Charles River Laboratories International (CRL) 10-K risk factor changes: FY2018 vs FY2017
The 2018-12-29 10-K against the 2017-12-30 one, compared heading by heading and sentence by sentence. One of these filings carries no fiscal year tag, so its year is the calendar year of the period end.
Item 1A48 rewritten33 added30 removed366 unchanged
All filing items998 rewritten797 added538 removed2,343 unchanged
Summary
counted, not written
- Item 1A headings could not be compared: only 0 carried over between the two years, which usually means one filing was read wrongly, so none is reported as new or removed.
- Sentence by sentence, 797 added, 538 removed, 998 rewritten and 2,343 unchanged across 16 items that differ.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2018; struck-through words were in FY2017. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
48 rewritten, 33 added, 30 removed, 366 unchanged
[removed: Research and development budgets fluctuate due to changes in available resources, mergers of] pharmaceutical and biotechnology companies, spending priorities (including available resources of our biotechnology clients, particularly those that are cash-negative, who may be highly focused on rationing their liquid assets in a challenging funding environment), general economic conditions, [removed: and] institutional budgetary [removed: policies.][added: policies and the impact of government regulations, including potential drug pricing legislation.]
Similarly, economic factors and industry trends that affect our clients in these industries also affect their research [added: and development budgets and, consequentially, our business as well.]
Any failure on our part to comply with applicable regulations could result in the termination of ongoing research or the disqualification of data for submission [added: on behalf of our clients] to regulatory authorities.
For example, the issuance of a notice of objectionable observations or a warning from the FDA based on a finding of a material violation [added: affecting data integrity] by us for GLP or cGMP requirements could materially and adversely affect us.
In addition, the FDA’s recently applicable SEND (Standardization for Exchange of Nonclinical Data) standards which apply to our [removed: customers’] [added: clients’] NDA [removed: (and as of December 18, 2017, IND)] [added: and IND] submissions require us to provide electronic data in specific formats that will allow for more efficient, higher quality regulatory reviews.
Accordingly, our [removed: customers] [added: clients] expect us to timely deliver their nonclinical data compliant with SEND.
[added: 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.
We believe that we have taken appropriate measures to protect them from intrusion, and we continue to improve and enhance our systems in this [removed: regard,] [added: regard (including with respect to how we process and report any breaches),] but in the event that our efforts are unsuccessful, we could suffer significant harm.
Governmental agencies throughout the [removed: world, but particularly in the U.S.,] [added: world] strictly regulate the drug development process.
The Court’s decision [removed: allows] [added: allowed] implementation of key provisions impacting drug manufacturers going forward, including, but not limited to, (1) expansion of access to health insurance coverage, (2) expansion of the Medicaid program, (3) enactment of an industry fee on pharmaceutical companies, and (4) imposition of an excise tax on the sale of medical devices.
[removed: Specific legislative and regulatory proposals discussed during and after the election that may have a material impact on us or our clients include, but are not limited to, appeal or reform of the ACA; and] [added: Furthermore,] modifications to international trade policy, public company reporting requirements, environmental regulation and antitrust [removed: enforcement.][added: enforcement may have a material impact on us or our clients.]
Many of our agreements with both large and small clients, including those which underlie our strategic relationships with some of our more significant [removed: customers,] [added: clients,] provide for termination or reduction in scope with little or no notice.
During the past [removed: fifteen] [added: sixteen] years, we have steadily expanded our business through numerous acquisitions.
[removed: On February 12,] [added: In April] 2018, we [removed: entered into a definitive agreement to acquire] [added: acquired] MPI Research, a non-clinical CRO, providing comprehensive testing services to biopharmaceutical and medical device companies worldwide.
| • | difficulties and expenses incurred in assimilating and integrating operations, services, products, technologies, or pre-existing relationships with our [removed: customers,] [added: clients,] distributors, and suppliers; |
We continually evaluate the performance and strategic fit of our [removed: businesses.][added: businesses (including specific product lines and service offerings).]
We may not be successful in managing these or any other significant risks that we encounter in divesting a business, site, or product [removed: line,] [added: line or service offering,] and as a result, we may not achieve some or all of the expected benefits of the divestiture.
To the extent goodwill or other intangible assets are impaired, their carrying value will be written down to their implied fair values and a charge will be made to our income from continuing [removed: operations.]
As of December [removed: 30, 2017,] [added: 29, 2018,] the carrying amount of goodwill and other intangibles on our consolidated balance sheet was [removed: $1,174.7 million.][added: $1.9 billion.]
| • | foreign currencies we receive for sales and in which we record expenses outside the U.S. could be subject to unfavorable exchange rates with the U.S. dollar and reduce the amount of revenue and cash flow (and increase the amount of expenses) that we recognize and cause fluctuations in reported financial [removed: results;] [added: results. The favorable effects of changes in currency exchange rates increased our 2018 revenue by approximately $24 million, or 1.3%, while unfavorable foreign currency effects decreased our 2017 revenues by less than $1 million, or less than 1%, respectively;] |
| • | general economic and political conditions in the markets in which we [removed: operate;] [added: operate, including possible implications of Brexit;] |
| • | difficulties and costs associated with staffing and managing foreign operations, including risks of work stoppages and/or strikes, as well as violations of local laws or anti-bribery laws such as the U.S. Foreign Corrupt Practices [removed: Act,] [added: Act (FCPA),] the U.K. Bribery Act, and the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions; |
| • | potentially negative consequences from changes in [added: U.S. and/or foreign tax laws,] or interpretations [removed: of] [added: thereof, notably tax regulations issued and to-be-issued with respect to] U.S. [added: Tax Reform] and [removed: foreign tax laws;] [added: the EU Anti-Tax Avoidance Directives I and II;] |
| • | compliance with [added: export controls,] import requirements and other trade regulations. |
For example, as mentioned above, we are subject to compliance with the [removed: U.S. Foreign Corrupt Practices Act] [added: FCPA] and similar anti-bribery laws, which generally prohibit companies and their [added: third-party] intermediaries from making improper payments to foreign government officials for the purpose of obtaining or retaining business.
A disruption resulting from any one of these events could cause significant delays in shipments of our products, reduce our capacity to provide services, eradicate unique manufacturing capabilities and, ultimately, result in the loss of revenue and [removed: customers.][added: clients.]
Notwithstanding, certain special interest groups categorically object [added: to the use of animals for valid research purposes.]
Any negative attention, threats or acts of vandalism directed against either our animal research activities or our third party service [removed: providers] [added: providers,] such as our airline [removed: carriers] [added: carriers,] in the future could impair our ability to operate our business efficiently.
[removed: Our debt could have significant adverse effects on our business, including making it more difficult for us to obtain additional financing on favorable terms; requiring us to dedicate a substantial] portion of our cash flows from operations to the repayment of debt and the interest on this debt; limiting our ability to capitalize on significant business opportunities; and making us more vulnerable to rising interest rates.
For additional information regarding our debt, please see Note [removed: 7,] [added: 9,] “Long-Term Debt and Capital Lease Obligations”, included in the Notes to Consolidated Financial Statements included elsewhere in this Form 10-K.
| • | [removed: price/value;] [added: price/value, spend and flexibility;] |
| • | technological [added: and scientific] expertise and efficient drug development processes; |
[added: More generally, our] competitors or others might develop technologies, services or products that are more effective or commercially attractive than our current or future technologies, services, or products, or that render our technologies, services, or products less competitive or obsolete.
On December 22, 2017, President Trump signed into law significant U.S. tax law changes (U.S. Tax Reform) which [removed: reduces] [added: reduced] the U.S. federal statutory tax rate, [removed: broadens] [added: broadened] the corporate tax base through the elimination or reduction of deductions, exclusions, and credits, [removed: limits] [added: limited] the ability of U.S. corporations to deduct interest expense, and [removed: transitions] [added: transitioned] to a territorial tax system which [removed: will allow] [added: allows] for the repatriation of foreign earnings to the U.S. with a 100% federal dividends received deduction prospectively.
In addition, U.S. Tax Reform [removed: requires] [added: required] a one-time transitional tax on foreign cash equivalents and previously unremitted earnings.
Several of the new provisions enacted as part of U.S. Tax Reform require clarification and guidance from the Internal Revenue [removed: Service (IRS) and Treasury Department.]
[removed: Currently, the] [added: The] OECD has developed an action plan to address concerns regarding base erosion and profit shifting (BEPS).
This initiative [removed: has] resulted in proposed and enacted changes to tax laws in various countries including France, Germany, Luxembourg, [added: Netherlands] and the U.K. Future changes to tax laws or interpretation of tax laws resulting from the BEPS project could increase our effective tax rate, which would affect our profitability.
We also often contractually indemnify our clients (subject to a limitation of liability), similar to the way they indemnify us, and we may be materially [added: adversely affected if we have to fulfill our indemnity obligations.]
The expansion [added: and ongoing implementation] of the [removed: ERP system to other international locations] [added: systems] may occur at a future date based on value to the business.
Research and development budgets fluctuate due to changes in available resources, mergers of
We also sell directly to the NIH and these other agencies.
We are required to comply with the data privacy and security laws in many jurisdictions.
For example, we are required to comply with the European Union (EU) General Data Protection Regulation (GDPR) which became effective on May 25, 2018 and imposes heightened obligations and enhanced penalties for noncompliance (including up to four percent (4%) of global revenue).
The cost of compliance with the GDPR and the potential for fines and penalties in the event of a violation of the GDPR may have a significant adverse effect on our business and operations.
We have made changes to, and investments in, our business practices and will continue to monitor developments and make appropriate changes to help attain compliance with these evolving and complex regulations.
While some of these models are owned by us and maintained at our facilities, others are reserved for us, and maintained at sites operated by the original provider.
In May 2017, the U.S. House of Representatives voted to pass the American Health Care Act (the AHCA), which would repeal many provisions of the ACA.
Although the U.S. Senate considered but failed to pass the AHCA and other comparable measures, the U.S. Congress may consider further legislation to repeal or replace elements of the ACA.
In addition, the Tax Cuts and Jobs Act, which President Trump signed into law in December 2017, repeals the ACA’s individual health insurance mandate, which is considered a key component of the ACA.
This transaction was our largest acquisition since 2004.
In February 2019, we signed a binding offer to acquire Citoxlab for €448 million in cash (or approximately $510 million based on current exchange rates).
Citoxlab is a non-clinical CRO, specializing in regulated safety assessment services, non-regulated discovery services, and medical device testing.
operations.
| • | foreign currency exposure associated with differences between where we conduct business, our exposure to currency exchange rate fluctuations results from the currency translation exposure associated with the preparation of our consolidated financial statements, as well as from the exposure associated with transactions of our subsidiaries that are denominated in a currency other than the respective subsidiary's functional currency. While our financial results are reported in U.S. Dollars, the financial statements of many of our subsidiaries outside the U.S. are prepared using the local currency as the functional currency. During consolidation, these results are translated into U.S. Dollars by applying appropriate exchange rates. As a result, fluctuations in the exchange rate of the U.S. Dollar relative to the local currencies in which our foreign subsidiaries report could cause significant fluctuations in our reported results. Moreover, as exchange rates vary, revenue and other operating results may differ materially from our expectations. Adjustments resulting from financial statement translations are included as a separate component of shareholders' equity. In the year ended December 29, 2018, we recorded net losses from currency translation adjustments of $27.4 million. In the year ended December 30, 2017, we recorded net gains from currency translation adjustments of $77.1 million; |
For example, our Safety and Assessment businesses have a program to evaluate the utility of induced pluripotent stems cells, advanced in vitro models, “organ-on-a-chip” technologies, artificial intelligence and machine learning in preclinical development.
As of December 29, 2018, we had $1.7 billion of debt.
In connection with our intended acquisition of Citoxlab, we anticipate increasing our debt to finance a substantial portion of the purchase price of approximately €448 million in cash (or approximately $510 million based on current exchange rates).
Our debt could have significant adverse effects on our business, including making it more difficult for us to obtain additional financing on favorable terms; requiring us to dedicate a substantial
Service (IRS) and Treasury Department.
