk factor headings: 25 new, 4 reworded and 30 unchanged since FY2020. 2 headings from FY2020 no longer appear.
- Sentence by sentence, 835 added, 622 removed, 1,123 rewritten and 2,186 unchanged across 21 items that differ.
- New this year: Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
New Item 1A headings (25)
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- Failure to execute our business strategy could adversely impact our growth and profitability.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- Our CDMO business, financial condition and results of operations may be adversely affected if the products we manufacture for our customers do not gain market acceptance.
- Manufacturing services are highly complex and failure to provide quality and timely services to our CDMO customers, could adversely impact our business.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- Legal & Regulatory Risk Factors
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- We are required to comply with stringent, complex and evolving laws, rules, regulations and standards in many jurisdictions, as well as contractual obligations, relating to data privacy and security. Any actual or perceived failure to comply with these requirements could have a material adverse effect on our business.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- Labor & Employment Risk Factors
- Financial and Accounting Risk Factors
- CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Removed Item 1A headings (2)
- We are required to comply with the data privacy and security laws in many jurisdictions. Failure to comply with these laws and regulations could subject us to denial of the right to conduct business, fines, criminal penalties and/or other enforcement actions that could have a material adverse effect on our business.
- The decision by British voters to exit the European Union may adversely affect our business.
Reworded Item 1A headings (4)
- We have in the past experienced and in the future could experience
[removed: an]unauthorized access into our information systems. - Costs increasing more rapidly than market prices [added: in certain of our businesses] could reduce profitability.
- The failure to successfully obtain, maintain and enforce intellectual property rights and defend against
[removed: challenges][added: assertions of third-parties] to[removed: our]intellectual property rights could adversely affect us. - Impairment of [added: long lived tangible assets and intangible assets (such as] goodwill
[removed: or][added: and] other intangible[removed: assets][added: assets)] may adversely impact future results of operations.
A heading is new when no FY2020 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
23 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2021; struck-through words were in FY2020. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
91 rewritten, 151 added, 32 removed, 288 unchanged
- deterioration in the financial condition and prospects of our customers or attempts by customers, suppliers or service providers to invoke force majeure contractual clauses, or the legal doctrines of impossibility or [removed: impracticability (or] [added: impracticability, or] other similar [removed: doctrines)] [added: doctrines,] as a result of delays or other disruptions;
Our counterparties (including our clients who are competitors) may elect to terminate their agreements with us for various reasons including: the invocation of force majeure clauses, or the legal doctrines of impossibility or [removed: impracticability (or] [added: impracticability, or] other similar legal [removed: doctrines),] [added: doctrines,] as a result of the COVID-19 pandemic; the products being tested fail to satisfy safety requirements; unexpected or undesired study results; production problems resulting in shortages of the drug being tested; a client’s decision to forego or terminate a particular study; our competitors’ establishment of alternative distribution channels; dissatisfaction with our performance under the agreement; the loss of funding for the particular research study; or general convenience/counterparty preference.
The expansion and ongoing implementation of [removed: the] [added: 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, data conversion, network and system [removed: cutover and] [added: cutover,] user [removed: training.][added: training, and integration with existing processes or systems.]
[removed: Problems] [added: Incongruities] in any of these areas could cause operational problems during implementation including [added: inconsistent practices,] delayed [added: report and/or data] shipments, missed sales, billing errors and accounting errors.
[removed: We] [added: - We] have in the past experienced and in the future could experience [removed: an] unauthorized access into our information [removed: systems.][added: systems.]
Like other companies, we have on occasion experienced, and will continue to experience, threats and incursions to our data and systems, including malicious [removed: codes] [added: software] and viruses, phishing, business email compromise and social engineering attacks or other cyber-attacks.
During the last two decades, we have steadily expanded our business through numerous acquisitions, including our recent acquisitions of HemaCare, [removed: Cellero and] [added: Cellero,] Distributed [removed: Bio and our recently announced planned acquisition of] [added: Bio, Retrogenix,] Cognate BioServices, Inc. [removed: However, businesses and technologies may not be available on terms] [added: (Cognate),] and [removed: conditions we find acceptable.][added: Vigene Biosciences, Inc. (Vigene).]
- difficulties in achieving business and financial success [removed: (including] [added: (due to unplanned events such] as [removed: a result of] [added: the] COVID-19 pandemic and the long-term economic impact of the pandemic);
- challenges with developing and operating new businesses, including those that are materially different from our existing [removed: businesses and that] [added: businesses, which] may require the development or acquisition of new internal capabilities and expertise;
- potential losses resulting from undiscovered liabilities of acquired companies that are not covered by the [removed: indemnification] [added: indemnifications] we may obtain from [removed: the seller] [added: sellers] or [removed: the] [added: any] insurance we [added: may] acquire in connection with [removed: the transaction;][added: transactions;]
- [removed: acquisitions could be dilutive] [added: dilution] to earnings, or in the event of acquisitions made through the issuance of our common stock to the shareholders of the acquired company, [removed: dilutive] [added: dilution] to the percentage of ownership of our existing shareholders;
Some of the same risks exist when we decide to sell a business, [removed: site or] [added: site,] product [removed: line.][added: line or service offering.]
[removed: In addition,] [added: Such] divestitures could involve additional risks, [removed: including the following:] [added: other than those listed above, including:] difficulties in the separation of operations, services, products, and [removed: personnel; diversion of management’s attention from other business concerns; and] [added: personnel,] the need to agree to retain or assume certain current or future liabilities in order to complete the [removed: divestiture.][added: divestiture, and 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.]
We continually evaluate the performance and strategic fit of our [removed: businesses (including specific product lines and service offerings)] [added: business] to determine whether any divestitures are appropriate.
- general economic and political conditions in the markets in which we operate, including implications of [removed: Brexit and] the COVID-19 pandemic;
- potentially negative consequences from changes in U.S. and/or foreign tax laws, or interpretations and enforcement thereof, notably tax regulations issued and to-be-issued with respect to [removed: U.S.] [added: the] Tax [removed: Reform] [added: Cuts] and [added: Jobs Act of 2017 (2017 Tax Act) and] the EU Anti-Tax Avoidance Directives I and II, and the creation of the Joint Chiefs of Global Tax Enforcement;
- longer accounts receivable cycles in certain foreign countries (including as a result of the COVID-19 pandemic and the impact of measures intended to reduce the spread of COVID-19); [removed: and]
For example, as mentioned above, we are subject to compliance with the [removed: FCPA and similar anti-bribery laws,] [added: FCPA,] which [removed: generally prohibit] [added: prohibits] companies and their third-party intermediaries from [added: offering or] making improper payments to foreign government officials for the purpose of obtaining or retaining business.
While our [removed: employees, distributors] [added: employees] and [removed: agents] [added: third-party intermediaries] are required to comply with these laws, we cannot be sure that our internal policies and procedures will always protect us from violations of these laws despite our commitment to legal compliance and corporate ethics.
We depend on our customers [added: continued demand] and [added: solvency at our] facilities for the continued operation of our business.
Despite any precautions we take for natural disasters or other catastrophic events, these events, including terrorist attack, a pandemic (including the COVID-19 pandemic), epidemic or outbreak of a disease, hurricanes, [added: tornadoes,] fire, 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.
As described herein, the COVID-19 pandemic has already, and [removed: will] [added: may] continue to, [removed: materially] disrupt our operations, though the full extent of such impact remains uncertain.
[removed: For additional discussion of the factors that we believe have recently] been influencing R&D budgets at our clients, please see the sections entitled “Our Strategy” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this Form 10-K.
Further, our Research [removed: Products] [added: and GMP-Compliant Cells] operations are structured to produce [removed: particular] [added: research materials, such as] blood products based on customers’ existing demand, and perceived potential changes in demand, for these products.
The impact of measures intended to reduce the spread of COVID-19 caused us to temporarily suspend blood [removed: donations,] [added: donations in early 2020,] which have since resumed, at our Research [removed: Products] [added: and GMP-Compliant Cells] facilities, further limiting our ability to respond to changes in demand.
Disruptions to their continued supply from time to time arise from health problems (including as a result of the COVID-19 pandemic and the spread of other diseases), export or import laws/restrictions or embargoes, tariffs, [added: inflation,] international trade regulations, foreign government or economic instability, severe weather conditions, increased competition among suppliers for models, disruptions to the air travel system, activist campaigns, commercial disputes, supplier insolvency, geopolitical disputes, measures intended to slow the spread of COVID-19 or other ordinary course or unanticipated events.
For example, as with other industry participants, certain of our activities rely on a sufficient supply of large research models, which has seen increasing demand as compared to supply in 2020 and [removed: into] 2021 [added: and into 2022] due to a variety of factors.
Further, [added: portions of] our Research [removed: Products] [added: and GMP-Compliant Cells] business depends on the availability of appropriate donors.
As a result of the COVID-19 pandemic and the impact of measures intended to reduce the spread of COVID-19, we temporarily [removed: suspended blood donations at one of our Research Products facilities.]
Due to any pandemic, epidemic or outbreak in one or more regions in which our Research [removed: Products] [added: and GMP-Compliant Cells] business operates, the portion of the donor pool that typically donates may be unable, or unwilling to donate, thereby significantly reducing the availability of research products upon which we rely.
If donor participation declines, we may not be able to reduce costs sufficiently to maintain profitability of the Research [removed: Products] [added: and GMP-Compliant Cells] business.
Our research models and fertile chicken eggs must be free of certain infectious agents, such as certain [removed: viruses] [added: viruses, parasites,] and bacteria, because the presence of these contaminants can distort or compromise the quality of research results and could adversely impact human or animal health.
[removed: The presence of these infectious agents in our animal production facilities and certain] service operations could disrupt our contaminant-free research model and fertile egg production as well as our animal services businesses, including GEMS, harm our reputation for contaminant-free production and result in decreased sales.
[added: In addition to microbiological contaminations, the potential for genetic contaminations also] exists and may require us to restart the applicable colonies, and would [removed: likely] result in inventory loss, additional start-up costs and possibly reduced sales.
For additional discussion of the factors that we believe have recently influenced outsourcing demand from our clients, please see the section entitled “Our Strategy” [removed: included in our Form 10-K for the fiscal year ended December 28, 2019, filed with the Commission on February 11, 2020.][added: above.]
We compete for business with other CROs and blood product and therapeutic services companies, [added: other CDMOs,] as well as internal discovery and development departments within our larger clients, who may have greater resources than ours.
[added: In addition, small, specialized entities considering] entering the CRO industries will continue to find lower barriers to entry, and private equity firms may determine that there are opportunities to acquire and consolidate these companies, thus further increasing possible competition.
In addition, technological [removed: improvements to existing or new processes,] [added: improvements,] such as imaging and other translational biomarker technologies, could [removed: result in the refinement and utility] [added: impact demand] for [removed: the number of] animal research [removed: models necessary to improve the translation from non-clinical to clinical studies.][added: models.]
Further, some companies are developing [removed: synthetic alternatives to] [added: recombinantly produced versions of] LAL, which [removed: is] [added: has been historically] derived from live animals.
Risk Factor Summary
As noted above, we are subject to a number of risks that if realized could cause actual results to differ materially from the results contemplated herein.
Some of the more significant risks and uncertainties we face include those summarized below.
The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors"
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
section.
Please carefully consider all of the information in this Form 10-K, including the full set of risks set forth in this "Risk Factors" section, and in our other filings with the SEC before making an investment decision regarding Charles River.
- Our business may be further adversely impacted by the COVID-19 pandemic.
- We bear financial risk for contracts that may be terminated or reduced in scope, underpriced, subject to cost overruns or delayed.
- Upgrading and integrating our business systems could result in implementation issues and business disruptions.
- 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 divestitures, our business may be adversely impacted.
- Our business is subject to risks relating to operating internationally, including changes in foreign currency exchange rates.
- Our operations might be affected by the occurrence of a natural disaster or other catastrophic event, such as the COVID-19 pandemic.
- Negative attention from special interest groups may impair our business.
- A reduction in demand or a reduction or delay in government funding of R&D may adversely affect our business.
- Several of our product and service offerings are dependent on a limited source of supply that, when interrupted, adversely affects our business.
- Contract development and manufacturing services create a risk of liability, including risk that our products will not gain market acceptance and risk of failure to provide quality and timely service to customers.
- Contaminations in our animal populations can damage our inventory, harm our reputation for contaminant-free production, result in decreased sales and cause us to incur additional costs.
- The outsourcing trend in non-clinical stages of drug discovery and development may decrease, which could impair our growth.
- The industries in which we operate are highly competitive.
- New technologies may be developed, validated and increasingly used in biomedical research, which could reduce demand for some of our products and services.
- We may not be able to successfully develop and market new services and products.
- Any failure by us to comply with applicable regulations and related guidance could harm our reputation and operating results, and compliance with new regulations and guidance may result in additional costs.
- Changes in government regulation or in practices relating to the pharmaceutical or biotechnology industries, including potential healthcare reform, could decrease the need for the services we provide.
- Failure to comply with U.S., state, local or international environmental, health and safety laws and regulations could result in fines and penalties and loss of licensure, and have a material adverse effect upon the Company’s business.
- Changes in U.S. and International Tax Law or material changes in our stock price could have a material adverse impact on our effective tax rate.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
- Contract research services create a risk of liability.
- We depend on key personnel and may not be able to retain these employees, which would harm our business.
- We depend on the availability of, and good relations with, our team members.
- Our debt level could adversely affect our business and growth prospects.
- Since we do not expect to pay any cash dividends for the foreseeable future, our shareholders will benefit from an investment in our common stock only if it appreciates in value.
- Our quarterly operating results may vary, which could negatively affect the market price of our common stock.
Risk Factors
Business and Operational Risks
- constraints on international routes for shipment of products and materials impact timelines to support client demands;
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
We have in the past experienced and in the future could experience unauthorized access into our information systems.
However, businesses and technologies may not be available on terms and conditions we find acceptable.
Any divestitures may result in significant 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 to microbiological contaminations, the potential for genetic mix-ups or mis-matings also
In addition, small, specialized entities considering
The scientific and research communities continue to develop methods to improve cellular and animal model systems that would increase the translation to human studies and vice-versa and possibly replace or supplement the use of traditional living animals in biomedical research.
Some companies have developed techniques in these areas that may have scientific merit to improve translation between species.
In March 2010, the U.S. Congress enacted healthcare reform legislation, the Patient Protection and Affordable Care Act (ACA), which includes provisions impacting drug manufacturers, such as (1) the expansion of access to health insurance coverage, (2) the expansion of the Medicaid program, (3) the enactment of an industry fee on pharmaceutical companies and (4) the imposition of an excise tax on the sale of medical devices.
