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ALGNAlign Technology

Health care · Medical Devices · Nasdaq
Employees
20,290
Headquarters
Tempe, AZ
CEO
Joseph Hogan
Next results
around Feb 3, 2027
Compare with peers → Embed

10-K 0001097149-26-000014 (2026-02-27) vs 10-K 0001097149-25-000012 (2025-02-28)

SectionCompared textWords nowChanged
Risk FactorsItem 1A13,441 29.2%
MD&AItem 77,618 30.2%
Legal ProceedingsItem 3, via Note 8 – Legal Proceedings1,692 57.4%
Accounting PoliciesItem 8, Note 1 – Summary of Significant Accounting Policies6,527 9.4%

The redline: what was cut and what was added

In each section, the paragraph that changed most, marked against last year's 10-K: cut words struck through, new words highlighted and underlined.

Risk Factors 346 words changed in this paragraph; it is 33% similar to last year's version.
Tariffs or proposed tariffs, such as those on Chinese, Mexican, Canadian customs duties, or other foreign goods, fees, and any retaliatory tariffs, international trade disputes, or protectionist trade measures taken in response to such tariffs may increase the cost of our products and the components and or the raw materials used to make them. Specifically, them, reduce demand for our products and adversely impact our gross margin and results of operations, limit our ability to sell to certain customers, limit or prohibit the availability of certain raw materials, components and parts necessary for our products or the products of our suppliers, or impede or slow the movement of our goods across borders. For example, the U.S. Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices. A significant portion of the products we sell, and the components and raw materials used in our products are originally manufactured or sourced outside the United States. For example, we manufacture clear aligners in our facility in Mexico and ship them to the United States, primarily for our United States customers customers, with the remainder eventually shipping shipped to other international locations. Tariffs would have and could in the future result in additional costs for our products, which may impact operating margin, reduce demand for our products and adversely impact our gross margin. Foreign countries may also adopt or rescind other measures, such as controls on the import or export margin and results of goods, technology or data, including personal data, that could adversely impact our operations and supply chains or limit our ability to offer certain products and services. These measures could require us to take various actions, including changing suppliers, where we manufacture our products, or restructuring business relationships. Complying with new or revised trade restrictions may be expensive, time-consuming, disruptive to our logistics and operations, and more costly for us and our customers. Such restrictions may be announced with little or no advance notice and we may not be unable able to effectively fully or substantially mitigate the impact of any adverse impacts in a timely manner new or at all. increased tariffs or pass price increases on to our customers and to the extent we do, we may experience reduced demand for our products. The extent and duration of any tariffs and the resulting impact on general economic conditions and on our business, financial condition and results of operations are uncertain.

Source: Item 1A, 10-K 0001097149-26-000014 vs Item 1A, 10-K 0001097149-25-000012

Legal Proceedings 180 words changed in this paragraph; it is 50% similar to last year's version.
On April 11, 2024, we filed a lawsuit in the U.S. District Court for the Western District of Texas against ClearCorrect Operating, LLC, ClearCorrect Holdings, Inc., Inc. and Institut Straumann AG. AG, (collectively the “Defendants”). The complaint asserts claims of false advertising, unfair competition, civil conspiracy, and asserted infringement of Align our patents related to aligner material, treatment planning, and intraoral scanner technologies. Among other things, the complaint seeks relief enjoining the defendants’ Defendants’ infringement of multiple Align multilayer material patents through defendants’ Defendants’ manufacture, sale and offer for sale of aligners made with Zendura FLX/ClearQuartz materials. On June 20, 2024, September 12, 2025, Defendants filed motions to dismiss the Complaint, which are pending. On July 9, 2024, ClearCorrect Operating, LLC, ClearCorrect Holdings, Inc. and Straumann USA LLC filed counterclaims against Align for alleged antitrust violations, false advertising, unfair competition, and breach of contract. Among other things, the counterclaims seek relief enjoining Align’s accused business practices, invalidating Align’s asserted patents, and money damages. On September 13, 2024, we filed a motion to dismiss defendants’ counterclaims. On February 7, 2025, the magistrate judge recommended denial of the amended complaint. That motion to dismiss. On February 21, 2025, we filed objections dismiss remains pending. Defendants are also seeking to the recommendation, which are pending before invalidate all of our asserted patents at the district court judge. The District Court has scheduled a trial for February 16, 2026. Align believes these claims are without merit and intends to vigorously defend itself. Align is currently unable to predict the outcome of this lawsuit and cannot determine the likelihood of loss nor estimate a range of possible loss. court.

