Biggest changeOur certificate of incorporation and Delaware bylaws and the General Corporation Law of Delaware (the “DGCL”) contain provisions that could make it difficult for a third party to acquire IQVIA even if doing so might be beneficial to its stockholders, including: • the division of the board of directors into three classes (subject to gradual declassification which began at the 2023 annual meeting of stockholders, such that our board of directors will be fully declassified and each director will be elected to a one-year term beginning at the 2025 annual meeting of stockholders); • the sole ability of the board of directors to fill a vacancy created by the death or resignation of a director or the expansion of the board of directors; • advance notice requirements for stockholder proposals and director nominations; • limitations on the ability of stockholders to call special meetings and to take action by written consent; • the approval of holders of a majority of the outstanding shares of IQVIA entitled to vote on any amendment, alteration, change, addition or repeal of the Delaware bylaws is required to amend, alter, change, add to or repeal the Delaware bylaws; 42 • the required approval of holders of a majority of the outstanding shares of IQVIA to remove directors, which removal may only be for cause; and • the ability of the board of directors to issue new series of, and designate the terms of, preferred stock, without stockholder approval, which could be used to, among other things, institute a rights plan that would have the effect of significantly diluting the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by the board of directors.
Biggest changeOur certificate of incorporation and Delaware bylaws and the General Corporation Law of Delaware (the “DGCL”) contain provisions that could make it difficult for a third party to acquire IQVIA even if doing so might be beneficial to its stockholders, including: • the sole ability of the board of directors to fill a vacancy created by the death or resignation of a director or the expansion of the board of directors; • advance notice requirements for stockholder proposals and director nominations; • limitations on the ability of stockholders to call special meetings and to take action by written consent; • the approval of holders of a majority of the outstanding shares of IQVIA entitled to vote on any amendment, alteration, change, addition or repeal of the Delaware bylaws is required to amend, alter, change, add to or repeal the Delaware bylaws; • the required approval of holders of a majority of the outstanding shares of IQVIA to remove directors, which removal may only be for cause; and 42 • the ability of the board of directors to issue new series of, and designate the terms of, preferred stock, without stockholder approval, which could be used to, among other things, institute a rights plan that would have the effect of significantly diluting the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by the board of directors.
Restructuring presents significant potential risks of events occurring that could adversely affect us, including: • actual or perceived disruption of service or reduction in service standards to clients; 36 • the failure to preserve supplier relationships and distribution, sales and other important relationships and to resolve conflicts that may arise; • loss of sales as we reduce or eliminate staffing on non-core services; • diversion of management attention from ongoing business activities; and • the failure to maintain employee morale and retain key employees.
Restructuring presents significant potential risks of events occurring that could adversely affect us, including: • actual or perceived disruption of service or reduction in service standards to clients; • the failure to preserve supplier relationships and distribution, sales and other important relationships and to resolve conflicts that may arise; • loss of sales as we reduce or eliminate staffing on non-core services; • diversion of management attention from ongoing business activities; and • the failure to maintain employee morale and retain key employees.
Client Risks • Consolidation in the industries in which our clients operate may reduce the volume of services purchased by consolidated clients following an acquisition or merger. • We may be adversely affected by client or therapeutic concentration. • Our relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use our services. • There is a risk that we may initiate a clinical trial for a client, and then the client becomes unwilling or unable to fund the completion of the clinical trial, and we may be ethically bound to complete or wind down the clinical trial at our own expense. 19 Market Forces • Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition. • Our effective income tax rate may fluctuate for a variety of reasons. • 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.
Client Risks • Consolidation in the industries in which our clients operate may reduce the volume of services purchased by consolidated clients following an acquisition or merger. • We may be adversely affected by client or therapeutic concentration. • Our relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use our services. • There is a risk that we may initiate a clinical trial for a client, and then the client becomes unwilling or unable to fund the completion of the clinical trial, and we may be ethically bound to complete or wind down the clinical trial at our own expense. 18 Market Forces • Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition. • Our effective income tax rate may fluctuate for a variety of reasons. • 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.
Further restructuring or reorganization activities may also be required in the future beyond what is currently planned, which could further enhance the risks associated with these activities. Risks Relating to Our Industry The biopharmaceutical services industry is highly competitive and our business could be materially impacted if we do not compete effectively or rapidly adapt to technological change.
