What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2022-02-16 compared with 2021-02-12 · 46 added, 46 removed, 612 unchanged (13% of the section changed)

33 unchanged sentences

• Due to the global nature of our business we are subject to international economic, political and other risks that could negatively affect our results of operations and financial condition.

• Climate change may have an impact on our business.

Liability Exposure

23 unchanged sentences

Our business and operations has been and may in the future be adversely affected by the novel coronavirus (COVID-19) pandemic.

The outbreak of the novel coronavirus, or COVID-19, and the various governmental, industry and consumer actions related thereto, could have a material and adverse effect on our business, financial condition and results of operations.

These effects, which largely depend on future developments that cannot be accurately predicted and are uncertain, could include a negative impact on the availability of our key personnel, temporary closures of our facilities or the facilities of our business partners, customers, suppliers, third party service providers or other vendors, an increased risk of customer defaults or delays in payments or purchasing decisions, and the interruption of domestic and global supply chains, distribution channels, liquidity and capital or financial markets.

As COVID-19 continues to spread, we have and may in the future experience disruptions that could severely impact our business, including:

The COVID-19 pandemic, and the various governmental, industry and consumer actions related thereto, had, and may continue to have, an adverse effect on our business, financial condition and results of operations.

These effects have included, and may include in the future, a negative impact on the availability of our key personnel, temporary closures of our facilities or the facilities of our business partners, customers, suppliers, third party service providers or other vendors, an increased risk of customer defaults or delays in payments or purchasing decisions, and the interruption of domestic and global supply chains, distribution channels, liquidity and capital or financial markets.

As COVID-19, including any variants, continues to spread, we have and may in the future experience disruptions that could severely impact our business, including:

• closure or inaccessibility of clinical site locations;

4 unchanged sentences

• significant disruption in our businesses that rely on face-to-face interactions or are dependent on in-person gatherings, events or conferences;

• significant and unpredictable reductions or increases in demand for certain of our offerings.

In addition, we have directed a substantial portion of our workforce to work from home while the outbreak persists in order to help minimize the risk of COVID-19 to our employees.

Having a significant portion of our workforce working from home could cause an increased risk of loss of productivity, greater cybersecurity risk, and increased risk to our system of internal controls over financial reporting.

Having a significant portion of our workforce working from home has caused an increased risk of loss of productivity, greater cybersecurity risk, and increased risk to our system of internal controls over financial reporting.

To the extent global conditions improve, the duration and sustainability of any such improvements will be uncertain and continuing adverse impacts and/or the degree of improvement may vary by geography.

The actions we take in response to any improvements in conditions, such as our return-to-office plans, may also vary by geography and by business and will likely be made with incomplete information.

There is a risk that such actions may prove to be premature, incorrect or insufficient and could have a material and adverse impact on our business and results of operations.

Further, the effects of the pandemic may also increase our cost of capital or make additional capital more difficult or available only on terms less favorable to us.

69 unchanged sentences

We may be required to incur significant costs to alleviate, remedy or protect against damage caused by these disruptions or security breaches in the future.

We may also face inquiry or

increased scrutiny from government agencies as a result of any such disruption or breach.

We may also face inquiry or increased scrutiny from government agencies as a result of any such disruption or breach.

While we have insurance coverage for certain instances of a cyber security breach, our coverage may not be sufficient if we suffer a significant attack or multiple attacks.

10 unchanged sentences

We continue to invest significantly in growth opportunities, including the development and acquisition of new data, technologies and services to meet our clients’ needs.

For example, we are expanding our services and technology offerings, such as the development of a cloud-based platform with a growing number of applications to support commercial and clinical operations for life sciences companies (e.g., multi-channel marketing, marketing campaign management, customer relationship management, incentive compensation management, targeting and segmentation, performance management, site engagement payments, trial master file, risk based monitoring, clinical trial management and decentralized trials and other applications).

For example, we are expanding our services and technology offerings, such as the development of a cloud-based platform with a growing number of applications to support commercial and clinical operations for life sciences companies (e.g., multi-channel marketing, marketing campaign management, customer relationship management, incentive compensation management, targeting and segmentation, performance management, site engagement payments, trial master file, risk based monitoring, in-home nursing and other services, clinical trial management and decentralized trials and other applications).