Source: Item 3, via Note 8 – Legal Proceedings, 10-K 0001097149-26-000014 vs Item 3, via Note 8 – Legal Proceedings, 10-K 0001097149-25-000012

MD&A 122 words changed in this paragraph; it is 61% similar to last year's version.
Additionally, More directly, we believe government actions in various countries relating to implemented actual or proposed tariffs, tariffs and retaliatory actions in key strategic countries or regions, particularly in the United States, China, Mexico, Europe, Brazil, Canada, Israel and Europe are expected to Mexico may adversely impact our revenue and cost of goods sold if implemented. sold. Additionally, the trade war and geopolitical tensions between the United States and China may result in the limitation or prohibition of the availability of certain raw materials, components and parts necessary for our products or the products of our suppliers. The degree of our exposure is dependent depends on, among other things, the type of goods subject to any tariffs or trade restrictions enacted, the tariff rates or limits imposed, the timing of the tariffs or restrictions and any other retaliatory measures enacted. The impact of declining demand may vary by time and region, making operational results uncertain and difficult to predict. These events may also cause a shift in public opinion about companies based in the United States and this may have an adverse impact on our reputation and business. We continue to closely monitor the foregoing issues, assess their potential impact on our operations and financial results, and implement plans to seek to mitigate the impact of any adverse events.

Source: Item 7, 10-K 0001097149-26-000014 vs Item 7, 10-K 0001097149-25-000012

Accounting Policies 93 words changed in this paragraph; it is 37% similar to last year's version.
Our cash and investments are held primarily by five financial institutions. Financial instruments which potentially expose us the Company to concentrations concentration of credit risk consist primarily principally of cash and cash equivalents. These instruments have minimal credit risk exposures. Management regularly monitors their compositions and maturities. The Company maintains its cash and cash equivalents and marketable securities. We invest excess cash primarily in money market funds, corporate bonds, asset-backed securities, municipal and U.S. government agency bonds and treasury bonds and periodically evaluate them for credit losses. Such bank accounts that exceed federally insured FDIC limits. Through December 31, 2025, the Company has not experienced any material credit losses have not been material to our financial statements. on such deposits.

Source: Item 8, Note 1 – Summary of Significant Accounting Policies, 10-K 0001097149-26-000014 vs Item 8, Note 1 – Summary of Significant Accounting Policies, 10-K 0001097149-25-000012

Every change, by type

Sentences and paragraphs of ALGN's Risk Factors and MD&A, 10-K 2026-02-27 against 10-K 2025-02-28. Each links to the text at sec.gov.

Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier (may, could, will, not, significant, material…). A year or date rolling forward is not counted.

The full word listadverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would

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

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
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.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
Tariffs or proposed tariffs, customs duties, or fees, and any retaliatory tariffs, international trade disputes, or protectionist trade measures taken in response to such tariffs may increase the cost of our products and the components or the raw materials used to make them, reduce demand for our products and adversely impact our gross margin and results of operations, limit our ability to sell to certain customers, limit or prohibit the availability of certain raw materials, components and parts necessary for our products or the products of our suppliers, or impede or slow the movement of our goods across borders. For example, the U.S. Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices. A significant portion of the products we sell, and the components and raw materials used in our products are originally manufactured or sourced outside the United States. For example, we manufacture clear aligners in our facility in Mexico and ship them to the United States, primarily for our United States customers, with the remainder eventually shipped to other international locations. Tariffs have and could in the future result in additional costs for our products, which may reduce demand for our products and adversely impact our gross margin and results of operations, and we may not be able to fully or substantially mitigate the impact of any new or increased tariffs or pass price increases on to our customers and to the extent we do, we may experience reduced demand for our products. The extent and duration of any tariffs and the resulting impact on general economic conditions and on our business, financial condition and results of operations are uncertain.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
We also face competition from traditional products and services, such as wires and brackets, which doctors have historically been able to purchase at a lower price point. We have and will likely continue to experience price-focused competition as we continue to expand into new markets, which could contribute to the commoditization of our products or services if we are unable to otherwise differentiate our offerings from those of our competitors.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
•ultimately own less than a majority of the outstanding shares of the company and be unable to control or have significant influence over critical issues that could harm the value of our investment;

