Align Technology Inc.: 10-K Risk Factor Changes

2024 vs 2023  ·  SEC EDGAR  ·  2026-05-22
Other years: 2026 vs 2025 · 2025 vs 2024
⚠ 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 restructured its risk factor presentation by eliminating nine categorical risk groupings (including macroeconomic, business and industry, operational, and pandemic-related risks) and consolidating them into a more streamlined framework, while adding a new risk focused on artificial intelligence implementation and its legal, regulatory, and reputational consequences. The company modified 25 existing risks substantively, including heightened focus on financial market exposure, equity repurchase programs, tax rate volatility, and distributor relationships. This reorganization reflects a shift from broad categorical risk disclosure to more granular, issue-specific risk articulation, with particular emphasis on emerging technology risks and financial management challenges.

✓ 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
9
Removed
25
Modified
7
Unchanged
🟢 New in Current Filing We have been incorporating and continue to work to further incorporate artificial intelligence (“AI”) into our products, services and internal operations. Implementation of AI and machine learning technologies may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business. 🔒
🔴 No Match in Current Filing Summary of Risk Factors 🔒
🔴 No Match in Current Filing Macroeconomic and External Risks 🔒
🔴 No Match in Current Filing Business and Industry Risks 🔒
🔴 No Match in Current Filing Operational Risks 🔒
🔴 No Match in Current Filing Legal, Regulatory and Compliance Risks 🔒
🔴 No Match in Current Filing Intellectual Property Risks 🔒
🔴 No Match in Current Filing Financial, Tax and Accounting Risks 🔒
🔴 No Match in Current Filing Our business could be impacted by major public health issues, including pandemics, and our business has been and continues to be materially affected by the global and regional spread of COVID-19. 🔒
🔴 No Match in Current Filing Business disruptions could seriously harm our financial condition. 🔒
🟡 Modified 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 We cannot guarantee that we will continue to repurchase our common stock in the future, and any repurchases we may make may not achieve our desired objectives. 🔒
🟡 Modified Our effective tax rate may vary significantly from period to period. 🔒
🟡 Modified We use distributors for a portion of the importation, marketing and sales of our products and services, which exposes us to risks to our sales, operations and reputation, including the risk that these distributors do not comply with applicable laws or our internal procedures. 🔒
🟡 Modified Our success depends in part on our proprietary technology, and if we fail to successfully obtain or enforce our IP rights, our competitive position may be harmed. 🔒
🟡 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 and operating results as well as those of our customers and suppliers. 🔒
🟡 Modified Security breaches, data breaches, cybersecurity attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmed. 🔒
🟡 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 and adversely affect our results of operations. 🔒
🟡 Modified Demand for our products may not increase or may decrease due to resistance to non-traditional treatment methods, which could have a material impact on our business and operating results. 🔒
🟡 Modified Our success depends on our ability to successfully develop, introduce, achieve market acceptance of, and manage new products and services. 🔒
🟡 Modified Increased focus on current and anticipated environmental, social and governance (“ESG”) laws and scrutiny of our ESG policies and practices may materially increase our costs, expose us to liability, 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 are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our business and operating results could be harmed if supply is restricted or ends, or if the price of raw materials used in our manufacturing process increases. 🔒
🟡 Modified Our operations and financial performance depend on global and regional economic conditions. Inflation, fluctuations in currency exchange rates, changes in consumer confidence and demand, and general economic weakness and threats, or actual recessions, have and could in the future materially affect our business, results of operations, and financial condition. 🔒
🟡 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 and cause harm to our reputation. 🔒
🟡 Modified A disruption in the operations of a primary freight carrier, higher shipping costs or shipping delays could disrupt our supply chain and impact our operating and financial results. 🔒
🟡 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 We depend on our marketing activities to deepen our market penetration and raise awareness of our brands and products, which may prove unsuccessful or may become less effective or more costly to maintain in the long term. 🔒
🟡 Modified Our operating results have and will continue to fluctuate in the future, which makes predicting the timing and amount of customer demand, our revenues, costs and expenditures difficult. 🔒
🟡 Modified Our net revenues depend primarily on our Invisalign system and iTero scanners and declines in sales or average selling price of these products may adversely affect net revenues, gross margin and net income. 🔒
🟡 Modified We are subject to operating risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operations. 🔒
🟡 Modified Competition in the markets for our products is increasing and we expect aggressive competition from existing competitors, other companies that introduce new technologies or products 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 Our success depends on our personnel. If we cannot attract, motivate, train or retain personnel, it may be difficult to achieve our strategic priorities, materially effecting our results of operations. 🔒
🟡 Modified If our goodwill, intangible or long-lived assets become impaired, we may be required to record a material charge to earnings. 🔒
🟡 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 or operational changes which could materially impact our business. 🔒
🟡 Modified Our business could be impacted by geopolitical events, trade and other international disputes, war, and terrorism, or major public health crises. 🔒
35 changes in this historical filing

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