Further restructuring or reorganization activities may also be required in the future beyond what is currently planned, which could further enhance the risks associated with these activities. 36 Risks Relating to Our Industry The biopharmaceutical services industry is highly competitive and our business could be materially impacted if we do not compete effectively or rapidly adapt to technological change.
As a result, failure to comply with these rules could have an adverse effect on our future business, reputation, operating results and financial condition. 32 If we are unable to successfully develop and market new services or enter new markets, our growth, results of operations or financial condition could be adversely affected.
As a result, failure to comply with these rules could have an adverse effect on our future business, reputation, operating results and financial condition. If we are unable to successfully develop and market new services or enter new markets, our growth, results of operations or financial condition could be adversely affected.
Changes to these programs may adversely impact our ability to provide services to our clients or develop new products or services. Federal, state and foreign governments are contemplating or have proposed or adopted new Privacy Laws or modifications to existing Privacy Laws, including by amendment, replacement or interpretation through judicial or administrative decisions.
Changes to these programs may adversely impact our ability to provide services to our clients or develop new products or services. Federal, state and foreign governments are contemplating or have proposed or adopted new privacy laws and regulations or modifications to existing privacy laws and regulations, including by amendment, replacement or interpretation through judicial or administrative decisions.
In addition, the United States or other governments may seek to hold us liable for successor liability FCPA violations or violations of other anti-corruption laws committed by companies in which we invest or that we acquired or will acquire. We face risks related to sales to government entities.
In addition, the United States or other governments may seek to hold us liable for successor liability FCPA violations or violations of other anti-corruption laws committed by companies in which we invest or that we acquired or will acquire. 31 We face risks related to sales to government entities.
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. Our results of operations may be adversely affected if we fail to realize the full value of our goodwill and acquired intangible assets.
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. 35 Our results of operations may be adversely affected if we fail to realize the full value of our goodwill and acquired intangible assets.
Any of the above may result in lower demand for our services, which could result in a material adverse impact on our operating results and financial condition. Outsourcing trends in the biopharmaceutical industry and changes in aggregate spending and research and development budgets could adversely affect our operating results and growth rate.
Any of the above may result in lower demand for our services, which could result in a material adverse impact on our operating results and financial condition. 37 Outsourcing trends in the biopharmaceutical industry and changes in aggregate spending and research and development budgets could adversely affect our operating results and growth rate.
Such changes could result in a material adverse impact on our results of operations and financial condition. 35 Our relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use our services, which may adversely affect our results of operations.
Such changes could result in a material adverse impact on our results of operations and financial condition. Our relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use our services, which may adversely affect our results of operations.
As a result, we are subject to heightened risks inherent in conducting business internationally, including the following: • 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; 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, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenues; • the United States or foreign countries have and could continue to enact legislation or impose regulations or other restrictions, including unfavorable labor regulations, tax policies, trade barriers, 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; • foreign countries are expanding or may expand their regulatory framework with respect to patient informed consent, protection and compensation in clinical trials, which could delay or inhibit our ability to conduct clinical trials in such jurisdictions; • the regulatory or judicial authorities of foreign countries may not enforce legal rights and recognize business procedures in a manner in which we are accustomed or would reasonably expect; • local, economic, political and social conditions, including sustained increases in inflation rates and/or potential hyperinflationary conditions, political instability, and potential nationalization, repatriation, expropriation, price controls or other restrictive government actions, including changes in political and economic conditions may lead to changes in the business environment in which we operate, as well as changes in foreign currency exchange rates; • immigration laws are subject to legislative change and varying standards of application and enforcement due to political forces, economic conditions or other events (including proposals in the U.S. to change limitations on temporary and permanent workers), and local immigration laws may require us to meet certain other legal requirements as a condition to obtaining or maintaining entry visas, which may impact our ability to provide services to our clients; • potential violations of local laws or anti-bribery laws, such as the United States Foreign Corrupt Practices Act (“FCPA”), and the UK Bribery Act, may cause difficulty in managing foreign operations, as well as significant consequences to us if those laws are violated; • clients in foreign jurisdictions may have longer payment cycles, and it may be more difficult to collect receivables in foreign jurisdictions; and 30 • natural disasters, public health emergencies and pandemics such as the COVID-19, including any variants, or international conflict, such as the ongoing conflict between Russia and Ukraine, or 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.
