Align Technology (ALGN) 10-K risk factor changes: FY2022 vs FY2021

[removed: The first, entitled “Risks Relating to our Business Operations and Strategy,”] [added: *The following] discusses some of the risks that may affect our business, results of operations and financial condition.

You should carefully review [removed: both sections,] [added: this section,] as well as our consolidated financial statements and notes thereto and other information appearing in this Annual Report on Form 10-K, for important information regarding these and other risks that may affect us.

[removed: *forward-looking] [added: These risk factors should be considered in connection with evaluating the forward-looking] statements contained in this report because they could cause our actual results and conditions to differ materially from those statements.

[removed: - Our] [added: Our] net revenues [removed: are dependent] [added: depend] primarily on our Invisalign system and iTero scanners and any decline in sales or average selling price of these [removed: products, for any reason,] [added: products] may adversely affect net revenues, gross margin and net [removed: income.][added: income.]

[removed: - Competition] [added: Competition] in the markets for our products is increasing and we expect aggressive competition from existing competitors, other companies that may introduce new technologies [added: or products] in the future and customers who alone or with others create orthodontic appliances and solutions or other products or services that compete with [removed: us.][added: us.]

[removed: - Our] [added: Our] success depends on our ability to [removed: develop,] successfully [added: develop,] introduce, achieve market acceptance of, and manage new products and [removed: services.][added: services.]

[removed: - As we continue to grow, we] [added: We] are subject to [removed: growth related] [added: operating] risks, including [removed: risks related to] excess or constrained capacity and operational [removed: inefficiencies at] [added: inefficiencies, which could adversely affect] our [removed: manufacturing and treat facilities.][added: results of operations.]

Issues with product development or enhancements, IT system integration, implementation, updates and upgrades [removed: along with security and data protection risks] have previously and could again in the future disrupt our [removed: operations, which could] [added: operations and] have a material [removed: adverse] impact on our business and operating [removed: results.][added: results.]

[removed: - If we are unable or fail to protect our customer or patient information] [added: Security breaches, data breaches, cyber attacks, other cybersecurity incidents] or [removed: if we are unable] [added: the failure] to comply with [removed: applicable] privacy, security and data protection [removed: laws,] [added: laws could materially impact] our [removed: operations may be severely adversely impacted,] [added: operations,] patient care could suffer, we could be liable for [removed: related] damages, and our business, operations and reputation could be [removed: harmed.][added: harmed.]

[removed: - Our] [added: Our] operating results have and will continue to fluctuate in the future, which makes predicting the timing and amount of [added: customer demand,] our revenues, costs and expenditures [removed: difficult.][added: difficult.]

[removed: - A] [added: A] disruption in the operations of a primary freight carrier, higher shipping costs or shipping delays could disrupt our supply chain and [removed: cause a decline in] [added: impact] our [removed: net] revenues or [removed: a reduction in our earnings.][added: gross margin.]

[removed: - Our] [added: Our] success depends in part on our proprietary technology, and if we fail to successfully obtain or enforce our intellectual property (“IP”) rights, our competitive position may be [removed: harmed.][added: harmed.]

[removed: - If we] [added: Litigation regarding our IP rights, rights claimed by third parties,] or [added: IP litigation by] any vendors on whose products or services we rely for our products and services [removed: infringe the patents or IP rights of other parties or are subject to a patent infringement claim,] [added: may impact] our ability to grow our [removed: business may be severely limited.][added: business, adversely impact our results of operations and adversely impact our reputation.]

[removed: - Obtaining approvals and complying with governmental regulations, particularly those related to personal healthcare information, financial information, quality systems and data privacy, is expensive and time-consuming, and any] [added: Any] failure to obtain or maintain approvals or comply with regulations regarding our products or services or the products and services of our suppliers or customers could materially harm our sales, result in substantial penalties and [added: fines and] cause harm to our [removed: reputation.][added: reputation.]

[removed: - We] [added: We] are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our business and operating results could be harmed if supply is restricted or [removed: ends] [added: ends,] or [added: if] the price of raw materials used in our manufacturing process [removed: increases.][added: increases.]

[removed: - We rely] [added: Our success depends largely] on [removed: highly skilled personnel and, if] [added: the talents and efforts of our personnel, and if] we [removed: fail] [added: are unable] to attract, motivate, train or retain [removed: highly skilled] [added: our] personnel, it may be more difficult to grow effectively and pursue our strategic [removed: priorities.][added: priorities, and could materially effect on our results of operations.]

[removed: - We] [added: We] use distributors for a portion of the importation, marketing and sales efforts related to our products and services, which exposes us to risks [removed: that may be harmful] to our sales and operations, including [added: the risk] that these distributors do not comply with applicable laws or our internal [removed: procedures.][added: procedures.]

[removed: - Compliance with] [added: Increased focus on] current [removed: or future] [added: and anticipated] environmental, [removed: social,] [added: social] and governance (“ESG”) laws [added: and increased scrutiny of our ESG policies and practices] may materially increase our costs, expose us to potential [removed: liability and otherwise materially] [added: liability, adversely] impact our [removed: business.][added: reputation, employee retention, willingness of customers and suppliers to do business with us and willingness of investors to invest in us.]

[removed: - We] [added: We] are required to annually assess our internal control over financial reporting and any adverse results from such assessment may result in a loss of investor confidence in our financial reports and [removed: have an adverse] [added: adversely] effect [removed: on] our stock [removed: price.][added: price.]

[removed: - If] [added: If] our goodwill or long-lived assets become impaired, we may be required to record a [removed: significant] [added: material] charge to [removed: earnings.][added: earnings.]

[removed: - New] [added: New] tax laws and [removed: practice,] [added: practices,] changes to existing tax laws and [removed: practice,] [added: practices,] or disputes regarding the positions we take regarding tax laws, could negatively affect our provision for income taxes as well as our ongoing [removed: operations.][added: operations.]

[removed: The broad and extensive impact of the COVID-19 pandemic on virtually all aspects of our business and society] [added: It] has exacerbated many pre-existing risks to our business by making them more likely to occur or more impactful when they do occur.

COVID-19 has created significant, widespread and unprecedented volatility, uncertainty, and economic instability, disrupting broad aspects of [removed: the] global [removed: economy,] [added: and regional economies,] our operations and the businesses of our customers and suppliers.

Many of these effects continue to varying [removed: degrees and further mutated] [added: degree as] variants [added: of COVID-19] and outbreaks globally or regionally continue to harm recovering consumer [removed: confidence and have led to renewed implementation of harsh preventative measures by local and regional governments and businesses.][added: confidence.]

Therefore, comparing our financial results for the reporting periods of [removed: 2021] [added: 2022] to the same reporting periods of [removed: 2020] [added: 2021] or [removed: 2019] [added: earlier] may not be a useful means by which to evaluate the health of our business and our results of operations.

As a result of [removed: the pandemic,] [added: outbreaks of COVID-19 and its variants,] customer demand and doctor availability has been inconsistent and difficult to predict.

Although the practices of the doctors, dental service organizations and labs that are our principal customers have largely [removed: reopened,] [added: reopened following the initial outbreak of COVID-19 in 2020,] many continue to operate at less than pre-pandemic capacities.

These fluctuations [added: are currently and] have [added: previously] adversely impacted our results of operations [removed: from time to time in the recent past] and are expected to continue to impact our results, particularly in the near term.

[removed: - data privacy and cybersecurity risks from new or expanded use of] [added: Expanded] remote working [removed: and/or teledentistry] [added: and increased usage of online and hosted technology platforms] by [added: us,] our [removed: suppliers, customers,] [added: customers] and [removed: us,] [added: suppliers,] including [added: teledentistry and] new or expanded use of online service platforms, products and solutions such as video conferencing applications, doctor, consumer and patient [removed: apps, inadequately secured computing networks, servers, software or software applications, overheard telephone conversations, viewable computer screens, stolen passwords or access information,] [added: apps have] increased [removed: phishing] [added: the demands on] and [removed: other cyber threats;][added: risks to our IT systems and personnel.]

The effects of the pandemic continue to linger and evolve and we cannot predict future direct and ancillary impacts on our business or results of operations, although they may [removed: have a] [added: be] material [removed: adverse effect on] [added: to] our [removed: business, financial condition, results of operations, cash flows and stock price] [added: business] as well as the businesses of our customers, suppliers and economic activity generally.

Our iTero [removed: scanners have become] [added: business also contributes] a material percentage of our overall [added: net] revenues.

[removed: Although exocad and its] [added: Our] CAD/CAM software solutions are important to the continuing evolution of [removed: the] [added: our] Align [removed: digital platform, the contributions to] [added: Digital Platform and] our [removed: total net revenues from the exocad solutions remain immaterial.][added: business overall.]

- consumers [removed: prove] [added: are] unwilling to adopt Invisalign system treatment as rapidly or in the volumes we anticipate and at the prices offered;

- sales of our iTero scanners decline or fail to grow sufficiently or as [removed: expected;][added: anticipated;]

- the growth of CAD/CAM solutions does not produce the results [removed: expected;] [added: anticipated;] or

Our average selling prices [added: for our Invisalign system and iTero scanners] have been impacted in the past and may be adversely affected again in the future if:

- we introduce new or change existing products or services, or modify how we market or sell any of our new or existing products or services; [removed: or]

[removed: While solutions such as our Invisalign system, iTero scanners and CAD/CAM] software facilitate this transition, whether our technologies will achieve market acceptance and, if adopted, whether and when they may become [removed: obsolete as new offerings become available] [added: obsolete,] remains unclear.

Currently, the Invisalign system competes [removed: directly] [added: primarily] against traditional metal wires and brackets and increasingly against clear aligners manufactured and distributed by new market entrants and manufacturers of traditional wires and brackets, both within and outside the U.S., and from traditional medical device companies, laboratories, startups and, in some cases, doctors and DSOs themselves.

They vary by segment, geography, and size, and include new and well-established regional [removed: competitors,] [added: competitors in dental markets,] as well as larger companies or divisions of larger companies with substantial sales, marketing, research [removed: financial capabilities,] and [removed: existing dental market channels.][added: financial capabilities.]

Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows, and prospects.

These risks are discussed more fully below and include, but are not limited to:

Macroeconomic and External Risks

- Global and regional economic conditions

- Major health crises

- Political events, international disputes, war and terrorism

- Natural disasters

Business and Industry Risks

- Changes in demand for our products

- Increased competition

- Failure of our new products, or changes to our existing products, to attract or retain consumers or generate revenue

- Our ability to successfully integrate our acquisitions

Operational Risks

- Business disruptions

- Predicting demand

- Availability of supplies

- Shipping delays

- Personnel development and retention

- Effectiveness of marketing and our ability to attract consumers

Legal, Regulatory and Compliance Risks

- Government investigations, enforcement actions, and settlements

- Our ability to comply with laws and regulatory and legislative mandates or guidance

- Privacy, cybersecurity and data protection

- Litigation, including class action lawsuits

Intellectual Property Risks

- Our ability to obtain, maintain, protect, and enforce our intellectual property rights

Financial, Tax and Accounting Risks

- Impairment of our goodwill

- Compliance with accounting, financial reporting, and tax laws

- Management of our stock plans

- Volatility of our stock

Macroeconomic and External Risks

Our operations and financial performance depend on global and regional economic conditions.

