Align Technology (ALGN) 10-K risk factor changes: FY2021 vs FY2020

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

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

- 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 [removed: in] [added: as] the [removed: future.][added: virus evolves and circumstances dictate.]

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

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

- 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, [removed: political] [added: 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 [removed: a] [added: changing consumer demand, inflation,] weakness in general economic [removed: conditions] [added: conditions, recessions] and resistance to non-traditional treatment methods.

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

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

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

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

- Our [added: products and] information technology systems are critical to our business.

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

- If [removed: the security of] [added: we are unable or fail to protect] our customer [removed: and] [added: or] patient information [removed: is compromised] or [added: if] we are unable to comply with [added: applicable privacy, security and] data protection laws, our operations may be severely adversely impacted, patient care could suffer, we could be liable for related damages, and our [added: business, operations and] reputation could be [removed: impaired.][added: harmed.]

- [removed: In order] [added: We are dependent on our marketing activities] to deepen our market penetration and raise awareness of our brand and products, [removed: we may increase the amount we spend on marketing activities,] which may not [removed: ultimately] prove successful or [removed: an] [added: may become less] effective [removed: use of our resources.][added: or more costly to maintain in the long term.]

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

Litigating claims of this type [removed: are] [added: is] costly and could distract our management and cause a decline in our results of operations and stock price.

- Obtaining approvals and complying with governmental regulations, particularly [added: those related to personal] healthcare [added: information, financial information, quality systems] and data [removed: privacy compliance,] [added: privacy,] is expensive and time-consuming, and 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 cause harm to our reputation.

- If we or any vendors on whose products or services we rely for our products and [removed: service] [added: services] infringe the patents or IP rights of other parties or are subject to a patent infringement claim, our ability to grow our business may be severely limited.

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

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

- 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 [added: found] liable for substantial damages or penalties if we are subject to claims or litigation.

- We are exposed to fluctuations in currency exchange [removed: rates,] [added: 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 [removed: risk] [added: risks] successfully, our operating results and financial statements could be materially impacted.

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

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

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 [removed: in] [added: as] the [removed: future.][added: virus evolves and circumstances dictate.]

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

Accordingly, you should consider the risks [added: described] in this risk factor in addition to, and not in lieu of, the risks [removed: identified] [added: described elsewhere] throughout [removed: this section discussing the risks related to our business.][added: these risk factors.]

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

In response to [removed: COVID-19,] [added: 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, [added: and] prohibiting non-essential [removed: travel, and converting underutilized manufacturing capacity to produce personal protective equipment.][added: travel.]

Many of these actions remain in effect [added: to varying degrees] and we may implement new or revise existing [removed: requirements] [added: measures] as circumstances [removed: require, some of which may be highly disruptive to our business and may ultimately prove wholly or partially ineffective.][added: require.]

[removed: Even if effective, if employees perceive them to be inadequate or overly burdensome, or they prove difficult to maintain over extended periods of time, productivity may decline or we may experience employee unrest, slowdowns, stoppages or other demands,] [added: 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.

As the economic and societal impact of the pandemic [removed: continues to unfold,] [added: continues,] we are continually evaluating macroeconomic as well as industry-specific factors, including the extent our business and financial results [removed: are or may be impacted as well as those of our customers] and [removed: suppliers, and] the [removed: financial health] [added: business] and [removed: stability] [added: financial results] of [removed: businesses] [added: our customers’] and [removed: consumers overall depends on numerous evolving factors, many of which we cannot control nor accurately predict.][added: suppliers’ have been and in the future may be impacted.]

- the liquidity [added: of funds] and financial stability of consumers, customers, and patients, including their willingness to purchase our products and services, delays paying for products or services, requests for extended payment terms, or payment defaults;

- travel [added: and gathering] restrictions, including those that adversely impair or prohibit [removed: patients from visiting their doctors and] our sales personnel from interacting with [removed: customers;][added: customers or that limit patients from visiting their doctors or capacity limits on the number of patients doctors can see in their offices;]

- diversion of [removed: management] [added: management’s attention] as they focus on the short- and long-term ramifications of the [removed: pandemic;][added: pandemic.]

- actions by [removed: us or our] competitors such as price reductions, aggressive product promotions, changes in or the launch or termination of products or product lines, and mergers, consolidations and liquidations;

- customer and consumer purchasing behavior changes as pandemic-related restrictions are [removed: curtailed] [added: curtailed, lifted] or [removed: lifted, remote working declines] [added: reinstated,] and travel and discretionary spending patterns shift;

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

- We rely on highly skilled personnel and, if we fail to attract, motivate, train or retain highly skilled personnel, it may be more difficult to grow effectively and pursue our strategic priorities.

- Compliance with current or future environmental, social, and governance (“ESG”) laws may materially increase our costs, expose us to potential liability and otherwise materially impact our business.

- 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.

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

- 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.

Many of these effects continue to varying degrees and further mutated variants and outbreaks globally or regionally continue to harm recovering consumer confidence and have led to renewed implementation of harsh preventative measures by local and regional governments and businesses.

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

As a result of the pandemic, 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 reopened, many continue to operate at less than pre-pandemic capacities.

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.

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.

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.

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.”*

The financial health and stability of businesses and consumers overall depends on numerous evolving factors, many of which we cannot control nor accurately predict.

- the response of employees, customers and suppliers to the reimplementation or easing of social distancing mandates and returning to in-office or facility working, including anxieties regarding the continuing risks of the spread of the virus or any of its variants, vaccination requirements, and other mandates that may impact employee productivity and engagement, retention or require additional costly protective measures;

- disruptions and shortages impacting the cost, availability and timing of the procurement, delivery, manufacturing and overall supply chain for raw materials, components, parts and products, including semiconductor chips;

- delays and cancellations as a result of port congestion and intermittent supplier shutdowns;

Our iTero scanners have become a material percentage of our overall revenues.

Although exocad and its CAD/CAM software solutions are important to the continuing evolution of the Align digital platform, the contributions to our total net revenues from the exocad solutions remain immaterial.

Our operating results could be harmed if:

- orthodontists and GPs experience a reduction in consumer demand for orthodontic services;

- orthodontists or GPs choose to continue using wires and brackets or competitive products rather than the Invisalign system or the rates at which they utilize the Invisalign system fail to increase or increase as rapidly as anticipated;

- sales of our iTero scanners decline or fail to grow sufficiently or as expected;

- the growth of CAD/CAM solutions does not produce the results expected; or

- if the average selling price of our products declines.

Our average selling prices have been impacted in the past and may be adversely affected again in the future if:

- we introduce new or change existing promotions, general or volume-based discount programs, product or services bundles, or consumer rebate programs;

- participation in any promotions or programs unexpectedly increases or decreases or drives demand in unexpected and material ways;

- our geographic, channel, or product mix shifts to lower priced products or to products that have a higher percentage of deferred revenue;

- we decrease prices on one or more products or services in response to increasing competitive pricing pressures;

- 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; or

- our critical accounting estimates materially differ from actual behavior or results.

The number and types of competitors are diverse and growing rapidly.

- threats, tensions, actions and responses to any social, economic, business, geopolitical, military, terrorism, or acts of war, including the possibility, threat of, imposition of, or changes in sanctions, trade restrictions and tariffs, as well as

- We may not achieve the anticipated benefits from our recent acquisition of exocad in the timeframe expected, or at all, which may have an adverse effect on our business and our financial results.

- We primarily rely on our direct sales force to sell our products, and any failure to train and maintain our key sales force personnel could harm our business.

- We are subject to risks associated with our strategic investments.

Impairments in the value of our investments could negatively impact our financial results.

- If we lose our key personnel or are unable to attract and retain key personnel, we may be unable to pursue business opportunities or develop our products.

- Changes in tax laws or tax rulings could negatively impact our income tax provision and net income.

Renewed outbreaks of COVID-19 may harm recovering consumer confidence or renew implementation of harsh preventative measures.

Because COVID-19 spreads readily through airways in nasal passages and the mouth, our principal customers, dental and orthodontic practices, were an initial focus leading to the complete or substantial closures of their operations; materially harming our sales and sales efforts.

While practices across all regions have largely reopened, many have not returned to pre-pandemic capacities.

- the time in which dental practices return to pre-pandemic operating capacities and our ability to timely and effectively respond to decreases or increases in demand;

- changes in product and services demand, particularly for products or services that may be deemed discretionary or that can be delayed or cancelled;

Sales of our iTero scanners are becoming a larger percentage of our overall revenues and we expect the acquisition of exocad to complement the adoption of digital dentistry.

using wires and brackets or competitive products rather than the Invisalign System, if sales of our iTero scanners decline or fail to grow sufficiently or as expected, if the acquisition of exocad does not produce the results expected, or if the average selling price of our products declines for any reason, our operating results could be harmed.

We provide volume-based discount programs to our customers.

If we change volume-based discount programs that affect our average selling prices; if we introduce price reductions or consumer rebate programs; if we implement new or expand existing discount programs or participation in these programs increases; if our critical accounting estimates materially differ from actual behavior or results; or if our geographic, channel, or product mix shifts to lower priced products or to products that have a higher percentage of deferred revenue, our average selling prices would be adversely affected.

Moreover, some programs may be unsuccessful or may drive demand in unexpected ways.

Moreover, many of our key production steps are performed in locations outside of the U.S. For instance, technicians use a sophisticated, internally developed computer-modeling program to prepare digital treatment plans

(“ClinCheck”), which are approved by licensed doctors before being transmitted electronically for to our aligner fabrication facilities.

These digital files form the basis of the ClinCheck treatment plan and are used to manufacture our aligners.

- difficulties hiring and retaining employees, particularly employees with software and technological design and development backgrounds necessary to create, develop and perform the more technical aspects of our operations as well as to service, market and sell complex medical devices and technologies;

- political, military, social, economic, or business instability, acts of terrorism and acts of war, including increased levels of violence and protests in various regions of the world, including regions in which we operate such as the United States, Mexico, Hong Kong, the Middle East and Africa.

- interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure;

A decrease in U.S. or certain international economies or an uncertain economic outlook, both of which have or are occurring as a result of the COVID-19 pandemic, would adversely affect consumer spending

- correctly predict, timely develop and cost effectively manufacture or bring to market solutions that meet future customer needs and preferences with the features and functionality they desire or expect;

- successfully identify, timely develop and market products and services to new and evolving target markets; and

- encourage customers to adopt new technologies.

Any failure to successfully develop and introduce or achieve market acceptance of new products or enhancements to existing products could materially adversely affect our operating results and cause our net revenues to decline.

We may not achieve the anticipated benefits from our recent acquisition of exocad in the timeframe expected, or at all, which may have an adverse effect on our business and our financial results.

We closed our acquisition of exocad on April 1, 2020.

There is no guarantee that the acquisition will achieve the desired benefits and synergies or that the exocad CAD/CAM software will continue to succeed in the marketplace.

In addition, we do not have a history of significant acquisitions and integrating exocad during the COVID-19 pandemic poses challenges which may make it difficult to achieve the expected financial, technical or strategic benefits of the acquisition in the time frames anticipated if at all.