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
•changes in the timing of revenue recognition and our ASPs as a result of changes to the amount allocated to the standalone selling price of the distinct performance obligations under sales contracts;

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
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.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
DSOs, OSOs and other large group practices have become an increasingly important channel for adoption of our products and services. If doctors at DSOs, OSOs or other large group practices reduce, delay, or do not expand their purchasing of our products and services, or otherwise change priorities, protocols, or workflows in ways that reduce utilization of our products, demand for our products and services may not increase or may decrease, which could have a material impact on our business, financial condition and results of operations. In addition, on behalf of the doctors in their affiliated practices, DSOs and other large group practices may have greater leverage to negotiate pricing, volume‑based discounts, rebates, extended payment terms, or other commercial concessions, which could adversely affect our ASPs, gross margins and profitability.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
products while addressing safety and security, track orders and timely ship products, manage our supply chain, and aggregate financial and operational data. Failure to adequately protect and maintain the integrity of our products, IT systems and data in those systems, and those of our suppliers and customers may materially impact our reputation, business, financial condition, and results of operations.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
Seamless leadership transitions for key positions are critical to sustaining our culture and organizational success. If our succession planning is ineffective, it could adversely impact our business. Organizational changes, such as our past and any future restructuring efforts, such as the restructuring plans we have implemented in each of the past three fiscal years, and most recently in the third quarter of 2025, may increase attrition and adversely impact our ability to successfully attract, motivate, and retain key personnel. In September, 2025, we required most of our employees to return to working five days per week in the office for most locations, which could impact our ability to attract and retain qualified personnel, particularly if companies that we compete with for talent have adopted work policies and arrangements that our employees may consider to be more appealing. We have experienced and may continue to experience difficulties attracting and retaining personnel that meet the qualifications, experience, compliance mindset and values we expect and share our core values of Agility, Customer and Accountability, which could impact our ability to achieve our strategic objectives and maintain compliance with obligations under our internal controls and other requirements. We provide significant training and experience to our personnel that, for certain roles, can make key personnel, such as our commercial and sales personnel, highly desirable to competitors and lead to increased attrition.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
reputation harmed, any of which could materially affect our business, financial condition and results of operations. The harm of negative publicity, particularly on social media platforms, may be immediate, without affording us an opportunity for redress or correction.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedRisk Factors
Antitrust considerations may also hinder our ability to settle such matters on favorable terms, as certain types of settlement agreements may be subject to heightened scrutiny by antitrust authorities. In the E.U., for instance, antitrust regulators closely monitor settlement agreements for compliance with competition laws, adding another layer of complexity and potential risk to these proceedings.

Read it in 10-K 2026-02-27 at sec.gov ↗

RemovedRisk Factors
rates have and could in the future reduce consumers’ disposable income, which could cause a decrease in discretionary spending for our products.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
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.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
In addition, we periodically introduce new business and sales initiatives to meet customers’ needs and demands. In general, our internal resources support these initiatives without clear indications they will prove successful or be without short-term execution challenges. Should these initiatives fail, our business, financial condition and results of operations could be materially adversely impacted.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
If we fail to accurately predict product demand, we may not have the appropriate level of our manufacturing capacity or that of one or more of our suppliers, staffing, materials, components, space, equipment or finished products. Specifically, our manufacturing process relies on sophisticated computer software and requires new technicians to undergo a long training process, often 120 days or longer. Additionally, production levels for our iTero intraoral scanners are generally based on forecasts and historic demand and we often place orders with suppliers for materials, components, sub-assemblies and finished products weeks or more in advance of projected orders. If we do not hire and train the appropriate number of technicians in anticipation of demand, our costs and expenditures may not align with our revenues or revenue growth. Additionally, to secure supplies for production of products, we periodically enter into non-cancelable minimum purchase commitments with vendors,