In addition, the Tax Cuts and Jobs Act, enacted in 2017, repeals the ACA’s individual health insurance mandate, which is considered a key component of the ACA.
Since the ACA and its implementation continue to face challenges in Congress and federal courts, and from certain state governments, opposition advocacy groups and some small business organizations, the ultimate effects of this legislation are unclear on our business and are unable to predict what legislative proposals will be adopted in the future.
We are required to comply with the data privacy and security laws in many jurisdictions.
We are required to comply with the data privacy and security laws in many jurisdictions.
Recent legal developments in the EU have created complexity and uncertainty regarding transfers of personal data from the EU to the US, including the invalidation of the EU-US Privacy Shield Framework in July 2020 and proposed updates to the EU standard contractual clauses in November 2020.
Additionally, following the United Kingdom’s withdrawal from the EU, we will have to comply with the EU GDPR and the GDPR as implemented in the United Kingdom.
The relationship between the United Kingdom and the EU with respect to certain aspects of data protection law remains unclear, for example around how data can lawfully be transferred between each jurisdiction, which exposes us to further compliance risk.
In 2017, significant U.S. tax law changes from the Tax Cuts and Jobs Act of 2017 (U.S. Tax Reform) went into effect and reduced the U.S. federal statutory tax rate, broadened the corporate tax base through the elimination or reduction of deductions, exclusions and credits, limited the ability of U.S. corporations to deduct interest expense and allowed for the repatriation of foreign earnings to the U.S. with a 100% federal dividends received deduction prospectively.
In addition, U.S. Tax Reform required a one-time transitional tax on foreign cash equivalents and previously unremitted earnings.
In our DSA and Manufacturing businesses, we attempt to reduce these risks by contractual risk transfer provisions entitling us to be indemnified by our clients and subject to a limitation of liability, by insurance maintained by our clients and/or by us and by various regulatory requirements we must follow in connection with our business.
Existing laws of certain countries outside of the United States in which we operate offer only limited protection, and these are subject to change at any time.
These adverse effects could include us having to abandon, alter or delay the deployment of products, services or processes that rely on such intellectual property; having to procure and pay for licenses from the holders of intellectual property rights that we seek to use; and having to pay damages, fines, court costs and attorney's fees in connection with intellectual property litigation.
Legal proceedings relating to intellectual property are expensive, take significant time, and divert management’s attention from other business concerns, whether we win or lose.
The decision by British voters to exit the European Union may adversely affect our business.
The first stage of the U.K.’s withdrawal from the European Union (“Brexit”) took place on January 31, 2020, when the U.K. left the European Union and entered a transition phase.
During the transition phase, the U.K. engaged in negotiations with the European Union on the terms of its future trading and other relationships with the European Union.
The scope and timing of these negotiations created significant uncertainty.
The timing of the agreement reached between the U.K. and the European Union at the end of 2020 continues that uncertainty and, given the need to understand the implications of the agreement and the formalities required in respect of the U.K.’s future relationship with the European Union, we have formed a committee (comprised of senior managers across our business functions) to address key risks among four main themes: (1) trade and customs, (2) employees and immigration, (3) strategy and business planning and (4) legislative changes.
That committee will continue until the situation is clarified.
Notwithstanding the agreement reached the movement of goods between the U.K. and the remaining member states of the European Union will be subject to additional inspections and documentation checks, leading to possible delays at ports of entry and departure and additional VAT requirements.
These changes to the trading relationship between the U.K and European Union would likely result in increased cost of goods imported into and exported from the U.K. and may decrease the profitability of our U.K. and other operations.
Additional currency volatility could drive a weaker British pound, which increases the cost of goods imported into our U.K. operations and may decrease the profitability of our U.K. operations.
A weaker British pound versus the U.S. dollar also causes local currency results of our U.K. operations to be translated into fewer U.S. dollars during a reporting period.
Although we are undertaking efforts to mitigate those risks within our control, a failure to adequately mitigate such risks or other factors outside our control could adversely affect our business, business opportunities, results of operations, financial condition and cash flows.”
In connection with our intended acquisition of Cognate BioServices, Inc., we anticipate increasing our debt to finance a substantial portion of the purchase price of approximately $875 million in cash.
In 2017, the Financial Conduct
An excerpt. Shown here: 40 of 91 rewritten, 40 of 151 added and all 32 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2021 filing and the FY2020 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
156 rewritten, 127 added, 235 removed, 253 unchanged
[removed: The] [added: In addition to historical consolidated financial information, the] following discussion contains forward-looking statements.
We are a full service, [removed: early-stage] [added: non-clinical] contract research organization (CRO).
For [removed: over 70] [added: 75] years, we have been in the business of providing the research models required in research and development of new drugs, devices, and therapies.
Over this time, we have built upon our original core competency of laboratory animal medicine and science (research model technologies) to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, [removed: that enable us] [added: which is able] to support our clients from target identification through non-clinical development.
We also provide a suite of products and services to support our clients’ manufacturing [removed: activities.][added: activities, including our newly acquired contract development and manufacturing organization (CDMO) business.]
Our client base includes [removed: all] major global biopharmaceutical companies, many biotechnology [removed: companies, CROs,] [added: companies;] agricultural and industrial [removed: chemical companies,] [added: chemical,] life [removed: science companies,] [added: science,] veterinary [removed: medicine companies, contract manufacturing companies,] [added: medicine,] medical [removed: device companies, and] [added: device,] diagnostic and [added: consumer product companies; contract research and contract manufacturing organizations; and] other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world.
We currently operate in over [removed: 100 facilities] [added: 110 locations] and in over 20 countries worldwide, which numbers exclude our Insourcing Solutions (IS) sites.
Our three reportable segments are Research Models and Services (RMS), Discovery and Safety Assessment (DSA), and Manufacturing [removed: Support] [added: Solutions] (Manufacturing).
Our RMS reportable segment includes the Research Models, Research Model Services, and Research [removed: Products] [added: and GMP-Compliant Cells] businesses.
Research [removed: Products] [added: and GMP-Compliant Cells] supplies controlled, consistent, customized primary cells and blood components derived from normal and mobilized peripheral blood, bone marrow, and cord blood.
Our Manufacturing reportable segment includes Microbial Solutions, which provides *in vitro* (non-animal) lot-release testing products, microbial detection products, and species identification services; Biologics [removed: Testing Services] [added: Solutions] (Biologics), which performs specialized testing of [removed: biologics;] [added: biologics (Biologics Testing Solutions) as well as contract development] and [added: manufacturing products and services (CDMO); and] Avian Vaccine Services (Avian), which supplies specific-pathogen-free chicken eggs and chickens.
The COVID-19 pandemic is [removed: dynamic and expanding,] [added: dynamic,] and its ultimate scope, duration and effects are uncertain.
This pandemic has [removed: had] and [removed: may continue] [added: continues] to result [removed: in] [added: in, and any future epidemic or pandemic crises may potentially result in,] direct and indirect adverse effects on our industry and customers, which in turn has [removed: impacted] [added: (with respect to COVID-19) and may (with respect to future epidemics or crises) impact] our business, results of [removed: operations,] [added: operations] and financial condition.
Further, the COVID-19 pandemic may also affect our operating and financial results in [removed: ways] [added: a manner] that [removed: are and are] [added: is] not presently known to [removed: us,] [added: us] or that we currently do not expect to present significant risks to our operations or financial [removed: results but which may in fact turn out to negatively affect us to a magnitude greater than anticipated.][added: results.]
[removed: Giving consideration to each of these risk factors, the following] is our current estimate and belief of the impact of the COVID-19 pandemic during fiscal year [removed: 2020] [added: 2021] and how it may continue to affect us in subsequent periods.
[removed: As a result, all] [added: All] of our operating sites remain open and adequately staffed as of the date of this annual report.
We [removed: have encouraged and expressed our expectations that employees work remotely whenever possible;] [added: are adhering to guidelines from government, health,] and [added: other regulatory agencies] for those employees who need to come into our sites to fulfill their [removed: responsibilities, we are adhering to guidelines from government, health, and other regulatory agencies.][added: responsibilities.]
Due to the nature of our business, many employees already work in biosecure environments that require [removed: PPE] [added: personal protective equipment (PPE)] and adhere to other procedures to safely accomplish their daily responsibilities.
Accordingly, we have and expect to continue to increase inventory and supplies in [removed: 2021.][added: 2022.]
We [removed: proactively engaged] [added: continuously engage] with our suppliers [removed: beginning in January 2020] to limit any potential disruption to our supply chain.
We are a global company that operates in over [removed: 100 facilities] [added: 110 locations] and in over 20 countries worldwide.
We are continuing to see demand for products and services across all of our businesses, although as described below [added: within Results of Operations,] the impact of the COVID-19 pandemic on the level of demand varies with our different businesses.
[removed: Our RMS business] [added: DSA revenue] was [removed: meaningfully] [added: not significantly] impacted by the COVID-19 pandemic during fiscal [removed: year] [added: years 2021 and] 2020.
[removed: The] [added: | 5.5%] Senior Notes [removed: become] due [removed: in] 2026 [removed: and 2028.][added: | | | — | | | | | | 500.0 | | |]
There are judgments involved as it relates to reviewing our allowance for [removed: doubtful accounts,] [added: credit losses,] valuation of inventory, and valuations/recovery of investments.
Should a prolonged disruption occur where there is a material change from our current expectation of future cash flows, we could experience additional write-offs of client receivables or impairments to certain asset balances due to [added: collectability and valuation issues.]
Review of impairment indicators and quantifying any impact will continue to be a focus throughout fiscal year [removed: 2021.][added: 2022.]
As of December [removed: 26, 2020] [added: 25, 2021] and through the issuance of these financial statements, we did not have any material changes to our internal controls over financial reporting.
System and efficiency programs implemented in recent years, as well as those implemented as part of business continuity plans, have enabled us to effectively complete our financial reporting process in a similar way we completed it prior to the COVID-19 [removed: pandemic despite a largely remote working environment.]
We [removed: continued] [added: continue] to make strategic acquisitions designed to expand our portfolio of products and services to support the drug discovery and development continuum.
[added: On March 29, 2021, we acquired] Cognate BioServices, Inc. [removed: is] [added: (Cognate),] a cell and gene therapy CDMO offering comprehensive manufacturing solutions for cell therapies, as well as for the [removed: development and] production of plasmid DNA and [removed: viral vectors for gene therapies.][added: other inputs in the CDMO value chain.]
The [removed: planned] acquisition of Cognate [removed: BioServices, Inc. will create] [added: establishes us as] a scientific partner for cell and gene therapy development, testing, and manufacturing, providing clients with an integrated solution from basic research [added: and discovery] through cGMP production.
The [removed: proposed] acquisition [removed: and associated fees are expected to be financed] [added: was funded] through a combination of available cash and proceeds from our Credit [removed: Facility under the multi-currency revolving facility.][added: Facility.]
This business is [removed: expected to be] reported as part of our Manufacturing reportable segment.
On December 31, [removed: 2020 (fiscal year 2021),] [added: 2020,] we acquired Distributed Bio, [removed: Inc] [added: Inc.] (Distributed Bio), a next-generation antibody discovery company with technologies specializing in enhancing the probability of success for delivering high-quality, readily formattable antibody fragments to support antibody and cell and gene therapy candidates to biopharmaceutical clients.
This business [removed: will be] [added: is] reported as part of our DSA reportable segment.
The purchase price for Cellero was [removed: $37.4] [added: $36.9 million, net of $0.5] million in cash.
The purchase price of HemaCare was [removed: $379.8] [added: $376.7 million, net of $3.1] million in cash.
The purchase price [removed: for Citoxlab] [added: of Retrogenix] was [removed: $527.1] [added: $53.9 million, net of $8.5] million in cash.
[removed: Citoxlab] [added: The business] is reported as part of our DSA reportable segment.
A discussion of our results of operations for the fiscal year ended December 26, 2020 and a comparison of our results for the fiscal years ended December 26, 2020 and December 28, 2019 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 26, 2020, filed with the SEC on February 17, 2021.
Giving consideration to each of these risk factors, the following
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
We have continuously refined our plans as the virus has spread and have encouraged and expressed our expectations that employees work remotely whenever possible.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
pandemic despite a largely remote working environment.
On June 28, 2021, we acquired Vigene Biosciences, Inc. (Vigene), a gene therapy contract development and manufacturing organization (CDMO), providing viral vector-based gene delivery solutions.
The acquisition enables clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner.
The preliminary purchase price of Vigene was $323.9 million, net of $2.7 million in cash, and includes $34.5 million of contingent consideration (maximum contingent payments of up to $57.5 million based on future performance).
On March 30, 2021, we acquired Retrogenix Limited (Retrogenix), an early-stage CRO providing specialized bioanalytical services utilizing its proprietary cell microarray technology.
The acquisition of Retrogenix enhances our scientific expertise with additional large molecule and cell therapy discovery capabilities.
Included in the purchase price are additional payments up to $6.9 million, which are contingent on future performance.
The preliminary purchase price of Cognate was $879.0 million, net of $70.5 million in cash, subject to certain post-closing adjustments and includes $15.7 million of consideration for an approximate 2% ownership interest not acquired.
This business is reported as part of our Manufacturing reportable segment.
On March 3, 2021, we acquired certain assets from a distributor that supports our DSA reportable segment.
The purchase price was $35.4 million, which includes $19.5 million in cash paid ($5.5 million of which was paid in fiscal 2020), and $15.9 million of contingent consideration (the maximum contingent contractual payments are up to $17.5 million).
The total consideration includes $80.8 million cash paid, settlement of $3.0 million in convertible promissory notes previously issued by us during prior fiscal years, and $14.0 million of contingent consideration (the maximum contingent contractual payments are up to $21.0 million).
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Recent Divestitures
On October 12, 2021, we completed two separate divestitures.
We sold our RMS Japan operations to The Jackson Laboratory for a preliminary purchase price of $73.5 million, which included $8.2 million in cash, $3.6 million pension over funding, and certain post-closing adjustments.
We also sold our gene therapy CDMO site in Sweden to a private investor group for a preliminary purchase price of $59.6 million, net of $0.2 million in cash and certain post-closing adjustments.
Included in the purchase price are contingent payments fair valued at $15.3 million, (the maximum contingent contractual payments are up to $25.0 million based on future performance), as well as a purchase obligation of approximately $10 million between the parties.
The COVID-19 pandemic continued in 2021, but the global economy endured the challenges of the pandemic and recovered, as did biopharmaceutical research activity.
Our ability to continue to deliver our leading suite of research and non-clinical development solutions has endeavored our clients to increasingly choose to partner with us for our flexible and efficient outsourcing solutions, broad scientific capabilities, and global scale, as well as our resilience throughout the pandemic.