As a result, we are subject to heightened risks inherent in conducting business internationally, including the following: • 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; 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, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenues; • the United States or foreign countries have and could continue to enact legislation or impose regulations or other restrictions, including unfavorable labor regulations, tax policies, trade barriers, tariffs, 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; • foreign countries are expanding or may expand their regulatory framework with respect to patient informed consent, protection and compensation in clinical trials, which could delay or inhibit our ability to conduct clinical trials in such jurisdictions; • the regulatory or judicial authorities of foreign countries may not enforce legal rights and recognize business procedures in a manner in which we are accustomed or would reasonably expect; • local, economic, political and social conditions, including sustained increases in inflation rates and/or potential hyperinflationary conditions, political instability, and potential nationalization, repatriation, expropriation, price controls or other restrictive government actions, including changes in political and economic conditions may lead to changes in the business environment in which we operate, as well as changes in foreign currency exchange rates; • immigration laws are subject to legislative change and varying standards of application and enforcement due to political forces, economic conditions or other events (including proposals in the U.S. to change limitations on temporary and permanent workers), and local immigration laws may require us to meet certain other legal requirements as a condition to obtaining or maintaining entry visas, which may impact our ability to provide services to our clients; • potential violations of local laws or anti-bribery laws, such as the United States Foreign Corrupt Practices Act (“FCPA”), and the UK Bribery Act, may cause difficulty in managing foreign operations, as well as significant consequences to us if those laws are violated; 29 • clients in foreign jurisdictions may have longer payment cycles, and it may be more difficult to collect receivables in foreign jurisdictions; and • natural disasters, public health emergencies and pandemics, or international conflict, such as the ongoing conflict between Russia and Ukraine, or 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.
Further, although no single individual data supplier is material to our business, if a number of suppliers collectively representing a significant amount of data that we use for one or more of our services were to impose additional contractual restrictions on our use of or access to data, fail to adhere to our quality-control standards, repeatedly fail to deliver data or refuse to provide data, now or in the future, our ability to provide those services to our clients could be materially adversely impacted, which may harm our operating results and financial condition. 21 Additionally, we depend on third parties for support services to our business.
Further, although no single individual data supplier is material to our business, if a number of suppliers collectively representing a significant amount of data that we use for one or more of our services were to impose additional contractual restrictions on our use of or access to data, fail to adhere to our quality-control standards, repeatedly fail to deliver data or refuse to provide data, now or in the future, our ability to provide those services to our clients could be materially adversely impacted, which may harm our operating results and financial condition. 20 Additionally, we depend on third parties for support services to our business.
Exchange rate fluctuations between local currencies and the United States dollar create risk in several ways, including: 31 • Foreign Currency Translation Risk. The revenues and expenses of our foreign operations are generally denominated in local currencies and translated into United States dollars for financial reporting purposes.
Exchange rate fluctuations between local currencies and the United States dollar create risk in several ways, including: • Foreign Currency Translation Risk. The revenues and expenses of our foreign operations are generally denominated in local currencies and translated into United States dollars for financial reporting purposes.
These laws are complex and there is no assurance that the safeguards and controls employed by us or our data suppliers will be sufficient to prevent a breach of these laws, or that claims will not be filed against us or our data suppliers despite such safeguards and controls.
These laws and regulations are complex, and there is no assurance that the safeguards and controls employed by us or our data suppliers will be sufficient to prevent a breach of these laws or regulations, or that claims will not be filed against us or our data suppliers despite such safeguards and controls.
Additionally, changes in Privacy Laws may limit our data access, use and disclosure, and may require increased expenditures by us or may dictate that we not offer certain types of services.
Additionally, changes in privacy laws and regulations may limit our data access, use and disclosure, and may require increased expenditures by us or may dictate that we not offer certain types of services.
A number of factors may affect backlog, including: • the size, complexity and duration of the projects; • the percentage of full services versus functional services; • the cancellation or delay of projects; and • change in the scope of work during the course of a project. 27 Although an increase in backlog will generally result in an increase in revenues to be recognized over time (depending on the level of cancellations), an increase in backlog at a particular point in time does not necessarily correspond directly to an increase in revenues during a particular period.