We also continue to invest significantly in growth opportunities in emerging markets, such as the development, launch and enhancement of services in China, India, Russia, Turkey, and other countries.

9 unchanged sentences

For example, United States federal regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) create specific requirements for the protection of the privacy and security of individual health information.

These provisions apply to both “covered entities” (primarily health care

providers and health insurers) and their “business associates” or service providers.

These provisions apply to both “covered entities” (primarily health care providers and health insurers) and their “business associates” or service providers.

As there are some instances where we are a HIPAA “business associate” of a “covered entity,” we can be directly liable for mishandling protected health information.

28 unchanged sentences

Many Privacy Laws protect more than patient information, and although they vary by jurisdiction, these laws can extend to employee information, business contact information, provider information and other information relating to identifiable individuals.

Failure to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to our

reputation and liability under contractual provisions.

Failure to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to our reputation and liability under contractual provisions.

In addition, compliance with such laws may require increased costs to us or may dictate that we not offer certain types of services.

59 unchanged sentences

The rate at which our backlog converts to revenue may vary over time for a variety of reasons.

The revenue recognition on larger, more global projects could be slower than on smaller, less global projects for a variety of reasons, including but not limited to an extended period of negotiation between the time the project is awarded to us and the actual execution of the contract, as well as an

increased timeframe for obtaining the necessary regulatory approvals.

Additionally, the increased complexity of the drug development pipeline and the need to enroll precise patient populations could extend the length of clinical trials causing revenue to be recognized over a longer period of time.

55 unchanged sentences

• required compliance with a variety of local laws and regulations which may be materially different than those to which we are subject in the United States or which may change unexpectedly;

limiting the amount of data necessary for a clinical trial to proceed, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenue;

for example, conducting a single clinical trial across multiple countries is complex, and issues in one country, such as a failure to comply with local regulations or restrictions, may affect the progress of the clinical trial in the other countries, for example, by limiting the amount of data necessary for a clinical trial to proceed, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenue;

• the United States or foreign countries could enact legislation or impose regulations or other restrictions, including unfavorable labor regulations, tax policies or economic sanctions, which could have an adverse effect on our ability to conduct business in or expatriate profits from the countries in which we operate, including hiring, retaining and overseeing qualified management personnel for managing operations in multiple countries, differing employment practices and labor issues, and tax-related risks, including the imposition of taxes and the lack of beneficial treaties, that result in a higher effective tax rate for us;

7 unchanged sentences

• clients in foreign jurisdictions may have longer payment cycles, and it may be more difficult to collect receivables in foreign jurisdictions;

• natural disasters, pandemics such as the COVID-19 (coronavirus), or international conflict, including terrorist acts, could interrupt our services, endanger our personnel, lower patient visits and increase patient drop-out rates, cause delays in recruitment of new patients, decrease the productivity of our clinical research associates, cause other project delays or loss of clinical trial materials or results.

• natural disasters, public health emergencies and pandemics such as the COVID-19, including any variants, or international conflict, including terrorist acts, could interrupt our services, endanger our personnel, lower patient visits and increase patient drop-out rates, cause delays in recruitment of new patients, decrease the productivity of our clinical research associates, cause other project delays or loss of clinical trial materials or results.

These risks and uncertainties could negatively impact our ability to, among other things, perform large, global projects for our clients.

1 unchanged sentence

Any such risks could have an adverse impact on our financial condition and results of operations.

Climate change may have an impact on our business.

While we have determined that, at this time, climate change does not present a material risk to our business given the nature of our activities, we continue to evaluate and mitigate our business risks associated with climate change, and we recognize that there are inherent climate-related risks wherever business is conducted.

Any of our office or IT systems locations may be vulnerable to the adverse effects of climate change.

Furthermore, climate change may impact patients in our clinical trials and our employees, particularly where they work remotely.

Changing market dynamics, global policy developments, and the increasing frequency and impact of extreme weather events on critical infrastructure have the potential to disrupt our business, the business of our third-party suppliers, and the business of our customers, and may cause us to experience losses and additional costs to maintain or resume operations.