Potential risks we may experience include:

- difficulties integrating the business of exocad in the timeframes expected or as anticipated and without adversely impacting our existing operations or the operations of exocad;

- slower adoption of or technological difficulties uniting our product and service offerings to produce solutions that efficiently and effectively integrate with the workflows between doctors, laboratories and other market participants;

- diversion of management resources;

- the failure to accurately estimate the potential markets and market shares for the companies’ products, the nature and extent of competitive responses to the acquisition and the ability to achieve or exceed projected market growth rates;

- difficulties cost-effectively integrating and dealing with tax, employment, logistics, and other related issues unique to international operations, particularly when travel restrictions make collaboration efforts more difficult;

- the potential that our due diligence did not uncover risks and potential liabilities, that we fail to adequately mitigate or control them, or that new risks and potential liabilities associated with exocad arise;

- the failure to successfully manage relationships with Align and exocad’s historic customers, suppliers and strategic partners and develop new relationships;

- product development delays and errors;

A discussion regarding our financial condition and results of operations for fiscal [removed: 2020] [added: 2021] compared to fiscal [removed: 2019] [added: 2020] is presented under Results of Operations of this Form 10-K.

Discussions regarding our financial condition and results of operations for fiscal [removed: 2019] [added: 2020] compared to [removed: 2018] [added: 2019] have been omitted from this Annual Report on Form 10-K, but can be found in "Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2019,] [added: 2020,] filed with the SEC on February [removed: 28, 2020,] [added: 26, 2021,] which is available without charge on the SEC's website at [removed: www.sec.gov] [added: *www.sec.gov*] and on our investor relations website at [removed: investor.aligntech.com.][added: *investor.aligntech.com*.]

[removed: To date,] [added: As of December 31, 2021,] over [removed: 9.6] [added: 12] million people worldwide have been treated with our Invisalign [removed: System.][added: system, over 68,000 iTero scanners have been sold and over 47,000 exocad software licenses have been installed.]

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

- For the fourth quarter of [removed: 2020,] [added: 2021,] total Invisalign cases submitted with a digital scanner in the Americas increased to [removed: 84.0%,] [added: 89.1%,] up from [removed: 79.5%] [added: 84.0%] in the fourth quarter of [removed: 2019] [added: 2020] and international scans increased to [removed: 73.7%,] [added: 80.8%,] up from [removed: 64.7%] [added: 73.7%] in the fourth quarter of [removed: 2019.][added: 2020.]

For the fourth quarter of [removed: 2020, 94.8%] [added: 2021, 96.4%] of Invisalign cases submitted by North American orthodontists were submitted digitally.

[removed: ][added: ]

* Invisalign utilization rates are calculated by [removed: dividing] the number of cases shipped [added: divided] by the number of doctors to whom cases were shipped.

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

- Total utilization rate in [removed: 2020] [added: 2021] increased to [removed: 16.1] [added: 20.8] cases per doctor compared to [removed: 15.9] [added: 16.1] cases per doctor in [removed: 2019] [added: 2020] and [removed: 15.7] [added: 15.9] cases per doctor in [removed: 2018.][added: 2019.]

- *North America:* Utilization rate among our North American orthodontist customers increased to [removed: 67.3] [added: 98.1] cases per doctor in [removed: 2020] [added: 2021] compared to [removed: 65.0] [added: 67.3] cases per doctor in [removed: 2019] [added: 2020] and [removed: 56.7] [added: 65.0] cases per doctor in [removed: 2018] [added: 2019] and the utilization rate among our North American GP customers increased to [removed: 9.6] [added: 14.3] cases per doctor in [removed: 2020] [added: 2021] compared to [removed: 9.5] [added: 9.6] cases per doctor in [removed: 2019] [added: 2020] and [removed: 9.1] [added: 9.5] cases per doctor in [removed: 2018.][added: 2019.]

- *International:* International doctor utilization rate [removed: was 14.5] [added: increased to 17.5] cases per doctor in [removed: 2020] [added: 2021] compared to [removed: 13.8] [added: 14.5] cases [added: per doctor] in [removed: 2019] [added: 2020] and [removed: 13.9] [added: 13.8] cases per doctor in [removed: 2018.][added: 2019*.*]

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

In addition, the teenage and younger market makes up 75% of the approximately [removed: 15] [added: 21] million total [added: annual global] orthodontic case starts each [removed: year, and as we continue to drive adoption by teenage and younger patients through sales and marketing programs, we expect utilization rates to improve.][added: year.]

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: office closures or slowdowns related to] COVID-19-related preventative measures and adoption rates for new products and features.

[removed: Notwithstanding these uncertainties, we] [added: - We] continue to see growth opportunities with international orthodontists and GP customers, particularly with adopters of digital dentistry platforms [removed: and] as we continue to [removed: segment] [added: tailor] our sales and marketing [removed: resources] [added: strategies] and [removed: programs specifically] [added: resources] around [added: the unique needs of] each customer channel.

[removed: We also] [added: As we continue growing, we] intend to [removed: continue expanding] [added: expand] our [removed: manufacturing] [added: investments in research] and [added: development, manufacturing,] treatment [removed: planning] [added: planning, sales and marketing] operations to meet local and regional demand.

[removed: Overall,] [added: Over the longer-term,] we expect [removed: International] [added: international] revenues to grow [removed: at a] faster [removed: rate] than Americas' revenues [removed: for the foreseeable future due to] [added: 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 of these regions.

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

We expect to make further investments to create additional demand for Invisalign [removed: System treatment;] [added: system treatment] driving more consumers to dental professionals for those treatments.

*COVID-19 [added: Pandemic] Update*

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

We group our operations into two reportable segments: Clear Aligner segment and [removed: Imaging] Systems and [removed: CAD/CAM] Services [removed: (“Systems and Services”)] segment.

- Non-Comprehensive Products include, but are not limited to, Invisalign Moderate, Lite and Express packages and Invisalign [removed: Go.][added: Go and Invisalign Go Plus.]

- Our Systems and Services segment consists of our iTero intraoral scanning systems, which includes a single hardware platform and restorative or orthodontic software [removed: options, OrthoCAD services and ancillary products, as well as exocad’s CAD/CAM software solution that integrates workflows to dental labs and dental practices.][added: options.]

Net revenues for our Clear Aligner and Systems and Services segments by region for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] are as follows (in millions):

| Net Revenues | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | Change | | | | | | | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | | | | | Change | | | | | | | | |

| Americas | | | | | | $ | [removed: 1,010.2] [added: 1,544.8] | | | | | $ | [removed: 1,022.1] [added: 1,010.2] | | | | | $ | [removed: (11.9)] [added: 534.5] | | | | | [removed: (1.2)] [added: 52.9] | | % | | | | $ | [removed: 1,022.1] [added: 1,010.2] | | | | | $ | [removed: 903.3] [added: 1,022.1] | | | | | $ | [removed: 118.8] [added: (11.9)] | | | | | [removed: 13.2] [added: (1.2)] | | % |

| International | | | | | | [removed: 965.4] [added: 1,498.7] | | | | | | [removed: 881.4] [added: 965.4] | | | | | | [removed: 84.1] [added: 533.2] | | | | | | [removed: 9.5] [added: 55.2] | | % | | | | [removed: 881.4] [added: 965.4] | | | | | | [removed: 684.2] [added: 881.4] | | | | | | [removed: 197.2] [added: 84.1] | | | | | | [removed: 28.8] [added: 9.5] | | % |

| Non-case | | | | | | [removed: 125.8] [added: 203.7] | | | | | | [removed: 122.3] [added: 125.8] | | | | | | [removed: 3.5] [added: 77.8] | | | | | | [removed: 2.9] [added: 61.9] | | % | | | | [removed: 122.3] [added: 125.8] | | | | | | [removed: 104.0] [added: 122.3] | | | | | | [removed: 18.3] [added: 3.5] | | | | | | [removed: 17.6] [added: 2.9] | | % |

| Total Clear Aligner net revenues | | | | | | $ | [removed: 2,101.5] [added: 3,247.1] | | | | | $ | [removed: 2,025.8] [added: 2,101.5] | | | | | $ | [removed: 75.7] [added: 1,145.6] | | | | | [removed: 3.7] [added: 54.5] | | % | | | | $ | [removed: 2,025.8] [added: 2,101.5] | | | | | $ | [removed: 1,691.5] [added: 2,025.8] | | | | | $ | [removed: 334.3] [added: 75.7] | | | | | [removed: 19.8] [added: 3.7] | | % |

| Systems and Services net revenues | | | | | | [removed: 370.5] [added: 705.5] | | | | | | [removed: 381.0] [added: 370.5] | | | | | | [removed: (10.6)] [added: 335.0] | | | | | | [removed: (2.8)] [added: 90.4] | | % | | | | [removed: 381.0] [added: 370.5] | | | | | | [removed: 275.0] [added: 381.0] | | | | | | [removed: 106.0] [added: (10.6)] | | | | | | [removed: 38.5] [added: (2.8)] | | % |

| Total net revenues | | | | | | $ | [removed: 2,471.9] [added: 3,952.6] | | | | | $ | [removed: 2,406.8] [added: 2,471.9] | | | | | $ | [removed: 65.1] [added: 1,480.6] | | | | | [removed: 2.7] [added: 59.9] | | % | | | | $ | [removed: 2,406.8] [added: 2,471.9] | | | | | $ | [removed: 1,966.5] [added: 2,406.8] | | | | | $ | [removed: 440.3] [added: 65.1] | | | | | [removed: 22.4] [added: 2.7] | | % |

Clear Aligner Case [removed: Volume by Region][added: Volume]

Case volume data which represents Clear Aligner case shipments [removed: by region] for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] is as follows (in thousands):

| [removed: Region] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | Change | | | | | | | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | | | | | Change | | | | | | | | |

| Total case volume | | | | | | [removed: 1,645.3] [added: 2,547.7] | | | | | | [removed: 1,537.1] [added: 1,645.3] | | | | | | [removed: 108.3] [added: 902.4] | | | | | | [removed: 7.0] [added: 54.8] | | % | | | | [removed: 1,537.1] [added: 1,645.3] | | | | | | [removed: 1,280.6] [added: 1,537.1] | | | | | | [removed: 256.5] [added: 108.3] | | | | | | [removed: 20.0] [added: 7.0] | | % |

Americas net revenues [removed: decreased] [added: increased] by [removed: $11.9] [added: $534.5] million in [removed: 2020] [added: 2021] as compared to [removed: 2019] [added: 2020] primarily due to [added: a 57.6% increase in volume which resulted in higher net revenues of $582.1 million, partially offset by] lower [removed: Clear Aligner] ASP that decreased net revenues by [removed: $34.6 million.]

International net revenues increased by [removed: $84.1] [added: $533.2] million in [removed: 2020] [added: 2021] as compared to [removed: 2019] [added: 2020] primarily due to [removed: higher Clear Aligner] [added: a 51.6% increase in] volume which [removed: increased net revenues by $117.2 million partially offset by lower ASP which reduced] [added: resulted in higher] net revenues by [removed: $33.1] [added: $497.8] million.

Executive Overview of Results

Trends and Uncertainties

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

We continue to invest in manufacturing operations, research and development, clinical treatment planning, sales and marketing and building our quality and regulatory capabilities in existing and emerging markets globally.