A number of factors may affect backlog, including: • the size, complexity and duration of the projects; • the percentage of full services versus functional services; • the cancellation or delay of projects; and • change in the scope of work during the course of a project. 26 Although an increase in backlog will generally result in an increase in revenues to be recognized over time (depending on the level of cancellations), an increase in backlog at a particular point in time does not necessarily correspond directly to an increase in revenues during a particular period.
Our inability to effectively manage the implementation and adapt to new processes designed into new or upgraded systems in a timely and cost-effective manner may result in disruption to our business and negatively affect our operations. 28 We have entered into agreements with certain vendors to provide systems development, integration services and hosting of IT platform(s) for programs to optimize our business processes.
Our inability to effectively manage the implementation and adapt to new processes designed into new or upgraded systems in a timely and cost-effective manner may result in disruption to our business and negatively affect our operations. 27 We have entered into agreements with certain vendors to provide systems development, integration services and hosting of IT platform(s) for programs to optimize our business processes.
Accordingly, we are subject to any flaw in or breaches to their computer and communications systems or those that they operate for us, which could result in a material adverse effect on our business, operations and financial results. 23 The risk of cyberattacks has increased in connection with geopolitical events and dynamics.
Accordingly, we are subject to any flaw in or breaches to their computer and communications systems or those that they operate for us, which could result in a material adverse effect on our business, operations and financial results. 22 The risk of cyberattacks has increased in connection with geopolitical events and dynamics.
For a more complete discussion of the material risk facing our business, see below. 20 Risks Relating to Our Business The potential loss or delay of our large contracts or of multiple contracts could adversely affect our results. Most of our Research & Development Solutions clients can terminate our contracts upon 30 to 90 days' notice.
For a more complete discussion of the material risk facing our business, see below. 19 Risks Relating to Our Business The potential loss or delay of our large contracts or of multiple contracts could adversely affect our results. Most of our Research & Development Solutions clients can terminate our contracts upon 30 to 90 days' notice.
Also, there are ongoing public policy discussions regarding whether the standards for de-identified, anonymous or pseudonymized health information are sufficient, and the risk of re-identification sufficiently small, to adequately protect patient privacy. These discussions may lead to further restrictions on the use of such information.
Also, there are ongoing public policy discussions and legal challenges regarding whether the standards for de-identified, anonymous or pseudonymized health information are sufficient, and the risk of re-identification sufficiently small, to adequately protect patient privacy. These discussions may lead to further restrictions on the use of such information.
In addition, negative publicity regarding regulatory compliance of our clients’ clinical trials, programs or drugs could have an adverse effect on our business and reputation. 22 Insufficient client funding to complete a clinical trial. As noted above, clinical trials can cost hundreds of millions of dollars.
In addition, negative publicity regarding regulatory compliance of our clients’ clinical trials, programs or drugs could have an adverse effect on our business and reputation. 21 Insufficient client funding to complete a clinical trial. As noted above, clinical trials can cost hundreds of millions of dollars.
New or modified Privacy Laws might, among other things, require us to implement new security measures and processes or bring within the scope of the Privacy Law other data not currently regulated, each of which may require substantial expenditures or limit our ability to offer some of our services.
New or modified privacy laws or regulations might, among other things, require us to implement new security measures and processes or bring within the scope of the privacy law or regulation other data not currently regulated, each of which may require substantial expenditures or limit our ability to offer some of our services.
These incidents and claims could harm our business, reduce revenues, increase expenses and harm our reputation. 26 We may be subject to claims by others that we are infringing on their intellectual property rights.
These incidents and claims could harm our business, reduce revenues, increase expenses and harm our reputation. 25 We may be subject to claims by others that we are infringing on their intellectual property rights.
Any of the foregoing may have a material adverse impact on our ability to provide services to our clients or maintain our profitability. 25 There is ongoing concern from privacy advocates, regulators and others regarding data protection and privacy issues, and the number of jurisdictions with Privacy Laws has been increasing.
Any of the foregoing may have a material adverse impact on our ability to provide services to our clients or maintain our profitability. 24 There is ongoing concern from privacy advocates, regulators and others regarding data protection and privacy issues, and the number of jurisdictions with privacy laws and regulations has been increasing.