Exchange rate fluctuations may affect our results of operations and financial condition.

31 unchanged sentences

As we develop new services or enter new markets, including services targeted at participants in the broader healthcare industry, we may not have or adequately build the competencies necessary to perform such services satisfactorily, may not receive market acceptance for such services or may face increased competition.

If we are unable to

succeed in developing new services, entering new markets or attracting a client base for our new services or in new markets, we will be unable to implement this element of our growth strategy, and our future business, reputation, results of operations and financial condition could be adversely affected.

If we are unable to succeed in developing new services, entering new markets or attracting a client base for our new services or in new markets, we will be unable to implement this element of our growth strategy, and our future business, reputation, results of operations and financial condition could be adversely affected.

Our Research & Development Solutions business could subject us to potential liability that may adversely affect our results of operations and financial condition.

33 unchanged sentences

For example, if we are unable to engage investigators to conduct clinical trials as planned or enroll sufficient patients in clinical trials, we might need to expend additional funds to obtain access to resources or else be compelled to delay or modify the clinical trial plans, which may result in additional costs to us.

If we lose the services of key personnel or are unable to recruit additional qualified personnel, our business could be adversely affected.

If we lose the services of key personnel or experience sustained labor shortages and are unable to recruit additional qualified personnel, or we are required to substantially increase wage rates to attract or retain employees, our business could be adversely affected.

Our success substantially depends on the collective performance, contributions and expertise of our personnel including senior management and key personnel, qualified professional, scientific and technical operating staff and qualified sales representatives for our contract sales services.

There is significant and increasing competition for qualified personnel, particularly those with higher educational degrees, such as a medical degree, a Ph.D.

or an equivalent degree, or relevant experience in the industry and in the locations in which we operate.

In addition, the departure of our key employees, or our inability to continue to identify, attract and retain qualified personnel or replace any departed personnel in a timely fashion, may impact our ability to grow our business and compete effectively in our industry and may negatively affect our ability to meet financial and operational goals.

or an equivalent degree, or relevant experience in the industry, including highly technical specialties such as clinical research associates, project managers and technology developers, and in the locations in which we operate.

This increase in competition and shortage of qualified personnel in certain specialty areas may make it more difficult to hire and retain our key employees and could result in substantial increased costs, such as increased wage rates to attract and retain employees.

The departure of our key employees, or our inability to continue to identify, attract and retain qualified personnel or replace departed personnel in a timely fashion, may impact our ability to grow our business and compete effectively in our industry and may negatively affect our ability to meet financial and operational goals.

Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition.

12 unchanged sentences

tax law which has been substantially modified by the Tax Cuts and Jobs Act enacted in 2017 (“Tax Act”).

Currently, regulations regarding Global Intangible Low-Taxed Income (“GILTI”) and the use of Foreign Tax Credits have been issued in proposed form, and if the application of these provisions are modified to change the interpretation to us it could have an adverse impact on our effective income tax rate.

In the course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain which may require the use of estimates and significant judgement to account for their impact on the effective income tax rate in our consolidated financial statements.

21 unchanged sentences

We may also spend time and money investigating and negotiating with potential acquisition targets but not complete the transaction.

Any future acquisition could involve other risks, including, among others, the assumption of additional liabilities and expenses, difficulties and

expenses in connection with integrating the acquired companies and achieving the expected benefits, issuances of potentially dilutive securities or interest-bearing debt, loss of key employees of the acquired companies, transaction costs, diversion of management’s attention from other business concerns and, with respect to the acquisition of foreign companies, the inability to overcome differences in foreign business practices, language and customs.

Any future acquisition could involve other risks, including, among others, the assumption of additional liabilities and expenses, difficulties and expenses in connection with integrating the acquired companies and achieving the expected benefits, issuances of potentially dilutive securities or interest-bearing debt, loss of key employees of the acquired companies, transaction costs, diversion of management’s attention from other business concerns and, with respect to the acquisition of foreign companies, the inability to overcome differences in foreign business practices, language and customs.