For instance, 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;

◦announced plans to open an aligner fabrication facility in Wroclaw, Poland as a part of our strategy to bring operational facilities closer to customers and thereby serve them more quickly and respond to their needs more effectively as well as new treatment planning operations in targeted regional geographies; and

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

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

- We believe our training and education efforts are important to building the confidence within the GP and orthodontic communities needed to increase their adoption and utilization of 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 the profitability of their dental practices by enhancing patient experiences.

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

We need to continue to innovate, develop and bring to market products and solutions that deliver the ever-increasing clinical precision and predictability doctors expect with the speed and convenience their patients require.

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.

- Patient demand and conversion depends on making targeted investments in advertising and public relations through social media, influencers and other forms of digital communications to encourage patients to seek treatment from Invisalign trained doctors.

For instance, in 2021, we introduced the “Invis-is” consumer advertising campaign with new creative content and influencers focused on teens, moms and young adults.

In addition, we are pursuing new lines of Consumer Products that are complementary to our doctor-prescribed principal products currently available in certain e-commerce channels in the U.S. Similarly, in order to grow our retainer business, which is significantly underpenetrated, we have begun investing more directly in marketing strategies focused on driving adoption and increasing market share in the U.S.

As we continue to emphasize the benefits of the Invisalign system for teenage and younger patient treatments through education, training and sales and marketing programs, we expect utilization rates to rise.

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.

*Key financial and operating metrics*

We measure our performance against these strategic priorities by the achievement of key financial and operating metrics.

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:

Overview

Our purpose is to transform smiles and change lives, and we are accomplishing this goal by establishing clear aligners as the principal solution for the treatment of malocclusions and our Invisalign clear aligners as the treatment solution of choice by orthodontists, general dental practitioners and patients globally.

To encourage consumers to treat malocclusions with clear aligners under the direction and supervision of licensed dental professionals, we have developed a business strategy designed to bring to market solutions that we believe strengthen our digital dental platform for doctors, labs and partners, including establishing the iTero intraoral scanner and related services as the preferred 3D digital scanning solution and integrating computer-aided design and computer-aided manufacturing (“CAD/CAM”) solutions and workflows into the markets for clear aligner orthodontics and dental restorative treatments.

For a further description of our strategic growth drivers, please see the *Business - Business Strategy* section of this Annual Report on Form 10-K.

- *New Technology, Products, and Feature Enhancements.* We believe technological innovations allowing dental professionals to more quickly and accurately diagnose, plan and treat a wide range of cases from simple to complex combined with new and improved products drives greater treatment predictability, clinical applicability, ease of use and confidence for the dental professionals we serve; thereby supporting adoption of Invisalign treatment in their practices.

Furthermore, we believe the digital revolution in dentistry is an important aspect of the experience for our customers and their patients, encouraging the utilization of our Invisalign solution and therefore comprising an important component of our digital approach.

▪*Invisalign clear aligners:* Our product portfolio includes Invisalign treatment with Mandibular Advancement, Invisalign Go, Invisalign First and Invisalign Moderate.

We also continue to increase the clinical efficacy and applicability of our products as exemplified most recently in the announcement of Invisalign G8 with SmartForce Aligner Activation, and our ClinCheck Pro 6.0 3D treatment planning software.

Each of these advancements broadens and strengthens our reach into key markets and demographics central to our strategic plans.

▪*iTero Scanner:* We continue to expand our intraoral digital scanning solutions; periodically launching or announcing new offerings including most recently the iTero Element® Plus Series of scanner solutions and previously the iTero Element 2, iTero Element Flex and the iTero Element 5D Imaging System, for which we announced in March 2020 that we had obtained U.S. FDA 501(K) clearance and which we continue to release in additional countries.

The clearance of the iTero Element 5D Imaging system in the U.S. markets and its release in other countries allows us to sell this first integrated dental imaging system that simultaneously records 3D, intra-oral color and near-infrared (“NIRI”) images into a single, integrated scan that enables comparison over time using the iTero TimeLapse technology; thereby improving doctor experiences and improving engagement opportunities and communications with their patients.

The iTero Element 5D aids in the detection and monitoring of interproximal caries lesions above the gingiva without using harmful radiation.

- *exocad:* On April 1, 2020, we completed the acquisition of privately-held exocad Global Holdings GmbH (“exocad”), a German dental CAD/CAM software company that offers fully integrated workflows to dental labs and practices.

We believe the acquisition strengthens our digital platform by adding exocad’s expertise in restorative dentistry, implantology, guided surgery, and smile design to extend our digital dental solutions and broadens the Align digital platform towards fully interdisciplinary end-to-end workflows dentistry in lab and at chairside.

exocad also broadens our reach in digital dentistry with over 200 partners and more than 40,000 licenses installed worldwide.

To further the transformation of dental and orthodontic practices from outdated manual and analog practices to end-to-end digital workflows, in 2020 we introduced virtual solutions such as Invisalign® Virtual Appointment and Invisalign® Virtual Care; solutions that facilitate the safe, effective and successful continuity of treatment of patients by conveniently connecting doctors and their patients throughout their treatment plans.

- *Invisalign Adoption.* Our goal is to establish Invisalign clear aligners as the treatment of choice for treating malocclusion, ultimately driving increased product adoption and frequency of use by dental professionals, which we refer to as “utilization rates.”

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

- *Invisalign Doctor Training.* We believe our training and education efforts are an important aspect of each of our strategic growth drivers and, accordingly, we continue to expand our Invisalign customer base through the training of new doctors.

During 2020, we trained 21,100 new Invisalign doctors of which 9,075 were trained in the Americas region and 12,025 in the International region.

In 2019, we trained a total of 22,275 new Invisalign doctors, of which 9,765 were trained in the Americas region and 12,510 in the International region.

- *International Invisalign Growth.* Our future growth is dependent upon the continued penetration and expansion of Invisalign product usage in international markets.

Accordingly, we continue to focus our efforts towards increasing Invisalign clear aligner adoption by dental professionals internationally.

In 2020, the COVID-19 pandemic caused unprecedented disruptions in our business as we, our customers, and suppliers experienced varying degrees of business and facilities closures and restrictions at various times that differed by geography and conditions and significant uncertainties remain.

*For a further discussion of COVID-19 and its impact on our business, see the section entitled "COVID-19 Update" below.* Moreover, even under ideal circumstances the difficulties and intricacies of international sales and operations can be difficult to manage and we expect to periodically experience fluctuations in growth rates in emerging markets for reasons ranging from regional and macroeconomic conditions, geopolitical tensions and competition among others.

For a description of the risks related our international growth efforts, please see the *Risk Factors* section of this Annual Report on Form 10-K.

For instance, prior to the impact of COVID-19, we experienced slower growth rates than prior periods in China which we believe were primarily due to the U.S.-China trade war and resulting economic uncertainty which caused headwind for consumer demand especially for consumption of luxury goods and considered purchases.

We also believe there has been increased competitive activity in China from clear aligner suppliers.

Furthermore, we continue to expand in our existing markets through targeted investments in sales coverage and professional marketing and education programs, along with consumer marketing in select country markets.

For instance, we increased our sales presence in APAC in the first half of 2020 and will continue to strategically invest in regions as we deem appropriate for long-term success.

- *Increasing Competition.* Our primary competition for the sale of our clear aligners remains traditional wires and brackets although the number of clear aligner competitors, primarily targeting the young adult demographic, continues to increase.

We also have competitors in the markets for other products and services, including intraoral scanners and CAD/CAM software.

We believe our continued investments in product improvements and operational efficiencies make our products more compelling for our customers and their patients and we intend to maintain these efforts.

During 2020, our marketing and consumer engagement included

social media campaigns targeting teens and mothers through social media influencers, becoming the Official Clear Aligner Sponsor of the National Football League and introducing Invisalign Stickables which patients can apply to their aligners as a fun and simple way to distinguish themselves and our products from the competition.

We also believe that investing in our sales teams is important to our success.

The addition of sales representatives in APAC in 2020 follows increases in the U.S. in 2019.

We believe the realignment of our sales teams to focus on the channels they serve, allows us to partner with doctors in more meaningful ways; assessing their specific needs and helping to tailor their practices for success while encouraging increased adoption and engagement of a variety of our products and services.

The COVID-19 pandemic disrupted our business and the businesses and lives of our customers, their patients and our suppliers in unprecedented ways; requiring us to reevaluate priorities, adapt to new ways of doing business and developing new strategies and plans quickly and revising them frequently as conditions evolved.

By the end of the fourth quarter of 2020, many dental practices had resumed operations although often at capacities less than pre-pandemic levels.

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

As of December 31, [removed: 2020,] [added: 2021,] we had [removed: no investments] [added: approximately $197.3 million invested] in available-for-sale marketable securities.

Based on interest bearing liabilities we have as of December 31, [removed: 2020,] [added: 2021,] we are not subject to risks from immediate interest rate increases.

Prior to the closing of the exocad acquisition on April 1, 2020, we entered into a Euro foreign currency forward contract with a notional contract amount of €376.0 million.

During the year ended December 31, 2020, we recognized a loss of $10.2 million within other income (expense), net in our Consolidated Statement of Operation.

Align Technology, Inc. (“We”, “Our”, “Align”) is a global medical device company [added: primarily] engaged in the design, manufacture and marketing of Invisalign® clear [removed: aligners and] [added: 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.

Our [removed: products are] [added: Invisalign system is] intended [removed: primarily] [added: mainly] for the treatment of [removed: malocclusion or the misalignment of teeth] [added: malocclusions] and [removed: are] [added: is] designed to help dental professionals achieve the clinical outcomes that they expect and the results patients desire.

Our [removed: goal is] [added: primary goals are] to establish clear aligners as the principal solution for the treatment of [removed: malocclusions] [added: malocclusions, or the misalignment of teeth,] and our Invisalign [removed: System] [added: system] as the treatment solution of choice by orthodontists, general dental practitioners and patients [removed: globally.][added: globally, our intraoral scanners as the]

To date, over [removed: 9.6] [added: 12] million people worldwide have been treated with our Invisalign [removed: System.][added: system.]

[removed: Effective January 1, 2021,] Align’s corporate headquarters [removed: is] [added: are] located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona [removed: 85281, and our telephone number is 408-470-1000.][added: 85281.]

Our internet address is [removed: www.aligntech.com.][added: *www.aligntech.com*.]

For the year ended December 31, [removed: 2020,] [added: 2021,] Clear Aligner net revenues represented approximately [removed: 85%] [added: 82%] of worldwide net revenues, while Systems and Services net revenues represented the remaining [removed: 15% of worldwide net revenues.][added: 18%.]

We also sell through [removed: non-inventory carrying] sales agents and distributors in certain countries.

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

Our Systems and Services [removed: products] [added: products, which includes our iTero intraoral scanners,] are primarily sold through our direct sales force and through [removed: non-inventory carrying] sales agents and distributors in certain countries and directly to DSOs.

[removed: We acquired] [added: Our] exocad [removed: for its expertise in] [added: CAD/CAM software products provide] restorative dentistry, implantology, guided surgery, and smile design to [removed: extend the Invisalign System and iTero digital solutions] [added: dental labs] and [removed: pave] [added: dental practices through fully integrated workflows, paving] the way for new, cross-disciplinary dentistry in labs and at chairside.

[removed: exocad now has] [added: There are] over 200 [added: exocad strategic distribution] partners and [removed: more than 40,000] [added: over 47,000] software licenses installed worldwide.

[removed: Malocclusion, or the misalignment of teeth,] [added: Malocclusion] is one of the most prevalent clinical dental conditions, affecting [removed: billions of people, or] approximately 60% to 75% of the global population.

Annually, approximately [removed: 15] [added: 21] million people [removed: in major developed countries] [added: globally] elect treatment by [removed: orthodontists worldwide.][added: orthodontists.]

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

Upon completion of the treatment, the dental professional [removed: may, at his or her discretion, have] [added: may recommend] the patient use a retainer appliance.

Of the [removed: 15] [added: 21] million [removed: annual global orthodontic] cases started, we estimate that approximately 90% or [removed: 13.5] [added: 19] million could be treated using our Invisalign [removed: clear aligners.][added: system.]

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

An Invisalign [removed: System] 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.

[added: Globally, more than 85% of Invisalign system case submissions are now submitted via digital scan, increasing the accuracy of] treatments, reducing the time from prescription submission to patient receipt, and decreasing the carbon footprint resulting from the shipment of the materials used to form PVS impressions to the doctors and shipping those PVS impressions back to us.

Using the [removed: information,] [added: digital scans or PVS impressions,] certain doctor preferences and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a ClinCheck® treatment plan using proprietary software we have developed through significant, ongoing investments over more than 20 years.

*Review and approval of the treatment plan by an Invisalign trained doctor.* The patient’s ClinCheck treatment plan is then made available to the prescribing dental professional via Align’s Invisalign Doctor [removed: Site which enables] [added: Site, enabling] the dental professional to evaluate projected tooth movement from initial position to final position and compare multiple treatment plan options.

*Manufacture of custom aligners.* Following the dental professional’s approval of [removed: the] [added: a] ClinCheck treatment plan, we use the data underlying the simulation as input for the next stage in which we use stereolithography technology (a form of 3D printing technology) to construct a series of molds depicting the future position of the patient’s teeth.

Aligners are thin, clear polymer, removable dental appliances that are custom manufactured in a series [added: designed] to correspond to each stage of the patient's ClinCheck treatment plan.

*Shipment to the dental professional and patient aligner wear.* Once manufactured, [removed: in most countries] all the aligners for a patient's [added: doctor-approved] treatment plan are [added: typically] shipped directly to the dental professional, who then dispenses them to the patient at regular check-up intervals.

Aligners are generally worn for a short period of time corresponding to the stages of the patient’s approved ClinCheck treatment [removed: plan.][added: plan and their doctor’s discretion.]

We offer our Invisalign [removed: clear aligner products] [added: system] in a variety of treatment packages designed to correspond with the case-by-case treatment needs of our doctors and their patients.

The table below provides a general description of the [removed: types] [added: categories] of treatment products we offer in various regions as they typically correspond to the severity of malocclusion and length of anticipated treatment.

| Malocclusion | | | Very Mild | | | [removed: ] [added: ] | | | Moderate | | | [removed: ] [added: ] | | | Severe | | |

| Product | | | Invisalign Express Package | | | Invisalign Lite Package | | | Invisalign Go Limited Movement (GP) | | | Invisalign Moderate Packages [added: (& Invisalign Go Plus)] | | | Invisalign Comprehensive Packages | | |

| [removed: Stages] [added: Treatment Stages*] | | | 7 | | | 14 | | | 20 | | | 20-26 | | | As many as required | | |

| Clinical Scope | | | Relapse and minor movement, anterior esthetic alignment | | | Class I, mild crowding/spacing, non-extraction, pre-restorative | | | Class I, no anterior / posterior correction, mild to moderate crowding, spacing, non-extraction, pre-restorative Tooth movement from 2nd premolar to 2nd premolar (5x5) | | | Class I, mild Class II, mild to moderate crowding/spacing, mild anterior / posterior and vertical discrepancies, [removed: pre-restorative] [added: pre-restorative, (Go Plus tooth movement from 1st molar to 1st molar (6X6))] | | | Class I, II, III, moderate to severe crowding/spacing, anterior / posterior and vertical discrepancies, extractions, complex pre-restorative | | |

The Invisalign Comprehensive Package is used to treat adults and teens [removed: for] [added: over] a [removed: full] [added: wide] spectrum of mild to severe malocclusion and contains a [removed: wide] [added: broad] variety of Invisalign features to address the [removed: doctor's] [added: desired] treatment goals.

Invisalign First Phase 1 treatment provides early interceptive orthodontic treatment, traditionally done through arch [removed: expanders,] [added: expansion,] or partial metal braces, before all permanent teeth have erupted.

Invisalign First Phase 1 clear aligners are designed specifically to address a [removed: broad] [added: wide] range of younger patients' malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion.

Our Invisalign First Comprehensive Phase 2 Package is [removed: a continuation of] [added: complementary to] Invisalign First Phase 1 and is generally consistent with our Invisalign Comprehensive Package.

After a patient completes Invisalign First Phase 1, doctors have the option to purchase a [removed: discounted] Comprehensive Phase 2 Package for that same patient.

Clear Aligner non-case products include retention products, Invisalign [removed: training fees and sales of ancillary products, such as cleaning material and] [added: training,] adjusting tools used by dental professionals during the course of [removed: treatment.][added: treatment and ancillary Consumer Products and other oral health products available in certain e-commerce channels in the U.S.]

We offer up to four sets of custom clear aligners called Vivera [removed: Retainers] [added: retainers] made with proprietary material strong enough to maintain tooth position and correct minor relapse, if [removed: necessary.][added: necessary, as well as Invisalign retainers.]

*SmartTrack Aligner [removed: Material*][added: Material:*]

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”).

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

Our telephone number is 602-742-2000.

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.

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.

Additionally, it is during this stage that exocad’s CAD/CAM software platform can be used to identify, assess and assist doctors and dental labs to collaborate on any needed ortho-restorative treatment options through comprehensive interdisciplinary workflows.

Additionally, for patients treated using many of our Invisalign system treatments, doctors have the option to adjust treatment plans to achieve desired results by ordering additional clear aligners in accordance with pre-defined terms.

* The number of stages can vary by product and region.

*Feature Enhancement / New Products*

*New Invisalign Innovations in Treatment Planning for Align Digital Platform.* Released in early 2022, the new Invisalign system innovations as a part of the Align digital platform is a combination of software, systems and services designed to provide a seamless experience and workflow that integrates and connects all users – doctors, labs, patients and consumers.

These new innovations include ClinCheck Live Update for 3D controls, the Invisalign Practice App, Invisalign Personalized Plan and Invisalign Smile Architect.

Further, in the third quarter of 2021, we announced a multi-year supply and distribution agreement with Ultradent Products to allow Invisalign trained doctors to exclusively offer a professional whitening system using Ultradent’s Opalescence PF whitening system with Vivera retainers.

We also offer in the U.S., 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 doctors who are currently not regularly using our retainers or low-stage aligners.

SmartTrack material maintains more constant force over time.

and is pending regulatory approval in others.

The iTero Element Plus Series of intraoral scanners and imaging systems was introduced in the first quarter of 2021 and offers restorative and orthodontic digital workflows that include enhanced visualization for optimized patient experience, including a fully integrated 3D intraoral camera in certain models,; seamless scanning with reduced processing time, artificial intelligence-based features, and, in certain models, NIRI technology.

Services and Ancillary Products. Our services include subscription software, disposables, rentals, and pay per scan as well as exocad’s CAD/CAM software solutions that integrate workflows to dental labs and dental practices.

iTero intraoral scans can enhance the accuracy and precision of a doctor’s downstream restorative process.

The platform provides doctors and dental labs with digital clinical solutions that aid general dentists and dental labs in planning and delivering restorative dental treatments, adding restorative functionality to our comprehensive digital platform to deliver digital ortho-restorative workflows and interdisciplinary dentistry.

We also recently introduced our 5D Photo uploader enhanced workflow that simplifies the process for submitting images needed for treatment planning.

Other proprietary software mentioned in this Annual Report on Form 10-K, such as software embedded in our iTero

In 2021, the number of international doctors trained to prescribe treatment using the Invisalign system grew by approximately 21% compared to 2020.

We continue expansion of our sales and marketing by reaching into new countries and regions, including new areas within Africa.

By the end of 2021, we were selling directly or through authorized distributors in more than 100 countries.

In 2021, we announced similar plans to open a clear aligner manufacturing facility in Wroclaw, Poland.

Expected to begin serving doctors during the first half of 2022, the new manufacturing facility will be our third aligner fabrication facility and allow us to more quickly and effectively serve tens of thousands of customers throughout EMEA.

To support our belief in the benefits of using our iTero scanners, in October 2021 we announced the findings of a clinical study that validates and demonstrates that the NIRI technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing x-ray radiography for detection of interproximal lesions, without the use of harmful radiation.

To further drive consumer awareness, in 2021 we began offering additional dental-related Consumer Products under the Invisalign brand name available in certain e-commerce channels in the U.S.

adults with the Invisalign system.

This is especially important to treating teenage patients who make up the largest portion of the 21 million annual orthodontic case starts each year.

In combination with the new Invisalign system innovations that are part of the Align digital platform, we are enhancing the digital treatment planning experience for orthodontics and restorative dentistry by providing doctors with greater flexibility, consistency of treatment preferences and real-time treatment plan access and modification capabilities.

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.

Expected to begin serving doctors during the first half of 2022, the new aligner fabrication facility will be our third and allow us to more quickly and effectively serve tens of thousands of customers throughout EMEA.

Additionally, in the third quarter of 2021, we opened our multi-story iTero scanner and services facilities in Petach Tikva, Israel to further the design and development of our portfolio of iTero intraoral scanners, imaging systems and services.

We are routinely audited by third party certification bodies as well as global health authorities for our compliance to this quality standard as well as international regulations.

In each region, we have direct sales, marketing and support

Additionally, our consumer marketing programs are designed to create awareness and educate consumers on the benefits of Invisalign treatment and Vivera retainers, including where they can find a trained doctor to provide treatment.

The Invisalign System is regulated by the FDA as a Class II medical device.

We received 510(k) clearance from the FDA to market iTero software for expanded indications in 2013.

In April 2020, we completed the acquisition of privately-held exocad Global Holdings GmbH (“exocad”), a German dental CAD/CAM software company that offers fully integrated workflows to dental labs and dental practices.

See “Third Party Scanners and Digital scans.” More than 79% of Invisalign System case submissions are now submitted via digital scan, increasing the accuracy of

At the treating doctor’s discretion, weekly aligner changes are recommended for all Invisalign treatments except for Express packages and may provide shorter treatment time compared with two-week aligner wear.

*Feature Enhancements*

We continually introduce enhanced features across our digital platform that includes our Invisalign System, iTero intraoral scanners, exocad CAD/CAM solutions and digital workflows to improve treatment outcomes, address broader clinical indications or respond to customer demand.

2020 saw a number of new innovations intended to enhance the ease by which doctors can diagnose, plan and treat patients more efficiently and effectively, many of which became critically important to patient care in the wake of limited in-person visits as a result of the COVID-19 pandemic.

In addition to other examples referenced throughout this Annual Report on Form 10-K, in 2020 Align launched the following products:

- *Invisalign Virtual Appointment and Invisalign Virtual Care* - Two continuity of care virtual solutions generally released in May 2020 that offer practice and care transformation to doctors by enabling a range of remote practice services for their patients such as video appointments and care and treatment progress reviews and communications.

- *ClinCheck 6.0 Pro Software* \- Released in the third quarter of 2020, ClinCheck Pro 6.0 software is the latest release of Align’s proprietary 3D treatment planning software showing the planned tooth movements throughout a patient’s Invisalign treatment, now more broadly available to doctors on multiple devices at any time via the cloud.

ClinCheck Pro 6.0 software also included the ClinCheck “In-Face” Visualization tool, enhancing the digital treatment planning experience for doctors and their patients by incorporating a front-facing image of a patient’s face into their 3D ClinCheck treatment plan to create a personalized view of how their new smile could look with Invisalign System treatment.

- *Invisalign Stickables -* Released in the third quarter of 2020, Invisalign Stickables are sticker accessories designed exclusively for use with our patented SmartTrack® material in Invisalign clear aligners to personalize Invisalign clear aligners.

Invisalign Stickables are available in an array of designs, colors, shapes, and themes and allow patients to show their personal flair during Invisalign System treatment in fun and engaging ways.

The iTero Element scanner is available as a single hardware platform with software options for restorative or orthodontic procedures.

In February 2019, we launched the iTero Element 5D Imaging system which provides a new comprehensive approach to clinical applications, workflows and user experience that expands the suite of existing high-precision, full-color imagining and fast scan times of the iTero Element scanner portfolio and in March 2020, we received U.S. FDA 501(K) clearance for the system.

We also recently announced the launch of the iTero Element Plus Series next generation of scanners and imaging systems featuring advanced technology and capabilities designed to improve the scanning experience and increase practice productivity.

The iTero Element Plus Series offers faster processing times and advanced visualization capabilities in an ergonomically designed package available in both cart and mobile configurations for greater practice flexibility.

*Orthodontic software for iTero.

*CAD/CAM Services and Ancillary Products*

*TimeLapse Technology.

Our goal remains to establish the Invisalign System as the standard method for treating malocclusion and our intraoral scanning platform as the preferred scanning protocol for digital dental scans.

During 2020, we shipped our Invisalign System to our 2 millionth patient in EMEA and 1 millionth patient in APAC.

As our core

and judgmental tasks for each case, thereby increasing the efficiency of our technicians.

A discussion of the risks of our supply and manufacturing operations may be found in *Item 1A* of this Annual Report on Form 10-K under the heading "*Risk Factors."*

Our clear aligner products compete directly against traditional treatments using metal brackets and wires and increasingly against clear aligner products manufactured and distributed by various companies, both within and outside the U.S. We also face competition in the emerging and rapidly evolving markets for intraoral scanners and CAD/CAM software.

We are also subject to various laws inside and outside the U.S. concerning our relationships with healthcare professionals and government officials, price reporting and regulation, the promotion, sale and marketing of our products and services, the importation and exportation of our products, the operation of our facilities and distribution of our products.

As a global company, we are subject to varying degrees of government regulation in the various countries in which we do business, and the general trend is toward increasingly stringent oversight and enforcement.

We are also required to be in compliance with the California Consumer Privacy Act (“CCPA”).

With relocation of our EMEA headquarters to Switzerland, the Swiss Federal Act on Data Protection (“FADP”), passed September 25, 2020, becomes increasingly important.

This is in addition to opportunities offered for job development such as management skills training and trainings that improve their opportunities for advancement.

Importantly, during the initial onset of the pandemic in early 2020, we committed to protect our employees financially by declaring that we did not intend to furlough, lay off or cut employee pay.

We believe our strong operational performance in the second half of 2020 is directly attributable to that decision along with the exceptional efforts of our employees throughout the pandemic.

We also invest to ensure our facilities and equipment are safe by complying with OSHA or other statutory standards.

For example, in 2020 we pledged a $1 million donation to support COVID-19 global relief efforts.

This was in addition to a 1 million renminbi donation to the Chinese Red Cross to support its COVID-19 prevention and control efforts and donations of personal protective equipment to hospitals and healthcare providers treating patients with COVID-19.

*Information Systems.* We understand the critical nature of measurable data and insights from a human capital perspective.

We made the decision to leverage a cloud-based human capital management software solution that unifies our wide range of human relations functionality onto one single platform.

This allows support for the entire enterprise with qualitative and quantitative analytics specific to employee transactions, processes and programs, thereby creating a culture where data and analytics are the norm and to drive key decisions.

For the fiscal year ended December 31, [removed: 2020][added: 2021]

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $14.5] [added: $34.7] billion as of June 30, [removed: 2020] [added: 2021] based on the closing sale price of the registrant’s common stock on the NASDAQ Global Market on such date.

On February [removed: 22, 2021, 79,132,723] [added: 21, 2022, 78,795,494] shares of the registrant’s common stock were outstanding.

Portions of the registrant’s definitive Proxy Statement relating to its [removed: 2021] [added: 2022] Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end of December 31, [removed: 2020] [added: 2021] are incorporated by reference into Part III of this Annual Report on Form 10-K.

For the Year Ended December 31, [removed: 2020][added: 2021]

| Item 1. | | | [removed: Business] [added: [Business](#if1d94140443e4bd999abda4b2e587ec9_13)] | | | [removed: [3](#i36420fe7c39c4c91ac8d2d223148c9b1_13)] [added: [3](#if1d94140443e4bd999abda4b2e587ec9_13)] | | |

| Item 1A. | | | [removed: Risk Factors] [added: [Risk Factors](#if1d94140443e4bd999abda4b2e587ec9_19)] | | | [removed: [14](#i36420fe7c39c4c91ac8d2d223148c9b1_19)] [added: [16](#if1d94140443e4bd999abda4b2e587ec9_19)] | | |

| Item 1B. | | | [removed: Unresolved] [added: [Unresolved] Staff [removed: Comments] [added: Comments](#if1d94140443e4bd999abda4b2e587ec9_22)] | | | [removed: [32](#i36420fe7c39c4c91ac8d2d223148c9b1_22)] [added: [38](#if1d94140443e4bd999abda4b2e587ec9_22)] | | |

| Item 2. | | | [removed: Properties] [added: [Properties](#if1d94140443e4bd999abda4b2e587ec9_25)] | | | [removed: [32](#i36420fe7c39c4c91ac8d2d223148c9b1_25)] [added: [39](#if1d94140443e4bd999abda4b2e587ec9_25)] | | |

| Item 3. | | | [removed: Legal Proceedings] [added: [Legal Proceedings](#if1d94140443e4bd999abda4b2e587ec9_28)] | | | [removed: [32](#i36420fe7c39c4c91ac8d2d223148c9b1_28)] [added: [39](#if1d94140443e4bd999abda4b2e587ec9_28)] | | |

| Item 4. | | | [removed: Mine] [added: [Mine] Safety [removed: Disclosures] [added: Disclosures](#if1d94140443e4bd999abda4b2e587ec9_31)] | | | [removed: [32](#i36420fe7c39c4c91ac8d2d223148c9b1_31)] [added: [39](#if1d94140443e4bd999abda4b2e587ec9_31)] | | |

| Item 5. | | | [removed: Market] [added: [Market] for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities] [added: Securities](#if1d94140443e4bd999abda4b2e587ec9_37)] | | | [removed: [33](#i36420fe7c39c4c91ac8d2d223148c9b1_37)] [added: [40](#if1d94140443e4bd999abda4b2e587ec9_37)] | | |

| Item 7. | | | [removed: Management’s] [added: [Management’s] Discussion and Analysis of Financial Condition and Results of [removed: Operations] [added: Operations](#if1d94140443e4bd999abda4b2e587ec9_43)] | | | [removed: [34](#i36420fe7c39c4c91ac8d2d223148c9b1_43)] [added: [41](#if1d94140443e4bd999abda4b2e587ec9_43)] | | |

| Item 7A. | | | [removed: Quantitative] [added: [Quantitative] and Qualitative Disclosures About Market [removed: Risk] [added: Risk](#if1d94140443e4bd999abda4b2e587ec9_82)] | | | [removed: [50](#i36420fe7c39c4c91ac8d2d223148c9b1_82)] [added: [52](#if1d94140443e4bd999abda4b2e587ec9_82)] | | |

| Item 8. | | | [removed: Consolidated Financial] [added: [Financial] Statements and Supplementary [removed: Data] [added: Data](#if1d94140443e4bd999abda4b2e587ec9_85)] | | | [removed: [52](#i36420fe7c39c4c91ac8d2d223148c9b1_85)] [added: [54](#if1d94140443e4bd999abda4b2e587ec9_85)] | | |

| Item 9. | | | [removed: Changes] [added: [Changes] in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure] [added: Disclosure](#if1d94140443e4bd999abda4b2e587ec9_175)] | | | [removed: [93](#i36420fe7c39c4c91ac8d2d223148c9b1_181)] [added: [92](#if1d94140443e4bd999abda4b2e587ec9_175)] | | |

| Item 9A. | | | [removed: Controls] [added: [Controls] and [removed: Procedures] [added: Procedures](#if1d94140443e4bd999abda4b2e587ec9_178)] | | | [removed: [94](#i36420fe7c39c4c91ac8d2d223148c9b1_184)] [added: [92](#if1d94140443e4bd999abda4b2e587ec9_178)] | | |

| Item 9B. | | | [removed: Other Information] [added: [Other Information](#if1d94140443e4bd999abda4b2e587ec9_181)] | | | [removed: [94](#i36420fe7c39c4c91ac8d2d223148c9b1_187)] [added: [93](#if1d94140443e4bd999abda4b2e587ec9_181)] | | |

| Item 10. | | | [removed: Directors,] [added: [Directors,] Executive Officers and Corporate [removed: Governance] [added: Governance](#if1d94140443e4bd999abda4b2e587ec9_187)] | | | [removed: [94](#i36420fe7c39c4c91ac8d2d223148c9b1_193)] [added: [93](#if1d94140443e4bd999abda4b2e587ec9_187)] | | |

| Item 11. | | | [removed: Executive Compensation] [added: [Executive Compensation](#if1d94140443e4bd999abda4b2e587ec9_190)] | | | [removed: [94](#i36420fe7c39c4c91ac8d2d223148c9b1_196)] [added: [93](#if1d94140443e4bd999abda4b2e587ec9_190)] | | |

| Item 12. | | | [removed: Security] [added: [Security] Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters] [added: Matters](#if1d94140443e4bd999abda4b2e587ec9_193)] | | | [removed: [95](#i36420fe7c39c4c91ac8d2d223148c9b1_199)] [added: [94](#if1d94140443e4bd999abda4b2e587ec9_193)] | | |

| Item 13. | | | [removed: Certain] [added: [Certain] Relationships and Related Transactions and Director [removed: Independence] [added: Independence](#if1d94140443e4bd999abda4b2e587ec9_196)] | | | [removed: [95](#i36420fe7c39c4c91ac8d2d223148c9b1_202)] [added: [94](#if1d94140443e4bd999abda4b2e587ec9_196)] | | |

| Item 14. | | | [removed: Principal Accounting Fees] [added: [Principal Account](#if1d94140443e4bd999abda4b2e587ec9_199)[ant](#if1d94140443e4bd999abda4b2e587ec9_199) [Fees] and [removed: Services] [added: Services](#if1d94140443e4bd999abda4b2e587ec9_199)] | | | [removed: [95](#i36420fe7c39c4c91ac8d2d223148c9b1_205)] [added: [94](#if1d94140443e4bd999abda4b2e587ec9_199)] | | |

| Item 15. | | | [removed: Exhibits, Financial] [added: [Exhibits](#if1d94140443e4bd999abda4b2e587ec9_205) [and](#if1d94140443e4bd999abda4b2e587ec9_205) [Financial] Statement [removed: Schedules] [added: Schedules](#if1d94140443e4bd999abda4b2e587ec9_205)] | | | [removed: [96](#i36420fe7c39c4c91ac8d2d223148c9b1_211)] [added: [95](#if1d94140443e4bd999abda4b2e587ec9_205)] | | |

| Item 16. | | | [removed: Form] [added: [Form] 10-K [removed: Summary] [added: Summary](#if1d94140443e4bd999abda4b2e587ec9_208)] | | | [removed: [98](#i36420fe7c39c4c91ac8d2d223148c9b1_214)] [added: [97](#if1d94140443e4bd999abda4b2e587ec9_208)] | | |

These statements include, among other things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our estimates regarding the size and opportunities of the markets we are targeting along with our expectations for growth in those markets, our beliefs regarding the impact of technological innovation in general, and in our solutions and products in particular, on target markets and patient care, our beliefs regarding digital dentistry and its potential to impact our business, our intentions regarding expanding our business, including its impact on our operational flexibility and responsiveness to customer demand, our [removed: expectations for the impact of the exocad acquisition, our] beliefs regarding the potential for clinical solutions and their utilization to increase sales of our Invisalign system as well as the complementary products and solutions themselves, our beliefs regarding doctor training and its impact on Invisalign [removed: System] [added: system] utilization, our beliefs regarding the importance of our manufacturing operations on our success, our beliefs regarding the need for and benefits of our technological development on Invisalign treatment, the areas of development in which we focus our efforts, and the advantages of our intellectual property portfolio, our beliefs regarding our business strategy and growth drivers, our expectations regarding product mix and product adoption, our expectations regarding the utilization rates for our products, including the impact of marketing on those rates and causes for periodic fluctuations of the rates, our expectations regarding the existence and impact of seasonality and the COVID-19 disruptions to seasonality, our expectations regarding the sales growth of our intraoral scanner sales in international markets, our expectations regarding the productivity impact additional sales representatives will have on our sales and the impact of specialization of those representatives in sales channels, our expectations regarding the continued expansion of our international [removed: markets, including our expectation that international revenues will grow at a faster rate than Americas for the foreseeable future,] [added: markets and their growth,] our expectation regarding customer and consumer purchasing behavior, including expectations related to the consumer demand environment in China especially for U.S. based products and services, our expectations regarding competition and our ability to compete in our target markets, our beliefs concerning our compliance with applicable laws and regulations, our beliefs regarding our culture and commitment [added: and] its impact on our financial and operational performance and its importance to our future success, our expectations for future investments in and benefits from consumer demand sales and marketing activities, our expectations regarding the implications of the COVID-19 pandemic and the health, safety and economic [removed: recovery] [added: impact] from it, on the global economy, the businesses of our customers, and us, including our preparedness to react to changing circumstances and overall on our revenues, results of operations and financial condition, our expectations for our expenses and capital obligations and expenditures in particular, the actions we will take to control spending and for investments, our intentions regarding the investment of our international earnings from operations, our belief regarding the sufficiency of our cash balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition, and assessment of goodwill and intangible assets, our expectations regarding our tax positions and the [removed: judgments] [added: assumptions] we make related to our tax obligations, our expectations regarding potential additional litigation with SDC Financial LLC and certain [removed: affiliates regarding the “capital account” balance and other matters,] [added: affiliates,] the level of our operating expenses and gross [removed: margins] [added: margin] and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business [removed: strategies.][added: strategies and any other statements that address events or developments that we intend or believe will or may occur in the future.]

These [added: or any] forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements.

(602) 742-2000

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

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

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

| Item 6. | | | [\[Reserved\]](#if1d94140443e4bd999abda4b2e587ec9_40) | | | [41](#if1d94140443e4bd999abda4b2e587ec9_40) | | |

| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#if1d94140443e4bd999abda4b2e587ec9_1099511629825) | | | [93](#if1d94140443e4bd999abda4b2e587ec9_1099511629825) | | |

| [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.

(408) 470-1000

| [PART I](#i36420fe7c39c4c91ac8d2d223148c9b1_10) | | | | | | [3](#i36420fe7c39c4c91ac8d2d223148c9b1_10) | | |

| | | | Executive Officers of the Registrant | | | [14](#i36420fe7c39c4c91ac8d2d223148c9b1_16) | | |

| [PART II](#i36420fe7c39c4c91ac8d2d223148c9b1_34) | | | | | | [33](#i36420fe7c39c4c91ac8d2d223148c9b1_34) | | |

| Item 6. | | | Selected Consolidated Financial Data | | | [34](#i36420fe7c39c4c91ac8d2d223148c9b1_40) | | |

| [PART III](#i36420fe7c39c4c91ac8d2d223148c9b1_190) | | | | | | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_190) | | |

| [PART IV](#i36420fe7c39c4c91ac8d2d223148c9b1_208) | | | | | | [96](#i36420fe7c39c4c91ac8d2d223148c9b1_208) | | |

| Signatures | | | | | | [99](#i36420fe7c39c4c91ac8d2d223148c9b1_217) | | |

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

[removed: At] [added: As of] December 31, [removed: 2020,] [added: 2021,] the significant facilities occupied were as follows:

| Location | | | | | | Lease/Own | | | Primary Use | | | [removed: Expiration of Lease] | | |

| San Jose, California, U.S.A. | | | | | | Own | | | Office for [removed: corporate headquarters1,] research & development and administrative personnel | | | [removed: N/A] | | |

| Raleigh, North Carolina, [removed: U.S.A] [added: U.S.A.] | | | | | | Own | | | Office for Americas regional headquarters | | | [removed: N/A] | | |

| San Jose, Costa Rica | | | | | | Lease and Own | | | Office for administrative personnel, treatment personnel, and customer care | | | [removed: July 2023] | | |

| Moscow, Russia | | | | | | Lease | | | Office for research & development | | | [removed: March 2024] | | |

| [removed: Or Yehuda,] [added: Petah Tikva,] Israel | | | | | | Lease and Own | | | Manufacturing and office for research & development and administrative personnel | | | [removed: February 2022] | | |

| Rotkreuz, Switzerland | | | | | | Lease | | | Office for EMEA regional [removed: headquarters, sales and marketing and administrative personnel] [added: headquarters] | | | [removed: July 2024] | | |

| Juarez, Mexico | | | | | | Own | | | Manufacturing and office for administrative personnel | | | [removed: N/A] | | |

| Ziyang, China | | | | | | [removed: Lease and] Own | | | Manufacturing and office for administrative personnel | | | [removed: May 2021] | | |

| Tempe, Arizona, U.S.A. | | | | | | Lease | | | Office for corporate headquarters | | | | | |

We believe our existing facilities are in good operating condition and are suitable for the conduct of our business.

The significant facilities noted above are used mostly by all our reportable segments.

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.

1 During the fourth quarter of 2020, we entered into a lease agreement for office space in Tempe, Arizona which was designated as our new corporate headquarters effective January 1, 2021.

As of February [removed: 22, 2021,] [added: 21, 2022,] there were approximately [removed: 57] [added: 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: 2015] [added: 2016] to December 31, [removed: 2020.][added: 2021.]

[removed: ][added: ]

Unregistered Sales of Equity [removed: Securities and Use of Proceeds][added: Securities]

[removed: As of December 31, 2020, we have $100.0 million available for repurchase under the $600.0 million repurchase program authorized by our Board of Directors in May 2018 (Refer to] [added: See] *Note [removed: 13 “Common] [added: 13* “*Common] Stock Repurchase Programs” of the Notes to Consolidated Financial Statements* for details on [removed: our stock repurchase program).][added: the May 2021 Repurchase Program.]

Our common stock is traded on the NASDAQ Global Market under the symbol ALGN.

None.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

The following table summarizes the stock repurchase activity for the three months ended December 31, 2021:

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

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

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

| 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 | | | | | | | | |

*1* *May 2021 Repurchase Program.* On May 13, 2021, we announced that our Board of Directors had authorized a plan to repurchase up to $1.0 billion of our common stock.

Securities Authorized for Issuance under Equity Compensation Plans

Refer to *Part III, Item 12 “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters”* of this Annual Report on Form 10-K for more information regarding securities authorized for issuance.

There were no stock repurchases during the three months ended December 31, 2020.

We have applied the amendment to Regulation S-K Item 301 which became effective on February 10, 2021.

| [removed: Report] [added: [Report] of Management on Internal Control over Financial [removed: Reporting] [added: Reporting](#if1d94140443e4bd999abda4b2e587ec9_91)] | | | [removed: [53](#i36420fe7c39c4c91ac8d2d223148c9b1_91)] [added: [55](#if1d94140443e4bd999abda4b2e587ec9_91)] | | |

| [removed: Report] [added: [Report] of Independent Registered Public Accounting [removed: Firm] [added: Firm](#if1d94140443e4bd999abda4b2e587ec9_94) (PCAOB ID 238)] | | | [removed: [54](#i36420fe7c39c4c91ac8d2d223148c9b1_94)] [added: [56](#if1d94140443e4bd999abda4b2e587ec9_94)] | | |

| [removed: Consolidated] [added: [Consolidated] Statements of Operations for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019](#if1d94140443e4bd999abda4b2e587ec9_97)] | | | [removed: [57](#i36420fe7c39c4c91ac8d2d223148c9b1_97)] [added: [58](#if1d94140443e4bd999abda4b2e587ec9_97)] | | |

| [removed: Consolidated] [added: [Consolidated] Statements of Comprehensive Income for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019](#if1d94140443e4bd999abda4b2e587ec9_100)] | | | [removed: [58](#i36420fe7c39c4c91ac8d2d223148c9b1_100)] [added: [59](#if1d94140443e4bd999abda4b2e587ec9_100)] | | |

| [removed: Consolidated] [added: [Consolidated] Balance Sheets as of December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020](#if1d94140443e4bd999abda4b2e587ec9_103)] | | | [removed: [59](#i36420fe7c39c4c91ac8d2d223148c9b1_103)] [added: [60](#if1d94140443e4bd999abda4b2e587ec9_103)] | | |

| [removed: Consolidated] [added: [Consolidated] Statements of Stockholders’ Equity for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019](#if1d94140443e4bd999abda4b2e587ec9_106)] | | | [removed: [60](#i36420fe7c39c4c91ac8d2d223148c9b1_109)] [added: [61](#if1d94140443e4bd999abda4b2e587ec9_106)] | | |

| [removed: Consolidated] [added: [Consolidated] Statements of Cash Flows for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019](#if1d94140443e4bd999abda4b2e587ec9_109)] | | | [removed: [61](#i36420fe7c39c4c91ac8d2d223148c9b1_112)] [added: [62](#if1d94140443e4bd999abda4b2e587ec9_109)] | | |

| [removed: Notes] [added: [Notes] to Consolidated Financial [removed: Statements] [added: Statements](#if1d94140443e4bd999abda4b2e587ec9_112)] | | | [removed: [62](#i36420fe7c39c4c91ac8d2d223148c9b1_115)] [added: [63](#if1d94140443e4bd999abda4b2e587ec9_112)] | | |

Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2020.][added: 2021.]