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
We provide significant training to our personnel and our business will be harmed if our training fails to properly prepare them to perform the work required, we are unable to successfully instill technical expertise in new and existing personnel, or if our techniques prove unsuccessful or are not cost-effective. Moreover, for certain roles, this training and experience can make key personnel, such as our sales personnel, highly desirable to competitors and lead to increased attrition. It can take 12 months or more to train sales representatives to successfully market and sell our products and services and for them to establish strong customer relationships. The loss of the services and knowledge of our highly-skilled personnel may significantly delay or prevent the achievement of our development, operational or strategic objectives.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
Additionally, seamless leadership transitions for key positions are critical to sustaining our culture and organizational success. If our succession planning is ineffective, it could adversely impact our business. We continually assess key personnel we believe are essential to our long-term success. Moreover, future organizational changes may cause attrition rates to increase. If we fail to effectively manage any organizational or strategic changes, our financial condition, results of operations, and reputation, as well as our ability to successfully attract, motivate, and retain key personnel, may be adversely affected.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
We have adopted a hybrid work schedule in many of our offices, allowing employees to collaborate and connect with others several days each week while providing the option to work remotely other days. This hybrid work approach may create challenges with maintaining our corporate culture, employee satisfaction, and hiring, promotion and retention.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
We believe a key to our success has been the culture we have created that emphasizes a shared vision and core values of Agility, Customer and Accountability. We have experienced and may continue to experience difficulties attracting and retaining personnel that meet the qualifications, experience, compliance mindset and values we expect. If we cannot attract and retain personnel that meet our selection criteria or relax our standards, our corporate culture, ability to achieve our strategic objectives and our compliance with obligations under our internal controls and other requirements may be harmed. This could have a material adverse effect on our results of operations and our ability to maintain market share.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
criminal prosecution. Delays or failures to obtain or maintain regulatory approvals, clearances or to comply with regulatory requirements may materially adversely affect our domestic or international operations, and adversely impact our business.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
In June 2024, the U.S. Supreme Court reversed its longstanding approach to evaluating administrative rulemaking under the Chevron doctrine, which provided for judicial deference to regulatory agencies, including the FDA. There may be increased challenges to existing agency regulations or how lower courts will apply the decision in the context of other regulatory schemes without more specific guidance from the courts. For example, this decision may result in more companies suing the FDA to challenge its longstanding decisions and policies, which could undermine the FDA's authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, which could impact the timely review of any regulatory filings or applications we submit.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
We are also subject to data export restrictions and international transfer laws and regulations that prohibit or impose conditions upon certain data transfers. The mechanisms upon which we and many other companies rely upon for European data transfers have been the subject of legal challenge, regulatory interpretation and judicial decisions by the EU courts and regulators, and may be subject to significant changes. Several countries, including the United States, China, Australia, and Japan, have established legal requirements for cross-border transfers of all or certain personal information and certain countries have also established legal requirements for data localization. These laws and regulations are constantly evolving and may be created, interpreted, applied or amended in ways that could restrict our activities in certain jurisdictions, limit our ability to provide our products and services in those jurisdictions, require us to modify our policies and practices and to engage in additional contractual negotiations, or increase our costs and obligations and impose limitations upon our ability to efficiently transfer personal data across borders. We have and likely will again in the future be required to implement new or expand existing data storage protocols, build new storage facilities, devote additional resources, and modify relevant policies or procedures to comply with the foregoing laws, any of which could be costly and which may adversely affect our business and our customers' businesses, our financial condition and our results of operations in those jurisdictions.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedRisk Factors
With laws, regulations and other obligations relating to privacy, data protection, data governance and cybersecurity imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so. Further, any failure or perceived failure by us or our vendors, customers, or service providers to comply with our applicable policies or notices relating to privacy, data protection, data governance or cybersecurity, our contractual or other obligations to third parties, or any of our other legal obligations, laws, rules, regulations or standards relating to privacy, data protection, data governance or cybersecurity, may result in governmental investigations or enforcement actions, litigation, claims and other proceedings, harm our reputation, and could result in significant liability.

