What the changes say
- IQVIA updated its risk factors to explicitly incorporate artificial intelligence development risks and increased competition for AI talent.
What changed since the prior 10-K
New
- NewRisks Relating to Our Business
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
The company faces potential liabilities and penalties under HIPAA and global privacy regulations for improper handling of protected health information.
- NewRisks Relating to Our Business
Environmental events may have an impact on our business
Extreme weather events and changing climate policies could disrupt operations for the company, its suppliers, clinical trial patients, and employees.
- NewRisks Relating to Our Business
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
Diverging global regulatory and stakeholder expectations regarding sustainability and corporate governance could increase compliance costs and damage reputation.
Dropped
- DroppedRisks Relating to Our Business
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
- DroppedRisks Relating to Our Business
Climate change may have an impact on our business
- DroppedRisks Relating to Our Business
Increasing focus on sustainability and other similar initiatives could increase our costs, and inaction could harm our reputation and adversely impact our financial results
Reworded
- 41% rewrittenRisks Relating to Our Business
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
Added cutting-edge skillsets such as AI and machine learning to the specific areas experiencing intense competition for qualified personnel.
- 37% rewrittenRisks Relating to Our Industry
We may be affected by healthcare reform and potential additional reforms, which may adversely impact the biopharmaceutical industry and reduce demand for our services or negatively impact our profitability
Maintained standard language concerning healthcare reform and cost containment measures impacting the biopharmaceutical industry.
- 34% rewrittenRisks Relating to Our Business
We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our business
Added specific risks regarding AI-enabled offerings, including model performance failures, biased outputs, and slower customer adoption than expected.
- 28% rewrittenRisks Relating to Our Business
If we are unsuccessful at investing in growth opportunities, our business could be materially and adversely affected
Retained descriptions of investments in cloud-based platforms and commercial and clinical operations support for life sciences companies.
All 50 risk factors
Headings as the filing states them, in filing order.
Risks Relating to Our Business
- 01The potential loss or delay of our large contracts or of multiple contracts could adversely affect our results
- 02Our 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
- 03If we fail to perform our services in accordance with contractual requirements, regulatory standards and ethical considerations, we could be subject to significant costs or liability and our reputation could be harmed
- 04Security breaches and unauthorized use of our IT systems and information, or the IT systems or information in the possession of our vendors, could expose us, our clients, our data suppliers or others to risk of loss
- 05Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results
- 06If we are unsuccessful at investing in growth opportunities, our business could be materially and adversely affected28% rewritten
- 07The 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 processedNew
- 08Our success depends on our ability to protect our intellectual property rights
- 09We may be subject to claims by others that we are infringing on their intellectual property rights
- 10We rely on licenses from third parties to certain technology and intellectual property rights for some of our services and the licenses we currently have could terminate or expire
- 11Our financial results may be adversely affected if we underprice our contracts, overrun our cost estimates or fail to receive approval for or experience delays in documenting change orders
- 12The relationship of backlog to revenues varies over time
- 13Our business depends on the continued effectiveness and availability of our information systems, including the information systems we use to provide our services to our clients, and failures of these systems may materially limit our operations
- 14We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our business34% rewritten
- 15Consolidation 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
- 16We may be adversely affected by client or therapeutic concentration
- 17Our business is subject to international economic, political and other risks that could negatively affect our results of operations and financial condition
- 18Environmental events may have an impact on our businessNew
- 19The 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 resultsNew
- 20Exchange rate fluctuations may affect our results of operations and financial condition
- 21We face risks related to sales to government entities
- 22If 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
- 23Our Research & Development Solutions business could subject us to potential liability that may adversely affect our results of operations and financial condition
- 24Some 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
- 25Our Commercial Solutions business could result in liability to us if a drug causes harm to a patient. While we are generally indemnified and insured against such risks, we may still suffer financial losses
- 26Our insurance may not cover all of our indemnification obligations and other liabilities associated with our operations
- 27If we are unable to attract suitable investigators and patients for our clinical trials, our clinical development business might suffer
- 28If 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 affected41% rewritten
- 29Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition
- 30Our effective income tax rate may fluctuate for a variety of reasons, which may adversely affect our operations, earnings and earnings per share
- 31Changes in accounting standards issued by the Financial Accounting Standards Board (“FASB”) or other standard-setting bodies may adversely affect our financial statements
- 32Our 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
- 33If we are unable to successfully identify, acquire and integrate existing businesses, services and technologies, our business, results of operations and financial condition could be adversely impacted
- 34Our results of operations may be adversely affected if we fail to realize the full value of our goodwill and acquired intangible assets
- 35We face risks arising from the restructuring of our operations
- 36Because of these and other factors, we cannot predict whether we will realize the purpose and anticipated benefits of these measures and, if we do not, our business and results of operations may be adversely affected
Risks Relating to Our Industry
- 37The 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
- 38Outsourcing trends in the biopharmaceutical industry and changes in aggregate spending and research and development budgets could adversely affect our operating results and growth rate
- 39Our business may be materially and adversely impacted by factors affecting the biopharmaceutical and healthcare industries
- 40We may be affected by healthcare reform and potential additional reforms, which may adversely impact the biopharmaceutical industry and reduce demand for our services or negatively impact our profitability37% rewritten
- 41Actions by government regulators or clients to limit a prescription’s scope or withdraw an approved drug from the market could adversely affect our business and result in a loss of revenues
- 42Laws restricting biopharmaceutical sales and marketing practices may adversely impact demand for our services
- 43Our Research & Development Solutions clients face intense competition from lower cost generic products, which may lower the amount that they spend on our services
Risks Relating to Our Indebtedness
- 44Despite 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
- 45Restrictive 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
- 46Interest rate fluctuations and our ability to deduct interest expense may affect our results of operations and financial condition
Risks Relating to Ownership of Our Common Stock
- 47Provisions of the corporate governance documents of IQVIA could make an acquisition of IQVIA difficult and may prevent attempts by its stockholders to replace or remove its management, even if beneficial to its stockholders
- 48Our operating results and share price may be volatile, which could cause the value of our stockholders’ investments to decline
- 49Since we have no current plans to pay regular cash dividends on our common stock, stockholders may not receive any return on investment unless they sell their common stock for a price greater than that which they paid for it
- 50Our certificate of incorporation contains a provision renouncing any interest and expectancy in certain corporate opportunities identified by certain parties, even if such corporate opportunities are ones that we might reasonably be deemed to have pursued or had the ability or desire to pursue
Other IQVIA Holdings 10-Ks
- FY2024 10-K risk factors50 risks
This filing has no prior year, so risks are dominated by contract dependencies, client concentration, cybersecurity, and regulatory compliance.
Filed Feb 13, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.