Most of our businesses rebounded from the impact of the COVID-19 pandemic by early 2021, subsequently resulting in unprecedented client demand throughout the year.
The strength of the demand environment was further reinforced by strong biotech funding and continued scientific innovation, resulting in robust revenue growth across all three of our reportable segments in fiscal year 2021.
Our DSA reportable segment continued to benefit from these trends in fiscal year 2021.
Demand for our Microbial Solutions significantly rebounded in fiscal year 2021 from last year’s COVID-19 restrictions that limited access to certain client sites, and the business completed the delayed instrument installations.
In 2021, we continued to enhance our Biologics Solutions portfolio with the acquisitions of Cognate (March 2021) and Vigene (June 2021) to expand our scientific capabilities into the cell and gene therapy CDMO sector.
We believe these businesses enable Charles River to be a premier scientific partner for development, testing, and manufacturing of advanced drug modalities and further enhance our presence in the high-growth cell and gene therapy sector.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Demand for our Research Models and Services returned to pre-pandemic levels as clients returned to their research sites and resumed their biomedical research efforts in earnest, which drove robust revenue growth in fiscal year 2021.
This was particularly true in China, as the resurgence in demand outpaced North America and Europe due in part to an expanded product offering and ongoing efforts to enhance the geographic reach in China.
While the performance of these cell supply businesses continued to be impacted by COVID-19-related disruptions to donor availability in fiscal year 2021, we believe that we are taking the necessary actions to enable these businesses to achieve their full growth potential and capitalize on the robust, underlying demand from cell therapy developers and manufacturers in the near future.
The increases in operating income and operating income margin were primarily due to the contribution of higher revenue described above and the recovery from the effects from the COVID-19 pandemic compared to the corresponding period in 2020.
During fiscal year 2021, we issued $1 billion of debt split between $500 million of 3.75% Senior Notes due in 2029 (2029 Senior Notes), and $500 million of 4.00% Senior Notes due in 2031 (2031 Senior Notes), in an unregistered offering.
Interest on the 2029 and 2031 Senior Notes is payable semi-annually on March 15 and September 15.
Proceeds from the 2029 and 2031 Senior Notes were used as follows: prepay the $500 million 2026 Senior Notes, $21 million of debt extinguishment costs, and $13 million of accrued interest; prepay the $146.9 million remaining term loan; pay down $135 million of the revolving facility; and pay for a portion of the Cognate acquisition.
Many government agencies have provided guidance permitting “essential” or “critical” business operations to remain open.
As of the date of this annual report, in the geographies where business restrictions have been imposed, we believe all of our business operations have satisfied the requirements to be designated to be “essential” or “critical” according to the guidance provided by government, health and other regulatory agencies with authority over such matters.
We implemented our initial plans in China beginning in January 2020, and have continuously refined our plans for other regions as the virus has spread.
This includes social distancing, flexible scheduling such as split shifts, restricting visitors, enhanced cleaning, and providing personal protective equipment (PPE), such as masks and gloves, to employees.
Demand for research models declined due primarily to the physical shutdown of our client’s facilities, principally academic institutions.
While many of our clients are deemed essential businesses as well, we experienced a slowdown, initially in China in January 2020, and then across Europe and North America later in the first fiscal quarter of 2020, as measures were implemented by various governments to slow the spread of the COVID-19 pandemic.
This trend of reduced demand for research models continued during the second fiscal quarter of 2020, which negatively impacted revenue, operating income, operating income margins, and cash flows.
During the third fiscal quarter of 2020, we experienced an increase in demand as our clients reopened impacted sites and resumed their research activity, which positively impacted revenue, operating income, operating income margins, and cash flows, which continued through the fourth fiscal quarter of 2020.
Research models services, specifically our GEMS and Insourcing Solutions businesses, experienced higher revenues during fiscal year 2020 compared to the corresponding prior period and were not as adversely impacted by the COVID-19 pandemic.
Our DSA business was not significantly impacted by the COVID-19 pandemic during fiscal year 2020.
Towards the end of the first fiscal quarter of 2020, we experienced some client work shifting towards subsequent quarters of fiscal year 2020 due to the
various actions and restrictions put in place by governments around the world intended to slow the spread of the COVID-19 pandemic.
The work performed in our Discovery Services and Safety Assessment businesses are largely dependent on our internal sites being open.
Therefore, to the extent that clients require work to be completed, we have been able to continue to meet client demands and perform the work so long as our work force at the specific site the work is done is not significantly adversely impacted by the COVID-19 pandemic.
This trend is expected to continue as government actions to slow the spread of the COVID-19 pandemic continues to subside, employees return to work, and economies across the world reopen.
Costs of supply have and may continue to increase as we procure the materials required to perform our work.
Our Manufacturing business was not significantly impacted by the COVID-19 pandemic during fiscal year 2020, however, some of our customers experienced disruptions in their manufacturing operations.
This resulted in delays in instrument installations in our Microbial Solutions business, which began during the first half of fiscal 2020 and continued, to a lesser extent, during the second half of fiscal 2020.
Demand for certain Manufacturing products was not significantly impacted, such as Microbial Solutions endotoxin products and Avian products.
Our Biologics testing facilities remain open and performing services for our clients.
Similar to our other services businesses, our ability to perform work is contingent on our internal facilities and our work force not being significantly adversely impacted by the COVID-19 pandemic.
*Liquidity, capital and financial resources*
We require cash to fund working capital needs as well as capital expansion, acquisitions, venture capital and strategic investments, debt obligations, leases, and pension obligations.
The principal sources of liquidity have been cash flows from operations, supplemented by long-term borrowings.
In fiscal year 2019, we issued $500 million Senior Notes, repaid part of our term loan for $500 million, and increased our multi-currency revolving facility by $500 million, from $1.55 billion to $2.1 billion.
As of December 26, 2020, we had $2.0 billion of debt and finance leases outstanding, of which $50.2 million is current.
Available on the revolving line of credit (Revolver) is $1.2 billion, which matures on March 26, 2023 and does not require scheduled payments before that date should additional borrowings occur.
The term loan facility matures in 19 quarterly installments with the last installment due March 26, 2023.
Due to the uncertainty resulting from the COVID-19 pandemic, we borrowed an additional $150 million from the Revolver during the first fiscal quarter of 2020 to protect against any prolonged adverse impacts on liquidity markets.
While there remained uncertainty throughout fiscal 2020, we did not need to use these borrowings to fund operations and these funds were repaid during the third fiscal quarter of 2020.
We expect to generate cash inflows from our operating activities sufficient to satisfy our working capital needs as well as to service our debt, pension, and venture capital obligations.
Due to this higher debt, we incurred immaterially higher interest expense.
We did not need to borrow additional funds during 2020.
As of December 26, 2020 there is significant capacity on the remaining Revolver.
Accordingly, we do not anticipate a material risk of non-compliance with our debt covenants based on our current estimate of future earnings.
To protect against adverse liquidity concerns, there are various mechanisms for us to improve cash flows.
During the second fiscal quarter of 2020 we implemented certain cost reduction plans including delaying compensation related increases, implementing hiring restrictions, reducing working hours, reducing all non-essential travel, and reducing certain discretionary spending.
Beginning in the third fiscal quarter of 2020, we reinstated certain annual compensation increases, which had previously been delayed from the beginning of the second quarter of 2020.
Additionally, we had temporarily slowed our investment activity, including acquisitions and capital projects, but have since resumed certain of those activities, including the acquisitions of Cellero, LLC (Cellero) during the third fiscal quarter of 2020 and Distributed Bio during the first fiscal quarter of 2021.
As of the date these financial statements are issued, based on our current and expected liquidity position, we do not believe there is significant uncertainty in our ability to continue as a going concern.
An excerpt. Shown here: 40 of 156 rewritten, 40 of 127 added and 40 of 235 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 FY2021 filing and the FY2020 filing.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
6 rewritten, 1 added, 1 removed, 14 unchanged
As of December [removed: 26, 2020,] [added: 25, 2021,] our debt portfolio was comprised primarily of floating interest rate borrowings.
A 100-basis point increase in interest rates would increase our annual pre-tax interest expense by [removed: $9.6] [added: $11.6] million.
The principal functional currencies of the Company’s foreign subsidiaries are the Euro, British Pound, [removed: Canadian Dollar,] and [removed: Chinese Yuan Renminbi.][added: Canadian Dollar.]
During fiscal year [removed: 2020,] [added: 2021,] the most significant drivers of foreign currency translation adjustment the Company recorded as part of other comprehensive income (loss) were the [removed: Euro,] [added: Japanese Yen,] British Pound, [removed: Canadian Dollar, Chinese Yuan Renminbi, Japanese Yen] [added: Euro,] and [removed: Brazilian Real.][added: Hungarian Forint.]
[added: For fiscal year 2021, our revenue would] have [removed: increased] [added: decreased] by [removed: $96.1] [added: $122.1] million and our operating income would have [removed: increased] [added: decreased] by [removed: $0.4] [added: $5.3] million, if the U.S. dollar exchange rate had strengthened by 10%, with all other variables held constant.
During fiscal years [removed: 2020, 2019] [added: 2021] and [removed: 2018,] [added: 2020] we entered into foreign exchange forward contracts to limit our foreign currency exposure related to both intercompany loans and a U.S. dollar denominated loan borrowed by a non-U.S. Euro functional currency entity under our Credit Facility.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
For fiscal year 2020, our revenue would
Item 1. Business
118 rewritten, 73 added, 21 removed, 355 unchanged
Words such as “expect,” “anticipate,” “target,” “goal,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “likely,” “may,” “designed,” “would,” “future,” “can,” “could” and other similar [removed: expressions that] [added: expressions, which] are [removed: predictions,] [added: predictions of,] indicate future events and trends or which do not relate to historical matters are intended to identify such forward-looking statements.
For example, we may use forward-looking statements when addressing topics such as: [removed: trends in] [added: the COVID-19 pandemic, its duration, its impact on] our [added: business, results of operations, financial condition, liquidity, use of our borrowings,] business [added: practices, operations, suppliers, inventory] and [removed: industry; goodwill] [added: supplies, third party service providers, customers, employees, industry, ability to meet future performance obligations, ability to timely account for assets on our balance sheet, ability to efficiently implement advisable safety precautions,] and [removed: asset impairments still under review;] [added: internal controls over financial reporting; the COVID-19 pandemic’s impact on demand, the global economy and financial markets, changes and uncertainties in the global economy; client demand, particularly] future demand for drug discovery and development products and services, including the outsourcing of these services; 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; [added: our ability to successfully execute our business strategy; our ability to timely build infrastructure to satisfy capacity needs and support business growth, our ability to fund our operations for the foreseeable 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; our strategic relationships with leading pharmaceutical [removed: companies] and [added: biotechnology companies,] venture capital [removed: limited partnerships,] [added: investments,] and opportunities for future similar arrangements; our cost structure; the impact of [removed: completed and in-process] acquisitions and [removed: the timing of closing of in-process acquisitions;] [added: divestitures;] our expectations with respect to revenue growth and operating synergies (including the impact of specific actions intended to cause related improvements); the impact of specific actions intended to improve overall operating efficiencies and profitability (and our ability to accommodate future demand with our infrastructure), including gains and losses attributable to businesses we plan to close, [removed: consolidate] [added: consolidate, divest] or [removed: divest;] [added: repurpose;] 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; and our liquidity.
In addition, these statements include the impact of economic and market conditions on us and our clients, the effects of our cost-saving actions and the steps to optimize returns to shareholders on an effective and timely [removed: basis.][added: basis; and our ability to withstand the current market conditions.]
Factors that might cause or contribute to such differences [removed: include] [added: include, but are not limited to,] those discussed in this Form 10-K under the sections entitled “Our Strategy,” “Risk Factors,” “Management's Discussion and Analysis of Financial Condition and Results of Operations,” in our press releases and other financial filings with the SEC.
Our stock is traded on the New York Stock Exchange under the symbol “CRL” and is included in the Standard & Poor’s [removed: 1000, MidCap 400] [added: 500] and Composite 1500 indices, the Dow Jones U.S. Health Care Index, the [removed: NYSE] [added: New York Stock Exchange (NYSE)] Arca Biotechnology Index, the NYSE Composite and many of the Russell indices, among others.
We are a full service, [removed: early-stage] [added: non-clinical] contract research organization (CRO).
We also provide a suite of products and services to support our clients’ manufacturing [removed: activities.][added: activities, including our newly acquired contract development and manufacturing organization (CDMO) business.]
During the non-clinical stage of the development process, a drug candidate is tested [removed: in vitro] [added: *in vitro*] (non-animal, typically on a cellular or sub-cellular level in a test tube or multi-well petri plate) and [removed: in vivo] [added: *in vivo*] (in research models) to establish drug safety prior to and in support of human clinical trials.
For [removed: over 70] [added: 75] years, we have been in the business of providing the research models required in the research and development of new drugs, devices and therapies.
Over this time, we have built upon our core competency of [removed: in vivo] [added: *in vivo*] biology to develop a diverse and expanding portfolio of products and services, which now encompasses the broader [removed: early-stage] [added: non-clinical] drug research process.
We are positioned to leverage our leading portfolio in [removed: early-stage] [added: non-clinical] drug research in an efficient and cost-effective way to aid our clients in bringing their drugs to market faster.
We currently operate in over [removed: 100 facilities] [added: 110 locations] and in over 20 countries worldwide (excluding our Insourcing Solutions sites).
Our products and services, supported by our global infrastructure and deep scientific expertise, enable our clients to overcome many of the challenges of [removed: early-stage] [added: non-clinical] life sciences research.
In [removed: 2020,] [added: 2021,] our total revenue was [removed: $2.9] [added: $3.5] billion and our [removed: operating] income [removed: from continuing operations,] before income taxes, was [removed: $447.1] [added: $480.7] million.
We have three reporting segments: Research Models and Services (RMS), Discovery and Safety Assessment (DSA) and Manufacturing [removed: Support] [added: Solutions] (Manufacturing).
With over [removed: 150] [added: 160] different stocks and strains, we continue to maintain our position as a global leader in the production and sale of the most widely used rodent research model strains and purpose-bred rats and mice.
In [removed: 2020,] [added: 2021,] RMS accounted for [removed: 19.6%] [added: 19.5%] of our total revenue and approximately 3,900 of our employees, including approximately [removed: 220] [added: 190] science professionals with advanced degrees.
The demand for these services is driven by the needs of large global pharmaceutical companies that [removed: have exceeded their internal capacity or that] continue to transition to an outsourced drug development model, as well as by the needs of [removed: small] [added: mid-size and emerging] biotechnology companies, [removed: chemical] [added: industrial and agrochemical] companies and non-governmental organizations that rely on [removed: outsourcing for most of their discovery, development and safety testing programs.][added: outsourcing.]