Read it in 10-K 2025-02-28 at sec.gov ↗

RewordedRisk Factors
We currently are and may in the future be subject to antitrust, competition or unfair competition-related investigations, enforcement actions or claims by governmental agencies, competitors, consumers, customers and others which, even if unfounded, could cause us to incur substantial costs, costs (including fines), enter into settlements, settlements or consent decrees, be subject to judgments, involve receive negative publicity and publicity, forego certain mergers, acquisitions, business combinations, investments or other transactions, divert management time and attention, which may materially impact or change our business, financial condition business in ways that could have a material adverse effect on our business practices, revenues and results of operations. operations, such as limiting our ability to provide certain benefits to our customers and consumers, reducing the attractiveness of our products, services and the net revenue derived from them.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
We are also or may become, or alleged to be or become, subject to stringent federal, state, and foreign laws and regulations respecting regulations, such as HIPAA, which regulates the security and privacy of patient healthcare information applicable to healthcare providers and their business associates, such as HIPPA, the HITECH Act, and the Privacy Standards and Security Standards, as well as those relating to privacy, data security, content regulation and consumer protection, such as the California Consumer Protection Act, as amended by the California Privacy Rights Act (as amended, the “CCPA”). Act, which regulates privacy, data security, content regulation and consumer protection.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
There is no assurance our Our advertising campaigns will may not achieve the desired returns on advertising spend, increase brand, product or services awareness sufficiently or generate goodwill and positive reputational goals, or that we will be able goals among the teen and adult markets, enable us to maintain commercial relationships with social media influencers and other strategic partners. partners, or differentiate our products from those featured in the growing number of advertising campaigns by competitors promoting similar products and messaging.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Changes in tax laws laws, such as the Inclusive Framework on Base Erosion and Profit Shifting (“BEPS”) established by Organization for Economic Cooperation and Development (“OECD”), the OECD/G20 Framework’s Pillar Two 15% global minimum tax, and the One Big Beautiful Bill Act, or changes to how those laws are applied to our business could affect the amount of tax which we are subject to and the manner in which we operate.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Climate change could increase the frequency and severity of natural disasters such as hurricanes, tornadoes, earthquakes, wildfires, droughts, extreme temperatures, or flooding which could cause supply chain interruptions, increase demand and could change the supply, demand or negatively impact availability of sources of energy or resources material to manufacturing our products and operations. operations, or cause damage to our products and facilities.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
To stimulate product and services demand, we We have a history of offering volume discounts, price reductions, reductions and other promotions to targeted customers and consumers and releasing lower priced products. products which have had, and may in the future have, unexpected and unintended consequences, including reduced net revenues, gross profit, operating profit and net income.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
We have and are continuing to incorporate AI, including AI and machine learning and independent algorithms, in technologies into certain of our products, services and IT systems, which is intended while continuing to enhance their operation and effectiveness internally and for explore the opportunities that AI could bring to our customers, consumers and suppliers. company.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
For example, the collection and use of health data and other personal information is governed in the EU by the General Data Protection Regulation (“GDPR”), EU GDPR, which imposes significant obligations upon companies and rights for individuals, with substantial penalties for noncompliance up to the greater of €20,000,000 or 4% of the total worldwide annual turnover of the preceding financial year, and by certain EU member state-level legislation. noncompliance.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Orthodontists, GPs and DSOs have and may continue to sample competitive and alternative products and products, take advantage of competitive promotions and sale opportunities. opportunities, or engage in “bait and switch,” “margin steering” or similar practices that take advantage of the significant brand recognition of Invisalign to offer alternative products.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Further, For instance, decreased demand for dental services can has and may in the future cause dentists doctors and labs to revert to wires and brackets and postpone investments in capital equipment, such as intraoral scanners and CAD/CAM equipment and software. equipment.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Moreover, independent actions by competitors, customers, or others have alleged that our efforts to enforce our IP rights constitute unfair competition or violations of antitrust laws and investigations Investigations and additional litigation based on the same or similar claims may be brought in the future.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedRisk Factors
Our operations may be impacted by natural disasters, which may become more frequent or severe as a result of climate change, and 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, distributors commercial intermediaries and other business partners.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
Our business, reputation, results of operations, financial condition, cash flows and stock price can be affected by a number of factors, whether currently known or unknown, or that we currently believe to be immaterial. material. including those described below.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
We may not be able to fully mitigate the impact of the increased costs or pass price increases on to our customers, resulting which could result in downward pressure on our operating results.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
Additionally, the third-party software integrated into or interoperable with our iTero intraoral scanners will routinely reach end of life, and as a consequence, certain applications and models may be exposed to additional vulnerabilities, including security risks, errors, and malfunctions that may be irreparable or difficult to repair.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
Many U.S. and foreign regulators have or are considering enacting new or additional disclosure requirements or limits on the emissions of greenhouse gases from power generated using by fossil fuels.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
We may also suffer financial and reputational harm if customers require, and we are unable to cannot deliver, certification that our products are compliant.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
We may not be afforded the protection of a patent if our currently pending or future patent filings do not result in the issuance of patents or if we fail to timely apply for patent protection.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesRisk Factors
Our inability to maintain the proprietary nature of our technology through patents, copyrights, or trade secrets would could impair our competitive advantages and could have a material effect on our operating results, financial condition, and future growth prospects.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
We strive to help our doctor customers move their practices forward by connecting them with new patients, providing digital solutions to help increase practice efficiency and helping them deliver the best possible treatment outcomes and experiences to millions of people around the world. We strive to achieve this through our continued focus on, and execution of, our strategic growth drivers:

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
International Expansion: Continually increasing the presence of our operations and commercial organization globally, expanding our products and service offerings and training and educating more doctors in more markets.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
General Practitioner dentists (“GP”) treatment: Making teeth straightening more relevant for GPs by enabling them to effectively scan, identify, treat, and monitor malocclusion.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
Patient Demand: Making the Invisalign® system the most recognized brand name in orthodontics by creating awareness and preference among consumers and motivating potential patients to start treatment.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
Orthodontist Utilization: Continually innovating in digital orthodontics to increase product applicability and predictability to address a range of malocclusion, especially for teens and growing patients, enabling doctors to confidently diagnose and treat more patients.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
•Investing in research and development that allows us to innovate, develop and bring to market products and solutions that deliver the ever-increasing clinical precision and predictability that doctors expect with the speed and convenience their patients require. For instance, in 2025, we announced several new enhancements to the AlignTM Digital Platform, including (i) restorative capabilities to our iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the new iTero Lumina™ Pro dental imaging system (with iTero NIRI technology), and (ii) iTero Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and integrated software tools, including enhancements to the Align™ Oral Health Suite, Invisalign® Outcome Simulator Pro with ClinCheck® Smile Video, and the iTero™ Design Suite. Additionally, we continue to invest in AI infrastructure, specialized talent, and strategic partnerships to further enhance the capabilities of the Align™ Digital Platform and differentiate our product portfolio from traditional and emerging competitors. We believe our commitment to AI can unlock new and adjacent market opportunities, and sharpen our operational focus and capital efficiency by driving automation, scalability, and productivity across our operations, while enabling doctors and their patients to benefit from more efficient and predictable treatment experiences. We maintain governance frameworks, internal controls, and oversight mechanisms designed to promote responsible AI development and deployment, mitigate associated risks, and ensure alignment with applicable laws.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
Our revenues may fluctuate as a result of events and circumstances impacting customer confidence, consumer sentiment, discretionary spending and ultimately demand for dental services and our products. These events and circumstances include, but are not limited to, macroeconomic conditions, fluctuations in foreign currency exchange rates, tariffs or proposed tariffs, customs duties or fees, and any retaliatory tariffs or protectionist trade measures taken in response to such tariffs or as a result of trade and international disputes, inflation, elevated interest rates, actual or potential slowdowns or recessions, wages, employment levels and health insurance coverage, debt obligations, discretionary income, supply chain challenges, market volatility, and other factors. For more information on events and circumstances that could impact our revenues, refer to Part II, Item 1A “Risk Factors—Macroeconomic and External Risks.”

