What the changes say
- The company added specific operational risks covering customer concentration, internal controls, and asset divestitures like the AbbVie SmartDose deal.
What changed since the prior 10-K
New
- NewBusiness and Operational Risks
In the normal course of business, we engage in discussions with third parties relating to possible divestitures, acquisitions and other strategic transactions
Divesting businesses like the SmartDose system to AbbVie carries risks of failed liability transfers and retained warranty obligations.
- NewBusiness and Operational Risks
The concentration of our customer base could adversely affect our financial condition and operating results
Relying on a limited number of customers exposes the company to pricing pressures, contract disputes, and revenue loss.
- NewLegal, Regulatory and Compliance Risks
If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results, which could lead to a loss of investor confidence in our financial statements and have an adverse effect on our stock price
Internal control failures under Sarbanes-Oxley could harm stock prices and data privacy breaches could trigger regulatory fines.
Dropped
- DroppedBusiness and Operational Risks
We may not succeed in finding and completing acquisitions or other strategic transactions, which could have an adverse effect on our business and results of operations
Reworded
- 52% rewrittenLegal, Regulatory and Compliance Risks
Significant developments in U.S. tax policies could have a material adverse effect on our business and/or results of operations
No substantive textual changes were made regarding U.S. and foreign tax policy risks.
- 33% rewrittenLegal, Regulatory and Compliance Risks
Changing climate, global climate change regulations and greenhouse gas effects may adversely affect our operations and financial performance
Updated references from ESG initiatives to specific climate issues regarding regulatory and environmental impacts.
- 32% rewrittenLegal, Regulatory and Compliance Risks
Our operations must comply with environmental statutes and regulations, and any failure to comply could result in extensive costs which would harm our business
Minor formatting adjustments were made with no substantive changes to hazardous material and environmental compliance risks.
- 31% rewrittenBusiness and Operational Risks
A loss of or inability to attract key personnel or highly skilled employees could disrupt our operations
Minor formatting adjustments were made with no substantive changes to key personnel attraction and retention risks.
- 24% rewrittenLegal, Regulatory and Compliance Risks
Our share price has been volatile and may fluctuate, and accordingly, the value of an investment in our common stock may also fluctuate
Removed trailing Item 1B unresolved staff comments text from the end of the stock price volatility risk paragraph.
All 32 risk factors
Headings as the filing states them, in filing order.
Other
- 01Global economic conditions, including inflation and supply chain disruptions, could adversely affect our operations
- 02Unauthorized access to our or our customers’ information and systems could negatively impact our business
- 03We are a global company with significant revenues and earnings generated internationally, which exposes us to the impact of foreign currency fluctuations and tariffs, as well as political and economic risks
- 04We are exposed to credit risk on accounts receivable and certain prepayments made in the normal course of business. This risk is heightened during periods when economic conditions worsen
- 05Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business and financial condition
Industry Risks
- 06If we are unable to provide comparative value advantages, timely fulfill customer orders, or resist pricing pressure, we will have to reduce our prices, which may reduce our profit margins
- 07Consolidation in the pharmaceutical and healthcare industries could adversely affect our future revenues and operating income
- 08The medical technology industry is very competitive and customer requests and/or new products in the marketplace could cause a reduction in demand
Business and Operational Risks
- 09Disruption in our manufacturing facilities could have a material adverse effect on our ability to make and sell products and have a negative impact on our reputation, performance or financial condition
- 10Our international sales and operations are subject to risks and uncertainties that vary by country and which could have a material adverse effect on our business and/or results of operations
- 11Disruptions in the supply of key raw materials could adversely impact our operations
- 12Raw material and energy prices have a significant impact on our profitability. If raw material and/or energy prices increase, and we cannot pass those price increases on to our customers, our profitability and financial condition may suffer
- 13If we are not timely or successful in new-product innovation or the development and commercialization of proprietary multi-component systems, our future revenues and operating income could be adversely affected
- 14In the normal course of business, we engage in discussions with third parties relating to possible divestitures, acquisitions and other strategic transactionsNew
- 15Product defects could adversely affect the results of our operations
- 16A loss of or inability to attract key personnel or highly skilled employees could disrupt our operations31% rewritten
- 17The concentration of our customer base could adversely affect our financial condition and operating resultsNew
- 18We may be unable to increase capacity or efficiency at our own manufacturing facilities, which could adversely affect our business, financial condition, and results of operations
- 19Our results of operations and earnings may not meet guidance or expectations
- 20No assurance can be given that we will continue to pay or declare dividends
- 21If we fail to comply with our obligations under our distributorship or license agreements with Daikyo or the agreements are terminated early or not renewed, we could lose license rights and access to certain product and technology that are important to our business
Legal, Regulatory and Compliance Risks
- 22We are subject to regulation by governments around the world, and if these regulations are not complied with, existing and future operations may be curtailed, and we could be subject to liability
- 23Products that incorporate our technologies and medical devices that we produce are subject to regulations and extensive approval or clearance processes, which make the timing and success of new-product commercialization difficult to predict
- 24Changes in the regulation of drug products and devices may increase competitive pressure and adversely affect our business
- 25If we are not successful in protecting our intellectual property rights, our ability to compete may be affected
- 26Significant developments in U.S. tax policies could have a material adverse effect on our business and/or results of operations52% rewritten
- 27If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results, which could lead to a loss of investor confidence in our financial statements and have an adverse effect on our stock priceNew
- 28Changing climate, global climate change regulations and greenhouse gas effects may adversely affect our operations and financial performance33% rewritten
- 29Failure to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences
- 30Our operations must comply with environmental statutes and regulations, and any failure to comply could result in extensive costs which would harm our business32% rewritten
- 31Changes in reimbursement practices of third-party payers or other cost containment measures, including changes to applicable laws and regulations, could affect the demand for our products and the prices at which they are sold
- 32Our share price has been volatile and may fluctuate, and accordingly, the value of an investment in our common stock may also fluctuate24% rewritten
Other West Pharmaceutical Services 10-Ks
- FY2024 10-K risk factors30 risks
International operations generate 57.5 percent of net sales, exposing the company to global economic and currency risks. Regulatory approvals from the FDA and global bodies govern core product commercialization and compliance. Sole-source raw material availability and manufacturing concentration in specific plants threaten operational continuity.
Filed Feb 18, 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.