In recent years, we have been updating and consolidating systems and automating processes in many parts of our business with a variety of systems.
The U.K. is currently negotiating the terms of its exit from the European Union (“Brexit”) scheduled for March 29, 2019.
In November 2018, the U.K. and the European Union agreed upon a draft Withdrawal Agreement that sets out the terms of the U.K.’s departure, including commitments on citizen rights after Brexit, a financial settlement from the U.K., and a transition period from March 29, 2019 through December 31, 2020 to allow time for a future trade deal to be agreed.
On January 15, 2019, the draft Withdrawal Agreement was rejected by the U.K. Parliament creating significant uncertainty about the terms (and timing) under which the U.K. will leave the European Union.
Given the uncertainty concerning the terms of the UK’s departure from the EU, including the possibility of no negotiated agreement, we have formed a committee (comprised of senior managers across our business functions) to address the three main risks: (1) trade and customs, (2) employees and immigration, and (3) strategy and business planning.
In the absence of a future trade deal, the U.K.’s trade with the European Union and the rest of the world would be subject to tariffs and duties set by the World Trade Organization.
Additionally, 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.
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 efforts are being undertaken to mitigate for risks within our control, other factors outside our control could adversely affect our business, business opportunities, results of operations, financial condition and cash flows.
| | |
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and development budgets and, consequentially, our business as well.
The presence of these infectious agents in our animal production facilities and certain service
While often we own these models, they may be maintained on our behalf at a site operated by the original provider.
The current Executive Branch of the U.S. government has disclosed a key initiative as being to repeal or substantially unwind the ACA.
Many of our contracts are fixed price and may be delayed or terminated or reduced in scope for reasons beyond our control, or we may under‑price or overrun cost estimates with these contracts, potentially resulting in financial losses.
In addition, these contracts may be terminated or reduced in scope either immediately or upon notice.
Cancellations may occur for a variety of reasons, and often at the discretion of the client.
The loss, reduction in scope or delay of a large contract or the loss or delay of multiple contracts could materially adversely affect our business, although our contracts frequently entitle us to receive the costs of
winding down the terminated projects, as well as all fees earned by us up to the time of termination.
Some contracts also entitle us to a predetermined termination fee and irrevocably committed costs/expenses.
If consummated, this transaction will be the largest acquisition in nearly fifteen years.
Refer to Item 8, “Financial Statements and Other Supplementary Data” in this Annual Report on Form 10-K for more details.
Changes in E.U. privacy and data protection regulations could have a material adverse impact on our operations.
The General Data Protection Regulation (GDPR) becomes effective in May 2018 and will replace the 1995 Data Protection Directive.
The GDPR will impose heightened obligations on businesses that control and manage the personal data of E.U. citizens.
The penalties for non-compliance are significant, including up to four percent of global revenue.
For example, Charles River Laboratories Cleveland, Ind.
(f/k/a ChanTest Corporation) has a well-developed program to evaluate the utility of induced pluripotent stem cell-derived cardiomyocytes, advanced in vitro models and “organ-on-a-chip” technologies.
to the use of animals for valid research purposes.
As of December 30, 2017, we had $1.1 billion of debt and in connection with our plan to acquire MPI Research (See Note 17 “Subsequent Event”, included in the Notes to Consolidated Financial Statements elsewhere in this Form 10-K), we announced our intention to increase our debt level by approximately $830 million by obtaining a commitment letter for a bridge loan facility.
We are evaluating fixed-rate debt financing alternatives which could be used to finance the acquisition and for general corporate purposes.
More generally, our
adversely affected if we have to fulfill our indemnity obligations.
In recent years, we implemented a project to replace many of our numerous legacy business systems at certain sites worldwide with an enterprise wide, integrated enterprise resource planning (ERP) system.
In July 2015, IDEXX Laboratories, Inc. and IDEXX Distribution, Inc. (collectively, IDEXX) filed a complaint in the United States District Court for the District of Delaware alleging we have infringed three (3) recently issued patents related to a blood spot sample collection method used in determining the presence or absence of an infectious disease in a population of rodents.
In February 2017, we entered into a settlement agreement with IDEXX, which included a license to us of the relevant technology, the withdrawal by IDEXX of their complaint and withdrawal by us of our inter partes review filing.
On June 23, 2016, the U.K. held a referendum in which voters approved an exit from the European Union (E.U.), referred to as “Brexit.” As a result of the referendum, the British government continues to negotiate the terms of the U.K.’s future relationship with the E.U. The decision by referendum to withdraw the U.K. from the E.U. caused significant volatility in global stock markets and currency exchange rate fluctuations.
The execution of Brexit also may create global economic uncertainty, which may cause our customers and potential customers to monitor their costs and reduce their budgets for our products and services.
In addition, Brexit could lead to legal uncertainty and potentially divergent national laws and regulations as the U.K. determines which E.U. laws to replace or replicate.
Given that we conduct a substantial portion of our business in the E.U. and the U.K., these effects of Brexit, among others, could adversely affect our business, business opportunities, results of operations, financial condition, and cash flows.
An excerpt. Shown here: 40 of 48 rewritten, all 33 added and all 30 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2018 filing and the FY2017 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
131 rewritten, 235 added, 147 removed, 261 unchanged
We currently operate [removed: approximately] [added: in over] 80 facilities [added: and] in [removed: 23] [added: approximately 20] countries worldwide, which numbers exclude our Insourcing Solutions (IS) sites.
We continued to make strategic acquisitions designed to expand our portfolio of services to support the drug discovery and [removed: early-stage] development continuum and position us as a market leader in the outsourced discovery services market.
On [removed: February 12,] [added: April 3,] 2018, we [removed: entered into a definitive agreement to acquire] [added: acquired] MPI Research, a non-clinical [removed: CRO,] [added: CRO] providing comprehensive testing services to biopharmaceutical and medical device companies worldwide.
[removed: Acquiring MPI Research will enhance] [added: The acquisition enhances] our position as a leading global early-stage CRO by strengthening our ability to partner with clients across the drug discovery and development continuum.
The [added: proposed] transaction is expected to close [removed: early] in the second quarter of [removed: 2018,] [added: 2019,] subject to [added: labor consultations,] regulatory [removed: approvals] [added: requirements,] and customary closing [removed: conditions.]
The [removed: preliminary] purchase price [removed: will be approximately $800] [added: for MPI Research was $829.7] million in cash, subject to [removed: customary closing] [added: certain post-closing] adjustments.
The [added: proposed] acquisition and associated fees are expected to be financed through [removed: an expansion of] our [added: existing revolving] credit facility and cash.
[added: In the] event the agreement is terminated under specified circumstances, we may be required to pay a termination fee of [removed: $48 million, increasing to $56 million based on other specific circumstances.][added: €18.2 million.]
The purchase price for KWS BioTest was $20.3 million in cash, subject to certain post-closing [removed: adjustments that may change the purchase price, and was funded by our various borrowings.][added: adjustments.]
In addition to the initial purchase price, the transaction includes aggregate, undiscounted contingent payments of up to £3.0 million (approximately [removed: $4.1] [added: $3.8] million based on recent exchange rates), based on future performance.
[removed: This] [added: The MPI Research] business [removed: will be] [added: is] reported as part of our DSA reportable segment.
The purchase price for Brains On-Line was $21.3 million in [removed: cash, subject to certain post-closing adjustments.][added: cash.]
In addition to the initial purchase price, the transaction includes [removed: potential additional] [added: aggregate, undiscounted contingent] payments of up to €6.7 million (approximately [removed: $7.9] [added: $7.7] million based on recent exchange rates), based on future [removed: performance.][added: performance and due in the first quarter of fiscal year 2019 if achieved.]
The demand for our products and services increased [added: meaningfully] in fiscal year [removed: 2017.][added: 2018.]
In addition, small and mid-size biopharmaceutical clients benefited from the continued strength in the biotechnology funding environment in fiscal year [removed: 2017,] [added: 2018,] from capital markets, partnering with large biopharmaceutical companies, and investment by venture capital.
Our full service, early-stage portfolio continued to lead to additional client discussions [added: and new business opportunities] in fiscal year [removed: 2017 regarding strategic relationships, where] [added: 2018, as] clients seek to outsource larger portions of their early-stage drug research programs to us.
The primary result of these trends was [removed: improved] [added: robust] demand for our Safety Assessment services in fiscal year [removed: 2017,] [added: 2018,] particularly from biotechnology clients.
[removed: This improvement led to increased capacity utilization in] [added: As a result of this improvement,] our Safety Assessment [removed: facilities, which] [added: facilities] remained well utilized in fiscal year [removed: 2017.][added: 2018.]
Price also improved slightly in fiscal year [removed: 2017,] [added: 2018,] as [added: we believe] industry capacity utilization continued to [removed: increase.][added: increase, as well.]
[removed: As our clients continue to pursue their] goal of more efficient and effective drug research, they are evaluating outsourcing new areas of their research programs, such as discovery services.
We have enhanced our Discovery Services capabilities over the past [removed: four] [added: five] years to enable us to work with clients at the earliest stages of the discovery process.
[removed: The completion of a few large, integrated early discovery projects from biopharmaceutical clients in] [added: In] fiscal year [removed: 2016 was largely offset with improving] [added: 2018,] demand [removed: from] [added: in our Discovery Services business also increased meaningfully, driven by] biotechnology clients as many of these clients either initiated or continued to work with us on integrated programs and other projects.
[removed: Large biopharmaceutical companies] [added: These clients] continue to have significant internal discovery capabilities, on which they can choose to rely.
In order for large biopharmaceutical clients to increasingly outsource more work to us, we must continue to [added: demonstrate that our services can augment and accelerate our clients’ drug discovery processes.]
Demand for our products and services that support our clients’ manufacturing activities was also robust in fiscal year [removed: 2017.][added: 2018.]
Demand for [removed: our Research Models and Services was stable] [added: research models services also improved] in fiscal year [removed: 2017.][added: 2018, particularly for our IS and GEMS businesses.]
The continued effect of the consolidation of internal infrastructure within our large biopharmaceutical clients and a longer-term trend towards more efficient use of research models has led to reduced demand for research [removed: models.][added: models outside of China.]
Demand for research models in China continued to be robust in fiscal year [removed: 2017,] [added: 2018,] as clients in this growing market continue to value our high-quality research [removed: models.][added: models and we expanded our geographic footprint.]
Demand for [removed: research models services also improved] [added: our Research Models and Services increased] in fiscal year [removed: 2017, particularly] [added: 2018, driven by strong demand] for [removed: our GEMS] [added: research models in China, higher revenue for research model services,] and [removed: IS businesses.][added: improved pricing.]
[removed: Revenue] [added: Other Income, Net Other income, net, was $37.8 million] for fiscal year [removed: 2017 was $1,857.6 million] [added: 2017, an increase of $26.0 million, or 221.0%,] compared to [removed: $1,681.4] [added: $11.8] million [removed: in] [added: for] fiscal year 2016.
The [removed: 2017] [added: 2018] increase as compared to the corresponding period in [removed: 2016] [added: 2017] was [removed: $176.2] [added: $408.5] million, or [removed: 10.5%,] [added: 22.0%,] and was primarily due to [added: both] growth in our DSA and Manufacturing segments, as discussed in the above “Business Trends” [removed: section.][added: section, as well as the recent acquisitions of MPI Research, KWS BioTest, and Brains On-Line.]
In fiscal year [removed: 2017,] [added: 2018,] our operating income and operating income margin were [removed: $287.5] [added: $331.4] million and [removed: 15.5%,] [added: 14.6%,] respectively, compared with [removed: $237.4] [added: $288.3] million and [removed: 14.1%,] [added: 15.5%,] respectively, in fiscal year [removed: 2016.][added: 2017.]
The increase in operating income [removed: and operating income margin] was primarily due to [removed: increased demand in] our [removed: DSA and Manufacturing segments, the effects of our] recent [removed: acquisitions,] [added: acquisitions] and [removed: various productivity initiatives.][added: increased demand from biotechnology and global biopharmaceutical clients.]
Net income attributable to common shareholders [removed: decreased] [added: increased] to [removed: $123.4] [added: $226.4] million in fiscal year [removed: 2017,] [added: 2018,] from [removed: $154.8] [added: $123.4] million in the corresponding period of [removed: 2016.][added: 2017.]
The [removed: decrease] [added: increase] in net income attributable to common shareholders of [removed: $31.4] [added: $103.0] million was primarily due to [removed: an] [added: the] increase in [removed: the provision for] [added: operating] income [removed: taxes of $104.6 million as] [added: discussed above and] a [removed: result] [added: lower effective tax rate driven primarily by net benefits] of U.S. Tax [removed: Reform,] [added: Reform;] partially offset by [removed: an increase in operating income as discussed above, as well as] [added: lower gains on our venture capital and life insurance policy investments, higher interest expense related to higher debt balances to support our recent acquisitions, and the absence of] a gain [removed: of $10.6 million] [added: recorded in other income, net] on the CDMO divestiture [removed: and an increase of $12.6 million] in [removed: gains on our venture capital investments.][added: 2017.]
During fiscal year [removed: 2017,] [added: 2018,] our cash flows from operations was [removed: $318.1] [added: $441.1] million compared with [removed: $316.9] [added: $318.1] million for fiscal year [removed: 2016.][added: 2017.]
The increase [added: in net cash provided by operating activities from fiscal year 2016 to 2017] was primarily driven by positive changes in operating assets and liabilities due to the recognition of a tax payable in connection with [removed: the recent] U.S. Tax Reform, and the timing of our accounts payable and accrued compensation payments.
[added: These] estimates and assumptions are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.
We consider matters to be effectively settled once the taxing authority has completed all of its required or expected examination procedures, including all appeals and administrative reviews; we have no plans to appeal or litigate any aspect of the tax position; and we believe that it is highly unlikely that the taxing authority would re-examine the [removed: related tax position.]
U.S. Tax Reform makes broad and complex changes to the U.S. tax code, including, but not limited to, (i) reducing the U.S. federal statutory tax rate from 35% to 21%; (ii) requiring companies to pay a one-time transition tax [added: (Transition Tax)] on certain unrepatriated earnings of foreign subsidiaries; (iii) generally eliminating U.S federal income taxes on dividends from foreign subsidiaries; (iv) requiring a current inclusion in U.S. federal taxable income of certain earnings of controlled foreign corporations; (v) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (vi) [removed: creating the] [added: subjecting certain foreign earnings to U.S. taxation through] base erosion anti-abuse tax [removed: (BEAT), a new minimum tax;] [added: (BEAT) and global intangible low-taxed income (GILTI);] (vii) creating a new limitation on deductible interest expense; (viii) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017, and (ix) modifying the officer’s compensation limitation.
Our strategy is to augment internal growth of existing businesses with complementary acquisitions.
On February 13, 2019, we announced that we signed a binding offer to acquire Citoxlab for €448 million in cash (or approximately $510 million based on current exchange rates), subject to customary closing adjustments.
Citoxlab is a non-clinical CRO, specializing in regulated safety assessment services, non-regulated discovery services, and medical device testing.
With operations in Europe and North America, the proposed acquisition of Citoxlab would further strengthen our position as the leading, global, early-stage CRO by expanding our scientific portfolio and geographic footprint, which would enhance our ability to partner with clients across the drug discovery and development continuum.
conditions.
Upon completion of the labor consultations, Citoxlab’s shareholders are expected to enter into a definitive purchase agreement.
The acquisition was funded by borrowings on our $2.3 billion credit facility ($2.3B Credit Facility) as well as the issuance of $500.0 million of our senior notes.
During the three months ended September 29, 2018, the terms of these contingent payments were amended, resulting in a fixed payment of £2.0 million (approximately $2.5 million based on recent exchange rates), due in the first quarter of fiscal year 2019.
The KWS BioTest business is reported as part of our DSA reportable segment.
In order to accommodate increasing client demand, we continued to open modest amounts of capacity at legacy sites, and gained additional capacity through the acquisition of MPI Research in April 2018.
As our clients continue to pursue their
Our efforts to enhance our sales strategies and become a trusted scientific partner for our clients’ early-stage programs have been successful, and enabled us to attract new clients for our early discovery services, including a growing base of biotechnology clients.
Demand from large biopharmaceutical companies also increased.
Demand for our in vivo discovery services continued to increase in fiscal year 2018, and we acquired KWS BioTest in January 2018 to enhance our discovery expertise and provide immuno-oncology capabilities to our clients.
The IS business further benefited from being awarded a five-year, $95.7 million contract from the National Institute of Allergy and Infectious Diseases, or NIAID, which commenced in September 2018.
Revenue for fiscal year 2018 was $2.3 billion compared to $1.9 billion in fiscal year 2017.
The decrease in operating income margin was primarily due to increased amortization expense and costs related to our recent acquisitions; as well as continued investments to support future growth of the Company, which includes increased investments in personnel (staffing levels and hourly wage increase), facility expansions (primarily in the RMS, Microbial Solutions, and Biologics businesses), and company-wide IT and infrastructure projects.
Offsetting the decreases in operating income margin were the realization of improved volume, mix, and pricing across our products and services portfolio as well as the impact of recent productivity initiatives across all businesses.
and liabilities resulting from an increase in our deferred revenue and customer contract deposits as well as improved collections of our receivables.
On March 26, 2018, we amended and restated our credit facility creating a $2.3B Credit Facility.
On April 3, 2018, we issued $500.0 million of 5.5% Senior Notes (Senior Notes) due in 2026 in an unregistered offering.
Interest on the Senior Notes is payable semi-annually on April 1 and October 1 of each year, beginning on October 1, 2018.
Revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers.
Revenue is measured as the amount of consideration we expect to receive in exchange for transferring products or services to a customer (“transaction price”).
To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing the amount to which we expect to be entitled.
Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.
Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our anticipated performance and all information (historical, current and forecasted) that is reasonably available.
Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component.
Generally, we do not extend payment terms beyond one year.
Applying the practical expedient, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less.
None of our contracts contained a significant financing component during fiscal year 2018.
Contracts with customers may contain multiple performance obligations.
For such arrangements, the transaction price is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation.
We determine standalone selling prices based on the price at which the performance obligation is sold separately.
If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.
Contracts are often modified to account for changes in contract specifications and requirements.
Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations.
Generally, when contract modifications create new performance obligations, the modification is considered to be a separate contract and revenue is
recognized prospectively.
We entered into a commitment letter, pursuant to which we will be provided up to $830 million under a bridge loan facility.
In the
Following a strategic review that was finalized subsequent to December 31, 2016, we determined that the CDMO business was not optimized within our portfolio at its current scale, and that the capital could be better deployed in other long-term growth opportunities.
Academia has also benefited from partnering activities, as large biopharmaceutical companies have increasingly utilized academic research capabilities to broaden the scope of their research activities.
In order to accommodate increasing client demand, we continued to open small amounts of new capacity in fiscal year 2017.
In fiscal year 2017, demand in our Discovery Services business was stable.
demonstrate that our services can augment and accelerate our clients’ drug discovery processes.
The business changes that we implemented in fiscal year 2016, including a small site consolidation and realignment of sales strategies in our early discovery business have been successful resulting in the stabilization of the business in fiscal year 2017 and in attracting new clients, including a growing base of biotechnology clients.
Demand for our in vivo discovery services continued to increase in fiscal year 2017, and we acquired Brains On-Line in August 2017 to enhance our position as the premier single-source provider for a broad portfolio of discovery CNS services.
In addition, we acquired KWS BioTest Limited in January 2018 to enhance our discovery expertise, with complementary offerings that provide our customers with additional tools in the active therapeutic research areas of oncology and immunology.
Demand for research models in mature markets outside of China declined modestly, partially offset by improved pricing.
To accommodate increased demand, we opened a new research models facility in China in late 2017.
These increases were partially offset by a decrease in income from continuing operations.
In the fourth quarter of fiscal 2017, as part of our efficiency initiatives, we committed to a plan to close our RMS production facility in Maryland before the end of 2018, consolidate production in other facilities, and to reduce our workforce at certain other global RMS facilities.
Total costs recognized in the fourth quarter of fiscal 2017 were $18.1 million, of which $17.7 million related to asset impairments and accelerated depreciation.
Additional costs are expected to be incurred during 2018 resulting from accelerated lease obligations, severance and transition costs, and site consolidation costs in the range of $6.5 million to $7.5 million.
These
We recognize revenue when all of the following conditions are satisfied: persuasive evidence of an arrangement exists, delivery has occurred or services have been provided, our price to the customer is fixed or determinable, and collectibility is reasonably assured.
Service revenue is generally evidenced by client contracts, which range in duration from a few weeks to a few years and typically take the form of an agreed upon rate per unit or fixed fee arrangements.
Such contracts typically do not contain acceptance provisions based upon the achievement of certain study or laboratory testing results.
Revenue of agreed upon rate per unit contracts is recognized as services are performed, based upon rates specified in the contract.
In cases where performance spans reporting periods, revenue of fixed fee contracts is recognized as services are performed, measured on the ratio of outputs or performance obligations completed to the total contractual outputs or performance obligations to be provided.
Changes in estimated effort to complete the fixed fee contract are reflected in the period in which the change becomes known.
Changes in scope of work are common, especially under long-term contracts, and generally result in a change in contract value.
Once the parties have agreed to the changes in scope and renegotiated pricing terms, the contract value is amended and revenue is typically recognized as described above.
Most contracts are terminable by the client, either immediately or upon notice.
These contracts often require payment to us of expenses to wind down the project, fees earned to date or, in some cases, a termination fee.
Such payments are included in revenues when earned.
We recognize product revenue, net of allowances for estimated returns, rebates and discounts, when title and risk of loss pass to customers.
When we sell equipment with specified acceptance criteria, we assess our ability to meet the acceptance criteria in order to determine the timing of revenue recognition.
We defer revenue until completion of customer acceptance testing if we are not able to demonstrate the ability to meet such acceptance criteria.
A portion of our revenue is from multiple-element arrangements that include multiple products and/or services as deliverables in a single arrangement, with each deliverable, or a combination of the deliverables, representing a separate unit of accounting.
We allocate revenues to each element in a multiple-element arrangement based upon the relative selling price of each deliverable.
Revenue allocated to each deliverable is then recognized when all revenue recognition criteria are met.
Judgments as to the identification of deliverables, units of accounting, the allocation of consideration to the deliverable, and the appropriate timing of revenue recognition are critical with respect to these arrangements.
At the inception of each arrangement that includes milestone payments, we evaluate whether each milestone is substantive.
This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) our performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from our performance to achieve the milestone; (b) the consideration relates solely to past performance; and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
We evaluate factors such as the scientific, clinical, regulatory, and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required, and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment.
If a substantive milestone is achieved and collection of the related receivable is reasonably assured, we recognize revenue related to the milestone in its entirety in the period in which the milestone is achieved.
If we were to achieve milestones that we consider substantive under any of our revenue arrangements, we may experience significant fluctuations in our revenue from quarter to quarter and year to year depending on the timing of achieving such substantive milestones.
An excerpt. Shown here: 40 of 131 rewritten, 40 of 235 added and 40 of 147 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 FY2018 filing and the FY2017 filing.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
4 rewritten, 3 added, 2 removed, 14 unchanged
As of December [removed: 30, 2017,] [added: 29, 2018,] 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: $11.0] [added: $11.3] million.
During fiscal year [removed: 2017,] [added: 2018,] the most significant drivers of foreign currency translation adjustment the Company recorded as part of other comprehensive income (loss) were the Euro, British Pound, Canadian Dollar, [added: and] Chinese Yuan [removed: Renminbi, and Japanese Yen.][added: Renminbi.]
[removed: For fiscal year 2017, our revenue would] have increased by approximately [removed: $72.0] [added: $81.8] million and our operating income would have increased by approximately [removed: $5.2] [added: $7.0] million, if the U.S. dollar exchange rate had strengthened by 10%, with all other variables held constant.
For fiscal year 2018, our revenue would
During fiscal year 2018, 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.
We did not have any foreign currency contracts open related to intercompany loans as of December 29, 2018.
During fiscal year 2017, we utilized foreign exchange contracts, principally to hedge certain balance sheet exposures resulting from currency fluctuations.
No foreign currency contracts were open as of December 30, 2017.
Item 1. Business
127 rewritten, 59 added, 43 removed, 346 unchanged
For example, we may use forward-looking statements when addressing topics such as: goodwill and asset impairments still under review; 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; 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 companies and venture capital limited partnerships, and opportunities for future similar arrangements; our cost structure; the impact of completed and in-process acquisitions (including Argenta, BioFocus, VivoPath, ChanTest, Sunrise, Celsis, Oncotest, WIL Research, Blue Stream, Agilux, Brains On-Line, KWS BioTest, [removed: and] MPI [removed: Research)] [added: Research,] and [added: Citoxlab) and] the timing of closing of in-process acquisitions; 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, consolidate or divest; 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.
This Form 10-K, as well as all other reports filed with the SEC, is available free of charge through the Investor Relations section of our Internet site [added: (www.criver.com)] as soon as practicable after we electronically file such material with, or furnish it [removed: to, the SEC.]
During the non-clinical stage of the development process, a drug candidate is tested in vitro (non-animal, typically on a cellular or sub-cellular level in a test tube or multi-well petri plate) and in vivo (in research models) to support [removed: planned or on-going] human clinical trials.
The development of new drugs requires [removed: the] [added: a] steadily increasing investment of time and money.
We currently operate [removed: approximately] [added: in over] 80 facilities [added: and] in [removed: 23] [added: approximately 20] countries worldwide, which numbers exclude our Insourcing Solutions (IS) sites.
In [removed: 2017,] [added: 2018,] our total revenue was [removed: $1.9] [added: $2.3] billion and our operating income from continuing operations, before income taxes, was [removed: $297.0] [added: $281.7] million.
With over 150 different strains, we continue to maintain our position as a global leader in the production and sale of the most widely used rodent research model [removed: strains, principally genetically] [added: strains] and [removed: microbiologically defined] purpose-bred rats and mice.
In [removed: 2017,] [added: 2018,] RMS accounted for [removed: 26.6%] [added: 22.9%] of our total revenue and approximately [removed: 3,200] [added: 3,600] of our employees, including approximately [removed: 100] [added: 130] science professionals with advanced degrees.
Our DSA business segment provides services that enable our clients to outsource their innovative drug discovery research, their related drug development activities, and their regulatory-required [removed: regulatory] safety testing of potential new drugs, industrial and agricultural chemicals and medical devices to us.
The demand for these services [removed: has historically been] [added: is] driven by the needs of large global pharmaceutical companies that have exceeded their internal capacity [removed: and] [added: or that are, or who are transitioning, to an outsourcing model of drug development, as well as] by the needs of [added: small] biotechnology companies and non-governmental organizations [removed: (NGOs)] who [removed: traditionally outsourced] [added: rely on outsourcing for] most of their discovery, development and safety testing programs.
Global pharmaceutical, biotechnology, and chemical companies choose to outsource their discovery, development, and safety activities because outsourcing reduces the significant investment in [removed: personnel and] [added: personnel,] facilities and capital resources necessary to efficiently and effectively conduct required scientific studies.
We are the largest provider of drug discovery, non-clinical development, and safety testing services worldwide and offer a comprehensive portfolio of services required for [added: the development and] regulatory submission of [removed: pharmaceuticals,] [added: pharmaceuticals] and industrial and agricultural [added: chemicals.]
We have extensive expertise in the discovery of [removed: small molecule] clinical candidates and in the design, execution, and reporting of safety assessment studies for numerous types of compounds including small and large molecule pharmaceuticals, industrial and agricultural chemicals, biocides and medical devices.
Our DSA segment represented [removed: 52.8%] [added: 58.1%] of our total revenue in [removed: 2017] [added: 2018] and employed approximately [removed: 6,400] [added: 8,800] of our employees including approximately [removed: 1,000] [added: 1,300] science professionals with advanced degrees.
Our Biologics Testing Solutions business provides specialized testing of biologics [removed: and devices] frequently outsourced by global pharmaceutical and biotechnology companies.
In [removed: 2017,] [added: 2018,] Manufacturing accounted for [removed: 20.7%] [added: 19.0%] of our total revenue from continuing operations and approximately [removed: 1,500] [added: 1,800] of our employees, including approximately [removed: 100] [added: 140] science professionals with advanced degrees.
In recent years, we have focused our efforts on improving the efficiency of our global operations to enhance our ability to support our [removed: key] clients.
Our [removed: key] pharmaceutical and biotechnology clients are increasingly seeking full service, “one-stop” global partners to whom they can outsource more of their drug discovery and development efforts.
It is estimated that the market for regulated safety assessment services is at least 50% outsourced, while emerging growth areas such as [removed: early and in vivo] discovery and certain research model services are currently believed to be less outsourced.
| • | spontaneous mutant, whose genotype results in a naturally occurring genetic mutation (such as immune deficiency); [added: and] |
| • | hybrid, which are the offspring of two different inbred parents; [removed: and] |
Certain of our research models are proprietary rodent models used to research treatments for diseases such as diabetes, obesity, cardiovascular, [removed: cancer] [added: cancer, central nervous system (CNS)] and kidney disease.
The creation of a genetically engineered model (GEM) is a critical scientific event, but it is only the first step in the discovery process, and our scientists can advise clients on how to efficiently create custom models utilizing [removed: together with] in-licensed technologies and approaches to modify the genome.
We manage research operations (including recruitment, training, [removed: staffing,] [added: staffing] and management services) [removed: for] [added: in our clients’ facilities or in custom-designed facilities in which we lease space to] government entities, academic organizations, and commercial clients.
Our Early [removed: Discovery] [added: Discovery, In Vitro] and In Vivo Discovery businesses are integrated into a single business line - Discovery Services - as evidence of our efforts to streamline and enhance the support we can provide for clients’ integrated drug discovery [removed: programs.][added: programs from target identification to a therapeutic candidate before progressing into safety assessment process.]
One seamless discovery organization [added: also] allows us to better engage with clients at [removed: the earliest stages] [added: any stage] of [added: their] drug discovery and support their complex scientific needs.
We support a variety of therapeutic areas including oncology, [removed: central nervous system,] [added: CNS, immunology,] bone and musculoskeletal, inflammation, metabolic diseases, respiratory and fibrotic diseases, cardiovascular, gastrointestinal, genito-urinary, anti-infectives, and ophthalmology.
We believe there are emerging opportunities to assist our clients in a variety of drug discovery applications and platforms from target discovery to candidate [removed: selection.][added: selection and across a range of modalities including small molecules, antibody and gene therapy.]
We are a global leader in integrated drug discovery services, with a predominant focus on in vitro biology [removed: capabilities] and medicinal [removed: chemistry.][added: chemistry capabilities.]
Our full suite of service offerings allows us to support our clients at the earliest stages of their research, and to stay with them through the entire [removed: early-stage] [added: drug discovery] process.
We also offer ion channel testing for both discovery and [removed: non-clinical] [added: pre-clinical] purposes.
Our genome editing capabilities enable us to develop more [removed: translational] [added: translationally relevant] research models designed to enhance scientific understanding and improve [added: the efficiency and effectiveness of the drug discovery process.]
In [removed: addition to providing these services to our clients at our research laboratories,] [added: addition,] we also provide [removed: some] [added: many] of these services at our clients’ laboratories with Charles River scientists as [added: part of] an in-sourcing service model.
In Vivo Discovery Services are essential in early stage, non-clinical [removed: discovery,] [added: discovery research,] directed at the identification, screening, [added: optimization] and selection of a [removed: lead compound] [added: candidate compounds] for drug development.
[removed: In] [added: These in] vivo activities typically extend anywhere from [removed: 4] [added: 2] to [removed: 6] [added: 4] years in conventional pharmaceutical research and development timelines.
In addition, we provide in vitro [removed: and in vivo] assays in support of lead optimization to candidate selection activities.
Examples of this include early pharmacokinetic and pharmacodynamic studies and in vitro and in vivo assays to assess mechanism, bioavailability, metabolism, efficacy, [added: pharmacology] and [removed: safety pharmacology.][added: safety.]
In August 2017, we acquired Brains On-Line (BOL), a leading CRO that provides critical data that advances novel therapeutics for the treatment of [removed: central nervous system (CNS)] [added: CNS] diseases.
Pharmacokinetics refers to the understanding of what the body does to a drug or compound administered at therapeutic dose levels, including the process by which the drug is absorbed, distributed in the body, metabolized and [removed: excreted (ADME).][added: excreted.]
After performing sample analysis in support of non-clinical studies, we also have the capabilities to [removed: capture the benefits of bridging] [added: support] the [removed: non-clinical] [added: clinical] bioanalysis [removed: with subsequent] [added: required in] clinical [removed: development.][added: trials.]
to, the SEC.
Our Early Discovery service capabilities include:
| • | target discovery and validation; |
| • | hit identification and optimization to deliver candidate molecules; and |
| • | target engagement biomarker development to support pre-clinical and potentially downstream clinical studies. |
In October 2018, we entered into an exclusive partnership with Distributed Bio, Inc., a leader in the computational design and optimization of antibody platforms.
This partnership will enable our clients to access Distributed Bio’s extensive antibody libraries and integrated antibody optimization technologies.
The combination of Distributed Bio’s antibody libraries with our extensive biologics development expertise creates a unique end-to-end platform for therapeutic antibody discovery and development.
In recent years we have made key acquisitions designed to augment our In Vivo Discovery Services offerings.
Through partnerships, we are also expanding towards the integrated discovery and pre-clinical development of therapeutic antibodies.
Our clients are also required to conduct an assessment of Safety Pharmacology.
This suite of studies is used to determine any effects on the vital organ systems of the body - cardiovascular, respiratory and CNS.
Along with heart rate and blood pressure measurements, the cardiovascular assessment will also assess if the test article has the potential to inhibit the cardiac ion channel and prolong the cardiac QT interval of the electrocardiogram.
Additionally, effects on the CNS and respiratory systems are assessed to complete the battery of studies to evaluate the vital organ systems of the body.
Supplemental studies can also be performed to assess the renal, gastrointestinal, and autonomic nervous systems, as well as, dependency potential.
Our capabilities can also be used to investigate the mode of action behind an adverse effect found in a safety assessment study.
| • | expertise in determining the potential for abuse of human pharmaceuticals (Drug Abuse Liability Testing); |
| • | expertise in testing of medical devices in the assessment of those devices and surrounding tissues; |
| • | expertise and experience and expertise in immunology and immunotoxicology; |
identify potential test compound-related changes.
In April 2018, we acquired MPI Research (MPI), a premier non-clinical contract research organization providing comprehensive testing services to biopharmaceutical and medical device companies worldwide.
Acquiring MPI enhanced our position as a leading global early-stage CRO by strengthening our ability to partner with clients across the drug discovery and development continuum.
The MPI business we acquired reports through our Discovery and Safety Assessment segment.
To meet growing demand, we are currently expanding our Biologics Testing Solutions service offerings and facilities in the US and Europe.
We also continue to enhance our small molecule and biologics manufacturing portfolio in areas of greatest industry need,
We also continue to broaden and extend our relationships with other research institutions across the portfolio.
For example, during the past year we were awarded a large multi-year contract in our RMS segment with the National Institute of Allergy and Infectious Diseases (NIAID), one of the NIH’s largest institutes, to manage NIAID’s research model operations.
We also extended our long-standing collaboration with The Michael J.
Fox Foundation for Parkinson’s Research (MJFF).
Since 2011, we have worked together with MJFF to accelerate the discovery of therapies for Parkinson’s disease.
Our clients' research and development needs continue to evolve, particularly with regard to larger biopharmaceutical companies.
This should lead to more opportunities for strategic
By partnering with a CRO like Charles River, they can take advantage of scientific reporting efficiencies that can result in months or years saved in getting a drug to market.
In addition, with one of the largest and most experienced SEND team in the industry, we believe that our services, quality and ability to navigate the complex world of electronic data for submission is an unmatched competitive advantage to be shared with all our clients.
As a result of this strategy, we have been successfully renewing the majority of our strategic partnerships.
In August 2017, we acquired Brains On-Line (BOL), a leading CRO that provides critical data that advances novel therapeutics for the treatment of CNS diseases.
In addition to conventional mergers and acquisitions, our long-term strategy includes growth through establishing relationships and exploring other opportunities and areas that have the potential to strengthen our broad-based portfolio of products and services.
Among other arrangements could include entering into a license agreement, strategic partnership or joint venture which will allow us to access cutting-edge or nascent technologies with an investment component (which ultimately may later become an acquisition).
For example, in October 2018, we entered into an exclusive partnership with Distributed Bio, Inc., a leader in the computational design and optimization of antibody platforms.
Clients
You may read and copy any materials we file with the SEC at the SEC's Public Reference Room at 100 F Street, NE, Washington,
DC 20549.
In addition, you may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
chemicals.
Our Early Discovery service capabilities include: target discovery and validation (which includes custom in vivo and in vitro genome editing), hit identification, medicinal chemistry, scale-up chemistry and testing how a drug is absorbed, distributed in the body, metabolized, and excreted (ADME).
the efficiency and effectiveness of the drug discovery process.
This acquisition strategically expands our existing CNS capabilities and establishes us as a single-source provider for a broad portfolio of discovery CNS services.
The addition of KWS enhances our discovery expertise, with complementary offerings that provide our clients with additional tools in the active therapeutic research areas of oncology and immunology.
In support of non-clinical drug safety testing, our clients are required to demonstrate that the test article as formulated does not have the potential to prolong the cardiac QT interval, effects on CNS and respiratory system.
laboratory services to a broad range of companies manufacturing and releasing products from the pharmaceutical, biotechnology, consumer products, and dairy industries worldwide.
In 2017, we launched our Cortex software that provides an integrated solution to securely consolidate, query and analyze data.
As these groups increasingly rely on and interact with one another in this field, we assist them in working together by developing deeper strategic relationships with each of these constituencies.
experience in project management.
For example, during the past year:
| • | We launched a multi-year strategic partnership with Nimbus Therapeutics to advance new programs spanning the disease areas of immunology, metabolic disorders and oncology from the discovery phase through to Investigational New Drug submission. |
| • | We extended our longstanding, strategic, integrated drug discovery partnership with Chiesi Farmaceutici SpA in the field of respiratory disease. Through this continued partnership, we provide Chiesi an extensive portfolio of integrated drug discovery capabilities, including medicinal chemistry, ADME/DMPK studies, pharmaceuticals, in vitro assays, in vivo models and safety pharmacology studies to help identify and test Chiesi’s candidates for preclinical development. |
For some of our partners, we provide a broad suite of research models and discovery and safety assessment services and for others we provide a customized and select array of discovery and safety assessment services and/or research models.
Offering flexibility enables our clients to utilize our products and services to deliver innovative health solutions in a manner which best suits their individual needs.
There have been fundamental changes in our clients' research and development needs, particularly with regard to the large pharmaceutical industry.
Our goal is to prevail in the majority of these opportunities.
Our clients have utilized this capability, which blends resources both inside and outside their walls.
In 2016, we completed three acquisitions.
In April 2016, we acquired WIL Research, a premier provider of safety assessment and contract development and manufacturing services to biopharmaceutical and agricultural and industrial chemical companies worldwide.
In June 2016, we acquired Blue Stream, an analytical CRO supporting the development of complex biologics and biosimilars.
In September 2016, we acquired Agilux, a CRO that provides a suite of integrated discovery small and large molecule bioanalytical services, drug metabolism and pharmacokinetic services, and pharmacology services.
Customers
We maintain a three-pronged sales organization with a focus on:
| • | global biopharmaceutical companies; |
| • | small and mid-sized pharmaceutical, biotechnology, agrochemical, industrial chemical, and veterinary medicine companies, as well as contract research organizations; and |
| • | academic and government institutions. |
This allows us to provide comprehensive coverage of all of the market segments among our diverse client population.
also adhere to the PHS Policy on Humane Care and Use of Laboratory Animals and follow the Guide for the Care and Use of Laboratory Animals produced by the Institute for Laboratory Animal Research.
New guidance related to the need for data integrity compliance programs have recently been released and may require additional efforts by CRL for validation, audit trail review and archiving activities to be considered.
To assure that we have proper regulatory oversight over electronic records, a dedicated quality function reviews computerized system practices to ensure that appropriate record controls are in place and that a robust audit strategy confirms requirements for compliance.
To assure these compliance
Mr. Johst currently serves as a trustee of Mt.
Ida College.
Davide Molho, age 48, joined our Italian operations in 1999 and was promoted to Director of Operations for RMS Italy in 2002.
In 2005, his role was expanded to include French RMS operations and in 2007, he became Corporate Vice President, European Research Models and Services with responsibility for all European RMS operations.
In July 2009, Dr. Molho was promoted to Corporate Senior Vice President, North American and European Research Models and Services.
An excerpt. Shown here: 40 of 127 rewritten, 40 of 59 added and 40 of 43 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2018 filing and the FY2017 filing.
Cover and table of contents
26 rewritten, 7 added, 7 removed, 62 unchanged
| FOR THE FISCAL YEAR ENDED DECEMBER [removed: 30, 2017] [added: 29, 2018] | |
[removed: ][added: ]
Indicate by check mark whether the registrant has submitted electronically [removed: and posted on its corporate Website, if any,] every Interactive Data File required to be submitted [removed: and posted] pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit [removed: and post] such files.) Yes ý No o
| Large accelerated filer ý | | Accelerated filer o | | Non-accelerated filer o [removed: (Do not check if smaller reporting company)] |
On [removed: July 1, 2017,] [added: June 30, 2018,] the aggregate market value of the Registrant’s voting common stock held by non-affiliates of the Registrant was approximately [removed: $4,728,183,315.][added: $5,286,825,427.]
As of January [removed: 26, 2018,] [added: 25, 2019,] there were [removed: 47,428,916] [added: 48,226,323] 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: 2018] [added: 2019] Annual Meeting of Shareholders scheduled to be held on May [removed: 8, 2018,] [added: 21, 2019,] which will be filed with the Securities and Exchange Commission (SEC) not later than 120 days after December [removed: 30, 2017,] [added: 29, 2018,] are incorporated by reference into Part III of this Annual Report on Form 10-K.
With the exception of the portions of the [removed: 2018] [added: 2019] 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: 2017][added: 2018]
| 1A | [Risk [removed: Factors](#sBBAE85FD77C65387B6C7C8E8CACA6140)] [added: Factors](#sBC58CDA292A9588DB4A4AEB18C53C9AB)] | [removed: [15](#sBBAE85FD77C65387B6C7C8E8CACA6140)] [added: [15](#sBC58CDA292A9588DB4A4AEB18C53C9AB)] |
| 1B | [Unresolved Staff [removed: Comments](#sDB1C4F2975835776AB164A6454B2126A)] [added: Comments](#s16DED8AD752556849B4FA4B039F939E7)] | [removed: [25](#sDB1C4F2975835776AB164A6454B2126A)] [added: [26](#s16DED8AD752556849B4FA4B039F939E7)] |
| 3 | [Legal [removed: Proceedings](#s7F9743983A135BABB24B700C59E1D8DC)] [added: Proceedings](#s161DE2A7DDE757C1B050C6D5EA228489)] | [removed: [26](#s7F9743983A135BABB24B700C59E1D8DC)] [added: [26](#s161DE2A7DDE757C1B050C6D5EA228489)] |
| 4 | Mine Safety Disclosures | [removed: [26](#sD9D2DE5BB2945D8EBE576627FAF3CC75)] [added: [27](#s4AAF21206131591CB5D7B2BDB8BC5E44)] |
| 5 | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | [removed: [26](#sC6C543BFBB62516F8D9EF53F0A337A8F)] [added: [27](#s0F8D48B5DC3855B7877B420ACE1CE73D)] |
| 6 | [Selected Consolidated Financial [removed: Data](#sB1501134F66553698207C10E72EEDDE3)] [added: Data](#sF735285D058857F7B99A49D58BF66272)] | [removed: [29](#sB1501134F66553698207C10E72EEDDE3)] [added: [29](#sF735285D058857F7B99A49D58BF66272)] |
| 7 | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s0365D1EEFFCC53679257005C53052B83)] [added: Operations](#s0E678A82ADBB5538BF95539D3807CC67)] | [removed: [30](#s26F9350516FA508D84A03B63D5F720C6)] [added: [30](#sFF02EB78B04B5E35BCF69A53D929E723)] |
| 7A | [Quantitative and Qualitative [removed: Disclosures](#sE5DC9931AB1E5C5DBA2607E5988C24DB)] [added: Disclosures](#sED479F1671CB57CEA2672F9FFD8F2E18)] about Market Risk | [removed: [47](#sE5DC9931AB1E5C5DBA2607E5988C24DB)] [added: [46](#sED479F1671CB57CEA2672F9FFD8F2E18)] |
| 8 | [Financial Statements and Supplementary [removed: Data](#s3BB79365FA8E5DBB9B57ADC735995631)] [added: Data](#s88AC47FF9A265D2F9F92C77CF1202195)] | [removed: [49](#s3BB79365FA8E5DBB9B57ADC735995631)] [added: [48](#s88AC47FF9A265D2F9F92C77CF1202195)] |
| 9 | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#s27065596F11359A3B8C2AABF86495B76)] [added: Disclosure](#s1914D365382F500188B9670301182D3A)] | [removed: [102](#s27065596F11359A3B8C2AABF86495B76)] [added: [103](#s1914D365382F500188B9670301182D3A)] |
| 9A | [Controls and [removed: Procedures](#s6958A33DC2CB508FBE98D1CCE1A7931F)] [added: Procedures](#s4465AFE6426B51509C12E4744702055F)] | [removed: [102](#s6958A33DC2CB508FBE98D1CCE1A7931F)] [added: [103](#s4465AFE6426B51509C12E4744702055F)] |
| 10 | [Directors, Executive Officers and Corporate [removed: Governance](#s71455A30232555DD8E22E516A46422AE)] [added: Governance](#s75E6DEEFED485ED29B2EE420452539B2)] | [removed: [103](#s71455A30232555DD8E22E516A46422AE)] [added: [104](#s75E6DEEFED485ED29B2EE420452539B2)] |
| 12 | [Security Ownership of Certain Beneficial Owners and Management and Related [removed: Stockholder](#sA56B4EB74FF057B2B5FBF6E9C3D0F466)] [added: Stockholder](#s04D698E1F2195AD9A3DD4990A518CD8E)] Matters | [removed: [103](#sA56B4EB74FF057B2B5FBF6E9C3D0F466)] [added: [104](#s04D698E1F2195AD9A3DD4990A518CD8E)] |
| 13 | [Certain Relationships and Related Transactions, and Director [removed: Independence](#sCF5E3C7E933551AA85DEEB91398B2377)] [added: Independence](#sFCD7817E279357FD8BE4C44CF8EEA5E0)] | [removed: [103](#sCF5E3C7E933551AA85DEEB91398B2377)] [added: [104](#sFCD7817E279357FD8BE4C44CF8EEA5E0)] |
| 14 | [Principal Accountant Fees and [removed: Services](#s7F600ECF29BB577280450CE1595256B0)] [added: Services](#sCBB59AC930B45C4E9CA6A88C449BE85B)] | [removed: [103](#s7F600ECF29BB577280450CE1595256B0)] [added: [104](#sCBB59AC930B45C4E9CA6A88C449BE85B)] |
| 15 | [Exhibits and Financial Statement [removed: Schedules](#s2A63922AF0D65784860B61D7EF0B1D1B)] [added: Schedules](#s50F0AC8A9AFB53E18F64DFD6F035A954)] | [removed: [104](#s2A63922AF0D65784860B61D7EF0B1D1B)] [added: [105](#s50F0AC8A9AFB53E18F64DFD6F035A954)] |
| Exhibit Index | | [removed: [107](#s853DE612D17C5FA2BA65DF92858CC155)] [added: [107](#sB3B1207C3F775711B2EAE9CD2FA82A95)] |
10-K 1 crl1229201810-k.htm 10-K
| 1 | [Business](#s00C7A97BB402589488D90BF6310DAE90) | [1](#s00C7A97BB402589488D90BF6310DAE90) |
| 2 | [Properties](#sDECE6B40F1B65F419E38ECAEE945AD44) | [26](#sDECE6B40F1B65F419E38ECAEE945AD44) |
| 9B | [Other Information](#s938E2549472C5A0E8CDC580C17FFCA49) | [103](#s938E2549472C5A0E8CDC580C17FFCA49) |
| 11 | [Executive Compensation](#s2D14B95E2965506EBCD6E7990A8CA070) | [104](#s2D14B95E2965506EBCD6E7990A8CA070) |
| 16 | Form 10-K Summary | [105](#sF92394E3EDF256CBB69B0FA353D19622) |
| Signatures | | [106](#s92EB2B004CD35E229C6A22A42E3E1ABE) |
10-K 1 crl1230201710-k.htm 10-K
| 1 | [Business](#s1C677B8C865D5F45A26AAABB3532DBE1) | [1](#s1C677B8C865D5F45A26AAABB3532DBE1) |
| 2 | [Properties](#sE5145F09ABFA57F48E903DD50CFA3523) | [25](#sE5145F09ABFA57F48E903DD50CFA3523) |
| 9B | [Other Information](#sDBAD204B5F5850FE9E83668E8F987ECD) | [102](#sDBAD204B5F5850FE9E83668E8F987ECD) |
| 11 | [Executive Compensation](#s2A5BEA488BC552A78A9FD852BB7F38A3) | [103](#s2A5BEA488BC552A78A9FD852BB7F38A3) |
| 16 | Form 10-K Summary | [104](#s4E13D47429ED57F39A52989A22A994B6) |
| Signatures | | [105](#s708AE9F5B5495CF2BAEC7BF7C031E6A4) |
Item 2. Properties
2 rewritten, 1 added, 0 removed, 9 unchanged
We own large facilities (facilities over 50,000 square feet) for our DSA businesses in Canada, France, Ireland, Netherlands, Scotland, and the U.S. and lease large facilities in England and the U.S. We own large RMS facilities in Canada, [removed: China,] France, Germany, Italy, Japan, England, and the U.S. We [removed: own] [added: lease] large [removed: Manufacturing segment] [added: RMS] facilities in [removed: the U.S. and] China.
For additional information, see Note [removed: 7,] [added: 9,] “Long-Term Debt and Capital Lease Obligations” and Note [removed: 13,] [added: 16,] “Commitments and Contingencies” included in Item 8, “Financial Statements and [removed: Other] Supplementary Data” in this Annual Report on Form 10-K.
We own large Manufacturing facilities in the U.S. and China.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
9 rewritten, 6 added, 23 removed, 21 unchanged
[added: 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: 2017.][added: 2018.]
As of January [removed: 26, 2018,] [added: 25, 2019,] there were [removed: 353] [added: 92] 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: 2017:][added: 2018:]
| October [removed: 1, 2017 to October] 28, [removed: 2017] [added: 2018 to November 24, 2018] | [removed: —] [added: 46] | | | [removed: $] [added: 121.82] | [removed: —] | | | — | | | [removed: $ |] 129,105 | | [added: |]
| Total | [removed: 89] [added: 413] | | | | | | | — | | | | | |
During the fourth quarter of fiscal year [removed: 2017,] [added: 2018,] we did not repurchase any shares of common stock under our [removed: Rule 10b5-1 Purchase Plan] [added: stock repurchase program] or in open market trading.
The following stock performance graph compares the annual percentage change in the Company’s cumulative total shareholder return on its Common Stock during a period commencing on December [removed: 29, 2012] [added: 28, 2013] and ending on December [removed: 30, 2017] [added: 29, 2018] (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: 2012 | | | |] 2013 | | | | 2014 | | | | 2015 | | | | 2016 | | | | 2017 | | | [added: | 2018 | | |]
| September 30, 2018 to October 27, 2018 | 173 | | | $ | 133.55 | | | — | | | $ | 129,105 | |
| November 25, 2018 to December 29, 2018 | 194 | | | 134.85 | | | | — | | | 129,105 | | |
As of December 29, 2018, we had $129.1 million remaining on the authorized stock repurchase program.
| Charles River Laboratories International, Inc. | $ | 100 | | | $ | 121 | | | $ | 150 | | | $ | 143 | | | $ | 205 | | | $ | 209 | |
| S&P 500 | 100 | | | | 114 | | | | 115 | | | | 129 | | | | 157 | | | | 150 | | |
| S&P 500 Health Care | 100 | | | | 125 | | | | 134 | | | | 130 | | | | 159 | | | | 169 | | |
Our common stock began trading on the New York Stock Exchange on June 23, 2000 under the symbol “CRL.” The following table shows the high and low sales prices for our common stock:
| | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Fiscal 2018 | High | | | | Low | | |
| First quarter (through January 26, 2018) | $ | 112.47 | | | $ | 104.00 | |
| Fiscal 2017 | High | | | | Low | | |
| First quarter | $ | 91.57 | | | $ | 75.25 | |
| Second quarter | 102.32 | | | | 86.44 | | |
| Third quarter | 109.59 | | | | 94.15 | | |
| Fourth quarter | 119.05 | | | | 99.12 | | |
| Fiscal 2016 | High | | | | Low | | |
| First quarter | $ | 81.61 | | | $ | 65.70 | |
| Second quarter | 87.95 | | | | 73.42 | | |
| Third quarter | 89.18 | | | | 75.54 | | |
| Fourth quarter | 84.53 | | | | 67.20 | | |
Dividends
We have not declared or paid any cash dividends on shares of our common stock in the past two years and we do not intend to pay cash dividends in the foreseeable future.
We currently intend to retain any earnings to finance future operations and expansion.
| October 29, 2017 to November 25, 2017 | — | | | — | | | | — | | | 129,105 | | |
| November 26, 2017 to December 30, 2017 | 89 | | | 104.20 | | | | — | | | 129,096 | | |
| Charles River Laboratories International, Inc. | $ | 100 | | | $ | 145 | | | $ | 174 | | | $ | 217 | | | $ | 207 | | | $ | 297 | |
| S&P 500 | 100 | | | | 132 | | | | 151 | | | | 153 | | | | 171 | | | | 208 | | |
| S&P 500 Health Care | 100 | | | | 141 | | | | 177 | | | | 190 | | | | 184 | | | | 225 | | |
Item 6. Selected Consolidated Financial Data
12 rewritten, 0 added, 0 removed, 14 unchanged
| | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | |
| Total revenue | $ | [removed: 1,857,601] [added: 2,266,096] | | | $ | [removed: 1,681,432] [added: 1,857,601] | | | $ | [removed: 1,363,302] [added: 1,681,432] | | | $ | [removed: 1,297,662] [added: 1,363,302] | | | $ | [removed: 1,165,528] [added: 1,297,662] | |
| Income from continuing operations, net of income taxes | [removed: 125,586] [added: 227,218] | | | | [removed: 156,086] [added: 125,586] | | | | [removed: 152,037] [added: 156,086] | | | | [removed: 129,924] [added: 152,037] | | | | [removed: 105,416] [added: 129,924] | | |
| Income (loss) from discontinued operations, net of income taxes | [added: 1,506 | | | |] (137 | | ) | | 280 | | | | (950 | | ) | | (1,726 | | ) | [removed: | (1,265 | | ) |]
| Basic | $ | [removed: 2.60] [added: 4.69] | | | $ | [removed: 3.28] [added: 2.60] | | | $ | [removed: 3.23] [added: 3.28] | | | $ | [removed: 2.76] [added: 3.23] | | | $ | [removed: 2.18] [added: 2.76] | |
| Diluted | $ | [removed: 2.54] [added: 4.59] | | | $ | [removed: 3.22] [added: 2.54] | | | $ | [removed: 3.15] [added: 3.22] | | | $ | [removed: 2.70] [added: 3.15] | | | $ | [removed: 2.15] [added: 2.70] | |
| Depreciation and amortization | $ | [removed: 131,159] [added: 161,779] | | | $ | [removed: 126,658] [added: 131,159] | | | $ | [removed: 94,881] [added: 126,658] | | | $ | [removed: 96,445] [added: 94,881] | | | $ | [removed: 96,636] [added: 96,445] | |
| Capital expenditures | [removed: 82,431] [added: 140,054] | | | | [removed: 55,288] [added: 82,431] | | | | [removed: 63,252] [added: 55,288] | | | | [removed: 56,925] [added: 63,252] | | | | [removed: 39,154] [added: 56,925] | | |
| Cash and cash equivalents | $ | [removed: 163,794] [added: 195,442] | | | $ | [removed: 117,626] [added: 163,794] | | | $ | [removed: 117,947] [added: 117,626] | | | $ | [removed: 160,023] [added: 117,947] | | | $ | [removed: 155,927] [added: 160,023] | |
| Total assets | [removed: 2,929,922] [added: 3,855,879] | | | | [removed: 2,711,800] [added: 2,929,922] | | | | [removed: 2,068,497] [added: 2,711,800] | | | | [removed: 1,870,578] [added: 2,068,497] | | | | [removed: 1,623,438] [added: 1,870,578] | | |
| Long-term debt, net and capital leases | [removed: 1,114,105] [added: 1,636,598] | | | | [removed: 1,207,696] [added: 1,114,105] | | | | [removed: 845,997] [added: 1,207,696] | | | | [removed: 740,557] [added: 845,997] | | | | [removed: 635,226] [added: 740,557] | | |
| Redeemable noncontrolling interest | [removed: 16,609] [added: 18,525] | | | | [removed: 14,659] [added: 16,609] | | | | [removed: 28,008] [added: 14,659] | | | | [removed: 28,419] [added: 28,008] | | | | [removed: 20,581] [added: 28,419] | | |
Item 8. Financial Statements and Supplementary Data
585 rewritten, 443 added, 279 removed, 1,154 unchanged
| [Report of Independent Registered Public Accounting [removed: Firm](#s17CE96C900545CC491A6E63B16A02653)] [added: Firm](#sACED2226FC245E8BADBC4CD5E693EE5C)] | [removed: [50](#s17CE96C900545CC491A6E63B16A02653)] [added: [49](#sACED2226FC245E8BADBC4CD5E693EE5C)] |
| Consolidated Statements of Income for fiscal years [removed: 2017, 2016] [added: 2018, 2017] and [removed: 2015] [added: 2016] | [removed: [52](#s733A9DFC826B50B5B5E1566E03DF0BB1)] [added: [51](#s0BCF4D90F1A350A487478276620ACFCE)] |
| Consolidated Statements of Comprehensive Income for fiscal years [removed: 2017, 2016] [added: 2018, 2017] and [removed: 2015] [added: 2016] | [removed: [53](#s1C3F8A5E5E1C503A853669B9E8F9F8AC)] [added: [52](#s93BCFD444E285190BF6FA33C17C65B31)] |
| Consolidated Balance Sheets as of December [removed: 30, 2017] [added: 29, 2018] and December [removed: 31, 2016] [added: 30, 2017] | [removed: [54](#s36959B6DE584523183DC0266F10A206E)] [added: [53](#s0BAA5AED934353A59E7AED11AE3E33AE)] |
| Consolidated Statements of Cash Flows for fiscal years [removed: 2017, 2016] [added: 2018, 2017] and [removed: 2015] [added: 2016] | [removed: [55](#s2275925CAD545DC5BF69B15CABFF5056)] [added: [54](#s005D0C30DE145B27AC42154F8A9D2740)] |
| Consolidated Statements of Changes in Equity for fiscal years [removed: 2017, 2016] [added: 2018, 2017] and [removed: 2015] [added: 2016] | [removed: [57](#sD01B76E17AAB5016B3049E07F77A2C91)] [added: [56](#s0355B3DCFF315178A565AC05446BEE1D)] |
| [Notes to Consolidated Financial [removed: Statements](#sF272A979C27E58CD91F6601357BDB6FF)] [added: Statements](#s1725686765285889BF798805F451060D)] | [removed: [58](#sF272A979C27E58CD91F6601357BDB6FF)] [added: [57](#s1725686765285889BF798805F451060D)] |
We have audited the accompanying consolidated balance sheets of Charles River Laboratories International, Inc. and its subsidiaries [added: (the “Company”)] as of December [removed: 30, 2017] [added: 29, 2018] and December [removed: 31, 2016,] [added: 30, 2017,] and the related consolidated statements of income, comprehensive income, changes in equity and cash flows for each of the three years in the period ended December [removed: 30, 2017,] [added: 29, 2018,] 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: 30, 2017,] [added: 29, 2018,] based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December [removed: 30, 2017] [added: 29, 2018] and December [removed: 31, 2016,] [added: 30, 2017,] and the results of its operations and its cash flows for each of the three years in the period ended December [removed: 30, 2017] [added: 29, 2018] in conformity with accounting principles generally accepted in the United States of America.
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December [removed: 30, 2017,] [added: 29, 2018,] based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) [removed: ("PCAOB")] [added: (PCAOB)] and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
As described in Management’s Report on Internal Control over Financial Reporting, management has excluded [removed: Brains On-Line] [added: MPI Research and KWS BioTest] from its assessment of internal control over financial reporting as of December [removed: 30, 2017] [added: 29, 2018] because [removed: it was] [added: they were] acquired by the Company in [removed: a] purchase business [removed: combination] [added: combinations] during [removed: 2017.][added: 2018.]
We have also excluded [removed: Brains On-Line] [added: MPI Research and KWS BioTest] from our audit of internal control over financial reporting.
[removed: Brains On-Line is a] [added: MPI Research and KWS BioTest are] wholly-owned [removed: subsidiary] [added: subsidiaries] whose total assets and total revenues excluded from management’s assessment and our audit of internal control over financial reporting [removed: each] represent [removed: less than 1%] [added: 5.4% and 9.6% respectively,] of the related consolidated financial statement amounts as of and for the year ended December [removed: 30, 2017.][added: 29, 2018.]
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 [removed: dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit]
[added: dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit] preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
| | Fiscal Year [removed: | | | | | | | |] [added: 2016] | | |
| | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | |
| Service revenue | $ | [removed: 1,298,298] [added: 1,687,941] | | | $ | [removed: 1,130,733] [added: 1,298,298] | | | $ | [removed: 858,244] [added: 1,130,733] | |
| Product revenue | [removed: 559,303] [added: 578,155] | | | | [removed: 550,699] [added: 559,303] | | | | [removed: 505,058] [added: 550,699] | | |
| Total revenue | [removed: 1,857,601] [added: 2,266,096] | | | | [removed: 1,681,432] [added: 1,857,601] | | | | [removed: 1,363,302] [added: 1,681,432] | | |
| Cost of products sold (excluding amortization of intangible assets) | [removed: 289,669] [added: 275,658] | | | | [removed: 277,034] [added: 289,669] | | | | [removed: 263,983] [added: 277,034] | | |
| Amortization of intangible assets | [removed: 41,370] [added: 64,830] | | | | [removed: 41,699] [added: 41,370] | | | | [removed: 24,229] [added: 41,699] | | |
| Interest income | [removed: 690] [added: 812] | | | | [removed: 1,314] [added: 690] | | | | [removed: 1,043] [added: 1,314] | | |
| Interest expense | [removed: (29,777] [added: (63,772] | | ) | | [removed: (27,709] [added: (29,777] | | ) | | [removed: (15,072] [added: (27,709] | | ) |
| Income from continuing operations, before income taxes | [removed: 296,955] [added: 281,681] | | | | [removed: 222,921] [added: 296,955] | | | | [removed: 195,428] [added: 222,921] | | |
| Provision for income taxes | [removed: 171,369] [added: 54,463] | | | | [removed: 66,835] [added: 171,369] | | | | [removed: 43,391] [added: 66,835] | | |
| Income from continuing operations, net of income taxes | [removed: 125,586] [added: 227,218] | | | | [removed: 156,086] [added: 125,586] | | | | [removed: 152,037] [added: 156,086] | | |
| Income (loss) from discontinued operations, net of income taxes | [removed: (137] [added: 1,506] | | [removed: )] | | [removed: 280] [added: (137] | | [added: )] | | [removed: (950] [added: 280] | | [removed: )] |
| Net income | [removed: 125,449] [added: 228,724] | | | | [removed: 156,366] [added: 125,449] | | | | [removed: 151,087] [added: 156,366] | | |
| Less: Net income attributable to noncontrolling interests | [removed: 2,094] [added: 2,351] | | | | [removed: 1,601] [added: 2,094] | | | | [removed: 1,774] [added: 1,601] | | |
| Net income attributable to common shareholders | $ | [removed: 123,355] [added: 226,373] | | | $ | [removed: 154,765] [added: 123,355] | | | $ | [removed: 149,313] [added: 154,765] | |
| Earnings (loss) per common share | | | | | | | | | | | | [added: | | | |]
| Continuing operations attributable to common shareholders | $ | [removed: 2.60] [added: 4.69] | | | $ | [removed: 3.28] [added: 2.60] | | | $ | [removed: 3.23] [added: 3.28] | |
| Discontinued operations | $ | [removed: —] [added: 0.03] | | | $ | [removed: 0.01] [added: —] | | | $ | [removed: (0.02] [added: 0.01] | [removed: )] |
| Net income attributable to common shareholders | $ | [removed: 2.60] [added: 4.72] | | | $ | [removed: 3.29] [added: 2.60] | | | $ | [removed: 3.21] [added: 3.29] | |
| Continuing operations attributable to common shareholders | $ | [removed: 2.54] [added: 4.59] | | | $ | [removed: 3.22] [added: 2.54] | | | $ | [removed: 3.15] [added: 3.22] | |
| Net income attributable to common shareholders | $ | [removed: 2.54] [added: 4.62] | | | $ | [removed: 3.23] [added: 2.54] | | | $ | [removed: 3.13] [added: 3.23] | |
| Net income | $ | [removed: 125,449] [added: 228,724] | | | $ | [removed: 156,366] [added: 125,449] | | | $ | [removed: 151,087] [added: 156,366] | |
February 13, 2019
| Cost of services provided (excluding amortization of intangible assets) | 1,150,371 | | | | 867,014 | | | | 760,439 | | |
| Selling, general and administrative | 443,854 | | | | 371,266 | | | | 364,708 | | |
| Operating income | 331,383 | | | | 288,282 | | | | 237,552 | | |
| Other income, net | 13,258 | | | | 37,760 | | | | 11,764 | | |
| Weighted-average number of common shares outstanding: | | | | | | | | | | | |
| Basic | 47,947 | | | | 47,481 | | | | 47,014 | | |
| Diluted | 49,018 | | | | 48,564 | | | | 47,958 | | |
| Goodwill | 1,247,133 | | | | 804,906 | | |
| Net income | $ | 228,724 | | | $ | 125,449 | | | $ | 156,366 | |
| Deferred revenue | 36,072 | | | | (8,466 | | ) | | 14,580 | | |
| Customer contract deposits | 28,115 | | | | — | | | | — | | |
| Payments on debt financing costs | (18,337 | | ) | | — | | | | (3,659 | | ) |
| Cash, cash equivalents, and restricted cash, end of period | $ | 197,318 | | | $ | 166,331 | | | $ | 119,894 | |
| Net income | — | | | — | | | | — | | | | 226,373 | | | | — | | | | — | | | — | | | | 226,373 | | | | 1,550 | | | | 227,923 | | |
| Reclassification due to adoption of ASU 2018-02 (See Note 1) | — | | | — | | | | — | | | | 3,330 | | | | (3,330 | | ) | | — | | | — | | | | — | | | | — | | | | — | | |
| Adjustment due to adoption of ASU 2016-01 (see Note 1) | — | | | — | | | | — | | | | 1,424 | | | | — | | | | — | | | — | | | | 1,424 | | | | — | | | | 1,424 | | |
| Dividends declared to noncontrolling interest | — | | | — | | | | — | | | | — | | | | — | | | | — | | | — | | | | — | | | | (1,431 | | ) | | (1,431 | | ) |
| Acquisition of treasury shares | — | | | — | | | | — | | | | — | | | | — | | | | 129 | | | (13,846 | | ) | | (13,846 | | ) | | — | | | | (13,846 | | ) |
| Retirement of treasury shares | (40,221 | ) | | (402 | | ) | | (1,195,614 | | ) | | (477,689 | | ) | | — | | | | (40,221 | ) | | 1,673,705 | | | | — | | | | — | | | | — | | |
| December 29, 2018 | 48,210 | | | $ | 482 | | | $ | 1,447,512 | | | $ | 42,096 | | | $ | (172,703 | ) | | 1 | | | $ | (55 | ) | | $ | 1,317,332 | | | $ | 2,446 | | | $ | 1,319,778 | |
Inventory value is based on the standard cost method for all businesses except for the Avian business, which is based on an average cost.
Standard costs are trued-up to reflect actual cost.
For publicly-held investments in the LPs, the Company adjusts for changes in fair market value based on reported share holdings at the end of each fiscal quarter.
Revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers.
Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”).
To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the amount to which the Company expects to be entitled.
Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.
Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available.
Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component.
Generally, the Company does not extend payment terms beyond one year.
Applying the practical expedient, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less.
None of the Company’s contracts contained a significant financing component during fiscal year 2018.
Contracts with customers may contain multiple performance obligations.
For such arrangements, the transaction price is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation.
The Company determines standalone selling prices based on the price at which the performance obligation is sold separately.
If the standalone selling price is not observable through past transactions,
the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.
Contracts are often modified to account for changes in contract specifications and requirements.
| | |
| --- | --- |
February 13, 2018
| | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Cost of services provided (excluding amortization of intangible assets) | 865,618 | | | | 757,732 | | | | 568,227 | | |
| Selling, general and administrative | 373,446 | | | | 367,548 | | | | 300,414 | | |
| Operating income | 287,498 | | | | 237,419 | | | | 206,449 | | |
| Other income, net | 38,544 | | | | 11,897 | | | | 3,008 | | |
| Cumulative translation adjustment related to intercompany loan forgiveness | — | | | | — | | | | (2,341 | | ) |
| (Gain) loss on bargain purchase | (277 | | ) | | 16 | | | | (9,837 | | ) |
| Capitalized interest | $ | 36 | | | $ | 4 | | | $ | 424 | |
| December 27, 2014 | 84,503 | | | $ | 845 | | | $ | 2,307,640 | | | $ | (138,775 | ) | | $ | (74,247 | ) | | 37,176 | | | $ | (1,423,260 | ) | | $ | 672,203 | | | $ | 3,724 | | | $ | 675,927 | |
| Net income | — | | | — | | | | — | | | | 149,313 | | | | — | | | | — | | | — | | | | 149,313 | | | | 936 | | | | 150,249 | | |
| Tax benefit associated with stock issued under employee compensation plans | — | | | — | | | | 10,608 | | | | — | | | | — | | | | — | | | — | | | | 10,608 | | | | — | | | | 10,608 | | |
| Acquisition of treasury shares | — | | | — | | | | — | | | | — | | | | — | | | | 1,590 | | | (117,478 | | ) | | (117,478 | | ) | | — | | | | (117,478 | | ) |
Unrealized gains and losses on available-for-sale marketable securities are included in accumulated other comprehensive loss.
| • | Redeemable noncontrolling interest - Valued using the income approach based on estimated future cash flows of the underlying business discounted by a weighted average cost of capital. |
Cost is determined on the average cost method for the small model business and first-in-first-out for the Company’s large model and Microbial Solutions businesses.