In [removed: 2020,] [added: 2021,] our DSA segment represented [removed: 62.8%] [added: 59.5%] of our total revenue and employed approximately [removed: 11,600] [added: 12,400] of our employees including approximately [removed: 2,000] [added: 1,600] science professionals with advanced degrees.
Within our Manufacturing segment, we [removed: help] [added: work with our clients and the biopharmaceutical industry to] ensure the safe production and release of products manufactured [added: both] by our [added: clients and, with the acquisition of our CDMO services, internally for our] clients.
Our Manufacturing Segment is comprised of three businesses: Microbial Solutions, Biologics [removed: Testing Solutions] [added: Solutions,] and Avian Vaccine Services.
Our Microbial Solutions products and services businesses provide [removed: in vitro] [added: *in vitro*] methods for conventional and rapid quality control testing of sterile and non-sterile pharmaceuticals and consumer products.
Our Avian Vaccine Services business provides specific-pathogen-free (SPF) fertile chicken eggs, SPF chickens and diagnostic products used to manufacture [added: vaccines, principally veterinary] vaccines.
In [removed: 2020,] [added: 2021,] Manufacturing accounted for [removed: 17.6%] [added: 21.0%] of our total revenue from continuing operations and approximately [removed: 2,000] [added: 2,900] of our employees, including approximately [removed: 180] [added: 290] science professionals with advanced degrees.
Our RMS segment is comprised of three businesses: Research Models, Research Model Services and Research [removed: Products.][added: and GMP-Compliant Cells.]
We have a global footprint with production facilities strategically located in [removed: 8] [added: 7] countries, in close proximity to our clients.
Our services include those related to the maintenance and monitoring of research models, and managing research operations for government entities, academic [added: organizations, and commercial clients.]
We monitor and analyze the health profiles of our clients’ research models and research biologics by [removed: providing] [added: assessing] infectious agents and [removed: pathology assessment.][added: pathology.]
Our Research [removed: Products] [added: and GMP-Compliant Cells] business provides human-derived cellular materials used in the development [removed: of] [added: and] production of cell therapies.
Research [removed: Products] [added: and GMP-Compliant Cells] supports biotechnology and pharmaceutical companies, academic institutions and other research organizations who rely on high-quality, viable and functional human primary cells and blood components for biomedical and drug discovery research and cell therapy development.
We currently offer regulated and non-regulated DSA services, including [added: therapeutic discovery and optimization plus] *in vitro* and *in vivo* studies, laboratory support services, and strategic non-clinical consulting and program management to support product development.
We offer a full spectrum of discovery services from identification and validation of novel targets, chemical compounds [added: and antibodies] with actual or potential intellectual property value through to delivery of non-clinical drug and therapeutic candidates ready for safety assessment.
Our [removed: discovery services] [added: Discovery Services] business [removed: unit] focuses on all of the major therapeutic areas, with a strategic focus on oncology, immunology and neuroscience.
Our full suite of service offerings, together with our knowledge and expertise, allows us to support our clients at the earliest stages of their research, including the design and [added: implementations of their research programs, and to stay with them through the entire drug discovery process.]
We [added: also] provide these services at our clients’ laboratories with Charles River scientists as part of an insourcing service model.
Through strategic partnerships, we also offer [removed: a human antibody discovery and development platform,] an artificial intelligence drug design [removed: platform] [added: platform, 3D *in vitro* oncology models, implantable micro device in animal tumor models to investigate pharmacological effects of multiple substances simultaneously] and a human stem cell model platform.
The [removed: transaction combines] [added: acquisition of] Distributed [removed: Bio’s antibody libraries and immuno-engineering platform with] [added: Bio expands] our [removed: extensive drug] [added: capabilities with an innovative, antibody] discovery [added: platform,] and [removed: non-clinical development expertise to create] [added: leveraging their antibody libraries and immune-engineering platform, creates] an integrated, end-to-end platform for therapeutic antibody and cell and gene therapy discovery and development.
*Toxicology.* We offer a broad offering of in vitro and [removed: in vivo] [added: *in vivo*] capabilities and study types designed to identify possible safety risks as well as a broad offering of [removed: in vitro] [added: *in vitro*] and [removed: in vivo] [added: *in vivo*] studies in support of general toxicology (acute, sub-acute and chronic studies), genetic toxicology, safety [removed: pharmacology] [added: pharmacology, reproductive] and [added: 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.
We have expertise in the design and execution of development programs in support of a broad diversity of therapeutic [removed: modalities.][added: modalities in numerous laboratory species and test systems.]
*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 [removed: agriculture chemicals] [added: agricultural chemicals, veterinary medicines,] and medical devices.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
In fiscal 2021, we
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
acquired Distributed Bio, Inc. (Distributed Bio), a next-generation antibody discovery company with technologies specializing in enhancing the probability of success for delivering high-quality, readily formattable antibody fragments to support antibody and cell and gene therapy candidates to biopharmaceutical clients, as well as Retrogenix Limited (Retrogenix), an early-stage contract research organization providing specialized bioanalytical services for antibodies and related therapeutic products utilizing its proprietary cell microarray technology to identify potential interactions with a host of cell surface and secreted proteins.
In 2021 we added CDMO services to our Biologics Solutions business through the acquisitions of Cognate BioServices, Inc. and Vigene Biosciences, Inc. (Vigene).
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Research and GMP-Compliant Cells.
In 2020 we acquired HemaCare Corporation (HemaCare) and Cellero, LLC (Cellero) to establish our Research and GMP-Compliant Cells business.
On December 31, 2020, we acquired Distributed Bio, a next-generation antibody discovery company with technologies specializing in enhancing the probability of success for delivering high-quality, readily formattable antibody fragments to support antibody and cell and gene therapy candidates to biopharmaceutical clients.
In April 2021, we acquired Retrogenix, an early-stage contract research organization providing specialized bioanalytical services utilizing its
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
proprietary cell microarray technology analytical platform, which provides on target and off target safety assessment of antibodies and related modalities.
The acquisition of Retrogenix enhances our scientific expertise with additional large molecule and cell therapy discovery capabilities.
Through strategic technology partnerships, we also offer artificial intelligence-enabled drug design and multiple advanced biology analytics platforms, both *in vivo* and *in vitro*, that address human and disease translatability.
Additionally, we can support safety studies in numerous specialty areas including abuse and seizure liability, ecotoxicology, environmental risk, musculoskeletal toxicology, neurotoxicology, ocular toxicology, phototoxicology and radiation biology.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Manufacturing Solutions
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
environment.
In 2021, we launched the Celsis Adapt™, an accessory instrument for the Celsis® rapid detection systems, which is used to prepare and concentrate samples and provide a rapid testing solution for advanced therapy medicinal products, cell therapies, gene therapies, and other cell-containing products.
In 2021, we launched AccuFUN-ID, a service that identifies fungal isolates through MALDI-TOF technology, which is a critical element for environmental programs in pharmaceutical and other regulated product manufacturing industries.”
Our Biologics Solutions (Biologics) business is comprised of our Biologics Testing Services business and CDMO business.
Biologics provides clients with analytical testing and related capabilities to support the safe manufacture of their biologic drugs, as well as a suite of manufacturing services to produce our clients’ advanced therapeutics.
*Biologics Testing Services*
We have also commissioned a BSL3 facility to provide *in vivo* and *in vitro* testing services for BSL3 materials, such as SARS-CoV2.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
*CDMO Services*
In 2021, we acquired Cognate BioServices, Inc., a cell and gene therapy contract development and manufacturing organization (CDMO) offering comprehensive manufacturing solutions for cell and gene therapies, as well as for the production of plasmid DNA and other inputs in the CDMO value chain, and Vigene, a gene therapy CDMO, providing plasmid DNA and viral vector-based gene delivery solutions.
These acquisitions expanded our Biologics Solutions business, into the high-growth advanced therapy CDMO market and into each of the three major platforms: cell therapy, viral vector, and plasmid DNA production.
Our CDMO services establish us as a premier scientific partner for cell and gene therapy development, testing, and manufacturing; enable us to provide clients with an integrated solution from basic research and discovery through cGMP production; enable us to drive efficiency and accelerate clients’ speed-to-market by integrating manufacturing and the required testing; and enable our clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner.
To connect with our therapeutic design and testing capabilities in Discovery we can also manufacture cell and gene therapies for clinical and commercial use.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
for our clients and where we could provide significant benefits given our unique early-stage development portfolio and global footprint.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
In recent years, we have expanded our Biologics Solutions services into the established high-growth market 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 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 market, 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.
The acquisitions of Cognate and Vigene, combined with our comprehensive portfolio, most notably our Biologics Testing Solutions business, industry experience, and established infrastructure, helped solidify the Company as a premier scientific partner for cell and gene therapy development, testing, and manufacturing.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
clinical portfolio.
In addition, in 2020, we added new services in our Research Products business through the acquisition of HemaCare Corporation (HemaCare) and Cellero, LLC (Cellero).
organizations, and commercial clients.
Research Products.
In August 2020, we acquired Cellero, a provider of cellular products for cell therapy developers and manufacturers worldwide as part of our Research Products business.
The addition of Cellero enhances our unique, comprehensive solutions for the high-growth cell therapy market, strengthening the ability to help accelerate clients’ critical programs from basic research and proof-of-concept to regulatory approval and commercialization.
implementations of their research programs, and to stay with them through the entire drug discovery process.
In December 2020, we acquired Distributed Bio, a next-generation antibody discovery company.
The acquisition expands Charles River’s scientific capabilities with an innovative, large-molecule discovery platform.
evaluation of fluid, tissue and cellular changes that our experts identify and interpret for our clients.
Manufacturing Support
We are a market leader in endotoxin testing products and services, which are used for FDA-required quality control testing of injectable drugs and medical devices, their components, and the processes by which they are manufactured.
Generally, the
We maintain a quarterly award recognizing our
In fiscal 2020, we hired over 3,700 people and our voluntary turnover was below 9%.
We look forward to continuing to make additional progress, including expanding education, allyship, and integrating diversity and inclusion into our client, supplier, and business strategies.
We recognize the importance of generating quality, reliable, sustainable
Where we consider it appropriate, steps are taken to protect our know-how through confidentiality agreements and registrations.
With the exception of technology related to our Microbial Solutions testing business, we have no patents, trademarks, licenses, franchises, or concessions that are material and upon which any of our products or services are dependent.
All of our board committees (except our Executive Committee and Strategic Planning and Capital Allocation Committee) are composed entirely of independent directors.
Prior to joining the Company, Ms. Creamer served in senior management human resource positions at each of ITT and IBM.
Mr.
An excerpt. Shown here: 40 of 118 rewritten, 40 of 73 added and all 21 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2021 filing and the FY2020 filing.
Item 3. Legal Proceedings
1 rewritten, 0 added, 0 removed, 0 unchanged
We are not party to any legal proceedings that [added: we believe] are material to our business or financial condition.
Cover and table of contents
24 rewritten, 10 added, 12 removed, 57 unchanged
FOR THE FISCAL YEAR ENDED December [removed: 26, 2020][added: 25, 2021]
[removed: ][added: ]
[removed: |] Large accelerated filer [removed: | | |] ☑ [removed: | | |] Accelerated filer [removed: | | |] ☐ [removed: | | |][added: Non-accelerated filer ☐]
[removed: | | | | | | |] [added: Smaller reporting company ☐] Emerging growth company [removed: | | |] ☐ [removed: | | |]
On June [removed: 27, 2020,] [added: 26, 2021,] the aggregate market value of the registrant’s voting common stock held by non-affiliates of the registrant was approximately [removed: $8,333,378,287.][added: $18,338,961,840.]
As of January [removed: 22, 2021,] [added: 21, 2022,] there were [removed: 49,776,227] [added: 50,486,047] 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: 2021] [added: 2022] Annual Meeting of Shareholders scheduled to be held on May [removed: 6, 2021,] [added: 10, 2022,] which will be filed with the Securities and Exchange Commission (SEC) not later than 120 days after December [removed: 26, 2020,] [added: 25, 2021,] are incorporated by reference into Part III of this Annual Report on Form 10-K.