Inflation, fluctuations in currency exchange rates, changes in consumer confidence and demand, and weakness in general economic conditions and threats, or actual recessions, have and could in the future materially affect our business, results of operations, and financial condition.

Macroeconomic conditions impact consumer confidence and discretionary spending, which can adversely affect demand for our products.

The recent declines in, or uncertain economic outlooks for, the U.S., Chinese, European and certain other international economies has and may continue to adversely affect consumer and dental practice spending.

The increase in the cost of fuel and energy, food and other essential items along with climbing interest rates could reduce consumers' disposable income, resulting in less discretionary spending for products like ours.

Decreases in disposable income and discretionary spending or change in consumer confidence and spending habits has and may continue to adversely affect our revenues and operating results.

Inflation continues to adversely impact spending and trade activities and we are unable to predict the impacts of higher inflation on global and regional economies.

Higher inflation has also increased domestic and international shipping costs, raw material prices, and labor rates, which could adversely impact the costs of producing, procuring and shipping our products.

*The following discussion is divided into two sections.

The second, captioned “General Risk Factors,” discusses some of the risks that apply generally to companies and to owning our common stock, in particular.

These risk factors should be considered in connection with evaluating the*

The following is a summary of the risks that are more fully described below in this “Risk Factors” section:

Risks Relating to our Business Operations and Strategy

- Our results of operations have been materially adversely affected by global and regional efforts to mitigate the spread of COVID-19 and we expect this will continue in as yet unknown ways and to varying degrees as the virus evolves and circumstances dictate.

- An increasingly larger portion of our total revenues are derived from international sales and we are dependent on our international operations, which exposes us to foreign operational, political, military and other risks that may harm our business.

- Demand for our products may not increase as rapidly as we anticipate or may decrease due to a variety of factors, including changing consumer demand, inflation, weakness in general economic conditions, recessions and resistance to non-traditional treatment methods.

- Our products and information technology systems are critical to our business.

- If we fail to sustain or increase revenue growth while controlling expenses, our profitability may decline.

- If we fail to accurately predict our volume growth, hire too many or too few technicians, or manufacture too many or too few products, the delivery time for our products could be delayed or our costs may exceed our revenues, each of which could adversely affect our results of operations.

- We are dependent on our marketing activities to deepen our market penetration and raise awareness of our brand and products, which may not prove successful or may become less effective or more costly to maintain in the long term.

Litigating claims of this type is costly and could distract our management and cause a decline in our results of operations and stock price.

- Our business exposes us to potential liability for the quality and safety of our products and services, how we advertise and market those products and services and how and to whom we sell them, and we may incur substantial expenses or be found liable for substantial damages or penalties if we are subject to claims or litigation.

General Risk Factors

- We rely on our personnel and, if we fail to attract, motivate or retain personnel, or if our growth harms our corporate culture, it may be more difficult to grow effectively and pursue our strategic priorities.

- Business disruptions could seriously harm our financial condition.

- Changes in, or interpretations of, accounting rules and regulations, could result in unfavorable accounting charges.

- We are exposed to fluctuations in currency exchange rates and inflation, each of which could negatively affect our financial condition and 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.

- We have in the past and may again in the future invest in or acquire other businesses, products or technologies which may require significant management attention, disrupt our business, dilute stockholder value and adversely affect our results of operations.

- Historically, the market price for our common stock has been volatile.

- We cannot guarantee that we will continue to repurchase our common stock in the future, and any repurchases that we may make may not achieve our desired objectives.

- Future sales of significant amounts of our common stock may depress our stock price.

- Increased scrutiny of our ESG policies and practices have and will likely continue to result in additional costs and risks, and may adversely impact our reputation, employee retention, and willingness of customers and suppliers to do business with us.

Risks Relating to our Business Operations and Strategy

Our results of operations have been materially adversely affected by global and regional efforts to mitigate the spread of COVID-19 and we expect this will continue in as yet unknown ways and to varying degrees as the virus evolves and circumstances dictate.

In addition, new variants of the virus have caused unpredictable fluctuations in the number of patients seeking treatment and the number of doctors providing the services and

treatments.

While the pandemic increased demand for digital solutions such as the products and solutions we offer for the dental field, it is unclear whether increased demand for our products will continue.

For instance, if the use of video conferencing declines when employees return to office work environments or the availability of travel, dining, entertainment and other consumer spending categories rebound, demand for our products or the growth rates for our products may decline.

In response to the pandemic, in 2020 we implemented measures aimed at limiting its spread for the health and safety of our employees, customers, patients and the communities in which we live and work as well as in accordance with orders and decrees of governmental agencies.

These measures included diagnostic screenings at our facilities, increased social distancing mandates, closures of physical offices, manufacturing and treatment planning facilities, including our U.S. corporate headquarters and regional facilities worldwide, implementing remote working where feasible, and prohibiting non-essential travel.

Many of these actions remain in effect to varying degrees and we may implement new or revise existing measures as circumstances require.

The actions and reactions to voluntary and involuntary protective measures have been highly disruptive to our business and may continue to be disruptive.

The rules and regulations for reopening and operating our offices will likely increase in complexity, making compliance more difficult.

Furthermore, if employees perceive the protocols and requirements we implement to create a safe and effective work environment to be inadequate, overly burdensome or no longer necessary, or alternatively, if we require employees to return to the office when they prefer the safety or convenience of working from home, employees may choose to leave, productivity may decline or we may experience employee unrest, slowdowns, stoppages or other demands.

Additionally, we may fail to timely meet customer demand or fulfill orders, the costs to maintain or implement protective measures or deliver our products may increase, and we may be subject to increased litigation, including product liability and occupational safety and condition claims.

For further discussion or the risks related to employee satisfaction, retention and engagement see the risk factor “*We rely on our personnel and, if we fail to attract, motivate or retain personnel, or if our growth harms our corporate culture, it may be more difficult to grow effectively and pursue our strategic priorities.”*

A discussion regarding our financial condition and results of operations for fiscal [removed: 2021] [added: 2022] compared to fiscal [removed: 2020] [added: 2021] is presented under Results of Operations of this Form 10-K.

Discussions regarding our financial condition and results of operations for fiscal [removed: 2020] [added: 2021] compared to [removed: 2019] [added: 2020] have been omitted from this Annual Report on Form 10-K, but can be found in [removed: "Item] [added: *"Item] 7.

Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations"] [added: Operations"*] in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2020,] [added: 2021,] filed with the SEC on February [removed: 26, 2021,] [added: 25, 2022,] which is available without charge on the SEC's website at *www.sec.gov* and on our investor relations website at *investor.aligntech.com*.

Our business strategic priorities remain focused on four principal pillars [removed: of] [added: for] growth: (i) international expansion; (ii) GP adoption; (iii) patient demand and conversion; and (iv) orthodontic utilization.

[removed: We continue to invest] [added: - Continuing penetration and adoption of Invisalign products, intraoral scanners and CAD/CAM solutions] in [added: 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.

[removed: ◦announced plans to open an] [added: For instance, in 2022, we opened a new] aligner fabrication facility in Wroclaw, Poland as a part of our strategy to bring operational facilities closer to customers [removed: and thereby] [added: to] serve them more quickly and respond to their needs more effectively as well as new treatment planning operations in targeted regional [removed: geographies; and][added: geographies.]

- [removed: We continue to see] [added: Targeting] growth opportunities with international orthodontists and GP customers, particularly with adopters of digital dentistry platforms [removed: as we continue to tailor] [added: by tailoring] our sales and marketing [removed: strategies] [added: strategies, manufacturing operations] and resources around the [removed: unique needs of each customer channel.]

As we continue growing, we intend to opportunistically expand our research, development, manufacturing, treatment planning, [added: and] sales and marketing operations to meet local and regional demand thoughtfully and deliberately.

Over the longer-term, we expect international revenues to grow faster than Americas' revenues as a result of growing international demand, our continued investment in international market expansion, the size of the market opportunities and our relatively low market penetration [removed: of] [added: in] these regions.

- [removed: We believe our training and education efforts are important to building the] [added: Building] confidence within the GP and orthodontic communities [removed: needed] [added: through training and education efforts] to increase their adoption and utilization of [added: digital dental practice transformation and] clear aligner treatment.

Accordingly, we continue to expand our Invisalign customer base by educating new doctors on the benefits of digital dentistry through the Invisalign system and demonstrating to GPs and orthodontists how the iTero portfolio of intraoral scanners and CAD/CAM restorative services and workflows can increase [removed: the] [added: revenues and] profitability [removed: of] [added: for] their dental practices by enhancing patient [removed: experiences.][added: experiences and creating operation practice efficiencies.]

[removed: We need to continue] [added: - Investing in research and development that allows us] to innovate, develop and bring to market products and solutions that deliver the ever-increasing clinical precision and predictability [added: that] doctors expect with the speed and convenience their patients require.

- [removed: Patient] [added: Creating] demand and [added: enabling patient] conversion [removed: depends on making] [added: through] targeted investments in advertising and public relations through social media, influencers and other forms of digital communications to encourage [removed: patients to seek] treatment [removed: from] [added: by] Invisalign trained doctors.

We believe that well-designed, targeted sales and marketing promotions that build on our strong brand awareness [removed: and] allow us to differentiate our products and solutions from traditional and emerging competitors.

[removed: For instance, in 2021,] [added: In 2022,] we [removed: introduced] [added: continued to build on] the [added: success of the] “Invis-is” consumer advertising campaign with [removed: new] creative content and influencers focused on [removed: teens, moms] [added: teens] and young adults.

[removed: In addition, we are pursuing] [added: - Pursuing] new [added: product] lines [removed: of Consumer Products] that [removed: are complementary to] [added: complement] our doctor-prescribed principal products currently available in certain e-commerce [added: and retail] channels in the U.S. Similarly, in [removed: order] [added: 2023 we expect] to [added: continue to focus on our doctor subscription plan and] grow our [added: underpenetrated share of the] retainer [removed: business, which is significantly underpenetrated, we have begun investing more directly in] [added: business through strategic] marketing [removed: strategies] [added: campaigns] focused on driving adoption and increasing market share in the U.S.

- [removed: We expect] [added: Increasing] global orthodontic utilization rates [removed: to continue increasing overall] as doctors’ clinical confidence in the efficacy and predictability of the Invisalign system increases with advancements in products and technology and as patients and doctors demand treatments that emphasize convenience and safety through fewer [removed: in office] visits and less invasive and quicker [removed: treatments rise.][added: treatments.]

However, our utilization rates will fluctuate from period to period due to a variety of factors, which may include seasonal trends in our business, [added: consumer demand due to macroeconomic factors,] office closures or slowdowns related to [removed: COVID-19-related preventative measures and] [added: COVID-19-and] adoption rates for new products and features.

Further discussion of the impact of [removed: the COVID-19 pandemic] [added: these challenges] on our business may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading *“Risk Factors.”*

[removed: *Key financial] [added: Key Financial] and [removed: operating metrics*][added: Operating Metrics]

◦Revenues of [removed: $3,952.6] [added: $3,734.6] million, [removed: an increase] [added: a decrease] of [removed: 59.9%] [added: 5.5%] year-over-year;

*▪*Americas Clear Aligner revenues of [removed: $1,544.8] [added: $1,458.8] million, [removed: an increase] [added: a decrease] of [removed: 52.9%] [added: 5.6%] year-over-year;

▪International Clear Aligner revenues of [removed: $1,498.7] [added: $1,349.0] million, [removed: an increase] [added: a decrease] of [removed: 55.2%] [added: 10.0%] year-over-year;

▪Clear Aligner volume [removed: increase] [added: decrease] of [removed: 54.8%] [added: 7.4%] year-over-year and Clear Aligner volume [removed: increase] [added: decrease] for teenage patients of [removed: 47.3%] [added: 0.2%] year-over-year;

*◦*Income from operations of [removed: $976.4] [added: $642.6] million and operating margin of [removed: 24.7%;][added: 17.2%;]

◦Effective tax rate of [removed: 23.7%;][added: 39.6%;]

◦Net income of [removed: $772.0] [added: $361.6] million with diluted net income per share of [removed: $9.69;][added: $4.61;]

◦Cash, cash equivalents and marketable securities of [removed: $1,296.7] [added: $1,041.6] million as of December 31, [removed: 2021;][added: 2022;]

◦Operating cash flow of [removed: $1,172.5] [added: $568.7] million;

◦Capital expenditures of [removed: $401.1] [added: $291.9] million, predominantly related to increases in our manufacturing capacity and facilities; and

◦Number of employees was [removed: 22,540] [added: 23,165] as of December 31, [removed: 2021,] [added: 2022,] an increase of [removed: 24.7%] [added: 2.8%] year-over-year.

[removed: *Other] [added: Other] Statistical Data and [removed: Trends*][added: Trends]

[added: -] As of December 31, [removed: 2021,] [added: 2022,] over [removed: 12] [added: 14] million people worldwide have been treated with our Invisalign [removed: system, over 68,000 iTero scanners have been sold and over 47,000 exocad software licenses have been installed.][added: system.]

Management measures these results by comparing to the [removed: estimated 500 million] [added: millions of] people who can benefit from straighter [removed: teeth, 21 million annual orthodontic case starts and 2 million dental practices that could use intraoral scanners] [added: teeth] and uses this data to target opportunities to expand the market for orthodontics by educating consumers about the benefits of straighter teeth using the Invisalign [removed: system, dental professionals and/or labs and service providers to use iTero intraoral scanners, and dental labs and practitioners to install exocad CAD/CAM software.][added: system.]

- For the fourth quarter of [removed: 2021,] [added: 2022,] total Invisalign cases submitted with a digital scanner in the Americas increased to [removed: 89.1%,] [added: 92.5%,] up from [removed: 84.0%] [added: 89.1%] in the fourth quarter of [removed: 2020] [added: 2021] and international scans increased to [removed: 80.8%,] [added: 86.8%,] up from [removed: 73.7%] [added: 80.8%] in the fourth quarter of [removed: 2020.][added: 2021.]

For the fourth quarter of [removed: 2021, 96.4%] [added: 2022, 97.4%] of Invisalign cases submitted by North American orthodontists were submitted digitally.

[removed: ][added: ]

Latin America (“LATAM”) is excluded from the International region based on its immateriality to the [removed: year,] [added: year;] however is included in the Total utilization.

- [removed: Total] [added: The total] utilization rate in [removed: 2021 increased to 20.8] [added: 2022 was 18.9] cases per doctor compared to [removed: 16.1] [added: 20.8] cases per doctor in [removed: 2020] [added: 2021] and [removed: 15.9] [added: 16.1] cases per doctor in [removed: 2019.][added: 2020.]

- *North America:* [removed: Utilization] [added: The utilization] rate among our North American orthodontist customers [removed: increased to 98.1] [added: was 89.2] cases per doctor in [removed: 2021] [added: 2022] compared to [removed: 67.3] [added: 98.1] cases per doctor in [removed: 2020] [added: 2021] and [removed: 65.0] [added: 67.3] cases per doctor in [removed: 2019] [added: 2020] and the utilization rate among our North American GP customers [removed: increased to 14.3] [added: was 13.9] cases per doctor in [removed: 2021] [added: 2022] compared to [removed: 9.6] [added: 14.3] cases per doctor in [removed: 2020] [added: 2021] and [removed: 9.5] [added: 9.6] cases per doctor in [removed: 2019.][added: 2020.]

Our growth strategy depends on our ability to facilitate the digital transformation of dentistry happening around the world, our continuous focus on innovation, and expansion to meet and exceed evolving customer expectations as the array of products and services available to them increases.

We also diversified our research and development activities throughout Europe in 2022, which has created a longer term, more stable environment for consistent hiring, retention and innovation in a variety of high technology sectors.

unique needs of each customer channel.

*Macroeconomic Challenges and Military Conflict in Ukraine*

Our revenues are susceptible to fluctuations in macroeconomic conditions, in line with inflation, rising interest rates, threats of or actual recessions, fluctuations in currency exchange rates, supply chain challenges, market volatility, wars and military actions, and other factors, each of which impact customer confidence, consumer sentiment and demand.

Many of these same factors are also impacting our costs through higher raw material prices, transportation costs, labor costs, supply and distribution operations and the operations of our suppliers.

Additionally, many of our international operations are denominated in currencies other than the U.S. dollar and in 2022 were impacted, and may continue to be impacted, by macroeconomic slowing or contraction causing weakening against the U.S. dollar, which is negatively impacting our financial condition and results of operations.

While we expect moderation of the strength of the dollar, we also expect the dollar to remain historically strong against many of these currencies.

The nature and extent of the impact of these factors varies by time and region and remains uncertain and unpredictable.

The military conflict between Russia and Ukraine increased the unpredictability of the already uncertain macroeconomic conditions during 2022 and may continue to impact this unpredictability.

While we continue to employ research and development personnel in Russia as well as certain sales, marketing and administrative personnel, the total number of employees in Russia was significantly reduced in 2022, complementing programs previously underway aimed at maintaining and growing our research and development operations and diversifying the facilities at which our personnel are located.

Although immaterial to our consolidated financial statements, our commercial business operations in Russia were significantly impacted by the conflict in 2022.

Although we remain committed to providing continuity of care consistent with our values and ethical responsibility to patients who are in Invisalign treatment in Russia, we deemed it prudent to align the size of our commercial operations with the ongoing resources needed to perform those functions.

Accordingly, in the fourth quarter of 2022, we initiated a restructuring plan to increase efficiencies across the organization and lower our overall cost structure, which reduced the number of employees and our commercial business operations in Russia.

Refer to *Note 16 “Restructuring and Other Charges*” *of the Notes to Consolidated Financial Statements* for further details.

Our Board of Directors and its applicable committees receive regular updates from management regarding the military conflict between Russia and Ukraine and continue to provide oversight of the risks to our personnel, operations and other areas of strategic importance.

Our management continues to closely monitor the situation and evaluate additional ways in which we can support our employees and operations.

Although there remains significant uncertainty surrounding the COVID-19 pandemic for regional economies, its global impact has gradually declined.

During 2022, we experienced the impacts of the COVID-19 pandemic primarily in the Asia Pacific region, particularly in China, where lockdowns decreased economic activity throughout most of the year.

With the easing of the restrictions in China in 2023 and the increased rate of infections, the impacts of the COVID-19 pandemic are likely to persist into 2023 and remain unpredictable, but we expect it to be at a lesser extent than in 2022.

Nevertheless, comparing our financial results for the reporting periods of 2023 to the same reporting periods of 2022 or earlier may not be a useful means by which to evaluate our business and results of operations due to volatility in regional business environments caused by the pandemic.

*Changing Product Preferences*

As the markets for clear aligners and digital processes and workflows used to transform the practice of dentistry continue to mature, we anticipate customer and patient expectations and demands will evolve.

We expect to meet customer demands with innovative treatment options that include more choices to address a wider scope of treatment goals and budgets based on our existing and new products.

This may result in larger and unpredictable variations in geographic and product mix and selling prices with uncertain implications on our financial statements and business operations.

We strive to manage the challenges from the macroeconomic conditions, the conflict in Ukraine, COVID-19 and the evolution of our target markets by focusing on improving our operations, building flexibility and efficiencies in our processes, adjusting our business models to changing circumstances and offering products that meet market demand.

Specifically, we are managing cost impacts through pricing actions, implementing cost saving measures and slowing hiring.

We also continue to innovate and introduce new and enhanced products that augment our doctor customer and patient experiences.

For the year ended December 31, 2022, our business operations reflect the following:

◦Clear Aligner revenues of $3,072.6 million, a decrease of 5.4% year-over-year;

◦Imaging Systems and CAD/CAM Services revenues of $662.1 million, a decrease of 6.2% year-over-year;

Our utilization rates have declined in 2022 due to the macroeconomic conditions, COVID-19 impacts, and other factors as described in the Trends and Uncertainties section above.

In general, we expect utilization rates to rise over time although they are likely to fluctuate from period to period.

Our International region includes Europe, Middle East and Africa (“EMEA”) and Asia Pacific (“APAC”).

We also offer in the U.S. and Canada, a Doctor Subscription Program which is a monthly subscription program based on the doctor’s monthly need for retention or limited treatment.

The program allows doctors the flexibility to order both “touch-up” or retention aligners within their subscribed tier and is designed for a segment of experienced Invisalign trained doctors who are currently not regularly using our retainers or low-stage aligners.

Total net revenues decreased by $217.9 million in 2022 as compared to 2021, primarily due to unfavorable foreign exchange rates, a decrease in both Clear Aligner case volumes and scanner volumes, partially offset by increases in Clear Aligner non-case revenues, service revenues and an increase in Clear Aligner average selling price (“ASP”).

Higher ASP was mainly due to processing fees charged on most shipments and price increases in certain markets which increased net revenues by $54.2 million along with lower net deferrals which increased net revenues by $34.5 million.

International net revenues decreased by $149.7 million in 2022 as compared to 2021 due to a 5.0% decrease in case volumes, which decreased net revenues by $75.1 million, and lower ASP, which decreased net revenues by $74.6 million.

Lower ASP was largely due to unfavorable foreign exchange rates which resulted in lower net revenues of $150.6 million, a product mix shift to lower priced products which decreased net revenues by $60.5 million, and unfavorable promotional discounts which decreased net revenues $39.4 million.

- Our growth depends on the continued penetration and adoption of Invisalign products, intraoral scanners and CAD/CAM solutions in international markets.

For instance, in 2021, we:

◦opened new offices in Israel to support the long-term growth of iTero scanner and services business for treatment planning and other operations;

◦expanded our sales and marketing efforts into new countries and regions, including establishing offices in the African countries of Ghana and Morocco.

However, training and education alone are insufficient to drive adoption and utilization growth sufficiently.

For this reason, we expect to continue to invest in research and development and open facilities closer to our customers and their patients to timely and conveniently support them.

Accordingly, we continue to increase investments intended to grow consumer demand.

Refer to “*COVID-19 Pandemic Update*” below for further details.

- To achieve these strategic pillars, we expect to continue hiring skilled employees in our clinical engineering, technology development, manufacturing, sales and management teams.

Expanding our workforce will require that we offer competitive compensation and result in increasing costs which we expect to offset with increasing revenues.

The COVID-19 pandemic continues to cause significant volatility and uncertainty in the global and regional economies, leading to changes in consumer and business behavior, fear and market fluctuations, materials and product shortages and restrictions on business and individual activities, all of which is materially impacting supply and demand in broad sectors of the world markets.

During 2021, many businesses and countries, including the U.S., continued imposing preventative and precautionary measures to mitigate the spread of the virus and its variants.

As a result of the restrictive measures imposed, the

demand for digital solutions has increased.

Society and businesses continue to adapt to practices such as social distancing and remote working that further the need for greater flexibility and convenience of digital solutions.

Our efforts to promote the digital transformation of dental practices with our clear aligners, intraoral scanners, clinical treatment planning and other offerings has allowed us to quickly respond to fluctuating demands in the dental field in various regions.

Consequently, despite the economic challenges caused by the pandemic, our revenue grew by 59.9% in 2021 compared to 2020.

The growth was a combination of non-COVID related increases as well as lower revenues in 2020 as the initial preventative measures to combat the spread of the virus resulted in significant office closures and materially reduced operating capacities for many of our customers.

Our overall business performance has been strong, and we believe the digital transition to dentistry that began before the pandemic will continue to be positive for our business, results of operations, cash flows, and financial condition, although we intend to adjust spending to coincide with the fluctuating pace of recovery and changes in demand.

As such, our recent operating results and levels of growth may not be indicative of our future performance.

The continuing evolution of the pandemic remains highly fluid and unpredictable, including the setbacks occurring as a result of new virus strains and new or additional operating restrictions imposed on businesses, supply chain shortages and delays, the positive impacts of vaccinations, the uncertainties regarding consumer spending as demand for entertainment, dining, and travel returns and remote working diminishes.

Our top priority continues to be the health and safety of our employees and their families, our customers and their staff.

In addition, new variants of the virus have caused unpredictable fluctuations in the number of patients seeking treatment and the number of doctors providing the services and treatments.

These fluctuations have adversely impacted our results of operations from time to time in the recent past and are expected to continue to impact our results, particularly in the near term.

We continue to follow recommended safety measures, including encouraging employees to work from home when possible, suspending non-essential work travel, and implementing various access controls at our facilities.

In order to overcome the supply chain shortages and delays, we are also proactively communicating with our suppliers and distributors and modifying our purchase order commitments to mitigate the risks of supply chain interruptions and maintaining inventory levels greater than historically required.

For the year ended December 31, 2021, we achieved the following, taking into consideration that percentage changes from prior year financial results include the impact of COVID-19 and do not necessarily reflect our future growth rates:

◦Clear Aligner revenues of $3,247.1 million, an increase of 54.5% year-over-year reflecting the expanding opportunity for Invisalign system treatment among adults globally, as well as the underlying orthodontic market as we continue to build awareness of the Invisalign brand and drive utilization among teens and younger patients through increased consumer marketing.

◦Imaging Systems and CAD/CAM Services revenues of $705.5 million, an increase of 90.4% year-over-year reflecting strong growth across all regions with continued adoption of the iTero Element 5D and 5D Plus Series of next generation scanners and imaging systems launched in February 2021, as well as increased average selling prices (“ASP”) predominately due to favorable product mix shift towards higher priced scanners;

- Our primary goal is to establish clear aligners as the principal solution for the treatment of malocclusions and our Invisalign system as the treatment solution of choice by orthodontists, GPs and patients globally, our intraoral scanning platform as the preferred scanning protocol for digital dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.

Our annual utilization rates for the last three fiscal years are as follows:

Our International region includes EMEA, APAC.

Total net revenues increased by $1,480.6 million in 2021 as compared to 2020 primarily as a result of increases in Clear Aligner volume of 54.8% and an increase in the number of scanners recognized across most regions.

$47.7 million.

Lower ASP was mostly due to higher promotional discounts which decreased revenue by $52.1 million and net deferrals which decreased revenues by $40.3 million.

The decreases in ASP were partially offset by favorable product mix shift which increased net revenues by $34.2 million and favorable exchanges rates which increased net revenues by $12.2 million.

International net revenues increased by $533.2 million in 2021 as compared to 2020 primarily due to a 51.6% increase in volume which resulted in higher net revenues by $497.8 million.

Higher ASP increased net revenues by $35.4 million mostly due to favorable exchange rates which increased net revenues by $61.8 million and favorable product mix shift which increased net revenues by $27.6 million.

Net revenues also increased by $97.7 million as a result of higher iTero service revenues mostly due to a larger scanner install base and additional exocad CAD/CAM revenues.

Additionally, higher scanner ASP increased net revenues by $51.0 million mostly due to favorable product mix shift towards higher priced scanners such as the iTero Element Plus Series.

In the normal course of business, we are exposed to [added: interest rate,] foreign currency exchange [removed: rate] and [removed: interest rate] [added: inflation] risks that could impact our financial position and results of operations.

In addition, we are subject to the broad market risk that is created by the global market disruptions and uncertainties resulting from [added: macroeconomic challenges,] the [added: military conflict between Russia and Ukraine and the] COVID-19 pandemic.

Further discussion [removed: of the impact of the COVID-19 pandemic] on [removed: our business] [added: these risks] may be found in *Item 1A* of this Annual Report on Form 10-K under the heading *“Risk Factors”*.

As of December 31, [removed: 2021,] [added: 2022,] we had approximately [removed: $197.3] [added: $99.5] million invested in available-for-sale marketable securities.

As a result of our international business activities, our financial results [removed: could be] [added: have been] affected by factors such as changes in foreign currency exchange rates [removed: or] [added: as well as] economic conditions in foreign markets, and there is no assurance that exchange rate fluctuations will not harm our business in the future.

We [removed: primarily] enter into foreign currency forward contracts [added: for currencies where we have exposures, primarily the Euro, Chinese Yuan, Polish Zloty and Canadian Dollar,] to minimize the short-term impact of foreign currency exchange rate fluctuations on cash and certain trade and intercompany receivables and payables.

These [added: forward contracts are not designated as hedging] instruments [added: and] are [added: generally one month in original maturity and are] marked to market through earnings every [removed: period and generally are one month in original maturity.][added: period.]

As of December 31, 2022, we are not subject to risks from immediate interest rate increases on our unsecured revolving line of credit facility.

*Military Conflict between Russia and Ukraine*

Beginning 2022, the military conflict between Russia and Ukraine has continued to escalate and create challenges to already uncertain macroeconomic conditions.

As of December 31, 2022, we do not expect these events to have any material impact on our operations.

Our Russia net revenues as a percentage of our consolidated net revenues and our assets domiciled in Russia, including cash and cash equivalents, as a percentage of our total assets, are immaterial.

Inflation Risk

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 globally, and which we expect will continue into the foreseeable future.

If our costs become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases.

There can be no assurance that our results of operations and financial condition will not be materially impacted by inflation in the future.

Based on interest bearing liabilities we have as of December 31, 2021, we are not subject to risks from immediate interest rate increases.

Regardless of this natural hedging, our results of operations may be adversely impacted by exchange rate fluctuations.

These forward contracts are not designated as hedging instruments and do not subject us to material balance sheet risk due to fluctuations in foreign currency exchange rates.

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, iTero® intraoral scanners and services for dentistry, and exocad® computer-aided design and computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners.

We also market and sell consumer products that are complementary to our doctor-prescribed principal products under the Invisalign and other brands, including retainers, aligner cases (clamshells), teeth whitening products and cleaning solutions (crystals, foam and other material) (collectively “Consumer Products”).

Our primary goals are to establish clear aligners as the principal solution for the treatment of malocclusions, or the misalignment of teeth, and our Invisalign system as the treatment solution of choice by orthodontists, general dental practitioners and patients globally, our intraoral scanners as the

preferred scanning technology for digital dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.

Align’s corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85281.

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, 2021, Clear Aligner net revenues represented approximately 82% of worldwide net revenues, while Systems and Services net revenues represented the remaining 18%.

We sell the majority of our products directly through a dedicated and specialized sales force to our customers: orthodontists, general practitioner dentists (“GPs”), restorative and aesthetic dentists, including prosthodontists, periodontists, and 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, and we sell products used by dental laboratories who manufacture or customize a variety of products used by licensed dentists to provide oral health care.

We sell our Consumer Products online through our corporate website and large e-commerce websites.

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 that they expect and the results patients desire.

To date, over 12 million people worldwide have been treated with our Invisalign system.

We received 510(k) clearance from the United States (“U.S.”) Food and Drug Administration (“FDA”) to market the Invisalign system in 1998.

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.

To date, over 68,000 iTero scanners have been sold.

We received 510(k) clearance in the U.S. for the caries detection feature of the iTero Element 5D in 2020.

Our Systems and Services products, which includes our iTero intraoral scanners, are primarily sold through our direct sales force and through sales agents and distributors in certain countries and directly to DSOs.

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, paving the way for new, cross-disciplinary dentistry in labs and at chairside.

There are over 200 exocad strategic distribution partners and over 47,000 software licenses installed worldwide.

Clear Aligner Segment

*Malocclusion and Traditional Orthodontic Treatment*

Malocclusion is one of the most prevalent clinical dental conditions, affecting approximately 60% to 75% of the global population.

Annually, approximately 21 million people globally elect treatment by orthodontists.

Today, most orthodontic patients continue to have their malocclusions treated with the use of traditional methods such as metal arch wires and brackets, referred to as braces, augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary devices as needed.

Upon completion of the treatment, the dental professional may recommend the patient use a retainer appliance.

