What changed in this filing

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Item 1A. Risk Factors

2022-02-24 compared with 2021-02-25 · 86 added, 62 removed, 221 unchanged (40% of the section changed)

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Certain of our businesses operate in industries that may experience periodic, cyclical downturns.

We are subject to risks associated with public health crises and epidemics/pandemics, such as the COVID-19 pandemic.

Our global operations expose us to risks associated with public health crises and epidemics/pandemics, such as COVID-19.

The global spread of COVID-19 has created significant volatility, uncertainty and worldwide economic disruption, resulting in an economic slowdown of potentially extended duration.

COVID-19 has had an adverse impact on certain of our operations, supply chains and distribution systems, including as a result of impacts associated with preventive and precautionary measures that we, other businesses and governments are taking.

Due to these impacts and measures, we have experienced significant and unpredictable reductions as well as increases in demand for certain of our products.

Many employers in the United States and Europe are continuing to require their employees to work from home or not go into their offices.

If the pandemic continues and conditions worsen, we could experience a decline in sales activities and customer orders in certain of our businesses, and it remains uncertain what impact these declines would have on future sales and customer orders once conditions begin to improve.

In addition to existing travel restrictions, countries may continue to close or decline to reopen borders, impose prolonged quarantines, and further restrict travel, which would significantly impact our ability to support our sites and customers in those locations and the ability of our employees to get to their places of work to produce products, or significantly hamper our products from moving through the supply chain.

As a result, COVID-19 may materially adversely affect revenue growth in certain of our businesses, and it is uncertain how materially COVID-19 will affect our global operations generally if these impacts were to persist or worsen over an extended

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Risk Factors (continued)

period of time.

The extent and duration of the impacts are uncertain and dependent in part on customers returning to work and economic activity ramping up.

The company has mobilized to support the COVID-19 response with products and services that help diagnose the virus as well as assisting customers to develop potential therapeutics and vaccines used to protect from the virus.

Our ability to continue to manufacture products is highly dependent on our ability to maintain the safety and health of our factory employees.

The ability of our employees to work may be significantly impacted by individuals contracting or being exposed to COVID-19.

While we are following the requirements of governmental authorities and taking preventative and protective measures to prioritize the safety of our employees, these measures may not be successful, and we may be required to temporarily close facilities or take other measures.

While we are staying in close communication with our sites, employees, customers and suppliers and acting to mitigate the impact of this dynamic and evolving situation, the duration and extent of the effect of COVID-19 on the company is not determinable.

In addition, several of the company’s businesses have had an increase in revenues due to sales of products addressing diagnosis and treatment of COVID-19.

While these positive impacts are expected to continue into 2021, the duration and extent of future revenues from such sales are uncertain and dependent primarily on customer testing demand.

Our business is affected by general economic conditions and related uncertainties affecting markets in which we operate.

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dollar relative to other currencies in which the company sells products and services.

In addition, many of our employees, contract manufacturers, suppliers, job functions, outsourcing activities and manufacturing facilities are located outside the United States.

Some emerging market countries may be particularly vulnerable to periods of global and local political, legal, regulatory and financial instability, including issues of geopolitical relations, the imposition of international sanctions in response to certain state actions and/or sovereign debt issues, and may have a higher incidence of corruption and fraudulent business practices.

As a result of these and other factors, our strategy to grow in emerging markets may not be successful, and growth rates in these markets may not be sustainable.

In addition, many of our employees, contract manufacturers, suppliers, job functions, outsourcing activities and manufacturing facilities are located outside the U.S.

Accordingly, our future results could be harmed by a variety of factors, including:

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on goods from other countries and tariffs imposed by other countries on U.S.

goods, including the tariffs recently adopted by the U.S.

goods, including the tariffs adopted by the U.S.

government on various imports from China and by the Chinese government on certain U.S.