With the exception of the portions of the [removed: 2021] [added: 2022] 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: 2020][added: 2021]
| 1A | | | [Risk [removed: Factors](#i9272c3bc8e81459da82f0056b2a89930_16)] [added: Factors](#i3b4c4eb652194ed5994dc94bc56e5bfe_16)] | | | [removed: [16](#i9272c3bc8e81459da82f0056b2a89930_16)] [added: [16](#i3b4c4eb652194ed5994dc94bc56e5bfe_16)] | | |
| 1B | | | [Unresolved Staff [removed: Comments](#i9272c3bc8e81459da82f0056b2a89930_19)] [added: Comments](#i3b4c4eb652194ed5994dc94bc56e5bfe_19)] | | | [removed: [30](#i9272c3bc8e81459da82f0056b2a89930_19)] [added: [34](#i3b4c4eb652194ed5994dc94bc56e5bfe_19)] | | |
| 3 | | | [Legal [removed: Proceedings](#i9272c3bc8e81459da82f0056b2a89930_25)] [added: Proceedings](#i3b4c4eb652194ed5994dc94bc56e5bfe_25)] | | | [removed: [31](#i9272c3bc8e81459da82f0056b2a89930_25)] [added: [35](#i3b4c4eb652194ed5994dc94bc56e5bfe_25)] | | |
| 4 | | | [removed: Mine] [added: [Mine] Safety [removed: Disclosures] [added: Disclosures](#i3b4c4eb652194ed5994dc94bc56e5bfe_28)] | | | [removed: [31](#i9272c3bc8e81459da82f0056b2a89930_28)] [added: [35](#i3b4c4eb652194ed5994dc94bc56e5bfe_28)] | | |
| 5 | | | [removed: Market] [added: [Market] for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities] [added: Securities](#i3b4c4eb652194ed5994dc94bc56e5bfe_34)] | | | [removed: [31](#i9272c3bc8e81459da82f0056b2a89930_34)] [added: [36](#i3b4c4eb652194ed5994dc94bc56e5bfe_34)] | | |
| 7 | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i9272c3bc8e81459da82f0056b2a89930_46)] [added: Operations](#i3b4c4eb652194ed5994dc94bc56e5bfe_46)] | | | [removed: [34](#i9272c3bc8e81459da82f0056b2a89930_40)] [added: [38](#i3b4c4eb652194ed5994dc94bc56e5bfe_40)] | | |
| 7A | | | [Quantitative and Qualitative [removed: Disclosures](#i9272c3bc8e81459da82f0056b2a89930_55)] [added: Disclosures](#i3b4c4eb652194ed5994dc94bc56e5bfe_55)] about Market Risk | | | [removed: [54](#i9272c3bc8e81459da82f0056b2a89930_55)] [added: [54](#i3b4c4eb652194ed5994dc94bc56e5bfe_55)] | | |
| 8 | | | [Financial Statements and Supplementary [removed: Data](#i9272c3bc8e81459da82f0056b2a89930_58)] [added: Data](#i3b4c4eb652194ed5994dc94bc56e5bfe_58)] | | | [removed: [56](#i9272c3bc8e81459da82f0056b2a89930_58)] [added: [55](#i3b4c4eb652194ed5994dc94bc56e5bfe_58)] | | |
| 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i9272c3bc8e81459da82f0056b2a89930_166)] [added: Disclosure](#i3b4c4eb652194ed5994dc94bc56e5bfe_145)] | | | [removed: [110](#i9272c3bc8e81459da82f0056b2a89930_166)] [added: [108](#i3b4c4eb652194ed5994dc94bc56e5bfe_145)] | | |
| 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#i9272c3bc8e81459da82f0056b2a89930_178)] [added: Governance](#i3b4c4eb652194ed5994dc94bc56e5bfe_157)] | | | [removed: [112](#i9272c3bc8e81459da82f0056b2a89930_178)] [added: [111](#i3b4c4eb652194ed5994dc94bc56e5bfe_157)] | | |
| 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related [removed: Stockholder](#i9272c3bc8e81459da82f0056b2a89930_184)] [added: Stockholder](#i3b4c4eb652194ed5994dc94bc56e5bfe_163)] Matters | | | [removed: [112](#i9272c3bc8e81459da82f0056b2a89930_184)] [added: [111](#i3b4c4eb652194ed5994dc94bc56e5bfe_163)] | | |
| 13 | | | [removed: [Certain] [added: Certain] Relationships and Related Transactions, and Director [removed: Independence](#i9272c3bc8e81459da82f0056b2a89930_187)] [added: Independence] | | | [removed: [112](#i9272c3bc8e81459da82f0056b2a89930_187)] [added: [111](#i3b4c4eb652194ed5994dc94bc56e5bfe_166)] | | |
| 14 | | | [Principal Accountant Fees and [removed: Services](#i9272c3bc8e81459da82f0056b2a89930_190)] [added: Services](#i3b4c4eb652194ed5994dc94bc56e5bfe_169)] | | | [removed: [112](#i9272c3bc8e81459da82f0056b2a89930_190)] [added: [111](#i3b4c4eb652194ed5994dc94bc56e5bfe_169)] | | |
| 15 | | | [Exhibits and Financial Statement [removed: Schedules](#i9272c3bc8e81459da82f0056b2a89930_196)] [added: Schedules](#i3b4c4eb652194ed5994dc94bc56e5bfe_175)] | | | [removed: [113](#i9272c3bc8e81459da82f0056b2a89930_196)] [added: [112](#i3b4c4eb652194ed5994dc94bc56e5bfe_175)] | | |
| 16 | | | [removed: Form] [added: [Form] 10-K [removed: Summary] [added: Summary](#i3b4c4eb652194ed5994dc94bc56e5bfe_178)] | | | [removed: [113](#i9272c3bc8e81459da82f0056b2a89930_199)] [added: [113](#i3b4c4eb652194ed5994dc94bc56e5bfe_178)] | | |
| 1 | | | [Business](#i3b4c4eb652194ed5994dc94bc56e5bfe_13) | | | [1](#i3b4c4eb652194ed5994dc94bc56e5bfe_13) | | |
| 2 | | | [Properties](#i3b4c4eb652194ed5994dc94bc56e5bfe_22) | | | [34](#i3b4c4eb652194ed5994dc94bc56e5bfe_22) | | |
| 6 | | | [Reserved](#i3b4c4eb652194ed5994dc94bc56e5bfe_37) | | | [37](#i3b4c4eb652194ed5994dc94bc56e5bfe_37) | | |
| 9A | | | [Controls and Procedures](#i3b4c4eb652194ed5994dc94bc56e5bfe_148) | | | [109](#i3b4c4eb652194ed5994dc94bc56e5bfe_148) | | |
| 9B | | | [Other Information](#i3b4c4eb652194ed5994dc94bc56e5bfe_151) | | | [110](#i3b4c4eb652194ed5994dc94bc56e5bfe_151) | | |
| 9C | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#i3b4c4eb652194ed5994dc94bc56e5bfe_2017) | | | [110](#i3b4c4eb652194ed5994dc94bc56e5bfe_2017) | | |
| 11 | | | [Executive Compensation](#i3b4c4eb652194ed5994dc94bc56e5bfe_160) | | | [111](#i3b4c4eb652194ed5994dc94bc56e5bfe_160) | | |
| | | | | | | | | |
| [Signatures](#i3b4c4eb652194ed5994dc94bc56e5bfe_181) | | | | | | [114](#i3b4c4eb652194ed5994dc94bc56e5bfe_181) | | |
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
| (Mark One) | | | | | | | | |
| | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Non-accelerated filer | | | ☐ | | | Smaller reporting company | | | ☐ | | |
| 1 | | | [Business](#i9272c3bc8e81459da82f0056b2a89930_13) | | | [1](#i9272c3bc8e81459da82f0056b2a89930_13) | | |
| 2 | | | [Properties](#i9272c3bc8e81459da82f0056b2a89930_22) | | | [30](#i9272c3bc8e81459da82f0056b2a89930_22) | | |
| 6 | | | [Selected Consolidated Financial Data](#i9272c3bc8e81459da82f0056b2a89930_37) | | | [33](#i9272c3bc8e81459da82f0056b2a89930_37) | | |
| 9A | | | [Controls and Procedures](#i9272c3bc8e81459da82f0056b2a89930_169) | | | [110](#i9272c3bc8e81459da82f0056b2a89930_169) | | |
| 9B | | | [Other Information](#i9272c3bc8e81459da82f0056b2a89930_172) | | | [111](#i9272c3bc8e81459da82f0056b2a89930_172) | | |
| 11 | | | [Executive Compensation](#i9272c3bc8e81459da82f0056b2a89930_181) | | | [112](#i9272c3bc8e81459da82f0056b2a89930_181) | | |
| Signatures | | | | | | [114](#i9272c3bc8e81459da82f0056b2a89930_202) | | |
| Exhibit Index | | | | | | [116](#i9272c3bc8e81459da82f0056b2a89930_205) | | |
Item 2. Properties
3 rewritten, 2 added, 1 removed, 10 unchanged
We own large facilities (facilities over 50,000 square feet) for our DSA businesses in Canada, China, France, Hungary, Netherlands, Scotland and the U.S. and lease large facilities in England and the U.S. We own large RMS facilities in Canada, France, Germany, Italy, [removed: Japan,] England and the U.S. We lease [added: large RMS facilities in China.]
We lease large Manufacturing facilities in [added: England,] France and the U.S. None of our leases is individually material to our business operations.
[removed: In certain circumstances, we dispose of or consolidate] operations, which could result in impairment charges.
In certain circumstances, we dispose of or consolidate
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
large RMS facilities in China.
Item 4. Mine Safety Disclosures
0 rewritten, 1 added, 0 removed, 2 unchanged
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
12 rewritten, 4 added, 3 removed, 19 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: 2020.][added: 2021.]
As of January [removed: 22, 2021,] [added: 21, 2022,] there were [removed: 84] [added: 78] 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: 2020:][added: 2021:]
| September [removed: 27, 2020] [added: 26, 2021] to October [removed: 24, 2020] [added: 23, 2021] | | | [removed: 177] [added: 96] | | | | | | $ | [removed: 230.68] [added: 412.67] | | | | | — | | | | | | $ | 129,105 | |
| October [removed: 25, 2020] [added: 24, 2021] to November [removed: 21, 2020] [added: 20, 2021] | | | [removed: 47] [added: 101] | | | | | | [removed: 227.70] [added: 444.18] | | | | | | — | | | | | | 129,105 | | |
| November [removed: 22, 2020] [added: 21, 2021] to December [removed: 26, 2020] [added: 25, 2021] | | | [removed: 98] [added: 500] | | | | | | [removed: 235.06] [added: 365.87] | | | | | | — | | | | | | 129,105 | | |
During the fourth quarter of fiscal year [removed: 2020,] [added: 2021,] we did not repurchase any shares of common stock under our stock repurchase program or in open market trading.
As of December [removed: 26, 2020,] [added: 25, 2021,] we had $129.1 million remaining on the 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: 26, 2015] [added: 31, 2016] and ending on December [removed: 26, 2020] [added: 25, 2021] (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.
[removed: ][added: ]
| | | | [removed: 2015] [added: 2016] | | | | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | |
[removed: | Charles River Laboratories International, Inc. | | | $ | 100 | | | | | $ | 95 | | | | | $ | 137 | | | | | $ | 140 | | | | | $ | 190 | | | | | $ | 314 | |][added: CHARLES RIVER LABORATORIES INTERNATIONAL, INC.]
| Total | | | 697 | | | | | | | | | | | | — | | | | | | | | |
| Charles River Laboratories International, Inc. | | | $ | 100 | | | | | $ | 144 | | | | | $ | 147 | | | | | $ | 199 | | | | | $ | 330 | | | | | $ | 485 | |
| S&P 500 | | | 100 | | | | | | 122 | | | | | | 116 | | | | | | 153 | | | | | | 181 | | | | | | 233 | | |
| S&P 500 Health Care | | | 100 | | | | | | 122 | | | | | | 130 | | | | | | 157 | | | | | | 178 | | | | | | 225 | | |
| Total | | | 322 | | | | | | | | | | | | — | | | | | | | | |
| S&P 500 | | | 100 | | | | | | 112 | | | | | | 136 | | | | | | 130 | | | | | | 171 | | | | | | 203 | | |
| S&P 500 Health Care | | | 100 | | | | | | 97 | | | | | | 119 | | | | | | 126 | | | | | | 153 | | | | | | 173 | | |
Item 6. Reserved
0 rewritten, 2 added, 30 removed, 0 unchanged
Not applicable.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
The selected financial data presented below for the fiscal years ended 2020, 2019, and 2018 and as of the fiscal years ended 2020 and 2019, is derived from our audited consolidated financial statements and should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Item 7 and “Financial Statements and Supplementary Data” contained in Item 8 of this Annual Report on Form 10-K.
The selected financial data presented below for the fiscal years ended 2017 and 2016 and as of the fiscal years ended 2018, 2017 and 2016, is derived from our audited consolidated financial statements within previously filed Annual Reports on Form 10-K.
Our fiscal year is typically based on 52-weeks, with each quarter composed of 13 weeks ending on the last Saturday on, or closest to, March 31, June 30, September 30, and December 31.
A 53rd week was included in the fourth quarter of fiscal year 2016, which is occasionally necessary to align with a December 31 calendar year-end.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Fiscal Year | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |
| | | | (in thousands, except per share amounts) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Statement of Income Data | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total revenue | | | $ | 2,923,933 | | | | | $ | 2,621,226 | | | | | $ | 2,266,096 | | | | | $ | 1,857,601 | | | | | $ | 1,681,432 | |
| Income from continuing operations, net of income taxes | | | 365,306 | | | | | | 254,061 | | | | | | 227,218 | | | | | | 125,586 | | | | | | 156,086 | | |
| Income (loss) from discontinued operations, net of income taxes | | | — | | | | | | — | | | | | | 1,506 | | | | | | (137) | | | | | | 280 | | |
| Common Share Data | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Earnings per common share from continuing operations attributable to common shareholders: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Basic | | | $ | 7.35 | | | | | $ | 5.17 | | | | | $ | 4.69 | | | | | $ | 2.60 | | | | | $ | 3.28 | |
| Diluted | | | $ | 7.20 | | | | | $ | 5.07 | | | | | $ | 4.59 | | | | | $ | 2.54 | | | | | $ | 3.22 | |
| Other Data | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Depreciation and amortization | | | $ | 234,924 | | | | | $ | 198,095 | | | | | $ | 161,779 | | | | | $ | 131,159 | | | | | $ | 126,658 | |
| Capital expenditures | | | 166,560 | | | | | | 140,514 | | | | | | 140,054 | | | | | | 82,431 | | | | | | 55,288 | | |
| Balance Sheet Data (as of period end) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cash and cash equivalents | | | $ | 228,424 | | | | | $ | 238,014 | | | | | $ | 195,442 | | | | | $ | 163,794 | | | | | $ | 117,626 | |
| Total assets | | | 5,490,831 | | | | | | 4,692,790 | | | | | | 3,855,879 | | | | | | 2,929,922 | | | | | | 2,711,800 | | |
| Long-term debt, net and finance leases | | | 1,929,571 | | | | | | 1,849,666 | | | | | | 1,636,598 | | | | | | 1,114,105 | | | | | | 1,207,696 | | |
| Redeemable noncontrolling interests | | | 25,499 | | | | | | 28,647 | | | | | | 18,525 | | | | | | 16,609 | | | | | | 14,659 | | |
Refer to the following included in Item 8, “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K as well as within previously filed Annual Reports on Form 10-K for additional information:
- Note 2, “Business Combinations” concerning the impact of our recent acquisitions, including revenue, operating income, assets acquired and liabilities assumed, and related acquisition and integration costs;
- Note 9, “Long-Term Debt and Finance Lease Obligations” concerning the impact of debt related activities in connection with our recent acquisitions;
- Note 11, “Income Taxes” concerning the impact of U.S. Tax Reform in fiscal year ended 2017; and
- Note 1, “Description of Business and Summary of Significant Accounting Policies” and Note 16, “Leases” concerning the impact of adopting Accounting Standards Codification 842, “Leases” beginning in fiscal year 2019.
