Align Technology Inc.: 10-K Risk Factor Changes

2025 vs 2024  ·  SEC EDGAR  ·  2026-05-22
Other years: 2026 vs 2025 · 2024 vs 2023
⚠ AI-Generated

The summary below was generated by an AI language model and may contain errors or omissions. All other content on this page is deterministically extracted from the original SEC EDGAR filing.

Align Technology removed a general financial market risk disclosure while adding a targeted risk specific to software and hardware vulnerabilities in its iTero intraoral scanner products, reflecting a shift toward product-specific operational concerns. Twenty of the company's risk factors underwent substantive modifications, with heightened emphasis on regulatory compliance and supply chain disruption risks alongside acquisition integration challenges, indicating increased focus on operational execution and external regulatory pressures. These changes suggest Align is recalibrating risk disclosures around its core digital scanning technology platform and the complexities of integrating acquired businesses in an increasingly regulated healthcare technology environment.

✓ Deterministic extraction — no AI-generated data

Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.

1
New Risks
1
Removed
20
Modified
12
Unchanged
🟢 New in Current Filing Products in our Systems and Services segment, such as our iTero intraoral scanners, are subject to software and hardware risks that, if improperly managed, could have a material adverse impact on our business and financial results. 🔒
🔴 No Match in Current Filing If we fail to manage our exposure to global financial and securities market risks successfully, our operating results and financial statements could be materially impacted. 🔒
🟡 Modified Failure to obtain or maintain approvals or comply with regulations regarding our products or services or those of our suppliers could materially harm our sales, result in substantial penalties and fines, interrupt our supply chain and cause harm to our reputation. 🔒
🟡 Modified We may invest in or acquire other businesses, products, technologies or other assets which may require significant management attention, disrupt our business, dilute stockholder value or adversely affect our business, financial condition and results of operations. 🔒
🟡 Modified New tax laws and practices, changes to existing tax laws and practices, or disputes regarding the positions we take regarding tax laws, could negatively affect our provision for income taxes as well as our ongoing operations. 🔒
🟡 Modified Our success depends on our ability to successfully develop, introduce, achieve market acceptance of, and manage new or improved products and services. 🔒
🟡 Modified Competition in the markets for our products and services is increasing and we expect aggressive competition from existing competitors, other companies that introduce new technologies, products or services in the future, and customers who alone or with others create orthodontic appliances and solutions or other products or services that compete with us. 🔒
🟡 Modified If our goodwill, intangible or long-lived assets become impaired, we may be required to record material charges to income. 🔒
🟡 Modified Our operating results have and will continue to fluctuate in the future, which makes predicting the timing and amount of customer demand and our revenues, costs, and expenditures difficult. 🔒
🟡 Modified We are subject to antitrust and competition regulations, litigation and enforcement that may result in fines, penalties, restrictions on our business practices, and product, services or operational changes which could materially impact our business, financial condition and results of operations. 🔒
🟡 Modified Changes in, or interpretations of, accounting rules and regulations, could result in unfavorable accounting charges. 🔒
🟡 Modified We are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our business, financial condition and results of operations could be materially adversely affected if supply is restricted or ends or the price materially increases. 🔒
🟡 Modified Our effective tax rate may vary significantly from period to period, which could result in volatility of our operating results and adversely affect our financial results. 🔒
🟡 Modified Our business, financial condition and results of operations depend on global and regional economic conditions. Inflation, fluctuations in foreign currency exchange rates, changes in consumer confidence and demand, general economic weakness and actual or potential slowdowns or recessions have and could in the future materially affect our business, financial condition, and results of operations. 🔒
🟡 Modified Our IT systems are critical to our business. Issues with IT system and software integration, implementation, updates, and upgrades, or third-party software have previously and could again in the future disrupt our operations and have a material impact on our business, our reputation, and operating results. 🔒
🟡 Modified Security breaches, data breaches, cybersecurity attacks, other cybersecurity incidents, or the failure to comply with privacy, security and data protection laws could materially adversely impact our operations and patient care, and we could be liable for damages, and our reputation, business, financial condition and results of operations could be harmed. 🔒
🟡 Modified Our net revenues depend primarily on sales of the Invisalign System and iTero intraoral scanners and declines in sales or the average selling price (“ASP”) of these products may adversely affect net revenues, gross profit, and net income. 🔒
🟡 Modified Current and anticipated sustainability and social (“Sustainability”) laws and scrutiny of our Sustainability policies and practices may materially increase our costs, expose us to liability, and adversely impact our reputation, employee retention, willingness of customers and suppliers to do business with us and willingness of investors to invest in us. 🔒
🟡 Modified We have been incorporating and continue to work to further incorporate AI technologies into our products, services and IT systems. Implementation of AI and machine learning technologies may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business. 🔒
🟡 Modified Our operations may be impacted by natural disasters, which may become more frequent or severe as a result of climate change, and may adversely impact our business, financial condition and results of operations, as well as those of our customers and consumers, suppliers, contract manufacturers, distributors and other business partners. 🔒
🟡 Modified Our business, financial condition and results of operations could be impacted by geopolitical events, tariffs, trade and international disputes, wars, military actions and terrorism, or major public health crises. 🔒
🟡 Modified Demand for our products and services may not increase or may decrease for many reasons, including resistance to the innovative and business-model-disruptive nature of some of our products and services, which could have a material impact on our business, financial condition and results of operations. 🔒
22 changes in this historical filing

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