• the impact of public health epidemics/pandemics on the global economy, such as the COVID-19 pandemic;

• negative consequences from changes in tax laws;

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Risk Factors (continued)

• the impact of public health epidemics/pandemics on the global economy, such as the COVID-19 pandemic;

• uncertainties regarding the collectability of accounts receivable;

• the imposition of governmental controls;

• diverse data privacy and protection requirements;

• supply interruptions, which could disrupt our ability to produce our products;

• negative consequences from changes in tax laws;

• difficulty in staffing and managing widespread operations;

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• unexpected changes in regulatory requirements;

• the effects of the U.K.'s departure from the E.U., known as Brexit;

• geopolitical uncertainty or turmoil, including terrorism and war.

For example, on January 31, 2020, the United Kingdom formally withdrew from the European Union, or EU (commonly referred to as “Brexit”) and on December 24, 2020, the U.K.

and EU announced they had entered into a post-Brexit deal on certain aspects of trade and other strategic and political issues.

This withdrawal has created political and economic uncertainty, particularly in the United Kingdom and the EU, and this uncertainty may last for years.

Our business could be affected during this period of uncertainty, and perhaps longer, by the impact of the United Kingdom’s withdrawal from the EU.

In addition, our business could be negatively affected by new trade agreements between the United Kingdom and other countries, including the United States, and by the possible imposition of trade or other regulatory barriers in the United Kingdom.

These possible negative impacts, and others resulting from the United Kingdom’s withdrawal from the EU, may adversely affect our operating results and our customers’ businesses.

Demand for some of our products depends on capital spending policies of our customers and on government funding policies.

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An impasse in federal government budget decisions could lead to substantial delays or reductions in federal spending.

We are subject to risks associated with public health crises and epidemics/pandemics, such as the COVID-19 pandemic.

Our global operations expose us to risks associated with public health crises and epidemics/pandemics, such as COVID-19.

The global spread of COVID-19 has created significant volatility, uncertainty and worldwide economic disruption, resulting in an economic slowdown of potentially extended duration.

National, state and local governments have implemented and may continue to implement safety precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter in place orders and shutdowns and other measures.

These measures may disrupt normal business operations and may have significant negative impacts on businesses and financial markets worldwide.

The company has mobilized to support the COVID-19 response with products and services that help diagnose the virus as well as assisting customers to develop therapeutics and vaccines used to protect from the virus.

Our ability to continue to manufacture products is highly dependent on our ability to maintain the safety and health of our factory employees.

The ability of our employees to work may be significantly impacted by individuals contracting or being exposed to COVID-19.

In addition, several of the company’s businesses have had an increase in revenues due to sales of products addressing diagnosis and treatment of COVID-19.

While these positive impacts are expected to continue into 2022, the duration and extent of future revenues from such sales are uncertain and dependent primarily on customer testing demand.

Business Risks

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We sell our products in several industries that are characterized by rapid and significant technological changes, frequent new product and service introductions and enhancements and evolving industry standards.

Competitive factors include technological innovation, price, service and delivery, breadth of product line, customer support, e-business capabilities and the ability to meet the special requirements of customers.

Competitive factors include technological innovation, price, service and delivery, breadth of product line, customer support, e-business

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Risk Factors (continued)

capabilities and the ability to meet the special requirements of customers.

Our competitors may adapt more quickly to new technologies and changes in customers’ requirements than we can.

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• combining sales and marketing operations in appropriate markets to compete more effectively;

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Risk Factors (continued)

• finding new markets for our products;

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Our business could be adversely affected in the short term if any of our large third-party suppliers abruptly discontinues selling products to us.

Integrating PPD into our business may be more difficult, costly or time consuming than expected and the anticipated benefits and cost savings of the transaction may not be fully realized.

The success of the PPD acquisition, including the realization of anticipated benefits and cost savings, depends, in part, on our ability to successfully integrate PPD into our business.

The integration is a difficult, costly and time-consuming process.

It is possible that the integration process could result in the loss of key employees or the disruption of our ongoing business or that the alignment of standards, controls, procedures and policies may adversely affect our ability to maintain relationships with clients, customers, suppliers and employees or to fully achieve the anticipated benefits and cost savings of the transaction.