Based on our assessment, management has concluded that, as of December 31, [removed: 2020,] [added: 2021,] 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: 2020] [added: 2021] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.

| Chief Financial Officer and [removed: Senior] [added: Executive] Vice President, Global Finance | | |

We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the “Company”) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the related consolidated statements of operations, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] including the related notes and financial statement schedule listed in the index appearing under Item [removed: 15 (a)(2)] [added: 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: 2020,] [added: 2021,] 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: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] 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: 2020,] [added: 2021,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the [added: company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.]

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

The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the consolidated financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that (i) [removed: relate] [added: relates] to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.

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 [removed: matters below,] [added: matter below,] providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]

As described in Notes 1 and 18 to the consolidated financial statements, the Company recognized net revenues of [removed: $2.1] [added: $3.2] billion from its Clear Aligner segment for the year ended December 31, [removed: 2020.][added: 2021.]

Management considers a variety of factors such as [added: same or similar product] historical sales, costs, and gross margin, which may vary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates.

These procedures also included, among others, (i) testing management’s process for determining the estimate of standalone selling price, which included testing the completeness and accuracy of inputs used and evaluating the reasonableness of factors considered by management related to [added: same or similar product] historical [removed: sales,] [added: sales and] usage rates, [removed: costs,] and [removed: gross margin, and] (ii) testing management’s process for estimating usage rates, which included evaluating the reasonableness of inputs evaluated by management related to historical usage data by region, country and channel.

| | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Net revenues | | | | | | $ | [removed: 2,471,941] [added: 3,952,584] | | | | | $ | [removed: 2,406,796] [added: 2,471,941] | | | | | $ | [removed: 1,966,492] [added: 2,406,796] | |

| Cost of net revenues | | | | | | [removed: 708,706] [added: 1,017,229] | | | | | | [removed: 662,899] [added: 708,706] | | | | | | [removed: 518,625] [added: 662,899] | | |

| Gross profit | | | | | | [removed: 1,763,235] [added: 2,935,355] | | | | | | [removed: 1,743,897] [added: 1,763,235] | | | | | | [removed: 1,447,867] [added: 1,743,897] | | |

| Selling, general and administrative | | | | | | [removed: 1,200,757] [added: 1,708,640] | | | | | | [removed: 1,072,053] [added: 1,200,757] | | | | | | [removed: 852,404] [added: 1,072,053] | | |

| Research and development | | | | | | [removed: 175,307] [added: 250,315] | | | | | | [removed: 157,361] [added: 175,307] | | | | | | [removed: 128,899] [added: 157,361] | | |

| Impairments and other charges (gains), net | | | | | | — | | | | | | [removed: 22,990] [added: —] | | | | | | [removed: —] [added: 22,990] | | |

| Litigation settlement gain | | | | | | — | | | | | | [removed: (51,000)] [added: —] | | | | | | [removed: —] [added: (51,000)] | | |

| Total operating expenses | | | | | | [removed: 1,376,064] [added: 1,958,955] | | | | | | [removed: 1,201,404] [added: 1,376,064] | | | | | | [removed: 981,303] [added: 1,201,404] | | |

| Income from operations | | | | | | [removed: 387,171] [added: 976,400] | | | | | | [removed: 542,493] [added: 387,171] | | | | | | [removed: 466,564] [added: 542,493] | | |

| Interest income | | | | | | [removed: 3,125] [added: 3,103] | | | | | | [removed: 12,482] [added: 3,125] | | | | | | [removed: 8,576] [added: 12,482] | | |

| Other income (expense), net | | | | | | [removed: (11,347)] [added: 32,920] | | | | | | [removed: 7,676] [added: (11,347)] | | | | | | [removed: (8,489)] [added: 7,676] | | |

| Total interest income and other income (expense), net | | | | | | [removed: (8,222)] [added: 36,023] | | | | | | [removed: 20,158] [added: (8,222)] | | | | | | [removed: 87] [added: 20,158] | | |

| Net income before provision for (benefit from) income taxes and equity in losses of investee | | | | | | [removed: 378,949] [added: 1,012,423] | | | | | | [removed: 562,651] [added: 378,949] | | | | | | [removed: 466,651] [added: 562,651] | | |

| Provision for (benefit from) income taxes | | | | | | [removed: (1,396,939)] [added: 240,403] | | | | | | [removed: 112,347] [added: (1,396,939)] | | | | | | [removed: 57,723] [added: 112,347] | | |

| Equity in losses of investee, net of tax | | | | | | — | | | | | | [removed: 7,528] [added: —] | | | | | | [removed: 8,693] [added: 7,528] | | |

| Net income | | | | | | $ | [removed: 1,775,888] [added: 772,020] | | | | | $ | [removed: 442,776] [added: 1,775,888] | | | | | $ | [removed: 400,235] [added: 442,776] | |

| February 25, 2022 | | |

| February 25, 2022 | | |

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

February 25, 2022

| Net income | | | | | | $ | 772,020 | | | | | $ | 1,775,888 | | | | | $ | 442,776 | |

| | | | | | | 2021 | | | | | | 2020 | | |

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 772,020 | | | | | | 772,020 | | |

| Common stock repurchased and retired | | | | | | (592) | | | | | | — | | | | | | (6,592) | | | | | | — | | | | | | (368,446) | | | | | | (375,038) | | |

| Balance as of December 31, 2021 | | | | | | 78,710 | | | | | | $ | 8 | | | | | $ | 999,006 | | | | | $ | 4,326 | | | | | $ | 2,619,374 | | | | | $ | 3,622,714 | |

| | | | | | | 2021 | | | | | | 2020 | | | | | | 2019 | | |

| Net income | | | | | | $ | 772,020 | | | | | $ | 1,775,888 | | | | | $ | 442,776 | |

| Arbitration award gain | | | | | | (43,403) | | | | | | — | | | | | | — | | |

| Proceeds from arbitration award | | | | | | 43,403 | | | | | | — | | | | | | — | | |

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”).

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, general dental practitioners 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.

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.

Our custody bank and asset managers independently use

All of our marketable securities are subject to a periodic impairment review.

We evaluate if an allowance for credit loss is necessary by considering available information relevant to the collectibility of the security and information about credit rating changes, past events, current conditions, and reasonable and supportable forecasts.

Any allowance for credit loss is recorded as a charge to other income (expense), net, in our Consolidated Statement of Operations.

If we have an intent to sell, or if it is more likely than not that we will be required to sell the security in an unrealized loss position before recovery of its amortized cost basis, we will write down the security to its fair value and record the corresponding charge as a component of other income (expense), net in our Consolidated Statement of Operations.

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.

Under the measurement alternative, the carrying value of our equity investment is adjusted to fair value for observable transactions for identical or similar investments of the same issuer.

Investments in equity securities are reported on our Consolidated Balance Sheet as other assets,

and we periodically evaluate them for impairment.

We record any change in carrying value of our equity securities, in other income (expense), net in our Consolidated Statement of Operations.

Such credit losses have not been material to our financial statements.

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.

Expected to begin serving doctors during the first half of 2022, the new aligner fabrication facility will be our third and allow us to more quickly and effectively serve tens of thousands of customers throughout EMEA.

Additionally, in the third quarter of 2021, we opened our multi-story iTero scanner and services facilities in Petach Tikva, Israel to further the design and development of our portfolio of iTero intraoral scanners, imaging systems and services.

Our digital treatment plans using a sophisticated, internally developed computer-modeling

The full extent to which the pandemic, including as a result of any new variants, business restrictions or lockdowns, and the impact of vaccinations, will directly or indirectly impact our business, results of operations, cash flows, and financial condition will depend on future developments that are highly uncertain and cannot be accurately determined.

Further, we could also be materially adversely affected by supply chain disruptions, including shortages and inflationary pressures, uncertain or reduced demand, labor shortages, delays in collection of outstanding receivables and the impact of any initiatives or programs that we may undertake to address financial and operational challenges faced by our customers.

Accounts Receivable, net

Trade accounts receivable are recorded at the invoiced amount.

Accounts receivable, net includes allowances for doubtful accounts for any potentially uncollectible amounts.

We periodically assess the adequacy of the allowance for doubtful accounts by reviewing the accounts receivable on a collective basis by considering factors such as aging of the receivables and customers’ expected ability to pay, and on an individual basis for specific customers with known disputes or collectability issues.

In determining the amount of the allowance for doubtful accounts, we also evaluate the creditworthiness of customers, current market conditions and forecasts of future economic conditions to make any adjustments.

We determine if an arrangement is a lease at inception.

| February 26, 2021 | | |

Change in Accounting Principle

As discussed in Note 1 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2019.

company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

*Deferred Tax Asset – Valuation of Intellectual Property Rights*

As described in Notes 1 and 15 to the consolidated financial statements, during the year ended December 31, 2020, the Company completed an intra-entity transfer of certain intellectual property rights to it’s Swiss subsidiary.

The transfer of intellectual property rights resulted in a step-up of the Swiss tax deductible basis in the transferred assets, and accordingly, created a temporary difference between the book basis and the tax basis of such intellectual property rights.

Consequently, the transaction resulted in the recognition of a deferred tax asset and related one-time tax benefit of $1.5 billion.

The establishment of deferred tax assets from the intra-entity transfer of intangible assets required management to make significant estimates and assumptions to determine the fair value of intellectual property rights transferred which include, but are not limited to, management’s expectations of growth rates in revenue, margins, future cash flows, and discount rates.

The principal considerations for our determination that performing procedures relating to the deferred tax asset, specifically the valuation of intellectual property rights, is a critical audit matter are the significant judgment by management when estimating the fair value of the intellectual property rights intangible assets.

This in turn led to significant auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to the growth rates in revenue, margins and future cash flows.

Also, the audit effort involved the use of professionals with specialized skill and knowledge.

These procedures included testing the effectiveness of controls over management’s valuation of intellectual property rights, including controls over the development of the growth rates in revenue, margins and future cash flows.

These procedures also included, among others, (i) reading the intellectual property license agreement, (ii) testing management’s process for estimating the fair value of intellectual property rights intangible assets transferred, which included evaluating the appropriateness of the valuation method, (iii) testing the completeness, accuracy, and relevance of data used in the method, and (iv) evaluating the reasonableness of management’s significant assumptions related to growth rates in revenue, margins and future cash flows.

Evaluating the reasonableness of the growth rates in revenue, margins and future cash flows involved considering current and past performance of the business.

Professionals with specialized skill and knowledge were used to assist in the evaluation of the valuation method and the future cash flows significant assumptions.

*Acquisition of exocad Global Holdings GmbH – Valuation of Existing Technology Intangible Asset*

As described in Notes 1 and 5 to the consolidated financial statements, the Company completed the acquisition of exocad Global Holdings GmbH for total purchase consideration of $430 million on April 1, 2020, which resulted in $119 million of intangible assets being recorded on the acquisition date.

Intangible assets recorded by the Company in connection with the acquisition primarily included existing technology of $87 million.

Management valued the existing technology using the multi-period excess earnings method under the income approach.

Management is required to make certain estimates and assumptions with respect to the fair value of intangible assets acquired.

The estimates and assumptions used in valuing the existing technology intangible asset include, but are not limited to, the amount and timing of projected future cash flows including forecasted revenues, the discount rate used to determine the present value of these cash flows, and the determination of the assets’ life cycle.

The principal considerations for our determination that performing procedures relating to the valuation of the existing technology intangible asset recorded in the acquisition of exocad Global Holdings GmbH is a critical audit matter are the significant judgment by management when estimating the fair value of the existing technology intangible asset.

This in turn led to significant auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to forecasted revenues.

These procedures included testing the effectiveness of controls relating to the acquisition accounting, including controls over management’s valuation of the existing technology intangible asset and controls over development of the significant assumptions related to forecasted revenues.

These procedures also included, among others, (i) reading the purchase agreement and (ii) testing management’s process for estimating the fair value of existing technology intangible asset, which included evaluating the appropriateness of the valuation method, (iii) testing the completeness and accuracy of data provided by management used in the method, and (iv) evaluating the reasonableness of management’s significant assumption related to forecasted revenue.

Evaluating the reasonableness of forecasted revenues involved gaining an understanding of management’s plans to integrate the existing technology into the Company’s business, as well as past performance of the business related to the existing technology.

Professionals with specialized skill and knowledge were used to assist in the evaluation of the valuation method and the forecasted revenues significant assumption.

February 26, 2021

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

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Balance as of December 31, 2017 | | | | | | 80,040 | | | | | | $ | 8 | | | | | $ | 886,435 | | | | | $ | 571 | | | | | $ | 267,274 | | | | | $ | 1,154,288 | |

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 400,235 | | | | | | 400,235 | | |

| Common stock repurchased and retired | | | | | | (1,057) | | | | | | — | | | | | | (10,252) | | | | | | — | | | | | | (289,750) | | | | | | (300,002) | | |

| Other | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 384 | | | | | | 384 | | |

| Impairments on equity investments | | | | | | 5,887 | | | | | | 3,975 | | | | | | — | | |

| Purchase of investment in privately held company | | | | | | — | | | | | | — | | | | | | (5,000) | | |

| Loan repayment from equity investee | | | | | | — | | | | | | — | | | | | | 30,000 | | |

Align’s products are intended primarily for the treatment of malocclusion or the misalignment of teeth and are designed to help dental professionals achieve the clinical outcomes that they expect and the results patients desire.

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: 2020] [added: 2021] 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: 2020] [added: 2021] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART III

Certain information required by Part III is omitted from this Form 10-K because we intend to file a definitive Proxy Statement for our 2020 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.

None.

PART III

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

We have a code of ethics [added: (which we call our Global Code of Conduct)] that applies to all of our employees, including our principal executive officer, principal financial officer and [removed: principal accounting officer.][added: controller.]

Our Global Code of Conduct is posted on the investor relations portion of our website at *http://investor.aligntech.com* within the section captioned “Corporate Governance”.

This code of ethics is posted on our Internet website.

The Internet address for our website is *www.aligntech.com*, and the code of ethics may be found on the “Corporate Governance” section of our “Investors” webpage.

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

The following table provides information as of December 31, [removed: 2020] [added: 2021] about our common stock that may be issued upon the [removed: exercise of options and] 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 [removed: ("ESPP"),] [added: (“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 [removed: column(a))] [added: column (a))] | | | | | |

| Equity compensation plans approved by security holders | | | | | | [removed: 859,149] [added: 665,957] | | | 1 | | | $ | — | | | | | [removed: 4,950,369] [added: 6,439,289] | | | 2, 3 | | |

2 Includes [removed: 325,665] [added: 2,194,566] shares available for issuance under our ESPP.

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

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

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)

| Total | | | | | | 859,149 | | | | | | $ | — | | | | | 4,950,369 | | | | | |

1 Includes 631,905 RSUs and 227,244 MSUs at target, which have an exercise price of zero

3 Includes 688,590 of potentially issuable MSUs if performance targets are achieved at maximum payout

| Report of Independent Registered Public Accounting Firm | | | [removed: [54](#i36420fe7c39c4c91ac8d2d223148c9b1_94)] [added: [56](#if1d94140443e4bd999abda4b2e587ec9_94)] | | |

| Consolidated Statements of Operations for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [57](#i36420fe7c39c4c91ac8d2d223148c9b1_97)] [added: [58](#if1d94140443e4bd999abda4b2e587ec9_97)] | | |

| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [58](#i36420fe7c39c4c91ac8d2d223148c9b1_100)] [added: [59](#if1d94140443e4bd999abda4b2e587ec9_100)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] | | | [removed: [59](#i36420fe7c39c4c91ac8d2d223148c9b1_103)] [added: [60](#if1d94140443e4bd999abda4b2e587ec9_103)] | | |

| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [60](#i36420fe7c39c4c91ac8d2d223148c9b1_109)] [added: [61](#if1d94140443e4bd999abda4b2e587ec9_106)] | | |

| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [61](#i36420fe7c39c4c91ac8d2d223148c9b1_112)] [added: [62](#if1d94140443e4bd999abda4b2e587ec9_109)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [62](#i36420fe7c39c4c91ac8d2d223148c9b1_115)] [added: [63](#if1d94140443e4bd999abda4b2e587ec9_112)] | | |

Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018][added: 2019]

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

| [removed: Exhibit Number] [added: Exhibit Number] | | | Description | | | Form | | | Date | | | Exhibit Number Incorporated by Reference herein | | | | | | Filed herewith | | |

| [10.2†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm) | | | [Registrant's 2005 Incentive Plan (as amended May 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm) | | | [added: 10-K] | | | [added: 2/26/2021] | | | [added: 10.2] | | | | | | [removed: *] | | |

| [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 [removed: for](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [MSU awards](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [granted in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2018](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[,] [added: for MSU awards granted in 2018,] 2019 [removed: and](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) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[to](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[officers] [added: and 2020 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 [removed: for](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [MSU] [added: for MSU] awards granted [removed: in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [20](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[18,] [added: in 2018,] 2019 [removed: a](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[nd 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [to](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[officers] [added: and 2020 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 | | | | | | | | |

| [10.9†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted in 2021 to officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm) | | | [added: 10-K] | | | [added: 2/26/2021] | | | [added: 10.9] | | | | | | [removed: *] | | |

| [10.9A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted in 2021 to officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm) | | | [added: 10-K] | | | [added: 2/26/2021] | | | [added: 10.9A] | | | | | | [removed: *] | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)[1](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)] [added: [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 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] [added: [10.12†](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: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[3](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] [added: [10.13†](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: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[4](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] [added: [10.14†](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 | | | [removed: 10.3] [added: 10.30] | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[5](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] [added: [10.15†](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)[7](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)[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)] | | | [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: [10.18](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)] [added: [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)] | | | [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: [10.2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[1](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] [added: [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)] | | | [Credit Agreement between Align Technology, Inc. [removed: and](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) [t](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[he lender](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[s] [added: and the lenders] party thereto from time to time and Citibank, N.A., as [removed: ad](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[minis](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[trative ag](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[ent,] [added: 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: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex211-20201231.htm)] [added: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex211-20211231.htm)] | | | [Subsidiaries of Align Technology, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex211-20201231.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex211-20211231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex231-20201231.htm)] [added: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex231-20211231.htm)] | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex231-20201231.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex231-20211231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex311-20201231.htm)] [added: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex311-20211231.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/1097149/000109714921000007/ex311-20201231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex311-20211231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex312-20201231.htm)] [added: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex312-20211231.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/1097149/000109714921000007/ex312-20201231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex312-20211231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [32](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex32-20201231.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex32-20201231.htm)] [added: [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)] | | | [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/1097149/000109714921000007/ex32-20201231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex32-20211231.htm)] | | | | | | | | | | | | | | | * | | |

| Year Ended December 31, 2021 | | | | | | $ | 10,239 | | | | | $ | 2,814 | | | | | $ | (3,808) | | | | | $ | 9,245 | |

| Year Ended December 31, 2021 | | | | | | $ | 1,325 | | | | | $ | 11,613 | | | | | $ | — | | | | | $ | 12,938 | |

| [3.2A](https://www.sec.gov/Archives/edgar/data/0001097149/000109714921000018/appendixa-amendedandrestat.htm) | | | [Amendment to Amended and Restated Bylaws of registrant](https://www.sec.gov/Archives/edgar/data/0001097149/000109714921000018/appendixa-amendedandrestat.htm) | | | Def 14A | | | 4/7/2021 | | | 1.0 | | | | | | | | |

| [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) | | | [Amended Registrant’s 2010 Employee Stock Purchase Plan](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000018/appendixb-alignamendedandr.htm) | | | Def 14A | | | 4/7/2021 | | | 2.0 | | | | | | | | |

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

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

| Exhibit Number | | | Description | | | Form | | | Date | | | Exhibit Number Incorporated by Reference herein | | | | | | Filed herewith | | |

| [10.19](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex1019-algnoct292021asr.htm) | | | [Fixed Dollar Accelerated Share Repurchase Transaction dated October 29, 2021](https://www.sec.gov/Archives/edgar/data/1097149/000109714922000011/ex1019-algnoct292021asr.htm) | | | | | | | | | | | | | | | * | | |

| Year Ended December 31, 2018 1 | | | | | | $ | 5,814 | | | | | $ | 870 | | | | | $ | (4,306) | | | | | $ | 2,378 | |

| Year Ended December 31, 2018 | | | | | | $ | 278 | | | | | $ | (27) | | | | | $ | — | | | | | $ | 251 | |

1 Certain prior period information has been recast to conform to current year presentation.

| [10.1†](http://www.sec.gov/Archives/edgar/data/1097149/000119312510128157/dex1002.htm) | | | [Registrant's 2010 Employee Stock Purchase Plan](http://www.sec.gov/Archives/edgar/data/1097149/000119312510128157/dex1002.htm) | | | 8-K | | | 5/25/2010 | | | 10.02 | | | | | | | | |

| [10.16†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex1016-20201231.htm) | | | [Form of Executive Officer Relocation Reimbursement Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex1016-20201231.htm) | | | | | | | | | | | | | | | * | | |

| [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110262416003155/exh10_1.htm)[9](http://www.sec.gov/Archives/edgar/data/1097149/000110262416003155/exh10_1.htm) | | | [Class C Non-Incentive Unit Purchase Agreement dated July 25, 2016](http://www.sec.gov/Archives/edgar/data/1097149/000110262416003155/exh10_1.htm) | | | 8-K | | | 7/28/2016 | | | 10.1 | | | | | | | | |

| [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000027/exhibit102.htm)[20](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000027/exhibit102.htm) | | | [Membership Interest Purchase Agreement dated July 24, 2017 between Align Technology, Inc. and SmileDirectClub, LLC.](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000027/exhibit102.htm) | | | 8-K | | | 7/27/2017 | | | 10.2 | | | | | | | | |

| Date: | | | February [removed: 26, 2021] [added: 25, 2022] | | |