West Pharmaceutical Services's biggest risks in the FY2024 10-K
- 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.
The risks most specific to West Pharmaceutical Services
We are a global company with significant revenues and earnings generated internationally, which exposes us to the impact of foreign currency fluctuations, as well as political and economic risks
Sales outside of the U.S. generated 57.5% of consolidated net sales in 2024, exposing us to foreign currency, political, and economic risks.
- Business and Operational Risks
Disruption 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
Manufacturing of certain product lines is concentrated in one or only a few plants, making us vulnerable to facility disruptions.
- Business and Operational Risks
Disruptions in the supply of key raw materials could adversely impact our operations
Many components and raw materials are purchased from a single supplier for quality assurance or cost effectiveness, risking supply disruptions.
- Business and Operational Risks
Raw 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
We rely on elastomers, aluminum, and plastic, and if raw material and energy prices increase, our profitability may suffer.
- Business and Operational Risks
If 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
If our distributorship or license agreements with Daikyo expiring in 2027 are terminated early, we could lose access to Crystal Zenith, FluroTec, and B2-coating.
- Legal and Regulatory Risks
Products 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
Most medical devices and technologies we produce are subject to the FDA's 510(k) approval process, which typically lasts from six to nine months.
All 30 risk factors
Headings as the filing states them, in filing order.
Other
- 01Global economic conditions, including inflation and supply chain disruptions, could continue to 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, 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 demands 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
- 14We 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
- 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 operations
- 17We 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
- 18Our results of operations and earnings may not meet guidance or expectations
- 19No assurance can be given that we will continue to pay or declare dividends
- 20If 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 and Regulatory Risks
- 21We 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
- 22Products 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
- 23Changes in the regulation of drug products and devices may increase competitive pressure and adversely affect our business
- 24If we are not successful in protecting our intellectual property rights, our ability to compete may be affected
- 25Significant developments in U.S. tax policies could have a material adverse effect on our business and/or results of operations
- 26Changing climate, global climate change regulations and greenhouse gas effects may adversely affect our operations and financial performance
- 27Failure to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences
- 28Our operations must comply with environmental statutes and regulations, and any failure to comply could result in extensive costs which would harm our business
- 29Changes 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
- 30Our share price has been volatile and may fluctuate, and accordingly, the value of an investment in our common stock may also fluctuate
Other West Pharmaceutical Services 10-Ks
- FY2025 10-K risk factors32 risks3 new1 dropped5 reworded
The company added specific operational risks covering customer concentration, internal controls, and asset divestitures like the AbbVie SmartDose deal.
Filed Feb 17, 2026
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.