Our failure to identify potential acquisitions, complete targeted acquisitions and integrate completed acquisitions could have a material adverse effect on our business, financial condition and results of operations.

24 unchanged sentences

If we do not compete successfully, our business will suffer.

The biopharmaceutical services industry is highly

fragmented, with numerous smaller specialized companies and a handful of companies with global capabilities similar to certain of our own capabilities.

The biopharmaceutical services industry is highly fragmented, with numerous smaller specialized companies and a handful of companies with global capabilities similar to certain of our own capabilities.

Increased competition has led to price and other forms of competition, such as acceptance of less favorable contract terms, that could adversely affect our operating results.

26 unchanged sentences

We are uncertain as to the effects of these recent reforms on our business and are unable to predict what legislative proposals, if any, will be adopted in the future.

If regulatory cost containment efforts limit the profitability of new drugs, our clients may reduce their research

and development spending or promotional, marketing and sales expenditures, which could reduce the business they outsource to us.

If regulatory cost containment efforts limit the profitability of new drugs, our clients may reduce their research and development spending or promotional, marketing and sales expenditures, which could reduce the business they outsource to us.

Similarly, if regulatory requirements are relaxed or simplified drug approval procedures are adopted, the demand for our services could decrease.

26 unchanged sentences

Availability of generic substitutes for our clients’ drugs may adversely affect their results of operations and cash flow, which in turn may mean that they would not have surplus capital to invest in research and development and drug commercialization, including in our services.

If competition from generic products impacts our clients’

finances such that they decide to curtail our services, our revenues may decline and this could have a material adverse effect on our business.

If competition from generic products impacts our clients’ finances such that they decide to curtail our services, our revenues may decline and this could have a material adverse effect on our business.

Risks Relating to Our Indebtedness

14 unchanged sentences

• engage in certain transactions with affiliates.

In addition, the revolving credit facility and the term A and B loans under the Credit Agreement (as defined below) require IQVIA to comply with a quarterly maximum senior secured net leverage ratio test and minimum interest coverage ratio test.

In addition, the revolving credit facility and the term A and B loans under the Fifth Amended and Restated Credit Agreement (as defined below) require IQVIA to comply with a quarterly maximum senior secured net leverage ratio test and minimum interest coverage ratio test.

IQVIA’s ability to comply with these financial covenants can be affected by events beyond our control, and IQVIA may not be able to satisfy them.

5 unchanged sentences

If we were unable to repay or otherwise refinance these borrowings and loans when due, the applicable lenders could proceed against the collateral granted to them to secure that indebtedness, which could force us into bankruptcy or liquidation.

In the event the

applicable lenders accelerate the repayment of our borrowings, we and our subsidiaries may not have sufficient assets to repay that indebtedness.

Any acceleration of amounts due under the Credit Agreement governing the Senior Secured Credit Facilities or the exercise by the applicable lenders of their rights under the security documents would likely have a material adverse effect on us.

In the event the applicable lenders accelerate the repayment of our borrowings, we and our subsidiaries may not have sufficient assets to repay that indebtedness.

Any acceleration of amounts due under the Fifth Amended and Restated Credit Agreement governing the senior secured credit facilities or the exercise by the applicable lenders of their rights under the security documents would likely have a material adverse effect on us.

Despite our level of indebtedness, we are able to incur more debt and undertake additional obligations.

Incurring such debt or undertaking such additional obligations could further exacerbate the risks to our financial condition.

Although the Credit Agreement, which governs the Senior Secured Credit Facilities of our wholly owned subsidiary through which we conduct our operations, IQVIA Inc., contains restrictions on the incurrence of additional indebtedness, these restrictions are subject to a number of qualifications and exceptions and the indebtedness incurred in compliance with these restrictions could increase.

Although the Fifth Amended and Restated Credit Agreement, which governs the senior secured credit facilities of our wholly owned subsidiary through which we conduct our operations, IQVIA Inc., contains restrictions on the incurrence of additional indebtedness, these restrictions are subject to a number of qualifications and exceptions and the indebtedness incurred in compliance with these restrictions could increase.