Of the 21 million cases started, we estimate that approximately 90% or 19 million could be treated using our Invisalign system.

In addition, globally approximately 500 million people with malocclusion could benefit from straightening their teeth.

This represents a significant opportunity for us as we expand the market for orthodontics by training more doctors, including GPs as well as orthodontists, educating more consumers about the benefits of straighter teeth using the Invisalign system and connecting consumers with an Invisalign-trained doctor of their choice.

*The Invisalign system*

The Invisalign system is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear polymer removable aligners.

The Invisalign system offers a range of treatment options, specialized services, and access to proprietary software for treatment visualization and is comprised of the following phases:

*Diagnosis and transmission of treatment data*.

An Invisalign trained dental professional prepares an online prescription form on our Invisalign Doctor Site and submits the patient's records, which include a digital intraoral scan or a polyvinyl-siloxane (“PVS”) impression of the relevant dental arches, photographs of the patient and, at the dental professional’s election, x-rays of the patient’s dentition.

[removed: *For] [added: For] a discussion of legal proceedings, refer to [removed: Note 10] [added: *Note 7] "Legal Proceedings" of the Notes to Consolidated Financial [removed: Statements] [added: Statements*] in Part II, Item 8 of this Form [removed: 10-K.*][added: 10-K.]

[removed: For] [added: For] the fiscal year ended December 31, [removed: 2021][added: 2022]

[removed: For] [added: For] the transition period from [removed: to][added: to]

[removed: Commission] [added: Commission] file number: [removed: 000-32259][added: 000-32259]

[removed: (Exact] [added: (Exact] name of registrant as specified in its [removed: charter)][added: charter)]

| [removed: (State] [added: (State] or other jurisdiction of incorporation or [removed: organization)] [added: organization)] | | | [removed: (I.R.S.] [added: (I.R.S.] Employer Identification [removed: Number)] [added: Number)] | | |

Tempe, Arizona [removed: 85281][added: 85288]

[removed: (Address] [added: (Address] of principal executive [removed: offices)][added: offices, including zip code)]

[removed: (Registrant’s] [added: (Registrant’s] telephone number, including area [removed: code)][added: code)]

[removed: Securities] [added: Securities] registered pursuant to Section 12(b) of the [removed: Act:][added: Act:]

| [removed: Title] [added: Title] of each [removed: class] [added: class] | | | [removed: Trading Symbol] [added: Trading Symbol(s)] | | | [removed: Name] [added: Name] of each exchange on which [removed: registered] [added: registered] | | |

| | | | | | | (NASDAQ Global [added: Select] Market) | | |

[removed: Securities] [added: Securities] registered pursuant to Section 12(g) of the Act: [removed: None][added: None]

| 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 [removed: 7(a)(2)(B)] [added: 13(a)] of the Securities Act. ☐ | | | | | | | | | | | |

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $34.7] [added: $13.3] billion as of June 30, [removed: 2021] [added: 2022] based on the closing sale price of the registrant’s common stock on the NASDAQ Global Market on such date.

On February [removed: 21, 2022, 78,795,494] [added: 20, 2023, 76,610,319] shares of the registrant’s common stock were outstanding.

Portions of the registrant’s definitive Proxy Statement relating to its [removed: 2022] [added: 2023] Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end of December 31, [removed: 2021] [added: 2022] are incorporated by reference into Part III of this Annual Report on Form 10-K.

For the Year Ended December 31, [removed: 2021][added: 2022]

| Item 1. | | | [removed: [Business](#if1d94140443e4bd999abda4b2e587ec9_13)] [added: [Business](#i2704b576f8bf446aa18dd6265ae58c92_13)] | | | [removed: [3](#if1d94140443e4bd999abda4b2e587ec9_13)] [added: [3](#i2704b576f8bf446aa18dd6265ae58c92_13)] | | |

[removed: | | | | [Information] [added: Information] about our Executive [removed: Officers](#if1d94140443e4bd999abda4b2e587ec9_16) | | | [16](#if1d94140443e4bd999abda4b2e587ec9_16) | | |][added: Officers]

| Item 1A. | | | [Risk [removed: Factors](#if1d94140443e4bd999abda4b2e587ec9_19)] [added: Factors](#i2704b576f8bf446aa18dd6265ae58c92_19)] | | | [removed: [16](#if1d94140443e4bd999abda4b2e587ec9_19)] [added: [19](#i2704b576f8bf446aa18dd6265ae58c92_19)] | | |

| Item 1B. | | | [Unresolved Staff [removed: Comments](#if1d94140443e4bd999abda4b2e587ec9_22)] [added: Comments](#i2704b576f8bf446aa18dd6265ae58c92_22)] | | | [removed: [38](#if1d94140443e4bd999abda4b2e587ec9_22)] [added: [37](#i2704b576f8bf446aa18dd6265ae58c92_22)] | | |

| Item 2. | | | [removed: [Properties](#if1d94140443e4bd999abda4b2e587ec9_25)] [added: [Properties](#i2704b576f8bf446aa18dd6265ae58c92_25)] | | | [removed: [39](#if1d94140443e4bd999abda4b2e587ec9_25)] [added: [38](#i2704b576f8bf446aa18dd6265ae58c92_25)] | | |

| Item 3. | | | [Legal [removed: Proceedings](#if1d94140443e4bd999abda4b2e587ec9_28)] [added: Proceedings](#i2704b576f8bf446aa18dd6265ae58c92_28)] | | | [removed: [39](#if1d94140443e4bd999abda4b2e587ec9_28)] [added: [38](#i2704b576f8bf446aa18dd6265ae58c92_28)] | | |

| Item 4. | | | [Mine Safety [removed: Disclosures](#if1d94140443e4bd999abda4b2e587ec9_31)] [added: Disclosures](#i2704b576f8bf446aa18dd6265ae58c92_31)] | | | [removed: [39](#if1d94140443e4bd999abda4b2e587ec9_31)] [added: [38](#i2704b576f8bf446aa18dd6265ae58c92_31)] | | |

| Item 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#if1d94140443e4bd999abda4b2e587ec9_37)] [added: Securities](#i2704b576f8bf446aa18dd6265ae58c92_37)] | | | [removed: [40](#if1d94140443e4bd999abda4b2e587ec9_37)] [added: [39](#i2704b576f8bf446aa18dd6265ae58c92_37)] | | |

| Item 6. | | | [removed: [\[Reserved\]](#if1d94140443e4bd999abda4b2e587ec9_40)] [added: [\[Reserved\]](#i2704b576f8bf446aa18dd6265ae58c92_40)] | | | [removed: [41](#if1d94140443e4bd999abda4b2e587ec9_40)] [added: [40](#i2704b576f8bf446aa18dd6265ae58c92_40)] | | |

| Item 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#if1d94140443e4bd999abda4b2e587ec9_43)] [added: Operations](#i2704b576f8bf446aa18dd6265ae58c92_43)] | | | [removed: [41](#if1d94140443e4bd999abda4b2e587ec9_43)] [added: [40](#i2704b576f8bf446aa18dd6265ae58c92_43)] | | |

| Item 7A. | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#if1d94140443e4bd999abda4b2e587ec9_82)] [added: Risk](#i2704b576f8bf446aa18dd6265ae58c92_88)] | | | [removed: [52](#if1d94140443e4bd999abda4b2e587ec9_82)] [added: [52](#i2704b576f8bf446aa18dd6265ae58c92_88)] | | |

| Item 8. | | | [Financial Statements and Supplementary [removed: Data](#if1d94140443e4bd999abda4b2e587ec9_85)] [added: Data](#i2704b576f8bf446aa18dd6265ae58c92_91)] | | | [removed: [54](#if1d94140443e4bd999abda4b2e587ec9_85)] [added: [54](#i2704b576f8bf446aa18dd6265ae58c92_91)] | | |

| Item 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#if1d94140443e4bd999abda4b2e587ec9_175)] [added: Disclosure](#i2704b576f8bf446aa18dd6265ae58c92_181)] | | | [removed: [92](#if1d94140443e4bd999abda4b2e587ec9_175)] [added: [90](#i2704b576f8bf446aa18dd6265ae58c92_181)] | | |

| Item 9A. | | | [Controls and [removed: Procedures](#if1d94140443e4bd999abda4b2e587ec9_178)] [added: Procedures](#i2704b576f8bf446aa18dd6265ae58c92_184)] | | | [removed: [92](#if1d94140443e4bd999abda4b2e587ec9_178)] [added: [90](#i2704b576f8bf446aa18dd6265ae58c92_184)] | | |

| Item 9B. | | | [Other [removed: Information](#if1d94140443e4bd999abda4b2e587ec9_181)] [added: Information](#i2704b576f8bf446aa18dd6265ae58c92_187)] | | | [removed: [93](#if1d94140443e4bd999abda4b2e587ec9_181)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_187)] | | |

| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#if1d94140443e4bd999abda4b2e587ec9_1099511629825)] [added: Inspections](#i2704b576f8bf446aa18dd6265ae58c92_190)] | | | [removed: [93](#if1d94140443e4bd999abda4b2e587ec9_1099511629825)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_190)] | | |

| Item 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#if1d94140443e4bd999abda4b2e587ec9_187)] [added: Governance](#i2704b576f8bf446aa18dd6265ae58c92_196)] | | | [removed: [93](#if1d94140443e4bd999abda4b2e587ec9_187)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_196)] | | |

| Item 11. | | | [Executive [removed: Compensation](#if1d94140443e4bd999abda4b2e587ec9_190)] [added: Compensation](#i2704b576f8bf446aa18dd6265ae58c92_199)] | | | [removed: [93](#if1d94140443e4bd999abda4b2e587ec9_190)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_199)] | | |

| Item 12. | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#if1d94140443e4bd999abda4b2e587ec9_193)] [added: Matters](#i2704b576f8bf446aa18dd6265ae58c92_202)] | | | [removed: [94](#if1d94140443e4bd999abda4b2e587ec9_193)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_202)] | | |

| Item 13. | | | [Certain Relationships and Related Transactions and Director [removed: Independence](#if1d94140443e4bd999abda4b2e587ec9_196)] [added: Independence](#i2704b576f8bf446aa18dd6265ae58c92_205)] | | | [removed: [94](#if1d94140443e4bd999abda4b2e587ec9_196)] [added: [91](#i2704b576f8bf446aa18dd6265ae58c92_205)] | | |

| Item 14. | | | [Principal [removed: Account](#if1d94140443e4bd999abda4b2e587ec9_199)[ant](#if1d94140443e4bd999abda4b2e587ec9_199) [Fees] [added: Accountant Fees] and [removed: Services](#if1d94140443e4bd999abda4b2e587ec9_199)] [added: Services](#i2704b576f8bf446aa18dd6265ae58c92_208)] | | | [removed: [94](#if1d94140443e4bd999abda4b2e587ec9_199)] [added: [92](#i2704b576f8bf446aa18dd6265ae58c92_208)] | | |

| Item 15. | | | [removed: [Exhibits](#if1d94140443e4bd999abda4b2e587ec9_205) [and](#if1d94140443e4bd999abda4b2e587ec9_205) [Financial] [added: [Exhibits and Financial] Statement [removed: Schedules](#if1d94140443e4bd999abda4b2e587ec9_205)] [added: Schedules](#i2704b576f8bf446aa18dd6265ae58c92_214)] | | | [removed: [95](#if1d94140443e4bd999abda4b2e587ec9_205)] [added: [93](#i2704b576f8bf446aa18dd6265ae58c92_214)] | | |

| Item 16. | | | [Form 10-K [removed: Summary](#if1d94140443e4bd999abda4b2e587ec9_208)] [added: Summary](#i2704b576f8bf446aa18dd6265ae58c92_217)] | | | [removed: [97](#if1d94140443e4bd999abda4b2e587ec9_208)] [added: [95](#i2704b576f8bf446aa18dd6265ae58c92_217)] | | |

or

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

| [PART I](#i2704b576f8bf446aa18dd6265ae58c92_10) | | | | | | [3](#i2704b576f8bf446aa18dd6265ae58c92_10) | | |

| | | | [Information about our Executive Officers](#i2704b576f8bf446aa18dd6265ae58c92_16) | | | [19](#i2704b576f8bf446aa18dd6265ae58c92_16) | | |

| [PART II](#i2704b576f8bf446aa18dd6265ae58c92_34) | | | | | | [39](#i2704b576f8bf446aa18dd6265ae58c92_34) | | |

| [PART III](#i2704b576f8bf446aa18dd6265ae58c92_193) | | | | | | [91](#i2704b576f8bf446aa18dd6265ae58c92_193) | | |

| [PART IV](#i2704b576f8bf446aa18dd6265ae58c92_211) | | | | | | [93](#i2704b576f8bf446aa18dd6265ae58c92_211) | | |

| [Signatures](#i2704b576f8bf446aa18dd6265ae58c92_220) | | | | | | [96](#i2704b576f8bf446aa18dd6265ae58c92_220) | | |

These statements may contain words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” or other words indicating future results.

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”), Vivera® retainers for retention, iTero® intraoral scanners and services for dentistry, and exocad® 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 and consumers, orthodontists and 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, 2022, Clear Aligner net revenues represented approximately 82% of worldwide net revenues, while Systems and Services net revenues represented the remaining 18%.

We sell the majority of our products directly through a dedicated and specialized sales force to our customers: orthodontists, GPs, including prosthodontists, periodontists, and 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, and we sell products used by dental laboratories who manufacture or customize a variety of products used by licensed dentists to provide oral health care.

We also market and sell doctor and consumer accessory products that are complementary to our doctor-prescribed principal products under the Invisalign® and other brands, including retainers, dental supplies, 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 that they expect and the results patients desire.

To date, over 14 million people worldwide have been treated with our 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, paving the way for new, cross-disciplinary dentistry in labs and at chairside.

Our Products, Services and Technologies

Align 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 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 that move all aspects of treatment forward, from first consultations to final smiles with our doctor-centered treatment model.

It 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.

OR

| [PART I](#if1d94140443e4bd999abda4b2e587ec9_10) | | | | | | [3](#if1d94140443e4bd999abda4b2e587ec9_10) | | |

| [PART II](#if1d94140443e4bd999abda4b2e587ec9_34) | | | | | | [40](#if1d94140443e4bd999abda4b2e587ec9_34) | | |

| [PART III](#if1d94140443e4bd999abda4b2e587ec9_184) | | | | | | [93](#if1d94140443e4bd999abda4b2e587ec9_184) | | |

| [PART IV](#if1d94140443e4bd999abda4b2e587ec9_202) | | | | | | [95](#if1d94140443e4bd999abda4b2e587ec9_202) | | |

| [Signatures](#if1d94140443e4bd999abda4b2e587ec9_211) | | | | | | [98](#if1d94140443e4bd999abda4b2e587ec9_211) | | |

Terminology such as “believe,” “anticipate,” “should,” “could,” “intend,” “will,” “plan,” “expect,” “estimate,” “project,” “target,” “may,” “possible,” “potential,” “forecast” and “positioned” and similar references to future periods are intended to identify forward-looking statements, although not all forward-looking statements are accompanied by such words.

As of December 31, [removed: 2021,] [added: 2022,] the significant facilities occupied were as follows:

The [removed: significant] facilities noted above are used mostly by all our reportable segments.

| Wroclaw, Poland | | | | | | Lease and Own | | | Manufacturing and office for treatment and administrative personnel | | | | | |

| Moscow, Russia | | | | | | Lease | | | Office for research & development | | | | | |

We also own property in Wroclaw, Poland where we expect to open a new aligner fabrication facility that will begin serving doctors during the first half of 2022.

As of February [removed: 21, 2022,] [added: 20, 2023,] there were approximately 53 holders of record of our common stock.

The graph tracks the performance of a $100 investment in our common stock and each index (with the reinvestment of all dividends) from December 31, [removed: 2016] [added: 2017] to December 31, [removed: 2021.][added: 2022.]

[removed: ][added: ]

The following table summarizes the stock repurchase activity for the three months ended December 31, [removed: 2021:][added: 2022:]

| Period | | | | | | Total Number of Shares [removed: Repurchased] [added: Purchased] | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares [removed: Repurchased] [added: Purchased] as Part of Publicly Announced Programs | | | | | | Approximate Dollar Value of Shares that May Yet Be [removed: Repurchased] [added: Purchased] Under the Programs(1) | | |

See *Note [removed: 13*] [added: 10*] “*Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements* for details on the May 2021 Repurchase Program.

| October 1, 2022 through October 31, 2022 | | | | | | 848,266 | | | | | | $ | 188.62 | | | | | 848,266 | | | | | | $ | 249,926,094 | |

| November 1, 2022 through November 30, 2022 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 249,926,094 | |

| December 1, 2022 through December 31, 2022 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 249,926,094 | |

| Total | | | | | | 848,266 | | | | | | | | | | | | 848,266 | | | | | | | | |

| October 1, 2021 through October 31, 2021 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 824,962,500 | |

| November 1, 2021 through November 30, 2021 | | | | | | 150,031 | | | | | | $ | 666.53 | | | | | 150,031 | | | | | | $ | 724,962,500 | |

| December 1, 2021 through December 31, 2021 | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 724,962,500 | |

| Total | | | | | | 150,031 | | | | | | | | | | | | 150,031 | | | | | | | | |

| [Report of Management on Internal Control over Financial [removed: Reporting](#if1d94140443e4bd999abda4b2e587ec9_91)] [added: Reporting](#i2704b576f8bf446aa18dd6265ae58c92_97)] | | | [removed: [55](#if1d94140443e4bd999abda4b2e587ec9_91)] [added: [55](#i2704b576f8bf446aa18dd6265ae58c92_97)] | | |

| [Report of Independent Registered Public Accounting [removed: Firm](#if1d94140443e4bd999abda4b2e587ec9_94)] [added: Firm](#i2704b576f8bf446aa18dd6265ae58c92_100)] (PCAOB ID 238) | | | [removed: [56](#if1d94140443e4bd999abda4b2e587ec9_94)] [added: [56](#i2704b576f8bf446aa18dd6265ae58c92_100)] | | |

| [Consolidated Statements of Operations for the year ended December 31, [removed: 2021, 2020 and 2019](#if1d94140443e4bd999abda4b2e587ec9_97)] [added: 202](#i2704b576f8bf446aa18dd6265ae58c92_103)[2](#i2704b576f8bf446aa18dd6265ae58c92_103)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_103)[1](#i2704b576f8bf446aa18dd6265ae58c92_103) [and 2](#i2704b576f8bf446aa18dd6265ae58c92_103)[020](#i2704b576f8bf446aa18dd6265ae58c92_103)] | | | [removed: [58](#if1d94140443e4bd999abda4b2e587ec9_97)] [added: [58](#i2704b576f8bf446aa18dd6265ae58c92_103)] | | |

| [Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2021, 2020 and 2019](#if1d94140443e4bd999abda4b2e587ec9_100)] [added: 202](#i2704b576f8bf446aa18dd6265ae58c92_106)[2](#i2704b576f8bf446aa18dd6265ae58c92_106)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_106)[1](#i2704b576f8bf446aa18dd6265ae58c92_106) [and 20](#i2704b576f8bf446aa18dd6265ae58c92_106)[20](#i2704b576f8bf446aa18dd6265ae58c92_106)] | | | [removed: [59](#if1d94140443e4bd999abda4b2e587ec9_100)] [added: [59](#i2704b576f8bf446aa18dd6265ae58c92_106)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2021 and 2020](#if1d94140443e4bd999abda4b2e587ec9_103)] [added: 202](#i2704b576f8bf446aa18dd6265ae58c92_109)[2](#i2704b576f8bf446aa18dd6265ae58c92_109) [and 202](#i2704b576f8bf446aa18dd6265ae58c92_109)[1](#i2704b576f8bf446aa18dd6265ae58c92_109)] | | | [removed: [60](#if1d94140443e4bd999abda4b2e587ec9_103)] [added: [60](#i2704b576f8bf446aa18dd6265ae58c92_109)] | | |

| [Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2021, 2020 and 2019](#if1d94140443e4bd999abda4b2e587ec9_106)] [added: 202](#i2704b576f8bf446aa18dd6265ae58c92_112)[2](#i2704b576f8bf446aa18dd6265ae58c92_112)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_112)[1](#i2704b576f8bf446aa18dd6265ae58c92_112) [and 20](#i2704b576f8bf446aa18dd6265ae58c92_112)[20](#i2704b576f8bf446aa18dd6265ae58c92_112)] | | | [removed: [61](#if1d94140443e4bd999abda4b2e587ec9_106)] [added: [61](#i2704b576f8bf446aa18dd6265ae58c92_112)] | | |

| [Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2021, 2020 and 2019](#if1d94140443e4bd999abda4b2e587ec9_109)] [added: 202](#i2704b576f8bf446aa18dd6265ae58c92_115)[2](#i2704b576f8bf446aa18dd6265ae58c92_115)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_115)[1](#i2704b576f8bf446aa18dd6265ae58c92_115) [and 20](#i2704b576f8bf446aa18dd6265ae58c92_115)[20](#i2704b576f8bf446aa18dd6265ae58c92_115)] | | | [removed: [62](#if1d94140443e4bd999abda4b2e587ec9_109)] [added: [62](#i2704b576f8bf446aa18dd6265ae58c92_115)] | | |

| [Notes to Consolidated Financial [removed: Statements](#if1d94140443e4bd999abda4b2e587ec9_112)] [added: Statements](#i2704b576f8bf446aa18dd6265ae58c92_118)] | | | [removed: [63](#if1d94140443e4bd999abda4b2e587ec9_112)] [added: [63](#i2704b576f8bf446aa18dd6265ae58c92_118)] | | |

Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

Based on our assessment, management has concluded that, as of December 31, [removed: 2021,] [added: 2022,] 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: 2021] [added: 2022] 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 “Company”) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the related consolidated statements of operations, [added: of] comprehensive income, [added: of] stockholders’ equity and [added: of] cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] including the related notes and financial statement schedule listed in the index appearing under Item 15(a)(2) (collectively referred to as the “consolidated financial statements”).

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate [added: because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.]

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter [removed: below,] [added: below,] providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

As described in Notes 1 and [removed: 18] [added: 15] to the consolidated financial statements, the Company recognized net revenues of [removed: $3.2] [added: $3.1] billion from its Clear Aligner segment for the year ended December 31, [removed: 2021.][added: 2022.]

Management identifies a performance obligation as distinct if both of the following criteria are met: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the [removed: customer,] [added: customer] and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.

| | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net revenues | | | | | | $ | [removed: 3,952,584] [added: 3,734,635] | | | | | $ | [removed: 2,471,941] [added: 3,952,584] | | | | | $ | [removed: 2,406,796] [added: 2,471,941] | |

| Cost of net revenues | | | | | | [removed: 1,017,229] [added: 1,100,860] | | | | | | [removed: 708,706] [added: 1,017,229] | | | | | | [removed: 662,899] [added: 708,706] | | |

| Gross profit | | | | | | [removed: 2,935,355] [added: 2,633,775] | | | | | | [removed: 1,763,235] [added: 2,935,355] | | | | | | [removed: 1,743,897] [added: 1,763,235] | | |

| Selling, general and administrative | | | | | | [removed: 1,708,640] [added: 1,674,469] | | | | | | [removed: 1,200,757] [added: 1,708,640] | | | | | | [removed: 1,072,053] [added: 1,200,757] | | |

| Research and development | | | | | | [removed: 250,315] [added: 305,258] | | | | | | [removed: 175,307] [added: 250,315] | | | | | | [removed: 157,361] [added: 175,307] | | |

| Total operating expenses | | | | | | [removed: 1,958,955] [added: 1,991,180] | | | | | | [removed: 1,376,064] [added: 1,958,955] | | | | | | [removed: 1,201,404] [added: 1,376,064] | | |

| Income from operations | | | | | | [removed: 976,400] [added: 642,595] | | | | | | [removed: 387,171] [added: 976,400] | | | | | | [removed: 542,493] [added: 387,171] | | |

| Interest income | | | | | | [removed: 3,103] [added: 5,367] | | | | | | [removed: 3,125] [added: 3,103] | | | | | | [removed: 12,482] [added: 3,125] | | |

| Other income (expense), net | | | | | | [removed: 32,920] [added: (48,905)] | | | | | | [removed: (11,347)] [added: 32,920] | | | | | | [removed: 7,676] [added: (11,347)] | | |

| Total interest income and other income (expense), net | | | | | | [removed: 36,023] [added: (43,538)] | | | | | | [removed: (8,222)] [added: 36,023] | | | | | | [removed: 20,158] [added: (8,222)] | | |

| Net income before provision for (benefit from) income taxes [removed: and equity in losses of investee] | | | | | | [removed: 1,012,423] [added: 599,057] | | | | | | [removed: 378,949] [added: 1,012,423] | | | | | | [removed: 562,651] [added: 378,949] | | |

| Provision for (benefit from) income taxes | | | | | | [removed: 240,403] [added: 237,484] | | | | | | [removed: (1,396,939)] [added: 240,403] | | | | | | [removed: 112,347] [added: (1,396,939)] | | |

| Net income | | | | | | $ | [removed: 772,020] [added: 361,573] | | | | | $ | [removed: 1,775,888] [added: 772,020] | | | | | $ | [removed: 442,776] [added: 1,775,888] | |

| Basic | | | | | | $ | [removed: 9.78] [added: 4.62] | | | | | $ | [removed: 22.55] [added: 9.78] | | | | | $ | [removed: 5.57] [added: 22.55] | |

| Diluted | | | | | | $ | [removed: 9.69] [added: 4.61] | | | | | $ | [removed: 22.41] [added: 9.69] | | | | | $ | [removed: 5.53] [added: 22.41] | |

| Basic | | | | | | [removed: 78,917] [added: 78,190] | | | | | | [removed: 78,760] [added: 78,917] | | | | | | [removed: 79,424] [added: 78,760] | | |

| Diluted | | | | | | [removed: 79,670] [added: 78,420] | | | | | | [removed: 79,230] [added: 79,670] | | | | | | [removed: 80,100] [added: 79,230] | | |

| Change in foreign currency translation adjustment, net of tax | | | | | | [removed: (38,680)] [added: (11,480)] | | | | | | [removed: 44,383] [added: (38,680)] | | | | | | [removed: 1,787] [added: 44,383] | | |

| Change in unrealized gains (losses) on investments, net of tax | | | | | | [removed: (495)] [added: (3,130)] | | | | | | [removed: (194)] [added: (495)] | | | | | | [removed: 299] [added: (194)] | | |

| Other comprehensive income (loss) | | | | | | [removed: (39,175)] [added: (14,610)] | | | | | | [removed: 44,189] [added: (39,175)] | | | | | | [removed: 2,086] [added: 44,189] | | |

| February 27, 2023 | | |

| February 27, 2023 | | |

Management allocates revenues for each treatment plan based on each unit’s standalone selling price.

In addition to historical data, they take into consideration changing trends and market conditions.

February 27, 2023

| Restructuring and other charges | | | | | | 11,453 | | | | | | — | | | | | | — | | |

| Net income | | | | | | $ | 361,573 | | | | | $ | 772,020 | | | | | $ | 1,775,888 | |

| | | | | | | 2022 | | | | | | 2021 | | |

| Inventories | | | | | | 338,752 | | | | | | 230,230 | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 361,573 | | | | | | 361,573 | | |

| Common stock repurchased and retired | | | | | | (1,748) | | | | | | — | | | | | | (20,777) | | | | | | — | | | | | | (414,259) | | | | | | (435,036) | | |

| Equity forward contract related to accelerated stock repurchase | | | | | | — | | | | | | — | | | | | | (40,000) | | | | | | — | | | | | | — | | | | | | (40,000) | | |

| Balance as of December 31, 2022 | | | | | | 77,267 | | | | | | $ | 8 | | | | | $ | 1,044,946 | | | | | $ | (10,284) | | | | | $ | 2,566,688 | | | | | $ | 3,601,358 | |

| | | | | | | 2022 | | | | | | 2021 | | | | | | 2020 | | |

| Net income | | | | | | $ | 361,573 | | | | | $ | 772,020 | | | | | $ | 1,775,888 | |

| Payment for equity forward contract related to accelerated stock repurchase agreement | | | | | | (40,000) | | | | | | — | | | | | | — | | |

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 and consumers, orthodontists and GPs and lab partners.

These forward contracts are not designated as hedging instruments.

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 have been impacted by the COVID-19 pandemic.

Although its impact has been gradually declining, we continue to be exposed to risks and uncertainties posed by it which varies by geographic regions at different levels.

The extent to which our business could be impacted in the future by the pandemic is highly uncertain and difficult to predict.

In 2022, we entered into factoring transactions on a non-recourse basis with financial institutions to sell certain of our non-U.S. accounts receivable.

We account for these transactions as sales of accounts receivables and include the cash proceeds as a part of our cash flows from operations in the Consolidated Statements of Cash Flows.

Total accounts receivable sold under the factoring arrangements was $37.0 million during the year ended December 31, 2022.

Factoring fees on the sales of receivables were recorded in other income (expense), net in our Consolidated Statement of Operations and were not material.

In

Development Costs for Software to be Marketed

Determining the standalone selling price (“SSP”) in order to allocate consideration from the contract to the individual performance obligations is the result of various factors, such as changing trends and market conditions, historical prices, costs, and gross margins.

Where processing fees are charged, the consideration received from the fees are included in the total consideration.

In addition to historical data, we take into consideration changing trends and market conditions.

We also have a rental program, where scanners are leased to customers.

| February 25, 2022 | | |

because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Determining the standalone selling price, allocation of consideration from the contract to the individual performance obligations, and the appropriate timing of revenue recognition is the result of significant qualitative and quantitative judgments.

February 25, 2022

| Impairments and other charges (gains), net | | | | | | — | | | | | | — | | | | | | 22,990 | | |

| Litigation settlement gain | | | | | | — | | | | | | — | | | | | | (51,000) | | |

| Equity in losses of investee, net of tax | | | | | | — | | | | | | — | | | | | | 7,528 | | |

| Inventories | | | | | | 230,230 | | | | | | 139,237 | | |

| Balance as of December 31, 2018 | | | | | | 79,778 | | | | | | $ | 8 | | | | | $ | 877,514 | | | | | $ | (2,774) | | | | | $ | 378,143 | | | | | $ | 1,252,891 | |

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 442,776 | | | | | | 442,776 | | |

| Common stock repurchased and retired | | | | | | (1,887) | | | | | | — | | | | | | (18,992) | | | | | | — | | | | | | (381,007) | | | | | | (399,999) | | |

| Allowance for doubtful accounts provisions | | | | | | 2,814 | | | | | | 12,073 | | | | | | 5,853 | | |

| Impairments on long-lived assets | | | | | | — | | | | | | — | | | | | | 28,498 | | |

| Equity in losses of investee | | | | | | — | | | | | | — | | | | | | 7,528 | | |

| Gain on lease terminations | | | | | | — | | | | | | — | | | | | | (6,792) | | |

| Gain from sale of equity method investment | | | | | | — | | | | | | — | | | | | | (15,769) | | |

| Purchase of finance lease | | | | | | — | | | | | | — | | | | | | (45,773) | | |

Align Technology, Inc. (“We”, “Our”, or “Align”) was incorporated in April 1997 in Delaware.

We also market and sell consumer products that are complementary to our doctor-prescribed principal products under the Invisalign brand, including retainers, aligner cases (clamshells), teeth whitening products and cleaning solutions (crystals, foam and other material) (collectively “Consumer Products”).

Out-of-Period Adjustments

For the year ended December 31, 2021 and 2020, we recorded out-of-period corrections that resulted in tax benefits of $16.0 million and $12.7 million, respectively, in our Consolidated Statement of Operations.

We do not believe these out-of-period adjustments are material to the interim or annual consolidated financial statements for the respective reporting period or to any of the related prior periods.

Our custody bank and asset managers independently use

We record our share of their operating results within equity in losses of investee, net of tax, in our Consolidated Statement of Operations.

Investments in privately held companies in which we cannot exercise significant influence and do not own a majority equity interest or otherwise control are accounted for under the measurement alternative.

and we periodically evaluate them for impairment.

These forward contracts are not designated as hedging instruments and do not subject us to material balance sheet risk due to fluctuations in foreign currency exchange rates.

Our operating results depend to a significant extent on our ability to market and develop our products.

The life cycles of our products are difficult to estimate due, in part, to the effect of future product enhancements and competition.

Our inability to successfully develop and market our products as a result of competition or other factors would have a material adverse effect on our business, financial condition and results of operations.

The U.S. Food and Drug Administration (“FDA”) and similar international agencies regulate the design, manufacture, distribution, pre-clinical and clinical study, clearance and approval of medical devices.

Products developed by us may require approvals or clearances from the FDA or other international regulatory agencies prior to commercialized sales.

There can be no assurance that our products will receive any of the required approvals or clearances.

If we were denied approval or clearance or such approval was delayed, it may have a material adverse impact on us.

We provide credit to customers in the normal course of business.

Collateral is not required for accounts receivable but ongoing evaluations of customers’ credit worthiness are performed.

We maintain an allowance for potential credit losses for uncollectible accounts and such losses have been within management’s expectations.

We have manufacturing facilities located in Juarez, Mexico where we conduct our aligner fabrication, distribution and perform certain services and in Ziyang, China where we fabricate aligners primarily for China and other APAC markets.

In addition, we produce our handheld intraoral scanner wand, perform final scanner assembly and repair our scanners at our facilities in Ziyang, China and Or Yehuda, Israel and service and repair certain scanners in Juarez, Mexico.

In the second quarter of 2021, we announced the start of a multi-million dollar project to bring operational facilities closer to our customers through the expansion of our manufacturing operations in Wroclaw, Poland.

None.

None

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: 2021] [added: 2022] 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 Securities and Exchange Commission rules and forms.

There have been no changes in our internal control over financial reporting during the quarter ended December 31, [removed: 2021] [added: 2022] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Certain information required by Part III is omitted from this Form 10-K because we intend to file a definitive Proxy Statement for our [removed: 2022] [added: 2023] 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.

The information required by Item 401 of Regulation S-K concerning our directors is incorporated by reference to the Proxy Statement under the section captioned [removed: “Election of Directors.”] [added: “Directors.”] The information required by Item 401 of Regulation S-K concerning our executive officers is set forth in *Item 1— “Business” of this Annual Report on Form 10-K*.

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 this code of ethics by posting such information on our website, at the address and location specified above, or as otherwise required by the NASDAQ Global [added: Select] Market.

The information required by Item 402 of Regulation S-K is incorporated by reference to the Proxy Statement under the section captioned “Executive [removed: Compensation.”] [added: Compensation - Compensation Discussion and Analysis.”] The information required by Items 407(e)(4) and (e)(5) is incorporated by reference to the Proxy Statement under the section captioned “Corporate Governance - [added: Committee Oversight -] Compensation Committee Interlocks and Insider Participation” and “Compensation Committee of the Board Report,” respectively.

The information required by Item 403 [added: and Item 201(d)] of Regulation S-K is incorporated by reference to the Proxy Statement under the [removed: section] [added: sections] captioned [removed: “Principal Stockholders”.][added: “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information,” respectively.]

Equity Compensation Plan Information

The following table provides information as of December 31, 2021 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 12 "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 | | | | | | 665,957 | | | 1 | | | $ | — | | | | | 6,439,289 | | | 2, 3 | | |

| Equity compensation plans not approved by security holders | | | | | | — | | | | | | — | | | | | | — | | | | | |

| Total | | | | | | 665,957 | | | | | | $ | — | | | | | 6,439,289 | | | | | |

1 Includes 491,858 RSUs and 174,099 MSUs at target

2 Includes 2,194,566 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 496,182 of potentially issuable MSUs above target if performance targets are achieved at maximum payout (counted one and nine-tenths (1 9/10) shares for every one (1) issuable share against the authorized share reserve)

The information required by Item 404 and Item 407 of Regulation S-K is incorporated by reference to the Proxy Statement under the sections captioned “Certain Relationships and Related Party Transactions” and “Corporate [removed: Governance—Director Independence,”] [added: Governance—Board and Committee Independence and Qualifications,”] respectively.

| Report of Independent Registered Public Accounting Firm | | | [removed: [56](#if1d94140443e4bd999abda4b2e587ec9_94)] [added: [56](#i2704b576f8bf446aa18dd6265ae58c92_100)] | | |

| Consolidated Statements of Operations for the year ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [58](#if1d94140443e4bd999abda4b2e587ec9_97)] [added: [58](#i2704b576f8bf446aa18dd6265ae58c92_103)] | | |

| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [59](#if1d94140443e4bd999abda4b2e587ec9_100)] [added: [59](#i2704b576f8bf446aa18dd6265ae58c92_106)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] | | | [removed: [60](#if1d94140443e4bd999abda4b2e587ec9_103)] [added: [60](#i2704b576f8bf446aa18dd6265ae58c92_109)] | | |

| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [61](#if1d94140443e4bd999abda4b2e587ec9_106)] [added: [61](#i2704b576f8bf446aa18dd6265ae58c92_112)] | | |

| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [62](#if1d94140443e4bd999abda4b2e587ec9_109)] [added: [62](#i2704b576f8bf446aa18dd6265ae58c92_115)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [63](#if1d94140443e4bd999abda4b2e587ec9_112)] [added: [63](#i2704b576f8bf446aa18dd6265ae58c92_118)] | | |

Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019][added: 2020]

| [removed: [10.1A](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000018/appendixb-alignamendedandr.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm)] [added: [10.1A†](http://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] | | | [removed: [Amended Registrant’s] [added: [Registrant’s] 2010 Employee Stock Purchase [removed: Plan](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000018/appendixb-alignamendedandr.htm)] [added: Plan (as amended and restated as of May 19, 2021)](http://www.sec.gov/Archives/edgar/data/1097149/000109714921000037/exhibit101-alignamendedand.htm)] | | | [removed: Def 14A] [added: 8-K] | | | [removed: 4/7/2021] [added: 5/20/2021] | | | [removed: 2.0] [added: 10.1] | | | | | | | | |

| [10.8†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted [removed: in 2018, 2019 and 2020 to] [added: in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2019](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[,](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [and 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [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 | | | | | | | | |

| [10.8A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted [removed: in 2018, 2019 and 2020 to] [added: in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [2019](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[,](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [and 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [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: [10.12†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[1](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)] | | | [Form of Employment Agreement entered into by and between registrant and each executive officer (other than CEO for executives appointed prior to September 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm) | | | 10-Q | | | 5/8/2008 | | | 10.3 | | | | | | | | |

| [removed: [10.13†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] | | | [Form of Employment Agreement entered into by and between registrant and each executive officer (other than CEO for executives appointed after September 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm) | | | 10-K | | | 2/28/2017 | | | 10.8 | | | | | | | | |

| [removed: [10.14†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[3](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] | | | [Amended and Restated Chief Executive Officer Employment Agreement between Align Technology, Inc. and Joseph Hogan](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm) | | | 10-Q | | | 5/1/2015 | | | 10.30 | | | | | | | | |

| [removed: [10.15†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[4](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] | | | [Employment Agreement between registrant and John F. Morici (Chief Financial Officer)](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm) | | | 10-Q | | | 11/8/2016 | | | 10.2 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[6](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: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[5](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)] | | | [Form of Indemnification Agreement by and between registrant and its Board of Directors and its executive officers](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt) | | | S-1 as amended (File No. 333-49932) | | | 1/17/2001 | | | 10.15 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)[7](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)] [added: [10.16](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 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[8](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] [added: [10.17](http://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, 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) | | | 10-Q | | | 10/30/2020 | | | 10.1 | | | | | | | | |

| [removed: [10.19](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex1019-algnoct292021asr.htm)] [added: [10.20](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm)] | | | [Fixed Dollar Accelerated Share [removed: Repurchase Transaction dated] [added: Repurchase](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [Transaction](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [between Goldman Sachs & Co. LLC and Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [dated] October [removed: 29, 2021](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex1019-algnoct292021asr.htm)] [added: 28, 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex211-20211231.htm)] [added: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex211-20221231.htm)] | | | [Subsidiaries of Align Technology, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex211-20211231.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex211-20221231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex231-20211231.htm)] [added: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex231-20221231.htm)] | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex231-20211231.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex231-20221231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex311-20211231.htm)] [added: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex311-20221231.htm)] | | | [Certifications of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex311-20211231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex311-20221231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex312-20211231.htm)] [added: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex312-20221231.htm)] | | | [Certifications of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex312-20211231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex312-20221231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [32](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex32-20211231.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex32-20211231.htm)] [added: [32](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex32-20221231.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex32-20221231.htm)] | | | [Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex32-20211231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex32-20221231.htm)] | | | | | | | | | | | | | | | * | | |

| Year Ended December 31, 2022 | | | | | | $ | 9,245 | | | | | $ | 4,102 | | | | | $ | (3,004) | | | | | $ | 10,343 | |

| Year Ended December 31, 2022 | | | | | | $ | 12,938 | | | | | $ | 10,348 | | | | | $ | — | | | | | $ | 23,286 | |

| [10.18](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) | | | | | | | | | | | | | | | * | | |

| [10.19](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) | | | | | | | | | | | | | | | * | | |

| Year Ended December 31, 2019 | | | | | | $ | 2,378 | | | | | $ | 5,853 | | | | | $ | (1,475) | | | | | $ | 6,756 | |

| Year Ended December 31, 2019 | | | | | | $ | 251 | | | | | $ | 835 | | | | | $ | — | | | | | $ | 1,086 | |

| [10.11†](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm) | | | [Form of Market Stock Unit Agreement for CEO Special MSU Award June 2018](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm) | | | 8-K | | | 6/25/2018 | | | 10.1 | | | | | | | | |

| Date: | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ JOSEPH M. HOGAN | | | | | | [removed: President and] [added: President,] Chief Executive Officer [added: and Director] (Principal Executive Officer) | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ JOHN F. MORICI | | | | | | Chief Financial Officer and Executive Vice President, Global Finance (Principal Financial Officer and Principal Accounting Officer) | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ KEVIN J. DALLAS | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ JOSEPH LACOB | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ C. RAYMOND LARKIN, JR. | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ GEORGE J. MORROW | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ ANNE M. MYONG | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ ANDREA L. SAIA | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ GREG J. SANTORA | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ SUSAN E. SIEGEL | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |

| /S/ WARREN S. THALER | | | | | | Director | | | | | | February [removed: 25, 2022] [added: 27, 2023] | | |