The loss of key employees could adversely affect our ability to successfully conduct our business in the markets in which PPD now operates, which could have an adverse effect on our financial results.

If we experience difficulties with the integration process, the anticipated benefits and cost savings of the PPD acquisition may not be realized fully or at all, or may take longer to realize than expected, and our business may be unable to grow as planned, which could materially impact our business, cash flow, financial condition or results of operations as well as adversely impact our share price.

The integration process may also result in significant expenses and charges, both cash and noncash.

Our inability to complete any pending acquisitions or to successfully integrate any new or previous acquisitions could have a material adverse effect on our business.

Our business strategy includes the acquisition of technologies and businesses that complement or augment our existing products and services.

Certain acquisitions may be difficult to complete for a number of reasons, including the need for antitrust and/or other regulatory approvals.

Any acquisition we may complete may be made at a substantial premium over the fair value of the net identifiable assets of the acquired company.

Certain acquisitions may be difficult to complete for a number of reasons, including the need for antitrust and/or other regulatory approvals, as well as disputes or litigation.

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Risk Factors (continued)

acquisition we may complete may be made at a substantial premium over the fair value of the net identifiable assets of the acquired company.

Further, we may not be able to integrate acquired businesses successfully into our existing businesses, make such businesses profitable, or realize anticipated cost savings or synergies, if any, from these acquisitions, which could adversely affect our business.

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In addition, if our new systems fail to provide accurate pricing and cost data our results of operations and cash flows could be adversely affected.

We also rely on our information technology systems to process, transmit and store electronic information (including sensitive data such as confidential business information and personally identifiable data relating to employees, customers and other business partners) and to manage or support a variety of critical business processes and activities (such as interacting with suppliers, selling our products and services, fulfilling orders and billing, collecting and making payments, shipping products,

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Risk Factors (continued)

providing services and support to customers, tracking customer activity, fulfilling contractual obligations and otherwise conducting business).

Our systems may be vulnerable to damage or interruption from natural disasters, power loss, telecommunication failures, terrorist attacks, computer hackers, computer viruses, ransomware, phishing, computer denial-of-service attacks, unauthorized access to customer or employee data or company trade secrets, and other attempts to harm our systems.

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Despite any precautions we may take, such problems could result in, among other consequences, interruptions in our services, which could harm our reputation and financial results.

Our key business partners face similar risks and any security breach of their systems could adversely affect our security posture.

Any of the cyber-attacks, breaches or other disruptions or damage described above, if significant, could materially interrupt our operations, delay production and shipments, result in theft of our and our customers’ intellectual property and trade secrets, damage customer, business partner and employee relationships and our reputation or result in defective products or services, legal claims and proceedings, liability and penalties under privacy laws and increased cost for security and remediation, each of which could adversely affect our business and financial results.

Our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyber-attacks and other related breaches.

If we are unable to maintain reliable information technology systems and appropriate controls with respect to global data privacy and security requirements and prevent data breaches, we may suffer regulatory consequences in addition to business consequences.

As a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of our business.

For example, in the United States, individual states regulate data breach and security requirements and multiple governmental bodies assert authority over aspects of the protection of personal privacy.

As a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed

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Risk Factors (continued)

controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of our business.

For example, in the U.S., individual states regulate data breach and security requirements and multiple governmental bodies assert authority over aspects of the protection of personal privacy.

European laws require us to have an approved legal mechanism to transfer personal data out of Europe, and the EU General Data Protection Regulation imposes significantly stricter requirements in how we collect and process personal data.

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Government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect our business, reputation and financial statements.

We may have difficulty attracting and retaining a highly qualified workforce.

Our success is largely dependent upon our ability to attract and retain highly qualified scientific, technical, clinical and management workforce in a highly competitive environment.

Qualified individuals are in high demand, and we may incur significant costs to attract them.

We may face difficulty in attracting and retaining key talent for a number of reasons, including management changes or recruitment by competitors.

Our ability to attract and retain key talent also depends in part on how well we maintain a strong workplace culture that is attractive to employees.