Item 8. Financial Statements and Supplementary Data
683 rewritten, 388 added, 224 removed, 1,118 unchanged
| [Report of Independent Registered Public Accounting [removed: Firm](#i9272c3bc8e81459da82f0056b2a89930_61)] [added: Firm](#i3b4c4eb652194ed5994dc94bc56e5bfe_61) (PCAOB ID 238)] | | | [removed: [57](#i9272c3bc8e81459da82f0056b2a89930_61)] [added: [56](#i3b4c4eb652194ed5994dc94bc56e5bfe_61)] | | |
| [removed: Consolidated] [added: [Consolidated] Statements of Income for fiscal [removed: years 2020,] [added: years](#i3b4c4eb652194ed5994dc94bc56e5bfe_64) 2021, 2020 [and](#i3b4c4eb652194ed5994dc94bc56e5bfe_64)] 2019 [removed: and 2018] | | | [removed: [60](#i9272c3bc8e81459da82f0056b2a89930_64)] [added: [59](#i3b4c4eb652194ed5994dc94bc56e5bfe_64)] | | |
| [removed: Consolidated] [added: [Consolidated] Statements of Comprehensive Income for fiscal [removed: years 2020,] [added: years](#i3b4c4eb652194ed5994dc94bc56e5bfe_67) [](#i3b4c4eb652194ed5994dc94bc56e5bfe_64)2021, 2020 [and](#i3b4c4eb652194ed5994dc94bc56e5bfe_67)] 2019 [removed: and 2018] | | | [removed: [61](#i9272c3bc8e81459da82f0056b2a89930_67)] [added: [60](#i3b4c4eb652194ed5994dc94bc56e5bfe_67)] | | |
| [removed: Consolidated] [added: [Consolidated] Balance [removed: Sheets] [added: Sheets](#i3b4c4eb652194ed5994dc94bc56e5bfe_70)] as of December [added: 25, 2021 [and](#i3b4c4eb652194ed5994dc94bc56e5bfe_70) December] 26, 2020 [removed: and December 28, 2019] | | | [removed: [62](#i9272c3bc8e81459da82f0056b2a89930_70)] [added: [61](#i3b4c4eb652194ed5994dc94bc56e5bfe_70)] | | |
| [removed: Consolidated] [added: [Consolidated] Statements of Cash Flows for fiscal [removed: years 2020, 2019] [added: years](#i3b4c4eb652194ed5994dc94bc56e5bfe_73) [](#i3b4c4eb652194ed5994dc94bc56e5bfe_64)2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [63](#i9272c3bc8e81459da82f0056b2a89930_76)] [added: [62](#i3b4c4eb652194ed5994dc94bc56e5bfe_73)] | | |
| [removed: Consolidated] [added: [Consolidated] Statements of Changes in Equity for fiscal [removed: years 2020, 2019] [added: years](#i3b4c4eb652194ed5994dc94bc56e5bfe_76) [](#i3b4c4eb652194ed5994dc94bc56e5bfe_64)2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [65](#i9272c3bc8e81459da82f0056b2a89930_79)] [added: [64](#i3b4c4eb652194ed5994dc94bc56e5bfe_76)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i9272c3bc8e81459da82f0056b2a89930_82)] [added: Statements](#i3b4c4eb652194ed5994dc94bc56e5bfe_79)] | | | [removed: [66](#i9272c3bc8e81459da82f0056b2a89930_82)] [added: [65](#i3b4c4eb652194ed5994dc94bc56e5bfe_79)] | | |
To the Board of Directors and Shareholders of Charles River Laboratories International, [removed: Inc.:][added: Inc.]
We have audited the accompanying consolidated balance sheets of Charles River Laboratories International, Inc. and its subsidiaries (the “Company”) as of December [removed: 26, 2020] [added: 25, 2021] and December [removed: 28, 2019,] [added: 26, 2020,] and the related consolidated statements of income, of comprehensive income, of changes in equity and of cash flows for each of the three years in the period ended December [removed: 26, 2020,] [added: 25, 2021,] including the related notes (collectively referred to as the “consolidated financial statements”).
We also have audited the Company's internal control over financial reporting as of December [removed: 26, 2020,] [added: 25, 2021,] 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: 26, 2020] [added: 25, 2021] and December [removed: 28, 2019,] [added: 26, 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December [removed: 26, 2020] [added: 25, 2021] 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: 26, 2020,] [added: 25, 2021,] based on criteria established in [removed: Internal] [added: *Internal] Control - Integrated [removed: Framework] [added: Framework*] (2013) issued by the COSO.
As described in Management’s Report on Internal Control Over Financial Reporting, management has excluded [removed: HemaCare] [added: Cognate BioServices, Inc. (Cognate)] and [removed: Cellero] [added: Vigene Biosciences, Inc. (Vigene)] from its assessment of internal control over financial reporting as of December [removed: 26, 2020] [added: 25, 2021] because they were acquired by the Company in purchase business combinations during [removed: 2020.][added: 2021.]
We have also excluded [removed: HemaCare] [added: Cognate] and [removed: Cellero] [added: Vigene] from our audit of internal control over financial reporting.
[removed: HemaCare] [added: Cognate] and [removed: Cellero] [added: Vigene] are wholly-owned subsidiaries whose total assets and total revenues excluded from management’s assessment and our audit of internal control over financial reporting collectively represent [removed: 1.0%] [added: 2.5%] and [removed: 1.6%,] [added: 3.1%,] respectively, of the related consolidated financial statement amounts as of and for the year ended December [removed: 26, 2020.][added: 25, 2021.]
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 [removed: company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.]
As described in Notes 1 and 2 to the consolidated financial statements, the Company completed the [removed: acquisition] [added: acquisitions] of [removed: HemaCare Corporation on January 3, 2020.][added: Cognate BioServices, Inc. (Cognate) and Vigene Biosciences, Inc. (Vigene) in 2021.]
The preliminary purchase price allocation [added: for Cognate and Vigene] included [removed: a] customer relationship intangible [removed: asset] [added: assets] (also referred to as client relationships) of [removed: $170.4 million.][added: $257.2 million and $87.5 million, respectively.]
[removed: As disclosed by management, the determination of the fair value of the intangible asset, which represents a significant portion of the purchase price, requires the use of significant judgment by management with regard to] [added: Significant judgments include] (i) the fair value; and (ii) the period and the method by which the intangible [removed: asset] [added: assets] will be amortized.
To determine the fair value of the acquired client relationships, management utilized the multiple period excess earnings model (a commonly accepted valuation technique), which [removed: includes] [added: relies on] the following key assumptions: projections of cash flows from the acquired [removed: entity,] [added: entities,] which [removed: include] [added: includes] future revenue growth rates, operating income margins, and [removed: the] customer attrition [removed: rate,] [added: rates,] as well as the discount [removed: rate] [added: rates] based on an analysis of the acquired [removed: entity’s] [added: entities’] weighted average cost of capital.
The principal considerations for our determination that performing procedures relating to the acquisition of [removed: HemaCare Corporation] [added: Cognate and Vigene] - valuation of acquired customer relationship intangible [removed: asset] [added: assets] is a critical audit matter are (i) the high degree of auditor judgment and subjectivity in [removed: applying] [added: performing] procedures relating to the fair value [removed: measurement] of the customer relationship intangible [removed: asset] [added: assets] acquired due to the significant amount of judgment [removed: and estimation] by management when developing the estimate, (ii) [added: the] significant audit effort [removed: was required] in evaluating the [removed: key] [added: significant] assumptions [removed: relating] [added: related] to the [removed: estimate, such as the] future revenue growth rates, operating income margins, customer attrition [added: rates, and discount rates related to the Cognate customer relationship intangible assets and the future revenue growth] rate, [added: operating income margin,] and discount rate [added: related to the Vigene customer relationship intangible asset] and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
These procedures included testing the effectiveness of controls relating to the [added: acquisition accounting, including controls over management’s] valuation of acquired customer relationship intangible [removed: asset, including controls over the review] [added: assets and development] of [removed: the valuation methodology, the] key assumptions [removed: underlying] [added: related to future revenue growth rates, operating income margins, customer attrition rates, and discount rates related to] the [removed: valuation,] [added: Cognate customer relationship intangible assets] and the [removed: useful lives of] [added: future revenue growth rate, operating income margin, and discount rate related to] the [removed: acquired] [added: Vigene] customer relationship intangible asset.
These procedures also included, among others, (i) reading the purchase agreement and (ii) testing management’s process for estimating the fair value of customer relationship intangible [removed: asset.][added: assets.]
Testing management’s process included evaluating the appropriateness of the valuation model, testing the completeness and accuracy of data provided by management, and evaluating reasonableness of significant assumptions related to the estimated future revenue growth rates, operating income margins, customer attrition [added: rates, and discount rates related to Cognate and estimated future revenue growth] rate, [added: operating income margin,] and discount [removed: rate.][added: rate related to Vigene.]
Evaluating the reasonableness of the estimated future revenue growth rates, operating income margins, customer attrition [removed: rate,] [added: rates,] and discount [removed: rate] [added: rates] assumptions involved considering their consistency with data from external sources, past performance of the acquired [removed: business,] [added: businesses,] and evidence obtained in other areas of the audit.
Professionals with specialized skill and knowledge were used to assist in the evaluation of the Company’s valuation model and [removed: management] [added: management’s] significant assumptions related to customer attrition and [removed: the] discount [removed: rate.][added: rates.]
As described in Notes 1 and 3 to the consolidated financial statements, the Company recognized revenue of [removed: $1,837.4] [added: $2,107.2] million in its Discovery and Safety Assessment (DSA) segment in [removed: 2020,] [added: 2021,] of which [removed: $1,836.5] [added: $2,103.4] million was recognized over time as services are delivered to the customer based on the extent of progress towards completion of the performance obligation using either the cost-to-cost (input method) or right to invoice (output method) measures of progress.
Management uses the cost-to-cost measure of progress when it best depicts the transfer of value to the customer, which occurs [removed: as the Company incurs costs on its contract, generally related to fixed fee service contracts.]
The principal considerations for our determination that performing procedures relating to DSA revenue recognized over time is a critical audit matter are the high degree of auditor [removed: judgment,] subjectivity and effort in performing procedures and in evaluating [removed: the] audit evidence [removed: obtained] related to the extent of progress towards completion, actual costs incurred, and management’s assumptions used in determining the total estimated costs at completion related to labor hours, allocation of overhead costs, research model costs, and subcontractor costs.
These procedures also included, among others, (i) reading agreements and reports describing the results of services provided for a sample of service contracts, (ii) evaluating and testing management’s process for determining the amount of revenue recognized for a sample of service contracts, which included evaluating the reasonableness of the estimates of costs and management’s assumptions related to labor hours, allocation of overhead costs, research model costs, and subcontractor costs through a comparison of actual current year project costs to historical management cost estimates for completed service contracts, and (iii) testing actual costs incurred for a sample of in-process service contracts by examining evidence of costs [removed: incurred, including invoices, time cards, human resources documents, and the completeness and accuracy of overhead allocations.][added: incurred.]
| | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |
| Service revenue | | | $ | [removed: 2,296,156] [added: 2,755,579] | | | | | $ | [removed: 2,029,371] [added: 2,296,156] | | | | | $ | [removed: 1,687,941] [added: 2,029,371] | |
| Product revenue | | | [removed: 627,777] [added: 784,581] | | | | | | [removed: 591,855] [added: 627,777] | | | | | | [removed: 578,155] [added: 591,855] | | |
| Total revenue | | | [removed: 2,923,933] [added: 3,540,160] | | | | | | [removed: 2,621,226] [added: 2,923,933] | | | | | | [removed: 2,266,096] [added: 2,621,226] | | |
| Cost of services provided (excluding amortization of intangible assets) | | | [removed: 1,533,230] [added: 1,837,487] | | | | | | [removed: 1,371,699] [added: 1,533,230] | | | | | | [removed: 1,150,371] [added: 1,371,699] | | |
| Cost of products sold (excluding amortization of intangible assets) | | | [removed: 317,162] [added: 368,035] | | | | | | [removed: 291,216] [added: 317,162] | | | | | | [removed: 275,658] [added: 291,216] | | |
| Selling, general and administrative | | | [removed: 528,935] [added: 619,919] | | | | | | [removed: 517,622] [added: 528,935] | | | | | | [removed: 443,854] [added: 517,622] | | |
| Amortization of intangible assets | | | [removed: 111,877] [added: 124,857] | | | | | | [removed: 89,538] [added: 111,877] | | | | | | [removed: 64,830] [added: 89,538] | | |
| Operating income | | | [removed: 432,729] [added: 589,862] | | | | | | [removed: 351,151] [added: 432,729] | | | | | | [removed: 331,383] [added: 351,151] | | |
| Interest income | | | [removed: 834] [added: 652] | | | | | | [removed: 1,522] [added: 834] | | | | | | [removed: 812] [added: 1,522] | | |
| [Note 1. Description of Business and Summary of Significant Accounting](#i3b4c4eb652194ed5994dc94bc56e5bfe_82) | | | [65](#i3b4c4eb652194ed5994dc94bc56e5bfe_82) | | |
| [Note 2. Acquisitions and Divestitures](#i3b4c4eb652194ed5994dc94bc56e5bfe_85) | | | [73](#i3b4c4eb652194ed5994dc94bc56e5bfe_85) | | |
| [Note 3. Revenue from Contracts with Customers](#i3b4c4eb652194ed5994dc94bc56e5bfe_88) | | | [82](#i3b4c4eb652194ed5994dc94bc56e5bfe_88) | | |
| [Note 4. Segment and Geographic Information](#i3b4c4eb652194ed5994dc94bc56e5bfe_94) | | | [84](#i3b4c4eb652194ed5994dc94bc56e5bfe_94) | | |
| [Note 5. Supplemental Balance Sheet Information](#i3b4c4eb652194ed5994dc94bc56e5bfe_97) | | | [86](#i3b4c4eb652194ed5994dc94bc56e5bfe_97) | | |
| [Note 6. Venture Capital Investments and Marketable Securities](#i3b4c4eb652194ed5994dc94bc56e5bfe_100) | | | [88](#i3b4c4eb652194ed5994dc94bc56e5bfe_100) | | |
| [Note 7. Fair Value](#i3b4c4eb652194ed5994dc94bc56e5bfe_103) | | | [89](#i3b4c4eb652194ed5994dc94bc56e5bfe_103) | | |
| [Note 8. Goodwill and Intangible Assets](#i3b4c4eb652194ed5994dc94bc56e5bfe_106) | | | [90](#i3b4c4eb652194ed5994dc94bc56e5bfe_106) | | |
| [Note 9. Long-Term Debt and Finance Lease Obligations](#i3b4c4eb652194ed5994dc94bc56e5bfe_109) | | | [91](#i3b4c4eb652194ed5994dc94bc56e5bfe_109) | | |
| [Note 10. Equity and Noncontrolling Interest](#i3b4c4eb652194ed5994dc94bc56e5bfe_112) | | | [93](#i3b4c4eb652194ed5994dc94bc56e5bfe_112) | | |
| [Note 11. Income Taxes](#i3b4c4eb652194ed5994dc94bc56e5bfe_115) | | | [95](#i3b4c4eb652194ed5994dc94bc56e5bfe_115) | | |
| [Note 12. Employee Benefit Plans](#i3b4c4eb652194ed5994dc94bc56e5bfe_118) | | | [97](#i3b4c4eb652194ed5994dc94bc56e5bfe_118) | | |
| [Note 13. Stock-based Compensation](#i3b4c4eb652194ed5994dc94bc56e5bfe_121) | | | [102](#i3b4c4eb652194ed5994dc94bc56e5bfe_121) | | |
| [Note 14. Foreign Currency Contracts](#i3b4c4eb652194ed5994dc94bc56e5bfe_124) | | | [104](#i3b4c4eb652194ed5994dc94bc56e5bfe_124) | | |
| [Note 15. Restructuring and Asset Impairments](#i3b4c4eb652194ed5994dc94bc56e5bfe_127) | | | [105](#i3b4c4eb652194ed5994dc94bc56e5bfe_127) | | |
| [Note 16. Leases](#i3b4c4eb652194ed5994dc94bc56e5bfe_130) | | | [106](#i3b4c4eb652194ed5994dc94bc56e5bfe_130) | | |
| [Note 17. Commitments and Contingencies](#i3b4c4eb652194ed5994dc94bc56e5bfe_136) | | | [108](#i3b4c4eb652194ed5994dc94bc56e5bfe_136) | | |
company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
*Acquisitions of Cognate BioServices, Inc. and Vigene Biosciences, Inc. – Valuation of Customer Relationship Intangible Assets*
The determination of the fair value of the intangible assets requires the use of significant judgment using management’s best estimates of inputs and assumptions that a market participant would use.
as the Company incurs costs on its contract, generally related to fixed fee service contracts.