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
Many of these factors may contribute to, among other things, higher raw material prices, increased transportation and labor costs, and interruptions in supply and distribution operations, each of which can also impact the availability of certain raw materials, parts and components used in our products as well as our costs and those of our suppliers. For example, we believe that in the beginning of the second quarter of 2025, sales of our products were adversely impacted compared to the same period in prior years by certain macroeconomic conditions, including global tariff volatility, inflation, and higher interest rates, which we believe may continue to impede dental patient demand. For example, patient traffic growth has been uneven for many doctors, with orthodontic starts down for four consecutive years. We believe uncertainty not only impacts consumer purchasing decisions but also the decisions and recommendations that doctors make, especially doctors who offer both clear aligners and wires and brackets in their practices and have the additional time to treat patients with wires and brackets when orthodontic starts are slowing or diminishing. We believe this has resulted in an increase in orthodontic starts using wires and brackets in lieu of clear aligners that was more pronounced in the second quarter of 2025. However, we believe these trends are continuing and will impede future sales for so long as consumer economic uncertainty persists, particularly to the extent it impairs discretionary spending. We also anticipate the geopolitical conflicts involving Ukraine, the Middle East, China and other regions will continue to add to market uncertainties and dampen consumer sentiment and demand.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
Beginning in the third quarter of 2025 and continuing into the fourth quarter, we initiated a series of restructuring actions to streamline our operations, realign parts of our organization, and optimize our global manufacturing footprint in response to the current macro environment. These actions included realigning certain business groups and reducing our global workforce, disposing of certain manufacturing assets prior to the end of their useful lives, and committing to the sale of a manufacturing facility and related assets.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
As part of these restructuring efforts, we incurred $41 million of expenses through December 31, 2025, primarily related to involuntary termination benefits, including employee severance and other post‑employment costs. We also recorded $76.9 million of accelerated depreciation associated with certain manufacturing assets we planned to dispose of other than by sale.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
In addition, we undertook actions to optimize our manufacturing footprint, including the planned sale of our manufacturing facility in Juarez, Mexico, consisting of land, building, and building improvements (the “disposal group”). During the third quarter of 2025, we determined that the disposal group met the criteria for classification as held for sale under ASC 360‑10. Accordingly, the disposal group was measured at its fair value less estimated costs to sell, resulting in an impairment charge of $23.1 million. As of December 31, 2025, we had $28.0 million of assets classified as held for sale.

Read it in 10-K 2026-02-27 at sec.gov ↗

AddedMD&A
We may incur additional costs not currently contemplated due to events related to or resulting from these restructuring actions. Refer to Note 1 “Summary of Significant Accounting Policies,” Note 17 “Restructuring and Other Charges,” and Note 18 “Assets Held for Sale,” in the Notes to Consolidated Financial Statements for further discussion.

Read it in 10-K 2026-02-27 at sec.gov ↗

RemovedMD&A
•Investing in research and development that allows us to innovate, develop and bring to market products and solutions that deliver the ever-increasing clinical precision and predictability that doctors expect with the speed and convenience their patients require.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
Our revenues are susceptible to fluctuations resulting from events and circumstances, including macroeconomic conditions, fluctuations in foreign currency exchange rates, inflation, higher interest rates, actual and threatened wars and military actions, threats or actual imposition of tariffs, customs duties and fees by nations and retaliatory actions, threats of or actual slowdowns or recessions, supply chain challenges, market volatility, employment levels, wages, debt obligations, discretionary income and other factors, each of which impacts customer confidence, consumer sentiment and demand. Many of these same factors also impact our costs and those of our suppliers through higher raw material prices, transportation costs, labor costs, supply and distribution operations. During 2024, we believe sales of our products were adversely impacted by macroeconomic conditions that negatively affected disposable income and consumer demand. We believe this trend will continue in 2025. We also expect the military conflict between Russia and Ukraine to continue to create market uncertainties and dampen consumer sentiment and demand, particularly in Europe.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
As an example, there was significant adoption of the Invisalign Comprehensive 3in3 product after it was introduced in 2023 that continued in 2024. The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration date and three additional clear aligners included prior to the treatment expiration date. The 3in3 product also allows us to recognize more revenue up front while doing so at a lower price as compared to our traditional Invisalign comprehensive product that has a five-year treatment expiration date with unlimited additional clear aligners prior to the treatment end date.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
•North America: The utilization rate among our North American orthodontist customers was 95.0 cases per doctor in 2024 compared to 94.5 cases per doctor in 2023 and 94.9 cases per doctor in 2022 and the utilization rate among our North American GP customers was 14.3 cases per doctor in 2024 compared to 14.0 cases per doctor in 2023 and 13.9 cases per doctor in 2022.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
•International: International doctor utilization rate was 16.2 cases per doctor in 2024 compared to 16.3 cases per doctor in 2023 and 16.2 cases per doctor in 2022.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
* Invisalign utilization rates are calculated by the number of cases shipped divided by the number of doctors to whom cases were shipped. Our International region includes Europe, Middle East and Africa (“EMEA”) and Asia Pacific (“APAC”). Latin America (“LATAM”) is excluded from the International region based on its immateriality to the year; however is included in the Total utilization.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
revenues by $66 million and unfavorable foreign exchange rates that decreased net revenues by $9 million. These decreases were partially offset by lower net deferrals which increased net revenues by $94 million and price changes which increased net revenues by $19 million. The decrease in ASP was partially offset by an increase in volume which increased net revenues by $7 million.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
Non-case net revenues increased by $16 million in 2024 compared to 2023 mainly due to increased volume of Vivera retainers which includes retention aligners ordered through our Doctor Subscription Program.