We cannot ensure that we will be able to hire or retain the personnel necessary for our operations or that the loss of any personnel will not have a material impact on our financial condition and results of operations.

We may incur unexpected costs from increases in fuel and raw material prices, which could reduce our earnings and cash flows.

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Any of these disruptions or other events outside of our control, such as strikes or other labor unrest, could have an adverse effect on our results of operations.

In addition, if any of our facilities, including our manufacturing or warehouse facilities, or the facilities of our suppliers, third-party service providers, or customers, is affected by natural disasters, such as earthquakes, tsunamis, power shortages or outages, floods or monsoons, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war, political instability or other conflict, or other events outside of our control, such as strikes or other labor unrest, our results of operations could be adversely affected.

In addition, if any of our facilities, including our manufacturing or warehouse facilities, or the facilities of our suppliers, third-party service providers, or customers, is affected by natural disasters, such as earthquakes, tsunamis, power shortages or outages, floods or monsoons, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war, political instability or other conflict, or other events outside of our control, such as trade protectionism, strikes or other labor unrest, our results of operations could be adversely affected.

Moreover, these types of events could negatively impact customer spending in the impacted regions or depending upon the severity, globally, which could also adversely impact our operating results.

For example, as described above, the COVID-19 pandemic has impacted and could have a material adverse effect on our business and results of operations.

Increasing attention to environmental, social and governance matters may impact our business, financial results or stock price.

Companies across all industries are facing increasing scrutiny from stakeholders related to their environmental, social and governance (ESG) practices and disclosures, including practices and disclosures related to climate change, diversity and inclusion and governance standards.

Investor advocacy groups, certain institutional investors, lenders, investment funds and other influential investors are also increasingly focused on ESG practices and disclosures and in recent years have placed increasing importance on the implications and social cost of their investments.

In addition, government organizations are enhancing or advancing legal and regulatory requirements specific to ESG matters.

The heightened stakeholder focus on ESG issues related to our business requires the continuous monitoring of various and evolving laws, regulations, standards and expectations and the associated reporting requirements.

A failure to adequately meet stakeholder expectations may result in noncompliance, the loss of business, reputational impacts, diluted market valuation, an inability to attract customers and an

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Risk Factors (continued)

inability to attract and retain top talent.

In addition, our adoption of certain standards or mandated compliance to certain requirements could necessitate additional investments that could impact our profitability.

Legal, Quality and Regulatory Risks

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Changes in the U.S.

Food and Drug Administration’s regulation of the drug discovery and development process could have an adverse effect on the demand for these products.

Food and Drug Administration’s (the FDA) regulation of the drug discovery and development process could have an adverse effect on the demand for these products.

We are subject to laws and regulations governing government contracts, and failure to address these laws and regulations or comply with government contracts could harm our business by leading to a reduction in revenues associated with these customers.

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If any of these products were to malfunction, it is possible that explosive or radioactive material could fail to be detected by our product, which could lead to product liability claims.

In addition, patients involved in our clinical services trials conducted by our clinical development services business or taking drugs approved on the basis of those trials may also bring personal injury claims against us.

There are also many other factors beyond our control that could lead to liability claims, such as the reliability and competence of the customers’ operators and the training of such operators.

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Although we carry product liability insurance, we cannot be certain that our current insurance will be sufficient to cover these claims or that it can be maintained on acceptable terms, if at all.

We are required to comply with a wide variety of laws and regulations, and are subject to regulation by various federal, state and foreign agencies.

We are subject to various local, state, federal, foreign and transnational laws and regulations, which include the operating and security standards of the U.S.

Federal Drug Administration (the FDA), the U.S.

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Risk Factors (continued)

We are required to comply with a wide variety of laws and regulations, and are subject to regulation by various federal, state and foreign agencies.

We are subject to various local, state, federal, foreign and transnational laws and regulations, which include the operating and security standards of the FDA, the U.S.

Drug Enforcement Agency (the DEA), various state boards of pharmacy, state health departments, the U.S.

