Align Technology Inc.: 10-K Risk Factor Changes

2026 vs 2025  ·  SEC EDGAR  ·  2026-05-22
Other years: 2025 vs 2024 · 2024 vs 2023
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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 added three new risk factor disclosures in 2026 addressing foreign currency exposure, dental service organization purchasing patterns, and data privacy/cybersecurity compliance, while substantially revising 21 existing risks including those covering IT system disruptions, Invisalign and iTero product dependencies, and sustainability regulations. The company made no deletions to previously disclosed risks, indicating an expansion rather than refinement of its risk profile. The modifications to top-tier risks suggest heightened focus on operational technology vulnerabilities, revenue concentration in core products, and regulatory compliance obligations.

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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.

3
New Risks
0
Removed
21
Modified
12
Unchanged
🟢 New in Current Filing

We are subject to foreign currency exchange fluctuations, which could have a material adverse effect on our financial condition or results of operations.

We have significant international operations and sales and are therefore exposed to fluctuations in foreign currencies that have and may continue to adversely impact our business, financial condition or results of operations. Although the U.S. dollar is our reporting currency, a…

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We have significant international operations and sales and are therefore exposed to fluctuations in foreign currencies that have and may continue to adversely impact our business, financial condition or results of operations. Although the U.S. dollar is our reporting currency, a large portion of our net revenues and expenses are generated in foreign currencies. While we forecast our balance sheet exposures to foreign currency fluctuations and utilize foreign currency forward contracts to moderate the impact of currency fluctuations on certain assets and liabilities, these contracts may not eliminate our exposure. Currency exchange rate fluctuations have and may continue to materially adversely affect our results of operations and cash flows.

🟢 New in Current Filing Our results of operations may be adversely affected if doctors at DSOs, orthodontic service organizations (“OSOs”) or other large group practices reduce, delay, or do not increase their purchasing of our products and services in ways that reduce adoption of our products and services. 🔒
🟢 New in Current Filing We are subject to various laws relating to privacy, data protection, data governance and cybersecurity, and face risks related to the data we collect, process, and share. 🔒
🟡 Modified 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. 🔒
🟡 Modified Our net revenues depend primarily on sales of the Invisalign System and iTero intraoral scanners and declines in volume or the average selling price (“ASP”) may adversely affect net revenues, gross profit, operating 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 are required to annually assess our internal control over financial reporting and any adverse results from such assessment may result in a loss of investor confidence in our financial reports and adversely affect our stock price. 🔒
🟡 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. 🔒
🟡 Modified If our goodwill, finite-lived intangible or long-lived assets become impaired, we may be required to record material charges to income. 🔒
🟡 Modified Historically, the market price for our common stock has been volatile. 🔒
🟡 Modified Our success depends on our ability to quickly and profitably develop, manufacture, market, and obtain and maintain regulatory approvals or clearances of new, improved or refurbished products and services. 🔒
🟡 Modified We are subject to operating risks, including excess or constrained capacity, operational inefficiencies and pressure on our internal systems, personnel and suppliers, including as a result of our past and any future restructuring efforts, which could adversely affect our results of operations. 🔒
🟡 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 We may not realize the anticipated benefits of acquisitions, investments or other strategic transactions, and they may require significant management attention, disrupt our business, dilute stockholder value or adversely affect our business, financial condition and results of operations. 🔒
🟡 Modified Our quarterly and annual results of operations have and will continue to fluctuate in the future, and we may not accurately predict the timing and amount of customer demand and our revenues, costs, and expenditures. 🔒
🟡 Modified Competition in the markets for our products and services is increasing. 🔒
🟡 Modified We may not continue repurchasing our common stock and any repurchases may not achieve our desired objectives. 🔒
🟡 Modified Global and regional economic conditions have and could in the future materially affect our business, financial condition and results of operations. 🔒
🟡 Modified Geopolitical events, tariffs and trade policies, and military conflicts have and could in the future materially affect our business, financial condition and results of operations. 🔒
🟡 Modified Security breaches, data breaches, cybersecurity attacks, or other cybersecurity incidents could materially adversely impact our operations and patient care, and our reputation, business, financial condition and results of operations could be harmed. 🔒
🟡 Modified Natural disasters may adversely impact our business, financial condition and results of operations, as well as those of our customers and consumers, suppliers, contract manufacturers, commercial intermediaries and other business partners. 🔒
🟡 Modified If we cannot attract, motivate, train or retain personnel, it will be difficult to achieve our strategic priorities, which could materially adversely affect our business, financial condition and results of operations. 🔒
🟡 Modified AI and machine learning technologies in our products, services and IT systems may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business. 🔒
🟡 Modified We contract with commercial intermediaries to distribute 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 these intermediaries do not comply with applicable laws or our internal procedures. 🔒
23 more changes in this filing

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