Exchange rate fluctuations may affect our results of operations and financial condition. Because a large portion of our revenues and expenses are denominated in currencies other than the United States dollar and our financial statements are reported in United States dollars, changes in foreign currency exchange rates could significantly affect our results of operations and financial condition.
Because a large portion of our revenues and expenses are denominated in currencies other than the United States dollar and our financial statements are reported in United States dollars, changes in foreign currency exchange rates could significantly affect our results of operations and financial condition.
We subcontract into a network of facilities where Phase I clinical trials are conducted, which ordinarily involve testing an investigational drug on a limited number of healthy individuals, typically 20 to 80 persons, to determine such drug’s basic safety.
We both own a facility and subcontract into a network of facilities where Phase I clinical trials are conducted, which ordinarily involve testing an investigational drug on a limited number of healthy individuals, typically 20 to 80 persons, to determine such drug’s basic safety.
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.
Environmental events may have an impact on our business. While we have determined that, at this time, environmental events do 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 environmental events, and we recognize that there are inherent climate-related risks wherever business is conducted.
This liability, particularly if it were to exceed the limits of any indemnification agreements and insurance coverage we may have, may adversely affect our financial condition, results of operations and reputation. 33 Our Contract Sales & Medical Solutions business could result in liability to us if a drug causes harm to a patient.
This liability, particularly if it were to exceed the limits of any indemnification agreements and insurance coverage we may have, may adversely affect our financial condition, results of operations and reputation. Our Commercial Solutions business could result in liability to us if a drug causes harm to a patient.
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, including highly technical specialties such as clinical research associates, project managers and technology developers, and in the locations in which we operate.
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, cutting-edge skillsets, such as AI and machine learning, 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.
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.
Any of our office or IT systems locations may be vulnerable to the adverse effects of environmental events. Furthermore, environmental events may impact patients in our clinical trials and our employees, particularly where they work remotely.
Regulations relating to the use of AI and the interpretation of those regulations by regulators, courts and others are in the early stages of development and evolving, which may make it difficult to identify adequate compliance requirements or suitable governance practices to meet those requirements.
Regulations relating to the use of AI and the interpretation of those regulations by regulators, courts and others are in the early stages of development and evolving, which may make it difficult to identify or implement adequate compliance requirements or suitable governance practices to meet those requirements, including the activities described in Item 1.
Each of our Technology & Analytics Solutions information services is derived from data we collect from third parties. These data suppliers are numerous and diverse, reflecting the broad scope of information that we collect and use in our business.
Our Commercial Solutions information services are derived from data we collect from third parties. These data suppliers are numerous and diverse, reflecting the broad scope of information that we collect and use in our business.
Cyber threats are rapidly evolving and are becoming increasingly sophisticated. As cyber threats evolve and become more difficult to detect and successfully defend against, one or more cyber threats might defeat the measures that we or our vendors take to anticipate, detect, avoid or mitigate such threats.
Cyber threats are rapidly evolving and are becoming increasingly sophisticated, including through the use of AI-supported attacks. As cyber threats evolve and become more difficult to detect and successfully defend against, one or more cyber threats might defeat the measures that we or our vendors take to anticipate, detect, avoid or mitigate such threats.
In 2024, financial regulators in various jurisdictions, including where we have variable-rate indebtedness outstanding, cut interest rates modestly while signaling that interest rates could remain higher compared to recent years for an extended period of time in an effort to lower inflation.
In 2025, financial regulators in various jurisdictions, including where we have variable-rate indebtedness outstanding, cut interest rates modestly while signaling that interest rates could remain higher compared to the pre-2022 period for an extended period of time in an effort to lower inflation.
Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results. We are pursuing business transformation initiatives to update technology, increase innovation and obtain operating efficiencies.
Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results. We are pursuing business transformation initiatives to update technology, increase innovation and obtain operating efficiencies, including through the use of AI.
Further, if we are unable to develop new technologies and services, clients do not purchase our new technologies and services, our new technologies and services do not work as intended or there are delays in the availability or adoption of our new technologies and services, then we may not be able to grow our business or growth may occur slower than anticipated.
Further, if we are unable to develop new technologies and services or keep up with the rapid pace of change in technological development and innovation, clients do not purchase our new technologies and services, our new technologies and services do not work as intended or there are delays in the availability or adoption of our new technologies and services, then we may not be able to grow our business or growth may occur slower than anticipated.