February 16, 2022
| Basic | | | $ | 7.77 | | | | | $ | 7.35 | | | | | $ | 5.17 | |
| Diluted | | | $ | 7.60 | | | | | $ | 7.20 | | | | | $ | 5.07 | |
| Goodwill | | | 2,711,881 | | | | | | 1,809,168 | | |
| Loss on debt extinguishment and other financing costs | | | 29,964 | | | | | | 3,661 | | | | | | 4,943 | | |
| Gain on sale of businesses | | | (25,026) | | | | | | — | | | | | | — | | |
| Contingent consideration | | | (34,303) | | | | | | (468) | | | | | | — | | |
| Other, net | | | 4,957 | | | | | | 14,080 | | | | | | 2,988 | | |
| Proceeds from sale of businesses, net | | | 122,694 | | | | | | — | | | | | | — | | |
| Cash, cash equivalents, and restricted cash, end of period | | | $ | 246,314 | | | | | $ | 233,119 | | | | | $ | 240,046 | |
| Purchases of Property, plant and equipment included in Accounts payable and Accrued liabilities | | | $ | 72,043 | | | | | $ | 25,614 | | | | | $ | 21,447 | |
| Net income | | | — | | | | | | — | | | | | | — | | | | | | 390,982 | | | | | | — | | | | | | — | | | | | | — | | | | | | 390,982 | | | | | | 2,480 | | | | | | 393,462 | | |
| Retirement of treasury shares | | | (148) | | | | | | (1) | | | | | | (5,061) | | | | | | (35,645) | | | | | | — | | | | | | (148) | | | | | | 40,707 | | | | | | — | | | | | | — | | | | | | — | | |
| December 25, 2021 | | | 50,480 | | | | | | $ | 505 | | | | | $ | 1,718,304 | | | | | $ | 980,751 | | | | | $ | (164,740) | | | | | — | | | | | | $ | — | | | | | $ | 2,534,820 | | | | | $ | 4,162 | | | | | $ | 2,538,982 | |
| Buildings and building improvements | | | 10 - 40 | | |
Gains and losses from life insurance contracts are recorded in Other (expense) income, net in the accompanying consolidated statements of income.
Total contract consideration is allocated to the
In October 2021, the Financial Accounting Standards Board (FASB) issued ASU 2021-08, “Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”.
ASU 2021-08 improves the accounting for acquired revenue contracts with customers in a business combination by addressing the diversity in practice and inconsistency related to the recognition of an acquired contract liability and payment terms and their effect on subsequent revenue recognized by the acquirer.
*Change in Accounting Principle*
As discussed in Note 1 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2019.
*Acquisition of HemaCare Corporation - Valuation of Acquired Customer Relationship Intangible Asset*
February 17, 2021
| | | | | | | | | | | | | | | | | | |
| Income from discontinued operations, net of income taxes | | | — | | | | | | — | | | | | | 1,506 | | |
| Basic: | | | | | | | | | | | | | | | | | |
| Continuing operations attributable to common shareholders | | | $ | 7.35 | | | | | $ | 5.17 | | | | | $ | 4.69 | |
| Discontinued operations | | | $ | — | | | | | $ | — | | | | | $ | 0.03 | |
| Diluted: | | | | | | | | | | | | | | | | | |
| Continuing operations attributable to common shareholders | | | $ | 7.20 | | | | | $ | 5.07 | | | | | $ | 4.59 | |
| Less: Income from discontinued operations, net of income taxes | | | — | | | | | | — | | | | | | 1,506 | | |
| Other, net | | | 17,273 | | | | | | 7,931 | | | | | | 15,613 | | |
| Discontinued operations | | | | | | | | | | | | | | | | | |
| Net cash used in operating activities from discontinued operations | | | — | | | | | | — | | | | | | (3,735) | | |
| December 30, 2017 | | | 87,495 | | | | | | $ | 875 | | | | | $ | 2,560,192 | | | | | $ | 288,658 | | | | | $ | (144,731) | | | | | 40,093 | | | | | | $ | (1,659,914) | | | | | $ | 1,045,080 | | | | | $ | 2,327 | | | | | $ | 1,047,407 | |
| Net income | | | — | | | | | | — | | | | | | — | | | | | | 226,373 | | | | | | — | | | | | | — | | | | | | — | | | | | | 226,373 | | | | | | 1,550 | | | | | | 227,923 | | |
| Reclassification due to adoption of ASU 2018-02 | | | — | | | | | | — | | | | | | — | | | | | | 3,330 | | | | | | (3,330) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
| Adjustment due to adoption of ASU 2016-01 | | | — | | | | | | — | | | | | | — | | | | | | 1,424 | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,424 | | | | | | — | | | | | | 1,424 | | |
| Retirement of treasury shares | | | (40,221) | | | | | | (402) | | | | | | (1,195,614) | | | | | | (477,689) | | | | | | — | | | | | | (40,221) | | | | | | 1,673,705 | | | | | | — | | | | | | — | | | | | | — | | |
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
| Buildings | | | 20 - 40 | | |
bargain purchase option, such finance lease assets are amortized over the useful life that would be assigned if such assets were owned.
carrying amount of the assets or asset group may not be recoverable.
The Company accounts for the investments in limited liability companies, which are not variable interest entities, under the equity method of accounting.
The Company adopted Accounting Standards Codification Topic 842, “Leases” on December 30, 2018 using the modified retrospective method for all leases that had commenced as of the effective date, along with certain available practical expedients.
Upon adoption the Company derecognized $26 million of property, plant and equipment, net and corresponding other debt associated with certain build-to-suit lease arrangements.
The Company recorded operating lease right-of-use assets, net of $134 million, inclusive of opening adjustments impacting prepaid assets and other assets, primarily related to prepaid rent existing at transition, and $127 million of operating lease right-of-use liabilities, within our consolidated balance sheet upon adoption.
There was no cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.
direct the use of the identified asset.
or circumstances related to a tax position.
In August 2018, the Financial Accounting Standards Board (FASB) issued ASU 2018-15, “Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computer Arrangement that is a Service Contract.” ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license).
In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement.” ASU 2018-13 removes the disclosure requirement for the amount and reasons for transfers between Level 1 and Level 2 fair value measurements as well as the process for Level 3 fair value measurements.
In addition, the ASU adds the disclosure requirements for changes in unrealized gains and losses included in Other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period as well as the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements.
In August 2018, the FASB issued ASU 2018-14, “Compensation Retirement Benefits - Defined Benefit Plans -General (Subtopic 715-20).” ASU 2018-14 removes the requirements to disclose the amounts in Accumulated other comprehensive income (loss) expected to be recognized as components of net periodic benefit cost over the next fiscal year and the related party disclosures about the amount of future annual benefits covered by insurance contracts.
In addition, the ASU adds the requirement to disclose an explanation for any significant gains and losses related to changes in the benefit obligation for the period.
In January 2017, the FASB issued ASU 2017-04, “Simplifying the Test for Goodwill Impairment.” The standard simplifies the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation.
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments - Credit Losses”.
The standard, including subsequently issued amendments, requires a financial asset measured at amortized cost basis, such as trade and notes receivables, to be presented at the net amount expected to be collected based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount.
The interest rate on the Company’s senior credit facility, which matures in fiscal year 2023, is linked to LIBOR.
An excerpt. Shown here: 40 of 683 rewritten, 40 of 388 added and 40 of 224 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2021 filing and the FY2020 filing.
Item 9A. Controls and Procedures
7 rewritten, 1 added, 0 removed, 10 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: 26, 2020,] [added: 25, 2021,] 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: 26, 2020.][added: 25, 2021.]
We have excluded [removed: the] [added: certain] business acquisitions completed during fiscal year [removed: 2020, including HemaCare] [added: 2021 (Cognate] and [removed: Cellero,] [added: Vigene)] from the assessment of the effectiveness of internal control over financial reporting as of December [removed: 26, 2020.][added: 25, 2021.]
Total assets and total [removed: revenue] [added: revenues] of [removed: the] [added: these] acquired businesses [removed: collectively] [added: that are excluded] represent [removed: 1.0%] [added: 2.5%] and [removed: 1.6%,] [added: 3.1%,] respectively, of the related consolidated financial statement amounts as of and for fiscal year ended December [removed: 26, 2020.][added: 25, 2021.]
The effectiveness of our internal control over financial reporting as of December [removed: 26, 2020,] [added: 25, 2021,] 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.
During fiscal year [removed: 2020,] [added: 2021,] the Company continued to execute a plan to centralize certain accounting transaction processing functions to internal shared service centers.
There were no other 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: 2020] [added: 2021] that materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Item 9B. Other Information
0 rewritten, 11 added, 2 removed, 0 unchanged
On February 15, 2022, we entered into a letter agreement with Mr. Smith, our Corporate Executive Vice President and Chief Financial Officer, that amends our existing Service Agreement with him and that establishes parameters regarding a gradual and well-planned transition of his responsibilities.
The letter agreement sets forth that in the event that Charles River appoints a successor to Mr. Smith’s role prior to September 30, 2022, Mr. Smith’s job title will change to Senior Financial Advisor though February 28, 2023, as he transitions his responsibilities to his successor.
Throughout this transition period, Mr. Smith will remain available to answer questions related to his role and to consult with his successor or our CEO about matters where Mr. Smith’s skill, expertise or insight is considered necessary.
Mr. Smith’s base compensation effective as of April 1, 2022 and through September 30, 2022 will be £479,981 per year.
Mr. Smith will be eligible to receive a bonus of up to 70% of his base annual salary for the 2022 fiscal year, such bonus to be reduced on a pro-rata basis to reflect time worked within the fiscal year up to and including September 30, 2022.
In lieu of a traditional annual equity grant made in May, Mr. Smith will receive a grant of restricted stock units on February 28, 2022 with a value of $1.5 million with a 12-month vesting period, such grant to be conditional upon Mr. Smith providing a smooth, structured handover of his responsibilities to his successor.
The vesting of any previously granted equity awards will be unaffected and continue through February 28, 2023, with any equity that remains unvested at that date to be forfeited.
The terms and conditions of any previously granted stock award agreements will be unaffected through February 28, 2023.
The letter agreement provides that, notwithstanding termination of his employment, Charles River will continue to procure accountant services to Mr. Smith to complete his US and UK annual tax returns until the 2025-2026 tax year.
In the event that a successor CFO is not appointed prior to September 30, 2022, Mr. Smith’s employment will continue as normal, and the terms of the letter agreement will no longer apply.
In consideration for the benefits provided under the letter agreement, Mr. Smith has agreed he is not entitled to other severance or compensation benefits.
None.
PART III
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
0 rewritten, 3 added, 0 removed, 0 unchanged
New section this year
Not applicable.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
3 rewritten, 0 added, 0 removed, 18 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: 2021] [added: 2022] 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: 2021] [added: 2022] 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: 2021] [added: 2022] 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.
Item 11. Executive Compensation
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item will be included in the [removed: 2021] [added: 2022] Proxy Statement under the sections captioned [removed: “2020] [added: “2021] 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.
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: 2021] [added: 2022] 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: 2021] [added: 2022] 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, 4 added, 0 removed, 3 unchanged
The information required by this Item will be included in the [removed: 2021] [added: 2022] Proxy Statement under the section captioned “Statement of Fees Paid to Independent Registered Public Accounting Firm” and is incorporated herein by reference thereto.
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Item 15(a)(1) and (2) Financial Statements and Schedules
See "Index to Consolidated Financial Statements and Financial Statements Schedules" at Item 8 to this Annual Report on Form 10-K.
Other financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto.
Item 15. (a)(3) and Item 15(b) Exhibits
1 rewritten, 57 added, 4 removed, 0 unchanged
We have identified [removed: in the Exhibit Index] [added: below] each management contract and compensation plan filed as an exhibit to this Annual Report on Form [removed: 10-K in response to Item 15(c) of Form] 10-K.