In addition, the receivables financing facility for one of our consolidated subsidiaries, a bankruptcy-remote special purpose entity (the “SPE”) limits borrowing based on the amount of receivables purchased by the SPE from certain of our other subsidiaries, but when supported by the value of such purchased receivables, the debt under our receivables financing facility can increase.

While the Credit Agreement also contains restrictions on our and our restricted subsidiaries’ ability to make loans and investments, these restrictions are subject to a number of qualifications and exceptions, and the investments incurred in compliance with these restrictions could be substantial.

While the Fifth Amended and Restated Credit Agreement also contains restrictions on our and our restricted subsidiaries’ ability to make loans and investments, these restrictions are subject to a number of qualifications and exceptions, and the investments incurred in compliance with these restrictions could be substantial.

Restrictive covenants in our other indebtedness may limit our flexibility in our current and future operations, particularly our ability to respond to changes in our business or to pursue our business strategies.

19 unchanged sentences

Because we have variable rate debt, fluctuations in interest rates affect our business.

We attempt to minimize interest rate risk and lower our overall borrowing costs through the utilization of derivative financial instruments, primarily interest rate caps and swaps.

We have entered into interest rate caps and swaps with financial institutions that have reset dates and critical terms that match those of our senior secured term loan credit facility.

Accordingly, any change in market value associated with the interest rate caps and swaps is offset by the opposite market impact on the related debt.

We attempt to minimize interest rate risk and lower our overall borrowing costs through the utilization of derivative financial instruments, primarily swaps.

We have entered into and will continue to enter into swaps with financial institutions that have reset dates and critical terms that match those of our senior secured term loan credit facility.

Accordingly, any change in market value associated with the swaps may be offset by the opposite market impact on the related debt.

Because we do not attempt to hedge all of our variable rate debt, we may incur higher interest costs for the portion of our variable rate debt which is not hedged.

1 unchanged sentence

We may be adversely affected by changes in the method of determining the London Interbank Offered Rate (“LIBOR”), or the replacement of LIBOR with an alternative reference rate, for our variable rate loans, derivative contracts and other financial assets and liabilities.

The interest rates under our credit facilities and related interest rate swaps may be impacted by the expected discontinuation of LIBOR.

The interest rates under our credit facilities and related interest rate swaps may be impacted by the discontinuation of LIBOR for various currencies.

LIBOR is used as a reference rate to calculate interest rates under our credit facilities.

In 2017, the United Kingdom's Financial Conduct Authority, which regulates LIBOR, announced that it intends to phase out LIBOR by the end of 2021.

It is unclear if LIBOR will cease to exist at that time or if new methods of calculating LIBOR will be established such that it continues to exist after 2021.

The banking industry alongside regulators have taken steps to introduce alternative reference rates to LIBOR particularly in the US, the UK and Switzerland.

Whether or not alternative reference rates attain market traction as a LIBOR replacement tool remains in question.

If LIBOR ceases to exist or another indexed rate gains wide market acceptance as the successor to LIBOR, our lenders will select a replacement index that will be applied under our credit facilities and related interest rate swaps, and certain of the interest rates under our credit facilities may change.

The new rates may not be as favorable to us as those in effect prior to any LIBOR phase-out.

In 2017, the United Kingdom's Financial Conduct Authority, which regulates LIBOR, announced that it intends to phase out LIBOR.

In March 2021, the ICE Benchmark Administration announced that it would cease to publish LIBOR for U.S.

Dollar borrowings after June 30, 2023.

The Alternative Reference Rates Committee convened by the Board of Governors of the Federal Reserve System has recommended the use of the Secured Overnight Funding Rate (“SOFR”) as a replacement benchmark index for borrowings of U.S.

Our credit facilities will need to be amended to give effect to SOFR as the benchmark rate with respect to our U.S.

Dollar-denominated term B loans.

Market terms are still developing for loans and other products linked to SOFR, EURIBOR and other benchmark replacements and there can be no assurance that rates linked to SOFR, EURIBOR and other benchmark replacements or related administrative terms will be as favorable to us as those rates and terms under our existing credit facilities, derivatives and other contracts.

Risks Relating to Ownership of Our Common Stock

51 unchanged sentences

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