Department of Health and Human Services (the DHHS), the European Medicines Agency (the EMA), in Europe, the EU member states and other comparable agencies and, in the future, any changes to such laws and regulations could adversely affect us.

Department of Health and Human Services (the DHHS), the European Medicines Agency (the EMA), the EU member states and other comparable agencies and, in the future, any changes to such laws and regulations could adversely affect us.

In particular, we are subject to laws and regulations concerning current good manufacturing practices and drug safety.

Our subsidiaries may be required to register for permits and/or licenses with, and may be required to comply with the laws and regulations of the DEA, the FDA, the DHHS, foreign agencies including the EMA, and other various state boards of pharmacy, state health departments and/or comparable state agencies as well as certain accrediting bodies depending upon the type of operations and location of product distribution, manufacturing and sale.

The manufacture, distribution and marketing of many of our products and services, including medical devices and pharma services, are subject to extensive ongoing regulation by the FDA, the DEA, the EMA, and other equivalent local, state, federal and non-U.S.

The manufacture, distribution and marketing of many of our products and services, including medical devices, and our pharma and clinical development services, are subject to extensive ongoing regulation by the FDA, the DEA, the EMA, and other equivalent local, state, federal and non-U.S.

regulatory authorities.

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Failure by us or by our customers to comply with the requirements of these regulatory authorities, including without limitation, remediating any inspectional observations to the satisfaction of these regulatory authorities, could result in warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution, restrictions on our operations, civil or criminal sanctions, or withdrawal of existing or denial of pending approvals, including those relating to products or facilities.

In addition, such a failure could expose us to contractual or product liability claims, contractual claims from our customers, including claims for reimbursement for lost or damaged active pharmaceutical ingredients, as well as ongoing remediation and increased compliance costs, any or all of which could be significant.

In addition, such a failure could expose us to contractual or product liability claims, contractual claims from our customers, including claims for reimbursement for lost or damaged active pharmaceutical ingredients or personal injury, as well as ongoing remediation and increased compliance costs, any or all of which could be significant.

We are the sole manufacturer of a number of pharmaceuticals for many of our customers and a negative regulatory event could impact our customers' ability to provide products to their customers.

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and/or non-U.S.

laws, including the laws governing payments to government officials, bribery, fraud, kickbacks and false claims, pricing, sales and marketing practices, conflicts of interest, competition, employment practices and workplace behavior, export and import compliance, money laundering and data privacy, but we cannot provide assurance that these controls and systems will prevent every such wrongful act.

laws, including the laws governing payments to government officials, bribery, fraud, kickbacks and false claims, pricing, sales and marketing practices, conflicts of interest, competition, employment practices and workplace behavior, export and import compliance, money laundering and data privacy, but these controls and systems may not be sufficient to prevent every such wrongful act.

In particular, the U.S.

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Bribery Act 2010 and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business, and we operate in many parts of the world that have experienced governmental corruption to some degree.

Any such improper actions or allegations of such acts could damage our reputation and subject us to civil or criminal investigations in the United States and in other jurisdictions and related shareholder lawsuits, could lead to substantial civil and criminal, monetary and nonmonetary penalties and could cause us to incur significant legal and investigatory fees.

Any such improper actions or allegations of such acts could damage our reputation and subject us to civil or criminal investigations in the U.S.

and in other jurisdictions and related shareholder lawsuits, could lead to substantial civil and criminal, monetary and nonmonetary penalties and could cause us to incur significant legal and investigatory fees.

In addition, the government may seek to hold us liable for violations committed by companies which we acquire.

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We place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and processes because of the length of time and expense associated with bringing new products through the development process and into the marketplace.

Our success depends in part on our ability to develop patentable products and obtain and enforce patent protection for our products both in the United States and in other countries.

Our success depends in part on our ability to develop patentable products and obtain and enforce patent protection for our products both in the U.S.

and in other countries.

We own numerous U.S.

and foreign patents, and we intend to file additional applications, as appropriate, for patents covering our products.

Patents may not be issued for any pending or future patent applications owned by or licensed to us, and the claims allowed under any issued patents may not be sufficiently broad to protect our technology.