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Exhibit No. | | | Description | | | Filed with this Form 10-K | | | Incorporation by Reference | | | | | | | | |
| Form | | | Filing Date | | | Exhibit No. | | | | | | | | | | | |
| 2.1 | | | [Agreement and Plan of Merger, dated as of February 17, 2021, by and among Charles River Laboratories International, Inc., Memphis Merger Sub, Inc., Cognate BioServices, Inc. and Mercury Fund 2 Holdco LLC, solely in its capacity as the initial representative of the Company Shareholders](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm) | | | | | | 8-K | | | February 17, 2021 | | | 2.1 | | |
| 3.1 | | | [Second Amended and Restated Certificate of Incorporation of Charles River Laboratories International, Inc. dated June 5, 2000](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-3_1.txt) | | | | | | S-1/A | | | June 23, 2000 | | | 3.1 | | |
| 3.2 | | | [Sixth Amended and Restated By-Laws of Charles River Laboratories International, Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000110068221000025/exhibit31121321.htm) | | | | | | 8-K | | | December 15, 2021 | | | 3.1 | | |
| 4.1 | | | [Form of Common Stock certificate, $0.01 par value, of Charles River Laboratories International, Inc.](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-4_1.txt) | | | | | | S-1/A | | | June 23, 2000 | | | 4.1 | | |
| 4.2 | | | [Description of Securities](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000005/crl1228201910-kxex42.htm) | | | | | | 10-K | | | February 11, 2020 | | | 4.2 | | |
| 4.3 | | | [Charles River Laboratories International, Inc. Form of Performance Share Unit granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/0001100682/000110068220000026/ex103-psu2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.3 | | |
| 4.4 | | | [Charles River Laboratories International, Inc. Indenture Agreement with MUFG Union Bank, N.A. as Trustee dated April 3, 2018](http://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, 2018](http://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 2028](http://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm) | | | | | | 8-K | | | October 23, 2019 | | | 4.2 | | |
| 4.7 | | | [Indenture, dated as of March 23, 2021, between Charles River International, Inc. and U.S. Bank National Association, as trustee](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321004449/dp148253_ex0401.htm) | | | | | | 8-K | | | March 23, 2021 | | | 4.1 | | |
| 4.8 | | | [First Supplemental Indenture, dated as of March 23, 2021, by and among the Charles River Laboratories International, Inc., the Guarantors and U.S. Bank National Association, as trustee](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321004449/dp148253_ex0402.htm) | | | | | | 8-K | | | March 23, 2021 | | | 4.2 | | |
| 4.9 | | | [Form of Note for 3.750% Senior Notes due 2029 (included with Exhibit 4.12)](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321004449/dp148253_ex0402.htm) | | | | | | 8-K | | | March 23, 2021 | | | 4.3 | | |
| 4.10 | | | [Form of Note for 4.000% Senior Notes due 2030 (included with Exhibit 4.12)](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321004449/dp148253_ex0402.htm) | | | | | | 8-K | | | March 23, 2021 | | | 4.4 | | |
| 4.11 | | | [Form of Senior Debt Indenture between Charles River Laboratories International, Inc. and U.S. Bank National Association](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321006693/dp150175_ex0401.htm) | | | | | | S-3 | | | May 4, 2021 | | | 4.1 | | |
| 4.12 | | | [Form of Subordinated Debt Indenture between Charles River Laboratories International, Inc. and U.S. Bank National Association](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321006693/dp150175_ex0402.htm) | | | | | | S-3 | | | May 4, 2021 | | | 4.2 | | |
| 10.1* | | | [Charles River Laboratories International, Inc. 2016 Incentive Plan](http://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 and restated May 6, 2020](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000012/ex101crl-ar2018incenti.htm) | | | | | | 10-Q | | | May 7, 2020 | | | 10.1 | | |
| 10.3* | | | [Charles River Laboratories International, Inc. Form of Stock Option granted under the 2016 Incentive Plan](http://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 Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex107.htm) | | | | | | 10-K | | | February 14, 2017 | | | 10.7 | | |
| 10.5* | | | [Charles River Laboratories International, Inc. Form of Non-Qualified Stock Option granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000026/ex101-nq2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.1 | | |
| 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/1100682/000110068220000026/ex102-rsu2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.2 | | |
CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Exhibit No. | | | Description | | | Filed with this Form 10-K | | | Incorporation by Reference | | | | | | | | |
| Form | | | Filing Date | | | Exhibit No. | | | | | | | | | | | |
| 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 | | |
| 10.8* | | | [Form of Change in Control Agreement](http://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, 2016](http://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 Plan](http://www.sec.gov/Archives/edgar/data/1100682/000104746905005909/a2152761zex-10_23.txt) | | | | | | 10-K | | | March 9, 2005 | | | 10.23 | | |
| 10.11* | | | [Agreement between David Smith and Charles River Laboratories, Inc. effective October 26, 2020](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000041/ex101drsrelocationagre.htm) | | | | | | 10-Q | | | October 29, 2020 | | | 10.1 | | |
| 10.12* | | | [Amended and Restated Employment Agreement by and between James C. Foster and Charles River International, Inc., dated May 18, 2021](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321007423/dp151239_ex9901.htm) | | | | | | 8-K | | | May 18, 2021 | | | 99.1 | | |
| 10.13* | | | [Executive Incentive Compensation Program effective January 1, 2021](https://www.sec.gov/Archives/edgar/data/0001100682/000110068221000010/ex102eicpplandocument2021f.htm) | | | | | | 10-Q | | | May 4, 2021 | | | 10.2 | | |
| 10.14* | | | [Charles River Laboratories amended and restated Deferred Compensation Plan, as amended](https://www.sec.gov/Archives/edgar/data/0001100682/000110068221000010/ex103dcplandocument-amende.htm) | | | | | | 10-Q | | | May 4, 2021 | | | 10.3 | | |
| 10.15 | | | [Ninth Amended and Restated Credit Agreement, dated as of April 21, 2021, 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 thereto](https://www.sec.gov/Archives/edgar/data/0001100682/000095010321005992/dp149793_ex1001.htm) | | | | | | 8-K | | | April 23, 2021 | | | 10.1 | | |
| 10.16* | | | [Charles River Laboratories International, Inc. Restricted Stock Unit Award, dated December 25, 2021 granted to Joseph W. LaPlume](https://www.sec.gov/Archives/edgar/data/0001100682/000110068221000028/exhibit101-8xkfiled122721.htm) | | | | | | 8-K | | | December 27, 2021 | | | 10.1 | | |
See "Index to Consolidated Financial Statements and Financial Statements Schedules" at Item 8 to this Annual Report on Form 10-K.
Other financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto.
Item 15(a)(3) and Item 15(b) Exhibits
The exhibits filed as part of this Annual Report on Form 10-K are listed in the Exhibit Index immediately preceding the exhibits.
An excerpt. Shown here: all 1 rewritten, 40 of 57 added and all 4 removed. The counts are complete. For every sentence, read Item 15. (a)(3) and Item 15(b) Exhibits in the FY2021 filing and the FY2020 filing.
Item 16. Form 10-K Summary
14 rewritten, 0 added, 57 removed, 37 unchanged
| February [removed: 17, 2021] [added: 16, 2022] | | | By: | | | /s/ DAVID R. SMITH | | |
| By: | | | /s/ JAMES C. FOSTER | | | *Chairman, President and Chief Executive Officer* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ DAVID R. SMITH | | | *Corporate Executive Vice President and* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ MICHAEL G. KNELL | | | *Corporate Senior Vice President and* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ NANCY C. ANDREWS | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ ROBERT J. BERTOLINI | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ DEBORAH T. KOCHEVAR | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ GEORGE LLADO | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ MARTIN MACKAY | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ GEORGE E. MASSARO | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ GEORGE M. MILNE, JR. | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ C. RICHARD REESE | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ RICHARD F. WALLMAN | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| By: | | | /s/ VIRGINIA M. WILSON | | | *Director* | | | February [removed: 17, 2021] [added: 16, 2022] | | |
| | | | | | | | | | | | |
| By: | | | /s/ STEPHEN D. CHUBB | | | *Director* | | | February 17, 2021 | | |
| | | | Stephen D. Chubb | | | | | | | | |
EXHIBIT INDEX
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Exhibit No. | | | Description | | | Filed with this Form 10-K | | | Incorporation by Reference | | | | | | | | |
| Form | | | Filing Date | | | Exhibit No. | | | | | | | | | | | |
| 2.1 | | | [Agreement and Plan of Merger, dated as of February 17, 2021, by and among Charles River Laboratories International, Inc., Memphis](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm) [](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm)[Merger Sub, Inc., Cognate BioServices, Inc. and Mercury Fund 2 Holdco LLC, solely in its capacity as the initial representative of the](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm) [](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm)[Company Shareholders](https://www.sec.gov/Archives/edgar/data/1100682/000095010321002397/dp146258_ex0201.htm) | | | | | | 8-K | | | February 17, 2021 | | | 2.1 | | |
| 3.1 | | | [Second Amended and Restated Certificate of Incorporation of Charles River Laboratories International, Inc. dated June 5, 2000](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-3_1.txt) | | | | | | S-1/A | | | June 23, 2000 | | | 3.1 | | |
| 3.2 | | | [Fifth Amended and Restated By-Laws of Charles River Laboratories International, Inc.](http://www.sec.gov/Archives/edgar/data/1100682/000129993316002465/exhibit1.htm) | | | | | | 8-K | | | May 16, 2016 | | | 3.2 | | |
| 4.1 | | | [Form of Common Stock certificate, $0.01 par value, of Charles River Laboratories International, Inc.](http://www.sec.gov/Archives/edgar/data/1100682/000091205700029480/ex-4_1.txt) | | | | | | S-1/A | | | June 23, 2000 | | | 4.1 | | |
| 4.2 | | | [Description of Securities](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000005/crl1228201910-kxex42.htm) | | | | | | 10-K | | | February 11, 2020 | | | 4.2 | | |
| 4.3* | | | [Charles River Laboratories International, Inc. Form of Performance Share Unit granted under the 2007 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000144530513000358/crl12292012-ex44.htm) | | | | | | 10-K | | | February 27, 2013 | | | 4.4 | | |
| 4.4* | | | [Charles River Laboratories International, Inc. Form of Performance Share Unit granted under the 2016 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex43.htm) | | | | | | 10-K | | | February 14, 2017 | | | 4.3 | | |
| 4.5* | | | [Charles River Laboratories International, Inc. Form of Performance Share Unit granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000026/ex103-psu2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.3 | | |
| 4.6 | | | [Charles River Laboratories International, Inc. Indenture Agreement with MUFG Union Bank, N.A. as Trustee dated April 3, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0401.htm) | | | | | | 8-K | | | April 3, 2018 | | | 4.1 | | |
| 4.7 | | | [Charles River Laboratories International, Inc. First Supplemental Indenture dated as of April 3, 2018 to the Indenture dated as of April 3, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0402.htm) | | | | | | 8-K | | | April 3, 2018 | | | 4.2 | | |
| 4.8 | | | [Form of Note for 5.500% Senior Notes due 2026](http://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0402.htm) | | | | | | 8-K | | | April 3, 2018 | | | 4.3 | | |
| 4.9 | | | [Charles River Laboratories International, Inc. Second Supplemental Indenture, dates as of October 23, 2019, to the Indenture dated as of April 3, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm) | | | | | | 8-K | | | October 23, 2019 | | | 4.1 | | |
| 4.10 | | | [Form of Note for 4.250% Senior Notes due 2028](http://www.sec.gov/Archives/edgar/data/1100682/000110068219000026/exhibit41.htm) | | | | | | 8-K | | | October 23, 2019 | | | 4.2 | | |
| 10.1* | | | [Charles River Laboratories International, Inc. 2007 Incentive Plan, as amended](http://www.sec.gov/Archives/edgar/data/1100682/000162828015000785/crl12272014-ex1013.htm) | | | | | | 10-K | | | February 17, 2015 | | | 10.13 | | |
| 10.2* | | | [Charles River Laboratories International, Inc. 2016 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068216000013/crl6252016ex101.htm) | | | | | | 10-Q | | | August 3, 2016 | | | 10.1 | | |
| 10.3* | | | [Charles River Laboratories International, Inc. Amended and Restated 2018 Incentive Plan, dated March 20, 2018, as amended and restated May 6, 2020](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000012/ex101crl-ar2018incenti.htm) | | | | | | 10-Q | | | May 7, 2020 | | | 10.1 | | |
| 10.4* | | | [Charles River Laboratories International, Inc. Form of Stock Option granted under the 2007 Incentive Plan, as amended](http://www.sec.gov/Archives/edgar/data/1100682/000104746908001507/a2182759zex-10_17.htm) | | | | | | 10-K | | | February 20, 2008 | | | 10.17 | | |
| 10.5* | | | [Charles River Laboratories International, Inc. Form of Stock Option granted under the 2016 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex104.htm) | | | | | | 10-K | | | February 14, 2017 | | | 10.4 | | |
| 10.6* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Award granted under the 2007 Incentive Plan, as amended](http://www.sec.gov/Archives/edgar/data/1100682/000104746908001507/a2182759zex-10_18.htm) | | | | | | 10-K | | | February 20, 2008 | | | 10.18 | | |
| 10.7* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Unit granted under the 2007 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex106.htm) | | | | | | 10-K | | | February 14, 2017 | | | 10.6 | | |
| 10.8* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Unit granted under the 2016 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1100682/000110068217000003/crl1231201610-kxex107.htm) | | | | | | 10-K | | | February 14, 2017 | | | 10.7 | | |
| 10.9* | | | [Charles River Laboratories International, Inc. Form of Non-Qualified Stock Option granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000026/ex101-nq2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.1 | | |
| 10.10* | | | [Charles River Laboratories International, Inc. Form of Restricted Stock Unit granted under the 2018 Incentive Plan](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000026/ex102-rsu2020.htm) | | | | | | 10-Q | | | August 5, 2020 | | | 10.2 | | |
| 10.11* | | | [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 | | |
| 10.12* | | | [Form of Change in Control Agreement](http://www.sec.gov/Archives/edgar/data/1100682/000104746909001689/a2190829zex-10_7.htm) | | | | | | 10-K | | | February 23, 2009 | | | 10.7 | | |
| 10.13* | | | [Executive Incentive Compensation Plan dated January 1, 2016](http://www.sec.gov/Archives/edgar/data/1100682/000110068216000006/crl12262015-ex104.htm) | | | | | | 10-K | | | February 12, 2016 | | | 10.4 | | |
| 10.14* | | | [Charles River Laboratories International, Inc. Non-Employee Directors Deferral Plan dated April 5, 2016](http://www.sec.gov/Archives/edgar/data/1100682/000110068216000010/crl3262016ex101.htm) | | | | | | 10-Q | | | May 4, 2016 | | | 10.1 | | |
| 10.15* | | | [Charles River Laboratories, Inc. Executive Life Insurance/Supplemental Retirement Income Plan](http://www.sec.gov/Archives/edgar/data/1100682/000104746905005909/a2152761zex-10_23.txt) | | | | | | 10-K | | | March 9, 2005 | | | 10.23 | | |
| 10.16* | | | [Charles River Laboratories amended and restated Deferred Compensation Plan, as amended](http://www.sec.gov/Archives/edgar/data/1100682/000151851912000030/crl12312011-ex101.htm) | | | | | | 10-K | | | February 27, 2012 | | | 10.11 | | |
| 10.17* | | | [Amended and Restated Deferred Compensation Plan Document dated July 17, 2012](http://www.sec.gov/Archives/edgar/data/1100682/000144530512002523/crl06302012-ex101.htm) | | | | | | 10-Q | | | August 7, 2012 | | | 10.1 | | |
| 10.18* | | | [Employment Agreement by and Between James C. Foster and the Company dated February 12, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000129993318000144/exhibit2.htm) | | | | | | 8-K | | | February 13, 2018 | | | 99.2 | | |
| 10.19* | | | [Agreement between David Smith and Charles River Laboratories, Inc. effective October 26, 2020](https://www.sec.gov/Archives/edgar/data/1100682/000110068220000041/ex101drsrelocationagre.htm) | | | | | | 10-Q | | | October 29, 2020 | | | 10.1 | | |
An excerpt. Shown here: all 14 rewritten, all 0 added and 40 of 57 removed. The counts are complete. For every sentence, read Item 16. Form 10-K Summary in the FY2021 filing and the FY2020 filing.