Align Technology (ALGN) 10-K risk factor changes: FY2020 vs FY2019

*The following discussion is divided into two sections.

The first, entitled “Risks Relating to our Business,” discusses some of the risks that may affect our business, results of operations and financial condition.

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

You should carefully review both sections, 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.

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.

The risks below are not the only ones we face.

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

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

Risks Relating to our Business Operations and Strategy

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

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

- Competition in the markets for our products is increasing and we expect aggressive competition from existing competitors, other companies that may introduce new technologies in the future and customers who create aligners or retainers in house.

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

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

- Our success depends on our ability to develop, successfully introduce and achieve market acceptance of new products and services.

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

- As we continue to grow, we are subject to growth related risks, including risks related to excess or constrained capacity and operational inefficiencies at our manufacturing and treat facilities.

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

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

- A disruption in the operations of a primary freight carrier or higher shipping costs could cause a decline in our net revenues or a reduction in our earnings.

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

- Our information technology systems are critical to our business.

System integration and implementation issues and system security risks could disrupt our operations, which could have a material adverse impact on our business and operating results.

- If the security of our customer and patient information is compromised or we are unable to comply with data protection laws, our operations may be severely adversely impacted, patient care could suffer, we could be liable for related damages, and our reputation could be impaired.

- In order to deepen our market penetration and raise awareness of our brand and products, we may increase the amount we spend on marketing activities, which may not ultimately prove successful or an effective use of our resources.

- Our success depends in part on our proprietary technology, and if we fail to successfully obtain or enforce our intellectual property rights, our competitive position may be harmed.

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

- Obtaining approvals and complying with governmental regulations, particularly healthcare and data privacy compliance, is expensive and time-consuming, and any failure to obtain or maintain approvals or comply with regulations regarding our products or services or the products and services of our suppliers or customers could materially harm our sales, result in substantial penalties and cause harm to our reputation.

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

- We maintain single supply relationships for certain key machines and materials, and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in our manufacturing process increases.

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

- We use distributors for a portion of the importation, marketing and sales efforts related to our products and services, which exposes us to risks that may be harmful to our sales and operations.

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

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

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

General Risk Factors

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

The following discussion and analysis of our financial condition and results of operations should be read together with [removed: “Selected Consolidated Financial Data” and] our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.

A discussion regarding our financial condition and results of operations for fiscal [removed: 2019] [added: 2020] compared to fiscal [removed: 2018] [added: 2019] is presented under Results of Operations of this Form 10-K.

Discussions regarding our financial condition and results of operations for fiscal [removed: 2018] [added: 2019] compared to [removed: 2017] [added: 2018] 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: 2018,] [added: 2019,] filed with the SEC on February 28, [removed: 2019,] [added: 2020,] which is available without charge on the SEC's website at www.sec.gov and on our investor relations website at investor.aligntech.com.

[removed: We intend to achieve these goals by continued focus and execution] [added: For a further description] of our strategic growth [removed: drivers set forth in] [added: drivers, please see] the *Business [added: - Business] Strategy* section of this Annual Report on Form 10-K.

[removed: | • |] [added: -] *New [removed: Invisalign Products] [added: Technology, Products,] and Feature [removed: Enhancements*.] [added: Enhancements.*] We believe [removed: product innovation] [added: technological innovations allowing dental professionals to more quickly and accurately diagnose, plan and treat a wide range of cases from simple to complex combined with new and improved products] drives greater treatment predictability, clinical [removed: applicability and] [added: applicability,] ease of use [added: and confidence] for the dental professionals we [removed: serve customers which supports] [added: serve; thereby supporting] adoption of Invisalign treatment in their practices. [removed: Our focus is to develop solutions and features to treat a wide range of cases from simple to complex. |]

[added: -] For the fourth quarter of [removed: 2019,] [added: 2020,] total Invisalign cases submitted with a digital scanner in the Americas increased to [removed: 79.5%,] [added: 84.0%,] up [removed: slightly] from [removed: 78.8%] [added: 79.5%] in the [removed: third] [added: fourth] quarter of [added: 2019 and international scans increased to 73.7%, up from 64.7% in the fourth quarter of] 2019.

[removed: | • |] [added: -] *Invisalign Adoption.* Our goal is to establish Invisalign [added: clear aligners] as the treatment of choice for treating [removed: malocclusion] [added: malocclusion,] ultimately driving increased product adoption and frequency of use by dental professionals, [removed: also known] [added: which we refer to] as “utilization rates.” [removed: Our annual utilization rates for the last three fiscal years are as follows: |]

[removed: ][added: ]

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

Our International region includes [removed: EMEA] [added: Europe, Middle East] and [removed: APAC.][added: Africa (“EMEA”) and Asia Pacific (“APAC”).]

[removed: LATAM] [added: Latin America (“LATAM”)] is excluded from the above chart [removed: as it is immaterial.][added: based on its immateriality.]

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

[removed: | ▪ |] [added: -] *North America:* Utilization [removed: for both] [added: rate among] our North American orthodontist [removed: and GP] customers increased [removed: in 2019] to [removed: 65.0 and 9.5] [added: 67.3] cases per doctor [added: in 2020] compared to [removed: 56.7] [added: 65.0] cases [added: per doctor in 2019] and [removed: 9.1] [added: 56.7] cases per doctor in [removed: 2018, respectively. The increase in] [added: 2018 and the] utilization [added: rate among our North American GP customers increased to 9.6 cases per doctor] in [removed: 2019 reflects improvements] [added: 2020 compared to 9.5 cases per doctor] in [removed: product] [added: 2019] and [removed: technology which continues to strengthen |][added: 9.1 cases per doctor in 2018.]

[removed: | *▪* |] [added: -] *International:* International doctor utilization [removed: remained relatively flat at 13.8] [added: rate was 14.5] cases per doctor in [removed: 2019] [added: 2020] compared to [added: 13.8 cases in 2019 and] 13.9 cases [added: per doctor] in 2018. [removed: |]

In addition, [removed: since] the teenage and younger market makes up 75% of the approximately [removed: 12] [added: 15] million total orthodontic case starts each year, and as we continue to drive adoption [removed: of] [added: by] teenage and younger patients through sales and marketing programs, we expect [removed: our] utilization rates to improve.

[removed: Our] [added: However, our] utilization [removed: rates, however, may] [added: rates will] fluctuate from period to period due to a variety of factors, [removed: including] [added: which may include] seasonal trends in our [removed: business along with] [added: business, COVID-19-related preventative measures and] adoption rates [removed: of] [added: for] new products and features.

[removed: | • | *Number of New Invisalign Doctors Trained.* We continue to expand our Invisalign customer base through the training of new doctors.] In 2019, we trained [removed: 22,270] [added: a total of 22,275] new Invisalign [removed: doctors] [added: doctors,] of which 9,765 were trained in the Americas region and [removed: 12,505] [added: 12,510] in the International region. [removed: |]

[removed: | ▪ | Investments in manufacturing] [added: ▪Manufacturing] capacity and facilities to enhance our regional capabilities; [removed: |]

[removed: | ▪ | Product] [added: ▪Product] and technology innovation to enhance product efficiency and operational productivity. [removed: |]

We believe [removed: that] these investments [removed: will] position us to [removed: increase] [added: take advantage of a recovering market and thereafter once markets return to greater normalcy, increasing] our revenues and [removed: continue to grow] [added: growing] our market [removed: share,] [added: share over the long term,] but [removed: will] [added: they could] negatively impact [added: our] results of operations, particularly in the near term.

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

[removed: | • |] [added: -] Our Clear Aligner segment consists of Comprehensive Products, Non-Comprehensive Products and Non-Case revenues as defined below: [removed: |]

[removed: | • |] [added: -] Comprehensive Products [removed: include] [added: include, but are not limited to,] Invisalign Comprehensive and Invisalign First. [removed: |]

[removed: | • |] [added: -] Non-Comprehensive Products include, but are not limited to, Invisalign Moderate, Lite and Express packages and Invisalign [removed: Go, in addition to revenues from the sale of aligners to SmileDirectClub (“SDC”) under our supply agreement that expired on December 31, 2019. |][added: Go.]

[removed: | • |] [added: -] Non-Case includes, but is not limited to, Vivera retainers along with our training and ancillary products for treating malocclusion. [removed: |]

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

Net revenues for our Clear Aligner and [removed: Scanner] [added: Systems and Services] segments by region for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] are as follows (in millions):

| | | [added: | | | |] Year Ended December 31, | | | | | | | | | | | | | | | [added: | | | | | | | | |] Year Ended December 31, | | | | | | | | | | | | | | [added: | | | | | | |]

| Net Revenues | | [removed: 2019] | | | | [removed: 2018] [added: 2020] | | | | [added: | | 2019 | | | | | |] Change | | | | | | | [removed: 2018] | | | | [removed: 2017] | [added: 2019] | | | [added: | | | 2018 | | | | | |] Change | | | | | | [added: | | |]

| Clear Aligner revenues: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Americas | | [added: | | | |] $ | [removed: 1,022.1] [added: 1,010.2] | | | [added: | |] $ | [removed: 903.3] [added: 1,022.1] | | | [added: | |] $ | [removed: 118.8] [added: (11.9)] | | | [removed: 13.2] | [added: | (1.2) | |] % | | [added: | |] $ | [removed: 903.3] [added: 1,022.1] | | | [added: | |] $ | [removed: 754.1] [added: 903.3] | | | [added: | |] $ | [removed: 149.2] [added: 118.8] | | | [removed: 19.8] | [added: | 13.2 | |] % |

| International | | [added: | | | | 965.4 | | | | | |] 881.4 | | | | [removed: 684.2] | | [added: 84.1] | | [removed: 197.2] | | | | [removed: 28.8] [added: 9.5] | [added: |] % | | [added: | | 881.4 | | | | | |] 684.2 | | | | [removed: 473.5] | | [added: 197.2] | | [removed: 210.7] | | | | [removed: 44.5] [added: 28.8] | [added: |] % |

| [removed: Non-Case] [added: Non-case] | | [added: | | | | 125.8 | | | | | |] 122.3 | | | | [removed: 104.0] | | [added: 3.5] | | [removed: 18.3] | | | | [removed: 17.6] [added: 2.9] | [added: |] % | | [added: | | 122.3 | | | | | |] 104.0 | | | | [removed: 81.7] | | [added: 18.3] | | [removed: 22.3] | | | | [removed: 27.3] [added: 17.6] | [added: |] % |

| Total Clear Aligner net revenues | | [added: | | | |] $ | [removed: 2,025.8] [added: 2,101.5] | | | [added: | |] $ | [removed: 1,691.5] [added: 2,025.8] | | | [added: | |] $ | [removed: 334.3] [added: 75.7] | | | [removed: 19.8] | [added: | 3.7 | |] % | | [added: | |] $ | [removed: 1,691.5] [added: 2,025.8] | | | [added: | |] $ | [removed: 1,309.3] [added: 1,691.5] | | | [added: | |] $ | [removed: 382.2] [added: 334.3] | | | [removed: 29.2] | [added: | 19.8 | |] % |

| Total net revenues | | [added: | | | |] $ | [removed: 2,406.8] [added: 2,471.9] | | | [added: | |] $ | [removed: 1,966.5] [added: 2,406.8] | | | [added: | |] $ | [removed: 440.3] [added: 65.1] | | | [removed: 22.4] | [added: | 2.7 | |] % | | [added: | |] $ | [removed: 1,966.5] [added: 2,406.8] | | | [added: | |] $ | [removed: 1,473.4] [added: 1,966.5] | | | [added: | |] $ | [removed: 493.1] [added: 440.3] | | | [removed: 33.5] | [added: | 22.4 | |] % |

Case volume data which represents Clear Aligner case shipments by region for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] is as follows (in thousands):

| | | [added: | | | |] Year Ended December 31, | | | | | | | | | | | | [added: | | | | | | | | | | | |] Year Ended December 31, | | | | | | | | | | | [added: | | | | | | | | | |]

| Region | | [added: | | | | 2020 | | | | | |] 2019 | | | [removed: 2018] | | | Change | | | | | | [added: | | | | | | 2019 | | | | | |] 2018 | | | [removed: 2017] | | | Change | | | | | [added: | | | |]

| Americas | | [added: | | | | 886.5 | | | | | |] 867.3 | | | [removed: 780.7] | | | [removed: 86.6] [added: 19.2] | | | [removed: 11.1] | [added: | | 2.2 | |] % | | [added: | | 867.3 | | | | | |] 780.7 | | | [removed: 631.6] | | | [removed: 149.1] [added: 86.6] | | | [removed: 23.6] | [added: | | 11.1 | |] % |

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

To date, over 9.6 million people worldwide have been treated with our Invisalign System.

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

Our business strategic priorities are currently based on four principal pillars of growth: (i) International expansion; (ii) GP adoption; (iii) Patient demand & conversion; and (iv) Orthodontic utilization.

We strive to deliver on each of our strategic growth drivers through a variety of interrelated enterprise-wide efforts including:

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

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

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

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

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

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

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

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

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

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

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

For the fourth quarter of 2020, 94.8% of Invisalign cases submitted by North American orthodontists were submitted digitally.

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

We expect global utilization rates to steadily improve as doctors’ clinical confidence in the use of Invisalign clear aligners increases with advancements in products and technology and as patient and doctor demands for treatments that emphasize convenience and safety through fewer in office visits and less invasive and quicker treatments rise.

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

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

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

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

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

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

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

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

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

Notwithstanding these uncertainties, we continue to see growth opportunities with international orthodontists and GP customers, particularly with adopters of digital dentistry platforms and as we continue to segment our sales and marketing resources and programs specifically around each customer channel.

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

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

We also intend to continue expanding our manufacturing and treatment planning operations to meet local and regional demand.

Overall, we expect International revenues to grow at a faster rate than Americas' revenues for the foreseeable future due to our continued investment in international market expansion, the size of the market opportunities and our relatively low market penetration of these regions.

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

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

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

Additionally, we believe that well-designed, targeted sales and marketing promotions help us build on our strong brand awareness and differentiate us from traditional and emerging competitors.

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

During 2020, our marketing and consumer engagement included

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

Our goals are to establish Invisalign clear aligners as the standard method for treating malocclusion which, to date, over 8 million people worldwide have been treated with our Invisalign System, and to establish the iTero intraoral scanner as the preferred scanning device for 3D digital scans, ultimately driving increased clear aligner and other product adoption by dental professionals.

The successful execution of our business strategy in 2020 and beyond may be affected by a number of factors including:

| | |

| --- | --- |

| • | We rolled out Invisalign treatment with Mandibular Advancement, the first clear aligner solution for Class II correction in growing tween and teen patients in multiple regions and countries throughout 2018. This offering combines the benefits of our clear aligner system with features for moving the lower jaw forward while simultaneously aligning the teeth without the need for elastics typically used to treat teen Class II patients. |

| • | In April 2018, we announced Invisalign Go product with more user-friendly iTero digital chairside experience and greater flexibility to treat a wider range of mild to moderate cases. Invisalign Go also incorporates new data-driven clinical protocols for predictable tooth movement and automated case assessments that leverages our Invisalign patients treated to date. These improvements make it easier for general practitioner (“GP”) dentists to tailor their treatment plans to the individual needs of each patient. |

| • | In July 2018, we announced Invisalign First clear aligners which are a treatment option designed with features specifically for younger patients with early mixed dentition with a mixture of primary/baby and permanent teeth. Phase 1 treatment is an early interceptive orthodontic treatment for young patients, traditionally done through arch expanders, or partial metal braces, before all permanent teeth have erupted, typically at ages seven through ten years. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion. |

| • | In October 2019, we launched the Invisalign Moderate Package for the treatment of mild to moderate malocclusion. The Invisalign Moderate treatment includes all the features of Invisalign treatment, plus additional features that address the orthodontic needs of teenage patients such as compliance indicators and compensation for tooth eruption. |

| • | *New iTero Products and Technology Innovation.* The iTero scanner is an important component to our customer experience and is central to a digital approach as well as overall customer utilization of Invisalign. |

| • | In April 2018, we expanded the iTero Element portfolio with the launch of the iTero Element 2 and the iTero Element Flex scanners, building on the existing high precision, full-color imaging and fast scan times of the iTero Element portfolio while streamlining orthodontic and restorative workflows. The next-generation iTero Element 2 is designed for greater performance with 2X faster start-up and 25% faster scan processing time compared to the iTero Element. The new iTero Element Flex wand-only configuration is a portable scanner for easy transport from office to office. |

As we continue to expand our global presence, we expect to seek regulatory approvals to offer our iTero portfolio products in more countries, thereby tapping potential growth opportunities in underserved markets

| • | In February 2019, we announced the launch of iTero Element 5D Imaging System for comprehensive, preventative and restorative oral care. The iTero Element 5D Imaging System provides a new comprehensive approach to clinical applications, workflows and user experience that expands the suite of existing high-precision, full color imaging and fast scan times of the iTero Element portfolio. The iTero Element 5D Imaging System is available in the majority of EMEA and select APAC countries. The iTero Element 5D Imaging System is pending regulatory approval and is not yet available in the U.S. or LATAM countries. |

| • | In June 2019, we announced the launch of iTero Element Foundation intraoral scanner with restorative software. The iTero Element Foundation extends Align’s portfolio of intraoral scanners with powerful 3D visualization to better meet the needs of doctors, labs and patients. The iTero Element Foundation is available in North America and will also be available in other select countries in 2020. |

We believe that over the longterm, clinical solutions and treatment tools will increase adoption of Invisalign and increase sales of our intraoral scanners; however, it is difficult to predict the rate of adoption which may vary by region and channel.

The use of iTero and other digital scanners for Invisalign case submission in place of PVS impressions continues to grow and remains a positive catalyst for Invisalign utilization.

International scans increased to 64.7%, up from 62.6% in the third quarter of 2019.

We believe that over the longterm, technology innovation and added features and functionality of our iTero scanners will increase adoption of Invisalign and increase sales of our intraoral scanners; however, it is difficult to predict the rate of adoption which may vary by region and channel.

our doctors’ clinical confidence such that they now utilize Invisalign more often and on more complex cases, including their teenage patients.

We expect our utilization rates to gradually improve as a result of advancements in product and technology, which continue to strengthen our doctors’ clinical confidence in the use of Invisalign clear aligners.

| • | *International Invisalign Growth.* We continue to focus our efforts towards increasing Invisalign clear aligner adoption by dental professionals in the EMEA and APAC markets. On a year-over-year basis, our International Invisalign volume increased 34.0% driven primarily by increased adoption as well as expansion of our customer base in both the EMEA and APAC regions. However, beginning in the second quarter of 2019, we experienced slower growth rates than prior periods in China primarily due to the US-China trade war and resulting economic uncertainty which caused headwind for consumer demand especially for consumption of luxury goods and considered purchases. We also believe there has been increased competitive activity from wires and bracket manufacturers and clear aligner suppliers. In addition, in the first quarter of 2020, the outbreak of the Novel Coronavirus (2019 NCov) in China has caused increased uncertainty and disruption to our employees, doctors’ practices, their patients and consumers. We expect the impact of the Novel Coronavirus and related efforts by the Chinese government to contain its spread, including travel restrictions, extension of the Lunar New Year and discouraging non-essential medical and dental procedures to adversely impact sales and operations in China for a currently indeterminate period of time. Notwithstanding these current issues in China, we continue to see growth from our international orthodontists and GP customers and are seeing more positive traction in the GP channel as we continue to segment our sales and marketing resources and programs specifically around each customer channel. In 2019, we continued to expand in our existing markets through targeted investments in sales coverage and professional marketing and education programs, along with consumer marketing in select country markets. We expect International revenues to continue to grow at a faster rate than the Americas for the foreseeable future due to our continued investment in international market expansion, the size of the market opportunities and our relatively low market penetration of these regions. Our future growth is dependent upon the continued growth of Invisalign adoption and international market penetration. |

| • | *Increasing Competition.* Starting in the second quarter of 2019, we began experiencing slower adult case growth from North American orthodontists, reflecting a more competitive environment especially for the young adult demographic. Given increased awareness for direct to consumer clear aligners and heavy advertising spend from direct to consumer companies, case starts may be shifting away from traditional practices. We also believe that doctors are sampling alternative products and/or taking advantage of wires and brackets bundles that essentially give clear aligners away for free or at low prices. In the third quarter of 2019, we increased investment in consumer demand with a new advertising campaign for North America and expanding marketing programs such as our Concierge Service, which connects potential patients with Invisalign doctors increasing conversion and loyalty. In addition, we launched new sales tools and professional marketing materials and we also expect to see increased productivity from the approximate 100 sales representatives we added in the first quarter of 2019. If, however, we are unable to compete effectively with existing products or respond effectively to any products developed by new or existing competitors, our business could be harmed*.* |

| • | *Establish Regional Order Acquisition, Treatment Planning and Manufacturing Operations.* We expect to continue establishing and expanding additional order acquisition, treatment planning and manufacturing operations closer to our international customers in order to improve our operational efficiency and increase doctors' confidence in Invisalign clear aligners. In the fourth quarter of 2018, we began fabricating our aligners in our manufacturing facility in Ziyang, China, our first aligner fabrication facility outside of Juarez, Mexico. In the third quarter of 2019, we opened our new order acquisition and treatment facility in Wroclaw, Poland and new treatment facility in Yokohama, Japan. |

| • | *Corporate Structure Reorganization.* In January 2020, we reorganized our corporate structure and intercompany relationships to more closely align with the international nature of our business activities with the goal of achieving financial and operational efficiencies. As part of this corporate structure reorganization, our EMEA regional headquarters |

was moved from Amsterdam, the Netherlands to Rotkreuz, Switzerland.

As a result, we will continue to incur expenses in the near term and expect to realize the related benefits in subsequent years.

The implementation of this reorganization plan has been disruptive to our business, and may not ultimately be more efficient or effective.

Moreover, our reorganization activities, including any related expenses and the impact from affected employees, could have a material adverse effect on our business, operating results, financial condition and effective tax rates.

| • | *Expenses.* We expect expenses to increase in 2020 due in part to: |

| ▪ | Investments in international expansion; |

| ▪ | Investments in expansion of number of direct sales force personnel; |

| ▪ | Increase in sales, marketing and customer support resources including our new advertising campaign; and |

| • | *Stock Repurchases.* During the year ended December 31, 2019, we repurchased $200.0 million of our common stock on the open market at an average price of $264.93 per share. We also entered into an accelerated stock repurchase agreement to repurchase $200.0 million of our common stock and received a total of 1.1 million shares for an average share price of $176.61. As of December 31, 2019, we have $100.0 million available for repurchase under the $600.0 million repurchase program authorized by our Board of Directors in May 2018 (Refer to *Note 12 “Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements* for details on our stock repurchase programs). |

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| Scanner net revenues | | 381.0 | | | | 275.0 | | | | 106.0 | | | | 38.5 | % | | 275.0 | | | | 164.1 | | | | 110.9 | | | | 67.6 | % |

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Americas net revenues increased by $118.8 million in 2019 as compared to 2018 due to Invisalign case volume growth across all channels and products which contributed to the net revenue growth by $100.2 million and higher average selling prices ("ASP") which increased net revenues by $18.7 million.

Higher ASP was mainly the result of price increases across most products which increased net revenues by $35.1 million and $23.4 million increase in net revenues driven by a product mix shift towards Comprehensive products and less SDC revenues, which carry a lower ASP.

We no longer manufacture aligners for SDC as our supply agreement with SDC expired by its terms on December 31, 2019.

As of December 31, [removed: 2019,] [added: 2020,] we had [removed: approximately $318.2 million invested] [added: no investments] in available-for-sale marketable securities.

Based on interest bearing liabilities we have as of December 31, [removed: 2019,] [added: 2020,] we are not subject to risks from immediate interest rate increases.

We [added: primarily] enter into foreign currency forward contracts to minimize the short-term impact of foreign currency exchange rate fluctuations on cash and certain trade and intercompany receivables and payables.

In addition, we are subject to the broad market risk that is created by the global market disruptions and uncertainties resulting from the COVID-19 pandemic.

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

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

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

The fair value of foreign exchange forward contracts outstanding as of December 31, 2019 was not material.

Align Technology, Inc. (“We”, “Our”, “Align”) is a global medical device company engaged in the design, manufacture and marketing of Invisalign® clear aligners and iTero® intraoral scanners and services for [removed: orthodontics,] [added: dentistry,] and [removed: restorative] [added: exocad® computer-aided design] and [removed: aesthetic dentistry.][added: computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners.]

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

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, [removed: Switzerland, which moved from Amsterdam, the Netherlands in January 2020;] [added: Switzerland;] and our Asia Pacific [removed: ("APAC")] [added: (“APAC”)] regional headquarters is located in Singapore.

We have two operating segments: (1) Clear Aligner and (2) [removed: Scanners] [added: Imaging Systems] and [added: CAD/CAM] Services [removed: ("Scanner").][added: (“Systems and Services”).]

For the year ended December 31, [removed: 2019,] [added: 2020,] Clear Aligner net revenues represented approximately [removed: 84%] [added: 85%] of worldwide net revenues, while [removed: Scanner] [added: Systems and Services] net revenues represented the remaining [removed: 16%] [added: 15%] of worldwide net revenues.

We sell the majority of our products directly [added: through a dedicated and specialized sales force] to our customers: [removed: orthodontists and] [added: orthodontists,] general practitioner dentists [removed: ("GPs"), as well as to] [added: (“GPs”),] restorative and aesthetic dentists, including prosthodontists, periodontists, and oral [removed: surgeons.][added: surgeons, and dental laboratories.]

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

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

To date, over [removed: 8] [added: 9.6] million people worldwide have been treated with our Invisalign System.

Our iTero [added: intraoral] scanner is used by dental professionals and/or labs and service providers for restorative and orthodontic digital procedures as well as Invisalign case [removed: submission.][added: submissions.]

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

Annually, approximately [removed: 12] [added: 15] million people in major developed countries elect treatment by orthodontists worldwide.

Of the [removed: 12] [added: 15] million annual [added: global] orthodontic cases started, we estimate that approximately [removed: 75%] [added: 90%] or [removed: 8.4] [added: 13.5] million could be treated using our Invisalign clear aligners.

In addition, [added: globally] approximately [removed: 300] [added: 500] million people with malocclusion could benefit from straightening their teeth.

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

The Invisalign System is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear [removed: plastic] [added: polymer] removable aligners.

[removed: *Orthodontic diagnosis] [added: *Diagnosis] and transmission of treatment [removed: data to us*.][added: data*.]

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

Intraoral digital scans may be submitted through [removed: either Align's] [added: Align’s] iTero scanner or certain third-party scanners capable of accurately interfacing with our systems and processes.

[removed: See "Third Party Scanners and Digital scans for Invisalign treatment submission." More than 73% of Invisalign case submissions are now submitted via digital scan, increasing the accuracy of] treatments, reducing the time from prescription submission to patient receipt, and decreasing the carbon footprint resulting from the shipment of the materials used to form [removed: the physical] PVS impressions [added: to the doctors] and shipping those PVS impressions [added: back] to us.

[removed: *Preparation of computer-simulated] [added: *Computer-simulated] treatment plan*.

Using the [removed: information] [added: information, certain doctor preferences] and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a [removed: ClinCheck] [added: ClinCheck®] treatment plan using [removed: our] proprietary [removed: software, which is not for sale or license.][added: software we have developed through significant, ongoing investments over more than 20 years.]

A patient’s ClinCheck treatment plan simulates [removed: expected] [added: desired] tooth movement in stages and details the timing and placement of any features or attachments to be used during treatment.

Attachments are tooth-colored “buttons” that are sometimes used to increase the biomechanical force on a specific tooth or teeth in order to [removed: effect] [added: affect] the desired movement(s).

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

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

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

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

Aligners are generally worn for a [added: short] period of time [removed: typically one to two weeks,] corresponding to the stages of the patient’s approved ClinCheck treatment plan.

At the treating doctor’s discretion, weekly aligner changes are recommended for all Invisalign treatments except for [removed: Invisalign Lite and] Express packages and may provide [removed: up to 50%] shorter treatment time compared with two-week aligner wear.

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

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

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

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

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

Most of our Invisalign [removed: Treatment Plans] [added: System treatment plans] described above provide dental professionals with the option to order additional aligners if the patient's treatment [removed: is not tracking against] [added: deviates from] the original treatment plan.

The number [added: and timing] of additional aligner orders [removed: and timing] are subject to certain requirements noted in our terms and conditions.

*Invisalign [removed: Comprehensive*.][added: Comprehensive Packages*.]

It also addresses the [added: frequently complex] orthodontic needs of teenage [removed: patients,] [added: or younger patients with advanced features] such as [removed: Mandibular Advancement,] [added: mandibular advancement,] compliance indicators and compensation for tooth eruption.

*Invisalign First Phase 1 and Invisalign First Comprehensive Phase 2 [removed: Package*.][added: Packages*.]

Our goal is to establish clear aligners as the principal solution for the treatment of malocclusions and our Invisalign System as the treatment solution of choice by orthodontists, general dental practitioners and patients globally.

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

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

We acquired exocad for its expertise in restorative dentistry, implantology, guided surgery, and smile design to extend the Invisalign System and iTero digital solutions and pave the way for new, cross-disciplinary dentistry in labs and at chairside.

exocad now has over 200 partners and more than 40,000 software licenses installed worldwide.

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

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

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

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

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

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

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

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

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

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

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

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These packages include Invisalign Comprehensive, Invisalign First Phase 1 and Invisalign First Comprehensive Phase 2.

These treatment packages include Invisalign Express, Lite, Go, Go Plus and Moderate.

Retainers are generally available for doctors to offer to any of their patients, whether they use the Invisalign System or other products, including wires and brackets.

In October 2020, we introduced Invisalign G8 with SmartForce Aligner Activation; a clear aligner biomechanical innovation that allows doctors to more predictably treat crowding, crossbite and deep bite cases through the targeted application of force to teeth through surface contours on the aligners that help control the location, direction and intensity of tooth movement.

Systems and Services Segment

Beginning patient care with the early usage of our iTero intraoral scanners and combining the results with digital workflows designed to assist doctors and patients visualize and evaluate various treatment options with detailed imagery and CAD/CAM solutions is helping improve treatments, outcomes and satisfaction.

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

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

*Orthodontic software for iTero.

*CAD/CAM Services.* The acquisition of exocad’s CAD/CAM software in April 2020 broadens Align’s digital platform reach by adding technology that addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-restorative and comprehensive dentistry.

exocad software is licensed and sold separately.

*TimeLapse Technology.

Our iTero Element scanners are offered in a number of software configurations such as Ortho Comprehensive, Restorative Comprehensive and Restorative Foundation.

These software packages are included in the price of the system.

They enable various orthodontic and restorative workflows as well as provide other applications, including Invisalign Outcome Simulator, Invisalign Case Assessment tool, Invisalign Progress Assessment tool, and iTero TimeLapse technology.

*International Expansion.* We continue increasing our presence globally by making our products available in more countries to more consumers.

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

We expect to continue expanding our business by investing in resources, infrastructure, and initiatives that will drive Invisalign treatment growth in our current and new international markets.

As our core

international countries continue to grow in both number of new Invisalign trained doctors and customer utilization, we strive to make sure we can support that growth through investments such as headcount, clinical support, product improvements, technological innovations, education and advertising.

For instance, primarily for the China and APAC markets we now fabricate our clear aligners in Ziyang, China and perform digital treatment planning and interpretation for restorative cases worldwide, including in Costa Rica, China, Germany, Spain, Poland, and Japan among others.

By establishing and expanding our key operational activities in locations closer to our customers, we have created an infrastructure that allows us to be responsive and flexible to more than 195,000 customers in approximately 100 countries, while providing operational flexibility and scale needed for variations in demand.

Align Technology was founded in March 1997 and incorporated in Delaware in April 1997.

Our corporate headquarters is located at 2820 Orchard Parkway, San Jose, California, U.S.A., 95134, and our telephone number is 408-470-1000.

The Invisalign System is sold primarily through a direct sales force in North America, APAC, Europe, EMEA and Latin America ("LATAM").

Scanners and computer-aided design/computer-aided manufacturing ("CAD/CAM") services are primarily

In addition, we sell iTero scanners and CAD/CAM services directly to DSOs.

We continue to introduce enhanced features across the Invisalign System to improve treatment outcomes or address broader clinical indications.

For example, in 2018, we extended the Invisalign product family with Invisalign First clear aligners, designed with features specifically for younger patients with early mixed dentition (with a mixture of primary/baby and permanent teeth).

In 2018, we also introduced enhancements designed to improve dental professional and patient experiences and clinical outcomes including: wing overlap and engagement in deep bite cases with anterior intrusion, new options for mandibular advancement and symmetrical advancement of the left and right side, a new default protocol for incremental advancement, and improvements to support leveling the curve of Spee in deep bite cases.

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Invisalign First clear aligners are designed specifically to address a broad range of younger patients' malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion.

Vivera Retainers are available to both Invisalign and non-Invisalign patients.

Scanner Segment

We also continue to offer the existing iTero Element scanner in existing markets.

In June 2019, we announced the launch of iTero Element Foundation intraoral scanner with restorative software.

The iTero Element Foundation extends our portfolio of intraoral scanners with powerful 3D visualization to better meet the needs of doctors, labs and patients.

The iTero Element Foundation is available in North America and Japan and will be available in other select APAC and EMEA countries in 2020.

iTero prosthetics have a near-zero remake rate.

This allows doctors to visually assess and communicate Invisalign treatment progress with an easy to read, color-coded tooth movement report.

Our iTero Element, iTero Element 2, iTero Element Flex and iTero Element 5D scanners include the Invisalign Outcome Simulator, Invisalign 3D Assessment tool and Timelapse as well as the orthodontic software and/or restorative software.

The orthodontic or restorative software may also be purchased subsequently for an upgrade fee.

Additional applications such as the Invisalign Outcome Simulator are not available for sale separately.

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| --- | --- |

| 1. | *International Expansion.* In order to provide the millions of consumers access to a better smile, we continue increasing our presence globally by making our products available in more countries. We expect to continue expanding our business by investing in resources, infrastructure, and initiatives that will drive Invisalign treatment growth in our current and new international markets. As our core international countries continue to grow in both number of new Invisalign trained doctors and customer utilization, we strive to make sure we can support that growth through investments such as headcount, clinical support, product improvements, education and advertising. We have transitioned most of our smaller country markets from an indirect to a direct sales model, and, while we do not expect a material impact from these countries for |

some time, in the near term we will leverage our existing infrastructure in adjacent country markets as we build local sales and support organizations to drive long-term market penetration.

In 2019, we opened a new order acquisition and treatment facility in Wroclaw, Poland and a new treatment planning facility in Yokohama, Japan to support customers within these regions.

| 2. | *GP Adoption.* We want to enable GPs, who have access to a large patient base, to more easily identify Invisalign cases they can treat, monitor patient progress or, if needed, help refer cases to an orthodontist while providing high-quality restorative, orthodontic, and dental hygiene care. In 2019, we continued to commercialize Invisalign Go, a simplified and streamlined solution designed for GPs and trained over 3,700 new Invisalign Go doctors primarily in EMEA. In the EMEA region, we segmented sales and marketing for certain country markets into two separate organizations to serve each customer segment, orthodontists and GP dentists separately, thereby increasing our focus and effectiveness on GP dentists. The iTero scanner is an important component to that customer experience and is central to a digital approach as well as overall customer utilization of Invisalign treatment. The iTero scanner is optimized for Invisalign treatment with the Invisalign Outcome Simulator, Invisalign Progress Assessment tool, and TimeLapse technology. This highlights areas of diagnostic interest to dental professionals and helps foster a proactive conversation with the patient regarding potential restorative or orthodontic solutions. In March 2019, we began a collaboration with Digital Smile Design to deliver dedicated education programs, enable simplified, streamlined integration of digital end-to-end workflows into GPs' practices and offer doctors more opportunities to learn about digital tools and treatment planning support. In September 2019, we formed a collaboration with Zimmer Biomet Dental to leverage their extensive direct global salesforce and network of dental clinicians and laboratories to help drive further penetration of iTero scanners and services in the growing digital restorative market. The collaboration also offers Zimmer Biomet Dental customers access to Invisalign clear aligners through the iTero platform to facilitate a comprehensive interdisciplinary treatment approach. |

| *3.* | *Patient Demand & Conversion.* Our goal is to make Invisalign a highly recognized name brand worldwide by creating awareness for Invisalign treatment among consumers and motivating potential patients to seek Invisalign treatment. We accomplish this objective through an integrated consumer marketing strategy that includes television, media, social networking and event marketing and strategic alliances with professional sports teams as well as educating patients on treatment options and directing them to high volume Invisalign doctors. In January 2019, we expanded our Smile Concierge program which educates consumers on the benefits of Invisalign treatment, answers their questions and helps them schedule an appointment with an Invisalign doctor. The program simultaneously helps doctors better engage with prospective customers through more detailed customer insights. Additionally, in August 2019, we significantly increased our investment in consumer marketing in the U.S. The U.S. campaign was launched across all key media channels to over 140 million consumers, combining a robust paid media strategy across prime broadcast, cable and connected TV channels with paid search and social media. |

In the fourth quarter of 2018, we also began fabricating our aligners in Ziyang, China, our first aligner fabrication facility outside of Juarez, Mexico.

Our Invisalign digital treatment planning and interpretation for iTero restorative cases are conducted at our facilities located in San Jose, Costa Rica, Chengdu, China, Cologne, Germany, Madrid, Spain, Wroclaw, Poland and Yokohama, Japan.

We maintain single supply relationships for many of these machines and materials technologies.

The need to replace one of our single source suppliers could cause a disruption in our ability to timely deliver certain of our products or increase costs.

In the EMEA region, we segmented sales and marketing for certain country markets into two separate organizations to serve each customer segment, orthodontists and GP dentists separately, thereby increasing our focus and effectiveness on GP dentists.

We cannot be certain that patents will be issued as a result of any patent application or that patents that have been issued to us or that may be issued in the future will remain valid and enforceable or sufficient to protect our technology or products.

Our intellectual property rights may not be successfully asserted in the future or may be invalidated, circumvented or challenged.

In addition, the laws of various foreign countries do not protect our intellectual property rights to the same extent as U.S. laws.

Our inability to protect our proprietary information could harm our business.

Information

Backlog

*For a discussion of legal proceedings, refer to Note [removed: 9] [added: 10] "Legal Proceedings" of the Notes to [removed: the] Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.*

[removed: FORM 10-K][added: FORM 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the fiscal year [removed: ended December] [added: ended December] 31, [removed: 2019][added: 2020]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

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

| Delaware | [added: | |] 94-3267295 | [added: | |]

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

[removed: (408) 470-1000][added: (408) 470-1000]

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

| Common Stock, $0.0001 par value | [added: | |] ALGN | [added: | |] The NASDAQ Stock Market [removed: LLC (NASDAQ Global Market)] [added: LLC] | [added: | |]

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, [removed: or] a smaller reporting [added: company, or an emerging growth] company.

See definitions of “large accelerated filer,” “accelerated filer,” [removed: and] “smaller reporting [removed: company”] [added: company,” and "emerging growth company"] in Rule 12b-2 of the Exchange Act.

| Large accelerated filer | [added: | |] ☒ | [added: | |] Accelerated filer | [added: | |] ☐ | [added: | |]

| Non-accelerated filer | [added: | |] ☐ | [added: | |] Smaller reporting company | [added: | |] ☐ | [added: | |]

| [added: | | | | | |] Emerging growth company | [added: | |] ☐ | | |

| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. [added: ☐] | | | | [added: | | | | | | | |]

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $15.9] [added: $14.5] billion as of June [removed: 28, 2019] [added: 30, 2020] based on the closing sale price of the registrant’s common stock on the NASDAQ Global Market on such date.

On February [removed: 21, 2020, 78,753,161] [added: 22, 2021, 79,132,723] shares of the registrant’s common stock were outstanding.

Portions of the registrant’s definitive Proxy Statement relating to its [removed: 2020] [added: 2021] Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end of December 31, [removed: 2019] [added: 2020] are incorporated by reference into Part III of this Annual Report on Form 10-K.

For the Year [removed: Ended December] [added: Ended December] 31, [removed: 2019][added: 2020]

| | | [added: | | | |] Page | [added: | |]

| Item 1. | [added: | |] Business | [removed: [3](#s4DD015EE7579569E987F82CA3A435E70)] | [added: | [3](#i36420fe7c39c4c91ac8d2d223148c9b1_13) | | |]

| | [added: | |] Executive Officers of the Registrant | [removed: [12](#s1A0668F0CF0B53ED9178E2F04E262510)] | [added: | [14](#i36420fe7c39c4c91ac8d2d223148c9b1_16) | | |]

| Item 1A. | [added: | |] Risk Factors | [removed: [13](#s1708C69ADE3F5FC398E808452814D0F8)] | [added: | [14](#i36420fe7c39c4c91ac8d2d223148c9b1_19) | | |]

| Item 1B. | [added: | |] Unresolved Staff Comments | [removed: [27](#s23520069AC775DBBA6E740A6C8374F53)] | [added: | [32](#i36420fe7c39c4c91ac8d2d223148c9b1_22) | | |]

| Item 2. | [added: | |] Properties | [removed: [27](#s09006CEE019F5C2D9F5F1C5E8472740E)] | [added: | [32](#i36420fe7c39c4c91ac8d2d223148c9b1_25) | | |]

| Item 3. | [added: | |] Legal Proceedings | [removed: [27](#sD278042355EE556D95E5AE3AB9EC8EB7)] | [added: | [32](#i36420fe7c39c4c91ac8d2d223148c9b1_28) | | |]

| Item 4. | [added: | |] Mine Safety Disclosures | [removed: [27](#s51B8432A1AA950E683C38D9427B3AB1B)] | [added: | [32](#i36420fe7c39c4c91ac8d2d223148c9b1_31) | | |]

| Item 5. | [added: | |] Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | [removed: [28](#sBAAD9D9DE82A57C7BFFB737DE57EB736)] | [added: | [33](#i36420fe7c39c4c91ac8d2d223148c9b1_37) | | |]

| Item 6. | [added: | |] Selected Consolidated Financial Data | [removed: [29](#sF0E4AABCB14855409AFD7CF0A66E8770)] | [added: | [34](#i36420fe7c39c4c91ac8d2d223148c9b1_40) | | |]

| Item 7. | [added: | |] Management’s Discussion and Analysis of Financial Condition and Results of Operations | [removed: [30](#s6733F4BB6FF65F13B6CE3E01F7E16DE5)] | [added: | [34](#i36420fe7c39c4c91ac8d2d223148c9b1_43) | | |]

| Item 7A. | [added: | |] Quantitative and Qualitative Disclosures About Market Risk | [removed: [44](#s92BF377AD00F562085536CA3100C0A65)] | [added: | [50](#i36420fe7c39c4c91ac8d2d223148c9b1_82) | | |]

| Item 8. | [added: | |] Consolidated Financial Statements and Supplementary Data | [removed: [45](#s6CD8093961A85CEF81930B18F3439481)] | [added: | [52](#i36420fe7c39c4c91ac8d2d223148c9b1_85) | | |]

| Item 9. | [added: | |] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | [removed: [86](#s9E39C1D21D065889BF11F3EC430921B9)] | [added: | [93](#i36420fe7c39c4c91ac8d2d223148c9b1_181) | | |]

| Item 9A. | [added: | |] Controls and Procedures | [removed: [87](#sCB32B0416E9A5534860C806BB6F09E0B)] | [added: | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_184) | | |]

| Item 9B. | [added: | |] Other Information | [removed: [87](#s1022975927AC553892449702A36F81AA)] | [added: | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_187) | | |]

| [PART [removed: III](#s17416F2FC85750E28A6113D99ACE4B9E)] [added: III](#i36420fe7c39c4c91ac8d2d223148c9b1_190)] | | [removed: [87](#s17416F2FC85750E28A6113D99ACE4B9E)] | [added: | | | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_190) | | |]

| Item 10. | [added: | |] Directors, Executive Officers and Corporate Governance | [removed: [87](#sFCDC7579446A5FF3861A296ED83DEC9D)] | [added: | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_193) | | |]

| Item 11. | [added: | |] Executive Compensation | [removed: [87](#s6AFB323C5D545CAA93F9176F410513AA)] | [added: | [94](#i36420fe7c39c4c91ac8d2d223148c9b1_196) | | |]

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________________________________________________________________________

________________________________________________________________________

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

410 North Scottsdale Road, Suite 1300

Tempe, Arizona 85281

________________________________________________________________________

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

| | | | | | | (NASDAQ Global Market) | | |

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Indicate by check mark whether the Registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

| | | | | | | | | |

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

| | | | | | | | | |

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

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

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

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

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

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| --- | --- |

_______________________________________________________

_____________________________________________________________________

2820 Orchard Parkway

San Jose, California 95134

______________________________________________________

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

None

| | | | |

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

| [PART I](#s5F3BC1614577553580EC6BEEF2E1BF4A) | | [3](#s5F3BC1614577553580EC6BEEF2E1BF4A) |

| [PART II](#s12ECE38888BB5687B38D8FC5DF573B2B) | | [28](#s12ECE38888BB5687B38D8FC5DF573B2B) |

| [PART IV](#s947EAB1FA789594085F040AA9CC72BE1) | | [89](#s947EAB1FA789594085F040AA9CC72BE1) |

| Signatures | | [92](#s86DEB2CB8A345F0D942D58EB8582C3A2) |

These statements include, among other things, our estimates concerning the number of people who can benefit from our products, expectations regarding the anticipated impact of our new products and product enhancements will have on the future of dentistry, doctor utilization and our market share, our beliefs regarding our technology development and the advantages of our intellectual property portfolio, our beliefs concerning our compliance with domestic and foreign laws and regulations, including data protection and security, our expectations regarding geographic and product mix and product adoption, our expectations for domestic and international growth, our expectations regarding the existence and impact of seasonality, our expectations regarding the sales growth of our iTero scanners, their utilization and the potential growth opportunities iTero scanners represent to our overall business, our beliefs concerning the manufacturing capabilities and expectations regarding the financial and strategic benefits of establishing regional order acquisition, treatment planning and manufacturing facilities, our expectations for competition, our expectations concerning the impact of the Novel Coronavirus on our sales and operating results, our intention to hire more sales representatives and their expected impact on our sales, our expectations regarding the continued expansion of our domestic and international markets including related infrastructure and staffing, our expectations related to our corporate structure reorganization, the level of our operating expenses, capital expenditures and gross margins, our intentions regarding earnings from international operations, our beliefs concerning our investment portfolio and the funding of our operations and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.

At December 31, [removed: 2019,] [added: 2020,] the significant facilities occupied were as follows:

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

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

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

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

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

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

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

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

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

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

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

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

As of February [removed: 21, 2020,] [added: 22, 2021,] there were approximately [removed: 70] [added: 57] holders of record of our common stock.

The graph below matches our cumulative 5-year total stockholder return on common stock with the cumulative total returns of the NASDAQ Composite index, the S&P 500 [added: index] and the S&P 1500 Composite Health Care Equipment & Supplies index.

The graph tracks the performance of a $100 investment in our common [removed: stock, in the peer group,] [added: stock] and [removed: the] [added: each] index (with the reinvestment of all dividends) from December 31, [removed: 2014] [added: 2015] to December 31, [removed: 2019.][added: 2020.]

[removed: ][added: ]

[removed: Following is a summary of] [added: There were no] stock repurchases [removed: for] [added: during] the three months ended December 31, [removed: 2019:][added: 2020.]

[removed: | 1 | In November 2019, we repurchased $100.5 million of our common stock on the open market.] As of December 31, [removed: 2019,] [added: 2020,] we have $100.0 million available for repurchase under the $600.0 million repurchase program authorized by our Board of Directors in May 2018 (Refer to *Note [removed: 12] [added: 13] “Common Stock Repurchase Programs” of the Notes to Consolidated Financial [removed: Statements*). |][added: Statements* for details on our stock repurchase program).]

Securities Authorized for Issuance under Equity Compensation Plans

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

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

| October 1, 2019 through October 31, 2019 | | — | | | $ | — | | | — | | | $ | 200,500,000 | |

| November 1, 2019 through November 30, 2019 | | 388,510 | | | $ | 258.67 | | | 388,510 | | | $ | 100,000,000 | |

| December 1, 2019 through December 31, 2019 | | — | | | $ | — | | | — | | | $ | 100,000,000 | |

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| --- | --- |

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

The following selected consolidated financial data should be read in conjunction with the consolidated financial statements and accompanying notes and *Management’s Discussion and Analysis of Financial Condition and Results of Operations*.

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

| | Fiscal Year | | | | | | | | | | | | | | | | | | |

| | 2019 | | | | 2018 | | | | 2017 2 | | | | 2016 2 | | | | 2015 | | |

| | (in thousands, except per share data) | | | | | | | | | | | | | | | | | | |

| Statement of Operations Data: | | | | | | | | | | | | | | | | | | | |

| Net revenues | $ | 2,406,796 | | | $ | 1,966,492 | | | $ | 1,473,413 | | | $ | 1,079,874 | | | $ | 845,486 | |

| Gross profit | 1,743,897 | | | | 1,447,867 | | | | 1,116,947 | | | | 815,294 | | | | 640,110 | | |

| Income from operations | 542,493 | | | | 466,564 | | | | 353,611 | | | | 248,921 | | | | 188,634 | | |

| Interest income | 12,482 | | | | 8,576 | | | | 6,948 | | | | 4,213 | | | | 2,938 | | |

| Other income (expense), net | 7,676 | | | | (8,489 | | ) | | 4,240 | | | | (10,568 | | ) | | (5,471 | | ) |

| Net income before provision for income taxes and equity in losses of investee | 562,651 | | | | 466,651 | | | | 364,799 | | | | 242,566 | | | | 186,101 | | |

| Provision for income taxes | 112,347 | | | | 57,723 | | | | 130,162 | | | | 51,200 | | | | 42,081 | | |

| Equity in losses of investee, net of tax | 7,528 | | | | 8,693 | | | | 3,219 | | | | 1,684 | | | | — | | |

| Net income | $ | 442,776 | | | $ | 400,235 | | | $ | 231,418 | | | $ | 189,682 | | | $ | 144,020 | |

| Net income per share: | | | | | | | | | | | | | | | | | | | |

| Basic | $ | 5.57 | | | $ | 5.00 | | | $ | 2.89 | | | $ | 2.38 | | | $ | 1.80 | |

| Diluted | $ | 5.53 | | | $ | 4.92 | | | $ | 2.83 | | | $ | 2.33 | | | $ | 1.77 | |

| Shares used in computing net income per share: | | | | | | | | | | | | | | | | | | | |

| Basic | 79,424 | | | | 80,064 | | | | 80,085 | | | | 79,856 | | | | 79,998 | | |

| Diluted | 80,100 | | | | 81,357 | | | | 81,832 | | | | 81,484 | | | | 81,521 | | |

| Financial Position Data: | | | | | | | | | | | | | | | | | | | |

| Working capital 1 | $ | 662,449 | | | $ | 610,406 | | | $ | 658,316 | | | $ | 597,772 | | | $ | 460,338 | |

| Total assets | 2,500,702 | | | | 2,052,458 | | | | 1,784,009 | | | | 1,402,305 | | | | 1,158,633 | | |

| Total long-term liabilities | 183,563 | | | | 107,494 | | | | 129,670 | | | | 46,427 | | | | 39,035 | | |

| Stockholders’ equity | $ | 1,346,169 | | | $ | 1,252,891 | | | $ | 1,154,288 | | | $ | 999,307 | | | $ | 847,926 | |

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| --- | --- |

| 1 | Working capital is calculated as the difference between total current assets and total current liabilities. |

| 2 | Balances have been recast to reflect the adoption of ASC 606. We recognized a $3.9 million cumulative effect upon adoption as an adjustment to our opening balance of retained earnings as of January 1, 2016 in our Consolidated Statements of Stockholders’ Equity. Refer to *Note 1 "Summary of Significant Accounting Policies" of the Notes to Consolidated Financial Statements* for details). |

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

| Net income per share: | | | | | | | | | | | | | | | | | | | | | [removed: | | | | | | | | | | |]

| Shares used in computing net income per share: | | | | | | | | | | | | | | | | | | | | | [removed: | | | | | | | | | | |]

| | [added: | |] Page | [added: | |]

| Report of Management on Internal Control over Financial Reporting | [removed: [47](#sBAF16E41BD50523CBA2DF2CDB168A1BC)] | [added: | [53](#i36420fe7c39c4c91ac8d2d223148c9b1_91) | | |]

| Report of Independent Registered Public Accounting Firm | [removed: [48](#sAE5974153B6A593EA99503AA3F90FBBA)] | [added: | [54](#i36420fe7c39c4c91ac8d2d223148c9b1_94) | | |]

| Consolidated Statements of Operations for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [50](#sDFAB7D29993258FFB48031ACD41FE96E)] | [added: | [57](#i36420fe7c39c4c91ac8d2d223148c9b1_97) | | |]

| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [51](#s44E9FFE3DA3D58DE80D7B405E291B658)] | [added: | [58](#i36420fe7c39c4c91ac8d2d223148c9b1_100) | | |]

| Consolidated Balance Sheets as of December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] | [removed: [52](#s2574B6FB8E105915877D73795C8A679A)] | [added: | [59](#i36420fe7c39c4c91ac8d2d223148c9b1_103) | | |]

| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [53](#s0BD901995D5559179456FF673A6DA098)] | [added: | [60](#i36420fe7c39c4c91ac8d2d223148c9b1_109) | | |]

| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [54](#s079DD1C1F99154399B1EA2AF69BC561B)] | [added: | [61](#i36420fe7c39c4c91ac8d2d223148c9b1_112) | | |]

| Notes to Consolidated Financial Statements | [removed: [55](#sF245520E109152DFAACDDC565AD63338)] | [added: | [62](#i36420fe7c39c4c91ac8d2d223148c9b1_115) | | |]

[removed: | • |] [added: -] pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Align; [removed: |]

[removed: | • |] [added: -] provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of Align are being made only in accordance with authorizations of management and directors of Align; and [removed: |]

[removed: | • |] [added: -] provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of [removed: Align's] [added: Align’s] assets that could have a material effect on the financial statements. [removed: |]

Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2019.][added: 2020.]

Based on our assessment, management has concluded that, as of December 31, [removed: 2019,] [added: 2020,] our internal control over financial reporting was effective based on criteria in *Internal Control - Integrated Framework (2013) issued by the COSO*.

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2019] [added: 2020] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.

| /S/ JOSEPH M. HOGAN | [added: | |]

| Joseph M. Hogan | [added: | |]

| President and Chief Executive Officer | [added: | |]

| /S/ JOHN F. MORICI | [added: | |]

| John F. Morici | [added: | |]

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

We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the “Company”) as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the related consolidated statements of operations, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2019,] [added: 2020,] including the related notes and financial statement schedule listed in the index appearing under [removed: item] [added: 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: 2019,] [added: 2020,] 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2019] [added: 2020] 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: 2019,] [added: 2020,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the [removed: company; and (iii) provide]

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

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

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

*Revenue Recognition [removed: -] [added: –] Determination of Standalone Selling Price of Distinct Performance Obligations in Clear Aligner Contracts*

As described in Notes 1 and [removed: 17] [added: 18] to the consolidated financial statements, the Company recognized net revenues of [removed: $2] [added: $2.1] billion from its Clear Aligner segment for the year ended December 31, [removed: 2019.][added: 2020.]

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

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

The principal considerations for our determination that performing procedures related to revenue recognition and the determination of standalone selling price of distinct performance obligations in Clear Aligner contracts is a critical audit matter are [removed: there was] [added: the] significant judgment by management in determining the [added: estimate of] standalone selling price, which includes significant assumptions related to usage rates for each distinct performance obligation.

This in turn led to significant [added: auditor] judgment, subjectivity, and effort in [removed: applying audit] [added: performing] procedures to evaluate [removed: the judgments made by management in determining] [added: management’s determination of] the estimates of standalone selling price and usage rates for each distinct performance obligation.

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

| | [added: | | | | |] Year Ended December 31, | | | | | | | | | | | [added: | | | |]

| | | |

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

| | | |

| February 26, 2021 | | |

| | | |

| | | |

| February 26, 2021 | | |

*Deferred Tax Asset – Valuation of Intellectual Property Rights*

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

February 26, 2021

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

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

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

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

| Interest income and other income (expense), net: | | | | | | | | | | | | | | | | | | | | |

| Total interest income and other income (expense), net | | | | | | (8,222) | | | | | | 20,158 | | | | | | 87 | | |

Quarterly Results of Operations

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

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

| | Three Months Ended | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | December 31, 2019 | | | | September 30, 2019 | | | | June 30, 2019 | | | | March 31, 2019 | | | | December 31, 2018 | | | | September 30, 2018 | | | | June 30, 2018 | | | | March 31, 2018 | | |

| | (in thousands, except per share data) (unaudited ) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Net revenues | $ | 649,787 | | | $ | 607,341 | | | $ | 600,697 | | | $ | 548,971 | | | $ | 534,020 | | | $ | 505,289 | | | $ | 490,259 | | | $ | 436,924 | |

| Gross profit | 471,958 | | | | 437,554 | | | | 432,289 | | | | 402,096 | | | | 383,096 | | | | 371,781 | | | | 365,582 | | | | 327,408 | | |

| Income from operations | 151,150 | | | | 127,152 | | | | 176,490 | | | | 87,701 | | | | 120,473 | | | | 125,208 | | | | 122,691 | | | | 98,192 | | |

| Net income | 121,262 | | | | 102,524 | | | | 147,142 | | | | 71,848 | | | | 97,392 | | | | 100,872 | | | | 106,105 | | | | 95,866 | | |

| Basic | $ | 1.54 | | | $ | 1.29 | | | $ | 1.84 | | | $ | 0.90 | | | $ | 1.22 | | | $ | 1.26 | | | $ | 1.32 | | | $ | 1.20 | |

| Diluted | $ | 1.53 | | | $ | 1.28 | | | $ | 1.83 | | | $ | 0.89 | | | $ | 1.20 | | | $ | 1.24 | | | $ | 1.30 | | | $ | 1.17 | |

| Basic | 78,578 | | | | 79,332 | | | | 79,943 | | | | 79,860 | | | | 79,891 | | | | 80,111 | | | | 80,216 | | | | 80,036 | | |

| Diluted | 79,137 | | | | 79,825 | | | | 80,590 | | | | 80,687 | | | | 80,943 | | | | 81,359 | | | | 81,471 | | | | 81,628 | | |

| | |

| --- | --- |

| |

| --- |

| February 28, 2020 |

February 28, 2020

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

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

| Shares used in computing net income per share: | | | | | | | | | | | |

| | | | | | | | |

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

| Equity method investments | — | | | | 45,913 | | |

| Goodwill and intangible assets, net | 75,692 | | | | 81,949 | | |

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

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

| Balances at December 31, 2016 | 79,553 | | | $ | 8 | | | $ | 864,871 | | | $ | (938 | ) | | $ | 135,366 | | | $ | 999,307 | |

| Cumulative effect adjustment from adoption of ASU 2016-16 | — | | | — | | | | — | | | | — | | | | (1,300 | | ) | | (1,300 | | ) |

| Net income | — | | | — | | | | — | | | | — | | | | 231,418 | | | | 231,418 | | |

| Common stock repurchased and retired | (586 | ) | | — | | | | (5,583 | | ) | | — | | | | (98,210 | | ) | | (103,793 | | ) |

| Purchases of investments in privately held companies | — | | | | (5,000 | | ) | | (12,764 | | ) |

| Loan repayment from equity investee | — | | | | 30,000 | | | | 6,000 | | |

We are headquartered in San Jose, California with offices worldwide.

During fiscal year 2018, we adopted Accounting Standards Codification (“ASC”) 606, “*Revenues from Contracts with Customers,*” using the full retrospective method and ASU 2016-18, “*Statement of Cash Flows - Restricted Cash,*” on a retrospective basis.

The Consolidated Statement of Cash Flow for the year ended December 31, 2017 and Consolidated Statement of Stockholders' Equity for the year ended December 31, 2017 have been recast to comply with the adoption of these standards.

Derivative Financial Instruments

In the fourth quarter of 2018, we also began fabricating our aligners in our manufacturing facility in Ziyang, China, our first aligner fabrication facility outside of Juarez, Mexico.

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: 2019] [added: 2020] 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: 2019] [added: 2020] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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

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

The following table provides information as of December 31, [removed: 2019] [added: 2020] about our common stock that may be issued upon the exercise of options and awards granted to employees, consultants or members of our Board of Directors under all existing equity compensation plans, including the 2005 Incentive Plan and the Employee Stock Purchase Plan ("ESPP"), each as amended, and certain individual arrangements (Refer to *Note [removed: 11] [added: 12] "Stockholders’ Equity” of the Notes to Consolidated Financial Statements* for a description of our equity compensation plans).

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

| Equity compensation plans [added: not] approved by security holders | | [removed: 939,539] | | [removed: 1] | [removed: $] | — | | | [removed: 5,450,153] | | [removed: 2, 3] | [added: — | | | | | | — | | | | | |]

| Equity compensation plans [removed: not] approved by security holders | | [removed: —] | | | [removed: —] | [added: 859,149] | | | [added: 1 | | | $ |] — | | | [added: | | 4,950,369 | | | 2, 3 | | |]

[removed: | 2 | Includes 441,293 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. [removed: |]

[removed: |] 3 [removed: |] Includes [removed: 653,854] [added: 688,590] of potentially issuable MSUs if performance targets are achieved at maximum [removed: payout. |][added: payout]

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

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

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

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

2 Includes 325,665 shares available for issuance under our ESPP.

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

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

| Total | | 939,539 | | | $ | — | | | 5,450,153 | | |

| | |

| --- | --- |

| 1 | Includes 695,650 restricted stock units and 243,889 market-performance based restricted stock units at target, which have an exercise price of zero. |

[removed: | (a) | Financial] [added: (a)Financial] Statements [removed: |]

| [removed: 1. |] [added: Notes to] Consolidated [removed: financial statements] [added: Financial Statements] | [added: | | [62](#i36420fe7c39c4c91ac8d2d223148c9b1_115) | | |]

| Report of Independent Registered Public Accounting Firm | [removed: [48](#sAE5974153B6A593EA99503AA3F90FBBA)] | [added: | [54](#i36420fe7c39c4c91ac8d2d223148c9b1_94) | | |]

| Consolidated Statements of Operations for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [50](#sDFAB7D29993258FFB48031ACD41FE96E)] | [added: | [57](#i36420fe7c39c4c91ac8d2d223148c9b1_97) | | |]

| Consolidated Statements of Comprehensive Income for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [51](#s44E9FFE3DA3D58DE80D7B405E291B658)] | [added: | [58](#i36420fe7c39c4c91ac8d2d223148c9b1_100) | | |]

| Consolidated Balance Sheets as of December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] | [removed: [52](#s2574B6FB8E105915877D73795C8A679A)] | [added: | [59](#i36420fe7c39c4c91ac8d2d223148c9b1_103) | | |]

| Consolidated Statements of Stockholders’ Equity for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [53](#s0BD901995D5559179456FF673A6DA098)] | [added: | [60](#i36420fe7c39c4c91ac8d2d223148c9b1_109) | | |]

| Consolidated Statements of Cash Flows for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [54](#s079DD1C1F99154399B1EA2AF69BC561B)] | [added: | [61](#i36420fe7c39c4c91ac8d2d223148c9b1_112) | | |]

[removed: | 2. | The] [added: 2.The] following financial statement schedule is filed as part of this Annual Report on Form 10-K: [removed: |]

Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017][added: 2018]

| | [added: | | | | |] Balance [removed: at Beginning of] [added: at Beginning of] Period | | | | [removed: Additions (Reductions) to Costs and Expenses] | | [added: Additions (Reductions) to Costs and Expenses] | | [removed: Write Offs] | | | | [added: Write Offs | | | | | |] Balance [removed: at End] [added: at End] of Period | | |

| | [added: | | | | |] (in thousands) | | | | | | | | | | | | | | | [added: | | | | | |]

| Allowance for doubtful accounts: | | | | | | | | | | | | | | | | [added: | | | | | | | | | | |]

| Year Ended December 31, 2018 [added: 1] | [added: | | | | |] $ | 5,814 | | | [added: | |] $ | [removed: 12,321] [added: 870] | | | [added: | |] $ | [removed: (15,757] [added: (4,306)] | [removed: )] | | [added: | |] $ | 2,378 | |

| Year Ended December 31, 2019 [added: 1] | [added: | | | | |] $ | 2,378 | | | [added: | |] $ | [removed: 15,126] [added: 5,853] | | | [added: | |] $ | [removed: (10,748] [added: (1,475)] | [removed: )] | | [added: | |] $ | 6,756 | |

| Valuation allowance for deferred tax assets: | | | | | | | | | | | | | | | | [added: | | | | | | | | | | |]

| Year Ended December 31, [removed: 2017 1] [added: 2018] | [added: | | | | |] $ | [removed: 256] [added: 278] | | | [added: | |] $ | [removed: 22] [added: (27)] | | | [added: | |] $ | — | | | [added: | |] $ | [removed: 278] [added: 251] | |

| Year Ended December 31, [removed: 2018] [added: 2019] | [added: | | | | |] $ | [removed: 278] [added: 251] | | | [added: | |] $ | [removed: (27] [added: 835] | [removed: )] | | [added: | |] $ | — | | | [added: | |] $ | [removed: 251] [added: 1,086] | |

| Year Ended December 31, [removed: 2019] [added: 2020] | [added: | | | | |] $ | [removed: 251] [added: 1,086] | | | [added: | |] $ | [removed: 835] [added: 239] | | | [added: | |] $ | — | | | [added: | |] $ | [removed: 1,086] [added: 1,325] | |

[removed: | (b) | The] [added: (b)The] following Exhibits are included in this Annual Report on Form 10-K: [removed: |]

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

| [3.1](http://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt) | [added: | |] [Amended and Restated Certificate of Incorporation of registrant](http://www.sec.gov/Archives/edgar/data/1097149/000092735600002267/0000927356-00-002267-0002.txt) | [removed: Form] [added: | |] S-1, as amended (File No. 333-49932) | [added: | |] 12/28/2000 | [added: | |] 3.1 | | | [added: | | | | | |]

| [3.1A](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm) | [added: | |] [Certificate of Amendment to the Amended and Restated Certificate of Incorporation](http://www.sec.gov/Archives/edgar/data/1097149/000109714916000055/exhibit301.htm) | [removed: Form] [added: | |] 8-K | [added: | |] 5/20/2016 | [added: | |] 3.01 | | | [added: | | | | | |]

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

| [4.1](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt) | [added: | |] [Form of Specimen Common Stock Certificate](http://www.sec.gov/Archives/edgar/data/1097149/000092962401000049/0000929624-01-000049-0002.txt) | [removed: Form] [added: | |] S-1, as amended (File No. 333-49932) | [added: | |] 1/17/2001 | [added: | |] 4.1 | | | [added: | | | | | |]

| [removed: [4.2](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm)] [added: [4.2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm)] | [added: | |] [Description of the Capital Stock of [removed: registrant](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm)] [added: registrant](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex42-20191231.htm)] | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 4.2 | | | | | | | | |]

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

| [removed: [10.2†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex101-20161231.htm)] [added: [10.2†](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm)] | [added: | |] [Registrant's 2005 Incentive Plan (as amended May [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex101-20161231.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714921000007/ex102-20201231.htm)] | [removed: Form 10-K] | [removed: 2/28/2017] | [removed: 10.1] | | | [added: | | | | | | | | | * | | |]

| [removed: [10.3†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] [added: [10.3†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] | [added: | |] [Form of RSU agreement under Registrant's 2005 Incentive Plan (Officer Form for officers appointed after September [removed: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] [added: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103-20191231.htm)] | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.3 | | | | | | | | |]

| [removed: [10.3A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] [added: [10.3A†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] | [added: | |] [Form of RSU agreement under Registrant's 2005 Incentive Plan (Officer Form for officers appointed prior to September [removed: 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] [added: 2016)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex103a-20191231.htm)] | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.3A | | | | | | | | |]

| [removed: [10.4†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] [added: [10.4†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] | [added: | |] [Form of RSU agreement [removed: (CEO)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] [added: (CEO)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex104-20191231.htm)] | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.4 | | | | | | | | |]

| [removed: [10.5†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] [added: [10.5†](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] | [added: | |] [Form of RSU agreement under Registrant's 2005 Incentive Plan (Non-employee Director [removed: Form)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] [added: Form)](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex105-20191231.htm)] | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.5 | | | | | | | | |]

| [removed: [10.6†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex106-20191231.htm)] [added: [10.6†](https://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex106-20181231.htm)] | [added: | |] [Align 2019 Global RSU [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex106-20191231.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex106-20181231.htm)] | [removed: Form] [added: | |] 10-K | [added: | |] 2/28/2019 | [added: | |] 10.6 | | | [added: | | | | | |]

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

| [10.8†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | [added: | |] [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form [removed: for officers] [added: for](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [MSU awards](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [granted in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2018](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[, 2019 and](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[to](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm)[officers] appointed after September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108-20191231.htm) | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.8 | | | | | | | | |]

| [10.8A†](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) | [added: | |] [Form of Market Stock Unit Agreement under Registrant's 2005 Incentive Plan (Officer Form [removed: for officers] [added: for](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [MSU awards granted in](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [20](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[18, 2019 a](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[nd 2020](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [to](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) [](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm)[officers] appointed prior to September 2016)](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex108a-20191231.htm) | | | [added: 10-K] | | [removed: *] | [added: 2/28/2020 | | | 10.8A | | | | | | | | |]

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

| [removed: [10.10†](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)] [added: [10.1](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)[1](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm)] | [added: | |] [Form of Market Stock Unit Agreement for CEO Special MSU Award June 2018](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000025/exhibit-ceomsuagreement.htm) | [removed: Form] [added: | |] 8-K | [added: | |] 6/25/2018 | [added: | |] 10.1 | | | [added: | | | | | |]

| [removed: [10.11†](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)[2](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000110465908031394/a08-11459_1ex10d3.htm)] | [added: | |] [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) | [removed: Form] [added: | |] 10-Q | [added: | |] 5/8/2008 | [added: | |] 10.3 | | | [added: | | | | | |]

| [removed: [10.12†](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)[3](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)[†](http://www.sec.gov/Archives/edgar/data/1097149/000109714917000009/ex108-20161231.htm)] | [added: | |] [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) | [removed: Form] [added: | |] 10-K | [added: | |] 2/28/2017 | [added: | |] 10.8 | | | [added: | | | | | |]

1.Consolidated financial statements

| | | | | | |

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

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

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

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

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

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

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

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

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

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

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

| [10.18](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 | | | | | | | | |

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

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

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

| [10.2](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[1](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) | | | [Credit Agreement between Align Technology, Inc. and](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) [t](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[he lender](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[s party thereto from time to time and Citibank, N.A., as ad](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[minis](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[trative ag](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm)[ent, dated July 21, 2020](http://www.sec.gov/Archives/edgar/data/1097149/000109714920000052/align-20200920xex101.htm) | | | 10-Q | | | 10/30/2020 | | | 10.1 | | | | | | | | |

| 101.INS | | | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). | | | | | | | | | | | | | | | * | | |

| 104 | | | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | | | | | | | | | | | | | | | * | | |

| | | | | | |

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

| t | | | Furnished herewith | | |

| | |

| --- | --- |

| Notes to Consolidated Financial Statements | [55](#sF245520E109152DFAACDDC565AD63338) |

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

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

| Year Ended December 31, 2017 1 | $ | 2,946 | | | $ | 9,948 | | | $ | (7,080 | ) | | $ | 5,814 | |

| 1 | Balances have been recast to reflect the adoption of new revenue accounting standard (Refer to *Note 1 "Summary of Significant Accounting Policies" of the Notes to Consolidated Financial Statements* for details). |

| | | | | | | |

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

| [10.15](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex1015-20191231.htm) | [Letter of Assignment - Long Term International Agreement between Align Technology, Inc. and Zelko Relic dated December 9, 2019](https://www.sec.gov/Archives/edgar/data/1097149/000109714920000008/ex1015-20191231.htm) | | | | | * |

| [10.17†](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000006/item502fy2018bonusawardssa.htm) | [Summary of 2019 Incentive Awards and Base Salary for NEOs](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000006/item502fy2018bonusawardssa.htm) | Form 8-K | 1/31/2020 | | | |

| [10.20](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000007/algn20170227exhibit101.htm) | [Credit Agreement between Align Technology, Inc. and Wells Fargo Bank, National Association dated February 27, 2018](http://www.sec.gov/Archives/edgar/data/1097149/000109714918000007/algn20170227exhibit101.htm) | Form 8-K | 2/27/2018 | 10.1 | | |

| [10.21](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex104-20181231.htm) | [Purchase and Sale Agreement between Align Technology, Inc. and Slater Road I, LLC dated January 29, 2019](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000009/ex104-20181231.htm) | Form 10-K | 2/28/2019 | 10.4 | | |

| [10.22](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000022/algn-20190331xex101.htm) | [Purchase and Sale Agreement between Align Technology, Ltd., a subsidiary of Align Technology, Inc. and Ganei Ben Zvi Ltd and Ramat HaChayal Equities LLC dated January 15, 2019.](http://www.sec.gov/Archives/edgar/data/1097149/000109714919000022/algn-20190331xex101.htm) | Form 8-K | 1/23/2019 | 10.1 | | |

| 101.INS | XBRL Instance Document | | | | | * |

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly [removed: authorized, on February 28, 2020.][added: authorized.]

| ALIGN TECHNOLOGY, INC. | | [added: | | | |]

| By: | [added: | |] /S/ JOSEPH M. HOGAN | [added: | |]

| | [added: | |] Joseph M. Hogan | [added: | |]

| | [added: | |] President and Chief Executive Officer | [added: | |]

| Signature | | [added: | | | |] Title | | [added: | | | |] Date | [added: | |]

| /S/ JOSEPH M. HOGAN | | [added: | | | |] President and Chief Executive Officer (Principal Executive Officer) | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| Joseph M. Hogan | | | | | [added: | | | | | | | | | |]

| /S/ JOHN F. MORICI | | [added: | | | |] Chief Financial Officer and Senior Vice President, Global Finance (Principal Financial Officer and Principal Accounting Officer) | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| John F. Morici | | | | | [added: | | | | | | | | | |]

| /S/ KEVIN J. DALLAS | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| Kevin J. Dallas | | | | | [added: | | | | | | | | | |]

| /S/ JOSEPH LACOB | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| Joseph Lacob | | | | | [added: | | | | | | | | | |]

| /S/ C. RAYMOND LARKIN, JR. | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| C. Raymond Larkin, Jr. | | | | | [added: | | | | | | | | | |]

| /S/ GEORGE J. MORROW | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| George J. Morrow | | | | | [added: | | | | | | | | | |]

| /S/ ANNE M. MYONG | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]

| Anne [added: M.] Myong | | | | | [added: | | | | | | | | | |]

| /S/ THOMAS M. PRESCOTT | | [added: | | | |] Director | | [added: | | | |] February [removed: 28, 2020] [added: 26, 2021] | [added: | |]