Any issued patents owned by or licensed to us may be challenged, invalidated or circumvented, and the rights under these patents may not provide us with competitive advantages.

Patents may not

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Risk Factors (continued)

addition, competitors may design around our technology or develop competing technologies.

be issued for any pending or future patent applications owned by or licensed to us, and the claims allowed under any issued patents may not be sufficiently broad to protect our technology.

Any issued patents owned by or licensed to us may be challenged, invalidated or circumvented, and the rights under these patents may not provide us with competitive advantages.

In addition, competitors may design around our technology or develop competing technologies.

Intellectual property rights may also be unavailable or limited in some foreign countries, which could make it easier for competitors to capture increased market position.

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We also rely on trade secrets and proprietary know-how with which we seek to protect our products, in part, by confidentiality agreements with our collaborators, employees and consultants.

These agreements may not adequately protect our trade secrets and other proprietary rights.

These agreements may be breached and we may not have adequate remedies for any breach.

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In preparing our financial statements, we record the amount of tax that is payable in each of the countries, states and other jurisdictions in which we operate.

Our future effective tax rate, however, may be lower or higher than experienced in the past due to numerous factors, including a change in the mix of our profitability from country to country, changes in accounting for income taxes and recently enacted and future changes in tax laws in jurisdictions in which we operate.

Our future effective tax rate, however, may be lower or higher than experienced in the past due to numerous factors, including a change in the mix of our profitability from country to country, changes in accounting for income taxes, the results of examinations and audits of our tax filings and recently enacted and future changes in tax laws in jurisdictions in which we operate.

Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could have an adverse effect on our business, results of operations and cash flows.

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As of December 31, 2021, we had approximately $34.87 billion in outstanding indebtedness.

In addition, we have availability to borrow under a revolving credit facility that provides for up to $3.00 billion of unsecured multi-currency revolving credit.

In addition, we have availability to borrow under a revolving credit facility that provides for up to $5.00 billion (as of January 7.

2022) of unsecured multi-currency revolving credit (the Facility).

We may also obtain additional long-term debt and lines of credit to meet future financing needs, which would have the effect of increasing our total leverage.

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If we are unable to service our debt, refinance our existing debt or obtain additional financing, we may be forced to delay strategic acquisitions, capital expenditures or research and development expenditures.

Additionally, the agreements governing our debt require that we maintain certain financial ratios, and contain affirmative and negative covenants that restrict our activities by, among other limitations, limiting our ability to incur additional indebtedness, merge or consolidate with other entities, make investments, create liens, sell assets and enter into transactions with affiliates.

Additionally, the agreements governing our debt require that we maintain a financial ratio, and contain affirmative and negative covenants that restrict our activities by, among other limitations, limiting our ability to incur additional indebtedness, merge or consolidate with other entities and create liens.

The covenants in the Facility include a Consolidated Net Interest Coverage Ratio (Consolidated EBITDA to Consolidated Net Interest Expense), as such terms are defined in the Facility.

Specifically, the company has agreed that, so long as any lender has any commitment under the Facility, any letter of credit is outstanding under the Facility, or any loan or other obligation is outstanding under the Facility, it will maintain a minimum Consolidated Interest Coverage Ratio of 3.5:1.0 as of the last day of any fiscal quarter.

Our ability to comply with these financial restrictions and covenants is dependent on our future performance, which is subject to prevailing economic conditions and other factors, including factors that are beyond our control such as the impact of public health epidemics/pandemics like COVID-19, foreign exchange rates and interest rates.

Our failure to comply with any of these restrictions or covenants may result in an event of default under the applicable debt instrument, which could permit

Our failure to comply with any of these restrictions or covenants may result in an event of default under the applicable debt instrument, which could permit acceleration of the debt under that instrument and

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Risk Factors (continued)

acceleration of the debt under that instrument and require us to prepay that debt before its scheduled due date.

require us to prepay that debt before its scheduled due date.

Also, an acceleration of the debt under certain of our debt instruments would trigger an event of default under other of our debt instruments.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors