Align Technology (ALGN) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-31 10-K against the 2023-12-31 one, compared heading by heading and sentence by sentence.
Item 1A278 rewritten76 added60 removed127 unchanged
All filing items1,030 rewritten943 added805 removed1,249 unchanged
Summary
counted, not written
- Item 1A lists 33 risk factor headings: 5 new, 18 reworded and 10 unchanged since FY2023. 4 headings from FY2023 no longer appear.
- Sentence by sentence, 943 added, 805 removed, 1,030 rewritten and 1,249 unchanged across 21 items that differ.
- New this year: Item 1. Business..
New Item 1A headings (5)
- 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.
- 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.
- Our success depends on our personnel. 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.
- 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.AI
- 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.
Removed Item 1A headings (4)
- 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.
- 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.
- 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.
- Our effective tax rate may vary significantly from period to period.
Reworded Item 1A headings (18)
- Our
[removed: operations and][added: business,] financial[removed: performance][added: condition and results of operations] depend on global and regional economic conditions. Inflation, fluctuations in [added: foreign] currency exchange rates, changes in consumer confidence and demand,[removed: and]general economic weakness and[removed: threats, or]actual[removed: recessions,][added: or potential slowdowns or recessions] have and could in the future materially affect our business, [added: financial condition, and] results of[removed: operations, and financial condition.][added: operations.] - Our
[removed: business][added: business, financial condition and results of operations] could be impacted by geopolitical events, [added: tariffs,] trade and[removed: other]international disputes,[removed: war,][added: wars, military actions] and terrorism, or major public health crises. - 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
[removed: business][added: business, financial condition] and[removed: operating]results [added: of operations,] as well as those of our customers and[removed: suppliers.][added: consumers, suppliers, contract manufacturers, distributors and other business partners.] - Our net revenues depend primarily on
[removed: our][added: sales of the] Invisalign[removed: system][added: System] and iTero [added: intraoral] scanners and declines in sales or [added: the] average selling price [added: (“ASP”)] of these products may adversely affect net revenues, gross[removed: margin][added: profit,] and net income. - Competition in the markets for our products [added: and services] is increasing and we expect aggressive competition from existing competitors, other companies that introduce new
[removed: technologies or][added: technologies,] products [added: or services] in the[removed: future][added: future,] and customers who alone or with others create orthodontic appliances and solutions or other products or services that compete with us. - Our success depends on our ability to successfully develop, introduce, achieve market acceptance of, and manage new [added: or improved] products and services.
- We may invest in or acquire other businesses, products,
[removed: technologies,][added: technologies] or other assets which may require significant management attention, disrupt our business, dilute stockholder value[removed: and][added: or] adversely affect our [added: business, financial condition and] results of operations. - Our operating results have and will continue to fluctuate in the future, which makes predicting the timing and amount of customer
[removed: demand,][added: demand and] our revenues,[removed: costs][added: costs,] and expenditures difficult. - Our
[removed: products and]IT systems are critical to our business. Issues with[removed: product development or enhancements,]IT system and software integration, implementation,[removed: updates][added: updates,] and[removed: upgrades][added: 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[removed: reputation][added: reputation,] and operating results. - We are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our
[removed: business][added: business, financial condition] and[removed: operating]results [added: of operations] could be[removed: harmed][added: materially adversely affected] if supply is restricted or[removed: ends,][added: ends] or[removed: if]the price[removed: of raw materials used in our manufacturing process][added: materially] increases. - 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
[removed: that]these distributors do not comply with applicable laws or our internal procedures. - We depend on our marketing activities to deepen our market penetration and raise awareness of our
[removed: brands and][added: brands,] products, [added: and services,] which may prove unsuccessful or may become less effective or more costly to maintain in the long term. - We are subject to antitrust and competition regulations, litigation and enforcement that may result in fines, penalties, restrictions on our business practices, and
[removed: product][added: product, services] or operational changes which could materially impact our[removed: business.][added: business, financial condition and results of operations.] - 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
[removed: fines][added: fines, interrupt our supply chain] and cause harm to our reputation. - Security breaches, data breaches, cybersecurity attacks, other cybersecurity
[removed: incidents][added: incidents,] or the failure to comply with privacy, security and data protection laws could materially [added: adversely] impact our[removed: operations,][added: operations and] patient[removed: care could suffer,][added: care, and] we could be liable for damages, and our [added: reputation,] business,[removed: operations][added: financial condition] and[removed: reputation][added: results of operations] could be harmed. [removed: Increased focus on current][added: Current] and anticipated[removed: environmental, social][added: sustainability] and[removed: governance (“ESG”)][added: social (“Sustainability”)] laws and scrutiny of our[removed: ESG][added: Sustainability] policies and practices may materially increase our costs, expose us to liability, [added: 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.- Litigation regarding our IP rights, rights claimed by third
[removed: parties,][added: parties] or IP litigation by any vendors on whose products or services we rely for our products and services may impact our ability to grow our[removed: business,][added: business and] adversely impact our [added: reputation and] results of[removed: operations and adversely impact our reputation.][added: operations.] - If our goodwill, intangible or long-lived assets become impaired, we may be required to record
[removed: a]material[removed: charge][added: charges] to[removed: earnings.][added: income.]
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors.
278 rewritten, 76 added, 60 removed, 127 unchanged
[removed: *The Company’s] [added: *Our] business, reputation, results of operations, financial [removed: condition] [added: condition, cash flows] and stock price can be affected by a number of factors, whether currently known or unknown, [removed: including those described below.][added: or that we currently believe to be immaterial.]
When any one or more of these risks materialize from time to time, [removed: the Company’s] [added: our] business, reputation, results of operations, financial [removed: condition] [added: condition, cash flows] and stock price can be materially and adversely affected.
Because of the following factors, as well as other factors affecting [removed: the Company’s] [added: our] results of operations and financial condition, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
Additionally, you should consider these risk factors in connection with evaluating the forward-looking statements contained in this [removed: report.*][added: Annual Report on Form 10-K.*]
Our [removed: operations and] [added: business,] financial [removed: performance] [added: condition and results of operations] depend on global and regional economic conditions.
Inflation, fluctuations in [added: foreign] currency exchange rates, changes in consumer confidence and demand, [removed: and] general economic weakness and [removed: threats, or] actual [removed: recessions,] [added: or potential slowdowns or recessions] have and could in the future materially affect our business, [added: financial condition, and] results of [removed: operations, and financial condition.][added: operations.]
Consumer spending habits are affected by, among other things, inflation, fluctuations in [added: foreign] currency exchange rates, [added: consumer confidence,] general economic weakness, [removed: threats or] actual [added: or potential slowdowns or] recessions, pandemics, wars and military actions, employment levels, wages, debt obligations, discretionary income, interest rates, volatility in [removed: capital, and consumer confidence] [added: capital] and perceptions of [added: current and future economic conditions.]
Macroeconomic conditions can, among other things, reduce or shift spending away from elective procedures, drive patients to pursue less costly orthodontic treatments, decrease the number of orthodontic case starts, reduce patient traffic in dentists’ [removed: offices] [added: offices,] or reduce demand for dental services generally.
The declines in, or uncertain economic outlooks for, the [removed: U.S.,] [added: United States,] Chinese, European and certain other international economies have and [removed: may continue to] [added: could in the future materially] adversely affect consumer and dental practice spending.
[removed: Increases in the cost of fuel and energy, food and other essential items as well as higher interest] rates have and [removed: may continue to] [added: could in the future] reduce [removed: consumers'] [added: consumers’] disposable income, which could cause a decrease in discretionary spending for [removed: products like ours.][added: our products.]
[removed: Further, we cannot predict the impact of efforts] [added: Efforts] by central banks and federal, state and local governments to combat [removed: inflation, which] [added: inflation] could result in an economic recession or [removed: have an adverse] [added: slowdown or adversely] impact [removed: on] consumer spending [removed: may] for a prolonged period of time.
Inflation [removed: continues] [added: has and may continue] to adversely impact spending and trade activities, [removed: causing unpredictable impacts on] [added: and may unpredictably impact] global and regional economies.
Higher inflation has [removed: also increased] [added: and may continue to increase] domestic and international shipping costs, raw material [removed: prices,] [added: prices] and labor rates, which [removed: has] [added: could] adversely [removed: impacted] [added: impact] the costs of producing, procuring and shipping our products.
Any of these events could materially affect our [removed: business and operating results.][added: business, financial condition or results of operations.]
We have significant international operations and sales and [removed: we] are [added: therefore] exposed to fluctuations in foreign currencies that have [added: and may continue to] adversely [removed: impacted] [added: impact] our [removed: business] [added: business, financial condition] or results of operations.
Although the U.S. dollar is our reporting currency, a large portion of our [removed: expenses,] net revenues and [removed: net income] [added: expenses] are generated in foreign currencies.
While we [added: forecast our balance sheet exposures to foreign currency fluctuations and] utilize [added: foreign currency] forward contracts to moderate the impact of exchange rate fluctuations on certain assets and liabilities, [removed: our hedging strategies] [added: these contracts] may not [removed: be successful, and currency exchange rate fluctuations have and may continue to materially adversely effect] [added: eliminate] our [removed: operating results and cash flows.][added: exposure to fluctuations in foreign currency.]
Our [removed: business] [added: business, financial condition and results of operations] could be impacted by geopolitical events, [added: tariffs,] trade and [removed: other] international disputes, [removed: war,] [added: wars, military actions] and terrorism, or major public health crises.
[removed: Political] [added: Geopolitical] events, [added: tariffs,] trade and [removed: other] international disputes, [removed: war] [added: wars, military actions] and terrorism, or major public health crises have and could in the future harm or disrupt international commerce and the global [removed: economy] [added: economy,] and could materially [removed: effect] [added: adversely affect] our business [removed: as well as] [added: with] our [removed: customers,] [added: customers and consumers,] suppliers, contract manufacturers, [removed: distributors,] [added: distributors] and other business partners.
Such [removed: risks include] [added: events have and could result in, among other things,] supply chain and trade disruptions, [added: changes in diplomatic and trade relationships, new tariffs and retaliatory] tariffs, trade [removed: sanctions] [added: protection measures, trade sanctions, customs inquiries] or restrictions, boycotts, reduced consumer spending, government shut downs, [removed: or] cyberattacks, energy shortages or power outages, energy rationing that adversely impacts our manufacturing facilities, rising fuel or rising costs of producing, [removed: procuring] [added: procuring,] and shipping our products, constraints, volatility or disruption in the financial markets, deaths or injuries to our employees, restrictions and shortages of food, water, [removed: shelter,] [added: shelter] and medical supplies, [removed: telecommunications failures] [added: data] or [added: information exchange, disruptions, interruptions or limitations in telecommunication services, critical systems or applications reliant on a stable and uninterrupted communications infrastructure, and protests that may impact delivery of our products to customers or] destruction of property.
[removed: Tariffs,] [added: Tariffs or proposed tariffs,] such as those on [removed: Chinese] [added: Chinese, Mexican, Canadian or other foreign] goods, and [removed: responses to the tariffs] [added: any retaliatory trade measures in response] may increase the cost of our products and the components and raw materials used to make them.
[removed: Increased] [added: Tariffs would result in additional] costs [removed: could adversely impact] [added: for] our [removed: gross margin and] [added: products, which may impact operating margin,] reduce demand for our [removed: products.][added: products and adversely impact our gross margin.]
[removed: Countries] [added: Foreign countries] may also adopt [added: or rescind] other measures, such as controls on the import or export of goods, technology or data, [added: including personal data,] that [removed: would] [added: could] adversely impact our operations and supply chains or limit our ability to offer [added: certain] products and services.
These measures could require us to take various actions, including changing [removed: suppliers] [added: suppliers, where we manufacture our products,] or restructuring business relationships.
Complying with new or [removed: changed] [added: revised] trade restrictions [removed: is] [added: may be] expensive, [removed: time-consuming and] [added: time-consuming,] disruptive to our [removed: operations.][added: logistics and operations, and more costly for us and our customers.]
Such restrictions [removed: can] [added: may] be announced with little or no advance notice and we may be unable to effectively mitigate any adverse [removed: impacts.][added: impacts in a timely manner or at all.]
Our iTero operations, headquartered in Israel, are close to areas that have been affected by ongoing violence and military [removed: action in the Middle East and this] [added: action, which] may impact our employees [removed: as well as] [added: and] our iTero [removed: business.][added: business and operations.]
Some employees and consultants in Israel have been called for military service in the current conflict [removed: in the Middle East] and they may be absent for [removed: an unknown period] [added: certain periods] of time.
[removed: The conflict in the Middle East] [added: These events could disrupt ongoing operations and] may materially impact the [added: logistics,] timing and cost of shipping of our [removed: products,] [added: products and materials or] our ability to operate out of [removed: Israel, or lead to sanctions or boycotts which could impact our sales and][added: impacted areas.]
Additionally, [removed: the recent election in Taiwan and] China’s territorial conflicts with other neighboring countries may impact our operations and sales in China.
We cannot predict the progress or outcome of these events or the reactions by governments, businesses or consumers [removed: but they could] [added: and each event could, individually or in the aggregate,] materially adversely affect our [removed: business] [added: business, financial condition,] and [removed: operating results.][added: results of operations.]
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 [removed: business] [added: business, financial condition] and [removed: operating] results [added: of operations,] as well as those of our customers and [removed: suppliers.][added: consumers, suppliers, contract manufacturers, distributors and other business partners.]
Natural disasters [removed: include] [added: such as] earthquakes, tsunamis, floods, droughts, hurricanes, wildfires, [added: urban fires] and extreme weather conditions [removed: that] [added: can] cause deaths, [removed: injuries,] [added: injuries] and [removed: critical] [added: major public] health crises, power outages, property [removed: damage] [added: damage,] restrictions and shortages of food, water, [removed: shelter,] [added: shelter] and medical supplies, telecommunications failures, materials scarcity, price volatility and other [removed: ramifications.][added: adverse consequences.]
If a natural disaster occurs in a region where one of [removed: these] [added: our] facilities or those of our customers or suppliers are located, our [added: or their] employees [added: or facilities] could be impacted, [added: valuable] research [added: could be] lost, and [added: our] ability to create treatment plans, respond to customer inquiries or manufacture and ship our [removed: aligners or intraoral scanners] [added: products] could be compromised, causing significant [removed: product] [added: delays] and [removed: services delays.][added: reputational harm.]
[removed: The effects of climate] [added: Climate] change [removed: on regional] [added: could increase the frequency] and [removed: global economies] [added: severity of natural disasters and] could change the supply, demand or availability of sources of energy or [removed: other] resources material to [added: manufacturing] our products and [removed: operations and affect the availability or cost of natural resources and goods and services on which we and our suppliers rely.][added: operations.]
Demand for our products [added: and services] may not increase or may decrease [removed: due to] [added: for many reasons, including] resistance to [removed: non-traditional treatment methods,] [added: the innovative and business-model-disruptive nature of some of our products and services,] which could have a material impact on our [removed: business] [added: business, financial condition] and [removed: operating results.][added: results of operations.]
Our products [added: and services] require our customers [added: and consumers] to [removed: change from] [added: forego] traditional treatment methods.
For example, Invisalign treatment is a significant [removed: change] [added: departure] from traditional orthodontic [removed: metal] wires and brackets, and [added: our] customers and consumers may not find it cost-effective or preferable.
Additionally, our clear aligners and iTero products utilize digital technology and some dental professionals have [removed: been] and may continue to resist moving to a digital platform.
Increased acceptance of our products [added: and services] depends in part on the recommendations of dental professionals, [added: professional associations, societies and organizations,] as well as other [removed: factors] [added: factors,] including efficacy, safety, ease of use, reliability, [removed: aesthetics] [added: aesthetics, third-party reimbursement] and price compared to competing products and [added: traditional] treatment methods.
including those described below.
Increases in the cost of fuel and energy, food and other essential items as well as higher interest
Our products or one or more of the materials or components of our products may also be subject to tariffs imposed by the United States or other countries.
We may not be able to fully mitigate the impact of the increased costs or pass price increases on to our customers, resulting in downward pressure on our operating results.
Currency exchange rate fluctuations have and may continue to materially adversely affect our results of operations and cash flows.
Specifically, 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 shipping to other international locations.
Military conflicts have and may in the future materially adversely impact the economies in which we operate.
Furthermore, our facilities may be damaged or our manufacturing capability or delivery schedules may be impacted as a result of the ongoing conflict.
Our supply chains and demand for our products could be impaired as a result of hostilities, export and import restrictions, sanctions or boycotts.
It could also affect the availability or cost of materials, goods, and services on which we and our suppliers, contract manufacturers, distributors and other business partners rely, which could materially adversely impact our business, financial condition and results of operations.
In addition, we sell our products at different prices and with varying shipping and handling charges or processing fees that may differ by country.
- we modify our pricing strategies for certain products or adjust pricing for certain items based on cancellation fees, shipping and handling charges or processing fees;
- our critical accounting estimates materially differ from actual results.
unattractive, particularly as competitors incorporate AI and machine learning into new or existing services and technologies that facilitate changes in doctor-patient interactions, expectations and treatment workflows.
We may be unable to devote adequate financial resources to develop or acquire new AI technologies and systems in the future and sufficiently meet evolving industry trends and consumer demands.
We have and may continue to experience competition with our scanners by competitors who introduce products at lower prices or with functionality that better meets customer demand.
- successfully predict, timely innovate, develop, and launch new or improved technologies, applications, features, products and services to meet market demand and keep pace with changes in technology, customers’ demands and industry standards;
- design and manufacture products that achieve the clinical and practice outcomes we believe necessary for market acceptance;
- manage government procurement program restrictions; and
- our ability to collect payments;
- our acceptance of longer customer payment cycles;
- geographic, channel or product mix shifts to lower priced products or to products with a higher percentage of deferred revenue;
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.
which could impact our ability to adjust inventory for declining demand.
This variability and unpredictability could also result in our failing to meet the expectations of industry, financial analysts or investors.
This entails certain risks, including operational disruptions, such as our ability to continue developing and updating products while addressing safety and security, track orders and timely ship products, manage our supply chain, and aggregate financial and operational data.
The discovery of a defect, error, or security vulnerability in our products, software applications or IT systems, incompatibility with customers’ computer operating systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems, which we are unable to cure in a timely fashion, may cause adverse consequences.
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.
The success of our Systems and Services segment depends on the quality and reliability of our products.
We face software and hardware risks related to the manufacturing, design, quality and safety of our complex, global installed base of iTero intraoral scanners, which are continually updated to add, expand, or improve features with new hardware we manufacture or components that we source, to integrate new or existing software or other components manufactured by third parties, or to provide repair or replacement parts, any of which may contain errors or exhibit failures, especially when products are first introduced.
If our products experience component aging, errors, or performance problems, or do not otherwise satisfy our stringent quality processes and controls we may choose to or be compelled to recall certain products, which may include, product withdrawals from the market, labeling changes, design changes, customer notifications, and notifications to global regulatory bodies.
We are reliant upon manufacturers that we contract with for quality and stability and any failures on their part may have an impact on our ability to supply our products.
- processing and use of children’s personal and health data;
- websites and application advertising, including that involving the use of cookies or involving the collection, use, disclosure, or other processing of data relating to individuals for marketing purposes;
criminal prosecution.
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.
This risk is exacerbated with the advancement of technologies like AI, which malicious third parties can use to create new, more sophisticated and more frequent or other attacks.
There can be no assurance our cybersecurity risk management program and processes, including our policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems and information or any other information we maintain or otherwise process.
current and future economic conditions.
Our ability to recover these cost increases through price increases may continue to lag, resulting in downward pressure on our operating results.
In addition, our foreign currency exposure on assets, liabilities and cash flows that we do not hedge have and could in the future materially impact our financial results in periods when the U.S. dollar significantly fluctuates in relation to foreign currencies.
Political events, trade and other international disputes, war, terrorism, or major public health crises involving key commercial, development or manufacturing markets such as China, Mexico, Israel, Europe, or other countries have and could again materially impact our international operations.
The impact to us, our employees and customers would be uncertain, particularly if emergency circumstances, armed conflicts or an escalation in political instability or violence, or viral out-breaks disrupt our product development, data or information exchange, payroll or banking operations, product or materials shipping by us or our suppliers.
Our internation operations would also be impacted by other unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.
Military conflicts and global pandemics have materially adversely impacted our global economies.
For example, our commercial operations in Russia were impacted by the conflict in Ukraine and we were affected by the COVID-19 pandemic.
Furthermore, our facility may be damaged or supply chains impaired as a result of hostilities which could disrupt ongoing operations and impact our financial results.
revenues.
Natural disasters can impact our operations as well as those of our customers and suppliers.
Climate change is likely to increase the frequency and severity of natural disasters and, consequently, the risks to our operations and financial results.
Our digital dental modeling and certain of our customer facing operations are primarily processed in our facilities in Costa Rica, our iTero scanners are primarily manufactured in China and Israel, and our aligner molds and finished aligners are fabricated in China, Mexico and Poland.
These zones are susceptible to natural disasters and their indirect effects.
In addition, we sell a number of products at different list prices which may differ based on country.
- estimates used in the calculation of deferred revenue differ from actual average selling prices.
These promotional campaigns and lower
They also compete with traditional bite wing 2D dental x-rays for detecting interproximal caries.
- successfully predict, timely innovate and develop new technologies, applications and products preferred by customers and consumers that have features and functionality to meet the needs of patients;
As an organization we do not have a history of significant acquisitions or integrating their operations and cultures with our own.
The sale of equity or issuance of debt to finance any acquisition could result in dilution to our stockholders.
The occurrence of indebtedness would result in increased fixed obligations and could also include covenants or other restrictions that impede our ability to manage our operations;
- longer customer payment cycles and greater difficulty in accounts receivable collection;
Conversely, if we overestimate customer demand, we may have excessive staffing, materials, components and finished products, or capacity.
If we hire and train too many technicians in anticipation of demand that does not materialize or materializes slower than anticipated, our costs and expenditures may outpace our revenues or revenue growth, harming our gross margin and financial results.
Responding to unanticipated changes in demand may take time, lower our gross margin, inhibit sales or harm our reputation.
We have a complex, global iTero scanner installed base of older and newer models.
These models are continually updated to add, expand or improve features with new hardware, or to provide repair or replacement parts.
We have experienced hardware issues in the past and may in the future, including issues relating to manufacturing, design, quality, or safety, of which we become aware only after products or changes have been introduced into the market.
As a result, there have been and may be widespread failures of our iTero scanners or we may experience epidemic failures of our iTero scanners to perform as anticipated.
competition, bribery and corruption, trade compliance, safety, data privacy and marketing and sales activities.
The conduct of these distributors also impacts our reputation and our brand.
The regulations may impose onerous obligations and may require us to unexpectedly rework or reevaluate improvements to be compliant.
Use of AI technologies may expose us to an increased risk of regulatory enforcement and litigation.
Moreover, some of the AI features involve the processing of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection.
AI development and deployment practices could subject us to competitive harm, regulatory enforcement, increased cybersecurity risks, reputational harm and legal liability.
We are currently subject to two antitrust actions with jury trials scheduled to begin on May 13, 2024, and January 21, 2025.
We believe the plaintiffs’ claims are without merit in each of these actions, but we will likely incur costs in connection with these trials and with our defense, and there is a risk that we will be subject to adverse judgments or negative publicity.
by organized groups and nation-state actors.
We are subject to various national and regional data localization or data residency laws, including U.S. state law, the EU General Data Protection Regulation and analogous laws in China which generally require certain types of data collected within a country be stored and processed only within that country or approved countries.
An excerpt. Shown here: 40 of 278 rewritten, 40 of 76 added and 40 of 60 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors. in the FY2024 filing and the FY2023 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
160 rewritten, 67 added, 40 removed, 173 unchanged
A discussion regarding our financial condition and results of operations for fiscal [removed: 2023] [added: 2024] compared to fiscal [removed: 2022] [added: 2023] is presented under Results of Operations of this Form 10-K.
Discussions regarding our financial condition and results of operations for fiscal [removed: 2022] [added: 2023] compared to [removed: 2021] [added: 2022] have been omitted from this Annual Report on Form 10-K, but can be found in *"Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations"* in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2022,] [added: 2023,] filed with the SEC on February [removed: 27, 2023,] [added: 28, 2024,] which is available without charge on the [removed: SEC's] [added: SEC’s] website at *www.sec.gov* and on our investor relations website at *investor.aligntech.com*.
Our [removed: business] strategic priorities focus on four principal pillars for growth: (i) international expansion; (ii) [removed: GP dentist] [added: general dental practitioners (“GP”)] treatment; (iii) patient demand; and (iv) orthodontic utilization.
- Continuing penetration and adoption of Invisalign [removed: products,] [added: clear aligners,] intraoral scanners and CAD/CAM solutions in international markets by investing in manufacturing operations, research and development, clinical treatment planning, sales and marketing and building our quality and regulatory capabilities in existing and emerging markets globally.
For instance, [removed: in 2022,] we [removed: opened a new aligner] [added: have] fabrication [removed: facility] [added: facilities] in [removed: Wroclaw, Poland] [added: three key regions] as a part of our strategy to bring operational facilities closer to customers to serve them more quickly and respond to their needs more effectively as well as new treatment planning operations in targeted regional geographies.
We have also diversified our research and development [removed: activities throughout Europe,] [added: activities,] which has created a longer term, more stable environment for consistent hiring, retention and innovation in a variety of high technology [removed: sectors.][added: locations.]
We furthermore demonstrate to GPs and orthodontists how the iTero portfolio of intraoral [removed: scanners] [added: scanners, products like Invisalign Go™ treatment,] and CAD/CAM restorative services and workflows can increase revenues and profitability for their dental practices by enhancing patient experiences and creating operational practice efficiencies.
- Creating demand and enabling patient conversion [removed: through] [added: with] targeted investments in advertising and public relations through social media, influencers and other forms of digital communications to encourage treatment by Invisalign trained doctors.
To increase awareness and educate young adults, parents and teens about the benefits of [removed: the] Invisalign [removed: brand,] [added: treatment,] in [removed: 2023] [added: 2024,] we continued to invest in and create campaigns across markets in media platforms such as TikTok, Instagram, YouTube, SnapChat, WeChat, and Douyin.
[removed: - Pursuing new product lines that complement our doctor-prescribed principal products currently available in certain e-commerce and retail channels in the U.S.] Similarly, in [removed: 2023,] [added: 2024,] we continued our focus on our doctor subscription plan and grew our underpenetrated share of the retainer business through strategic marketing campaigns focused on driving adoption and increasing market [removed: share in the U.S., Canada, Iberia and the Nordics.][added: share.]
In [removed: 2023,] [added: 2024,] we had record shipments to teenage and younger patients.
*Macroeconomic Challenges and Military [removed: Conflict] [added: Conflicts] in Ukraine and the Middle East*
Our revenues are susceptible to fluctuations [removed: caused by] [added: resulting from events and circumstances, including] macroeconomic conditions, [removed: inflation, changes to] [added: fluctuations in foreign] currency exchange rates, [removed: rising] [added: inflation, higher] interest rates, actual and threatened wars and military actions, threats [added: or actual imposition] of [added: tariffs, customs duties and fees by nations and retaliatory actions, threats of] or actual [added: slowdowns or] recessions, supply chain challenges, market volatility, [added: employment levels, wages, debt obligations, discretionary income] and other factors, each of which impacts customer confidence, consumer sentiment and demand.
[removed: In 2023,] [added: During 2024,] we believe [removed: that] sales of our products were [removed: primarily harmed] [added: adversely impacted] by macroeconomic conditions that [removed: ultimately adversely impacted] [added: negatively affected] disposable income and consumer demand.
The impact of declining demand [removed: varied] [added: may vary] by time and region, making operational results uncertain and difficult to predict.
Additionally, [added: a material amount of our revenues are derived internationally and] many of our international operations are denominated in currencies other than the U.S. dollar.
[added: Foreign exchange] volatility and the subsequent strengthening or weakening of the U.S dollar against other currencies remains uncertain and unpredictable.
[removed: While] [added: We also expect] the military conflict between Russia and Ukraine [removed: did not materially impact our 2023 financial condition and results of operations, we expect the conflict will] [added: to] continue to create market uncertainties and dampen consumer sentiment and demand, particularly in Europe.
[removed: Similarly, the recent conflict] [added: For instance, ongoing conflicts] in the Middle East may further exacerbate general and regional macroeconomic instability, particularly if fighting [removed: is prolonged, it] [added: intensifies,] spreads to other locations, creates shipping and logistical challenges or cost increases, [removed: or] leads to sanctions or [removed: boycotts.][added: boycotts, or otherwise may materially impact our operations.]
[removed: Our] [added: For instance, our] iTero business is headquartered in Israel [removed: and] [added: and, although] the [removed: timing] [added: sales, delivery times] and cost of shipping our [removed: products has been impacted.]
As the markets for clear aligners and digital processes and workflows used to transform the practice of dentistry continue to mature, we [added: continue to] anticipate customer and patient expectations and demands will [added: continue to] evolve.
We strive to manage the challenges from the trends and uncertainties, including the macroeconomic conditions, [added: tariffs and retaliatory measures,] military [removed: conflict] [added: conflicts] and the evolution of our target markets, by focusing on improving our operations, [removed: building] [added: further increasing] flexibility and efficiencies in our processes, adjusting our business models to changing circumstances and offering products that meet market demand.
Specifically, we are managing [removed: cost] [added: financial] impacts through [added: strategic product innovations, introductions and] pricing actions, implementing cost saving measures and [removed: slowing hiring.][added: evaluating hiring needs.]
The 3in3 product [added: also] allows us to recognize more revenue up front [removed: but is offered] [added: 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 [removed: aligner] [added: aligners] prior to the treatment end date.
For the year ended December 31, [removed: 2023,] [added: 2024,] our business operations reflect the following:
◦Revenues of [removed: $3,862.3] [added: $3,999.0] million, an increase of [removed: 3.4%] [added: 3.5%] year-over-year;
◦Clear Aligner revenues of [removed: $3,199.3] [added: $3,230.1] million, an increase of [removed: 4.1%] [added: 1.0%] year-over-year;
*▪*Americas Clear Aligner case revenues of [removed: $1,463.0] [added: $1,426.3] million, a decrease of [removed: 0.6%] [added: 2.5%] year-over-year;
▪International Clear Aligner case revenues of [removed: $1,449.5] [added: $1,500.5] million, an increase of [removed: 7.4%] [added: 3.5%] year-over-year;
▪Clear Aligner volume increase of [removed: 0.4%] [added: 3.5%] year-over-year and Clear Aligner volume increase for [removed: teenage patients] [added: kids and teens] of [removed: 7.8%] [added: 7.7%] year-over-year;
◦Imaging Systems and [removed: CAD/CAM] [added: computer-aided design and computer-aided manufacturing (“CAD/CAM”)] Services revenues of [removed: $662.9] [added: $768.9] million, an increase of [removed: 0.1%] [added: 16.0%] year-over-year;
*◦*Income from operations of [removed: $643.3] [added: $607.6] million and operating margin of [removed: 16.7%;][added: 15.2%;]
◦Effective tax rate of [removed: 30.6%;][added: 30.8%;]
◦Net income of [removed: $445.1] [added: $421.4] million with diluted net income per share of [removed: $5.81;][added: $5.62;]
[removed: ◦Cash,] [added: ◦Cash and] cash equivalents [removed: and marketable securities] of [removed: $980.8] [added: $1,043.9] million as of December 31, [removed: 2023;][added: 2024;]
◦Number of employees [removed: was 21,610] [added: of 20,945] as of December 31, [removed: 2023,] [added: 2024,] a decrease of [removed: 6.7%] [added: 3.1%] year-over-year.
- As of December 31, [removed: 2023, 17] [added: 2024, over 19] million people worldwide have been treated with our Invisalign [removed: system.][added: System.]
- [removed: The] [added: Our] total utilization rate in [removed: 2023 was] [added: 2024 of] 19.1 cases per doctor [added: was flat] compared to [removed: 19.3* cases per doctor in 2022] [added: 2023] and [removed: 20.9*] [added: slightly down from 19.3] cases per doctor in [removed: 2021.][added: 2022.]
Our utilization rates have [removed: declined in 2023 due to] [added: been impacted by] the macroeconomic conditions and other factors as described in the [removed: Trends] [added: “Trends] and [removed: Uncertainties] [added: Uncertainties”] section above.
DSOs represent a large and growing opportunity to help drive adoption of digital technology across the dental industry.
We have well established relationships with many DSOs globally that recognize the benefits of digital workflows enabled by our portfolio of products and services that make up the AlignTM Digital Platform, including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter cycle times and customer proximity.
We have and may continue to financially invest in or explore collaborations with key ecosystem partners, including DSOs, whose missions and visions align with our own vision, strategy, business model and goals.
- Pursuing new product lines that complement our doctor-prescribed principal products currently available in certain e-commerce and retail channels in the United States.
Below is a discussion of the significant trends and uncertainties that could impact our operations:
We believe this trend will continue in 2025.
Additionally, government actions in various countries relating to implemented or proposed tariffs, particularly the United States, China, Mexico, and Europe are expected to adversely impact our revenue and cost of goods sold if implemented.
The degree of our exposure is dependent on, among other things, the type of goods subject to any tariffs enacted, the tariff rates imposed, the timing of the tariffs and any retaliatory measures enacted.
We continue to closely monitor the foregoing issues, assess their potential impact on our operations and financial results, and implement plans to mitigate the impact of any adverse events.
In 2024, the U.S. dollar remained strong against major currencies, which negatively impacted our financial condition and results of operations for the year.
products have not been materially impacted and we have put measures in place to help reduce the future risks, it remains uncertain if there will be impacts on our sales, delivery times or cost of shipping our products.
While there have been export and import restrictions imposed against products originating from and businesses operating in Israel, they have not materially impacted our sales or operations to date although we continue to monitor the risk.
As an example, there was significant adoption of the Invisalign Comprehensive 3in3 product after it was introduced in 2023 that continued in 2024.
◦Cash provided by operating activities of $738.2 million;
◦Capital expenditures of $115.6 million, primarily related to investments in our manufacturing capacity and facilities; and
- The total number of Invisalign trained doctors cases were shipped to (doctor submitters) in 2024 was 130.4 thousand compared to 125.8 thousand in 2023, a 3.6% increase.
GP and orthodontist doctor submitters increased by approximately 3% and 4%, respectively, in 2024 compared to 2023.
Clear Aligner net revenues increased primarily from an increase in volume, partially offset by lower Clear Aligner ASP.
Americas net revenues decreased by $37 million in 2024 as compared to 2023, primarily due to a 3.0% decrease in ASP, resulting in a decrease of net revenues of $44 million.
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.
This increase was partially offset by a decrease of 3.3% in ASP which decreased net revenues by $50 million.
The decreases in ASP were partially offset by lower net deferrals and price changes which increased net revenues by $99 million and $72 million, respectively.
Systems and Services net revenues increased by $106 million in 2024 as compared to 2023 primarily due to higher scanner ASP which increased net revenues by $45 million, an increase in sales of upgrade scanner systems which increased net revenues by $38 million, higher services revenue which increased net revenues by $19 million and higher volume which increased net revenues by $4 million.
Additionally, CAD/CAM software revenues increased net revenues by $7 million.
These increases were partially offset by unfavorable foreign exchange rates which decreased net revenues by $7 million.
| | | | | | | 2024 | | | | | | 2023 | | | | | | Change | | | | | | 2023 | | | | | | 2022 | | | | | | Change | | |
| | | | | | | 2024 | | | | | | 2023 | | | | | | Change | | | | | | 2023 | | | | | | 2022 | | | | | | Change | | |
Restructuring and other charges increased in 2024 compared to 2023 due to higher severance and other one-time post-employment benefits, driven by a more significant restructuring plan initiated in 2024.
Refer to *Note 17* “*Restructuring and Other Charges” of the Notes to Consolidated Financial Statements* for more information.
Legal settlement loss (in millions):
| | | | | | | 2024 | | | | | | 2023 | | | | | | Change | | | | | | 2023 | | | | | | 2022 | | | | | | Change | | |
| Legal settlement loss | | | | | | $ | 31.0 | | | | | $ | — | | | | | $ | 31.0 | | | | | $ | — | | | | | $ | — | | | | | $ | — | |
| *% of net revenues* | | | | | | *0.8* | | *%* | | | | *—* | | *%* | | | | | | | | | | *—* | | *%* | | | | *—* | | *%* | | | | | | |
Legal settlement loss incurred during 2024 was due to litigation and other settlements.
Refer to *Note 8* *“Legal Proceedings” of the Notes to Consolidated Financial Statements* for more information.
| | | | | | | 2024 | | | | | | 2023 | | | | | | Change | | | | | | 2023 | | | | | | 2022 | | | | | | Change | | |
Total operating margin percentage decreased in 2024 compared to 2023 primarily due to increased legal settlement losses, restructuring and other charges and employee costs.
Refer to *Note 8* “*Legal Proceedings*” *of the Notes to Consolidated Financial Statements*.
We are in over 100 markets and have 13 fabrication and treatment locations throughout the world.
In particular, dental practices and industry research firms reported deteriorating orthodontic trends for the third and fourth quarters of 2023, including decreased patient visits and increased patient appointment cancellations, along with fewer case starts overall, especially among adult patients.
In 2023, the macroeconomic slowing or contraction resulted in foreign exchange volatility causing the U.S dollar to strengthen against other currencies.
This negatively impacted our financial condition and results of operation compared to 2022.
Foreign exchange
Moreover, military conflicts increase the unpredictability of the volatile macroeconomic conditions.
Additionally, we have employees and consultants in Israel that have been called for military service and they may be unavailable for an unknown period of time.
The conflict may continue to spread to other areas which may further impact our business.
We also continue to innovate and introduce new and enhanced products that augment our doctor customer and patient experiences.
For instance, in the first quarter of 2023, we successfully launched the Invisalign Comprehensive 3in3 product.
We anticipate adoption of the Invisalign Comprehensive 3in3 product will continue to increase in 2024.
◦Operating cash flow of $785.8 million;
◦Capital expenditures of $177.7 million, predominantly related to purchases of property, plant and equipment; and
- For the fourth quarter of 2023, total Invisalign cases submitted with a digital scanner in the Americas increased to 95.1%, up from 92.7%* in the fourth quarter of 2022 and international scans increased to 88.1%, up from 86.8% in the fourth quarter of 2022.
For the fourth quarter of 2023, 98.0% of Invisalign cases submitted by North American orthodontists were submitted digitally.
During the third quarter of 2023, we began including Touch Up case revenues in Americas and/or International net revenues that were previously included in Non-Case revenues and have recast business metrics for the periods presented above accordingly.
Our services include subscription software, disposables, rentals, leases, pay per scan services, as well as exocad’s CAD/CAM software solutions that integrate workflows to dental labs and dental practices.
*During 2023, we began including Touch Up case revenues in Americas and/or International net revenues.
Touch Up case revenues were previously recorded in Non-case revenues.
We have recast the year ended December 31, 2022 and 2021 to reflect this change.
Amount and percentage changes are based on recast amounts.
Amount and percentage changes are based recast amounts.
Americas net revenues decreased by $9.0 million in 2023 as compared to 2022, primarily due to a 2.1% decrease in case volumes, resulting in a reduction of net revenues of $31.4 million, partially offset by a $22.4 million increase due to higher ASP.
Higher ASP includes price increases which increased net revenues by $68.6 million along with higher additional aligners which increased net revenues by $43.9 million.
Higher ASP was largely due to higher additional aligners increasing net revenues by $100.8 million and price increases on most products which increased net revenues by $96.9 million.
Systems and Services net revenues decreased by $0.9 million in 2023 as compared to 2022 primarily due to a lower number of scanners sold which lowered net revenues by $26.1 million and lower scanner ASP which reduced net revenues by $23.9 million.
The decrease in scanner net revenues was mostly offset by higher service revenues of $31.8 million and other revenues which increased $19.1 million primarily due to revenue from sales of certified pre-owned scanners, CAD/CAM software, and scanner rentals.
Restructuring and other charges incurred during 2023 was primarily related to post employment benefits, including employee severance.
Operating margin percentage remained relatively flat in 2023 compared to 2022 primarily due to a decrease in gross margin which was offset by operating leverage.
credit.
Beginning in fiscal year 2023 our stock repurchases, net of certain issuances, were subject to a 1% excise tax.
This excise tax is not expected to have a material impact on our liquidity or capital resources.
- On January 2, 2024 we completed the acquisition of the remaining interest in privately held Cubicure GmbH for total purchase consideration of approximately $87 million.
We paid approximately $79 million in cash, which represents the total purchase consideration less credit for our previously owned interest.
- Inflow of $241.9 million, net from deferred revenues due to the deferral of revenue on shipments over the period as well as timing of revenue recognition;
- Outflow of $130.1 million, net from inventories primarily due to lower shipment volumes over the period in addition to our efforts to manage stock at appropriate levels as required; and
These outflows were partially offset by sales and maturities of marketable securities of $121.1 million.
We
We measure and allocate revenues according to ASC 606-10, *“Revenues from Contracts with Customers.”*
Both the determination of fair value and carrying value of a reporting unit require management to exercise significant judgement related to operating assumptions and estimates and allocation methodologies.
An excerpt. Shown here: 40 of 160 rewritten, 40 of 67 added and all 40 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. in the FY2024 filing and the FY2023 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
11 rewritten, 3 added, 5 removed, 10 unchanged
Further discussion on these risks may be found in [removed: *Item 1A*] [added: Part I, Item 1A] of this Annual Report on Form 10-K under the heading [removed: *“Risk Factors”*.][added: “*Risk Factors*.”]
Changes in interest rates could impact our anticipated interest income [added: earned] on our cash and cash equivalents [removed: and investments in marketable securities.][added: balance.]
As of December 31, [removed: 2023,] [added: 2024,] we are not [removed: subject] [added: exposed] to [removed: risks from immediate] interest rate [removed: increases] [added: risk] on our unsecured revolving line of [removed: credit facility.][added: credit.]
[removed: Currency] [added: Foreign Currency Exchange] Rate Risk
As a result of our international business activities, our financial results have been affected by [removed: factors such as] changes in foreign currency exchange rates as well as economic conditions in foreign [removed: markets, and there is no assurance that exchange rate fluctuations will not harm our business in the future.][added: markets.]
We generally sell our products in the local [removed: currency of the respective countries.]
This provides some natural hedging because most of the subsidiaries’ operating expenses are [added: also] generally denominated in their local currencies.
We enter into foreign currency forward contracts for currencies where we have exposures, primarily the Euro, British Pound, Chinese Yuan, Polish Zloty and Canadian Dollar, to minimize the short-term impact of foreign currency exchange rate fluctuations on [removed: cash and] certain [removed: trade and intercompany receivables] [added: assets] and [removed: payables.][added: liabilities.]
Although we will continue to monitor our exposure to currency fluctuations, and, where appropriate, [removed: may] use forward contracts to minimize the effect of these fluctuations, the impact of an aggregate change of 10% in foreign currency exchange rates relative to the U.S. dollar on our results of operations and financial position could be material.
The economy has been impacted by certain macroeconomic challenges which have contributed to a rising inflationary trend that have impacted both our revenues and costs [removed: globally, and which we expect will continue into the foreseeable future.][added: globally.]
There [removed: can be] [added: is] no assurance that our results of operations and financial condition will not be [removed: materially] [added: adversely] impacted by inflation in the future.
We have not historically used derivative financial instruments to manage our exposure to changes in interest rates.
There is no assurance that exchange rate fluctuations will not adversely impact our results of operations or financial condition in the future.
currency of the respective countries.
Our investments are fixed-rate short-term and long-term securities.
Fixed-rate securities may have their fair market value adversely impacted due to a rise in interest rates, and, as a result, our future investment income may fall short of expectations or we may suffer losses in principal if forced to sell securities which have declined in market value due.
As of December 31, 2023, we had approximately $43.3 million invested in available-for-sale marketable securities.
We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.
It is difficult to predict the impact forward contracts could have on our results of operations.
Item 1. Business.
0 rewritten, 490 added, 0 removed, 0 unchanged
New section this year
Our Company
Align Technology, Inc. (“we,” “us,” “our,” “Align” or the “Company”) is a global medical device company primarily engaged in the design, manufacture and marketing of Invisalign® clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (“GPs”), ViveraTM retainers for retention, iTeroTM intraoral scanners and services for dentistry, and exocadTM computer-aided design and computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners.
Our vision and strategy is to revolutionize orthodontic and restorative dentistry through digital treatment planning and implementation using the AlignTM Digital Platform, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs and lab partners.
We strive to achieve our vision and strategy through key objectives made possible with the proprietary technologies and services of the AlignTM Digital Platform to establish: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients globally, our iTero intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.
Our corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85288.
Our telephone number is 602-742-2000.
Our internet address is www.aligntech.com.
Our Americas regional headquarters is located in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific (“APAC”) regional headquarters is located in Singapore.
We have two operating segments: (1) Clear Aligner and (2) Imaging Systems and CAD/CAM Services (“Systems and Services”).
For the year ended December 31, 2024, Clear Aligner net revenues represented approximately 81% of worldwide net revenues, while Systems and Services net revenues represented the remaining 19%.
We sell the majority of our products and services directly through a dedicated and specialized sales force to our customers: orthodontists, GPs, including prosthodontists, periodontists, oral surgeons and dental laboratories.
We also sell through sales agents and distributors in certain countries.
In addition, we sell directly to Dental Support Organizations (“DSOs”) who contract with dental practices to provide critical business management and support including non-clinical operations.
We also sell our products to dental laboratories who use our products to manufacture or customize their own products for licensed dentists.
We furthermore market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under the Invisalign® and other brands, including retainers, dental supplies, clear aligner cases (clamshells), ultrasonic and UV electronic cleaning devices, teeth whitening products and cleaning solutions (collectively, “Invisalign Accessory Products”).
Depending on the product, our Invisalign Accessory Products are sold through a variety of channels, including online through large e-commerce websites, our doctor portal and in-store through large retailers and pharmacy stores.
Our clear aligners are sold under the Invisalign® brand name.
Our Invisalign System is intended mainly for the treatment of malocclusions and is designed to help dental professionals achieve the clinical outcomes they expect and the results patients desire.
To date, over 19 million people worldwide have been treated with the Invisalign System.
In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course.
Our iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures as well as Invisalign case submissions.
Our exocad CAD/CAM software products provide restorative dentistry, implantology, guided surgery and smile design to dental labs and dental practices through fully integrated workflows, with the goal to provide cross-disciplinary dentistry in labs and at chairside.
Our Products, Services and Technologies
AlignTM Digital Platform

We strive to be at the forefront of innovation in digital orthodontics and dentistry, helping doctors transform their practices using digital tools and technology to deliver exceptional, modern treatment experiences and outcomes to patients worldwide.
The AlignTM Digital Platform is the foundation of our goal to revolutionize the practice of dentistry, delivering interconnected, interdisciplinary workflows and treatment solutions designed to improve all aspects of treatment, from initial consultations to final smiles with our doctor-centered treatment model.
The AlignTM Digital Platform is an end-to-end digital platform that combines software, systems and services to seamlessly integrate and connect those critical to successful treatment outcomes –
doctors, labs, patients and consumers.
At the center of the AlignTM Digital Platform are Invisalign clear aligners, iTero intraoral scanners and exocad CAD/CAM software.
The AlignTM Digital Platform utilizes the AlignTM Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected workflows and treatment solutions, that includes the following key components:

- Connect: The initial stage of the platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign providers.
Some of the tools that support this stage are Invisalign.com, the Invisalign SmileViewTM tool, My Invisalign app, Doctor Locator, Invisalign® Practice App, and Invisalign® Virtual Appointment.
- Scan: During this stage, patient data is captured through intraoral scanning.
Doctors and their staffs use intraoral scanning tools designed to support diagnosis of a patient’s oral conditions and health and support doctors to develop appropriate treatment pathways.
Visualization of their potential smiles helps patients understand the benefits of treatment and increase patient conversion.
The tools that support this stage, include, iTero intraoral scanners and exocad CAD/CAM imaging systems, Invisalign® Outcome Simulator Pro, Invisalign Photo Uploader, Invisalign SmileViewTM tool, iTero ElementTM 5D auto-upload feature, iTeroTM Scan Report and iTero\-exocad ConnectorTM.
- Diagnose: Doctors can access and use tools that support diagnosis of a patient’s oral health and develop an appropriate treatment pathway.
The AlignTM Digital Platform facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations.
An excerpt. Shown here: all 0 rewritten, 40 of 490 added and all 0 removed. The counts are complete. For every sentence, read Item 1. Business. in the FY2024 filing.
Item 3. Legal Proceedings.
1 rewritten, 0 added, 0 removed, 0 unchanged
For a discussion of legal proceedings, refer to *Note [removed: 7 "Legal] [added: 8* *"Legal] Proceedings" of the Notes to Consolidated Financial Statements* in Part II, Item 8 of this Form 10-K.
Cover and table of contents
37 rewritten, 6 added, 488 removed, 68 unchanged
For the fiscal year ended December 31, [removed: 2023][added: 2024]
| (State or other jurisdiction of incorporation or organization) | | | (I.R.S. Employer Identification [removed: Number)] [added: No.)] | | |
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the [removed: Exchange] Act.
See [added: the] definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting [removed: company,”] [added: company”] and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the [removed: Securities] [added: Exchange] Act. ☐ | | | | | | | | | | | |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the [removed: Exchange] Act).
The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $13.7] [added: $12.9] billion as of June [removed: 30, 2023] [added: 28, 2024] based on the closing sale price of the registrant’s common stock on the [removed: NASDAQ] [added: Nasdaq] Global [added: Select] Market on such date.
On February [removed: 22, 2024, 75,104,132] [added: 20, 2025, 73,597,648] shares of the registrant’s common stock were outstanding.
Portions of the registrant’s definitive Proxy Statement relating to its [removed: 2024 Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end] [added: 2025 annual meeting] of [removed: December 31, 2023] [added: stockholders] are incorporated by reference into Part III of this Annual Report on Form [removed: 10-K.][added: 10-K where indicated.]
For the Year Ended December 31, [removed: 2023][added: 2024]
| Item 1. | | | [removed: [Business](#i417aa79b41cc44f4a8019aa6393b0501_13)] [added: [Business](#ia8729110fd5c4d108bec42cae655576a_13)] | | | [removed: [3](#i417aa79b41cc44f4a8019aa6393b0501_13)] [added: [3](#ia8729110fd5c4d108bec42cae655576a_13)] | | |
| | | | [Information about our Executive [removed: Officers](#i417aa79b41cc44f4a8019aa6393b0501_16)] [added: Officers](#ia8729110fd5c4d108bec42cae655576a_16)] | | | [removed: [20](#i417aa79b41cc44f4a8019aa6393b0501_16)] [added: [20](#ia8729110fd5c4d108bec42cae655576a_16)] | | |
| Item 1A. | | | [Risk [removed: Factors](#i417aa79b41cc44f4a8019aa6393b0501_19)] [added: Factors](#ia8729110fd5c4d108bec42cae655576a_19)] | | | [removed: [20](#i417aa79b41cc44f4a8019aa6393b0501_19)] [added: [20](#ia8729110fd5c4d108bec42cae655576a_19)] | | |
| Item 1B. | | | [Unresolved Staff [removed: Comments](#i417aa79b41cc44f4a8019aa6393b0501_22)] [added: Comments](#ia8729110fd5c4d108bec42cae655576a_22)] | | | [removed: [35](#i417aa79b41cc44f4a8019aa6393b0501_22)] [added: [35](#ia8729110fd5c4d108bec42cae655576a_22)] | | |
| Item 1C. | | | [removed: [Cybersecurity](#i417aa79b41cc44f4a8019aa6393b0501_1977)] [added: [Cybersecurity](#ia8729110fd5c4d108bec42cae655576a_25)] | | | [removed: [35](#i417aa79b41cc44f4a8019aa6393b0501_1977)] [added: [35](#ia8729110fd5c4d108bec42cae655576a_25)] | | |
| Item 2. | | | [removed: [Properties](#i417aa79b41cc44f4a8019aa6393b0501_25)] [added: [Properties](#ia8729110fd5c4d108bec42cae655576a_28)] | | | [removed: [36](#i417aa79b41cc44f4a8019aa6393b0501_25)] [added: [37](#ia8729110fd5c4d108bec42cae655576a_28)] | | |
| Item 3. | | | [Legal [removed: Proceedings](#i417aa79b41cc44f4a8019aa6393b0501_28)] [added: Proceedings](#ia8729110fd5c4d108bec42cae655576a_31)] | | | [removed: [36](#i417aa79b41cc44f4a8019aa6393b0501_28)] [added: [37](#ia8729110fd5c4d108bec42cae655576a_31)] | | |
| Item 4. | | | [Mine Safety [removed: Disclosures](#i417aa79b41cc44f4a8019aa6393b0501_31)] [added: Disclosures](#ia8729110fd5c4d108bec42cae655576a_34)] | | | [removed: [36](#i417aa79b41cc44f4a8019aa6393b0501_31)] [added: [37](#ia8729110fd5c4d108bec42cae655576a_34)] | | |
| Item 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i417aa79b41cc44f4a8019aa6393b0501_37)] [added: Securities](#ia8729110fd5c4d108bec42cae655576a_40)] | | | [removed: [37](#i417aa79b41cc44f4a8019aa6393b0501_37)] [added: [38](#ia8729110fd5c4d108bec42cae655576a_40)] | | |
| Item 6. | | | [removed: [\[Reserved\]](#i417aa79b41cc44f4a8019aa6393b0501_40)] [added: [\[Reserved\]](#ia8729110fd5c4d108bec42cae655576a_43)] | | | [removed: [38](#i417aa79b41cc44f4a8019aa6393b0501_40)] [added: [40](#ia8729110fd5c4d108bec42cae655576a_43)] | | |
| Item 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i417aa79b41cc44f4a8019aa6393b0501_43)] [added: Operations](#ia8729110fd5c4d108bec42cae655576a_46)] | | | [removed: [38](#i417aa79b41cc44f4a8019aa6393b0501_43)] [added: [40](#ia8729110fd5c4d108bec42cae655576a_46)] | | |
| Item 7A. | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i417aa79b41cc44f4a8019aa6393b0501_82)] [added: Risk](#ia8729110fd5c4d108bec42cae655576a_85)] | | | [removed: [50](#i417aa79b41cc44f4a8019aa6393b0501_82)] [added: [52](#ia8729110fd5c4d108bec42cae655576a_85)] | | |
| Item 8. | | | [Financial Statements and Supplementary [removed: Data](#i417aa79b41cc44f4a8019aa6393b0501_85)] [added: Data](#ia8729110fd5c4d108bec42cae655576a_88)] | | | [removed: [52](#i417aa79b41cc44f4a8019aa6393b0501_85)] [added: [54](#ia8729110fd5c4d108bec42cae655576a_88)] | | |
| Item 9. | | | [Changes in and [removed: Disagreements with] [added: Disagreements](#ia8729110fd5c4d108bec42cae655576a_181) [W](#ia8729110fd5c4d108bec42cae655576a_181)[ith] Accountants on Accounting and Financial [removed: Disclosure](#i417aa79b41cc44f4a8019aa6393b0501_175)] [added: Disclosure](#ia8729110fd5c4d108bec42cae655576a_181)] | | | [removed: [89](#i417aa79b41cc44f4a8019aa6393b0501_175)] [added: [92](#ia8729110fd5c4d108bec42cae655576a_181)] | | |
| Item 9A. | | | [Controls and [removed: Procedures](#i417aa79b41cc44f4a8019aa6393b0501_178)] [added: Procedures](#ia8729110fd5c4d108bec42cae655576a_184)] | | | [removed: [89](#i417aa79b41cc44f4a8019aa6393b0501_178)] [added: [92](#ia8729110fd5c4d108bec42cae655576a_184)] | | |
| Item 9B. | | | [Other [removed: Information](#i417aa79b41cc44f4a8019aa6393b0501_181)] [added: Information](#ia8729110fd5c4d108bec42cae655576a_187)] | | | [removed: [89](#i417aa79b41cc44f4a8019aa6393b0501_181)] [added: [92](#ia8729110fd5c4d108bec42cae655576a_187)] | | |
| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i417aa79b41cc44f4a8019aa6393b0501_184)] [added: Inspections](#ia8729110fd5c4d108bec42cae655576a_190)] | | | [removed: [89](#i417aa79b41cc44f4a8019aa6393b0501_184)] [added: [93](#ia8729110fd5c4d108bec42cae655576a_190)] | | |
| Item 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#i417aa79b41cc44f4a8019aa6393b0501_190)] [added: Governance](#ia8729110fd5c4d108bec42cae655576a_196)] | | | [removed: [89](#i417aa79b41cc44f4a8019aa6393b0501_190)] [added: [93](#ia8729110fd5c4d108bec42cae655576a_196)] | | |
| Item 11. | | | [Executive [removed: Compensation](#i417aa79b41cc44f4a8019aa6393b0501_193)] [added: Compensation](#ia8729110fd5c4d108bec42cae655576a_199)] | | | [removed: [90](#i417aa79b41cc44f4a8019aa6393b0501_193)] [added: [93](#ia8729110fd5c4d108bec42cae655576a_199)] | | |
| Item 12. | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i417aa79b41cc44f4a8019aa6393b0501_196)] [added: Matters](#ia8729110fd5c4d108bec42cae655576a_202)] | | | [removed: [90](#i417aa79b41cc44f4a8019aa6393b0501_196)] [added: [94](#ia8729110fd5c4d108bec42cae655576a_202)] | | |
| Item 13. | | | [Certain Relationships and Related [removed: Transactions and] [added: Transactions](#ia8729110fd5c4d108bec42cae655576a_205)[,](#ia8729110fd5c4d108bec42cae655576a_205) [and] Director [removed: Independence](#i417aa79b41cc44f4a8019aa6393b0501_199)] [added: Independence](#ia8729110fd5c4d108bec42cae655576a_205)] | | | [removed: [90](#i417aa79b41cc44f4a8019aa6393b0501_199)] [added: [94](#ia8729110fd5c4d108bec42cae655576a_205)] | | |
| Item 14. | | | [Principal Accountant Fees and [removed: Services](#i417aa79b41cc44f4a8019aa6393b0501_202)] [added: Services](#ia8729110fd5c4d108bec42cae655576a_208)] | | | [removed: [90](#i417aa79b41cc44f4a8019aa6393b0501_202)] [added: [94](#ia8729110fd5c4d108bec42cae655576a_208)] | | |
| Item 15. | | | [Exhibits and Financial Statement [removed: Schedules](#i417aa79b41cc44f4a8019aa6393b0501_208)] [added: Schedules](#ia8729110fd5c4d108bec42cae655576a_214)] | | | [removed: [92](#i417aa79b41cc44f4a8019aa6393b0501_208)] [added: [95](#ia8729110fd5c4d108bec42cae655576a_214)] | | |
| Item 16. | | | [Form 10-K [removed: Summary](#i417aa79b41cc44f4a8019aa6393b0501_211)] [added: Summary](#ia8729110fd5c4d108bec42cae655576a_217)] | | | [removed: [95](#i417aa79b41cc44f4a8019aa6393b0501_211)] [added: [98](#ia8729110fd5c4d108bec42cae655576a_217)] | | |
*Invisalign, Align, the Invisalign logo, ClinCheck, Invisalign Assist, Invisalign Teen, Invisalign First, Invisalign Go, the Invisalign sonic logo, Vivera, SmartForce, SmartTrack, SmartStage, SmileView, iTero, iTero Element, iTero Lumina, [added: Orthocad,] exocad, Align Digital Platform, [added: Invisalign] Smile Architect, iTero exocad Connector and exocad Dental CAD, among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries.*
*In addition to historical information, this annual report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of [removed: 1934.][added: 1934, as amended (the “Exchange Act”).]
These statements include, among other things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our beliefs and expectations regarding macroeconomic conditions, including [removed: inflation,] fluctuations in currency exchange rates, [removed: rising] [added: inflation, higher] interest rates, market volatility, [removed: weakness in general economic conditions and recessions and the impact] [added: threats or actual imposition] of [removed: efforts by central banks and federal, state and local governments to combat inflation and recession,] [added: tariffs, threats of or actual economic slowdowns or recessions,] our expectations and beliefs regarding customer and consumer purchasing behavior and changes in consumer spending habits, our expectations regarding product [removed: mix] [added: mix, product launches, product pilots] and product adoption, our expectations regarding competition and our ability to compete in our target markets, our expectations regarding the sales growth of our intraoral scanners, clear aligners and other products, our expectations regarding the impact of the military conflicts in the Middle East and Ukraine and our operations and assets in Israel and Russia, our marketing and efforts to build our brand awareness, our estimates regarding the size and opportunities of the markets we are targeting along with our expectations for growth in those [removed: markets,] [added: markets and potential collaboration opportunities,] our beliefs regarding the impact of technological innovation in general, and in our solutions and products in particular, on target markets and patient care, our beliefs regarding digital dentistry and its potential to impact our business, our intentions regarding expanding our business, including its impact on our operational flexibility and responsiveness to customer demand, our [added: expectations regarding our tax positions and the judgements we make related to our tax obligations, our] beliefs regarding the importance of our manufacturing operations on our success, our beliefs regarding the need for and benefits of our technological development on Invisalign treatment, the areas of development in which we focus our efforts, and the advantages of our intellectual property portfolio, our beliefs regarding our business strategy and growth drivers, our expectations regarding the utilization rates for our products, including the impact of marketing on those rates and causes for periodic fluctuations of the rates, our expectations regarding the existence and impact of seasonality, our expectations regarding the productivity impact sales representatives will have on our sales and the impact of specialization of those representatives in sales channels, our expectations regarding the continued expansion of our international markets and their growth, our expectations regarding [added: impacts or] staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our business both in the United States and internationally, our beliefs regarding our culture and commitment and its impact on our financial and operational performance and its importance to our future success, our expectations for future investments in and benefits from sales and marketing activities, our preparedness and our customers’ preparedness to react to changing circumstances and demand, our expectations for our expenses and capital obligations and expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of [removed: our international earnings from operations,] [added: and ability to repatriate foreign earnings,] our belief regarding the sufficiency of our cash and investment balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition and assessment of goodwill and intangible assets, our [removed: expectations regarding our tax positions and the judgements we make related to our tax obligations, our] predicted level of operating expenses and gross margins and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.
The registrant’s definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.
| [PART I](#ia8729110fd5c4d108bec42cae655576a_10) | | | | | | [3](#ia8729110fd5c4d108bec42cae655576a_10) | | |
| [PART II](#ia8729110fd5c4d108bec42cae655576a_37) | | | | | | [38](#ia8729110fd5c4d108bec42cae655576a_37) | | |
| [PART III](#ia8729110fd5c4d108bec42cae655576a_193) | | | | | | [93](#ia8729110fd5c4d108bec42cae655576a_193) | | |
| [PART IV](#ia8729110fd5c4d108bec42cae655576a_211) | | | | | | [95](#ia8729110fd5c4d108bec42cae655576a_211) | | |
| [Signatures](#ia8729110fd5c4d108bec42cae655576a_220) | | | | | | [99](#ia8729110fd5c4d108bec42cae655576a_220) | | |
(Check one):
| | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| [PART I](#i417aa79b41cc44f4a8019aa6393b0501_10) | | | | | | [3](#i417aa79b41cc44f4a8019aa6393b0501_10) | | |
| [PART II](#i417aa79b41cc44f4a8019aa6393b0501_34) | | | | | | [37](#i417aa79b41cc44f4a8019aa6393b0501_34) | | |
| [PART III](#i417aa79b41cc44f4a8019aa6393b0501_187) | | | | | | [89](#i417aa79b41cc44f4a8019aa6393b0501_187) | | |
| [PART IV](#i417aa79b41cc44f4a8019aa6393b0501_205) | | | | | | [92](#i417aa79b41cc44f4a8019aa6393b0501_205) | | |
| [Signatures](#i417aa79b41cc44f4a8019aa6393b0501_214) | | | | | | [96](#i417aa79b41cc44f4a8019aa6393b0501_214) | | |
Business.
Our Company
Align Technology, Inc. (“We”, “Our”, “Align”) is a global medical device company primarily engaged in the design, manufacture and marketing of Invisalign® clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (“GPs”), ViveraTM retainers for retention, iTeroTM intraoral scanners and services for dentistry, and exocadTM computer-aided design and computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners.
Our vision and strategy is to revolutionize orthodontic and restorative dentistry through digital treatment planning and implementation using our Align Digital PlatformTM, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs and lab partners.
We strive to achieve our vision and strategy through key objectives made possible with the proprietary technologies and services of the Align Digital Platform to establish: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign system as the treatment solution of choice by orthodontists, GPs and patients globally, our intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.
Align’s corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85288.
Our telephone number is 602-742-2000.
Our internet address is www.aligntech.com.
Our Americas regional headquarters is located
in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific (“APAC”) regional headquarters is located in Singapore.
We have two operating segments: (1) Clear Aligner and (2) Imaging Systems and CAD/CAM Services (“Systems and Services”).
For the year ended December 31, 2023, Clear Aligner net revenues represented approximately 83% of worldwide net revenues, while Systems and Services net revenues represented the remaining 17%.
We sell the majority of our products directly through a dedicated and specialized sales force to our customers: orthodontists, GPs, including prosthodontists, periodontists, oral surgeons and dental laboratories.
We also sell through sales agents and distributors in certain countries.
In addition, we sell directly to Dental Support Organizations (“DSOs”) who contract with dental practices to provide critical business management and support including non-clinical operations.
We also sell our products to dental laboratories who use our products to manufacture or customize their own products for licensed dentists.
We also market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under the Invisalign® and other brands, including retainers, dental supplies, clear aligner cases (clamshells), teeth whitening products and cleaning solutions (collectively “Invisalign Accessory Products”).
Depending on the product, our Invisalign Accessory Products are sold through a variety of channels, including online through large e-commerce websites, our doctor portal and in-store through large retailers and pharmacy stores.
Our clear aligners are sold under the Invisalign® brand name.
Our Invisalign system is intended mainly for the treatment of malocclusions and is designed to help dental professionals achieve the clinical outcomes they expect and the results patients desire.
To date, approximately 17 million people worldwide have been treated with the Invisalign system.
In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course.
Our iTero intraoral scanner is used by dental professionals and/or labs and service providers for restorative and orthodontic digital procedures as well as Invisalign case submissions.
Our exocad CAD/CAM software products provide restorative dentistry, implantology, guided surgery, and smile design to dental labs and dental practices through fully integrated workflows, with the goal to provide cross-disciplinary dentistry in labs and at chairside.
Our Products, Services and Technologies
Align Digital PlatformTM

We strive to be at the forefront of innovation in digital orthodontics and dentistry, helping doctors transform their practices using digital tools and technology to deliver great treatment experiences and outcomes to people worldwide.
The Align Digital Platform is the foundation of our goal to revolutionize the practice of dentistry, delivering interconnected, interdisciplinary workflows and treatment solutions designed to improve all aspects of treatment, from initial consultations to final smiles with our doctor-centered treatment model.
The Align Digital Platform is an end-to-end digital platform that combines software, systems and services to seamlessly integrate and connect those critical to successful treatment outcomes – doctors, labs, patients, and consumers.
At the center of the Align Digital Platform are Invisalign clear aligners, iTero intraoral scanners, and exocad CAD/CAM software.
The Align Digital Platform utilizes the AlignTM Digital Workflow to enable an end-to-end treatment experience that includes the following key components:
An excerpt. Shown here: all 37 rewritten, all 6 added and 40 of 488 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2024 filing and the FY2023 filing.
Item 1C. Cybersecurity.
12 rewritten, 21 added, 6 removed, 11 unchanged
We have implemented a [removed: cross-departmental approach] [added: cross-functional information security program] to [removed: managing] [added: assess, identify and manage material risks from] cybersecurity risk, which includes seeking input from our employees, management, third-party vendors, the Audit Committee of the Board of Directors [removed: (the “Audit Committee”),] [added: (“Audit Committee”)] and the Board of Directors.
[removed: We devote] [added: Our information security program devotes] significant resources to cybersecurity and risk management processes to adapt to the changing cybersecurity landscape and respond to emerging threats in a timely and effective manner.
To more effectively [removed: address] [added: assess and manage] cybersecurity threats, we have a dedicated Chief Information Security Officer (“CISO”) who is responsible for leading enterprise-wide information security strategy, policy, process, and technology.
Our [removed: cybersecurity risk management] [added: information security] program leverages the National Institute of Standards and Technology (NIST) [removed: framework, which organizes] [added: and International Organization for Standardization (ISO) 27001 frameworks choosing to organize our] cybersecurity risks into five categories: identify, protect, detect, respond and recover.
Our information security team, comprised of employees with an expertise in cybersecurity and information technology, regularly [removed: assess] [added: assesses] the threat landscape and [removed: take] [added: takes] a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, [removed: detection,] [added: detection] and response.
[removed: The] [added: Our information security] program also [removed: has] [added: includes] an information security awareness program, which includes annual training regarding our acceptable use and information classification and handling policies, regular phishing campaigns complemented by additional employee training as appropriate, and communications and companion trainings to keep [removed: our] users informed on current events.
[removed: The] [added: Our] information security program’s ultimate goal is preventing cybersecurity incidents to the extent feasible, while simultaneously increasing our system resilience to minimize the business impact should an incident occur.
In the event of an identified cybersecurity incident, we have developed a detailed cybersecurity incident response process, which outlines the steps to be followed from incident detection, analysis, containment, eradication, [removed: recovery,] [added: recovery] and notification, including notifying functional areas (e.g. information technology, legal, finance, operations, privacy), as well as senior leadership and the Audit Committee, as appropriate.
If a third-party vendor is unable to provide a SOC 1 or SOC 2 report, our information security team takes additional steps to assess [removed: their] [added: its] cybersecurity preparedness and our initiation or continued engagement with [removed: them.][added: it.]
Additionally, third-party vendors are required to include security and privacy [removed: addendums] [added: addenda] to our contracts where [added: determined] applicable and are reassessed periodically as necessary depending on the risk level that has been assigned to the third-party vendor.
In [removed: 2023,] [added: 2024,] our CISO or his team met with the Audit Committee four times to discuss cybersecurity risks and threats.
[removed: We] [added: As of the date of this Annual Report on Form 10-K, we] have not identified any risks from known cybersecurity threats, including as a result of any [removed: prior] [added: previous] cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our [removed: operations,] business strategy, results of [removed: operations,] [added: operations] or financial condition.
Overview
In certain instances, incidents are escalated to certain members of our legal team who are responsible for, among other things, the accurate and timely disclosure of material cybersecurity incidents required under federal securities laws, including making the materiality determination and approving related securities disclosures.
Risk Management and Strategy
This does not imply that we meet any particular technical standards, specifications, or requirements, only that we use the NIST and ISO frameworks as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
Our information security program is integrated into our overall enterprise risk management program.
Our information security program includes, among other things:
- cybersecurity incident response;
- vulnerability management;
- antivirus and malware protection;
- technology compliance and risk management;
- encryption;
- identity and access management;
- application security; and
- security monitoring.
For a discussion of our cybersecurity-related risks, see Part I, Item 1A of this Annual Report on Form 10-K under the heading *“Risk Factors.”*
Governance
*Role of Management*
In addition, our internal audit team conducts periodic audits of the Company’s systems and cybersecurity processes, with findings reported to the Audit Committee and senior management.
*Role of the Board of Directors and the Audit Committee*
Our Audit Committee has responsibility for overseeing and reviewing our cybersecurity, data privacy, and other information technology risks, controls and procedures, including our plans to mitigate cybersecurity risks and to respond to data breaches.
Our Audit Committee also reviews with management any specific cybersecurity issues that could affect the adequacy of our internal controls and disclosure procedures and any public disclosures about our cybersecurity controls and procedures, the Board of Directors’ cybersecurity expertise, and its oversight of cybersecurity risk.
Our information security program includes, among other things, cybersecurity incident response, vulnerability management, antivirus and malware protection, technology compliance and risk management, encryption, identity and access management, application security, and security monitoring.
For critical cybersecurity incidents, processes have been established for our legal team to determine the materiality of each incident.
Our Audit Committee is responsible for reviewing cybersecurity risks and our cybersecurity program.
It oversees and reviews our cybersecurity and other information technology risks, controls, policies, and procedures.
See Item 1A.
“Risk Factors” for a discussion of cybersecurity risks.
Item 2. Properties.
1 rewritten, 0 added, 0 removed, 17 unchanged
As of December 31, [removed: 2023,] [added: 2024,] the significant facilities occupied were as follows:
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
10 rewritten, 5 added, 5 removed, 7 unchanged
Our common stock is traded on the [removed: NASDAQ] [added: Nasdaq] Global [added: Select] Market under the symbol [removed: ALGN.][added: “ALGN.” As of February 20, 2025, there were approximately 52 holders of record of our common stock.]
*Notwithstanding any statement to the contrary in any of our previous or future filings with the SEC, the following information relating to the price performance of our common stock shall not be deemed “filed” with the SEC or [removed: “Soliciting Material”] [added: “soliciting material”] under the [removed: Securities] Exchange Act [removed: of 1934, as amended,] or subject to Regulation 14A or 14C, or to liabilities of Section 18 of the Exchange Act except to the extent we specifically request that such information be treated as soliciting material or to the extent we specifically incorporate this information by reference.*
The graph below [removed: matches our cumulative] [added: compares the] 5-year [added: cumulative] total stockholder return on [added: Align] common stock with the cumulative total returns of the NASDAQ Composite [removed: index,] [added: Index,] the S&P 500 [removed: index] [added: Index] and the S&P 1500 Composite Health Care Equipment & Supplies [removed: index.][added: Industry Index.]
The graph tracks the performance of a $100 investment in [removed: our] [added: Align] common stock and each index [removed: (with the] [added: (assuming] reinvestment of all dividends) from December 31, [removed: 2018] [added: 2019] to December 31, [removed: 2023.][added: 2024.]
[removed: ][added: ]
[removed: Unregistered] [added: Recent] Sales of [removed: Equity] [added: Unregistered] Securities
The following table summarizes the stock repurchase activity for the three months ended December 31, [removed: 2023:][added: 2024:]
| Period | | | | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares Purchased as Part of Publicly Announced [added: Plans or] Programs | | | | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the [added: Plans or] Programs(1) | | |
*1* *January 2023 Repurchase Program.* In January 2023, we announced that our Board of Directors had authorized a plan to repurchase up to $1,000,000,000 of our common [removed: stock.][added: stock (“January 2023 Repurchase Program”).]
See *Note [removed: 10*] [added: 11*] “*Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements* for details on the January 2023 Repurchase Program.
Past stock price performance is not necessarily indicative of future stock price performance.
| October 1, 2024 through October 31, 2024 | | | | | | 83,029 | | | | | | $ | 217.18 | | | | | 83,029 | | | | | | $ | 482,000,000 | |
| November 1, 2024 through November 30, 2024 | | | | | | 407,090 | | | | | | $ | 221.48 | | | | | 407,090 | | | | | | $ | 392,000,000 | |
| December 1, 2024 through December 31, 2024 | | | | | | 419,848 | | | | | | $ | 225.49 | | | | | 419,848 | | | | | | $ | 297,100,000 | |
| Total | | | | | | 909,967 | | | | | | | | | | | | 909,967 | | | | | | | | |
As of February 22, 2024, there were approximately 52 holders of record of our common stock.
| October 1, 2023 through October 31, 2023 | | | | | | 1,049,538 | | | | | | $ | 190.56 | | | | | 1,049,538 | | | | | | $ | 750,000,000 | |
| November 1, 2023 through November 30, 2023 | | | | | | 283,335 | | | | | | $ | 206.89 | | | | | 283,335 | | | | | | $ | 691,380,496 | |
| December 1, 2023 through December 31, 2023 | | | | | | 182,183 | | | | | | $ | 227.14 | | | | | 182,183 | | | | | | $ | 650,000,000 | |
| Total | | | | | | 1,515,056 | | | | | | | | | | | | 1,515,056 | | | | | | | | |
Item 8. Financial Statements and Supplementary Data.
441 rewritten, 259 added, 181 removed, 745 unchanged
[removed: | [Report of Management on Internal Control over Financial Reporting](#i417aa79b41cc44f4a8019aa6393b0501_91) | | | [53](#i417aa79b41cc44f4a8019aa6393b0501_91) | | |][added: MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING]
| [Report of Independent Registered Public Accounting [removed: Firm](#i417aa79b41cc44f4a8019aa6393b0501_94)] [added: Firm](#ia8729110fd5c4d108bec42cae655576a_97)] (PCAOB ID 238) | | | [removed: [54](#i417aa79b41cc44f4a8019aa6393b0501_94)] [added: [56](#ia8729110fd5c4d108bec42cae655576a_97)] | | |
| [Consolidated Statements of Operations for the year ended December [removed: 31,](#i417aa79b41cc44f4a8019aa6393b0501_97) [2023](#i417aa79b41cc44f4a8019aa6393b0501_97)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_97)[2](#i417aa79b41cc44f4a8019aa6393b0501_97) [and 202](#i417aa79b41cc44f4a8019aa6393b0501_97)[1](#i417aa79b41cc44f4a8019aa6393b0501_97)] [added: 31, 2024, 2023 and 2022](#ia8729110fd5c4d108bec42cae655576a_100)] | | | [removed: [56](#i417aa79b41cc44f4a8019aa6393b0501_97)] [added: [58](#ia8729110fd5c4d108bec42cae655576a_100)] | | |
| [Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 202](#i417aa79b41cc44f4a8019aa6393b0501_100)[3](#i417aa79b41cc44f4a8019aa6393b0501_100)[, 20](#i417aa79b41cc44f4a8019aa6393b0501_100)[22](#i417aa79b41cc44f4a8019aa6393b0501_100) [and 202](#i417aa79b41cc44f4a8019aa6393b0501_100)[1](#i417aa79b41cc44f4a8019aa6393b0501_100)] [added: 2024, 2023 and 2022](#ia8729110fd5c4d108bec42cae655576a_103)] | | | [removed: [57](#i417aa79b41cc44f4a8019aa6393b0501_100)] [added: [59](#ia8729110fd5c4d108bec42cae655576a_103)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 202](#i417aa79b41cc44f4a8019aa6393b0501_103)[3](#i417aa79b41cc44f4a8019aa6393b0501_103) [and 202](#i417aa79b41cc44f4a8019aa6393b0501_103)[2](#i417aa79b41cc44f4a8019aa6393b0501_103)] [added: 2024 and 2023](#ia8729110fd5c4d108bec42cae655576a_106)] | | | [removed: [58](#i417aa79b41cc44f4a8019aa6393b0501_103)] [added: [60](#ia8729110fd5c4d108bec42cae655576a_106)] | | |
| [Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[3](#i417aa79b41cc44f4a8019aa6393b0501_106)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[2](#i417aa79b41cc44f4a8019aa6393b0501_106) [and 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[1](#i417aa79b41cc44f4a8019aa6393b0501_106)] [added: 2024, 2023 and 2022](#ia8729110fd5c4d108bec42cae655576a_109)] | | | [removed: [59](#i417aa79b41cc44f4a8019aa6393b0501_106)] [added: [61](#ia8729110fd5c4d108bec42cae655576a_109)] | | |
| [Consolidated Statements of Cash Flows for the year ended December 31, [removed: 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[3](#i417aa79b41cc44f4a8019aa6393b0501_109)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[2](#i417aa79b41cc44f4a8019aa6393b0501_109) [and 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[1](#i417aa79b41cc44f4a8019aa6393b0501_109)] [added: 2024, 2023 and 2022](#ia8729110fd5c4d108bec42cae655576a_112)] | | | [removed: [60](#i417aa79b41cc44f4a8019aa6393b0501_109)] [added: [62](#ia8729110fd5c4d108bec42cae655576a_112)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i417aa79b41cc44f4a8019aa6393b0501_112)] [added: Statements](#ia8729110fd5c4d108bec42cae655576a_115)] | | | [removed: [61](#i417aa79b41cc44f4a8019aa6393b0501_112)] [added: [63](#ia8729110fd5c4d108bec42cae655576a_115)] | | |
[removed: REPORT OF MANAGEMENT ON INTERNAL CONTROL OVER FINANCIAL REPORTING][added: | [Management's Annual Report on Internal Control over Financial Reporting](#ia8729110fd5c4d108bec42cae655576a_94) | | | [55](#ia8729110fd5c4d108bec42cae655576a_94) | | |]
Management of Align is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of [removed: 1934.][added: 1934, as amended.]
[removed: In addition,] [added: Also,] projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2023.][added: 2024.]
Based on our assessment, management has concluded that, as of December 31, [removed: 2023,] [added: 2024,] our internal control over financial reporting was effective based on criteria in *Internal Control - Integrated Framework (2013)* issued by the COSO.
The effectiveness of our internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.
We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the [removed: “Company”)] [added: "Company")] as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the related consolidated statements of operations, of comprehensive income, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] including the related notes and [removed: financial statement] schedule [removed: listed] [added: of Valuation and Qualifying Accounts and Reserves for each of the three years] in the [removed: index] [added: period ended December 31, 2024] appearing under Item 15(a)(2) (collectively referred to as the [removed: “consolidated] [added: "consolidated] financial [removed: statements”).][added: statements").]
We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] in conformity with accounting principles generally accepted in the United States of America.
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying [added: Management’s Annual] Report [removed: of Management] on Internal Control [removed: Over] [added: over] Financial Reporting.
As described in Notes 1 and [removed: 15] [added: 16] to the consolidated financial statements, the Company recognized net revenues of $3.2 billion from its Clear Aligner segment for the year ended December 31, [removed: 2023.][added: 2024.]
The principal considerations for our determination that performing procedures [removed: related] [added: relating] to revenue recognition and the determination of standalone selling price of distinct performance obligations in Clear Aligner contracts is a critical audit matter are the significant judgment by management in determining the estimate of standalone selling price, which includes significant assumptions related to usage rates for each distinct performance obligation.
| | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |
| Net revenues | | | | | | $ | [removed: 3,862,260] [added: 3,999,012] | | | | | $ | [removed: 3,734,635] [added: 3,862,260] | | | | | $ | [removed: 3,952,584] [added: 3,734,635] | |
| Cost of net revenues | | | | | | [removed: 1,155,397] [added: 1,199,853] | | | | | | [removed: 1,100,860] [added: 1,155,397] | | | | | | [removed: 1,017,229] [added: 1,100,860] | | |
| Gross profit | | | | | | [removed: 2,706,863] [added: 2,799,159] | | | | | | [removed: 2,633,775] [added: 2,706,863] | | | | | | [removed: 2,935,355] [added: 2,633,775] | | |
| Selling, general and administrative | | | | | | [removed: 1,703,379] [added: 1,763,193] | | | | | | [removed: 1,674,469] [added: 1,703,379] | | | | | | [removed: 1,708,640] [added: 1,674,469] | | |
| Research and development | | | | | | [removed: 346,830] [added: 364,202] | | | | | | [removed: 305,258] [added: 346,830] | | | | | | [removed: 250,315] [added: 305,258] | | |
| Restructuring and other charges | | | | | | [removed: 13,316] [added: 33,168] | | | | | | [removed: 11,453] [added: 13,316] | | | | | | [removed: —] [added: 11,453] | | |
| Total operating expenses | | | | | | [removed: 2,063,525] [added: 2,191,531] | | | | | | [removed: 1,991,180] [added: 2,063,525] | | | | | | [removed: 1,958,955] [added: 1,991,180] | | |
| Income from operations | | | | | | [removed: 643,338] [added: 607,628] | | | | | | [removed: 642,595] [added: 643,338] | | | | | | [removed: 976,400] [added: 642,595] | | |
| Interest income | | | | | | [removed: 17,258] [added: 20,218] | | | | | | [removed: 5,367] [added: 17,258] | | | | | | [removed: 3,103] [added: 5,367] | | |
| Other income (expense), net | | | | | | [removed: (19,392)] [added: (18,887)] | | | | | | [removed: (48,905)] [added: (19,392)] | | | | | | [removed: 32,920] [added: (48,905)] | | |
| Total interest income and other income (expense), net | | | | | | [removed: (2,134)] [added: 1,331] | | | | | | [removed: (43,538)] [added: (2,134)] | | | | | | [removed: 36,023] [added: (43,538)] | | |
| Net income before provision for income taxes | | | | | | [removed: 641,204] [added: 608,959] | | | | | | [removed: 599,057] [added: 641,204] | | | | | | [removed: 1,012,423] [added: 599,057] | | |
| Provision for income taxes | | | | | | [removed: 196,151] [added: 187,597] | | | | | | [removed: 237,484] [added: 196,151] | | | | | | [removed: 240,403] [added: 237,484] | | |
| Net income | | | | | | $ | [removed: 445,053] [added: 421,362] | | | | | $ | [removed: 361,573] [added: 445,053] | | | | | $ | [removed: 772,020] [added: 361,573] | |
| Basic | | | | | | $ | [removed: 5.82] [added: 5.63] | | | | | $ | [removed: 4.62] [added: 5.82] | | | | | $ | [removed: 9.78] [added: 4.62] | |
| Diluted | | | | | | $ | [removed: 5.81] [added: 5.62] | | | | | $ | [removed: 4.61] [added: 5.81] | | | | | $ | [removed: 9.69] [added: 4.61] | |
| Basic | | | | | | [removed: 76,426] [added: 74,877] | | | | | | [removed: 78,190] [added: 76,426] | | | | | | [removed: 78,917] [added: 78,190] | | |
| Diluted | | | | | | [removed: 76,568] [added: 74,993] | | | | | | [removed: 78,420] [added: 76,568] | | | | | | [removed: 79,670] [added: 78,420] | | |
| February 28, 2025 | | |
| February 28, 2025 | | |
February 28, 2025
| Legal settlement loss | | | | | | 30,968 | | | | | | — | | | | | | — | | |
| Net income | | | | | | $ | 421,362 | | | | | $ | 445,053 | | | | | $ | 361,573 | |
| | | | | | | 2024 | | | | | | 2023 | | |
| Intangible assets, net | | | | | | 103,488 | | | | | | 82,118 | | |
| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 421,362 | | | | | | 421,362 | | |
| Common stock repurchased and retired | | | | | | (1,545) | | | | | | — | | | | | | (20,292) | | | | | | — | | | | | | (335,243) | | | | | | (355,535) | | |
| Equity forward contract related to accelerated stock repurchase | | | | | | — | | | | | | — | | | | | | 49,527 | | | | | | — | | | | | | (49,527) | | | | | | — | | |
| Stock-based compensation | | | | | | — | | | | | | — | | | | | | 173,703 | | | | | | — | | | | | | — | | | | | | 173,703 | | |
| Balance as of December 31, 2024 | | | | | | 73,849 | | | | | | $ | 7 | | | | | $ | 1,362,234 | | | | | $ | 5,978 | | | | | $ | 2,483,766 | | | | | $ | 3,851,985 | |
| | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |
| Net income | | | | | | $ | 421,362 | | | | | $ | 445,053 | | | | | $ | 361,573 | |
As of December 31, 2024 we have no short term or long term marketable securities.
Our evaluation includes identification of activities that are significant to the VIE and an assessment of our ability to direct those activities.
On April 24, 2023 and April 22, 2024, we entered into Subscription Agreements (the “Heartland Subscription Agreements”) with Heartland Dental Holding Corporation (“Heartland”).
Pursuant to the Heartland Subscription Agreements we acquired less than a 5% equity interest in total, through the purchase of Class A Common Stock for $150 million ($75 million in each April 2023 and April 2024).
On December 19, 2024, we entered into a Subscription Agreement (the “Smile Doctors Subscription Agreement”) with New SD Holding Company, L.P. (“SD Holding Company”).
SD Holding Company owns a controlling interest, through intermediary entities, in Smile Doctors, LLC.
Based on a review of the relevant facts and circumstances, primarily observable transactions for identical investments, we recorded a $6 million increase to the carrying value of our investment in Heartland for the year ended December 31, 2024.
We did not record an adjustment for the year ended December 31, 2023.
Leases - Lessor
We determine if an arrangement is or contains a lease at inception.
All of our leases in which we are the lessor are classified as operating leases, exclusive of leases with a term of 12 months or less.
The underlying asset in an operating lease arrangement is carried at depreciated cost within Property, plant, and equipment, net on our Consolidated Balance Sheets.
The average amortization period by intangible asset class ranges from ten to twelve years.
This amortization period reflects the period in which the economic benefits of the assets are expected to be realized.
The second step is to measure the tax benefit as the
We adopted this standard in the fiscal year ended December 31, 2024.
*Note 16 “Segments and Geographical Information" of the Notes of Consolidated Financial Statements*
There will be no impact to our consolidated balance sheets or statements of operations; however, the Company is evaluating the effect of this pronouncement on our consolidated financial statement disclosures.
On November 4, 2024, the FASB issued ASU 2024-03, *“Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures.”* The amendments in this ASU require a public entity to disclose, in the notes to the financial statements, specified information about certain costs and expenses, including the amounts of inventory purchases, employee compensation, depreciation and intangible asset amortization.
There will be no impact to our consolidated balance sheets or statements of operations; however, the Company is evaluating the effect of this pronouncement on our consolidated financial statement disclosures.
| Cash | | | | | | $ | 752,423 | | | | | $ | — | | | | | $ | — | | | | | $ | 752,423 | | | | | $ | 752,423 | | | | | $ | — | | | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total | | | | | | $ | 1,043,887 | | | | | $ | — | | | | | $ | — | | | | | $ | 1,043,887 | | | | | $ | 1,043,887 | | | | | $ | — | | | | | $ | — | |
We have no short-term or long-term marketable securities as of December 31, 2024.
| February 28, 2024 | | |
February 28, 2024
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance as of December 31, 2020 | | | | | | 78,860 | | | | | | 8 | | | | | | 974,556 | | | | | | 43,501 | | | | | | 2,215,800 | | | | | | 3,233,865 | | |
| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 772,020 | | | | | | 772,020 | | |
| Common stock repurchased and retired | | | | | | (592) | | | | | | — | | | | | | (6,592) | | | | | | — | | | | | | (368,446) | | | | | | (375,038) | | |
| Arbitration award gain | | | | | | — | | | | | | — | | | | | | (43,403) | | |
| Repayment on unsecured promissory note | | | | | | — | | | | | | — | | | | | | 4,594 | | |
| Proceeds from arbitration award | | | | | | — | | | | | | — | | | | | | 43,403 | | |
In September 2023, we completed an assessment of the useful lives of certain manufacturing equipment used in cutting, forming, assembling and scanning.
We adjusted the estimated useful life from ten (10) years to thirteen (13) years.
This change in accounting estimate was effective beginning September 2023.
These updated useful lives were applied to applicable assets in service as of the date of change and will be applied prospectively as assets are placed in service.
Based on the carrying amount of the assets recorded in our property, plant and equipment, net balance prior to the change, the effect of this change in estimate for fiscal year 2023 was a reduction in depreciation expense of approximately $5.4 million and an increase in net income of $3.7 million, or $0.05 per share basic and diluted, for the year ended December 31, 2023.
Our evaluation includes identification of significant activities and an assessment of our ability to direct those activities based on governance provisions and arrangements to provide or receive product and process technology, product supply, operations services, equity funding, financing, and other applicable agreements and circumstances.
the value of our investments in equity securities at cost, minus impairment, if any.
On April 24, 2023, we entered into a Subscription Agreement (the "Subscription Agreement") with Heartland Dental Holding Corporation (“Heartland”) who is an affiliate of KKR Core Holding Company LLC, which is an investment vehicle managed or advised by, or otherwise affiliated with, Kohlberg Kravis Roberts & Co. L.P. Heartland is a dental support organization (“DSO”) that provides nonclinical administrative and support services to supported dental professional corporations (“PCs”).
In connection with the Subscription Agreement, we entered into a Stockholders’ Agreement, by and among us, Heartland Dental Topco, LLC (“Topco”) and funds and accounts managed by affiliates of KKR & Co. Inc. (“KKR”), and a Side Letter, by and among us, Heartland, Topco and KKR (the "Side Letter").
Subject to certain restrictions set forth in the Side Letter, we agreed to provisions applicable to Heartland’s stockholders, including certain drag-along and voting obligations.
We are not the primary beneficiary of nor are we able to exercise significant influence over Heartland.
As such, we are accounting for our investment in Heartland as an investment in equity securities.
Based on review of our investment in Heartland, we determined that no adjustments to the carrying value were necessary; therefore, it is properly reflected on our Consolidated Balance Sheet in other assets at $75 million.
Investments in equity securities are reported on our Consolidated Balance Sheet as other assets.
The carrying value of our investments in equity securities, exclusive of Heartland, were not material as of December 31, 2023 or 2022 and the associated adjustments to the carrying values of the investments were not material during the year ended December 31, 2023, 2022 and 2021.
The carrying value of our equity method investments are reported on our Consolidated Balance Sheet as other assets and are not material as of December 31, 2023 or 2022.
On September 6, 2023, we entered into a definitive agreement to acquire privately held Cubicure GmbH (“Cubicure”).
The purchase price for the transaction will be approximately $87 million subject to customary closing adjustments and adjustments for Align’s existing ownership of capital stock of Cubicure.
The acquisition closed on January 2, 2024.
We are subject to risks including, but not limited to, global and regional economic market conditions, inflation, fluctuations in foreign currency exchange rates, changes in consumer confidence and demand, increased competition, dependence on key personnel, protection and litigation of proprietary technology, shifts in taxable income between tax jurisdictions and compliance with regulations of the U.S. Food and Drug Administration (“FDA”) and similar international agencies.
Further, our operations globally, particularly in prior years, have been impacted by the COVID-19 pandemic.
The lease term
exceeds its fair value.
We enter into sales contracts that may consist of multiple distinct performance obligations where certain performance obligations of the sales contract are not delivered in one reporting period.
We
Investment in SmileDirectClub, LLC (“SDC”)
After tendering of our SDC equity interest in 2019, on July 3, 2019, we filed a demand for arbitration regarding SDC’s calculation of the “capital account” balance.
On March 12, 2021, the arbitrator ruled in our favor and against SDC and issued an award of $43.4 million along with interest.
The gain of $43.4 million was recognized as a part of our other income (expense), net in our Consolidated Statement of Operation during the year ended December 31, 2021.
In October 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2021-08, “*Business Combinations (Topic 805) Accounting for Contract Assets and Contract Liabilities from Contracts with Customers,*” which requires contract assets and contract liabilities acquired in a business combination to be recognized and measured in accordance with ASC 606, *Revenue from Contracts with Customers* as if the acquirer had originated the contracts.
We early adopted this standard during 2022 which did not have a material impact on our consolidated financial statements and related disclosures.
An excerpt. Shown here: 40 of 441 rewritten, 40 of 259 added and 40 of 181 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data. in the FY2024 filing and the FY2023 filing.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
0 rewritten, 1 added, 1 removed, 0 unchanged
Not applicable.
None.
Item 9A. Controls and Procedures.
4 rewritten, 0 added, 0 removed, 3 unchanged
[removed: Under] [added: Our management, under] the supervision and with the participation of our [removed: management, including our] Chief Executive Officer and our Chief Financial Officer, [removed: we have] [added: has] evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act).
Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures are effective as of December 31, [removed: 2023] [added: 2024] to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and that such information is recorded, processed, summarized and reported within the time periods specified in the [removed: Securities and Exchange Commission] [added: SEC’s] rules and forms.
See [removed: “Report of Management] [added: “Management’s Annual Report] on Internal Control over Financial Reporting” [added: in Item 8] of this Annual Report on Form 10-K.
There have been no changes in our internal control over financial reporting [added: (as defined in Rule 13a-15(f) under the Exchange Act)] during the quarter ended December 31, [removed: 2023] [added: 2024] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
1 rewritten, 0 added, 0 removed, 0 unchanged
During the fiscal quarter ended December 31, [removed: 2023,] [added: 2024,] no director or [removed: officer, as] [added: officer (as] defined in Rule 16a-1(f) of the Exchange [removed: Act,] [added: Act)] adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading [removed: arrangement,” each] [added: arrangement” (each] as defined in [removed: Regulation S-K] Item [removed: 408.][added: 408 of Regulation S-K).]
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
1 rewritten, 1 added, 1 removed, 1 unchanged
Certain information required by Part III is omitted from this [added: Annual Report on] Form 10-K because we intend to file [removed: a] [added: our] definitive Proxy Statement for our [removed: 2023] [added: 2025] Annual Meeting of Stockholders (the “Proxy Statement”) not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and certain information to be included therein is incorporated herein by reference.
Not applicable.
None.
Item 10. Directors, Executive Officers and Corporate Governance.
5 rewritten, 5 added, 1 removed, 2 unchanged
The information required by Item 401 of Regulation S-K concerning our [removed: directors is incorporated by reference to the Proxy Statement under the section captioned “Directors.” The information required by Item 401 of Regulation S-K concerning our] executive officers is set forth in [removed: *Item 1—] [added: Part I, Item 1,] “Business” [removed: of] [added: contained in] this Annual Report on Form [removed: 10-K*.][added: 10-K under the section entitled “Information about our Executive Officers.”]
[removed: The] [added: If applicable, the] information required by Item 405 of Regulation S-K [removed: is] [added: concerning delinquent reports under Section 16(a) of the Exchange Act will be] incorporated by reference to the section entitled “Delinquent Section 16(a) Reports” contained in [added: the Proxy Statement.]
The information required by Item 407(c)(3), 407(d)(4) and 407(d)(5) of Regulation S-K is incorporated by reference to the [removed: Proxy Statement under the] section entitled “Corporate [removed: Governance”.][added: Governance” contained in the Proxy Statement.]
Our Global Code of Conduct is posted on the investor relations portion of our website at *http://investor.aligntech.com* within the section captioned “Corporate [removed: Governance”.][added: Governance.”]
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of [removed: this code] [added: our Global Code] of [removed: ethics] [added: Conduct] by posting such information on our website, at the address and location specified above, [removed: or as otherwise required] [added: rather than] by [removed: the NASDAQ Global Select Market.][added: filing a Current Report on Form 8-K.]
The information required by Item 401 of Regulation S-K concerning our directors is incorporated by reference to the section entitled “Director Nominees” contained in the Proxy Statement.
Insider Trading Arrangements and Policies
We have adopted an Insider Trading Policy governing the purchase, sale and other dispositions of our securities by our directors, officers, employees, consultants, contractors and our agents that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations and Nasdaq listing standards.
A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
In addition, it is our policy that any trades by us will comply with applicable law, including laws with respect to insider trading.
the Proxy Statement.
Item 11. Executive Compensation.
1 rewritten, 1 added, 0 removed, 0 unchanged
The information required by [removed: Item 402 of Regulation S-K is incorporated by reference to the Proxy Statement under the section captioned “Executive Compensation - Compensation Discussion and Analysis.” The information required by] Items 407(e)(4) and (e)(5) [added: of Regulation S-K] is incorporated by reference to the [removed: Proxy Statement under the section captioned] [added: sections entitled] “Corporate [removed: Governance - Committee] [added: Governance—Committee] Responsibilities and [removed: Oversight - Compensation] [added: Oversight—Compensation] and Human Capital [added: Committee—Compensation] Committee Interlocks and Insider Participation” and “Compensation and Human Capital Committee [removed: of the Board] Report,” [removed: respectively.][added: respectively, contained in the Proxy Statement.]
The information required by Item 402 of Regulation S-K is incorporated by reference to the sections entitled “Executive Compensation—Compensation Discussion and Analysis,” “Compensation Tables” and “Director Compensation” contained in the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
1 rewritten, 0 added, 12 removed, 0 unchanged
The information required by Item [added: 201(d) and Item] 403 of Regulation S-K is incorporated by reference to the [removed: Proxy Statement under the] sections [removed: captioned] [added: entitled “Equity Compensation Plan Information” and] “Security Ownership of Certain Beneficial Owners and [removed: Management”.][added: Management,” respectively, contained in the Proxy Statement.]
Equity Compensation Plan Information
The following table provides information as of December 31, 2023 about our common stock that may be issued upon the awards granted to employees, consultants or members of our Board of Directors under all existing equity compensation plans, including the 2005 Incentive Plan and the Employee Stock Purchase Plan (“ESPP”), each as amended, and certain individual arrangements (Refer to *Note 9 "Stockholders’ Equity” of the Notes to Consolidated Financial Statements* for a description of our equity compensation plans).
| | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Plan Category | | | | | | Number of securities to be issued upon exercise of outstanding options and restricted stock units (a) | | | | | | Weighted average exercise price of outstanding options (b) | | | | | | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | | | | | |
| Equity compensation plans approved by security holders | | | | | | 898,838 | | | 1 | | | $ | — | | | | | 7,241,323 | | | 2, 3 | | |
| Equity compensation plans not approved by security holders | | | | | | — | | | | | | — | | | | | | — | | | | | |
| Total | | | | | | 898,838 | | | | | | $ | — | | | | | 7,241,323 | | | | | |
1 Includes 741,185 RSUs and 157,653 MSUs at 100% of target
2 Includes 1,995,453 shares available for issuance under our ESPP.
We are unable to ascertain with specificity the number of securities to be issued upon exercise of outstanding rights or the weighted average exercise price of outstanding rights under the ESPP.
3 Includes additional 449,311 of potentially issuable MSUs above target if performance targets are achieved at maximum payout of 250% (in addition to the reserve for one and nine-tenths (1 9/10) shares for every one (1) issuable share against the authorized share reserve)
Item 13. Certain Relationships and Related Transactions, and Director Independence.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by Item 404 and Item 407 of Regulation S-K is incorporated by reference to the [removed: Proxy Statement under the] sections [removed: captioned] [added: entitled] “Certain Relationships and Related Party Transactions” and “Corporate Governance—Board Structure and Independence,” [removed: respectively.][added: respectively, contained in the Proxy Statement.]
Item 14. Principal Accountant Fees and Services.
1 rewritten, 0 added, 0 removed, 1 unchanged
The information required by Item 9(e) of Schedule 14A [removed: of the Securities Act of 1934, as amended,] is incorporated by reference to the [removed: Proxy Statement under the] section [removed: captioned] [added: entitled] “Ratification of Appointment of Independent Registered Public [removed: Accountants.”][added: Accounting Firm” contained in the Proxy Statement.]
Item 15. Exhibit and Financial Statement Schedules.
51 rewritten, 6 added, 4 removed, 44 unchanged
| Report of Independent Registered Public Accounting Firm | | | [removed: [54](#i417aa79b41cc44f4a8019aa6393b0501_94)] [added: [56](#ia8729110fd5c4d108bec42cae655576a_97)] | | |
| Consolidated Statements of Operations for the year ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [56](#i417aa79b41cc44f4a8019aa6393b0501_97)] [added: [58](#ia8729110fd5c4d108bec42cae655576a_100)] | | |
| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [57](#i417aa79b41cc44f4a8019aa6393b0501_100)] [added: [59](#ia8729110fd5c4d108bec42cae655576a_103)] | | |
| Consolidated Balance Sheets as of December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] | | | [removed: [58](#i417aa79b41cc44f4a8019aa6393b0501_103)] [added: [60](#ia8729110fd5c4d108bec42cae655576a_106)] | | |
| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [59](#i417aa79b41cc44f4a8019aa6393b0501_106)] [added: [61](#ia8729110fd5c4d108bec42cae655576a_109)] | | |
| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [60](#i417aa79b41cc44f4a8019aa6393b0501_109)] [added: [62](#ia8729110fd5c4d108bec42cae655576a_112)] | | |
| Notes to Consolidated Financial Statements | | | [removed: [61](#i417aa79b41cc44f4a8019aa6393b0501_112)] [added: [63](#ia8729110fd5c4d108bec42cae655576a_115)] | | |
Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021][added: 2022]
| [removed: [3.1](http://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt)] [added: [3.1](https://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt)] | | | [Amended and Restated Certificate of Incorporation of [removed: registrant](http://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt)] [added: Align Technology, Inc](https://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt)] | | | [removed: S-1, as amended] [added: S-1/A] (File No. 333-49932) | | | 12/28/2000 | | | 3.1 | | | | | | | | |
| [removed: [3.1A](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm)] [added: [3.1A](https://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm)] | | | [Certificate of Amendment to the Amended and Restated Certificate of [removed: Incorporation](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm)] [added: Incorporation of Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm)] | | | 8-K | | | 5/20/2016 | | | 3.01 | | | | | | | | |
| [3.1B](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/amendmenttocertificateofin.htm) | | | [Certificate of Amendment [removed: to] [added: of] the Amended and Restated Certificate of [removed: Incorporation](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/amendmenttocertificateofin.htm)] [added: Incorporation of Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/amendmenttocertificateofin.htm)] | | | 10-Q | | | 8/4/2023 | | | 3.1B | | | | | | | | |
| [3.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000003/amendedandrestatedbylawspr.htm) | | | [Amended and Restated Bylaws of [removed: registrant](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000003/amendedandrestatedbylawspr.htm)] [added: Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000003/amendedandrestatedbylawspr.htm)] | | | 8-K | | | 1/17/2024 | | | 3.1 | | | | | | | | |
| [removed: [4.1](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt)] [added: [4.1](https://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt)] | | | [Form of Specimen Common Stock [removed: Certificate](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt)] [added: Certificate](https://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt)] | | | [removed: S-1, as amended] [added: S-1/A] (File No. 333-49932) | | | 1/17/2001 | | | 4.1 | | | | | | | | |
| [removed: [10.1A†](http://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] [added: [10.1A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] | | | [removed: [Registrant’s] [added: [Align Technology, Inc.] 2010 Employee Stock Purchase Plan (as amended and restated as of May 19, [removed: 2021)](http://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] [added: 2021)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] | | | 8-K | | | 5/20/2021 | | | 10.1 | | | | | | | | |
| [10.2†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm) | | | [removed: [Registrant's] [added: [Align Technology, Inc.] 2005 Incentive Plan (as [removed: amended](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm) [and restated](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm) [May 20](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)[23](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)[)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)] [added: amended and restated May 17, 2023)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)] | | | 8-K | | | 5/18/2023 | | | 10.1 | | | | | | | | |
| [removed: [10.3†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] [added: [10.3†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] | | | [Form of [removed: RSU agreement under Registrant's 2005] [added: RSU](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm) [A](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)[greement under](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm) [2005] Incentive Plan [removed: (Officer Form for] [added: (](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)[Officer Form](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm) [for] officers appointed after September [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] | | | 10-K | | | 2/28/2020 | | | 10.3 | | | | | | | | |
| [removed: [10.3A†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] [added: [10.3A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] | | | [Form of [removed: RSU agreement under Registrant's 2005] [added: RSU](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm) [A](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)[greement under](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm) [2005] Incentive Plan [removed: (Officer Form for] [added: (](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)[Officer Form](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm) [for] officers appointed prior to September [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] | | | 10-K | | | 2/28/2020 | | | 10.3A | | | | | | | | |
| [removed: [10.4†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] [added: [10.4†#](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex104.htm)] | | | [Form of RSU [removed: agreement (CEO)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] [added: Agreement (CEO)](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex104.htm)] | | | [removed: 10-K] | | | [removed: 2/28/2020] | | | [removed: 10.4] | | | | | | [added: *] | | |
| [removed: [10.5†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] [added: [10.5†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] | | | [Form of RSU [removed: agreement] [added: Agreement] under Registrant's 2005 Incentive Plan (Non-employee Director [removed: Form)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] [added: Form)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] | | | 10-K | | | 2/28/2020 | | | 10.5 | | | | | | | | |
| [10.6†](https://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex106-20181231.htm) | | | [Align 2019 [removed: Global RSU] [added: Global](https://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex106-20181231.htm) [RSU] Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex106-20181231.htm) | | | 10-K | | | 2/28/2019 | | | 10.6 | | | | | | | | |
| [removed: [10.7†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganrsuagreement.htm)] [added: [10.7†#](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex107.htm)] | | | [Form of Restricted Stock Unit Agreement under [removed: Registrant's] 2005 Incentive Plan (CEO [removed: Form)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganrsuagreement.htm)] [added: Form)](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex107.htm)] | | | [removed: 10-Q] | | | [removed: 5/5/2023] | | | [removed: 10.1] | | | | | | [added: *] | | |
| [10.8†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) | | | [Form [removed: of Restricted] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) [Restricted] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) [2005] Incentive Plan (Executive Officer Form for officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) | | | 10-Q | | | 5/5/2023 | | | 10.2 | | | | | | | | |
| [10.9†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) | | | [Form [removed: of Restricted] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) [Restricted] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) [2005] Incentive Plan (Executive Officer Form for officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) | | | 10-Q | | | 5/5/2023 | | | 10.3 | | | | | | | | |
| [removed: [10.10†](http://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] [added: [10.10†](https://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] | | | [Form of [removed: option award agreement] [added: Option Award Agreement] under [removed: registrant’s] [added: Registrant's] 2005 Incentive [removed: Plan](http://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] | | | 10-Q | | | 8/4/2005 | | | 10.4 | | | | | | | | |
| [10.11†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005 Incentive] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2005](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [I](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[ncentive] Plan (Officer Form for MSU awards granted in 2019, 2020 and 2022 to officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.8 | | | | | | | | |
| [removed: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[11](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)] [added: [10.11A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [2005] Incentive Plan (Officer Form for MSU awards granted in 2019, 2020 and 2022 to officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.8A | | | | | | | | |
| [removed: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)[12](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)] [added: [10.12†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) [2005] Incentive Plan (Officer Form for MSU awards granted in 2021 to officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) | | | 10-K | | | 2/26/2021 | | | 10.9 | | | | | | | | |
| [removed: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[12](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)] [added: [10.12A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) [2](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[005] Incentive Plan (Officer Form for MSU awards granted in 2021 to officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) | | | 10-K | | | 2/26/2021 | | | 10.9A | | | | | | | | |
| [removed: [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)[3](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)] [added: [10.13†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm) [Market] Stock [removed: Unit Agreement for] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm) [for] CEO (Focal grants)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.9 | | | | | | | | |
| [removed: [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)[4](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)] [added: [10.14†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) [2005] Incentive Plan (CEO Form](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)) | | | 10-Q | | | 5/5/2023 | | | 10.4 | | | | | | | | |
| [removed: [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)[5](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)] [added: [10.15†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Uni](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) [2005] Incentive Plan (Executive Officer Form for officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) | | | 10-Q | | | 5/5/2023 | | | 10.5 | | | | | | | | |
| [removed: [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)[6](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)] [added: [10.16†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)] | | | [Form [removed: of Market] [added: of](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) [Market] Stock [removed: Unit Agreement under Registrant's 2005] [added: Unit](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) [under](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) [Registrant's](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) [2005] Incentive Plan (Executive Officer Form for officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) | | | 10-Q | | | 5/5/2023 | | | 10.6 | | | | | | | | |
| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[7](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] [added: [10.17†](https://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] | | | [Form of Employment Agreement entered into by and between [removed: registrant] [added: Align Technology, Inc.] and each executive officer [removed: (other than CEO for executives] [added: (non-CEO Form) (for executive officers] appointed prior to September [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] | | | 10-Q | | | 5/8/2008 | | | 10.3 | | | | | | | | |
| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[8](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] [added: [10.18†](https://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] | | | [Form of Employment Agreement entered into by and between [removed: registrant] [added: Align Technology, Inc.] and each executive officer [removed: (other than CEO for executives] [added: (non-CEO Form) (for executive officers] appointed after September [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] | | | 10-K | | | 2/28/2017 | | | 10.8 | | | | | | | | |
| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[9](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] [added: [10.19†](https://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] | | | [Amended and Restated Chief Executive Officer Employment [removed: Agreement between] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[, dated](https://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm) [as of April 16, 2025,](https://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm) [between] Align Technology, Inc. and Joseph [removed: Hogan](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] [added: Hogan](https://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] | | | 10-Q | | | 5/1/2015 | | | 10.30 | | | | | | | | |
| [removed: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[20](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] [added: [10.20†](https://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] | | | [Employment [removed: Agreement] [added: Agreement, dated as of April 16, 2025,] between [removed: registrant] [added: Align Technology, Inc.] and John F. [removed: Morici (Chief Financial Officer)](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] [added: Morici](https://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] | | | 10-Q | | | 11/8/2016 | | | 10.2 | | | | | | | | |
| [removed: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[21](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[†](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] [added: [10.21†](https://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] | | | [removed: [Form] [added: .[Form] of Indemnification Agreement by and between [removed: registrant] [added: Align Technology, Inc.] and its Board of Directors and its executive [removed: officers](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] [added: officers](https://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] | | | [removed: S-1 as amended] [added: S-1/A] (File No. 333-49932) | | | 1/17/2001 | | | 10.15 | | | | | | | | |
| [removed: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[23](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] [added: [10.22](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] | | | [Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, [removed: 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] [added: 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] | | | 10-Q | | | 10/30/2020 | | | 10.1 | | | | | | | | |
| [removed: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)[24](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)] [added: [10.23](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)] | | | [First Amendment, dated April 21, 2022, to Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm) | | | 10-K | | | 2/27/2023 | | | 10.18 | | | | | | | | |
| [removed: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)[25](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)] [added: [10.24](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)] | | | [Second Amendment, dated December 23, 2022, to Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm) | | | 10-K | | | 2/27/2023 | | | 10.19 | | | | | | | | |
| Year Ended December 31, 2024 | | | | | | $ | 14,893 | | | | | $ | 8,282 | | | | | $ | (4,044) | | | | | $ | 19,131 | |
| Year Ended December 31, 2024 | | | | | | $ | 14,991 | | | | | $ | 4,399 | | | | | $ | — | | | | | $ | 19,390 | |
| [4.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex42.htm) | | | [Description of the Registered Securities of Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex42.htm) | | | | | | | | | | | | | | | * | | |
| [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000049/subscriptionagreement-hear.htm)[30](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000049/subscriptionagreement-hear.htm)[](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000049/subscriptionagreement-hear.htm) | | | [Subscription Agreement, dated as of April 22, 2024, between Align Technology, Inc. and Heartland Dental Holding Corporation](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000049/subscriptionagreement-hear.htm) | | | 10-Q | | | 8/2/2024 | | | 10.1 | | | | | | | | |
| [19.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex191.htm) | | | [A](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex191.htm)[lign Technology, Inc. Insider Trading Policy](https://www.sec.gov/Archives/edgar/data/1097149/000109714925000012/ex191.htm) | | | | | | | | | | | | | | | * | | |
| # | | | This corrected version of the exhibit supersedes the prior version previously filed with the SEC. | | |
| Year Ended December 31, 2021 | | | | | | $ | 10,239 | | | | | $ | 2,814 | | | | | $ | (3,808) | | | | | $ | 9,245 | |
| Year Ended December 31, 2021 | | | | | | $ | 1,325 | | | | | $ | 11,613 | | | | | $ | — | | | | | $ | 12,938 | |
| [4.2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm) | | | [Description of the Capital Stock of registrant](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 4.2 | | | | | | | | |
| [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm) | | | [Sale and Purchase Agreement between CETP III Ivory S.a.r.l., and Align Technology, Inc. and its indirect wholly owned German subsidiary, mertus 602.GmbH, dated March 3, 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm) | | | 10-Q | | | 5/5/2020 | | | 10.1 | | | | | | | | |
An excerpt. Shown here: 40 of 51 rewritten, all 6 added and all 4 removed. The counts are complete. For every sentence, read Item 15. Exhibit and Financial Statement Schedules. in the FY2024 filing and the FY2023 filing.
Item 16. Form 10-K Summary.
13 rewritten, 2 added, 1 removed, 37 unchanged
| Date: | | | February 28, [removed: 2024] [added: 2025] | | |
Morici, [added: jointly and severally,] his or her attorney-in-fact, [added: each] with the [added: full] power of substitution, for [removed: him or her] [added: such person] in any and all capacities, to sign any amendments to this Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.
| [removed: /S/] [added: /s/] JOSEPH M. HOGAN | | | | | | President, Chief Executive Officer and Director [removed: (Principal] [added: (*Principal] Executive [removed: Officer)] [added: Officer*)] | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] JOHN F. MORICI | | | | | | Chief Financial Officer and Executive Vice President, Global Finance [removed: (Principal] [added: (*Principal] Financial Officer and Principal Accounting [removed: Officer)] [added: Officer*)] | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] KEVIN T. CONROY | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] KEVIN J. DALLAS | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] JOSEPH LACOB | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] C. RAYMOND LARKIN, JR. | | | | | | [removed: Director] [added: Chairman of the Board] | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] GEORGE J. MORROW | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] ANNE M. MYONG | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] MOJDEH POUL | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] ANDREA L. SAIA | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
| [removed: /S/] [added: /s/] SUSAN E. SIEGEL | | | | | | Director | | | | | | February 28, [removed: 2024] [added: 2025] | | |
None.
POWER OF ATTORNEY
Not applicable.