Certain businesses value inventory based on standard costs, which are periodically compared to and adjusted to actual costs.
The Company bases the fair value of identifiable intangible assets
performance.
Under the cost method of accounting, the Company’s investment is initially measured at cost, with distributions recognized in other income, net.
Distributions received in excess of earnings subsequent to the date of investment are considered a return of investment and are recorded as reductions of cost of the investment.
The Company reviews its cost method investments to determine whether a decline in fair value below the cost basis is other-than-temporary.
If the decline in fair value is determined to be other-than-temporary, the cost basis of the investment is written down to fair value.
In connection with the adoption of Accounting Standard Update (ASU 2016-09), “Improvements to Employee Share-Based Payment Accounting” (see further discussion in Newly Adopted Accounting Pronouncements), beginning in fiscal 2017, the Company elected to change its accounting policy to account for forfeitures when they occur on a modified retrospective basis, which resulted in an immaterial impact to the Company’s consolidated financial statements and related disclosures.
The Company recognizes revenue when all of the following conditions are satisfied: persuasive evidence of an arrangement exists, delivery has occurred or services have been provided, the price to the customer is fixed or determinable, and collectability is reasonably assured.
Service revenue is generally evidenced by client contracts, which range in duration from a few weeks to a few years and typically take the form of an agreed upon rate per unit or fixed fee arrangements.
Such contracts typically do not contain acceptance provisions based upon the achievement of certain study or laboratory testing results.
Revenue of agreed upon rate per unit contracts is recognized as services are performed, based upon rates specified in the contract.
In cases where performance spans reporting periods, revenue of fixed fee contracts is recognized as services are performed, measured on the ratio of outputs or performance obligations completed to the total contractual outputs or performance obligations to be provided.
Changes in estimated effort to complete the fixed fee contract are reflected in the period in which the change
becomes known.
Changes in scope of work are common, especially under long-term contracts, and generally result in a change in contract value.
Once the client has agreed to the changes in scope and renegotiated pricing terms, the contract value is amended and revenue is typically recognized as described above.
Billing schedules and payment terms are generally negotiated on a contract-by-contract basis.
Payments received in excess of revenue recognized are recorded as deferred revenue.
As the contracted services are subsequently performed and the associated revenue is recognized, the deferred revenue balance is reduced by the amount of revenue recognized during the period.
In other cases, services may be provided and revenue is recognized before the client is invoiced.
An excerpt. Shown here: 40 of 585 rewritten, 40 of 443 added and 40 of 279 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2018 filing and the FY2017 filing.
Item 9A. Controls and Procedures
7 rewritten, 0 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: 30, 2017,] [added: 29, 2018,] to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms.
Based on our assessment and those criteria, management concluded that the Company maintained effective internal control over financial reporting as of December [removed: 30, 2017.][added: 29, 2018.]
We have excluded the [removed: Brains On-Line] business [removed: acquisition] [added: acquisitions] completed during fiscal year [removed: 2017] [added: 2018, including MPI Research and KWS BioTest,] from the assessment of the effectiveness of internal control over financial reporting as of December [removed: 30, 2017.][added: 29, 2018.]
The acquired [removed: business is a] [added: businesses are] wholly-owned [removed: subsidiary] [added: subsidiaries] whose total assets and total revenue [removed: each] [added: collectively] represent [removed: less than 1.0%] [added: 5.4% and 9.6%, respectively,] of the related consolidated financial statement amounts as of and for fiscal year ended December [removed: 30, 2017.][added: 29, 2018.]
The effectiveness of our internal control over financial reporting as of December [removed: 30, 2017,] [added: 29, 2018,] 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 [removed: the fourth quarter of 2017,] [added: fiscal year 2018,] 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: 2017] [added: 2018] that materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
Item 10. Directors, Executive Officers and Corporate Governance
4 rewritten, 0 added, 0 removed, 17 unchanged
The 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: 2018] [added: 2019] Proxy Statement under the sections captioned “Nominees for Directors” and “Section 16(a) Beneficial Ownership Reporting Compliance” and is incorporated herein by reference thereto.
The information required by this Item regarding our corporate governance will be included in the [removed: 2018] [added: 2019] 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: 2018] [added: 2019] 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.
To obtain a copy, please mail a request to the Secretary, Charles River [removed: Laboratories,] [added: Laboratories International,] Inc., 251 Ballardvale Street, Wilmington, MA 01887.
Item 11. Executive Compensation
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item will be included in the [removed: 2018] [added: 2019] Proxy Statement under the sections captioned [removed: “2017] [added: “2018] 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: 2018] [added: 2019] 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: 2018] [added: 2019] Proxy Statement under the sections captioned “Related Person Transaction Policy” and “Corporate Governance-Director Qualification Standards; Director Independence” and is incorporated herein by reference thereto.
Item 14. Principal Accountant Fees and Services
1 rewritten, 0 added, 0 removed, 3 unchanged
The information required by this Item will be included in the [removed: 2018] [added: 2019] Proxy Statement under the section captioned “Statement of Fees Paid to Independent Registered Public Accounting Firm” and is incorporated herein by reference thereto.
Item 16. Form 10-K Summary
39 rewritten, 10 added, 7 removed, 54 unchanged
| | [removed: |] CHARLES RIVER LABORATORIES INTERNATIONAL, INC. | |
| | [removed: | By: | /s/ DAVID] [added: David] R. [removed: SMITH] [added: Smith] | [added: |]
| [added: February 13, 2019] | [added: By:] | [removed: David] [added: /s/ DAVID] R. [removed: Smith |] [added: SMITH] |
| [removed: Date:] | [removed: February 13, 2018 |] Corporate Executive Vice President and Chief Financial Officer | |
| By: | /s/ JAMES C. FOSTER | [removed: Chairman] [added: Chairman, President] and Chief Executive Officer | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ DAVID R. SMITH | Corporate Executive Vice President and | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ MICHAEL G. KNELL | Corporate Senior Vice President and | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ ROBERT J. BERTOLINI | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ STEPHEN D. CHUBB | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ DEBORAH T. KOCHEVAR | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ MARTIN MACKAY | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ JEAN-PAUL MANGEOLLE | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ GEORGE E. MASSARO | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ GEORGE M. MILNE, JR. | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ C. RICHARD REESE | Director | February 13, [removed: 2018] [added: 2019] |
| By: | /s/ RICHARD F. WALLMAN | Director | February 13, [removed: 2018] [added: 2019] |
| 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) | | [removed: S-1] [added: S-1/A] | June 23, 2000 | 4.1 |
| [removed: 4.2] [added: 4.2*] | [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 |
| [removed: 4.3] [added: 4.3*] | [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 |
| [removed: 10.3*] [added: 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 |
| [removed: 10.4*] [added: 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 |
| [removed: 10.5*] [added: 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 |
| [removed: 10.6*] [added: 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 |
| [removed: 10.7*] [added: 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 |
| [removed: 10.8*] [added: 10.9*] | [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 |
| [removed: 10.9*] [added: 10.10*] | [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 |
| [removed: 10.10*] [added: 10.11*] | [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 |
| [removed: 10.11*] [added: 10.12*] | [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 |
| [removed: 10.12*] [added: 10.13*] | [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 |
| [removed: 10.13*] [added: 10.14*] | [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 |
| [removed: 10.14*] [added: 10.15*] | [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 |
| [removed: 10.16*] [added: 10.21*] | [removed: [Agreement] [added: [Consulting Agreement] between [removed: Thomas Ackerman] [added: Davide Molho] and Charles River Laboratories, Inc. dated [removed: February 25, 2015](http://www.sec.gov/Archives/edgar/data/1100682/000129993315000318/exhibit1.htm)] [added: August 28, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000110068218000018/crl9292018ex103.htm)] | | [removed: 8-K] [added: 10-Q] | [removed: February 27, 2015] [added: November 7, 2018] | [removed: 99.10] [added: 10.3] |
| 10.18 | [Charles River Laboratories International, Inc. [removed: Seventh] [added: Eighth] Amended and Restated Credit Agreement dated March [removed: 30, 2016](http://www.sec.gov/Archives/edgar/data/1100682/000095010316012408/dp64764_ex1001.htm)] [added: 26, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000095010318003711/dp88533_ex1001.htm)] | | 8-K | [removed: April 5, 2016] [added: March 26, 2018] | 10.1 |
| [removed: 10.19*] [added: 10.16*] | [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 |
| 21.1 | [Subsidiaries of Charles River Laboratories International, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000110068218000005/crl1230201710-kxex211.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000004/crl1229201810-kxex211.htm)] | X | | | |
| 23.1 | [Consent of PricewaterhouseCoopers [removed: LLP](https://www.sec.gov/Archives/edgar/data/1100682/000110068218000005/crl1230201710-kxex231.htm)] [added: LLP](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000004/crl1229201810-kxex231.htm)] | X | | | |
| 31.1 | [Rule 13a-14(a)/15d-14(a) Certification of Chief Executive [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068218000005/crl1230201710-kxex311.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000004/crl1229201810-kxex311.htm)] | X | | | |
| 31.2 | [Rule 13a-14(a)/15d-14(a) Certification of Chief Financial [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068218000005/crl1230201710-kxex312.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000004/crl1229201810-kxex312.htm)] | X | | | |
| 32.1 | [Section 1350 Certification of the Chief Executive Officer and Chief Financial [removed: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068218000005/crl1230201710-kxex321.htm)] [added: Officer](https://www.sec.gov/Archives/edgar/data/1100682/000110068219000004/crl1229201810-kxex321.htm)] | X | | | |
| | | |
| --- | --- | --- |
| | | |
| 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. 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 |
| 4.6 | [Form of Note for 5.500% Senior Notes due 2026 (included with Exhibit 4.2)](http://www.sec.gov/Archives/edgar/data/1100682/000095010318004337/dp89174_ex0402.htm) | | 8-K | April 3, 2018 | 4.3 |
| 10.3* | [Charles River Laboratories International, Inc. 2018 Incentive Plan dated March 20, 2018](http://www.sec.gov/Archives/edgar/data/1100682/000110068218000008/crl3312018ex102.htm) | | 10-Q | May 10, 2018 | 10.2 |
| 10.19* | [Separation Memorandum between Davide Molho and Charles River Laboratories, Inc. dated August 1, 2018 (revised on August 28, 2018)](http://www.sec.gov/Archives/edgar/data/1100682/000110068218000018/crl9292018ex101.htm) | | 10-Q | November 7, 2018 | 10.1 |
| 10.20* | [Separation Agreement between Davide Molho and Charles River Laboratories, Inc. dated August 1, 2018 (revised on August 28, 2018)](http://www.sec.gov/Archives/edgar/data/1100682/000110068218000018/crl9292018ex102.htm) | | 10-Q | November 7, 2018 | 10.2 |
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| --- | --- | --- | --- |
| By: | /s/ CRAIG B. THOMPSON | Director | February 13, 2018 |
| | Craig B. Thompson | | |
| 2.1 | [Agreement and Plan of Merger, dated as of February 12, 2018, by and among Charles River Laboratories International, Inc., Forest Acquisition Corporation, ACP Mountain Holdings, Inc. and Avista Capital Partners IV GP, LP](http://www.sec.gov/Archives/edgar/data/1100682/000095010318001926/dp86745_ex0201.htm) | | 8-K | February 13, 2018 | 2.1 |
| 2.2 | [Commitment Letter dated as of February 12, 2018 between Charles River Laboratories International, Inc. and JPMorgan Chase Bank, N.A.](http://www.sec.gov/Archives/edgar/data/1100682/000095010318001926/dp86745_ex0202.htm) | | 8-K | February 13, 2018 | 2.2 |
| 10.15* | [Letter Agreements with Davide Molho dated May 22, 2009](http://www.sec.gov/Archives/edgar/data/1100682/000104746911001182/a2202149zex-10_17.htm) | | 10-K | February 23, 2011 | 10.17 |