Read it in 10-K 2025-02-28 at sec.gov ↗

RemovedMD&A
December 31, 2024 2023 Cash and cash equivalents $ 1,043,887 $ 937,438 Marketable securities, short-term — 35,304 Marketable securities, long-term — 8,022 Total $ 1,043,887 $ 980,764

Read it in 10-K 2025-02-28 at sec.gov ↗

RewordedMD&A
The increase decrease in our effective tax rate for the year ended December 31, 2024 2025 compared to the same period in 2023 2024 is primarily attributable to an increase a decrease in U.S. taxes on foreign earnings, partially offset by a change in our jurisdictional mix of income and release of unrecognized tax benefits due to a lapse statute of limitation lapse, partially offset by the remeasurement of the statute deferred tax asset due to tax rate change and change in our jurisdictional mix of limitation. income.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
For instance, we have Our fabrication facilities in our three key regions as a part of and treatment planning operations in targeted regional geographies brings our strategy to bring operational facilities operations closer to our customers and enables us to serve them more quickly and respond to their needs more effectively as well as new treatment planning operations in targeted regional geographies. effectively.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Total net revenues increased by $137 $36 million in 2024 2025 as compared to 2023, the same period in 2024, primarily due to an increase in Clear Aligner volume, partially offset by a decrease in ASP and an increase in Systems and Services net revenues from higher driven by strong scanner ASP, increase in non-system sales and services revenue. wand sales.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Additionally, More directly, we believe government actions in various countries relating to implemented actual or proposed tariffs, tariffs and retaliatory actions in key strategic countries or regions, particularly in the United States, China, Mexico, Europe, Brazil, Canada, Israel and Europe are expected to Mexico may adversely impact our revenue and cost of goods sold if implemented. sold.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Americas Clear Aligner net revenues decreased increased by $37 $15 million in 2024 2025 as compared to 2023, the same period in 2024, primarily due to a 3.0% decrease in ASP, higher Clear Aligner volume, resulting in a decrease an increase of net revenues of $44 $138 million.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
For instance, ongoing conflicts in the Middle East may further exacerbate general and regional macroeconomic instability, This is particularly true if fighting erupts, intensifies, spreads to other locations, creates shipping and logistical challenges or cost increases, leads to sanctions or boycotts, or otherwise may materially impact impacts our operations. operations or consumer spending.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Total operating margin percentage decreased in 2024 2025 compared to 2023 the same period in 2024 primarily due to increased legal settlement losses, lower gross margin and higher restructuring and other charges and employee costs. charges, offset by lower legal settlement loss.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
As of December 31, 2024 2025 and 2023, approximately $855 2024, we had cash and cash equivalents of $1,095 million and $785 $1,044 million, respectively, of cash, cash equivalents which approximately $929 million and marketable securities $855 million, respectively, were held by our foreign subsidiaries.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Selling, general and administrative expense increased decreased in 2025 compared to the same period in 2024 compared to 2023 primarily due to higher lower employee costs, including salaries, fringe benefits, stock-based compensation and bonus partially offset by bonus, and lower marketing and outside services expense.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Research and development expense increased in 2024 2025 compared to 2023 the same period in 2024 primarily due to higher employee costs, including salaries, fringe benefits, stock-based compensation, net of offset by lower capitalized labor costs related to internal use software, software and bonus, partially offset by lower outside services expense. bonus cost.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
We may, in the future, be required to increase the valuation allowance to take into account additional deferred tax assets that we may be unable to realize. realize, which would result in a material increase to our income tax provision in the period the determination is made.

Read it in 10-K 2026-02-27 at sec.gov ↗

RewordedMD&A
Operating margin percentage decreased in 2024 2025 compared to 2023 the same period in 2024 primarily due to a decrease in gross margin and an increase in employee costs. marketing and media expense and credit card transaction fees.

Read it in 10-K 2026-02-27 at sec.gov ↗

Quiet changesMD&A
In addition, the teenage and younger market makes up about approximately 70% of the approximately estimated 22 million total annual global orthodontic case starts.

Read it in 10-K 2026-02-27 at sec.gov ↗

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