Align Technology (ALGN) 10-K risk factor changes: FY2023 vs FY2022

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

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

Consumer spending habits are affected by, among other things, inflation, fluctuations in currency exchange rates, [removed: weakness in] general economic [removed: conditions,] [added: weakness,] threats or actual recessions, pandemics, wars and military actions, [removed: levels of employment,] [added: employment levels,] wages, debt obligations, discretionary income, interest rates, volatility in capital, and consumer confidence and perceptions of [removed: current and future economic conditions.]

[removed: Changes and uncertainty] [added: Macroeconomic conditions] can, among other things, reduce or shift spending away from elective [removed: treatments and] procedures, drive patients to [removed: purchase orthodontic treatments that may cost] [added: pursue] less [removed: than our Invisalign treatment options, result in a] [added: costly orthodontic treatments,] decrease [removed: in] the number of [removed: overall] orthodontic [removed: and dental] case starts, reduce patient traffic in dentists’ offices or reduce demand for dental services generally.

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

[removed: The increase] [added: Increases] in the cost of fuel and energy, food and other essential items [removed: along with climbing] [added: as well as higher] interest rates [removed: could] [added: have and may continue to] reduce consumers' disposable income, [removed: resulting] [added: which could cause a decrease] in [removed: less] discretionary spending for products like ours.

Inflation continues to adversely impact spending and trade [removed: activities and we are unable to predict the] [added: activities, causing unpredictable] impacts [removed: of higher inflation] on global and regional economies.

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

[removed: Our reliance on] [added: We have significant] international operations and sales [removed: exposes us] [added: and we are exposed] to fluctuations in foreign currencies that [removed: may] [added: have] adversely [removed: impact] [added: impacted] our business or results of operations.

Although the U.S. dollar is our reporting currency, a [removed: growing] [added: large] portion of our [added: expenses,] net revenues and net income are generated in foreign currencies.

While we utilize forward contracts to [removed: reduce] [added: moderate] the [removed: adverse earnings] impact [removed: from the effect] of exchange rate fluctuations on certain assets and liabilities, our hedging strategies may not be successful, and currency exchange rate fluctuations have and [removed: could] [added: may] continue to [removed: have a material adverse] [added: materially adversely] effect [removed: on] our operating results and cash flows.

In addition, our foreign currency exposure on assets, liabilities and cash flows that we do not hedge have and could [removed: continue to have a material] [added: in the future materially] impact [removed: on] our financial results in periods when the U.S. dollar significantly fluctuates in relation to foreign currencies.

Our business could be impacted by [removed: political] [added: geopolitical] events, trade and other international disputes, war, and terrorism, [removed: including the military conflict between Russia and Ukraine.][added: or major public health crises.]

Political events, trade and other international disputes, [removed: war,] [added: war] and [removed: terrorism] [added: terrorism, or major public health crises have and] could [added: in the future] harm or disrupt international commerce and the global economy and could [removed: have a material] [added: materially] effect [removed: on] our business as well as our customers, suppliers, contract manufacturers, distributors, and other business partners.

[removed: Tariffs] [added: Tariffs, such as those on Chinese goods, and responses to the tariffs may] increase the cost of our products and the components and raw materials [added: used] to make them.

[removed: These increased] [added: Increased] costs could adversely impact our gross margin and [removed: make our products less competitive or] reduce [removed: demand.][added: demand for our products.]

Countries [removed: could] [added: may] also adopt other measures, such as controls on [removed: imports] [added: the import] or [removed: exports] [added: export] of goods, technology or data, that [removed: could] [added: would] adversely impact our operations and supply [removed: chain and] [added: chains or] limit our ability to offer products and services.

Such restrictions can be announced with little or no advance notice and we may be unable to effectively mitigate [removed: the] [added: any] adverse [removed: impacts][added: impacts.]

Political [removed: unrest, threats, tensions, actions] [added: events, trade] and [removed: responses to any social, economic, business, geopolitical, military,] [added: other international disputes, war,] terrorism, or [removed: acts of war] [added: major public health crises] involving key commercial, development or manufacturing markets such as China, Mexico, Israel, Europe, or other countries [added: have and] could [added: again] materially impact our international [removed: operation.][added: operations.]

[removed: If any of these events or conditions occur, the] [added: The] impact to us, our employees and customers [removed: is] [added: would be] uncertain, particularly if emergency circumstances, armed conflicts or an escalation in political instability or [removed: violence disrupts] [added: violence, or viral out-breaks disrupt] our product development, data or information exchange, payroll or banking operations, product or materials shipping by us or our [removed: suppliers and other unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.][added: suppliers.]

Such risks include [removed: adverse effects on general economic and political conditions such as inflation,] supply chain and trade disruptions, [removed: and] [added: tariffs, trade sanctions or restrictions, boycotts,] reduced consumer [removed: spending; disruptions to our IT systems, including through network failures, malicious or disruptive software,] [added: spending, government shut downs,] or [removed: cyberattacks;] [added: cyberattacks,] energy shortages or [added: power outages, energy] rationing that [removed: may] adversely [removed: impact] [added: impacts] our manufacturing [removed: facilities;] [added: facilities,] rising fuel [removed: and/or] [added: or] rising costs of producing, procuring and shipping our [removed: products; our exposure to foreign currency exchange rate fluctuations; and] [added: products,] constraints, volatility or disruption in the financial [removed: markets.][added: markets, deaths or injuries to our employees, restrictions and shortages of food, water, shelter, and medical supplies, telecommunications failures or destruction of property.]

Natural disasters can impact [removed: us and] our [removed: customers,] [added: operations] as well as [removed: suppliers critical to] [added: those of] our [removed: operations.][added: customers and suppliers.]

Natural disasters include earthquakes, tsunamis, floods, droughts, hurricanes, wildfires, and [removed: other] extreme weather conditions that [removed: can] cause deaths, injuries, and critical health crises, power outages, [added: property damage] restrictions and shortages of food, water, shelter, and medical supplies, telecommunications failures, materials scarcity, price volatility and other ramifications.

Climate change is likely to increase [removed: both] the frequency and severity of natural disasters and, consequently, [added: the] risks to our [removed: business] [added: operations] and [removed: operations.][added: financial results.]

Our digital dental modeling and certain of our customer facing operations are primarily processed in our facilities [removed: located] in Costa [removed: Rica.][added: Rica, our iTero scanners are primarily manufactured in China and Israel, and our aligner molds and finished aligners are fabricated in China, Mexico and Poland.]

If [removed: there is] a natural disaster [added: occurs] in a region where one of these facilities [removed: is] [added: or those of our customers or suppliers are] located, our employees could be impacted, [removed: our] research [removed: could be] lost, and [removed: our] ability to create [removed: ClinCheck] treatment plans, respond to customer inquiries or manufacture and ship our aligners or intraoral scanners could be [removed: compromised which could result in our customers experiencing] [added: compromised, causing] significant product and services delays.

[added: For example,] Invisalign treatment [removed: represents] [added: is] a significant change from traditional [added: orthodontic] metal wires and [removed: brackets orthodontic treatment,] [added: brackets,] and customers and consumers may not find it cost-effective or [removed: preferable to traditional treatment.][added: preferable.]

[removed: For instance, a] [added: A] number of dental professionals [removed: continue to] believe [removed: the] Invisalign treatment is [added: only] appropriate for [removed: only] a limited percentage of patients.

Increased [removed: market] acceptance of our products depends in part [removed: upon] [added: on] the recommendations of dental professionals, as well as other factors including efficacy, safety, ease of use, reliability, [removed: aesthetics,] [added: aesthetics] and price compared to competing products and treatment methods.

If demand for our products fails to increase, [added: or decreases, our business,] including [removed: due to resistance to nontraditional treatment methods, this could materially affect] our [removed: business] [added: financial] and operating [removed: results.][added: results, may be harmed.]

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

Of the two, we expect [removed: net revenues from] the [removed: sale of the] Invisalign [removed: system, primarily our comprehensive products,] [added: system] will continue to account for the majority of our net revenues, making the [removed: continued and] widespread acceptance of the Invisalign system by orthodontists, GPs and consumers critical to our [removed: future] success.

The average selling prices of our products, particularly [removed: our] [added: the] Invisalign system, are influenced by numerous factors, including the type and timing of products sold (particularly the timing of orders for additional clear aligners for certain Invisalign products) and foreign [added: currency] exchange rates.

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

- we introduce new [removed: or] [added: promotions,] change existing promotions, [added: or offer] general or volume-based discount programs, product or services bundles, [added: large account sales] or consumer rebate programs;

- participation in [removed: any] promotions or programs unexpectedly [removed: increases or] [added: increases,] decreases or [removed: drives] [added: changes] demand in [removed: unexpected and] material ways;

- our geographic, [removed: channel,] [added: channel] or product mix shifts to lower priced products or to products [removed: that have] [added: with] a higher percentage of deferred revenue;

- governments impose pricing regulations such as [removed: the] volume-based procurement regulations in China; or

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

[removed: Currently, the] [added: The] Invisalign system competes primarily [removed: against] [added: with] traditional metal wires and brackets and increasingly against clear aligners [added: which are] manufactured and distributed by new [removed: market entrants] and [removed: manufacturers of traditional wires and brackets, both within and outside the U.S., and from] [added: existing market entrants, including] traditional medical device companies, laboratories, startups and, in some cases, doctors and [removed: DSOs themselves.][added: Dental Support Organizations (“DSOs”).]

*The Company’s business, reputation, results of operations, financial condition and stock price can be affected by a number of factors, whether currently known or unknown, including those described below.

When any one or more of these risks materialize from time to time, the Company’s business, reputation, results of operations, financial condition and stock price can be materially and adversely affected.

Because of the following factors, as well as other factors affecting the Company’s results of operations and financial condition, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.

Additionally, you should consider these risk factors in connection with evaluating the forward-looking statements contained in this report.*

current and future economic conditions.

Further, we cannot predict the impact of efforts by central banks and federal, state and local governments to combat inflation, which could result in an economic recession or have an adverse impact on consumer spending may for a prolonged period of time.

Our internation operations would also be impacted by other unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.

Military conflicts and global pandemics have materially adversely impacted our global economies.

For example, our commercial operations in Russia were impacted by the conflict in Ukraine and we were affected by the COVID-19 pandemic.

Our iTero operations, headquartered in Israel, are close to areas that have been affected by ongoing violence and military action in the Middle East and this may impact our employees as well as our iTero business.

Some employees and consultants in Israel have been called for military service in the current conflict in the Middle East and they may be absent for an unknown period of time.

Furthermore, our facility may be damaged or supply chains impaired as a result of hostilities which could disrupt ongoing operations and impact our financial results.

The conflict in the Middle East may materially impact the timing and cost of shipping of our products, our ability to operate out of Israel, or lead to sanctions or boycotts which could impact our sales and

revenues.

Additionally, the recent election in Taiwan and China’s territorial conflicts with other neighboring countries may impact our operations and sales in China.

We cannot predict the progress or outcome of these events or the reactions by governments, businesses or consumers but they could materially adversely affect our business and operating results.

These zones are susceptible to natural disasters and their indirect effects.

Our products require our customers to change from traditional treatment methods.

Additionally, our clear aligners and iTero products utilize digital technology and some dental professionals have been and may continue to resist moving to a digital platform.

These promotional campaigns and lower

The dental industry is experiencing immense and rapid digital transformation.

While solutions such as our Invisalign system, iTero scanners and CAD/CAM software facilitate this transition, we face competition from companies that also seek to introduce new technologies and products and companies that remain dedicated to conventional products.

Our iTero scanners are also facing increased competition.

iTero scanners compete with polyvinyl siloxane (“PVS”) impressions and numerous new or existing intraoral scanners.

We cannot assure successful development, sales or acceptance of our new or improved products and services.

- manage the impact of nationalism or initiatives encouraging consumer purchases from domestic vendors;

- offer attractive and competitive service and subscription plans;

- source and receive quality raw materials or parts from our suppliers.

- changes in consumer and doctor demand;

- changes in the timing of revenue recognition and our average selling prices;

- seasonal fluctuations;

- the timing of clear aligner treatment order submission, acceptance, processing and fulfillment, which can cause fluctuations in our backlog; and

Any of these events harm our sales, damage our reputation, adversely impact our strategic partners or result in litigation.

competition, bribery and corruption, trade compliance, safety, data privacy and marketing and sales activities.

The conduct of these distributors also impacts our reputation and our brand.

If our distributors fail to satisfy customers, our reputation and brand loyalty could be harmed.

Our success depends on our personnel.

We are highly dependent on the talent and efforts of our personnel.

However, competition for highly-skilled personnel is intense, particularly technical and digital talent, and our competitors have and are likely to continue to recruit our personnel.

We continue to assess key personnel we believe essential to our long-term success.

*The following discusses some of the risks that may affect our business, results of operations and financial condition.

The order we have chosen to list the risks below or the sections in which we have identified them should not be interpreted to mean we deem any risks to be more or less important or likely to occur or, if any do occur, that their impact may be any less significant than others.

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

Before you invest in Align, you should know that investing involves risks, including those described below.

If any of the risks actually occur, our business, financial condition and results of operations could be negatively affected, the trading price of our common stock could decline, and you may lose all or part of your investment.*

Summary of Risk Factors

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

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

Macroeconomic and External Risks

- Global and regional economic conditions

- Major health crises

- Political events, international disputes, war and terrorism

- Natural disasters

Business and Industry Risks

- Changes in demand for our products

- Increased competition

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

- Our ability to successfully integrate our acquisitions

Operational Risks

- Business disruptions

- Predicting demand

- Availability of supplies

- Shipping delays

- Personnel development and retention

- Effectiveness of marketing and our ability to attract consumers

Legal, Regulatory and Compliance Risks

- Government investigations, enforcement actions, and settlements

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

- Privacy, cybersecurity and data protection

- Litigation, including class action lawsuits

Intellectual Property Risks

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

Financial, Tax and Accounting Risks

- Impairment of our goodwill

- Compliance with accounting, financial reporting, and tax laws

- Management of our stock plans

- Volatility of our stock

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

Further, we are unable to predict the impact of efforts by central banks and federal, state and local governments to combat elevated levels of inflation.

If their efforts to reduce inflation are too aggressive, they may lead to a recession.

A discussion regarding our financial condition and results of operations for fiscal [removed: 2022] [added: 2023] compared to fiscal [removed: 2021] [added: 2022] is presented under Results of Operations of this Form 10-K.

Discussions regarding our financial condition and results of operations for fiscal [removed: 2021] [added: 2022] compared to [removed: 2020] [added: 2021] 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: 2021,] [added: 2022,] filed with the SEC on February [removed: 25, 2022,] [added: 27, 2023,] which is available without charge on the SEC's website at *www.sec.gov* and on our investor relations website at *investor.aligntech.com*.

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

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

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

[removed: 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] [added: We furthermore demonstrate] to GPs and orthodontists how the iTero portfolio of intraoral scanners and CAD/CAM restorative services and workflows can increase revenues and profitability for their dental practices by enhancing patient experiences and creating [removed: operation] [added: operational] practice efficiencies.

- Pursuing new product lines that complement our doctor-prescribed principal products currently available in certain e-commerce and retail channels in the U.S. Similarly, in [removed: 2023] [added: 2023,] we [removed: expect to continue to] [added: continued our] focus on our doctor subscription plan and [removed: grow] [added: grew] our underpenetrated share of the retainer business through strategic marketing campaigns focused on driving adoption and increasing market share in the [removed: U.S.][added: U.S., Canada, Iberia and the Nordics.]

In addition, the teenage and younger market makes up [removed: 75%] [added: about 70%] of the approximately [removed: 21] [added: 22] million total annual global orthodontic case [removed: starts each year.][added: starts.]

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

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

*Macroeconomic Challenges and Military Conflict in [removed: Ukraine*][added: Ukraine and the Middle East*]

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

Many of these same factors [removed: are] also [removed: impacting] [added: impact] our costs [added: and those of our suppliers] through higher raw material prices, transportation costs, labor costs, supply and distribution [removed: operations and the operations of our suppliers.][added: operations.]

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

For the year ended December 31, [removed: 2022,] [added: 2023,] our business operations reflect the following:

◦Revenues of [removed: $3,734.6] [added: $3,862.3] million, [removed: a decrease] [added: an increase] of [removed: 5.5%] [added: 3.4%] year-over-year;

[removed: ◦Clear] [added: *▪*Americas Clear] Aligner [added: case] revenues of [removed: $3,072.6] [added: $1,463.0] million, a decrease of [removed: 5.4%] [added: 0.6%] year-over-year;

[removed: *▪*Americas Clear] [added: ◦Clear] Aligner revenues of [removed: $1,458.8] [added: $3,199.3] million, [removed: a decrease] [added: an increase] of [removed: 5.6%] [added: 4.1%] year-over-year;

▪International Clear Aligner [added: case] revenues of [removed: $1,349.0] [added: $1,449.5] million, [removed: a decrease] [added: an increase] of [removed: 10.0%] [added: 7.4%] year-over-year;

▪Clear Aligner volume [removed: decrease] [added: increase] of [removed: 7.4%] [added: 0.4%] year-over-year and Clear Aligner volume [removed: decrease] [added: increase] for teenage patients of [removed: 0.2%] [added: 7.8%] year-over-year;

◦Imaging Systems and CAD/CAM Services revenues of [removed: $662.1] [added: $662.9] million, [removed: a decrease] [added: an increase] of [removed: 6.2%] [added: 0.1%] year-over-year;

*◦*Income from operations of [removed: $642.6] [added: $643.3] million and operating margin of [removed: 17.2%;][added: 16.7%;]

◦Effective tax rate of [removed: 39.6%;][added: 30.6%;]

◦Net income of [removed: $361.6] [added: $445.1] million with diluted net income per share of [removed: $4.61;][added: $5.81;]

◦Cash, cash equivalents and marketable securities of [removed: $1,041.6] [added: $980.8] million as of December 31, [removed: 2022;][added: 2023;]

◦Operating cash flow of [removed: $568.7] [added: $785.8] million;

◦Number of employees was [removed: 23,165] [added: 21,610] as of December 31, [removed: 2022, an increase] [added: 2023, a decrease] of [removed: 2.8%] [added: 6.7%] year-over-year.

- As of December 31, [removed: 2022, over 14] [added: 2023, 17] million people worldwide have been treated with our Invisalign system.

- For the fourth quarter of [removed: 2022,] [added: 2023,] total Invisalign cases submitted with a digital scanner in the Americas increased to [removed: 92.5%,] [added: 95.1%,] up from [removed: 89.1%] [added: 92.7%*] in the fourth quarter of [removed: 2021] [added: 2022] and international scans increased to [removed: 86.8%,] [added: 88.1%,] up from [removed: 80.8%] [added: 86.8%] in the fourth quarter of [removed: 2021.][added: 2022.]

For the fourth quarter of [removed: 2022, 97.4%] [added: 2023, 98.0%] of Invisalign cases submitted by North American orthodontists were submitted digitally.

- The total utilization rate in [removed: 2022] [added: 2023] was [removed: 18.9] [added: 19.1] cases per doctor compared to [removed: 20.8] [added: 19.3*] cases per doctor in [removed: 2021] [added: 2022] and [removed: 16.1] [added: 20.9*] cases per doctor in [removed: 2020.][added: 2021.]

Our utilization rates have declined in [removed: 2022] [added: 2023] due to the macroeconomic [removed: conditions, COVID-19 impacts,] [added: conditions] and other factors as described in the Trends and Uncertainties section above.

- *North America:* The utilization rate among our North American orthodontist customers was [removed: 89.2] [added: 94.5] cases per doctor in [removed: 2022] [added: 2023] compared to [removed: 98.1] [added: 94.9*] cases per doctor in [removed: 2021] [added: 2022] and [removed: 67.3] [added: 99.7*] cases per doctor in [removed: 2020] [added: 2021] and the utilization rate among our North American GP customers was [removed: 13.9] [added: 14.0] cases per doctor in [removed: 2022] [added: 2023] compared to [removed: 14.3] [added: 13.9] cases per doctor in [removed: 2021] [added: 2022] and [removed: 9.6] [added: 14.3] cases per doctor in [removed: 2020.][added: 2021.]

- *International:* International doctor utilization rate was [removed: 16.2] [added: 16.3] cases per doctor in [removed: 2022] [added: 2023] compared to [removed: 17.5] [added: 16.2] cases per doctor in [removed: 2021] [added: 2022] and [removed: 14.5] [added: 17.5] cases per doctor in [removed: 2020*.*][added: 2021*.*]

[removed: ][added: ]

- Non-Case products include, but are not limited to, retention [removed: products,] [added: products including retention aligners ordered through the Doctor Subscription Program,] Invisalign training, adjusting tools used by dental professionals during the course of treatment and Invisalign Accessory Products that are complementary to our doctor-prescribed principal products such as aligner cases (clamshells), teeth whitening products, cleaning solutions (crystals, foam and other material) and other oral health products available in certain [removed: e-commerce] [added: commerce] channels in select markets.

[added: -] We also offer in the [removed: U.S. and] [added: U.S.,] Canada, [added: and EMEA,] a Doctor Subscription Program which is [removed: a monthly subscription program based on the doctor’s] [added: our] monthly [removed: need for retention or limited treatment.][added: subscription-based clear aligner program.]

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

Net revenues for our Clear Aligner and Systems and Services segments by region for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] are as follows (in millions):

We are in over 100 markets and have 13 fabrication and treatment locations throughout the world.

We continue to expand our clear aligner customer base by educating new doctors on the benefits of digital dentistry through the Invisalign system.

To increase awareness and educate young adults, parents and teens about the benefits of the Invisalign brand, in 2023 we continued to invest in and create campaigns across markets in media platforms such as TikTok, Instagram, YouTube, SnapChat, WeChat, and Douyin.

In 2023, we had record shipments to teenage and younger patients.

We expect utilization rates to continue to rise.

In 2023, we believe that sales of our products were primarily harmed by macroeconomic conditions that ultimately adversely impacted disposable income and consumer demand.

In particular, dental practices and industry research firms reported deteriorating orthodontic trends for the third and fourth quarters of 2023, including decreased patient visits and increased patient appointment cancellations, along with fewer case starts overall, especially among adult patients.

The impact of declining demand varied by time and region, making operational results uncertain and difficult to predict.

Additionally, many of our international operations are denominated in currencies other than the U.S. dollar.

In 2023, the macroeconomic slowing or contraction resulted in foreign exchange volatility causing the U.S dollar to strengthen against other currencies.

This negatively impacted our financial condition and results of operation compared to 2022.

Foreign exchange

volatility and the subsequent strengthening or weakening of the U.S dollar against other currencies remains uncertain and unpredictable.

Moreover, military conflicts increase the unpredictability of the volatile macroeconomic conditions.

While the military conflict between Russia and Ukraine did not materially impact our 2023 financial condition and results of operations, we expect the conflict will continue to create market uncertainties and dampen consumer sentiment and demand, particularly in Europe.

Similarly, the recent conflict in the Middle East may further exacerbate general and regional macroeconomic instability, particularly if fighting is prolonged, it spreads to other locations, creates shipping and logistical challenges or cost increases, or leads to sanctions or boycotts.

Our iTero business is headquartered in Israel and the timing and cost of shipping our products has been impacted.

Additionally, we have employees and consultants in Israel that have been called for military service and they may be unavailable for an unknown period of time.

The conflict may continue to spread to other areas which may further impact our business.

We continue to monitor the potential for violence and military actions that may directly or indirectly impact our personnel, manufacturing, supply chain, and sales.

For instance, in the first quarter of 2023, we successfully launched the Invisalign Comprehensive 3in3 product.

The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration date and three additional clear aligners included prior to the treatment expiration date.

We anticipate adoption of the Invisalign Comprehensive 3in3 product will continue to increase in 2024.

The 3in3 product allows us to recognize more revenue up front but is offered at a lower price as compared to our traditional Invisalign comprehensive product that has a five-year treatment expiration date with unlimited additional clear aligner prior to the treatment end date.

◦Capital expenditures of $177.7 million, predominantly related to purchases of property, plant and equipment; and

During the third quarter of 2023, we began including Touch Up case revenues in Americas and/or International net revenues that were previously included in Non-Case revenues and have recast business metrics for the periods presented above accordingly.

The low-stage aligners, the Touch up product, are included as a Non-Comprehensive Product.

| Americas | | | | | | $ | 1,463.0 | | | | | $ | 1,471.9 | | | | | $ | (9.0) | | | | | (0.6) | | % | | | | $ | 1,471.9 | | | | | $ | 1,548.8 | | | | | $ | (76.9) | | | | | (5.0) | | % |

| Non-case | | | | | | 286.9 | | | | | | 251.7 | | | | | | 35.2 | | | | | | 14.0 | | % | | | | 251.7 | | | | | | 199.6 | | | | | | 52.1 | | | | | | 26.1 | | % |

*During 2023, we began including Touch Up case revenues in Americas and/or International net revenues.

Touch Up case revenues were previously recorded in Non-case revenues.

We have recast the year ended December 31, 2022 and 2021 to reflect this change.

Amount and percentage changes are based on recast amounts.

| Total case volume | | | | | | 2,408.5 | | | | | | 2,398.4 | | | | | | 10.2 | | | | | | 0.4 | | % | | | | 2,398.4 | | | | | | 2,559.6 | | | | | | (161.3) | | | | | | (6.3) | | % |

*During 2023, we began including Touch Up case revenues in Americas and/or International net revenues.

Touch Up case revenues were previously recorded in Non-case revenues.

We have recast the year ended December 31, 2022 and 2021 to reflect this change.

Amount and percentage changes are based recast amounts.

Higher ASP includes price increases which increased net revenues by $68.6 million along with higher additional aligners which increased net revenues by $43.9 million.

International net revenues increased by $100.5 million in 2023 as compared to 2022 due to a 3.5% increase in case volumes, resulting in an increase of net revenues by $46.9 million, and higher ASP increasing net revenues by $53.6 million.

unique needs of each customer channel.

In 2022, we continued to build on the success of the “Invis-is” consumer advertising campaign with creative content and influencers focused on teens and young adults.

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

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

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

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

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

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

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

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

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

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

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

*COVID-19 Pandemic Update*

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

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

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

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

◦Capital expenditures of $291.9 million, predominantly related to increases in our manufacturing capacity and facilities; and

| Americas | | | | | | $ | 1,458.8 | | | | | $ | 1,544.8 | | | | | $ | (85.9) | | | | | (5.6) | | % | | | | $ | 1,544.8 | | | | | $ | 1,010.2 | | | | | $ | 534.5 | | | | | 52.9 | | % |

| Non-case | | | | | | 264.8 | | | | | | 203.7 | | | | | | 61.1 | | | | | | 30.0 | | % | | | | 203.7 | | | | | | 125.8 | | | | | | 77.8 | | | | | | 61.9 | | % |

*Changes and percentages are based on actual values.

| Total case volume | | | | | | 2,358.7 | | | | | | 2,547.7 | | | | | | (189.0) | | | | | | (7.4) | | % | | | | 2,547.7 | | | | | | 1,645.3 | | | | | | 902.4 | | | | | | 54.8 | | % |

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

The decrease in ASP was partially offset by processing fees charged on most shipments which increased net revenues by $94.1 million and lower net deferrals which increased net revenues by $81.4 million.

The decreases were partially offset by higher service and other revenues which increased net revenues by $62.6 million mostly due to a larger scanner install base.

The gross margin percentage decreased in 2022 as compared to 2021 primarily due to manufacturing inefficiencies from lower production volumes and lower ASP.

These factors were partially offset by higher service revenues.

Selling, general and administrative expense decreased in 2022 compared to 2021 primarily due to lower incentive compensation, lower advertising and marketing costs and lower allocations of corporate overhead expenses.

These decreases were offset by higher salaries expenses, fringe benefits and stock-based compensation from increased headcount as well as higher equipment, software and maintenance costs.

These increases were partially offset by lower incentive compensation.

Restructuring and other charges includes $7.3 million of severance and related costs, in addition to lease termination charges and asset impairments.

Operating margin percentage decreased in 2022 compared to 2021 primarily due to higher operating expenses as a percentage of net revenues as well as lower gross margin.

Interest income increased in 2022 compared to 2021 primarily due to higher interest rates during 2022, which was partially offset by the interest earned from the arbitration award related to our investment in SmileDirectClub in the first quarter of 2021.

Other income (expense), net decreased in 2022 compared to 2021 primarily due to a $43.4 million gain associated to the arbitration award related to our investment in SmileDirectClub recognized in the first quarter of 2021 as well as $30.5 million of higher net foreign exchange losses from the weakening of international currencies against the U.S. dollar in 2022 as compared to 2021.

Additionally, a change in U.S. tax laws effective January 1, 2022 which requires capitalization and amortization of research and development expenses incurred after December 31, 2021 increased our effective tax rate for the year ended December 31, 2022.

During 2020, we completed an intra-entity transfer of certain intellectual property rights and fixed assets to our Swiss subsidiary, where our EMEA regional headquarters is located beginning January 1, 2020.

The transfer of intellectual property rights did not result in a taxable gain; however, it did result 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, this transaction resulted in the recognition of a deferred tax asset and related one-time tax benefit of approximately $1,493.5 million during the year ended December 31, 2020, which is the net impact of the deferred tax asset recognized as a result of the additional Swiss tax deductible basis in the transferred assets and certain costs related to the transfer of fixed assets and inventory.

The amortization of this deferred tax asset depends on the profitability of our Swiss headquarters and the recognition of this tax benefit is allowed for a maximum recovery period of 15 years.

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

Changes in interest rates could impact our anticipated interest income on our cash [added: and cash] equivalents and investments in marketable securities.

Fixed-rate securities may have their fair market value adversely impacted due to a rise in interest rates, and, as a result, our future investment income may fall short of expectations [removed: due to changes in interest rates] or we may suffer losses in principal if forced to sell securities which have declined in market value [removed: due to changes in interest rates.][added: due.]

As of December 31, [removed: 2022,] [added: 2023,] we had approximately [removed: $99.5] [added: $43.3] million invested in available-for-sale marketable securities.

As of December 31, [removed: 2022,] [added: 2023,] we are not subject to risks from immediate interest rate increases on our unsecured revolving line of credit facility.

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

*Military Conflict between Russia and Ukraine*

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

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

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

For the fiscal year ended December 31, [removed: 2022][added: 2023]

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $13.3] [added: $13.7] billion as of June 30, [removed: 2022] [added: 2023] based on the closing sale price of the registrant’s common stock on the NASDAQ Global Market on such date.

On February [removed: 20, 2023, 76,610,319] [added: 22, 2024, 75,104,132] shares of the registrant’s common stock were outstanding.

Portions of the registrant’s definitive Proxy Statement relating to its [removed: 2023] [added: 2024] Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end of December 31, [removed: 2022] [added: 2023] are incorporated by reference into Part III of this Annual Report on Form 10-K.

For the Year Ended December 31, [removed: 2022][added: 2023]

| Item 1. | | | [removed: [Business](#i2704b576f8bf446aa18dd6265ae58c92_13)] [added: [Business](#i417aa79b41cc44f4a8019aa6393b0501_13)] | | | [removed: [3](#i2704b576f8bf446aa18dd6265ae58c92_13)] [added: [3](#i417aa79b41cc44f4a8019aa6393b0501_13)] | | |

| | | | [Information about our Executive [removed: Officers](#i2704b576f8bf446aa18dd6265ae58c92_16)] [added: Officers](#i417aa79b41cc44f4a8019aa6393b0501_16)] | | | [removed: [19](#i2704b576f8bf446aa18dd6265ae58c92_16)] [added: [20](#i417aa79b41cc44f4a8019aa6393b0501_16)] | | |

| Item 1A. | | | [Risk [removed: Factors](#i2704b576f8bf446aa18dd6265ae58c92_19)] [added: Factors](#i417aa79b41cc44f4a8019aa6393b0501_19)] | | | [removed: [19](#i2704b576f8bf446aa18dd6265ae58c92_19)] [added: [20](#i417aa79b41cc44f4a8019aa6393b0501_19)] | | |

| Item 1B. | | | [Unresolved Staff [removed: Comments](#i2704b576f8bf446aa18dd6265ae58c92_22)] [added: Comments](#i417aa79b41cc44f4a8019aa6393b0501_22)] | | | [removed: [37](#i2704b576f8bf446aa18dd6265ae58c92_22)] [added: [35](#i417aa79b41cc44f4a8019aa6393b0501_22)] | | |

| Item 2. | | | [removed: [Properties](#i2704b576f8bf446aa18dd6265ae58c92_25)] [added: [Properties](#i417aa79b41cc44f4a8019aa6393b0501_25)] | | | [removed: [38](#i2704b576f8bf446aa18dd6265ae58c92_25)] [added: [36](#i417aa79b41cc44f4a8019aa6393b0501_25)] | | |

| Item 3. | | | [Legal [removed: Proceedings](#i2704b576f8bf446aa18dd6265ae58c92_28)] [added: Proceedings](#i417aa79b41cc44f4a8019aa6393b0501_28)] | | | [removed: [38](#i2704b576f8bf446aa18dd6265ae58c92_28)] [added: [36](#i417aa79b41cc44f4a8019aa6393b0501_28)] | | |

| Item 4. | | | [Mine Safety [removed: Disclosures](#i2704b576f8bf446aa18dd6265ae58c92_31)] [added: Disclosures](#i417aa79b41cc44f4a8019aa6393b0501_31)] | | | [removed: [38](#i2704b576f8bf446aa18dd6265ae58c92_31)] [added: [36](#i417aa79b41cc44f4a8019aa6393b0501_31)] | | |

| Item 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i2704b576f8bf446aa18dd6265ae58c92_37)] [added: Securities](#i417aa79b41cc44f4a8019aa6393b0501_37)] | | | [removed: [39](#i2704b576f8bf446aa18dd6265ae58c92_37)] [added: [37](#i417aa79b41cc44f4a8019aa6393b0501_37)] | | |

| Item 6. | | | [removed: [\[Reserved\]](#i2704b576f8bf446aa18dd6265ae58c92_40)] [added: [\[Reserved\]](#i417aa79b41cc44f4a8019aa6393b0501_40)] | | | [removed: [40](#i2704b576f8bf446aa18dd6265ae58c92_40)] [added: [38](#i417aa79b41cc44f4a8019aa6393b0501_40)] | | |

| Item 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i2704b576f8bf446aa18dd6265ae58c92_43)] [added: Operations](#i417aa79b41cc44f4a8019aa6393b0501_43)] | | | [removed: [40](#i2704b576f8bf446aa18dd6265ae58c92_43)] [added: [38](#i417aa79b41cc44f4a8019aa6393b0501_43)] | | |

| Item 7A. | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i2704b576f8bf446aa18dd6265ae58c92_88)] [added: Risk](#i417aa79b41cc44f4a8019aa6393b0501_82)] | | | [removed: [52](#i2704b576f8bf446aa18dd6265ae58c92_88)] [added: [50](#i417aa79b41cc44f4a8019aa6393b0501_82)] | | |

| Item 8. | | | [Financial Statements and Supplementary [removed: Data](#i2704b576f8bf446aa18dd6265ae58c92_91)] [added: Data](#i417aa79b41cc44f4a8019aa6393b0501_85)] | | | [removed: [54](#i2704b576f8bf446aa18dd6265ae58c92_91)] [added: [52](#i417aa79b41cc44f4a8019aa6393b0501_85)] | | |

| Item 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i2704b576f8bf446aa18dd6265ae58c92_181)] [added: Disclosure](#i417aa79b41cc44f4a8019aa6393b0501_175)] | | | [removed: [90](#i2704b576f8bf446aa18dd6265ae58c92_181)] [added: [89](#i417aa79b41cc44f4a8019aa6393b0501_175)] | | |

| Item 9A. | | | [Controls and [removed: Procedures](#i2704b576f8bf446aa18dd6265ae58c92_184)] [added: Procedures](#i417aa79b41cc44f4a8019aa6393b0501_178)] | | | [removed: [90](#i2704b576f8bf446aa18dd6265ae58c92_184)] [added: [89](#i417aa79b41cc44f4a8019aa6393b0501_178)] | | |

| Item 9B. | | | [Other [removed: Information](#i2704b576f8bf446aa18dd6265ae58c92_187)] [added: Information](#i417aa79b41cc44f4a8019aa6393b0501_181)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_187)] [added: [89](#i417aa79b41cc44f4a8019aa6393b0501_181)] | | |

| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i2704b576f8bf446aa18dd6265ae58c92_190)] [added: Inspections](#i417aa79b41cc44f4a8019aa6393b0501_184)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_190)] [added: [89](#i417aa79b41cc44f4a8019aa6393b0501_184)] | | |

| Item 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#i2704b576f8bf446aa18dd6265ae58c92_196)] [added: Governance](#i417aa79b41cc44f4a8019aa6393b0501_190)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_196)] [added: [89](#i417aa79b41cc44f4a8019aa6393b0501_190)] | | |

| Item 11. | | | [Executive [removed: Compensation](#i2704b576f8bf446aa18dd6265ae58c92_199)] [added: Compensation](#i417aa79b41cc44f4a8019aa6393b0501_193)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_199)] [added: [90](#i417aa79b41cc44f4a8019aa6393b0501_193)] | | |

| Item 12. | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i2704b576f8bf446aa18dd6265ae58c92_202)] [added: Matters](#i417aa79b41cc44f4a8019aa6393b0501_196)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_202)] [added: [90](#i417aa79b41cc44f4a8019aa6393b0501_196)] | | |

| Item 13. | | | [Certain Relationships and Related Transactions and Director [removed: Independence](#i2704b576f8bf446aa18dd6265ae58c92_205)] [added: Independence](#i417aa79b41cc44f4a8019aa6393b0501_199)] | | | [removed: [91](#i2704b576f8bf446aa18dd6265ae58c92_205)] [added: [90](#i417aa79b41cc44f4a8019aa6393b0501_199)] | | |

| Item 14. | | | [Principal Accountant Fees and [removed: Services](#i2704b576f8bf446aa18dd6265ae58c92_208)] [added: Services](#i417aa79b41cc44f4a8019aa6393b0501_202)] | | | [removed: [92](#i2704b576f8bf446aa18dd6265ae58c92_208)] [added: [90](#i417aa79b41cc44f4a8019aa6393b0501_202)] | | |

| Item 15. | | | [Exhibits and Financial Statement [removed: Schedules](#i2704b576f8bf446aa18dd6265ae58c92_214)] [added: Schedules](#i417aa79b41cc44f4a8019aa6393b0501_208)] | | | [removed: [93](#i2704b576f8bf446aa18dd6265ae58c92_214)] [added: [92](#i417aa79b41cc44f4a8019aa6393b0501_208)] | | |

| Item 16. | | | [Form 10-K [removed: Summary](#i2704b576f8bf446aa18dd6265ae58c92_217)] [added: Summary](#i417aa79b41cc44f4a8019aa6393b0501_211)] | | | [removed: [95](#i2704b576f8bf446aa18dd6265ae58c92_217)] [added: [95](#i417aa79b41cc44f4a8019aa6393b0501_211)] | | |

*Invisalign, Align, the Invisalign logo, ClinCheck, Invisalign Assist, Invisalign Teen, Invisalign [added: First, Invisalign] Go, [added: the Invisalign sonic logo,] Vivera, SmartForce, SmartTrack, SmartStage, SmileView, iTero, iTero Element, [removed: Orthocad, iCast, iRecord and] [added: iTero Lumina,] exocad, [added: Align Digital Platform, Smile Architect, iTero exocad Connector and exocad Dental CAD,] among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries.*

[removed: These statements include, among other things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our beliefs and expectations regarding macroeconomic conditions, including inflation, fluctuations in currency exchange rates, rising interest rates, market volatility, weakness in general economic conditions and recessions and the impact of efforts by central banks and federal, state and local governments to combat inflation and recession, our expectations and beliefs regarding customer and consumer purchasing behavior and changes in consumer spending habits, our expectations regarding the impact of the military conflict in Ukraine generally and specifically regarding our operations and assets in Russia, including the impact on our workforce located in Russia, our expectations regarding the near and long-term implications of the COVID-19 pandemic on the global and regional economies, our marketing and efforts to build our brand awareness, our estimates regarding the size and opportunities of the markets we are targeting along with our expectations for growth in those 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 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 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, 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 markets and their growth, our expectations regarding competition and our ability to compete in our target markets, our expectations regarding staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our business both in the United States and internationally, our beliefs regarding our culture and commitment and its impact on our financial and operational performance and its importance to our future success, our expectations for future investments in and benefits from consumer demand sales and marketing activities, our preparedness and our customers’ preparedness to react to changing circumstances and demand, our expectations for our expenses and capital obligations and expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of our international earnings from operations, our belief regarding the sufficiency of our cash and investment balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition and assessment of goodwill and intangible assets, our expectations regarding our tax positions and the judgements we make related to our tax obligations, our predicted level of operating expenses and gross margins and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.][added: These statements include, among other things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our beliefs and expectations regarding macroeconomic conditions, including inflation, fluctuations in currency exchange rates, rising interest rates, market volatility, weakness in general economic conditions and recessions and the impact of efforts by central banks and federal, state and local governments to combat inflation and recession, our expectations and beliefs regarding customer and consumer purchasing behavior and changes in consumer spending habits, our expectations regarding product mix and product adoption, our expectations regarding competition and our ability to compete in our target markets, our expectations regarding the sales growth of our intraoral scanners, clear aligners and other products, our expectations regarding the impact of the military conflicts in the Middle East and Ukraine and our operations and assets in Israel and Russia, our marketing and efforts to build our brand awareness, our estimates regarding the size and opportunities of the markets we are targeting along with our expectations for growth in those 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 beliefs regarding the importance of our manufacturing operations on our success, our beliefs regarding the need for and benefits of our technological development on Invisalign treatment, the areas of development in which we focus our efforts, and the advantages of our intellectual property portfolio, our beliefs regarding our business strategy and growth drivers, our expectations regarding the utilization rates for our products, including the impact of marketing on those rates and causes for periodic fluctuations of the rates, our expectations regarding the existence and impact of seasonality, our expectations regarding the productivity impact sales representatives will have on our sales and the impact of specialization of those representatives in sales channels, our expectations regarding the continued expansion of our international markets and their growth, our expectations regarding staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our business both in the United States and internationally, our beliefs regarding our culture and commitment and its impact on our financial and operational performance and its importance to our future success, our expectations for future investments in and benefits from sales and marketing activities, our preparedness and our customers’ preparedness to react to changing circumstances and demand, our expectations for our expenses and capital obligations and expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of our international earnings from operations, our belief regarding the sufficiency of our cash and investment balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition and assessment of goodwill and intangible assets, our expectations regarding our tax positions and the judgements we make related to our tax obligations, our predicted level of operating expenses and gross margins and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.]

Align Technology, Inc. (“We”, “Our”, “Align”) is a global medical device company primarily engaged in the design, manufacture and marketing of Invisalign® clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (“GPs”), [removed: Vivera®] [added: ViveraTM] retainers for retention, [removed: iTero®] [added: iTeroTM] intraoral scanners and services for dentistry, and [removed: exocad®] [added: exocadTM] computer-aided design and computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners.

Our vision and strategy is to revolutionize orthodontic and restorative dentistry through digital treatment planning and implementation using our Align Digital PlatformTM, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for [removed: patients and] [added: patients,] consumers, [removed: orthodontists and] [added: orthodontists,] GPs and lab partners.

We strive to achieve our vision and strategy through key objectives made possible with the proprietary technologies and services of the Align Digital Platform to establish: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign [removed: System] [added: system] as the treatment solution of choice by orthodontists, GPs and patients globally, our [added: intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.]

[removed: intraoral scanners as the preferred scanning technology for digital] dental scans, and [added: establish] our exocad CAD/CAM software as the [removed: dental restorative] solution of choice for dental [removed: labs.][added: labs in existing and new international markets.]

[removed: Our Americas regional headquarters is located] in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific (“APAC”) regional headquarters is located in Singapore.

For the year ended December 31, [removed: 2022,] [added: 2023,] Clear Aligner net revenues represented approximately [removed: 82%] [added: 83%] of worldwide net revenues, while Systems and Services net revenues represented the remaining [removed: 18%.][added: 17%.]

We sell the majority of our products directly through a dedicated and specialized sales force to our customers: orthodontists, GPs, including prosthodontists, periodontists, [removed: and] oral [removed: surgeons,] [added: surgeons] and dental laboratories.

In addition, we sell directly to Dental Support Organizations (“DSOs”) who contract with dental practices to provide critical business management and support including non-clinical [removed: operations, and we sell products used by dental laboratories who manufacture or customize a variety of products used by licensed dentists to provide oral health care.][added: operations.]

We also market and sell doctor and consumer accessory products [removed: that are] complementary to our doctor-prescribed principal products under the Invisalign® and other brands, including retainers, dental supplies, [added: clear] aligner cases (clamshells), teeth whitening products and cleaning solutions (collectively “Invisalign Accessory Products”).

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

| [PART I](#i417aa79b41cc44f4a8019aa6393b0501_10) | | | | | | [3](#i417aa79b41cc44f4a8019aa6393b0501_10) | | |

| Item 1C. | | | [Cybersecurity](#i417aa79b41cc44f4a8019aa6393b0501_1977) | | | [35](#i417aa79b41cc44f4a8019aa6393b0501_1977) | | |

| [PART II](#i417aa79b41cc44f4a8019aa6393b0501_34) | | | | | | [37](#i417aa79b41cc44f4a8019aa6393b0501_34) | | |

| [PART III](#i417aa79b41cc44f4a8019aa6393b0501_187) | | | | | | [89](#i417aa79b41cc44f4a8019aa6393b0501_187) | | |

| [PART IV](#i417aa79b41cc44f4a8019aa6393b0501_205) | | | | | | [92](#i417aa79b41cc44f4a8019aa6393b0501_205) | | |

| [Signatures](#i417aa79b41cc44f4a8019aa6393b0501_214) | | | | | | [96](#i417aa79b41cc44f4a8019aa6393b0501_214) | | |

Our Americas regional headquarters is located

We also sell our products to dental laboratories who use our products to manufacture or customize their own products for licensed dentists.

Doctors and their staffs use intraoral scanning tools designed to support diagnosis of a patient’s oral conditions and health and support doctors to develop appropriate treatment pathways.

The Align Digital Platform facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations.

Some of the tools that support this stage include AlignTM Oral Health Suite, iTeroTM NIRI technology (Near Infra-Red Imaging), iTeroTM TimeLapse technology and iTero Occlusogram.

In 2023, we launched several new products and technologies that further enhance the Align Digital Platform, including the enhanced precision wings for Invisalign treatment with mandibular advancement, the Invisalign® Palatal Expander system, the SmartForce™ attachment-free clear aligner activation feature, the Plan Editor in ClinCheck® treatment planning software, the Align™ Oral Health Suite, iTero-exocad Connector™, exoplan 3.1 Rijeka, ChairsideCAD 3.1 Rijeka, PartialCAD 3.1 Rijeka, and Invisalign™ Lens.

devices as needed.

As part of the Align™ Digital Workflow, Align has developed solutions to enable doctor diagnosis and drive patient conversion – providing tools to support diagnosis of a patients’ oral health and support to identify an appropriate treatment pathway, facilitating the doctor-patient conversation, education and clinical needs and expectations.

Our ClinCheck® treatment planning software is the cornerstone of the Align Digital Platform.

ClinCheck Pro treatment planning software uses proprietary algorithms based on the insights from data from our more than 17 million patients treated worldwide.

The majority of doctors then dispense all of the clear aligners to the patient.

In the first quarter of 2023, we launched the Invisalign Comprehensive 3in3 product.

The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration date and three additional clear aligners included prior to the treatment expiration date, instead of a five-year treatment expiration date with unlimited additional clear aligner sets prior to the treatment end date.

Invisalign Comprehensive 3in3 product is available in North America and in certain markets in EMEA and APAC, most recently launching in China, Korea, Hong Kong and Taiwan.

Invisalign Doctor Subscription Program (“DSP”) is our monthly subscription-based clear aligner program which includes retainers and low-stage “touch-up” clear aligner treatment.

As of September 31, 2023, Invisalign DSP touch-up cases have been reclassified to non-comprehensive cases and are now reflected in our reported case volumes and metrics.

Prior to this quarter, they were reported in the non-case category.

DSP is currently available in the U.S., Canada, Iberia, Nordics and, most recently in the UK.

*Invisalign® Palatal Expander.* In December 2023, we received 510(k) clearance in the U.S. for the Invisalign Palatal Expanders.The Invisalign Palatal Expander System is intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during patient treatment.

It provides an alternative to traditional palatal expanders that require the daily manual turning of a screw in the device in the mouth to achieve expansion.

The Invisalign Palatal Expander is our first direct 3D printed orthodontic device.

Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution such as Phase 1 or early interceptive treatment, traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted.

The Invisalign Palatal Expander is currently available on a limited basis in Canada and the U.S.

In January 2024, we completed the acquisition of Cubicure GmbH (“Cubicure”), a company that develops, produces and distributes innovative materials, equipment and processes for novel 3D printing solutions.

Cubicure’s patented Hot Lithography technology uses a special heating and coating mechanism that enables the processing of highly viscous resins to produce tough and temperature-resistant polymers.

We believe that the acquisition of Cubicure will support our long-term growth strategy by enabling us to scale our 3D printing operations to eventually direct print millions of custom appliances per day.

We expect the acquisition of Cubicure will ultimately extend and scale our printing, materials and manufacturing capabilities for our 3D printed products while concurrently materially reducing the amount of resin used in our manufacturing process.

gently push on.

In January 2024, we launched the iTero Lumina intraoral scanner.

The iTero Lumina intraoral scanner is designed with iTero Multi-Direct CaptureTM technology that we believe quickly, easily, and accurately captures more data while delivering exceptional scan quality and photorealistic images that eliminate the need for intraoral photos altogether.

iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models.

It has a wider field of capture and multi-angled scanning that enables simultaneous capture from multiple angles.

Additionally, the iTero Lumina scanner has a capture distance of up to 25mm, making it easier to scan complex oral regions such as narrow or deep palates, edentulous spaces, and partially erupted teeth.

It has a 50% smaller and 45% lighter wand (as compared to iTero Element™ 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids and teen patients.

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

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

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

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

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

In 2022, we launched significant new products and technologies that further enhance the Align Digital Platform, including the ClinCheck® Live Update software, Invisalign® Practice App, Invisalign® Personalized Plan, Invisalign Smile Architect™, Invisalign® Outcome Simulator Pro with in-face visualization, Cone Beam Computed Tomography integration with ClinCheck software, Invisalign® Virtual Care AI software, and the iTero-exocad Connector.

certain markets and geographies.

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.

*Invisalign Mandibular Advancement*.

Invisalign System with mandibular advancement is designed for tweens and teens.

It is targeted for patients with permanent teeth or stable baby teeth who have bite issues in which the lower jaw is further back and can benefit from being brought forward for a better bite relationship.

The Invisalign System with mandibular advancement addresses Class II bite correction with simultaneous alignment of the teeth.

In 2022, we enhanced the original design with new enhanced precision wings that provide increased durability and comfort, as well as greater overlap to help the aligners remain properly engaged to keep the patient’s lower jaw forward during treatment.

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 trained doctors who are currently not regularly using our retainers or low-stage aligners.

- *GP Adoption*.

offering redundancy in the event natural disasters or climate-related events affect operations at one or more facilities.

We

In addition, corresponding foreign patents began expiring in 2018 which has increased competition outside the U.S. These competitors include existing larger companies in certain markets who have the ability to leverage their existing channels in the dental market to compete directly with us, direct-to-consumer (“DTC”) companies that provide clear aligners requiring little or no in-office care from trained and licensed doctors themselves who can manufacture retainers and custom aligners for treatment of very simple malocclusion in their offices using modern 3D printing technology.

Unlike our DTC competitors, we are committed to doctors being at the core of our business strategy, and Invisalign treatment requires a doctor's prescription and an in-person physical examination of the patient’s dentition before treatment can begin.

Delays in receipt of, or a failure to receive, such marketing

As we expand our customer base and product offering, it is increasingly possible that there will be new opportunities to seek reimbursement from public and private payors for services that include our products, and additional laws or regulatory enforcement requirements may apply now or in the future.

In the EU, we must comply with the General Data Protection Regulation, which serves as a harmonization of European data-privacy law and the Swiss Federal Act on Data Protection, where we have our EMEA headquarters.

In LATAM markets, we must comply with Brazil's Lei Geral de Proteção de Dados.

We were selected by Untapped, a diversity recruiting platform, for having one of the Top Internship Programs of 2022.

Untapped created a list of 75 top programs at companies that provide quality internship experiences, career advancement opportunities, an inclusive and diverse work environment, and significant growth potential.

We were recognized for focus and dedication to diversity, equality, inclusion, and belonging.

In 2022 alone, we were recognized by:

- 100 Best Companies to Work for in Israel by CofaceBdi

- AmCham Cares Distinction Award Recipient in Singapore based on our volunteer and fundraising campaigns

In 2022, our global employee participation was 89% of eligible employees.

We have used information learned from our surveys to improve the way our employees experience us.

Examples of the improvements we have made as a result of employee feedback include the design of our hybrid return to office approach, increased career development training opportunities, and a pilot program that allows CAD designers to learn new skills that provide potential pathways to software and operations engineering, cybersecurity and quality/regulatory engineering.

In 2022, we introduced Voyage, Align’s approach to career development encouraging employees to think differently about career growth by challenging them to be intentional in planning their development, learning from others, practicing reflection, and embracing a growth mindset.

At the end of 2022, 65% of Align employees had completed at least one professional development opportunity.

In addition, we held several volunteer activities with Junior Achievement.

We have implemented a cross-departmental approach to managing cybersecurity risk, which includes seeking input from our employees, management, third-party vendors, the Audit Committee of the Board of Directors (the “Audit Committee”), and the Board of Directors.

We devote significant resources to cybersecurity and risk management processes to adapt to the changing cybersecurity landscape and respond to emerging threats in a timely and effective manner.

We regularly assess the threat landscape and take a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, detection and response.

To more effectively address cybersecurity threats, we have a dedicated Chief Information Security Officer (“CISO”) who is responsible for leading enterprise-wide information security strategy, policy, process, and technology.

Our current CISO has 20+ years of information security and risk management experience and holds a Certified Information Systems Security Professional (CISSP) certification.

Our CISO regularly briefs our Audit Committee on our cybersecurity and information security program and cybersecurity incidents deemed to pose a risk of a critical business impact or reputational harm.

Our cybersecurity risk management program leverages the National Institute of Standards and Technology (NIST) framework, which organizes cybersecurity risks into five categories: identify, protect, detect, respond and recover.

Our information security team, comprised of employees with an expertise in cybersecurity and information technology, regularly assess the threat landscape and take a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, detection, and response.

Our information security program includes, among other things, cybersecurity incident response, vulnerability management, antivirus and malware protection, technology compliance and risk management, encryption, identity and access management, application security, and security monitoring.

The program also has an information security awareness program, which includes annual training regarding our acceptable use and information classification and handling policies, regular phishing campaigns complemented by additional employee training as appropriate, and communications and companion trainings to keep our users informed on current events.

The information security program’s ultimate goal is preventing cybersecurity incidents to the extent feasible, while simultaneously increasing our system resilience to minimize the business impact should an incident occur.

In the event of an identified cybersecurity incident, we have developed a detailed cybersecurity incident response process, which outlines the steps to be followed from incident detection, analysis, containment, eradication, recovery, and notification, including notifying functional areas (e.g. information technology, legal, finance, operations, privacy), as well as senior leadership and the Audit Committee, as appropriate.

For critical cybersecurity incidents, processes have been established for our legal team to determine the materiality of each incident.

Our information security team engages third-party services to conduct evaluations of our security controls, including penetration testing and independent audits.

Annually, an external auditor conducts a System and Organization Controls (“SOC”) type 2 audit covering the security principle for systems supporting our products.

Our assessment of risks associated with the use of third-party vendors is part of our overall cybersecurity risk management framework.

If a third-party vendor is unable to provide a SOC 1 or SOC 2 report, our information security team takes additional steps to assess their cybersecurity preparedness and our initiation or continued engagement with them.

Additionally, third-party vendors are required to include security and privacy addendums to our contracts where applicable and are reassessed periodically as necessary depending on the risk level that has been assigned to the third-party vendor.

Our legal team also requires that our third-party vendors report cybersecurity incidents to us so the impact of the incident on us can be assessed.

Our Audit Committee is responsible for reviewing cybersecurity risks and our cybersecurity program.

It oversees and reviews our cybersecurity and other information technology risks, controls, policies, and procedures.

Our information security team annually performs a cybersecurity enterprise risk assessment and presents the results to management and the Audit Committee.

The Audit Committee periodically reports on its review of cybersecurity risks and our cybersecurity program to our Board of Directors.

In 2023, our CISO or his team met with the Audit Committee four times to discuss cybersecurity risks and threats.

We have not identified any risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our operations, business strategy, results of operations, or financial condition.

Notwithstanding the approach we take to cybersecurity, we may not successfully prevent or mitigate cybersecurity incidents that could have a material adverse effect on us.

While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be covered or, if covered, fully insured.

See Item 1A.

“Risk Factors” for a discussion of cybersecurity risks.

As of December 31, [removed: 2022,] [added: 2023,] the significant facilities occupied were as follows:

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

| La Lima, Cartago, Costa Rica | | | | | | Own | | | Office for administrative personnel, treatment personnel, and customer care | | | | | |

As of February [removed: 20, 2023,] [added: 22, 2024,] there were approximately [removed: 53] [added: 52] 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: 2017] [added: 2018] to December 31, [removed: 2022.][added: 2023.]

[removed: ][added: ]

The following table summarizes the stock repurchase activity for the three months ended December 31, [removed: 2022:][added: 2023:]

*1* [removed: *May 2021] [added: *January 2023] Repurchase Program.* [removed: On May 13, 2021,] [added: In January 2023,] we announced that our Board of Directors had authorized a plan to repurchase up to [removed: $1.0 billion] [added: $1,000,000,000] of our common stock.

See *Note 10* “*Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements* for details on the [removed: May 2021] [added: January 2023] Repurchase Program.

| October 1, 2023 through October 31, 2023 | | | | | | 1,049,538 | | | | | | $ | 190.56 | | | | | 1,049,538 | | | | | | $ | 750,000,000 | |

| November 1, 2023 through November 30, 2023 | | | | | | 283,335 | | | | | | $ | 206.89 | | | | | 283,335 | | | | | | $ | 691,380,496 | |

| December 1, 2023 through December 31, 2023 | | | | | | 182,183 | | | | | | $ | 227.14 | | | | | 182,183 | | | | | | $ | 650,000,000 | |

| Total | | | | | | 1,515,056 | | | | | | | | | | | | 1,515,056 | | | | | | | | |

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

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

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

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

| [Report of Management on Internal Control over Financial [removed: Reporting](#i2704b576f8bf446aa18dd6265ae58c92_97)] [added: Reporting](#i417aa79b41cc44f4a8019aa6393b0501_91)] | | | [removed: [55](#i2704b576f8bf446aa18dd6265ae58c92_97)] [added: [53](#i417aa79b41cc44f4a8019aa6393b0501_91)] | | |

| [Report of Independent Registered Public Accounting [removed: Firm](#i2704b576f8bf446aa18dd6265ae58c92_100)] [added: Firm](#i417aa79b41cc44f4a8019aa6393b0501_94)] (PCAOB ID 238) | | | [removed: [56](#i2704b576f8bf446aa18dd6265ae58c92_100)] [added: [54](#i417aa79b41cc44f4a8019aa6393b0501_94)] | | |

| [Consolidated Statements of Operations for the year ended December [removed: 31, 202](#i2704b576f8bf446aa18dd6265ae58c92_103)[2](#i2704b576f8bf446aa18dd6265ae58c92_103)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_103)[1](#i2704b576f8bf446aa18dd6265ae58c92_103)] [added: 31,](#i417aa79b41cc44f4a8019aa6393b0501_97) [2023](#i417aa79b41cc44f4a8019aa6393b0501_97)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_97)[2](#i417aa79b41cc44f4a8019aa6393b0501_97)] [and [removed: 2](#i2704b576f8bf446aa18dd6265ae58c92_103)[020](#i2704b576f8bf446aa18dd6265ae58c92_103)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_97)[1](#i417aa79b41cc44f4a8019aa6393b0501_97)] | | | [removed: [58](#i2704b576f8bf446aa18dd6265ae58c92_103)] [added: [56](#i417aa79b41cc44f4a8019aa6393b0501_97)] | | |

| [Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 202](#i2704b576f8bf446aa18dd6265ae58c92_106)[2](#i2704b576f8bf446aa18dd6265ae58c92_106)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_106)[1](#i2704b576f8bf446aa18dd6265ae58c92_106)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_100)[3](#i417aa79b41cc44f4a8019aa6393b0501_100)[, 20](#i417aa79b41cc44f4a8019aa6393b0501_100)[22](#i417aa79b41cc44f4a8019aa6393b0501_100)] [and [removed: 20](#i2704b576f8bf446aa18dd6265ae58c92_106)[20](#i2704b576f8bf446aa18dd6265ae58c92_106)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_100)[1](#i417aa79b41cc44f4a8019aa6393b0501_100)] | | | [removed: [59](#i2704b576f8bf446aa18dd6265ae58c92_106)] [added: [57](#i417aa79b41cc44f4a8019aa6393b0501_100)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 202](#i2704b576f8bf446aa18dd6265ae58c92_109)[2](#i2704b576f8bf446aa18dd6265ae58c92_109)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_103)[3](#i417aa79b41cc44f4a8019aa6393b0501_103)] [and [removed: 202](#i2704b576f8bf446aa18dd6265ae58c92_109)[1](#i2704b576f8bf446aa18dd6265ae58c92_109)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_103)[2](#i417aa79b41cc44f4a8019aa6393b0501_103)] | | | [removed: [60](#i2704b576f8bf446aa18dd6265ae58c92_109)] [added: [58](#i417aa79b41cc44f4a8019aa6393b0501_103)] | | |

| [Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 202](#i2704b576f8bf446aa18dd6265ae58c92_112)[2](#i2704b576f8bf446aa18dd6265ae58c92_112)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_112)[1](#i2704b576f8bf446aa18dd6265ae58c92_112)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[3](#i417aa79b41cc44f4a8019aa6393b0501_106)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[2](#i417aa79b41cc44f4a8019aa6393b0501_106)] [and [removed: 20](#i2704b576f8bf446aa18dd6265ae58c92_112)[20](#i2704b576f8bf446aa18dd6265ae58c92_112)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_106)[1](#i417aa79b41cc44f4a8019aa6393b0501_106)] | | | [removed: [61](#i2704b576f8bf446aa18dd6265ae58c92_112)] [added: [59](#i417aa79b41cc44f4a8019aa6393b0501_106)] | | |

| [Consolidated Statements of Cash Flows for the year ended December 31, [removed: 202](#i2704b576f8bf446aa18dd6265ae58c92_115)[2](#i2704b576f8bf446aa18dd6265ae58c92_115)[, 202](#i2704b576f8bf446aa18dd6265ae58c92_115)[1](#i2704b576f8bf446aa18dd6265ae58c92_115)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[3](#i417aa79b41cc44f4a8019aa6393b0501_109)[, 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[2](#i417aa79b41cc44f4a8019aa6393b0501_109)] [and [removed: 20](#i2704b576f8bf446aa18dd6265ae58c92_115)[20](#i2704b576f8bf446aa18dd6265ae58c92_115)] [added: 202](#i417aa79b41cc44f4a8019aa6393b0501_109)[1](#i417aa79b41cc44f4a8019aa6393b0501_109)] | | | [removed: [62](#i2704b576f8bf446aa18dd6265ae58c92_115)] [added: [60](#i417aa79b41cc44f4a8019aa6393b0501_109)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i2704b576f8bf446aa18dd6265ae58c92_118)] [added: Statements](#i417aa79b41cc44f4a8019aa6393b0501_112)] | | | [removed: [63](#i2704b576f8bf446aa18dd6265ae58c92_118)] [added: [61](#i417aa79b41cc44f4a8019aa6393b0501_112)] | | |

Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]

Based on our assessment, management has concluded that, as of December 31, [removed: 2022,] [added: 2023,] our internal control over financial reporting was effective based on criteria in *Internal Control - Integrated Framework [removed: (2013)] [added: (2013)*] issued by the [removed: COSO*.][added: COSO.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.

We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the “Company”) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the related consolidated statements of operations, of comprehensive income, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] including the related notes and financial statement schedule listed in the index appearing under Item 15(a)(2) (collectively referred to as the “consolidated financial statements”).

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] 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: 2022,] [added: 2023,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

As described in Notes 1 and 15 to the consolidated financial statements, the Company recognized net revenues of [removed: $3.1] [added: $3.2] billion from its Clear Aligner segment for the year ended December 31, [removed: 2022.][added: 2023.]

| | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Net revenues | | | | | | $ | [removed: 3,734,635] [added: 3,862,260] | | | | | $ | [removed: 3,952,584] [added: 3,734,635] | | | | | $ | [removed: 2,471,941] [added: 3,952,584] | |

| Cost of net revenues | | | | | | [removed: 1,100,860] [added: 1,155,397] | | | | | | [removed: 1,017,229] [added: 1,100,860] | | | | | | [removed: 708,706] [added: 1,017,229] | | |

| Gross profit | | | | | | [removed: 2,633,775] [added: 2,706,863] | | | | | | [removed: 2,935,355] [added: 2,633,775] | | | | | | [removed: 1,763,235] [added: 2,935,355] | | |

| Selling, general and administrative | | | | | | [removed: 1,674,469] [added: 1,703,379] | | | | | | [removed: 1,708,640] [added: 1,674,469] | | | | | | [removed: 1,200,757] [added: 1,708,640] | | |

| Research and development | | | | | | [removed: 305,258] [added: 346,830] | | | | | | [removed: 250,315] [added: 305,258] | | | | | | [removed: 175,307] [added: 250,315] | | |

| Restructuring and other charges | | | | | | [removed: 11,453] [added: 13,316] | | | | | | [removed: —] [added: 11,453] | | | | | | — | | |

| Total operating expenses | | | | | | [removed: 1,991,180] [added: 2,063,525] | | | | | | [removed: 1,958,955] [added: 1,991,180] | | | | | | [removed: 1,376,064] [added: 1,958,955] | | |

| Income from operations | | | | | | [removed: 642,595] [added: 643,338] | | | | | | [removed: 976,400] [added: 642,595] | | | | | | [removed: 387,171] [added: 976,400] | | |

| Interest income | | | | | | [removed: 5,367] [added: 17,258] | | | | | | [removed: 3,103] [added: 5,367] | | | | | | [removed: 3,125] [added: 3,103] | | |

| Other income (expense), net | | | | | | [removed: (48,905)] [added: (19,392)] | | | | | | [removed: 32,920] [added: (48,905)] | | | | | | [removed: (11,347)] [added: 32,920] | | |

| Total interest income and other income (expense), net | | | | | | [removed: (43,538)] [added: (2,134)] | | | | | | [removed: 36,023] [added: (43,538)] | | | | | | [removed: (8,222)] [added: 36,023] | | |

| Net income before provision for (benefit from) income taxes | | | | | | [removed: 599,057] [added: $] | [added: 641,204] | | | | | [removed: 1,012,423] [added: $] | [added: 599,057] | | | | | [removed: 378,949] [added: $] | [added: 1,012,423] | |

| Provision for (benefit from) income taxes | | | | | | [removed: 237,484] [added: $] | [added: 196,151] | | | | | [removed: 240,403] [added: $] | [added: 237,484] | | | | | [removed: (1,396,939)] [added: $] | [added: 240,403] | |

| Net income | | | | | | $ | [removed: 361,573] [added: 445,053] | | | | | $ | [removed: 772,020] [added: 361,573] | | | | | $ | [removed: 1,775,888] [added: 772,020] | |

| Basic | | | | | | $ | [removed: 4.62] [added: 5.82] | | | | | $ | [removed: 9.78] [added: 4.62] | | | | | $ | [removed: 22.55] [added: 9.78] | |

| Diluted | | | | | | $ | [removed: 4.61] [added: 5.81] | | | | | $ | [removed: 9.69] [added: 4.61] | | | | | $ | [removed: 22.41] [added: 9.69] | |

| Basic | | | | | | [removed: 78,190] [added: 76,426] | | | | | | [removed: 78,917] [added: 78,190] | | | | | | [removed: 78,760] [added: 78,917] | | |

| Diluted | | | | | | [removed: 78,420] [added: 76,568] | | | | | | [removed: 79,670] [added: 78,420] | | | | | | [removed: 79,230] [added: 79,670] | | |

| Change in foreign currency translation adjustment, net of tax | | | | | | [removed: (11,480)] [added: 28,419] | | | | | | [removed: (38,680)] [added: (11,480)] | | | | | | [removed: 44,383] [added: (38,680)] | | |

| Change in unrealized gains (losses) on investments, net of tax | | | | | | [removed: (3,130)] [added: 3,033] | | | | | | [removed: (495)] [added: (3,130)] | | | | | | [removed: (194)] [added: (495)] | | |

| Other comprehensive income (loss) | | | | | | [removed: (14,610)] [added: 31,452] | | | | | | [removed: (39,175)] [added: (14,610)] | | | | | | [removed: 44,189] [added: (39,175)] | | |

| Comprehensive income | | | | | | $ | [removed: 346,963] [added: 476,505] | | | | | $ | [removed: 732,845] [added: 346,963] | | | | | $ | [removed: 1,820,077] [added: 732,845] | |

| | | | | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |

| February 28, 2024 | | |

| February 28, 2024 | | |

February 28, 2024

| Net income before provision for income taxes | | | | | | 641,204 | | | | | | 599,057 | | | | | | 1,012,423 | | |

| Net income | | | | | | $ | 445,053 | | | | | $ | 361,573 | | | | | $ | 772,020 | |

| | | | | | | 2023 | | | | | | 2022 | | |

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

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

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

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

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

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

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

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 445,053 | | | | | | $ | 445,053 | |

| Common stock repurchased and retired | | | | | | (2,457) | | | | | | (1) | | | | | | (30,852) | | | | | | — | | | | | | (564,567) | | | | | | $ | (595,420) | |

| Balance as of December 31, 2023 | | | | | | 75,075 | | | | | | $ | 7 | | | | | $ | 1,162,140 | | | | | $ | 21,168 | | | | | $ | 2,447,174 | | | | | $ | 3,630,489 | |

| 1 Includes tax withholding shares related to net share settlements of equity awards. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

| Net income | | | | | | $ | 445,053 | | | | | $ | 361,573 | | | | | $ | 772,020 | |

| Impairments on equity investments | | | | | | 4,990 | | | | | | — | | | | | | — | | |

| Purchase of equity investments | | | | | | (76,999) | | | | | | — | | | | | | — | | |

| Activity for equity forward contracts related to accelerated stock repurchase agreements, net | | | | | | (10,000) | | | | | | (40,000) | | | | | | — | | |

In September 2023, we completed an assessment of the useful lives of certain manufacturing equipment used in cutting, forming, assembling and scanning.

We adjusted the estimated useful life from ten (10) years to thirteen (13) years.

This change in accounting estimate was effective beginning September 2023.

These updated useful lives were applied to applicable assets in service as of the date of change and will be applied prospectively as assets are placed in service.

Based on the carrying amount of the assets recorded in our property, plant and equipment, net balance prior to the change, the effect of this change in estimate for fiscal year 2023 was a reduction in depreciation expense of approximately $5.4 million and an increase in net income of $3.7 million, or $0.05 per share basic and diluted, for the year ended December 31, 2023.

We are ultimately responsible for these underlying estimates.

We have elected to account for all investments in equity securities in accordance with the measurement alternative.

Under the measurement alternative, we record

the value of our investments in equity securities at cost, minus impairment, if any.

On April 24, 2023, we entered into a Subscription Agreement (the "Subscription Agreement") with Heartland Dental Holding Corporation (“Heartland”) who is an affiliate of KKR Core Holding Company LLC, which is an investment vehicle managed or advised by, or otherwise affiliated with, Kohlberg Kravis Roberts & Co. L.P. Heartland is a dental support organization (“DSO”) that provides nonclinical administrative and support services to supported dental professional corporations (“PCs”).

Pursuant to the Subscription Agreement we acquired less than a 5% equity interest through the purchase of Class A Common Stock for $75 million.

In connection with the Subscription Agreement, we entered into a Stockholders’ Agreement, by and among us, Heartland Dental Topco, LLC (“Topco”) and funds and accounts managed by affiliates of KKR & Co. Inc. (“KKR”), and a Side Letter, by and among us, Heartland, Topco and KKR (the "Side Letter").

Subject to certain restrictions set forth in the Side Letter, we agreed to provisions applicable to Heartland’s stockholders, including certain drag-along and voting obligations.

We are not the primary beneficiary of nor are we able to exercise significant influence over Heartland.

As such, we are accounting for our investment in Heartland as an investment in equity securities.

Similar to our other investments in equity securities, Heartland is accounted for under the measurement alternative.

Based on review of our investment in Heartland, we determined that no adjustments to the carrying value were necessary; therefore, it is properly reflected on our Consolidated Balance Sheet in other assets at $75 million.

Our investments in privately held companies in which we can exercise significant influence are accounted for as equity method investments.

| February 27, 2023 | | |

February 27, 2023

| Balance as of December 31, 2019 | | | | | | 78,433 | | | | | | $ | 8 | | | | | $ | 906,937 | | | | | $ | (688) | | | | | $ | 439,912 | | | | | $ | 1,346,169 | |

| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,775,888 | | | | | | 1,775,888 | | |

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

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

We evaluate goodwill for impairment at least annually on November 30th or more frequently if indicators are present, an event occurs or changes in circumstances suggest an impairment may exist and that it would more likely than not reduce the fair value of a reporting unit below its carrying amount.

The allocation of goodwill to the respective reporting unit is based on relative synergies generated as a result of an acquisition.

In

The estimation of fair value utilizing a discounted cash flow approach includes numerous uncertainties which require our significant judgment when making assumptions of expected growth rates and the selection of discount rates, as well as assumptions regarding general economic and business conditions, and the structure that would yield the highest economic value, among other factors.

For both scanner and service sales, most consideration is

During fiscal 2020, we completed an intra-entity transfer of certain intellectual property rights and fixed assets to our Swiss subsidiary, which resulted in the recognition of deferred tax assets and related tax benefits.

Refer to *Note 12 “Income Taxes” of Notes to Consolidated Financial Statements* for more information.

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

The accuracy of these estimates could be affected by unforeseen events or actual

results, and the sustainability of our future tax benefits is dependent upon the acceptance of these valuation estimates and assumptions by the taxing authorities.

The U.S. Tax Cuts and Jobs Act includes provisions for certain foreign-sourced earnings referred to as Global Intangible Low-Taxed Income (“GILTI”) which imposes a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations.

We have made the election to record GILTI tax using the period cost method.

We continue to monitor new accounting pronouncements issued by the FASB and do not believe any of the recently issued accounting pronouncements will have a material impact on our consolidated financial statements or related disclosures.

| Cash | | | | | | $ | 754,802 | | | | | $ | — | | | | | $ | — | | | | | $ | 754,802 | | | | | $ | 754,802 | | | | | $ | — | | | | | $ | — | |

| Corporate bonds | | | | | | 115,507 | | | | | | 9 | | | | | | (398) | | | | | | 115,118 | | | | | | 1,042 | | | | | | 35,065 | | | | | | 79,011 | | |

| Asset-backed securities | | | | | | 32,031 | | | | | | — | | | | | | (40) | | | | | | 31,991 | | | | | | — | | | | | | 10,999 | | | | | | 20,992 | | |

| Municipal bonds | | | | | | 7,628 | | | | | | — | | | | | | (15) | | | | | | 7,613 | | | | | | 516 | | | | | | 3,657 | | | | | | 3,440 | | |

| Total | | | | | | $ | 1,297,157 | | | | | $ | 9 | | | | | $ | (504) | | | | | $ | 1,296,662 | | | | | $ | 1,099,370 | | | | | $ | 71,972 | | | | | $ | 125,320 | |

As of December 31, 2021, all gross unrealized losses had been in an unrealized loss position for less than 12 months.

| Israeli funds | | | | | | 3,841 | | | | | | — | | | | | | 3,841 | | | | | | | | |

| | | | | | | $ | 545,701 | | | | | $ | 385,938 | | | | | $ | 159,763 | | | | | | | |

| Euro | | | | | | €165,110 | | | | | | $ | 186,358 | |

| Canadian Dollar | | | | | | C$99,800 | | | | | | 78,018 | | |

| Polish Zloty | | | | | | PLN219,800 | | | | | | 54,014 | | |

| Japanese Yen | | | | | | ¥5,548,700 | | | | | | 48,206 | | |

| British Pound | | | | | | £34,740 | | | | | | 46,881 | | |

| Israeli Shekel | | | | | | ILS54,110 | | | | | | 17,416 | | |

| Mexican Peso | | | | | | M$311,500 | | | | | | 15,133 | | |

| Swiss Franc | | | | | | CHF9,950 | | | | | | 10,883 | | |

| Australian Dollar | | | | | | A$6,900 | | | | | | 5,009 | | |

| | | | | | | | | | | | | $ | 590,170 | |

*Other foreign currency forward contract*

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.

Relating to this forward contract, in 2020, we recognized a loss of $10.2 million within other income (expense), net in our Consolidated Statement of Operations.

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: 2022] [added: 2023] 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: 2022] [added: 2023] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

During the fiscal quarter ended December 31, 2023, no director or officer, as defined in Rule 16a-1(f) of the Exchange Act, adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Regulation S-K Item 408.

None.

The information required by Item 405 of Regulation S-K is incorporated by reference to the section entitled “Delinquent Section 16(a) Reports” contained in [removed: the Proxy Statement.]

the Proxy Statement.

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

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

Equity Compensation Plan Information

The following table provides information as of December 31, 2023 about our common stock that may be issued upon the awards granted to employees, consultants or members of our Board of Directors under all existing equity compensation plans, including the 2005 Incentive Plan and the Employee Stock Purchase Plan (“ESPP”), each as amended, and certain individual arrangements (Refer to *Note 9 "Stockholders’ Equity” of the Notes to Consolidated Financial Statements* for a description of our equity compensation plans).

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

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

| Plan Category | | | | | | Number of securities to be issued upon exercise of outstanding options and restricted stock units (a) | | | | | | Weighted average exercise price of outstanding options (b) | | | | | | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | | | | | |

| Equity compensation plans approved by security holders | | | | | | 898,838 | | | 1 | | | $ | — | | | | | 7,241,323 | | | 2, 3 | | |

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

| Total | | | | | | 898,838 | | | | | | $ | — | | | | | 7,241,323 | | | | | |

1 Includes 741,185 RSUs and 157,653 MSUs at 100% of target

2 Includes 1,995,453 shares available for issuance under our ESPP.

We are unable to ascertain with specificity the number of securities to be issued upon exercise of outstanding rights or the weighted average exercise price of outstanding rights under the ESPP.

3 Includes additional 449,311 of potentially issuable MSUs above target if performance targets are achieved at maximum payout of 250% (in addition to the reserve for one and nine-tenths (1 9/10) shares for every one (1) issuable share against the authorized share reserve)

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

| Report of Independent Registered Public Accounting Firm | | | [removed: [56](#i2704b576f8bf446aa18dd6265ae58c92_100)] [added: [54](#i417aa79b41cc44f4a8019aa6393b0501_94)] | | |

| Consolidated Statements of Operations for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [58](#i2704b576f8bf446aa18dd6265ae58c92_103)] [added: [56](#i417aa79b41cc44f4a8019aa6393b0501_97)] | | |

| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [59](#i2704b576f8bf446aa18dd6265ae58c92_106)] [added: [57](#i417aa79b41cc44f4a8019aa6393b0501_100)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] | | | [removed: [60](#i2704b576f8bf446aa18dd6265ae58c92_109)] [added: [58](#i417aa79b41cc44f4a8019aa6393b0501_103)] | | |

| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [61](#i2704b576f8bf446aa18dd6265ae58c92_112)] [added: [59](#i417aa79b41cc44f4a8019aa6393b0501_106)] | | |

| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [62](#i2704b576f8bf446aa18dd6265ae58c92_115)] [added: [60](#i417aa79b41cc44f4a8019aa6393b0501_109)] | | |

| Notes to Consolidated Financial Statements | | | [removed: [63](#i2704b576f8bf446aa18dd6265ae58c92_118)] [added: [61](#i417aa79b41cc44f4a8019aa6393b0501_112)] | | |

Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]

| [removed: [3.2](http://www.sec.gov/Archives/edgar/data/1097149/000119312512089369/d308363dex32.htm)] [added: [3.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000003/amendedandrestatedbylawspr.htm)] | | | [Amended and Restated Bylaws of [removed: registrant](http://www.sec.gov/Archives/edgar/data/1097149/000119312512089369/d308363dex32.htm)] [added: registrant](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000003/amendedandrestatedbylawspr.htm)] | | | 8-K | | | [removed: 2/29/2012] [added: 1/17/2024] | | | [removed: 3.2] [added: 3.1] | | | | | | | | |

| [removed: [10.2†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm)] [added: [10.2†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)] | | | [Registrant's 2005 Incentive Plan (as [removed: amended May 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm)] [added: amended](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm) [and restated](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm) [May 20](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)[23](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)[)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000049/align-2005incentiveplanmar.htm)] | | | [removed: 10-K] [added: 8-K] | | | [removed: 2/26/2021] [added: 5/18/2023] | | | [removed: 10.2] [added: 10.1] | | | | | | | | |

| [removed: [10.7†](http://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] [added: [10.10†](http://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm)] | | | [Form of option award agreement under registrant’s 2005 Incentive Plan](http://www.sec.gov/Archives/edgar/data/1097149/000110465905036404/a05-12559_1ex10d4.htm) | | | 10-Q | | | 8/4/2005 | | | 10.4 | | | | | | | | |

| [removed: [10.8†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)] [added: [10.11†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)] | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted [removed: in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2019](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[,](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [and 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [to] [added: in 2019, 2020 and 2022 to] officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.8 | | | | | | | | |

| [removed: [10.8A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)] [added: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[11](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)] | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form for MSU awards granted [removed: in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [2019](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[,](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [and 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [to] [added: in 2019, 2020 and 2022 to] officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.8A | | | | | | | | |

| [removed: [10.9†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)] [added: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)[12](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109-20201231.htm)] | | | [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) | | | 10-K | | | 2/26/2021 | | | 10.9 | | | | | | | | |

| [removed: [10.9A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)] [added: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[12](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)[A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex109a-20201231.htm)] | | | [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) | | | 10-K | | | 2/26/2021 | | | 10.9A | | | | | | | | |

| [removed: [10.10†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)] [added: [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)[3](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm)] | | | [Form of Market Stock Unit Agreement for CEO (Focal grants)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex109-20191231.htm) | | | 10-K | | | 2/28/2020 | | | 10.9 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[7](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] | | | [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)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[8](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] | | | [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)[3](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[9](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm)] | | | [Amended and Restated Chief Executive Officer Employment Agreement between Align Technology, Inc. and Joseph Hogan](http://www.sec.gov/Archives/edgar/data/1097149/000109714915000012/algn-2015331xex1030.htm) | | | 10-Q | | | 5/1/2015 | | | 10.30 | | | | | | | | |

| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[4](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] [added: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[20](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000065/algn-20160930ex102.htm)] | | | [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)[5](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[†](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] [added: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[21](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)[†](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0005.txt)] | | | [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: [10.16](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)] [added: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)[2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm)] | | | [Sale and Purchase Agreement between CETP III Ivory S.a.r.l., and Align Technology, Inc. and its indirect wholly owned German subsidiary, mertus 602.GmbH, dated March 3, 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000025/algn-20200331xex101.htm) | | | 10-Q | | | 5/5/2020 | | | 10.1 | | | | | | | | |

| [removed: [10.17](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] [added: [10.](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[23](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)] | | | [Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) | | | 10-Q | | | 10/30/2020 | | | 10.1 | | | | | | | | |

| [removed: [10.18](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)] [added: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)[24](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm)] | | | [First Amendment, dated April 21, 2022, to Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1018-alignx1stamendmentt.htm) | | | [added: 10-K] | | | [added: 2/27/2023] | | | [added: 10.18] | | | | | | [removed: *] | | |

| [removed: [10.19](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)] [added: [10.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)[25](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm)] | | | [Second Amendment, dated December 23, 2022, to Credit Agreement between Align Technology, Inc. and the lenders party thereto from time to time and Citibank, N.A., as administrative agent, dated July 21, 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1019-alignx2ndamendmentt.htm) | | | [added: 10-K] | | | [added: 2/27/2023] | | | [added: 10.19] | | | | | | [removed: *] | | |

| [removed: [10.20](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm)] [added: [10.26](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/algnasconfirmation20231026.htm)] | | | [Fixed Dollar Accelerated Share [removed: Repurchase](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [Transaction](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [between Goldman Sachs & Co. LLC] [added: Repurchase Transaction between Citibank, N.A] and Align Technology, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm) [dated] [added: Inc. dated] October [removed: 28, 2022](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex1020-algnxq422asragreeme.htm)] [added: 26, 2023](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/algnasconfirmation20231026.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex211-20221231.htm)] [added: [21.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex211-20231231.htm)] | | | [Subsidiaries of Align Technology, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex211-20221231.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex211-20231231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex231-20221231.htm)] [added: [23.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex231-20231231.htm)] | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex231-20221231.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex231-20231231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex311-20221231.htm)] [added: [31.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex311-20231231.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/1097149/000109714923000013/ex311-20221231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex311-20231231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex312-20221231.htm)] [added: [31.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex312-20231231.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/1097149/000109714923000013/ex312-20221231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex312-20231231.htm)] | | | | | | | | | | | | | | | * | | |

| [removed: [32](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex32-20221231.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000013/ex32-20221231.htm)] [added: [32](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex32-20231231.htm)[t](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex32-20231231.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/1097149/000109714923000013/ex32-20221231.htm)] [added: 2003](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/ex32-20231231.htm)] | | | | | | | | | | | | | | | * | | |

| Year Ended December 31, 2023 | | | | | | $ | 10,343 | | | | | $ | 8,002 | | | | | $ | (3,452) | | | | | $ | 14,893 | |

| Year Ended December 31, 2023 | | | | | | $ | 23,286 | | | | | $ | (8,295) | | | | | $ | — | | | | | $ | 14,991 | |

| [3.1B](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/amendmenttocertificateofin.htm) | | | [Certificate of Amendment to the Amended and Restated Certificate of Incorporation](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/amendmenttocertificateofin.htm) | | | 10-Q | | | 8/4/2023 | | | 3.1B | | | | | | | | |

| [10.7†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganrsuagreement.htm) | | | [Form of Restricted Stock Unit Agreement under Registrant's 2005 Incentive Plan (CEO Form)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganrsuagreement.htm) | | | 10-Q | | | 5/5/2023 | | | 10.1 | | | | | | | | |

| [10.8†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) | | | [Form of Restricted Stock Unit Agreement under Registrant's 2005 Incentive Plan (Executive Officer Form for officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementexecutive.htm) | | | 10-Q | | | 5/5/2023 | | | 10.2 | | | | | | | | |

| [10.9†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) | | | [Form of Restricted Stock Unit Agreement under Registrant's 2005 Incentive Plan (Executive Officer Form for officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023rsuagreementprior-sep.htm) | | | 10-Q | | | 5/5/2023 | | | 10.3 | | | | | | | | |

| [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)[4](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (CEO Form](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023hoganmsuagreement.htm)) | | | 10-Q | | | 5/5/2023 | | | 10.4 | | | | | | | | |

| [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)[5](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Executive Officer Form for officers appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementexecutive.htm) | | | 10-Q | | | 5/5/2023 | | | 10.5 | | | | | | | | |

| [10.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)[6](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm)[†](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) | | | [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Executive Officer Form for officers appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000046/a2023msuagreementprior-sep.htm) | | | 10-Q | | | 5/5/2023 | | | 10.6 | | | | | | | | |

| [10.27](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/subscriptionagreement-hart.htm) | | | [Subscription Agreement, dated as of April 24, 2023 between Align Technology, Inc. and Heartland Dental Holding Corporation](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/subscriptionagreement-hart.htm) | | | 10-Q | | | 8/4/23 | | | 10.1 | | | | | | | | |

| [10.28](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/align-hdstockholdersagreem.htm) | | | [Stockholders' Agreement, dated as of April 24, 2023 by and among Heartland Dental Holding Corporation, Heartland Dental Topco, LLC, KKR Core Holding Company LLC, KKR Partners IV L.P., any Sponsor Group Permitted Transferee as defined in the Agreement and Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/align-hdstockholdersagreem.htm) | | | 10-Q | | | 8/4/23 | | | 10.2 | | | | | | | | |

| [10.29](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/align-hdsideletteralignxhd.htm) | | | [Side Letter, dated as of April 24, 2023 by and among Heartland Dental Holding Corporation, Heartland Dental Topco, LLC, KKR Core Holding Company LLC, KKR Partners IV L.P., any Sponsor Group Permitted Transferee as defined in the Stockholders' Agreement and Align Technology, Inc.](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000059/align-hdsideletteralignxhd.htm) | | | 10-Q | | | 8/4/23 | | | 10.3 | | | | | | | | |

| [1](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000082/projectcabernet33_spa23090.htm)[0.30](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000082/projectcabernet33_spa23090.htm) | | | [Share Purchase Agreement, dated September 1, 2023, between Align Holdings GMBH, Align Technology Switzerland GMBH and the Sellers provided therein](https://www.sec.gov/Archives/edgar/data/1097149/000109714923000082/projectcabernet33_spa23090.htm) | | | 10-Q | | | 11/3/23 | | | 10.1 | | | | | | | | |

| [97.1](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/alignclawbackpolicyv6.htm) | | | [Clawback Policy](https://www.sec.gov/Archives/edgar/data/1097149/000109714924000011/alignclawbackpolicyv6.htm) | | | | | | | | | | | | | | | * | | |

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

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

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

| | | | Portions of the exhibit, marked by brackets and asterisks \[*\], have been omitted because the omitted information is not material and (i) would likely cause competitive harm to the registrant if publicly disclosed or (ii) is information that the registrant treats as private or confidential. | | |

| Year Ended December 31, 2020 | | | | | | $ | 6,756 | | | | | $ | 12,073 | | | | | $ | (8,590) | | | | | $ | 10,239 | |

| Year Ended December 31, 2020 | | | | | | $ | 1,086 | | | | | $ | 239 | | | | | $ | — | | | | | $ | 1,325 | |

| [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 | | | | | | | | |

| Date: | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ JOSEPH M. HOGAN | | | | | | President, Chief Executive Officer and Director (Principal Executive Officer) | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ JOHN F. MORICI | | | | | | Chief Financial Officer and Executive Vice President, Global Finance (Principal Financial Officer and Principal Accounting Officer) | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ KEVIN J. DALLAS | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ JOSEPH LACOB | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ C. RAYMOND LARKIN, JR. | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ GEORGE J. MORROW | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ ANNE M. MYONG | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ ANDREA L. SAIA | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ SUSAN E. SIEGEL | | | | | | Director | | | | | | February [removed: 27, 2023] [added: 28, 2024] | | |

| /S/ KEVIN T. CONROY | | | | | | Director | | | | | | February 28, 2024 | | |

| Kevin T. Conroy | | | | | | | | | | | | | | |

| /S/ MOJDEH POUL | | | | | | Director | | | | | | February 28, 2024 | | |

| Mojdeh Poul | | | | | | | | | | | | | | |

| /S/ GREG J. SANTORA | | | | | | Director | | | | | | February 27, 2023 | | |

| Greg J. Santora | | | | | | | | | | | | | | |

| /S/ WARREN S. THALER | | | | | | Director | | | | | | February 27, 2023 | | |

| Warren S. Thaler | | | | | | | | | | | | | | |