In addition, certain environmental and sustainability disclosures and commitments we make may be reliant in part or in whole on third party information, which we cannot verify the quality of, and third party performance, which we cannot guarantee. We may fail to meet our environmental and sustainability commitments either entirely or on the schedule we commit to.
In addition, certain environmental and sustainability disclosures and commitments we make may be reliant in part or in whole on third party information, which we cannot verify the quality of, and third party performance, which we cannot guarantee.
If any large client decreases or terminates its relationship with us, our business, results of operations or financial condition could be materially adversely affected. 29 Additionally, conducting multiple clinical trials for different clients in a single therapeutic class involving drugs with the same or similar chemical action has in the past and may in the future adversely affect our business if some or all of the clinical trials are canceled because of new scientific information or regulatory judgments that affect the drugs as a class or if industry consolidation results in the rationalization of drug development pipelines.
Additionally, conducting multiple clinical trials for different clients in a single therapeutic class involving drugs with the same or similar chemical action has in the past and may in the future adversely affect our business if some or all of the clinical trials are canceled because of new scientific information or regulatory judgments that affect the drugs as a class or if industry consolidation results in the rationalization of drug development pipelines.
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. 34 Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition.
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.
Any of the foregoing could have a material and adverse effect on our operating results and financial condition. 24 Data protection, privacy and similar laws in the United States and around the world restrict access, use and disclosure of personal information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
Data protection, privacy and similar laws and regulations in the United States and around the world restrict access, use and disclosure of personal information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
We operate in businesses that require sophisticated computer systems and software for data collection, data processing, cloud-based platforms, analytics, cryptography, statistical projections and forecasting, mobile computing, social media analytics and other applications and technologies, particularly in our Technology & Analytics Solutions and Research & Development Solutions businesses.
We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our business. We operate in businesses that require sophisticated computer systems and software for data collection, data processing, cloud-based platforms, analytics, cryptography, statistical projections and forecasting, mobile computing, social media analytics and other applications and technologies.
In addition, the emergence of the use of Real World Evidence and new approaches such as machine learning and artificial intelligence that capitalize on the availability of large data sets may reduce the time and costs of the discovery and development process, may allow our clients to more readily perform for themselves clinical development tasks and services that we have typically provided, may cause even greater price competition or may render certain data offerings less valuable or relevant.
In addition, the emergence of the use of Real World Evidence and the advancements in new approaches such as machine learning and artificial intelligence (AI), including generative, agentic and foundation models that are increasingly accessible through third‑party or open‑source platforms, that capitalize on the availability of large data sets may reduce the time and costs of the discovery and development process, may allow our clients to more readily perform for themselves clinical development tasks and services that we have typically provided, may cause even greater price competition and/or reduce the perceived differentiation of certain of our information, analytics and insight‑based offerings.
Some of our services involve direct interaction with clinical trial subjects or volunteers and subcontracting into a network of Phase I clinical facilities, which could create potential liability that may adversely affect our results of operations, financial condition and reputation.
When such disclosures occur, there is a risk that we may fail to monitor and comply with applicable adverse event reporting obligations. 32 Some of our services involve direct interaction with clinical trial subjects or volunteers and subcontracting into a network of Phase I clinical facilities, which could create potential liability that may adversely affect our results of operations, financial condition and reputation.
From time to time, we have adopted restructuring plans to improve our operating efficiency through various means such as reduction of overcapacity, elimination of non-billable support roles or other realignment of resources.
From time to time, we have adopted restructuring plans to improve our operating efficiency through various means such as reduction of overcapacity, elimination of non-billable support roles or other realignment of resources. For example, starting in the first quarter of 2026, we have restructured our operations to reduce our reportable segments from three to two.
We also expect that competition will continue to increase as a result of consolidation among these various companies. Large technology companies with substantial resources, technical expertise and greater brand power could also decide to enter or further expand in the markets where our business operates and compete with us.
Large technology companies with substantial resources, technical expertise and greater brand power could also decide to enter or further expand in the markets where our business operates and compete with us.
Our operating results and the trading price of our shares may fluctuate in response to various factors, including: • market conditions in the broader stock market; • actual or anticipated fluctuations in our quarterly and annual financial and operating results; • introduction of new services by us or our competitors; • issuance of new or changed securities analysts’ reports or recommendations; • sales, or anticipated sales, of large blocks of our stock; • additions or departures of key personnel; • regulatory or political developments; 43 • litigation and governmental investigations; • changing economic conditions; and • exchange rate fluctuations.
Our operating results and the trading price of our shares may fluctuate in response to various factors, including: • market conditions in the broader stock market; • actual or anticipated fluctuations in our quarterly and annual financial and operating results; • introduction of new services by us or our competitors; • changes in investor perception regarding the role, effectiveness, risks or regulatory implications of artificial intelligence in our business or in the healthcare and life sciences industries more broadly; • concerns, whether or not substantiated, regarding the accuracy, reliability, ethical use, governance, or regulatory compliance of AI-enabled solutions; • issuance of new or changed securities analysts’ reports or recommendations; • sales, or anticipated sales, of large blocks of our stock; 43 • additions or departures of key personnel; • regulatory or political developments; • litigation and governmental investigations; • changing economic conditions; and • exchange rate fluctuations.
These types of failures could have a material adverse effect on our operating results, financial condition and reputation. Consolidation in the industries in which our clients operate may reduce the volume of services purchased by consolidated clients following an acquisition or merger, which could materially harm our operating results and financial condition.
Consolidation in the industries in which our clients operate may reduce the volume of services purchased by consolidated clients following an acquisition or merger, which could materially harm our operating results and financial condition. Mergers or consolidations among our clients have in the past and could in the future reduce the number of our clients and potential clients.
All of these items described above may cause fluctuations in our effective income tax rate through increased income tax liability and/or the loss of tax attributes in any given year that could adversely affect our results of operations and impact our earnings and earnings per share.
As the regulations and guidance evolve with respect to current and newly enacted tax law, our results may differ from previous estimates and may materially affect our consolidated financial statements. 34 All of these items described above may cause fluctuations in our effective income tax rate through increased income tax liability and/or the loss of tax attributes in any given year that could adversely affect our results of operations and impact our earnings and earnings per share.
New services, or enhancements to existing services, may not adequately meet our own requirements or those of current and prospective clients or achieve any degree of significant market acceptance.
We may experience difficulties that could delay or prevent the successful design, development, testing, introduction or marketing of our services. New services, or enhancements to existing services, may not adequately meet our own requirements or those of current and prospective clients or achieve any degree of significant market acceptance.
We are building artificial intelligence (AI) technologies into internal applications and solutions we use with others, including clients; we expect the use of AI to grow. We seek to address some of our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and adapt these for our biopharmaceutical and healthcare industry clients.
We seek to address some of our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and adapt these for our biopharmaceutical and healthcare industry clients.
Our continued success will depend on our ability to adapt to changing technologies, manage and process ever-increasing amounts of data and information and improve the performance, features and reliability of our services in response to changing client and industry demands. We may experience difficulties that could delay or prevent the successful design, development, testing, introduction or marketing of our services.
Moreover, the introduction of new services embodying new technologies could render certain of our existing services obsolete. Our continued success will depend on our ability to adapt to changing technologies, manage and process ever-increasing amounts of data and information and improve the performance, features and reliability of our services in response to changing client and industry demands.
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.
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. 33 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.
We have established frameworks, models, processes and technologies to manage privacy and security for many data types, from a variety of sources, and under a myriad of Privacy Laws. In addition, we rely on our data suppliers to deliver information to us in a form and in a manner that complies with applicable Privacy Laws.
We have established frameworks, models, processes and technologies to manage privacy, data protection and security for many data types, from a variety of sources, and under a myriad of privacy and data protection laws.
Health information about an identifiable person carries additional obligations under these laws, including obtaining the explicit consent from the individual for collection, use or disclosure of the information.
Processing health information carries additional obligations under these laws and regulations, often including the need to obtain the explicit consent of the individual for collection, use or disclosure of the information.
Although we did not have any client that represented 10% or more of our revenues in 2024, 2023 and 2022, we derive the majority of our revenues from a number of large clients.
Any of these developments could materially harm our operating results and financial condition. 28 We may be adversely affected by client or therapeutic concentration. Although we did not have any client that represented 10% or more of our revenues in 2025, 2024 or 2023, we derive the majority of our revenues from a number of large clients.
Our failure to develop and offer competitive services that address these and other technological advances in a timely, cost-effective manner or to keep pace with rapid technological change could adversely affect our competitive position and our results of operations. 37 Our future growth and success will depend on our ability to successfully compete with other companies that provide similar services in the same markets, some of which may have financial, marketing, technical and other advantages.
Our failure to develop and offer competitive services that address these and other technological advances in a timely, cost-effective manner or to keep pace with rapid technological change could adversely affect our competitive position and our results of operations.
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.
Many privacy laws and regulations 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.
Our preventive and remedial actions may not be successful. We have acquired various companies, products, services and technologies over the years. While we make significant efforts to identify and address IT security issues with respect to these acquisitions, we may still inherit security risks associated with these activities.
While we make significant efforts to identify and address IT security issues with respect to these acquisitions, we may still inherit security risks associated with these activities.
In general, patient health information is among the most sensitive (and highly regulated) of personal information. Privacy Laws in the United States and around the world are designed to ensure that information about an individual’s healthcare is properly protected from inappropriate access, use and disclosure.
Privacy laws and regulations in all regions of the world are designed to ensure that information about an individual is properly protected from inappropriate access, use and disclosure.
There can be no assurance that those sources will be available in sufficient amounts to fund future growth opportunities when needed.
There can be no assurance that those sources will be available in sufficient amounts to fund future growth opportunities when needed. Any of the foregoing could have a material and adverse effect on our operating results and financial condition.
In addition, compliance with such laws may require increased costs to us or may dictate that we not offer certain types of services.
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.
Other services that were previously purchased by one of the merged or consolidated entities may be deemed unnecessary or cancelled. If our clients merge with or are acquired by other entities that are not our clients, or that use fewer of our services, they may discontinue or reduce their use of our services.
If our clients merge with or are acquired by other entities that are not our clients, or that use fewer of our services, they may discontinue or reduce their use of our services. There can be no assurance as to the degree to which we may be able to address the revenues impact of such consolidation.
Mergers or consolidations among our clients have in the past and could in the future reduce the number of our clients and potential clients. When companies consolidate, overlapping services previously purchased separately are usually purchased only once by the combined entity, leading to loss of revenues.
When companies consolidate, overlapping services previously purchased separately are usually purchased only once by the combined entity, leading to loss of revenues. Other services that were previously purchased by one of the merged or consolidated entities may be deemed unnecessary or cancelled.
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. Under HIPAA’s enforcement scheme, we can be subject to significant penalties in connection with HIPAA violations, along with the potential for significant other expenditures related to these activities.
Under HIPAA’s enforcement scheme, overseen by the US Department of Health and Human Services, covered entities and business associates may be subject to significant penalties and fines in connection with HIPAA violations, along with the potential for significant other expenditures related to these activities.
Privacy Laws also include the European Union’s (“EU”) General Data Protection Regulation, Canada’s Personal Information Protection and Electronic Documents Act and other data protection, privacy, data security, data localization and similar national, state/provincial and local laws. In the EU and in many other regions or countries, personal data includes any information that relates to an identifiable natural person.
Such laws and regulations also include the European Union’s (“EU”) General Data Protection Regulation (GDPR), Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA), Brazil’s General Data Protection Law (LGPR), India’s Digital Personal Data Protection Act (DPDP Act), Japan’s Act on the Protection of Personal Information (APPI), China’s Personal Information Protection Law (PIPL) and many other data protection and privacy laws at the national, state/provincial and local level.
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.
The confidentiality, collection, use, retention, security, transfer and disclosure of personal information is subject to governmental regulation in the countries where the personal information was collected or processed. 23 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 certain individually-identifiable health information, specifically protected health information (PHI).
Increasing focus on sustainability and other similar initiatives could increase our costs, and inaction could harm our reputation and adversely impact our financial results. There has been increasing public focus by investors, customers, environmental activists, the media, and governmental and nongovernmental organizations on a variety of environmental and sustainability matters.
The expectations and requirements of regulators and other key stakeholders on sustainability-related matters, continue to evolve and diverge, and our ability to meet these expectations and requirements could increase our costs, and inaction could harm our reputation and adversely impact our financial results .